Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe allergic reaction" after 3 days; Had vertigo; Lightheadedness; Palpitations, limitations to physical activity; painful stiff joints in hips/painful stiff joints in pelvic area; couldn't bend over/couldn't walk; had to stop physical activity; Headaches; Could hardly walk; Diagnosed with myalgia rheumatica, pelvic pain, join pain and stifness; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Diagnosed with myalgia rheumatica, pelvic pain, join pain and stifness) and HYPERSENSITIVITY (Severe allergic reaction" after 3 days) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concurrent medical conditions included Blood pressure high. Concomitant products included QUINAPRIL for Blood pressure high, METFORMIN, ATENOLOL and ATORVASTATIN for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA (Diagnosed with myalgia rheumatica, pelvic pain, join pain and stifness) (seriousness criterion medically significant) and GAIT INABILITY (Could hardly walk). On an unknown date, the patient experienced HYPERSENSITIVITY (Severe allergic reaction" after 3 days) (seriousness criterion medically significant), VERTIGO (Had vertigo), DIZZINESS (Lightheadedness), PALPITATIONS (Palpitations, limitations to physical activity), JOINT STIFFNESS (painful stiff joints in hips/painful stiff joints in pelvic area), HYPOKINESIA (couldn't bend over/couldn't walk), DECREASED ACTIVITY (had to stop physical activity) and HEADACHE (Headaches). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form and MAGNESIUM OXIDE for Adverse event, at a dose of UNK dosage form. At the time of the report, POLYMYALGIA RHEUMATICA (Diagnosed with myalgia rheumatica, pelvic pain, join pain and stifness) and JOINT STIFFNESS (painful stiff joints in hips/painful stiff joints in pelvic area) was resolving and HYPERSENSITIVITY (Severe allergic reaction" after 3 days), VERTIGO (Had vertigo), DIZZINESS (Lightheadedness), PALPITATIONS (Palpitations, limitations to physical activity), GAIT INABILITY (Could hardly walk), HYPOKINESIA (couldn't bend over/couldn't walk), DECREASED ACTIVITY (had to stop physical activity) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell sedimentation rate increased: high (High) sedimentation rate (which came high sedimentation).         Laboratory data included  blood tests, ultrasound, blood clot tests with unknown result, sedimentation rate (which came high sedimentation). No treatment was provided. The patient experienced Headaches, painful stiff joints in hips and pelvic area, couldn't bend over, couldn't walk, had to stop physical activity, diagnosed with polymyalgia rheumatica. Consumer states the pain in pelvic area is due to severe allergic reaction, which started 3 days after getting the vaccine.  Prednisone helped a bit with the adverse reactions.  Company Comment: This case concerns a  78-year-old, female patient with no relevant medical history, who experienced the unexpected event of polymyalgia rheumatica and hypersensitivity. The event occurred approximately 3 days after the second dose of Spikevax. The patient states the pain in pelvic area is due to severe allergic reaction. However, diagnosis of polymyalgia rheumatica was made based on the same symptoms the patient had. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report. FU information received on 14Sep2021 does not change company causality assessment".   This case was linked to MOD-2021-314573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received, included patient demographics updated. Laboratory data added. Concomitant medication added. Additional events added.; Sender's Comments: This case concerns a  78-year-old, female patient with no relevant medical history, who experienced the unexpected event of polymyalgia rheumatica and hypersensitivity. The event occurred approximately 3 days after the second dose of Spikevax. The patient states the pain in pelvic area is due to severe allergic reaction. However, diagnosis of polymyalgia rheumatica was made based on the same symptoms the patient had. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report. FU information received on 14Sep2021 does not change company causality assessment".