Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Lip swelling, Pharyngeal swelling, Swelling of eyelid, Swollen tongue
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 22Nov2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PEG allergy" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Sinus tachycardia" (unspecified if ongoing), notes: Sinus tachycardia Had complete heart work; "real mild form POTS syndrome" (unspecified if ongoing), notes: might have real mild form POTS syndrome.; "softball sized welts" (unspecified if ongoing), notes: in the past to other vaccines, like when she was a kid, she always got softball sized welts.; "Had allergies to old fashioned sulfa tablets from the 70's" (unspecified if ongoing), notes: Has been intermittent over the years.; "rash" (unspecified if ongoing), notes: Had allergies to old fashioned sulfa tablets from the 70's. Broke out in rash.; "hypothyroidism" (unspecified if ongoing), notes: Additional Information for Other medicines Synthroid: Has been taking for 30 years; "reflux" (unspecified if ongoing), notes: Additional Information for Other medicines Pepcid: Has been taking around 25 years; "allergic reactions" (unspecified if ongoing), notes: she is the only one unfortunate enough to experience this. Has had life long allergic reactions. Concomitant medication(s) included: ASPIRIN (E.C.); ATENOLOL taken for sinus tachycardia; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease; SYNTHROID taken for hypothyroidism. Past drug history included: Steroid, reaction(s): "rash", notes: Was injected with a steroid and got a rash and had broken out in hives.; Steroid, reaction(s): "broken out in hives.", notes: Was injected with a steroid and got a rash and had broken out in hives.; Miralax, reaction(s): "broke out into a rash"; Golytely, reaction(s): "rash". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: heart work: (unspecified date) didn't find anything; SARS-CoV-2 test: (Jan2022) Positive, notes: tested positive for Covid; Weight: (unspecified date) Abut 195.  Clinical course: Other Conditions and Investigations was no. Suspect products Pfizer BionTech Covid vaccine, NDC, EXP: Unknown, LOT: Was sloppy writing and thinks it is OR5730, that is what it looks like. Could also be OL5730. Dates of 2 Johnson and Johnson Covid vaccines provided as 22Nov2021 and had booster 25Apr2022. Actually did have Covid, end of or around middle Jan2022, about year ago. Got pretty sick but did not have to go to hospital. Ended up with some kidney failure too. There was a product complaint to report. Description of complaint was tested positive for Covid. Prior Vaccinations (within 4 weeks): No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.