Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Burning sensation, Heavy menstrual bleeding, Insomnia, Lip swelling
Clinical narrative: itch; Pain; I got the 1st vaccine a dark red spot started to show on the right side of my jaw; The rash covered the bottom of my face around one eye; my left three fingers are still scabby; During my period that month after the vaccine, I also had very large blood clots. Two of them size of small grapefruit.; everything I used on it made it burn; I couldn't sleep; swelled my face for two weeks, There was a hard knot in my jaw.; Lips felt swollen; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient herself).   A 35-years-old non-pregnant female (not-pregnant at the time of the vaccination) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0150; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 07Apr2021 11:00 (at the age of 35-years-old) as first dose single for COVID-19 immunization at Hospital. Medical history included non-compaction cardiomyopathy. Patient had known allergies Sulfur, sulfites, Penicillin, Sea Food, Cortisone, MSG. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included other medications the patient received within 2 weeks of vaccination was Metoprolol Tartrate (METOPROLOL TARTRATE) taken for an unspecified indication. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. It was reported that, two days after she got the 1st vaccine, on 09Apr2021 03:00pm a dark red spot started to show on the right side of her jaw. That soon started to itch. It swelled her face for two weeks. There was a hard knot in her jaw. She treated it like poison ivy but everything she used on it made it burn. The only thing that helped the itch and pain was Benadryl every four hours or she could not sleep this lasted for two weeks. The rash covered the bottom of her face around one eye. Down both arms and left side of her breast down the stomach. This rash also blustered on hand and other parts of her arm. It finally started really go away after three weeks. It had been four weeks and could see her left three fingers were still scabby. During her period that month after the vaccine, she also had very large blood clots. Two of them size of small grapefruit. On 09Apr2021 at 15:00, The patient got the 1st vaccine a dark red spot started to show on the right side of my jaw itch, Generalised rash began Right antecubital with itching red patch then spread to chest back neck extremities lips felt swollen. The symptoms occurred after 2 days after administration of vaccination. The reporter described all the signs and symptoms of the anaphylactic reaction: Generalised rash began Right antecubital with itching red patch then spread to chest back neck extremities lips felt swollen, anaphylactic reaction occurred 2 days after immunization administration. Patient visited Doctor or other healthcare professional office/clinic visit due to AE resulted. The Multi organ involvement included Lips felt swollen, Dermatological/ Mucosal, Generalized Pruritis with skin rash, included began Right antecubital with itching /ed patch then spread to chest back neck extremities. The patient was not hospitalised. Therapeutic measures were taken for adverse events which included cetirizine 10mg, famotidine 20mg and diphenhydramine 25mg, antihistamine. The outcome of the events were resolved on an unspecified date in 2021.  The reporter stated that the reported adverse event(s) with the use of the product. The Pfizer product had a casual effect to the adverse event.  Information about batch/ lot number has been requested.  Follow-up(17Jun2021)This is a follow up spontaneous report from a contactable other HCP. This other HCP reported in response to DCA letter sent via Follow up letter which included that: suspect details (Lot number, route of administration, anatomical location), Event information, Treatment, concomitant medication, causality were added and updated.