Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Confusional state, Feeling abnormal, Gait disturbance, Head discomfort
Clinical narrative: the caller is positive with Covid; the caller is positive with Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: ER8736), on 31May2021 as dose 2, single (Lot number: EW0173) and on 13Jan2022 as dose 3 (booster), single (Lot number: FL3209) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the caller is positive with Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: the caller is positive with Covid. It was reported that, the caller stated that she had her 1st dose of the Pfizer BioNTech Covid 19 vaccine, 2nd dose and a booster and she had severe adverse reaction after the booster. Right now she had neurological problems with tremors on the right side of her body on her arm and hand and states she also had a problem with walking a little bit. Agent (Name withheld) caller also had onset migraine since January and she states that this headache was not go away. She had to be on Tylenol and Ajovi which she took monthly to help the pain. Agent (Name withheld) the caller states she was hearing of more and more problems with neurological disorders after the vaccine. Agent (Name withheld) the caller states that her daughter was positive to Covid and her mother, and the caller was positive with Covid. Agent (Name withheld) the caller asked how long does it take for the vaccine to get out of your body. Agent (Name withheld) that she had 2 dates and she was not sure what they go to, she has 14Jan and 31May but did not know what they were for. States she thinks 31May was the last administration of Ajovi and 14Jan is the day she got the booster. Agent states she will have to listen to the call to get the correct details. Caller states this was from the vaccine, she did not have this before. Caller states she just wanted to know if there was anything to take it out of her body. Agent was heard stating she understand but she did not have that kind of information. Caller states that today was day 10 of having Covid. States that she had the symptoms starting after the 2nd vaccine dose and the 3rd was more severe and had not gone away. States the 2nd vaccine dose, the morning after she had the onset headache and numbness in her arms, legs and feet. Caller states with the 3rd dose she has nausea, severe nausea and onset of pain in her head again with numbness but with tremors on her right side and difficulty walking. States she was not having difficulty walking after her 2nd dose. Caller states she was worried about her health and has been in the ER multiple times and was hospitalized once. Caller states she was going on 5 months with these symptoms. Patient Details: Call states this was a previous weight, she thinks she lost a little weight. Caller states she worked in ER for years and was not working now due to this. Prescribing Healthcare Professional Info: States she has 2 neurologists, she has one from before her condition worsened and sees a new one listed in formal field. Caller does not have email to provide. Caller states she called and reported when she 1st started symptoms in she thinks Feb2022 and called again today as she had been in the ER multiple times and her symptoms worsened to tremors on the right side of her body. Caller does not have Report number to provide. States the tremors on her right hand and her arm are new to report. She believes when 1st reported she just had numbness and now it was difficult to walk, she has weakness and heaviness in her legs. Caller states she was 50 and healthy when she got the vaccines, she ran on the treadmill and did the stair master. Caller states the tremors started she would say probably in the last week. States they are getting worse because it was more severe pain in her head and that was what bring on the tremors. Caller states when she spoke to the agent she said that in the trials they had reports of others with headaches. Caller states the difficulty walking she would say started within the last 3 weeks and feels like it is staying the same. Caller states she went to her pharmacist and they said people are coming in for Ajovi. Caller states her headache was severe, it was bad where it was pressure. Caller states she was hospitalized once for a lumbar puncture on she believes it was on 30Mar2022 and discharged 01Apr2022. Caller clarifies that she was admitted to the hospital on 26Mar2022, they did the lumbar puncture on 27Mar2022 and she was discharged on 28Mar2022. Caller states she went back to the ER and was admitted to observation on 31Mar2022 and they did a blood patch on her and she was discharged on 01Apr2022. Caller would like to add with terrible pain in her head and numbness on her right side she have confusion that had even affected her, like foggy brain and memory, forgetful memory. States that started when she was admitted in the hospital before the lumbar puncture. Caller clarifies that she did have it the 1st time she reported, she felt disoriented and that was in Feb2022 with her 1st ER visit and she had a MRI. Caller states she has had problems with her vision and all of her symptoms started in Feb2022 and have progressively gotten worse. Caller states her question she was having is if we know how long it takes the vaccine to get out of her system, she is going on 5 months of these. Caller was asking if she should call her pharmacist. States the agent said she did not have information. Caller states she hopes they find whatever was causing these headaches with trials and information. Caller states it was really scary and she was a healthy person before and going through this was traumatizing to her. States she registered so many patients at the beginning of Covid and she was like this now and she just wanted to get better. There was a product complaint to report. Description of Product Complaint: Description of complaint: positive for Covid Product strength and count size dispensed: not probed. Additional lot numbers: EW0173, FL3209 was a sample of the product available to be returned, if requested: NA. Packaging sealed and intact: not probed. As part of the lack of effect 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 according to in PQS Q1215 and/or Q1252. Investigation results and conclusions: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot ER8736 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8736, fill lot EP8688, and the formulated drug product lot EP8585. 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. Investigation results and conclusions: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FL3209 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 FL3209, fill lot FL5838, and the formulated drug product lot FL3183. A complaint sample was not returned. 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.