Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a Nurse from product quality group, Program ID.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 67 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: E6203), on 25Mar2021 as dose 2, single (Lot number: ER8732), on 02Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 08Jul2022 as dose 4 (booster), single (Lot number: FN2908), all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Jun2023 as dose 6 (booster), single) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were not taken as a result of drug ineffective, covid-19, interchange of vaccine products. Clinical course: She was very meticulous or careful not to take like COVID but she said that she really need this medication felt very ill and has trouble breathing. She was not specific about like which vaccine she stated she was vaccinated two times." She got all the vaccine like boosted and vaccinated." She still looking for that, she found her original card that was her original booster, it said Pfizer, her first Pfizer dose, she had LOT# number and she had the date and all that. So, it said Pfizer, it looked like and E and 6203 and she received on 04Mar2021.She had one at 27Sep2022 (Consumer was unsure about the date of vaccination) and again that was Pfizer that number 6H9703. She was looking at it, she thought it might be 1 instead of 9, she didn't not know if that was November, she meant could think its 1 or 9. That is got to be 27Jan2022, no it does not matter, well that's what was 02Jun2023 (Consumer was unsure about the date of vaccination) and that was Moderna, that was her last booster. She was not sure that if 21Jun it looked like 21Jun2023. She was getting so tired, she did not not know." The last one, that was the booster. She didn't know S or a 5, 7642B. Patient experienced COVID after the vaccinations: stated, "Yes, she couldn't believe it. Vaccination facility, "Most of it, she got them at her (facility name withheld). The first one was right in, they had place it up, we went and get them, she remember way back then. she really don't feel good. Route of administration were all Intramuscular. It does not feel good. Other medical condition and concomitant medication: She stated, "Yes, but couldn't go on and didn't know if do this again." Treatment: she stated, No. didn't have any breathing problems. She was having a little, just feeling really tired. She didn't feel good at all.  Based on investigation of PFIZER-BIONTECH COVID-19 VACCINE result conclusion: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine lot ER8732, GH9703 was investigated. The investigation included a review of involved manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot ER8732, fill lot EP8684, and bulk formulation lot EP8571. The final scope was determined to be the associated lot(s) of the reported lot GH9703. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA 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: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.