Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Condition aggravated, Groin pain
Clinical narrative: did run a fever; pain in her groin; back pain; leg pain / pain running up and down her legs / pain in her arm that was minor from the vaccine site; joint pain; itchiness in stomach and back; getting worse by the day, and not better (like joint pain, back pain, itchiness in stomach and back); feels like she is getting the flu; pain in her arm that was minor from the vaccine site; cramps and pain in her legs and back; not feeling good; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Nov2024 as dose 1, single (Lot number: LM2223) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "metastatic melanoma stage 3" (unspecified if ongoing), notes: recurred 25 years ago; "blood clots" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "allergic to buffer solution in IV contrast" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer comirnaty 23-23 (DOSE 6 (BOOSTER), SINGLE. Lot: HH3221), administration date: 12Dec2023, when the patient was 64-year-old, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE. Lot: GI3275), administration date: 09Dec2022, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE. Lot: FP7138), administration date: 01Aug2022, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE. Lot: FJ8762), administration date: 08Dec2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 20Mar2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE. Lot: EN6204), administration date: 10Mar2021, when the patient was 61-year-old, for Covid-19 immunization; Flu (she had been getting flu shots and vaccines for years), for Immunization; Vaccine, for Immunisation, reaction(s): "high fever (104°F)". The following information was reported: BACK PAIN (non-serious) with onset Nov2024, outcome "not recovered"; MUSCLE SPASMS (non-serious) with onset Nov2024, outcome "unknown", described as "cramps and pain in her legs and back"; INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2024, outcome "unknown", described as "feels like she is getting the flu"; CONDITION AGGRAVATED (non-serious) with onset Nov2024, outcome "unknown", described as "getting worse by the day, and not better (like joint pain, back pain, itchiness in stomach and back)"; PRURITUS (non-serious) with onset Nov2024, outcome "not recovered", described as "itchiness in stomach and back"; ARTHRALGIA (non-serious) with onset Nov2024, outcome "not recovered", described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset Nov2024, outcome "unknown", described as "leg pain / pain running up and down her legs / pain in her arm that was minor from the vaccine site"; MALAISE (non-serious) with onset Nov2024, outcome "unknown", described as "not feeling good"; VACCINATION SITE PAIN (non-serious) with onset Nov2024, outcome "unknown", described as "pain in her arm that was minor from the vaccine site"; GROIN PAIN (non-serious) with onset Nov2024, outcome "unknown", described as "pain in her groin"; PYREXIA (non-serious) with onset 22Nov2024, outcome "unknown", described as "did run a fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had a complex immunological history, including metastatic melanoma stage 3, which recurred 25 years ago. Particularly had previously had an experimental vaccine for metastatic melanoma 25 years ago and ever since then had very a strong interesting immune reaction and felt like she was getting the flu but had no fever and had aches, pains and felt miserable and was masking now for 4 years. She described being highly sensitive to medications overall, and adverse reactions due to her small size (130 pounds). In the past, she experienced a high fever (104°F) after receiving a vaccine. As a teacher, she was frequently exposed to COVID-19. She got a shot of the booster on 22Nov2024 and, currently, she was experiencing back pain and leg pain and was concerned that she might be allergic to some of the vaccine components. She wanted to confirm whether the formulation has remained the same. Patient was worried maybe they changed one of the buffers or something in the formulation and she was reacting to it and was kind of bordering going to an urgent care but was not sure they can do anything and she wanted to check in first. Patient was allergic to buffer solution in intravenous (IV) contrast also. Clarified she did run a fever starting on 22Nov2024 afternoon; immediately after getting the vaccine she started running a fever and it went up to like 99 something and it was not a major fever. She had been getting flu shots and vaccines for years and this was the only time she had pain in her groin and pain in her back and pain running up and down her legs and pain in her arm that was minor from the vaccine site. She had cramps and pain in her legs and back and it was getting pretty bad and she was starting to feel like she might be running a fever again and now this was day four and she was getting itching on her stomach. Patient was really not feeling good. She was at work with the worst back ache in her life and cramps in her legs and was worried with her medical history about blood clots and she was getting kind concerned. Patient asked for some epidemiological data to support the duration of some of her symptoms she was been having in the last 4 days, which she expressed to be getting worse by the day, and not better (like joint pain, back pain, itchiness in stomach and back). Patient asked what timeframe was it considered advisable to go to urgent care if symptoms worsen or what was the maximum number of days reasonably attributed to vaccine side effects rather than something else. Patient mentioned that she had arthritis and osteoporosis, and wondered if that could potentially be interacting in the adverse reactions she was experiencing.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400310873 same patient, different AE/dose;