Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Lethargy, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: Really lethargic and fatigued; Tested positive for the Covid virus; Tested positive for the Covid virus; Can't taste or smell; Can't taste or smell; Horrible stomach ache; Diarrhea; Exhausted/really lethargic and fatigued; Felt ill, run down and not herself; Voice was gone and was very cracky; Did not feel good; Throat sore and vocal cords hurting; Throat sore and vocal cords hurting; Freezing cold and had the chills; Freezing cold and had the chills; Woke up in a puddle of sweat and hair was soaking wet and dripping; Nose really runny and super congested; Nose really runny and super congested; Deep cough/a little cough; Feels nauseas; Her energy was very low; She thought she caught the flu and was not thinking that it was Covid; freezing and shaking; She didn't have an appetite the first couple of days; She felt horrible in her chest and it was hard to breathe; Chest sore and felt like pressure on her chest; Chest sore and felt like pressure on her chest; This is a spontaneous report from a Pfizer sponsored program by a contactable consumer (patient). This 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration Arm Left on 25Feb2021 14:00 at age of 23 year-old (Lot: EL9267) as DOSE 1, SINGLE, Arm Left on 19Mar2021 11:00 at age of 23 year-old at DOSE 2, SINGLE (Lot # EN6208) for covid-19 immunisation. Medical history included none. Concomitant Products included ongoing lisdexamfetamine mesilate (VYVANSE) Has been taking since grade 10 at Believes it is 40mg, once daily for Attention deficit hyperactivity disorder. No prior vaccinations within 4 weeks.On 09Jul2021, she tested positive for Covid-19. States that she does not know the exact strain that it was. She is trying to get genome sequencing done so that they can find out. She has one but, she is (withheld) and has a PCP back home. She hasn't given them any info about her having Covid yet. She hasn't called her physician. She saw someone in the clinic. She hasn't told them yet, so she wants to call them first. In the clinic, they assumed it was as sinus infection and the prescribed her with Amoxicillin. She was taking it last week when she didn't know that she had it yet. She is still taking it right now. They gave her nasal spray and she did that for 2 days completely and it is clear now. She had every possible symptom she can think of. On Tuesday, 06Jul2021, she woke up with a horrible stomach ache and diarrhea. When she got to campus, she was more exhausted on 06Jul2021 and just felt ill and run down, not herself on 06Jul2021. Her voice was so gone. She did not feel good on 06Jul2021. She felt like that is probably because she took the vaccine while she was sick. She had all this work to do, so she went through it. She took her Vyvanse medication instead of resting and it almost masked the symptoms but, she felt ok for an hour, then all of a sudden she had to go to bed because she felt so sick. She just thought it was food she had eaten because of her birthday. She had eaten cake and a whole lot of junk food. She usually eats really healthy. She went to clinic that morning to see patients. She also had no voice and it was very crackly/ Voice was gone and was very cracky on 06Jul2021. Her throat didn't hurt, it was just very sore and her vocal chords were hurting on 06Jul2021. It hurt to talk. Those were the only 2 symptoms she had the first day. She felt ill, fatigued and her body started to hurt and she felt really tired. She came home and didn't feel like she usually did. She just felt really sick. She could taste and smell, it was all still there. She is still getting the runs though out the day. She was with family and 2 friends and did not pass anything on to them. They are all vaccinated. That night, she was exhausted and went to bed early, then she was freezing cold, had the chills but didn't take her temperature in Jul2021. She took Nyquil and Dayquil. She woke up again at night and was freezing and shaking and Woke up in a puddle of sweat and hair was soaking wet and dripping in Jul2021. She felt horrible. She thought she caught the flu and was not thinking that it was Covid in Jul2021. That day, she kind of tried to get though school and do work online. She was feeling really crummy. All of those symptoms, she had the next couple of days. Then her Nose really runny and super congested in Jul2021. her throat didn't really hurt but she had a kind of deep cough in Jul2021. This was the last night before she saw the doctor. She had tried going for testing the day before but the lines were 3 hours. She booked a test and a doctor's appointment for the next day because she thought she caught the cold or flu. One night, she woke up again and it was the same, with chills and sweat but, her chest was really sore. It felt like pressure on her chest in Jul2021. It felt not normal, like it was maybe a variant. She was super contagious and vaccines may not be fully effective against them. She felt horrible in her chest and it was hard to breathe in Jul2021. When going up and down the stairs, she would get really tired and was out of breath. She tested at the Drive through. It was a nasal swab in each nostril. That night, 08Jul2021, when she had dinner, she couldn't taste anything or smell anything on 08Jul2021. She thought, it must be Covid. The next day, she went to the clinic and saw a Nurse Practitioner. She made her put her head down to see if there was pressure in the sinuses. She tested her breathing and her lungs, everything was clear. She didn't really think it was Covid. She put her on amoxicillin and has been taking that ever since. She tested positive (09Jul2021) was when she was starting to feel better but really, she was still tired and exhausted. Her energy was very low in Jul2021. She was only really sick for 3 full days. On Saturday, she was really lethargic  on 10Jul2021 and fatigued. She knew she was getting better, just not 100 percent. When she knew that it was Covid, if it wasn't for the vaccine, she didn't think she would be able to tough it out. She still can't taste or smell at the moment. She is in self isolation. She feels completely normal. If she hadn't gotten the Covid test, she would have never thought that it was Covid. She feels 90% right now. She is back to studying. Horrible stomach ache and Diarrhea: Did not last very long, would say, like 30 minutes and then it passed.  Still has diarrhea every morning but it may because of the amoxicillin. Lethargy and fatigue and all of the other symptoms: They were all on 6Jul2021, 7Jul2021 and 8Jul2021. On 9Jul2021, she started to get better. Treatment included Before Friday, when she saw the Nurse practitioner on 9Jul2021, she started taking the Flonase. She only did it a couple of times. It was fluticasone propionate, Flonase nasal spray and Sodium chloride nasal spray, 1 spray in each nostril. She only did it 3 times since she got it. Her nose was really runny through out the time and super congested. The only thing is that her stomach feels a little nauseous and has a little cough. Her cough has gotten way better, so much better. The nausea/ Feels nauseas didn't happen that often in Jul2021. She didn't have an appetite the first couple of days in Jul2021. Just today, she is a little nauseated but, it may not be Covid. No Emergency Room and Physician Office. She went to the clinic. She barely had any symptoms from the second dose. She looks like she has Covid and it is not good. Was tested prior to getting the vaccine and was negative. Outcome of the event Tested positive for the Covid virus, Nose really runny and super congested, Nose really runny and super congested was unknown. Outcome of the event hard to breathe, Exhausted/really lethargic and fatigued, Felt ill, run down and not herself, Voice was gone and was very cracky, Did not feel good, Throat sore and vocal cords hurting, Freezing cold and had the chills, Woke up in a puddle of sweat and hair was soaking wet and dripping, Deep cough/a little cough, Really lethargic and fatigued, Chest sore and felt like pressure on her chest, Feels nauseas, Her energy was very low, She thought she caught the flu and was not thinking that it was Covid, freezing and shaking, She didn't have an appetite the first couple of days was recovering. Outcome of the event Horrible stomach ache was recovered in Jul2021. Outcome of the event Diarrhea, Can't taste or smell was not recovered. (Parent) Evaluation Comment: Pfizer withheld reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment actionis required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EN6208 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EN6208 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. 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. The complaint for an adverse event requested by safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EL1283 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EL1283, fill lot EL1281, and the bulk formulated drug product lot EL1279. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  Follow-up attempts are completed. No further information is expected.