Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Decreased appetite, Headache, Hypersensitivity, Malaise
Clinical narrative: Itching; Hives; Headache; Patient kind of feel a little nauseous; Allergic reaction; Decreased appetite; Patient kind of feel like she was unwell; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Oct2024 at 10:20 as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VALSARTAN; METFORMIN HCL; AMLODIPINE BESILATE; ATORVASTATIN; METOPROLOL SUCCINATE; HYDRALAZINE; AMLODIPINE. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itching"; URTICARIA (non-serious), outcome "unknown", described as "Hives"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown", described as "Patient kind of feel a little nauseous"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction"; DECREASED APPETITE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Patient kind of feel like she was unwell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, urticaria.  Additional information; Patient stated, "she was trying to find out, she was having some of the allergic reaction, the side effects due to the Covid shot, that patient took two days ago." Name of the vaccine: Consumer stated, "It's the Comirnaty." Consumer stated, "What her concern was, how long does the reaction last? Patient was doing the itching. Patient was just concerned about the itching and the hives. How long that lasts?" Height: Patient stated, "5 feet 3 and 3 quarters." Date and time: Patient stated, "17Oct (Clarified as 17Oct2024) and It was in the morning around 10:20 (AM)." LOT# and Expiry date: Patient stated, "she don't think that's on here. No, she do not know what it was." Patient was not probed for any 4 weeks prior vaccination. Lab tests (Last 2 weeks): Patient stated, "she had a mammogram on the 8th (Later clarified as 08Oct2024)." Patient stated, "she had a bone density scan too. Patient had mammogram and bone density scan. Patient did not even have time to look and see. Does that affect you? Does that affect you if Patient have had lab work done? Patient got a spread sheet that was about 7 or 8 pages, password for different account. so, you have to kind of, when you login but patient would like to know (Incomplete sentence)." Treatment: Patient stated, "No, she was just using alcohol and the pharmacist did tell me to make sure he drink plenty of water." Concomitant medications and any other medical conditions: Patient stated, "she take high blood pressure medication." Name of medication (High blood pressure): Consumer stated, "My mammogram was negative. My bone density scan was normal. Metoprolol succinate, that's I guess, it's Extended Release, 200 milligrams, once daily. Patient take Hydralazine, 50 milligrams, four times a day. Amlodipine, patient take that in the evening, after dinner." Patient further stated, "Do you need to know other side effects patient was having like, the headache, decreased appetite. In addition to the itching and hives, patient was having a headache and patient kind of feel a little nauseous and then, patient kind of feel like she was unwell, so you want to feel like you just want to lay down and patient had decreased appetite yesterday, patient didn't have no appetite but I knew I needed to eat because she take medication, so she went up, ate something. Patient didn't start eating up until 7 o'clock yesterday because she knew I needed to take my medication. Patient din't take her medication on the empty stomach. Patient don't feel around like that. Decreased appetite, nauseous and just headache and this feeling." Treatment (Side effects): Patient stated, "No, the only thing she was doing was taking Tylenol and patient did take a Tylenol and for the itching, patient was just taking a cotton ball and rubbing herself with alcohol because if she don't I would scratch her skin off." Patient was informed that everything was mentioned in the report.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.