Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | EH9899 | RA |
Stiffness of ankles, hips, shoulders, and knees; Severe fatigue; Joint swelling of bilateral multiple joints; Joint pain; Stiffness; stiffness of hands, fingers, feet, and neck; Injection site pain; Injection site swelling; Injection site heat; Fever at 101.4; maximum at 103.4; Severe headache; Body aches; mild to moderate bilateral pain; Nausea; Chills; Severe fatigue; This is a spontaneous report received from a consumer. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899) at the age of 51 years, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Does not tolerate non-selective beta blockers" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Nitroglycerin, reaction(s): "Does not tolerate". The patient had no known allergies but does not tolerate non-selective beta blockers or nitroglycerin. No other medication was given in two weeks. No other vaccine was administered within 4 weeks or on the same date as the suspect vaccine. The vaccine was administered in a public health clinic or Veterans administration facility. The following information was reported: PAIN (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), described as "Body aches; mild to moderate bilateral pain"; CHILLS (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020); PYREXIA (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), described as "Fever at 101.4; maximum at 103.4"; VACCINATION SITE WARMTH (disability) with onset 21Dec2020, outcome "recovered with sequelae" (23Dec2020), described as "Injection site heat"; VACCINATION SITE PAIN (disability) with onset 21Dec2020, outcome "recovered with sequelae" (23Dec2020), described as "Injection site pain"; VACCINATION SITE SWELLING (disability) with onset 21Dec2020, outcome "recovered with sequelae" (23Dec2020), described as "Injection site swelling"; ARTHRALGIA (disability) with onset 21Dec2020, outcome "recovered with sequelae", described as "Joint pain"; NAUSEA (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020); FATIGUE (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), FATIGUE (disability), outcome "recovered with sequelae" and all described as "Severe fatigue"; HEADACHE (disability) with onset 21Dec2020, outcome "recovered with sequelae" (27Dec2020), described as "Severe headache"; MUSCULOSKELETAL STIFFNESS (disability) with onset 21Dec2020, outcome "recovered with sequelae", described as "Stiffness; stiffness of hands, fingers, feet, and neck"; JOINT SWELLING (disability) with onset 25Dec2020, outcome "recovered with sequelae" (Jan2021), described as "Joint swelling of bilateral multiple joints"; JOINT STIFFNESS (disability), outcome "recovered with sequelae", described as "Stiffness of ankles, hips, shoulders, and knees". On 21Dec2020 (around 4 hours post-vaccine), the patient experienced injection site pain, swelling, and heat lasting 3 days. On 21Dec2020 (approximately 12 hours post-vaccine), fever 101.4 onset (with maximum fever at 103.4 in Dec2020; intermittent with response to Tylenol and ibuprofen) with severe headache, body aches, nausea, chills, and severe fatigue, ongoing for 7 days. On 25Dec2020 (4 days post-vaccine), the patient had joint swelling of bilateral multiple joints lasting approximately 1 month, with gradual improvement after first 4 to 5 days. Since then, the patient had intermittent acute on chronic episodes of joint pain, swelling, stiffness, severe fatigue, each exacerbation lasts from 3 to 4 days up to 3 weeks, every 6 to 9 weeks. Chronic aspect - constant mild to moderate bilateral pain, swelling, or stiffness of hands, fingers, feet, ankles, hips, shoulders, knees, and neck. The adverse events were considered serious resulting in disability or permanent damage. Treatment to all events included intermediate steroids (acute flares) and oral NSAIDs. The patient recovered from the events but with lasting effects. No follow-up attempts are possible.
Medical History/Concurrent Conditions: Drug intolerance
Test Date: 202012; Test Name: Body temperature; Result Unstructured Data: Test Result:103.4; Test Date: 20201221; Test Name: Body temperature; Result Unstructured Data: Test Result:101.4