Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Computerised tomogram, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: The caller had the Pfizer covid vaccine and now has covid.; The caller had the Pfizer covid vaccine and now has covid.; Please provide information on any new or worsened symptoms/signs during the COVID-19 illness experienced(including date of onset/worsening) Respiratory only; First Dose: Received 10Jul2021, lot, NDC and expiration date unknown.  Second Dose: Received 21Jul2021; This is a spontaneous report from Pfizer-sponsored program. A contactable nurse, the patient, reported a 67-year-old elderly male received COVID-19 immunization with the first dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route in the left arm on 10Jul2021 at 13:00, and the second dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route in the left arm on 21Jul2021 at 13:00. Relevant medical history included non-smoker, and COVID (2020-2020; described as covid about a year ago and almost died). The patient denied receiving any other vaccine within four weeks of this vaccine or any other vaccine on the same date as this vaccine. The patient denied taking any concomitant medications. The patient denied being treated with any immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient reported that he received the first dose of BNT162b2 on 10Jul2021, the second on 21Jul2021 and on 13Oct2021 he tested positive via nasal swab for COVID-19. The reporter indicated new or worsened symptoms/signs during the COVID-19 illness that he experienced included Respiratory only. On 18Oct2021 the patient underwent a CT, MRI, and chest x-ray which did not show any specific findings. It was unknown if the patient had any SARS-CoV2 antibodies at diagnosis. The patient denied and worsened pre-existing diseases during the SARS-CoV2 infection. The patient also denied the display of any clinical signs at rest indicative of severe systemic illness. The patient denied receiving any treatment for the events including additional therapies, new medication, other treatment / procedure, supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation, or hospitalization. The patient denied any visit to an emergency room or physician office. The patient reported that he has not been tested again for COVID-19. The outcome of the events COVID-19, and Respiratory disorder was recovering.   The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events Covid-19,Drug ineffective,Respiratory disorder and the suspect drug BNT162B2 cannot be excluded. 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.