Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Injection site erythema, Malaise, Pain in extremity
Clinical narrative: flushing; heart rate irregular; redness/erythema; felt weak and legs were "rubbery" and felt unsteady, weak; heart rate was fast; checked her blood pressure and it was low; arm was sore for over a week; light headed and was dizzy for 6-8 hours; didn't feel too well for a couple of weeks; injection site had a big red circle which was very hot to touch; Headache; Tired for several days, still tired...felt weak; just kind of tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for over a week), HEART RATE INCREASED (heart rate was fast), HYPOTENSION (checked her blood pressure and it was low), ASTHENIA (felt weak and legs were "rubbery" and felt unsteady, weak) and DIZZINESS (light headed and was dizzy for 6-8 hours) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Novacaine: Numbness lips, hands,feet), Drug allergy (Sumycin: Numbness lips, hands,feet), Blood pressure abnormal and Reflux esophagitis. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) for Blood pressure, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for Bone disorder (NOS), CENTRUM FOR WOMEN for Vitamin supplementation.   On 14-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021 at 1:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for over a week), HYPOTENSION (checked her blood pressure and it was low), DIZZINESS (light headed and was dizzy for 6-8 hours), MALAISE (didn't feel too well for a couple of weeks), INJECTION SITE ERYTHEMA (injection site had a big red circle which was very hot to touch), HEADACHE (Headache) and FATIGUE (Tired for several days, still tired...felt weak; just kind of tired). On 17-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate was fast) and ASTHENIA (felt weak and legs were "rubbery" and felt unsteady, weak). On 17-Mar-2021 at 1:00 PM, the patient experienced FLUSHING (flushing), HEART RATE IRREGULAR (heart rate irregular) and ERYTHEMA (redness/erythema). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 14-Mar-2021 for Headache, at a dose of 1 dosage form. On 18-Mar-2021 at 10:00 AM, FLUSHING (flushing), HEART RATE IRREGULAR (heart rate irregular) and ERYTHEMA (redness/erythema) had resolved. On 28-Mar-2021, MALAISE (didn't feel too well for a couple of weeks) and FATIGUE (Tired for several days, still tired..felt weak; just kind of tired) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore for over a week), HEART RATE INCREASED (heart rate was fast), HYPOTENSION (checked her blood pressure and it was low), ASTHENIA (felt weak and legs were "rubbery" and felt unsteady, weak), DIZZINESS (light headed and was dizzy for 6-8 hours), INJECTION SITE ERYTHEMA (injection site had a big red circle which was very hot to touch) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: low (Low) hypotension. On 17-Mar-2021, Heart rate: high (High) heart rate was fast.         This case was linked to MOD-2021-064419, MOD-2021-064419 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow -up received on 17-MAY-2021 where outcome of the events were  added On 09-Aug-2021: Follow -up received on 09-AUG-2021 containing Non significant FUP: reporter's email id has been updated On 11-Aug-2021: followup received on 11-AUG-2021 included no new information. On 14-Aug-2021: Significant follow up received on 14-Aug-2021- added patient medical history, concomitant medications and new events heart rate irregular, flushing and redness/ erythema added.