Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | LM2212 | OT / RA |
sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Lot number: LM2212) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cataracts are forming over the last few years" (ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "tetracycline allergy" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "deaf/profound hearing loss" (ongoing), notes: 50+ years; "Wore oticon 380P hearing aids" (ongoing). Concomitant medication(s) included: LEVOXYL taken for thyroid disorder; CLARITIN [CLARITHROMYCIN]. Vaccination history included: BNT162b2 (Dose 2; Lot: EP6955), administration date: 27Mar2021, for covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose 3; lot: EW0162), administration date: 19Apr2021, for covid-19 immunization, reaction(s): "sore arm"; bivalent (Dose 4; lot: GH9703), administration date: 12Oct2022, for covid-19 immunization, reaction(s): "sore arm"; comirnaty (Dose 5; lot: HD9876), administration date: 04Oct2023, for covid-19 immunization, reaction(s): "sore arm"; Biontech (Dose 1; lot: FL3198), administration date: Apr2020, for covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: The patient did not receive any other vaccines on the same date as Pfizer vaccine. The patient did not receive any other vaccine within 4 weeks prior to the first administration of the suspect vaccine. Patient reported that cataracts were forming before COVID vaccine and, therefore, cataract was not suspected due to Pfizer vaccine. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500040762 same patient/product/event; different dose;US-PFIZER INC-202500040763 same patient/product/event; different dose;US-PFIZER INC-202500040764 same patient/product/event; different dose;US-PFIZER INC-202500040765 same patient/product/event; different dose;US-PFIZER INC-202500040766 same patient/product/event; different dose;
Cataracts; Hearing aid user; Hearing loss (50+ years)
Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Latex allergy; Multiple allergies; Penicillin allergy; Sulfonamide allergy; Thyroid disorder
LEVOXYL; CLARITIN [CLARITHROMYCIN]