Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Flatulence, Inappropriate schedule of product administration, Pruritus
Clinical narrative: very itchy; Felt like she had a lot of weight carrying on her back. Felt very, very heavy.; Stomach started getting a little funny, nothing came of that, just felt a little uncomfortable and gassy; Stomach started getting a little funny, nothing came of that, just felt a little uncomfortable and gassy; welts across her chin; DOSE 1: 21Mar2021 and DOSE 2: 01Apr2021; The initial case was missing the following minimum criteria: Unspecified AE. Upon follow up receipt on 16Nov2022, this case contains all the necessary information that is required to consider this case valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Lot number: EP7533) at the age of 48 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; "antihistamine" (unspecified if ongoing), notes: Indication as Reported by the Primary Source: antihistamine; "allergic reaction for soy" (unspecified if ongoing), notes: Indication as Reported by the Primary Source: to help with allergic reaction for soy; "Cholesterol" (unspecified if ongoing), notes: Indication for use in the case: Cholesterol; "Birth control" (unspecified if ongoing), notes: Indication for use in the case: Birth control; "Anxiety" (unspecified if ongoing), notes: Indication for use in the case: Anxiety. 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 ACCUHALER 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; Anatomical location of injection: Upper arm, LOT: EN6207 or EN62A), administration date: 21Mar2021, when the patient was 48-year-old, for COVID-19 immunisation, reaction(s): "very itchy". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Apr2021, outcome "unknown", described as "DOSE 1: 21Mar2021 and DOSE 2: 01Apr2021"; FEELING ABNORMAL (non-serious) with onset 01Apr2021, outcome "unknown", described as "Felt like she had a lot of weight carrying on her back. Felt very, very heavy."; ABDOMINAL DISCOMFORT (non-serious), FLATULENCE (non-serious) all with onset 01Apr2021, outcome "unknown" and all described as "Stomach started getting a little funny, nothing came of that, just felt a little uncomfortable and gassy"; PRURITUS (non-serious) with onset 01Apr2021, outcome "unknown", described as "very itchy"; URTICARIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "welts across her chin". Therapeutic measures were taken as a result of pruritus.  Additional information: The patient had other conditions (name unspecified). No investigations done. The patient does have experience with this vaccine and was just trying to understand what she was reacting to, if she was allergic to soy. Had the first shot in 2020 and guesses she was 48. Actually the first one she had was Pfizer, 21Mar2021. That was before her birthday so she was 48. Also sees allergist who is the one she saw after her reaction. The allergist was the provider. Obviously, she went to the ER at the hospital she had the shot. Very itchy. Had the first shot 21Mar2021 and had the reaction within 25 minutes of the injection. Started getting very itchy and they kept her there for an hour and a half. Took Benadryl and they just monitored her. Very itchy, stomach felling funny and gassy: Took 2 Benadryl prior to the second injection, which was on 1Apr2021. Around the same time frame, within 25 minutes, started getting very itchy and they started monitoring her. Felt like she had a lot of weight carrying on her back. Felt very, very heavy. Stomach started getting a little funny, nothing came of that, just felt a little uncomfortable and gassy. They monitored her and then, she developed a welt across her chin. Her breathing at that point was fine. They monitored her then she went home. Bounced back the next day and was ok, versus the typical reaction that everyone else gets. The patient did not have any relevant family medical history relevant to adverse events. Treatment included for event very itchy with Benadryl. The patient is allergic to soy and had a reaction to both the Pfizer and Moderna Covid-19 vaccines. Was to understand what she was allergic to in the vaccine. Hoping that there is soy in there to understand why she had a reaction. She would have peace of mind of what is in our shot because now she is eerie of having anything from Pfizer. She cannot have our vaccines anymore.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201307611 same reporter/product, different patient/AE;US-PFIZER INC-202201307496 same reporter/patient, different product/AE/dose;US-PFIZER INC-202201307610 same reporter/patient/product, different dose/AEs;