Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Night sweats, Pain
Clinical narrative: Shortness of breath; Asthma symptoms/second shot exacerbated her asthma; runny nose; night sweats; headache; fatigue; pain in arm; fever; Body aches; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route in the left arm, on 19Apr2021 at 17:15 (lot/batch no: EW0164, expiration date: 31Aug2021), as 2nd dose, single dose, for COVID-19 immunization (at the age of 45-years), at a clinic. The patient was not pregnant at the time of vaccination. Medical history included, Sjogren's syndrome from 2015, asthma, unspecified allergies, and autoimmune disorder. Concomitant medications included fish oil (FISH OIL), biotin (BIOTIN), paracetamol (ACETAMINOFEN), montelukast sodium (SINGULAIR) taken for asthma from 2015. Historical vaccine included the first dose of COVID-19 vaccine (Lot number: ER8737) on 30Mar2021 at 17:15PM as 1st dose, single dose in the left arm , at age 45 years old, for COVID-19 immunization. The patient previously took sulfonamide and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Apr2021, the patient had body aches, fever, and on 21Apr2021, the patient experienced shortness of breath, asthma symptoms, pain in arm, runny nose, night sweats, headache, fatigue and flu like symptoms on an unspecified date in Apr2021. The patient stated that after the second dose she ended up going to emergency room for shortness of breath. Now it has been more than a month and she is still having problems breathing. The doctor said the second shot exacerbated her asthma. Caller adds she has autoimmune disease and has had asthma for some time but usually has no symptoms. She only has any problem when she has seasonal allergies. Wednesday the body aches and fever subsided but she started to have shortness of breath. Adds she couldn't get into the pulmonary doctor, so she went to the emergency room on Friday evening 23Apr2021. She was there a few hours; they did x rays and EKG and blood work and urine. Everything was fine. They told her to see her pulmonary doctor. They did give her ibuprofen (Ibuprofen 600mg; manufacturer Time CatLab; no NDC, lot or expiration date). Has use by date of 26Apr2021. When she went to the pulmonary doctor her treated her with prednisone and Symbicort (Symbicort; NDC 0186 0370 20; lot 3002410C00, expiration date: Feb2022). She was still experiencing shortness of breath which was worse when she lays down or sits back. She had a CAT Scan on her lungs which the pulmonologist said looks fine. He said it was taking her a long time to recover from the shot. He gave her second inhaler (Spiriva Respimat - sample inhaler; NDC not seen on the sample package; lot 905836B; expiration Sep2022), but nothing was correcting the issue, she states the Prednisone is long gone, it was six days package; no NDC, lot or expiration date. The patient underwent lab tests and procedures which included blood test: normal (everything was fine) on 23Apr2021, electrocardiogram: normal (everything was fine) on 23Apr2021, urine analysis: fine (everything was fine) on 23Apr2021, x-ray: normal (everything was fine) on 23Apr2021, and CAT scan: normal on an unspecified date. The outcome of the events was not recovered except for the events fever, flu like symptoms and body aches which resolved on 21Apr2021.  On 10Jun2021, investigation result and expiry date: 31Aug2021 for lot number EW0164 were provided by the product quality complaints group. The summary of investigation was as follows: The initial scope of the investigation was limited to the reported finished goods lot EW0164, fill lot EP8696, and the bulk formulated drug product lot EP8593. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint lot. Pfizer did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective or preventative actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the (name) site. Impact Analysis: Based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EW0164 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 EW0164, fill lot EP8696, and the formulated drug product lot EP8593. 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.  No follow-up attempts are needed. No further information is expected.  Follow-up (10Jun2021): New information received from the product quality complaints team includes: investigation result and expiry date for lot number EW0164. Additionally, the description as reported of the event coded to asthma was updated to "Asthma symptoms/second shot exacerbated her asthma".  Information on lot/batch number was available. Additional information has been requested.