Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Lung disorder, Myalgia, Sleep disorder
Clinical narrative: Arthritis became worse; Gastritis/stomach pain will not go away; Reflux; Weakness; Medical problem with her heart; She has been having to sleep sitting up, but has not been sleeping; a spot that showed up in her lungs associated with the reflux; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis became worse), GASTRITIS (Gastritis/stomach pain will not go away), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux), ASTHENIA (Weakness) and CARDIAC DISORDER (Medical problem with her heart) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoporosis (In the past year she had her bones go from severe osteopenia to osteoporosis. She believed that the osteoporosis was a secondary problem to her other medications treating her stomach pain). Concurrent medical conditions included Arthritis (arthritis in her thumb. She had been giving herself an injection with a pen).    On 20-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis became worse), GASTRITIS (Gastritis/stomach pain will not go away), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux), ASTHENIA (Weakness), CARDIAC DISORDER (Medical problem with her heart), SLEEP DISORDER (She has been having to sleep sitting up, but has not been sleeping), LUNG DISORDER (a spot that showed up in her lungs associated with the reflux) and MYALGIA (muscle pain). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MAALOX [ALUMINIUM HYDROXIDE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency and SUCRALFATE (CARAFATE) at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Arthritis became worse), GASTRITIS (Gastritis/stomach pain will not go away), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux), ASTHENIA (Weakness), CARDIAC DISORDER (Medical problem with her heart), SLEEP DISORDER (She has been having to sleep sitting up, but has not been sleeping), LUNG DISORDER (a spot that showed up in her lungs associated with the reflux) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: showed severe gastritis.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  Patient reported no other vaccinesrecieved in the 4 weeks prior to COVID-19 vaccine. She was sleep sitting up but had not been sleeping. She also had joint pain, muscle pain, and weakness. Her arthritis became worse 4 weeks after receiving the vaccine. She had some medical problem with her heart, and she was planning to see a cardiologist. She also had a spot that showed up in her lungs associated with the reflux. Her pharmacist stated that her stomach pain would not go away.  Company Comment: This spontaneous case concerns elderly female patient, with medical history of arthritis, who experienced the unexpected non-serious AESI of arthritis aggravated, which occurred in the context of the fourth dose of mRNA-1273.222 (BA.4/BA.5) (MODERNA COVID-19 VACCINE, BIVALENT ORIGINAL AND OMICRON BA.4/BA.5). The event occurred on an unknown date, thus, exact latency between vaccination and onset of the events could not be assessed. The patient received all four doses of mRNA-1273 within the appropriate schedule of COVID-19 vaccination. The patient started with stomach pain on the next month after the third dose of mRNA-1273 and then on an unknown date was diagnosed severe gastritis with an endoscope and took famotidine, magnesium hydroxide and sucralfate, which have been improving her symptoms. She had to sleep sitting up, but had not been sleeping. In addition, she had joint pain, muscle pain, and weakness. She had a history of arthritis in her thumb and had been giving herself an injection with a pen. The arthritis became worse 4 weeks after receiving the vaccine. She had some medical problem with her heart and was planning to see a cardiologist. She also had a spot that showed up in her lungs associated with the reflux. The medical history of arthritis could be a confounder for the non-serious events arthritis aggravated. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-699022 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-699022:Monovalent dose