Found 2,054 cases where Age is 12-or-more-and-under-18 and Location is U.S., Territories, or Unknown and Vaccine targets COVID-19 (COVID19 or COVID19-2) and Serious

Administered by: Senior Living       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen 160 mg/5 mL (5 mL) oral solution albuterol sulfate 2.5 mg/3 mL (0.083 %) solution for nebulization budesonide 0.5 mg/2 mL suspension for nebulization Certavite-Antioxidant 18 mg-400 mcg tablet ClearLax 17 gram/dose oral powder
Current Illness: Right lung atelectasis/infiltrate with right mediastinal shift on chest x-ray (12/25) that was treated with steroids and antibiotics
Preexisting Conditions: Chronic respiratory Failure Dependence on mechanical ventilation Seizure disorder Spastic quadriplegic cerebral palsy Encephalopathy
Allergies: NKA
Diagnostic Lab Data: 1/5/21 COVID PCR result: Positive
CDC Split Type:

Write-up: Administered first dose of COVID19 vaccine at 1:29pm on 1/4/21. At approximately 11:00pm resident exhibited acute respiratory decompensation with very limited air entry and hypoxemia. Patient received Benadryl, steroids, epinephrine, and Duoneb without improvement. Resident was referred to the emergency room and found to be COVID positive. No fever or rash were reported.

Administered by: Private       Purchased by: ?
Symptoms: Biopsy skin, Chills, Erythema, Headache, Pruritus, Rash papular, Scab, Skin discolouration, Skin lesion, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: prednisone, mercaptopurine, methotrexate, vincristine, trimethoprim-sulfamethoxazole, norethindrone, cholecalciferol, calcium carbonate, famotidine
Current Illness: currently undergoing chemotherapy for B cell acute lymphoblastic leukemia
Preexisting Conditions: B cell acute lymphoblastic leukemia
Allergies: shellfish and platelet blood products
Diagnostic Lab Data: Due to concern for reactivation of varicella zoster/disseminated varicella zoster, she was urgently biopsied by dermatology on 2/25/21 (result pending) and is currently receiving IV acyclovir.
CDC Split Type:

Write-up: 1. 48 hours after the first vaccine dose, she developed a raised, red, bump ~4-5cm area on her back with irregular borders. It was slightly itchy but not painful. 2. The area on her back worsened over the next 2-3 weeks and developed dark black scabs. 3. 24 hours after the second vaccine dose (which was given on 2/20/21), she developed scattered lesions on her neck, hairline, ear, face ? some with blisters, some with scabbed tops. Again slightly itchy but not painful. She also had a transient headache and chills that resolved on their own that same day.

Administered by: Public       Purchased by: ?
Symptoms: Off label use, Product administered to patient of inappropriate age, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Per MD''s note on patient''s chart on 2/26/21: Spoke with both the patient''s mother and father today. Patient is 16 and received Moderna vaccine. Both state''s current guidance and my correspondence with CDC indicate that she should receive 2nd dose of Moderna and not change to Pfizer. Patient does have a history of Rett Syndrome (rare neurologic genetic defect). Parents report 1 week after receiving Moderna vaccination, she experience her first seizure and was transported and treated at Hospital. Seizures can be a feature of this disorder but the patient had not experienced one in the past. Her parents report that her Neurologist does not believe the seizure to be related to vaccination. I informed parents I would search the VAERS system for similar reports. They were not enrolled in V-Safe, but I encouraged them to do so and gave them a link to the CDC site for registration. Correspondence with CDC (via email): "If the Moderna vaccine is inadvertently administered to patients 16 or 17 years old instead of Pfizer-BioNTech as the first dose, CDC currently recommends that the Moderna vaccine may be administered as the second dose (as off-label use). The second dose should be administered as close to the recommended interval as possible, 28 days for the Moderna vaccine. Additional information regarding administration errors and deviations can be found in CDC?s current interim clinical considerations regarding mRNA COVID-19 vaccines.

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood creatine phosphokinase MB increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Headache, Pericarditis, Pyrexia, Troponin T increased, Troponin increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), Noninfectious myocarditis/pericarditis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: obesity
Allergies: none
Diagnostic Lab Data: The patient was found to have significantly elevated Troponins and elevated CKMB. His troponin and CKMB down trended during his admission. Echocardiogram was performed to show no significant abnormalities. EKG changes noted were diffuse ST segment elevations, which persisted throughout his entire hospital stay. Troponin T Latest Ref Range: <=0.03 ng/mL 2/25/2021 03:33 : 2.54 (H) 2/25/2021 10:10 : 2.92 (H) 2/25/2021 17:55 : 3.38 (H) 2/26/2021 03:15 : 3.27 (H) 2/26/2021 10:15 : 2.57 (H) 2/26/2021 17:56 : 2.39 (H) 2/27/2021 02:00 : 2.01 (H) 2/27/2021 10:45: 2.02 (H) CKMB Latest Ref Range: 0.0 - 7.5 ng/mL 2/25/2021 03:33 - 123.4 (H) 2/25/2021 10:10 - 104.1 (H) 2/25/2021 17:55 - 63.7 (H) 2/26/2021 03:15 - 25.9 (H) 2/26/2021 10:15 - 17.3 (H) 2/26/2021 17:56 - 9.7 (H) 2/27/2021 02:00 - 5.8 2/27/2021 10:45 - 4.9 Echo 2/25 1. This was a technically difficult study, possibly affecting interpretation. 2. Normal segmental cardiac anatomy. 3. Normal right ventricular systolic shortening. 4. Left ventricular systolic function was low normal. 5. No evidence of elevated pulmonary artery pressure ECG 2/25 Normal sinus rhythm Low voltage QRS, consider pulmonary disease, pericardial effusion, or normal variant ST elevation consider inferolateral injury or acute infarct ** ** ACUTE MI / STEMI ** ** Abnormal ECG ECG: 2/26 Normal sinus rhythm Low voltage QRS, consider pulmonary disease, pericardial effusion, or normal variant ST elevation consider lateral injury or acute infarct ** ** ACUTE MI / STEMI ** ** Abnormal ECG
CDC Split Type:

Write-up: Since receiving his second dose of COVID-19 vaccine (Pfizer) on Sunday 2/21 he has had fever (tmax 103.0 F), headache, and stomach ache. His fever started on 2/21 and had persisted through 2/24. He woke up from a nap on 2/24 in the afternoon at 1600 had onset of severe chest pain. Then reoccurring multiple times throughout the evening. He was taken to a local hospital and the transferred to another hospital for higher level of care. Pediatric cardiology was consulted and treatment was started for suspected atypical pericarditis with colchicine 0.6mg BID and ibuprofen 600mg QID w/ famotidine 40mg QDay. His chest pain resolved the day of admission, even prior to starting treatment. Patient was discharged in clinically stable condition to follow up with pediatric cardiology in 2 weeks as outpatient.

Administered by: Military       Purchased by: ?
Symptoms: Basophil percentage decreased, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose increased, Blood lactic acid, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Carbon dioxide normal, Eosinophil percentage decreased, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Lymphocyte percentage decreased, Monocyte percentage, Neutrophil percentage increased, Platelet count normal, Pyrexia, Respiratory viral panel, SARS-CoV-2 test negative, White blood cell count increased
SMQs:, Haematopoietic leukopenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Briviact 10 mg/mL solution, 7 mL (70 mg) PO twice a day Miralax 1 capful daily PRN
Current Illness:
Preexisting Conditions: - Seizure disorder (no seizures since hippocampal ablation in Nov 2020) - Cortical dysplasia - Monosomy Xq26 and Trisomy 6p21.3 - Autism - Global developmental delay - Overactive bladder - Asthma
Allergies: Unasyn ? severe urticaria - Oxcarbazepine 300 mg (Trileptal) ? skin rash, fever, leukopenia, elevated liver labs - *Clobazam ? skin rash, angioedema
Diagnostic Lab Data: BMP: Na 139, K 3.6, Cl 104, CO2 23 BUN 12, Cr 0.66, Glu 124, Ca 9.0 Lacate 1.0 CBC: WBC 14.8, Hgb 13.9, Hct 40.1, Plt 342. 90.5% neutrophils, 4.5% lymphocytes, 4.7% monocytes, 0% eosinophils, 0.3% basophils, no bands ASAP SARS-CoV-2 Rapid: No pathogen detected RVP negative CRP 26.3
CDC Split Type:

Write-up: Fever of 103 F, received Tylenol, then developed tonic-clonic seizure activity for about 20 minutes (received 10mg intranasal midazolam and 0.5mg buccal clonazepam while awaiting EMS)

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactoid reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROAIR [SALBUTAMOL SULFATE]; AUVI Q; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITIN [LORATADINE]; TRIAMCINOLONE ACETONIDE
Current Illness: Allergy to legumes (Anaphylaxis); Asthma; Eczema; Food allergy (Flaxseed, Anaphylaxis); Food allergy (Chocolate, Anaphylaxis); Food allergy (Chickpea, Anaphylaxis); Peanut allergy (Anaphylaxis); Penicillin allergy (Anaphylaxis); Pollen allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts (tree nuts allergy Anaphylaxis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021082081

Write-up: Anaphylactoid reaction; PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for sponsored by BioNTech, managed and reported by Pfizer on the sponsor''s behalf. The subject was in the open-label phase of the study when the event occurred. A 17-year-old female subject with a past medical history significant for multiple allergies with anaphylaxis received first dose of blinded therapy (BNT162;PLACEBO) on 20Nov2020 at 17:04 and second dose on 15Dec2020 at 15:16. Per protocol, the participant was unblinded and confirmed to have received placebo and subsequently received third dose of study vaccine (BNT162B2) on 25Jan2021 at 16:50, all via intramuscular route in left deltoid as single doses for COVID-19 immunization. Ongoing medical history included penicillin allergy from 2010, peanut allergy from 2004, legume allergy from 2012, chickpea allergy from 2012, chocolate allergy from 2012, flaxseed allergy from 2016, all with anaphylaxis; pollen allergy from 2007, and asthma and eczema both from 2003. Additional medical history included: tree nuts allergy from 2004 (anaphylaxis). Ongoing concomitant medications included salbutamol sulfate (PROAIR) from 2010 for asthma, epinephrine (AUVI Q) from 2005 for penicillin allergy, peanut allergy, tree nuts allergy, legume allergy, chickpea allergy, flaxseed allergy and chocolate allergy, cetirizine hydrochloride (ZYRTEC) from 2007 for pollen allergy, loratadine (CLARITIN) from 2007 for pollen allergy, and triamcinolone acetonide from 2007 for eczema. There were no concomitant vaccines administered on same date of study vaccine and no prior vaccinations (within 4 weeks prior to the first administration date of study drug). The subject experienced hives left arm on 27Jan2021 at 10:30, shortness of breath 27Jan2021 at 11:00 and a diagnosis of anaphylactoid reaction on 27Jan2021 at 10:30, which were considered as life threatening (the event was considered life-threatening as subject with known anaphylaxis with tree nuts and subject reported similar symptoms). Clinical course was reported as follows: On 27Jan2021 at 10:30 (2 days after receiving BNT162B2 injection on her left arm) the subject started developing hives on her left arm and used her epinephrine pen at 10:54 and shortly after developed shortness of breath at 11:00. The subject did not touch or consume anything new prior to developing the hives on her left arm and the shortness of breath. The subject was not seen by a school nurse and self-administered her epi-pen. The hives resolved at 11:04 and the shortness of breath resolved at 11:24. The subject denied any other symptoms and did not seek further medical attention. There were no relevant tests done. The action taken in response to the events for study vaccine (BNT162B2) was permanently withdrawn (reported as not applicable as per investigator). The subject was not dosed vaccination 4 on 17Feb2021 (Visit 102). Outcome of the events was recovered on 27Jan2021. The investigator reported that there was a reasonable possibility that the event anaphylactoid reaction was related to Dose 3 of the study vaccine (BNT162B2), but not related to dose 1 and dose 2 of blinded therapy (BNT162;PLACEBO), concomitant drugs or clinical trial procedure. Follow-up (27Jan2021 and 03Feb2021): Seriousness life-threatening justification, additional medical history (tree nuts allergy) and clinical course (did not touch or consume anything new before SAE). Follow-up (18Feb2021): New information reported includes: action taken with the blinded study vaccine. Follow-up (02Mar2021): New information reported includes: concomitant medication and action taken with the blinded study vaccine. Follow-up (11Mar2021): New information reported includes: SAE term updated to ''anaphylactoid reaction''. This is a final report for initial notification of a life threatening event. .; Sender''s Comments: The event ''anaphylactoid reaction'' is unlisted in the protocol''s Single Reference Safety Document (IB). Pfizer''s safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 28-FEB-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Anaphylactoid reaction.Review of the database for the PT Anaphylactoid reaction had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 29 non clinical trial cases. The information available in this report is very limited. The Company considers that there is a reasonable possibility that ''anaphylactoid reaction'' is related to the study product. There is a plausible, although belated, time relationship between vaccination with BNT162b2 and onset of the event in a subject with a medical history of allergic diathesis; it is worth noting that symptoms resolved rapidly upon self-medication. From the available information for the rationale that led to attribution of a life-threatening seriousness criterion, it may not be justifiable based on past-history of anaphylaxis alone The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein increased, Ejection fraction decreased, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Inflammatory marker increased, Left ventricular dysfunction, Pyrexia, SARS-CoV-2 test negative, Troponin increased, Viral test
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Noninfectious myocarditis/pericarditis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ferrous sulfate, Flonase, methotrexate, protonix
Current Illness:
Preexisting Conditions: HLA B27+ juvenile idiopathic arthritis, enthesitis-related subtype with sacroilitis well controlled on methotrexate (previously on Humira)
Allergies: none
Diagnostic Lab Data: Echo concerning for moderate LV dysfunction EF 44%, normalized the next day. - CRP 18 - COVID PCR negative, viral PCR negative. Other infectious workup pending.
CDC Split Type:

Write-up: one day of fever found to have elevated inflammatory markers, LV dysfunction (now resolved), elevated troponin and ST elevation in EKG concerning for myopericarditis. Admitted to hospital. No documented fever in hospital, no rash, no GI symptoms, no other criteria met for MIS-C. Unclear etiology of myopericaraditis.

Administered by: Military       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Drug screen, Electroencephalogram, Full blood count, Headache, Lumbar puncture, Magnetic resonance imaging, Nausea, Pyrexia, SARS-CoV-2 test, Seizure, Vision blurred, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Irregular periods
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: Body Temperature; Result Unstructured Data: Test Result:100.4 Fahrenheit; Test Name: CRP; Result Unstructured Data: Test Result:elevated to 0.8 (normal less than 0.5); Test Name: Tox screen; Result Unstructured Data: Test Result:negative; Test Name: EEG; Result Unstructured Data: Test Result:shows localized to the occipital region; Test Name: CBC; Result Unstructured Data: Test Result:unremarkable; Test Name: LP; Result Unstructured Data: Test Result:shows 1 WBC, Gram stain negative; Test Name: MRI with contrast negative; Test Result: Negative ; Test Date: 20210317; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021300044

Write-up: Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Administered by: Private       Purchased by: ?
Symptoms: Anti-HLA antibody test positive, Atrioventricular block first degree, Biopsy heart abnormal, Cardiac arrest, Cardiac dysfunction, Complement fixation test positive, Echocardiogram abnormal, Electrocardiogram abnormal, Intensive care, Lung assist device therapy, Pain in extremity, Resuscitation, SARS-CoV-2 antibody test, SARS-CoV-2 test negative, Transplant rejection
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad), Noninfectious myocarditis/pericarditis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tacrolimus, Mycophenylate, Losartan, Vitamin D
Current Illness: none
Preexisting Conditions: heart transplant, limb-girdle muscular dystrophy, obesity
Allergies: none
Diagnostic Lab Data: Heart biopsy: 3/22/2021 Acute cellular and acute antibody-mediated rejection HLA testing: 3/22/2021 New donor specific antibody against donor heart Sars CoV PCR 3/22/2021 NEGATIVE Sars CoV Nucleocapsid IgG is pending
CDC Split Type:

Write-up: Sore arm on 3/20/2021. No other symptoms/signs. Presented for routine heart transplant follow up visit 3/22/2021 and was found to have new decreased cardiac function by echo, new 1st degree heart block by ECG, and new gallop. Patient taken to cath lab 3/22/2021 for biopsy and hemodynamic assessment, but he had V fib arrest with anesthesia induction. After initiation of CPR, patient was placed on ECMO. Biopsy shows ACR 2R (moderate cellular rejection) and pAMR 2 (moderate antibody-mediated rejection). Labs show new donor specific, complement-fixing Antibody against the cardiac allograft. Patient is in ICU being treated for acute rejection.

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Tongue blistering, Tongue pruritus
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Zoloft hydroxizine
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: blisters on the tongue, followed by itching, and anaphylactic shock from 11:30pm to 12:30am. benadryl and 2 epi pens were used and then at the hospital steroids and IV benadryl were utilized. Benadryl was used for the next 24 hours and then steroids were prescribed outpatient