Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | EH9899 | RA |
Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection site; Pain, swelling, increased warmth at injection site; Onset fever of 100.8; severe headache; body aches; chills; Fatigue; stiffness multiple bilateral joints; had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine; chronic joint pain/had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine; had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 2, single (Lot number: EH9899) at the age of 51 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Intolerant to non-specific beta blockers" (unspecified if ongoing); "Intolerant to non-specific beta blockers" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Nitroglycerin, reaction(s): "Known allergies: nitroglycerin". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EH9899, in the right arm), for Covid-19 immunization, reaction(s): "swelling, pain, stiffness multiple bilateral joints", "Chills", "Fatigue", "Headache", "swelling, pain, stiffness multiple bilateral joints", "swelling, pain, stiffness multiple bilateral joints", "Body aches", "Fever", "Pain, swelling, increased warmth at injection site", "Pain, swelling, increased warmth at injection site". Vaccination date of dose 1 was 21Dec2021 (as reported. The following information was reported: FATIGUE (disability) with onset 11Jan2021, outcome "recovered with sequelae"; PYREXIA (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "Onset fever of 100.8"; VACCINATION SITE PAIN (disability), VACCINATION SITE SWELLING (disability), VACCINATION SITE WARMTH (disability) all with onset 11Jan2021, outcome "recovered with sequelae" and all described as "Pain, swelling, increased warmth at injection site"; PAIN (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "body aches"; CHILLS (disability) with onset 11Jan2021, outcome "recovered with sequelae"; ARTHRALGIA (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "chronic joint pain/had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine"; JOINT SWELLING (disability), CONDITION AGGRAVATED (disability) all with onset 11Jan2021, outcome "recovered with sequelae" and all described as "had increased swelling, pain/Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine"; HEADACHE (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "severe headache"; JOINT STIFFNESS (disability) with onset 11Jan2021, outcome "recovered with sequelae", described as "stiffness multiple bilateral joints". The events "stiffness multiple bilateral joints", "had increased swelling, pain/joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine" and "chronic joint pain/had increased swelling, pain/joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (11Jan2021) 100.8. Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site warmth, pyrexia, headache, pain, chills, fatigue, joint stiffness, joint swelling, arthralgia, condition aggravated. Adverse event: Pain, swelling, increased warmth at injection site lasting approximately 24 hrs. Onset fever of 100.8, severe headache, body aches, chills, fatigue approximately 8 hours after vaccine, lasting approximately 24 hours. After initial symptoms resolved, had increased swelling, pain, stiffness multiple bilateral joints. Symptoms very similar to reaction to first dose, though less severe with shorter duration of acute symptoms. Joint symptoms that followed was exacerbation of already present symptoms associated with initial vaccine. No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500212222 same patient/suspect vaccine; different dose/AE;
Medical History/Concurrent Conditions: Drug allergy; Drug intolerance
Test Date: 20210111; Test Name: body temperature; Result Unstructured Data: Test Result:100.8