Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Burning sensation, Chills, Erythromelalgia
Clinical narrative: it burns and hurts really bad/hands burning; The bottoms of the caller's feet hurt really bad; ENG in right ulnar nerve: 7 Jul 2021, slowed and inflammation pressing on the nerve; hands tingling; mild pain; Bulging veins in her hands and feet/it burns and hurts really bad; Bulging veins in her hands and feet/it burns and hurts really bad; Erythromelalgia; Neuropathy; Fever; Chills; Generalized joint pain./joint pain spread to her wrist, then to her elbow and knees; This is a spontaneous report from a contactable Pharmacist (patient). A 37-Year-Old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in Arm Left on 23Jan2021 09:30 (at age of 37 years old) as 0.3 ml single for COVID-19 immunisation. Relevant medical history included: Insomnia, Sleep disorder. Prior Vaccinations (within 4 weeks) was None. Concomitant drug included: Melatonin for Sleep disorder, multi vitamin, colecalciferol (VIT D). The patient previously took first Dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot EL0140) on 02Jan2021 (at age of 37 years old) as single dose for COVID-19 immunisation. The patient had Fever From 23Jan2021 to 24Jan2021, Reporter seriousness for Fever: Not serious; Chills From 23Jan2021 to 24Jan2021, Reporter seriousness for Chills: Not serious; Generalized joint pain From 23Jan2021 to 24Jan2021, Reporter seriousness for Generalized joint pain: Medically significant; Bulging veins in her hands and feet From Apr2021, Reporter seriousness for Bulging veins in her hands and feet: Medically significant; Erythromelalgia From Apr2021, Reporter seriousness for Erythromelalgia: Medically significant; Neuropathy From Apr 2021, Reporter seriousness for Neuropathy: Medically significant. Fever, Chills, Generalized joint pain, Bulging veins in her hands and feet, Erythromelalgia, Neuropathy, Drug result was Related. This event happened after the second dose of the vaccine which was on 23Jan2021. Initially the caller developed joint pain in her hands. The caller had a fever, chills, and generalized joint pain 10 hours after the vaccine. The caller was better for about a day then she developed joint pain in her hands. This joint pain would switch from different parts of her hands. After about a month this joint pain spread to her wrist, then to her elbow, feet, and knees. Then the caller had nerve issues- tingling in her arms, she was diagnosed with Erythromelalgia. The caller has also had bulging veins in her hands and feet and it burns and hurts really bad. The bottoms of the caller's feet hurt really bad. The caller has joined some support groups and everyone is experiencing similar things that she is. It seems that everyone else's symptoms line up with the same timeline as the caller's. The joint pain that the caller has not is in her feet and it's intermittent, it comes in waves. The caller would have mild pain for a couple of days maybe a 2/10 and then it may flare for a couple of weeks. One joint feels better, then the next day it's a different joint. The caller's Erythromelalgia and neuropathy started at the end of Apr2021, same as the bulging veins. The Erythromelalgia and neuropathy came on quickly but has remained about the same. The caller's joint pain seriousness is in-between medically significant and disabling. The bulging veins result in the caller's hands burning and tingling and it's all related in the nervous system. AE(s) require a visit to Physician Office visit. CMP (Metabolic function test) in Apr2021: Normal; CBC (Full blood count) in Apr2021: Normal; ANA (Antinuclear antibody) in Feb2021: Negative; Rheumatoid factor in Feb2021: Negative; ENG in right ulnar nerve on 07Jul2021: slowed and inflammation pressing on the nerve. The outcome of the events Generalized joint pain, Fever, chills was recovered on 24Jan2021, Bulging veins in her hands and feet/it burns and hurts really bad, Erythromelalgia, Neuropathy was not recovered, for other events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported serious unlisted events i.e. Arthralgia, vein disorder, vascular pain, erythromelalgia and neuropathy peripheral neuropathy cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.