Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Inflammation, Limb discomfort, Necrosis, Pain
Clinical narrative: is blue, she is worry it could be necrosis, has this happened with other vaccine , but not turning blue; was in the ER. on Friday night and she is having some continued reactions; feels like she is having a very sever reaction; severe abdominal pain; and a sharp pain all the way down to her abdomen; continuing in her arm, is huge and it was pink and it's now turning blue; had a sharp pain under her left breast; blood pressure was low; had a lot of inflammation, and is not severe but is ongoing; on her arm she had wheal as high as an inch; little soreness; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient. Other Case identifier(s): MOD22-017670 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Jun2022 as dose number unknown (booster), single (Lot number: 059A22A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Thyroid; "Hypertension" (unspecified if ongoing), notes: more than 20 years ago; "Known allergies:antibiotics" (unspecified if ongoing); "Known allergies:iodine" (unspecified if ongoing); "COVID-19", start date: Jan2022 (unspecified if ongoing), notes: Has patient ever had COVID + test or diagnosis? Unsure, but think had it on Jan2022; "Known allergies:sulfa" (unspecified if ongoing), notes: Known allergies:sulfa; "gastric sleeve surgery", start date: 09Apr2022 (unspecified if ongoing), notes: gastric sleeve surgery. Concomitant medication(s) included: ATACAND; PREVACID; METOPROLOL; DULOXETINE; COLACE; MAGNESIUM; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; PROBIOTICS. Past drug history included: Keflex, reaction(s): "Known allergies:Keflex", notes: Known allergies:Keflex; Minocycline, reaction(s): "Known allergies:Minocycline", notes: Known allergies:Minocycline. Vaccination history included: moderna (1st booster, lot number: 027721B), administration date: 10Dec2021, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 30Jun2022, outcome "not recovered", described as "little soreness"; HYPOTENSION (non-serious) with onset 01Jul2022, outcome "not recovered", described as "blood pressure was low"; LIMB DISCOMFORT (non-serious) with onset 01Jul2022, outcome "not recovered", described as "continuing in her arm, is huge and it was pink and it's now turning blue"; INFLAMMATION (non-serious) with onset 01Jul2022, outcome "not recovered", described as "had a lot of inflammation, and is not severe but is ongoing"; BREAST PAIN (non-serious) with onset 01Jul2022, outcome "not recovered", described as "had a sharp pain under her left breast"; VACCINATION SITE URTICARIA (non-serious) with onset 01Jul2022, outcome "not recovered", described as "on her arm she had wheal as high as an inch"; ABDOMINAL PAIN (non-serious) with onset 01Jul2022, outcome "not recovered", described as "severe abdominal pain; and a sharp pain all the way down to her abdomen"; HYPERSENSITIVITY (non-serious) with onset 01Jul2022, outcome "not recovered", described as "was in the ER. on Friday night and she is having some continued reactions; feels like she is having a very sever reaction"; NECROSIS (medically significant) with onset 04Jul2022, outcome "not recovered", described as "is blue, she is worry it could be necrosis, has this happened with other vaccine , but not turning blue". The events "is blue, she is worry it could be necrosis, has this happened with other vaccine , but not turning blue", "was in the er. on friday night and she is having some continued reactions; feels like she is having a very sever reaction", "severe abdominal pain; and a sharp pain all the way down to her abdomen", "continuing in her arm, is huge and it was pink and it's now turning blue", "little soreness", "had a sharp pain under her left breast", "blood pressure was low", "had a lot of inflammation, and is not severe but is ongoing" and "on her arm she had wheal as high as an inch" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (01Jul2022) low; Computerised tomogram abdomen: (01Jul2022) did not saw anything.  Clinical course: Caller stated that she had second booster and it was the Moderna vaccine on Thursday of last week, believes that would be 30Jun2022 and is having some very severe reactions, and actually was in the ER. On Friday night and is having some continued reactions that are usual and would like to talk to someone about that if could please is having some severe abdominal pain did go to ER and was checked out for several things but it's continuing in arm, is huge and it was pink and it's now turning blue. So she has concerns about possible [unintelligible) arm. Ask for a call back as soon as possible, would appreciate it. Personal information, and stated that is a retired pharmacist, and was someone to get a follow up stated that received her vaccination last Thursday 30Jun2022 at 4PM EST, and had a little soreness and on Friday morning the 01Jul2022 had a sharp pain under left breast, and a sharp pain all the way down to abdomen and has a gastric sleeve surgery on the 09Apr2022, and doctors told to go to the ER because is not relative to the surgery, and blood pressure was low.Had a CT of abdomen, did not saw anything, and had a lot of inflammation, and is not severe but is ongoing. And on arm had wheal as high as an inch, and today on the 04Jul2022 is blue, is worry it could be necrosis, has this happened with other vaccine, but not turning blue, and has severe allergies to penicillin and antibiotics, and feels like is having a very sever reaction. Also original vaccination was with was Pfizer, and had only two boosters from Moderna, the first booster was on state that the 10Dec2021 with lot number 027721B and the second booster 30Jun2022 with lot number 059A22A. Concomitant medications are blood pressure medication, atacand, prevacid, metoprolol, thyroid medication, bariatric vitamins, duloxetine, colace, magnesium, vitamin D, vitamin b12 and probiotics.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event Necrosis 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.