Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had transmitted COVID last winter; had transmitted COVID last winter; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 15Oct2024, this case now contains all required information to be considered valid.  This is a spontaneous report and received from Pharmacists from a sales representative and product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 10:30 as does 1, single (Lot number: EL0140), in left arm and on 10Feb2021 at 10:00 as dose 2, single (Lot number: EM9810) at the age of 70 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing), notes: LDL/ chol (Cholesterol); "asthma" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Low magnesium" (unspecified if ongoing); "Vitamin D decreased" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "Illness", start date: 10Feb2021, stop date: 10Feb2021, notes: Lasted about 5-10mins;Not serious; Recovered, no treatment, no relevant tests. Concomitant medication(s) included: LOSARTAN oral taken for blood pressure abnormal (ongoing); PROZAC oral taken for anxiety (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for hypersensitivity (ongoing); B12 [CYANOCOBALAMIN]; MAGNESIUM oral taken for blood magnesium decreased (ongoing); LIPITOR oral taken for blood cholesterol increased (ongoing); VITAMIN D [COLECALCIFEROL] oral taken for vitamin d decreased (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "had transmitted COVID last winter".  Patient had no prior vaccination. Patient is a Pharm D who received the Comirnaty 2024-2025 vaccine - she reported vertigo 8 days after vaccination (AER 202400277726); she reported only having vertigo one other time and that was when she had transmitted covid last winter (in 2023). She additionally mentioned that a group of her friends had similar adverse reactions (vertigo), but did not provide specifics.   Complaint Investigation Summary and Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EM9810 was investigated in PR. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EM9810, fill lot EM9806, and the formulated drug product lot EM9808. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective , COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021161355 Same patient, different vaccine dose number and event.;US-PFIZER INC-202400277726 Same patient, different vaccine dose number and event.;