Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | 5b709A | — |
had a lot of body pain; it knocked him out for a day or 2; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021593 (BioNTech), 2025SA308506 (SANOFI). A 78-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Oct2025 as dose 1, single (Lot number: 5b709A, Expiration Date: 31Dec2027) for covid-19 immunisation; dupilumab (DUPIXENT), as 300 mg/2ml at a dose of 300 mg qow (every other week) subcutaneous for neurodermatitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRIAMCINOLONE ACETONIDE; ALBUTEROL SULFATE HFA; BUDESONIDE; SYMBICORT; MELATONIN; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3; TAMSULOSIN HCL; ATORVASTATIN CALCIUM; METOPROLOL SUCCINATE; ALLOPURINOL; ELIQUIS; OMEPRAZOLE. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Oct2025, outcome "recovering", described as "it knocked him out for a day or 2"; PAIN (non-serious), outcome "recovering", described as "had a lot of body pain". The action taken for dupilumab was unknown. Clinical details: On an unknown date, the patient started taking Dupilumab Solution for injection with the strength of 300 mg/2ml at a dose of 300 mg QOW (every other week) subcutaneously for prurigo nodularis and COVID-19 vaccine (unknown dose, strength, frequency, formulation, indication, route). It was reported patient had the covid vaccine last Thursday and had a horrible reaction to it. It knocked him out for a day or 2 (loss of consciousness) (onset: Oct2025 latency: unknown) but he was feeling better now and last time he took the medication, he had a bad reaction to it. He had a lot of (pain) (onset, latency: unknown) (batch number: 5b709A, expiry date on 31Dec2027 for both the events) but now he was getting better. Company comment: Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Moreover, due to compatible temporal relationship role of covid-19 vaccine cannot be overlooked either. Concomitant medications can be a confounding factor in this case. Case will be reevaluated post further update on medical history, family history, personal history, correctives received and relevant investigations. No follow-up attempts are possible. COMIRNATY (2025-2026 FORMULA) is under agreement with BIONTECH SE.
TRIAMCINOLONE ACETONIDE; ALBUTEROL SULFATE HFA; BUDESONIDE; SYMBICORT; MELATONIN; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3; TAMSULOSIN HCL; ATORVASTATIN CALCIUM; METOPROLOL SUCCINATE; ALLOPURINOL; ELIQUIS; OMEPRAZOLE; DUPIXENT