Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Chills; Arm soreness; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "arrhythmia" (unspecified if ongoing); "syncope" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: DOXAZOSIN; MELATONIN; METOPROLOL; MIRALAX; SIMVASTATIN; VITAMIN D [VITAMIN D NOS]. The following information was reported: CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness". Additional information: When the patient received the original two shots, the only reactions were chills and arm soreness. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500117105 same patient and drug, different dose and events;US-PFIZER INC-202500117641 same patient and drug, different dose and events;US-PFIZER INC-202500117116 same patient and drug, different dose and events;US-PFIZER INC-202500117114 same patient and drug, different dose and events;
Medical History/Concurrent Conditions: Arrhythmia; Atrial fibrillation; Enlarged prostate; Syncope
DOXAZOSIN; MELATONIN; METOPROLOL; MIRALAX; SIMVASTATIN; VITAMIN D [VITAMIN D NOS]