Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Just over 7 months after receiving my second shot, I got COVID-19 from another fully vaccinated person (she had Moderna).; Just over 7 months after receiving my second shot, I got COVID-19 from another fully vaccinated person (she had Moderna).; have been sick for over a week now; nasal drainage; sore throat; then congestion; fatigue; chills; fever; body aches; light-headedness; chest cough; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old female patient (age at vaccination: 34 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date in Mar2021, as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8732 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Apr2021 at 14:30 PM, as dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included hypertension and obesity. The patient did not have any known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on an unspecified date, just over 7 months after receiving her second shot, she got COVID-19 from another fully vaccinated person (she had Moderna) and vaccination failure. She was 100% sure she got it from her because she was the only person she was around for a week before she got sick. She tested negative for COVID after quarantining, but developed symptoms and took another test two days later that was positive and have been sick for over a week now, starting with some nasal drainage, sore throat, then congestion, fatigue, chills, fever, body aches, light-headedness and a chest cough on 06Nov2021 at 19:00 PM. The patient did not receive any treatment for the events. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab test and procedure included PCR (Nasal Swab) was negative on 05Nov2021 and PCR (Nasal Swab) was positive on 07Nov2021. Product quality complaints group reported that this was a notification generated from the database system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process. The investigation included a review of 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. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. 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. Outcome of the events was recovering.