Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19; shortness of breath; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse reported for Patient (Reporter's daughter).  A 16-year-old female 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 Deltoid Left, on 29Jul2021 at 11:00 (age at vaccination: 16 years), as a single dose for COVID-19 immunization. The patient's medical history included ongoing asthmatic (she had first asthma attack and end up in hospital at age 4). Concomitant medications were not reported. The reporter called on behalf of her daughter (patient) who received the COVID-19 Vaccine Thursday 29Jul2021. The next day, on 30Jul2021, after patient received the vaccine, the patient started having shortness of breath and her mother, ICU nurse, took her to the ER where she was diagnosed with COVID-19. The patient was hospitalized on an unspecified date. She had put the pulse oximeter on and oxygen level was 84 to 86%. The patient's lungs and there were no crackles. The patient was taking shallow breaths. In the ER they gave her a breathing treatment and ordered a spacer for her inhaler. She has been ok since. The reporter had questions regarding her 2nd dose of the vaccination and if the series will have to be restarted. Caller stated that when she was caring for patients in the ICU they were advising them at discharge to wait 6-8 weeks to get the vaccine after having COVID related illness/hospitalizations. Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. This recommendation applies to people who experience SARS-CoV-2 infection before receiving any vaccine dose and those who experience SARS- CoV-2 infection after the first dose of an mRNA vaccine but before receipt of the second dose. While there was no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection was low in the months after initial infection but may increase with time due to waning immunity. Advised the caller that this document did not advise to restart the vaccination series but to wait until after isolation period and recovered from acute illness as noted above with no "designated minimal time interval." The patient underwent lab tests and procedures which included oxygen saturation: 84 to 86 % on 30Jul2021 oxygen levels, sars-cov-2 test: positive on 01Aug2021, sars-cov-2 test: positive on 30Jul2021. Outcome of the event shortness of breath was recovered on an unspecified date in 2021 and for another event, it was unknown. There was a Product Complaint and description of complaint included Caller's daughter received first COVID19 Vaccine dose on Thursday. The next day she started having shortness of breath. Caller took her daughter to the hospital and she tested positive for COVID. The reason caller took her daughter to get tested is because her daughter is a severe asthmatic and said she was having trouble breathing. She had put the pulse oximeter on and oxygen level was 84 to 86%. In the ER they gave her a breathing treatment and ordered a spacer for her inhaler. She has been ok since. COVID19 Vaccine: the writing is a little bad on the card. The lot number is FAY485 or FAYU85. It was first dose. Product strength and count size dispensed: unknown Additional lot numbers: n/a Is a sample of the product available to be returned, if requested (Y/N): Not Provided Packaging sealed and intact? Not Provided; Sender's Comments: As there is limited information in the case provided, the causal association between the events covid-19 and dyspnea the suspect drug cannot be excluded. The case will be reassessed once new information is 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.