Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Eye pain, Headache, Magnetic resonance imaging
Clinical narrative: Intermittent pain over next months; Bursa inflammation; Adhesive capsulitis; more pain left arm up to left side of head; Pinky & 4th finger,left hand tingling; Intermittent dull / sharp pain left side of head; Pain and stiffness left shoulder and neck; Extreme injection site pain; Pain in upper left of mouth; stiff left shoulder & neck; Pain and stiffness left shoulder and neck; some pain blinking left eye; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pinky & 4th finger,left hand tingling), PAIN (Intermittent pain over next months), BURSITIS (Bursa inflammation), PERIARTHRITIS (Adhesive capsulitis) and ORAL PAIN (Pain in upper left of mouth) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (Dose 2, Batch no: EN6203, event on 10Mar2021) on 09-Mar-2021, pfizer (Dose 2, Batch no: EN6203, event on 10Mar2021) on 09-Mar-2021, Pfizer (Dose 2, Batch no: EN6203, event on 10Mar2021) on 09-Mar-2021, Pfizer (Dose 2, Batch no: EN6203, event on 10Mar2021) on 09-Mar-2021 and Pfizer (Dose 1). Past adverse reactions to the above products included Fatigue with pfizer; Headache with Pfizer; Injection site pain with Pfizer; Nausea with Pfizer; and No adverse event with Pfizer. Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (Darvocet) and Drug allergy (Volaren cream). Concomitant products included FAMOTIDINE, COLECALCIFEROL (D3), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), IRON, PLANTAGO OVATA SEED HUSK (PSYLLIUM SEED HUSK) and MAGNESIUM ASPARTATE, MAGNESIUM CHELATE, MAGNESIUM CITRATE NONAHYDRATE (MAGNESIUM POWDER [MAGNESIUM ASPARTATE;MAGNESIUM CHELATE;MAGNESIUM CITRATE NONAHYDRATE]) for an unknown indication.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced ORAL PAIN (Pain in upper left of mouth), MUSCULOSKELETAL STIFFNESS (stiff left shoulder & neck), NECK PAIN (Pain and stiffness left shoulder and neck), EYE PAIN (some pain blinking left eye), HEADACHE (Intermittent dull / sharp pain left side of head), ARTHRALGIA (Pain and stiffness left shoulder and neck) and VACCINATION SITE PAIN (Extreme injection site pain). On 24-Dec-2021, the patient experienced PARAESTHESIA (Pinky & 4th finger,left hand tingling) and HEADACHE (more pain left arm up to left side of head). On 15-Jan-2022, the patient experienced BURSITIS (Bursa inflammation) and PERIARTHRITIS (Adhesive capsulitis). On an unknown date, the patient experienced PAIN (Intermittent pain over next months). On 06-Nov-2021, ORAL PAIN (Pain in upper left of mouth), MUSCULOSKELETAL STIFFNESS (stiff left shoulder & neck), NECK PAIN (Pain and stiffness left shoulder and neck), EYE PAIN (some pain blinking left eye), HEADACHE (Intermittent dull / sharp pain left side of head), ARTHRALGIA (Pain and stiffness left shoulder and neck) and VACCINATION SITE PAIN (Extreme injection site pain) had resolved. At the time of the report, PARAESTHESIA (Pinky & 4th finger,left hand tingling), PAIN (Intermittent pain over next months), BURSITIS (Bursa inflammation), PERIARTHRITIS (Adhesive capsulitis) and HEADACHE (more pain left arm up to left side of head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, X-ray limb: results not reported Results not reported. On 15-Jan-2022, Magnetic resonance imaging: adhesive capsulitis and bursa inflammation (abnormal) Adhesive capsulitis and Bursa inflammation.         Patient concomitant drug include Probiotics. Patient age at vaccination was 68 years and 5 months. On 19Jan22, patient took steroid injection on left shoulder joint and upcoming steroid injection on 26Jan2022. Injection in left shoulder bursa if pain didn't dissipated.  Company comment:  This case concerns a 68-year-old female patient with no relevant medical history and previous administration of  COVID-19 Vaccine Pfizer BioNTech, who experienced non-serious unexpected AESI of periarthritis, reported as adhesive capsulitis. The event was diagnosed with MRI approximately 2.5 months after the booster dose of the mRNA-1273. Reportedly, the patient had injection site pain, musculoskeletal stiffness and pain including neck and shoulder, headache, fingers and hands tingling. The patient had an MRI which showed adhesive capsulitis and bursitis and started corticosteroid injections as a corrective treatment in the left shoulder joint. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2022: Follow up received contains no new information. On 26-Jan-2022: Follow up received contains no new information.; Sender's Comments: This case concerns a 68-year-old female patient with no relevant medical history and previous administration of  COVID-19 Vaccine Pfizer BioNTech, who experienced non-serious unexpected AESI of periarthritis, reported as adhesive capsulitis. The event was diagnosed with MRI approximately 2.5 months after the booster dose of the mRNA-1273. Reportedly, the patient had injection site pain, musculoskeletal stiffness and pain including neck and shoulder, headache, fingers and hands tingling. The patient had an MRI which showed adhesive capsulitis and bursitis and started corticosteroid injections as a corrective treatment in the left shoulder joint. The rechallenge was not applicable due to occurrence after the booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.