Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something; an allergic reaction (swelling, redness) as well as pain in both arms and legs; an allergic reaction (swelling, redness) as well as pain in both arms and legs; an allergic reaction (swelling, redness) as well as pain in both arms and legs; pain from left arm to leg, right arm to leg, 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): "allergy". The following information was reported: ALLERGIC REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something"; SWELLING (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "an allergic reaction (swelling, redness) as well as pain in both arms and legs"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain from left arm to leg, right arm to leg, shoulder". The events "an allergy to ingredient in covid-19 vaccine, clarified a peg, or something", "an allergic reaction (swelling, redness) as well as pain in both arms and legs" and "pain from left arm to leg, right arm to leg, shoulder" required physician office visit. Therapeutic measures were not taken as a result of allergic reaction to excipient, swelling, erythema, pain in extremity, arthralgia. Additional information: The patient has an allergy to ingredient in COVID-19 vaccine, clarified a PEG, or something. She said the ingredient in Miralax is also in the vaccine. She has something that feels like pain from left arm to leg, right arm to leg, shoulder, sometimes swollen and red like an allergic reaction. The patient and her son both have allergy to Miralax. The patient saw endocrinologist, did not do anything, told caller to obverse. Family does not have any thyroid problems. The events occurred after got the vaccine, she thinks not the only one case, other people have. She wants to check therapies, wants suggestion from doctor, wants to know how to treat, what do people do since was because of vaccine. She wants to know what treatment can be given. Confirmed received the Pfizer COVID-19 vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500062913 same reporter/patient, different vaccine dose/event;