Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| RSV | RSV (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Sore arms; Chills, especially at night; Muscle aches; Headache; Some itching on top of her head; This is a spontaneous report received from a Consumer or other non HCP from License Party. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MODAFINIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRAZODONE HCL; CLONAZEPAM; PROZAC; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; CALCIUM. The following information was reported: CHILLS (non-serious) with onset 16Dec2024, described as "Chills, especially at night"; HEADACHE (non-serious) with onset 16Dec2024; MYALGIA (non-serious) with onset 16Dec2024, described as "Muscle aches"; PRURITUS (non-serious) with onset 16Dec2024, described as "Some itching on top of her head"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2024, described as "Sore arms". Amendment: This follow-up report is being submitted to amend previous information: adding case identifiers, classification (At Risk) deleted.
MODAFINIL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TRAZODONE HCL; CLONAZEPAM; PROZAC; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; CALCIUM