Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
thyroid nodules; an allergic reaction (swelling, redness) / allergy to ingredient in COVID-19 vaccine; an allergic reaction (swelling, redness); an allergic reaction (swelling, redness); pain in both arms and legs/ pain from left arm to leg, right arm to leg; pain in shoulder; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Miralax, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "allergic reaction (swelling, redness)", "pain in shoulder", "allergic reaction (swelling, redness)", "pain in both arms and legs", "allergic reaction (swelling, redness)". The following information was reported: THYROID MASS (non-serious), outcome "unknown", described as "thyroid nodules"; ALLERGIC REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "an allergic reaction (swelling, redness) / allergy to ingredient in COVID-19 vaccine"; SWELLING (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "an allergic reaction (swelling, redness)"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in both arms and legs/ pain from left arm to leg, right arm to leg"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain in shoulder". The event "thyroid nodules" required physician office visit. Therapeutic measures were not taken as a result of thyroid mass. Additional information: Caller (patient) received 2 doses of the COVID-19 vaccine and her son received 3 doses. She developed thyroid nodules, and her son developed Grave's disease. After administering the dose of the vaccine, they noticed symptoms she identifies as an allergic reaction (swelling, redness) as well as pain in both arms and legs. No family history of thyroid problems. It was further reported that both caller (patient) and caller's son have an allergy to ingredient in COVID-19 vaccine, clarified a PEG, 3350 or something, allergy, an allergy to Miralax. Said the ingredient in Miralax is also in the vaccine. Caller has something that feels like pain from left arm to leg, right arm to leg, shoulder, sometimes swollen and red like an allergic reaction. Caller and caller's son both have allergy to Miralax. Caller has thyroid nodule. Wants to report this kind of problem, checked website, said 25.1 people have Grave's disease, and the size of the thyroid. This occurred after vaccine. Did not have thyroid problem before. Was after caller's 2nd dose that caller had thyroid nodule. Wants to ask how do people treat this from the vaccine since caused the problem? Caller saw endocrinologist, did not do anything, told caller to observe. Family does not have any thyroid problems. Occurred after got the vaccine, thinks not the only one case, other people have. Wants to check therapies, wants suggestion from doctor, wants to know how to treat, what do people do since was because of vaccine? Wants to know what treatment can be given.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500063398 same reporter/patient, different vaccine dose/event (DOSE 1);