Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Flushing, Headache, Mass, Musculoskeletal stiffness
Clinical narrative: Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body; Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body; Headache; Face flushing; Quite sore/ Sore arm; Pain in shoulder; Injection site reaction; Stiff neck due to tensing up to pain in shoulder/ Stiff shoulder; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Stiff neck due to tensing up to pain in shoulder/ Stiff shoulder), FLUSHING (Face flushing), MASS (Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body) and RASH (Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TRIAMCINOLONE ACETONIDE (ZILRETTA) injection for an unknown indication and BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.    No acute illnesses when vaccinated. There were no other vaccines taken on day of covid 19 vaccine and no other vaccines taken prior to or after 30 days of covid 19 vaccine.  The patient's past medical history included GI pain (hernia was almost surely the cause of many of the more minor GI pains that resolved w/o antibiotics.), Hernia (a previously undetected hernia (1.5cm x 3 cm) was found; the pocket was cleaned out and the tear repaired.), Joint arthroplasty (TMJ arthroplasty. No recent changes) on 03-Apr-1985, Hysterectomy (ovaries not removed) on 14-Nov-1989, Lymph node dissection (sentinel node dissection, port placement (though updated diagnosis changed and no chemo TX needed)) on 07-Mar-2016, Mastectomy bilateral (right side at my option) on 15-Apr-2016, Port removal (swap out expander for implants AND port removal) on 23-Sep-2016 and Bunionectomy on 25-Jan-2018. Previously administered products included for Breast cancer: Arimidex from 2016 to 28-Apr-2017 and Arimidex (Feeling awful) from 2016 to 28-Apr-2017; for Product used for unknown indication: Shingrix vaccination on 08-Aug-2018 and PFIZER DRUG (Minimal soreness at injection site) on 30-Mar-2022; for Knee arthritis: Hymovis shots on 11-Mar-2021 and Hymovis shots on 18-Mar-2021. Past adverse reactions to the above products included Feeling abnormal with Arimidex; Hot flashes with Arimidex; No adverse event with Hymovis shots, Hymovis shots and Shingrix vaccination; and Vaccination site pain with PFIZER DRUG. Concurrent medical conditions included Drug allergy (Danocrin (significant hives)), Drug allergy (depo-medrol (severe headache, insomnia, several days of hot flushingred faced)), Latex allergy (blistering with prolonged contact), Drug allergy (possible other drug (rash that is currently presumed to be due to new probiotics introduced after multiple rounds of antibiotics in the spring)), Diverticulitis (Subsequent bouts 15AUG2018 (possibly exacerbated by 08AUG2018 Shingrix vaccination), 22JUL2019, 23MAR2021, 23DEC 2021, 17MAR2022) since 28-Apr-2017, Estrogen receptor positive breast cancer (Arimidex was stopped on April 28 2017 due to onset of substantial side effects) since 2016, TMJ syndrome since 1980, Knee arthritis (TX for arthritis in Rt knee: some Hymovis injections and Zilretta injections every 3 months.) since December 2018, AFib, Progesterone receptor positive breast cancer since 2016 and HER2 negative breast cancer since 2016.   On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient started TRIAMCINOLONE ACETONIDE (ZILRETTA) (unknown route) at an unspecified dose. On an unknown date, the patient started BIFIDOBACTERIUM INFANTIS (ALIGN) (unknown route) at an unspecified dose. On 12-Sep-2022, the patient experienced VACCINATION SITE REACTION (Injection site reaction), MUSCULOSKELETAL STIFFNESS (Stiff neck due to tensing up to pain in shoulder/ Stiff shoulder), ARTHRALGIA (Pain in shoulder) and VACCINATION SITE PAIN (Quite sore/ Sore arm). On 16-Sep-2022, the patient experienced FLUSHING (Face flushing) and HEADACHE (Headache). On 23-Sep-2022, the patient experienced MASS (Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body) and RASH (Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Sep-2022, MUSCULOSKELETAL STIFFNESS (Stiff neck due to tensing up to pain in shoulder/ Stiff shoulder) and VACCINATION SITE PAIN (Quite sore/ Sore arm) had resolved. On 20-Sep-2022, FLUSHING (Face flushing) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE REACTION (Injection site reaction) and ARTHRALGIA (Pain in shoulder) had resolved and MASS (Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body) and RASH (Bumps, rash-like 50-60 in all, most around face, neck, shoulder and upper body) was resolving.            Patient received first dose of Moderna COVID-19 vaccine on 27-Jan-2021 at 10am (Lot 029L20A) of 0.5 milliliter on right arm. Patient received second dose of Moderna COVID-19 vaccine on 24-Feb-2021 at 11am (Lot 023M20A) of 0.5 milliliter on right thigh. Patient received third dose of Moderna COVID-19 vaccine on 27-Aug-2021 (Lot 002F21A) of 0.5 milliliter on right arm.  Patient thought the rash was attributable to the introduction of new probiotics (following a lot of antibiotics in the spring and colon surgery), and patient wanted to wait to do another challenge with a new probiotic and that worked like another rash. Patient had done the September probiotic challenge to get more confidence that the introduction of new probiotics was the likely cause of the rashes. So the patient did not think the rash was caused by the vaccine. 4 different probiotic challenges have resulted in a rash. Each time, the rash cleared over then subsequent 1-3 weeks. Patient reported that the introduction of new probiotics seems to have been the triggers 4 times for the 4 rounds of rash. Patient had experienced similar adverse events Sore arm and Stiff shoulder to all flu and COVID vaccine shots.  Patient had experienced similar adverse events Face flushing and  headache but the reaction to depo-medrol was much worse. No previous reaction to any. It was reported that other possible causes of Face flushing and Headache was Zilretta injection on 15-Sep-2022. It was reported that other possible causes of Bumps, rash-like was any drug in previous year contribute (Rash started after an intentional challenge with a different probiotic, Align). Face flushing, headache was recovered approximately on 20-SEP-2022 Rash had faded in approximately 2 weeks.   This case was linked to MOD-2022-628835, MOD-2022-628837, MOD-2022-628840 (Patient Link).