Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pleurosy in the lungs, diagnosed with Pleura in her lungs; to the full length of her arm, its sore and sensitive in the entire right arm, pain in the fingers; sometimes she can not pick up bottle of water with right hand; radiates to the elbow first; sensitive in  entire right arm; eyes hurt; Heart palpations; sore in right arm; pain in right arm goes from shoulders down to full length of arm; after second vaccine at injection site pain radiating down right arm to elbow; headaches; diagnosed with Covid; This spontaneous case was reported by a consumer and describes the occurrence of PLEURISY (Pleurosy in the lungs, diagnosed with Pleura in her lungs), PAIN IN EXTREMITY (to the full length of her arm, its sore and sensitive in the entire right arm, pain in the fingers), MUSCULAR WEAKNESS (sometimes she can not pick up bottle of water with right hand), PAIN (radiates to the elbow first) and SENSITIVE SKIN (sensitive in  entire right arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (Diabetic type 2), Heart disorder (Heart Condition), Sciatica, Sarcoidosis, Hypertension and Blood cholesterol. Concomitant products included VALSARTAN, OMEPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], DILTIAZEM, TERAZOSIN, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE TIMOLOL) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced COVID-19 (diagnosed with Covid). On an unknown date, the patient experienced PLEURISY (Pleurosy in the lungs, diagnosed with Pleura in her lungs), PAIN IN EXTREMITY (to the full length of her arm, its sore and sensitive in the entire right arm, pain in the fingers), MUSCULAR WEAKNESS (sometimes she can not pick up bottle of water with right hand), PAIN (radiates to the elbow first), SENSITIVE SKIN (sensitive in  entire right arm), EYE PAIN (eyes hurt), PALPITATIONS (Heart palpations), PAIN IN EXTREMITY (sore in right arm), ARTHRALGIA (pain in right arm goes from shoulders down to full length of arm), VACCINATION SITE PAIN (after second vaccine at injection site pain radiating down right arm to elbow) and HEADACHE (headaches). At the time of the report, PLEURISY (Pleurosy in the lungs, diagnosed with Pleura in her lungs), MUSCULAR WEAKNESS (sometimes she can not pick up bottle of water with right hand), PAIN (radiates to the elbow first), SENSITIVE SKIN (sensitive in  entire right arm), PALPITATIONS (Heart palpations), COVID-19 (diagnosed with Covid) and ARTHRALGIA (pain in right arm goes from shoulders down to full length of arm) outcome was unknown and PAIN IN EXTREMITY (to the full length of her arm, its sore and sensitive in the entire right arm, pain in the fingers), EYE PAIN (eyes hurt), PAIN IN EXTREMITY (sore in right arm), VACCINATION SITE PAIN (after second vaccine at injection site pain radiating down right arm to elbow) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Diagnosed with Covid in July2021. In September 2021, SARS-CoV-2 test: negative (Negative) she was tested twice, both tests were negative and negative (Negative) she was tested twice, both tests were negative.         Other concomitant include Humaland. No treatment medications were reported.   This case was linked to MOD-2021-326649 (Patient Link).; Sender's Comments: This case concerns 78-year-old female patient with a history of Type 2 diabetes mellitus (Diabetic type 2) and Heart disorder (Heart Condition), who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 4 after the second dose of Spikevax. Inappropriate schedule of vaccine administered was considered as an additional event. The rechallenge was not applicable as the events happened after the second dose and no additional dosing will be given. The medical history of Type 2 diabetes mellitus (Diabetic type 2) and Heart disorder (Heart Condition), remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.