Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Injection site pain, Insomnia, Myalgia
Clinical narrative: shortness of breath; Left knee burning sensation; Foggy feeling in head; itchness all over; large bruise on arm where shot was given; hives on face and chest; Severe joint all over body; Severe nerve/neurological pain; shoulder blade pain, hip pain, joints exploding with pain; Nerve pain in both arms and legs; discomfort; Very interrupted sleep; severe muscle pain in calves and upper arms; hot flushes; Eating normally though not that hungry; muscular pain in her back, lower back pain; severe pain; neck pain; dizziness; temperature goes up and down though she did not use a thermometer,; muscular pain in her trunk, sever muscle pain, dull aches,; headache; pain in her arm of the injection; tired, tiredness, extermly tired; Arm still swollen; arm still red; sore arm; Severe muscular pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm still swollen), HOT FLUSH (hot flushes) and INSOMNIA (Very interrupted sleep) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (bactrim). Concomitant products included VITAMIN C [ASCORBIC ACID], CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM) and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN MSM [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE;METHYLSULFONYLMETHANE]) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 PERIPHERAL SWELLING (Arm still swollen), ERYTHEMA (arm still red), PAIN IN EXTREMITY (sore arm), MYALGIA (Severe muscular pain all over body) and FATIGUE (tired, tiredness, extermly tired). On 11-Mar-2021, the patient experienced NECK PAIN (neck pain), DIZZINESS (dizziness), ARTHRALGIA (muscular pain in her back, lower back pain), MYALGIA (severe pain), MYALGIA (muscular pain in her trunk, sever muscle pain, dull aches,), HEADACHE (headache), INJECTION SITE PAIN (pain in her arm of the injection) and PYREXIA (temperature goes up and down though she did not use a thermometer,). On 12-Mar-2021, the patient experienced HOT FLUSH (hot flushes) and DECREASED APPETITE (Eating normally though not that hungry). On 13-Mar-2021, the patient experienced INSOMNIA (Very interrupted sleep), DISCOMFORT (discomfort) and MYALGIA (severe muscle pain in calves and upper arms). On 14-Mar-2021, the patient experienced NEURALGIA (Nerve pain in both arms and legs). On 16-Mar-2021, the patient experienced ARTHRALGIA (shoulder blade pain, hip pain, joints exploding with pain). On 17-Mar-2021, the patient experienced ARTHRALGIA (Severe joint all over body) and NEURALGIA (Severe nerve/neurological pain). On 18-Mar-2021, the patient experienced PRURITUS (itchness all over), VACCINATION SITE BRUISING (large bruise on arm where shot was given) and URTICARIA (hives on face and chest). On 22-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head) and BURNING SENSATION (Left knee burning sensation). On 24-Mar-2021, the patient experienced DYSPNOEA (shortness of breath). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form; IBUPROFEN (NUROFEN (P)) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 23-Mar-2021, DECREASED APPETITE (Eating normally though not that hungry) had resolved. At the time of the report, NECK PAIN (neck pain), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm still swollen), HOT FLUSH (hot flushes), INSOMNIA (Very interrupted sleep), NEURALGIA (Nerve pain in both arms and legs), FEELING ABNORMAL (Foggy feeling in head), DISCOMFORT (discomfort), PRURITUS (itchness all over), VACCINATION SITE BRUISING (large bruise on arm where shot was given), URTICARIA (hives on face and chest), BURNING SENSATION (Left knee burning sensation), DYSPNOEA (shortness of breath), ERYTHEMA (arm still red), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (muscular pain in her back, lower back pain), MYALGIA (severe pain), MYALGIA (muscular pain in her trunk, sever muscle pain, dull aches,), HEADACHE (headache), INJECTION SITE PAIN (pain in her arm of the injection), FATIGUE (tired, tiredness, extermly tired), PYREXIA (temperature goes up and down though she did not use a thermometer,), ARTHRALGIA (shoulder blade pain, hip pain, joints exploding with pain) and MYALGIA (severe muscle pain in calves and upper arms) outcome was unknown and MYALGIA (Severe muscular pain all over body), ARTHRALGIA (Severe joint all over body) and NEURALGIA (Severe nerve/neurological pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood test: normal (normal) blood tests tests were normal. On 15-Mar-2021, Urine analysis: normal (normal) urine tests were normal.         Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient demographics updated, medical history added,lab test added, dose details added, concomitant details added, treatment drugs added, events added.