Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Deafness, Drug ineffective, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: she could only taste salt; Has gotten Covid; Has gotten Covid/taste salt/bad cold/coughing; Can't really hear well; She had allergies and was sneezing a lot before confirmation; she had allergies and was sneezing a lot before confirmation; This is a spontaneous report from a Pfizer sponsored program female nurse reported for herself that. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EL9266; Expiration Date: 30May2021) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 (Batch/Lot Number: EL9263) as DOSE 1, SINGLE for covid-19 immunization(Age at vaccination 72 years). The patient past Medical history included dry eye from an unknown date and unknown if ongoing She doesn't usually take antihistamines because of her dry eye syndrome, nasopharyngitis from an unknown date and unknown if ongoing she has gotten in the past as far as a cold , hypersensitivity from an unknown date and unknown if ongoing Allergies. The patient's concomitant medications were not reported. ON 09Aug2021, The patient experienced Has gotten Covid/taste salt/bad cold/coughing.Has been doing research for 4 hours and is leaving on the 30th and wanting to know if the Pfizer vaccine is accepted. She is deaf and can't hear well and is calling in because they want to know if they may not be allowed overseas. No other vaccines given the same time and no problems with vaccines in past. After the Covid vaccines later she got the pneumonia vaccine. It would have been after Mar2021 when she was able to get it, does not know if it was 6 weeks or later when she got that, but it was well after she got the Covid shots. Unable to provide NDC, Lot, or expiry for the pneumonia shots.  States she didn't get any diagnosis for her ears. They were just full, and she couldn't hear. Must turn the tv way up to hear that. Was diagnosed this past Monday with Covid and then on Wednesday the 11th she could only taste salt. Prior to confirming Covid she had allergies and was sneezing a lot before confirmation and had stuff running down her throat on an unspecified date 2021. She tried to irrigate her sinuses on Monday or Tuesday and had been using an antihistamine ointment in nostrils to help. She doesn't usually take antihistamines because of her dry eye syndrome, but it built up a lot and she couldn't take it anymore. When she was diagnosed with Covid they didn't give her any treatment and the provider asked what she was taking. Informed provider she was taking Allegra and the antihistamines.  States her husband had the vaccines the same time as her, the same vaccines and they both were diagnosed with Covid on this past Monday. Declines to report for husband stating he is not available and doesn't think she can do that. Mentions she worked on a concert on a large venue and come to find out at the venue they allowed all the people to use their custom vape of marijuana which she does not do. Does not know, but she did wear her mask, but was worried because she had to inhale that would that havemade an affect. This was her first time experiencing anything like that before. Later states she only had the nasal testing for covid at an Urgent Care. She had quit taking the Allegra and antihistamines and now in a solid phase with the secretions. Had only used the Allegra and Tylenol intermittently. Felt like it was just a bad cold and no different from what she has gotten in the past as far as a cold. It could have been worse. She did have some coughing that was related to the crap that ran down her throat. Provides events are not serious and not medically significant, but it was tough, and she didn't end up in the hospital when queried for seriousness criteria for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Aug2021. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 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 EL9266, fill lot EL9257, and the formulated drug product lot EL9248. 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. The event outcome was Not recovered for Has gotten Covid/taste salt/bad cold/coughing and Can't really hear well. Unknown for rest of the events; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events of drug ineffective, COVID-19 and deafness cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.