Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Consumer stated that she had received COVID-19 vaccines from Moderna and Pfizer in the past and experienced a severe allergy to both of them; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (Consumer stated that she had received COVID-19 vaccines from Moderna and Pfizer in the past and experienced a severe allergy to both of them) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Allergy to vaccine (severe allergies to a lot of vaccines) and Drug allergy (severe allergies to other medications such as painkillers and over-the-counter drugs).   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Consumer stated that she had received COVID-19 vaccines from Moderna and Pfizer in the past and experienced a severe allergy to both of them) (seriousness criterion hospitalization). At the time of the report, ALLERGY TO VACCINE (Consumer stated that she had received COVID-19 vaccines from Moderna and Pfizer in the past and experienced a severe allergy to both of them) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the patient had received COVID-19 vaccines from Moderna and Pfizer in the past and experienced severe allergies to both of them.  It was reported that every time patient had a severe reaction, she ended up in hospital and it was pure agony. It was also reported that these severe allergic reactions caused her body to be stingy and swollen and that she even felt it in her feet. Patient had received a Johnson and Johnson COVID-19 vaccine because it had fewer ingredients and was labeled as 75% effective, as she was worried about experiencing a severe reaction.  The patient did not report any adverse reactions from the Johnson and Johnson vaccine. No treatment medications were reported. Company comment: This spontaneous case concerns a 72-year-old female patient, with medical history of severe allergies to a lot of vaccines and to other medications, who experienced the unexpected and serious (hospitalization) event of allergy to vaccine. The onset date of the event and the vaccination date were not reported; hence, latency to one dose of SPIKEVAX NOS (SPIKEVAX NOS) vaccine could not be properly assessed. No further clinical information was available for medical review. Patient´s medical history of drug allergy and the co-suspect TOZINAMERAN remain as confounders for the event. The benefit-risk relationship of SPIKEVAX NOS (SPIKEVAX NOS) vaccine is not affected by this report.