Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pharyngeal swelling, Pruritus, Swelling face, Swollen tongue
Clinical narrative: getting red; tongue swelling; throat was feeling uncomfortable, like it was getting inflamed inside her mouth and started to swell; throat was feeling uncomfortable, like it was getting inflamed inside her mouth and started to swell; Interchange of vaccine products; very itchy; headache; feeling uncomfortable; Voice was raspy; Face and lips started to puff; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 50 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma, Asthma is severe, that is why she got the shot; "Anxiety" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "antihistamine" (unspecified if ongoing); "to help with allergic reaction for soy" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for asthma (ongoing); SYMBICORT taken for asthma (ongoing); ACIPHEX taken for asthma (ongoing); XYZAL taken for antiallergic therapy (ongoing); XOLAIR taken for food allergy (ongoing); ATROVENT taken for asthma; VENTOLIN [SALBUTAMOL] taken for asthma; LIPITOR taken for blood cholesterol (ongoing); NORETHISTERONE taken for contraception; EPIPEN; VENLAFAXINE taken for anxiety (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Pfizer, 21Mar2021, Time: Anatomical Site of injection: unknown, which arm, upper arm , LOT: EN6207 or EN62A, NDC, EXP: Unknown), administration date: 21Mar2021, when the patient was 48-year-old, for Covid-19 immunization, reaction(s): "very itchy"; BNT162b2 (DOSE 2, SINGLE, Date: Pfizer, 01Apr2021, Anatomical Site of injection: unknown, which arm, upper arm , LOT:EP7533, NDC, EXP: Unknown), administration date: 01Apr2021, when the patient was 48-year-old, for Covid-19 immunization, reaction(s): "very itchy", "Stomach started getting a little funny, nothing came of that, just felt a little uncomfortable and gassy", "welt across her chin"; BNT162b2 (DOSE 2, SINGLE, Date: Pfizer, 01Apr2021, Anatomical Site of injection: unknown, which arm, upper arm , LOT:EP7533, NDC, EXP: Unknown), administration date: 01Apr2021, when the patient was 48-year-old, for COVID-19 immunization, reaction(s): "Felt like she had a lot of weight carrying on her back. Felt very, very heavy."; moderna coviD-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Moderna Date: 18Dec2021 , LOT: 05Z4Z10 or 0524Z10, NDC, EXP: Unknown, Reaction / Event as Reported by the Primary Source for Translation: asthma flared up, Date of start of reaction/event: 18Dec2021), administration date: 18Dec2021, when the patient was 49-year-old, for COVID-19 immunization, reaction(s): "asthma flared up". The following information was reported: SWELLING FACE (medically significant) with onset 04Oct2022, outcome "unknown", described as "Face and lips started to puff"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2022, outcome "unknown"; DYSPHONIA (medically significant) with onset 04Oct2022, outcome "unknown", described as "Voice was raspy"; FEELING ABNORMAL (medically significant) with onset 04Oct2022, outcome "unknown", described as "feeling uncomfortable"; HEADACHE (medically significant) with onset 04Oct2022, outcome "unknown"; PRURITUS (medically significant) with onset 04Oct2022, outcome "unknown", described as "very itchy"; ERYTHEMA (medically significant), outcome "unknown", described as "getting red"; SWOLLEN TONGUE (medically significant), outcome "unknown", described as "tongue swelling"; OROPHARYNGEAL DISCOMFORT (medically significant), PHARYNGEAL SWELLING (medically significant), outcome "unknown" and all described as "throat was feeling uncomfortable, like it was getting inflamed inside her mouth and started to swell". The events "interchange of vaccine products", "very itchy", "headache", "voice was raspy", "face and lips started to puff" and "throat was feeling uncomfortable, like it was getting inflamed inside her mouth and started to swell" required emergency room visit. Therapeutic measures were taken as a result of pruritus, headache, dysphonia, swelling face, oropharyngeal discomfort, pharyngeal swelling.  Clinical Course: Went back to Pfizer for the booster. On 04Oct2022, had the Pfizer vaccine, Omicron booster. Did pre-medicate with 20mg Prednisone and 2 Benadryl prior to the injection. Did the same thing prior to the Moderna shot as well, took 20mg Prednisone and 2 Benadryl. Took this about 4 and a half hours prior to both the Moderna shot and the Omicron booster. With the last shot, the Pfizer Omicron booster, within 25 minutes, felt very itchy, started feeling a headache, started feeling uncomfortable. They took baseline prior to this, monitoring her blood pressure and stuff, while things were going on. Voice started getting raspy and started getting red. Face and lips started to puff. Voice was raspy, typically when her breathing goes, that is her trigger for asthma. They called ambulance, when they came, her throat was feeling uncomfortable, like it was getting inflamed inside her mouth and started to swell. They put IVs in her and sent her to the Emergency Room. Was not admitted to hospital, just went to emergency room. They gave her Deca something, does not remember name, it was IV. They monitored her and sent her home on 40mg Prednisone for 5 days and was on her inhaler. When she got home, was still very itchy as well.Ended up staying on the prednisone an additional 2 weeks, with taper.very itchy treatment Yes, Benadryl, very itchy, headache, Voice raspy, Face, lips started to puff. AE required visit to: Emergency Room Treatment: They gave her Deca something, does not remember name, it was IV. They monitored her and sent her home on 40mg Prednisone for 5 days and was on her inhaler. When she got home, was still very itchy as well. Ended up staying on the prednisone an additional 2 weeks, with taper.