Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
redness and pain at the site; redness and pain at the site; stayed in bed with generalized muscle aches and fever for at least one full day.; stayed in bed with generalized muscle aches and fever for at least one full day.; This is a spontaneous report received from a Nurse. An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (unspecified if ongoing); "GI cramping" (unspecified if ongoing), notes: with cantaloupe and avocado. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunization, reaction(s): "Generalized muscle aches", "fever", "vaccination site erythema", "vaccination site pain". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 14Sep2025 at 04:30, outcome "unknown" and all described as "redness and pain at the site"; MYALGIA (non-serious), PYREXIA (non-serious) all with onset 14Sep2025 at 04:30, outcome "unknown" and all described as "stayed in bed with generalized muscle aches and fever for at least one full day.". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain, myalgia, pyrexia. 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-202500182329 same patient, different vaccine/event;
Medical History/Concurrent Conditions: Gastrointestinal cramps (with cantaloupe and avocado); Sulfonamide allergy