Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Interchange of vaccine products, Nucleic acid test
Clinical narrative: Novavax Covid-19 Vaccine, co-suspect product Moderna COVID-19 vaccine (elasomeran) and Pfizer Biontech COVID-19 Vaccine; COVID-19/SARS-CoV-2 test positive; COVID-19/SARS-CoV-2 test positive; Asthenia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. Other Case identifier(s): 2022NVX-US-000004128.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose number unknown, single (Lot number: EW0150) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Mar2021 as dose number unknown, single (Lot number: 033H21A) for covid-19 immunisation; coviD-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), as dose number unknown, single (Lot number: ER8727) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Pancreatitis relapsing" (ongoing); "Diarrhoea" (ongoing); "Peptic ulcer" (ongoing); "Unevaluable event (ETOH)" (ongoing), notes: Unevaluable event (ETOH). The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 30Aug2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Aug2022, outcome "unknown" and all described as "COVID-19/SARS-CoV-2 test positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Novavax Covid-19 Vaccine, co-suspect product Moderna COVID-19 vaccine (elasomeran) and Pfizer Biontech COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Nucleic acid test: (30Aug2022) Unknown result; SARS-CoV-2 test: (30Aug2022) Positive, notes: SARS-CoV-2 test positive (PT: SARS CoV-2 test positive). Clinical course: An 82 year-old female of an unspecified race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date. On unspecified dates, the individual started treatment with co-suspect product Moderna COVID-19 vaccine (elasomeran) and Pfizer Biontech COVID-19 Vaccine (tozinameran), both for COVID-19 immunization. Date vaccinated was given as 23Mar2021. The CDC's adverse event description (narrative) was provided as follows: 30Aug2022 presents to ED for "increased weakness for 1 week". Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events was considered Possible. Event Abated After Use Stopped or Dose Reduced was doesn't apply. Event Reappeared After Reintroduction was doesn't apply.   Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot ER8727 was investigated. 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 ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. 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.