Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Feeling hot, Malaise, Neuropathy peripheral, Paraesthesia
Clinical narrative: NEUROPATHY PERIPHERAL; CARDIAC MURMUR; SYNOVIAL CYST; FEELING HOT; PERIPHERAL COLDNESS; PARAESTHESIA; MALAISE; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1464812) concerned a 50 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent condition included seasonal allergies. The patient had no illness at the time of vaccination. The patient experienced drug allergy in past when treated with Erythromycin for an unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on 02-APR-2021 to right arm for prophylactic vaccination. All required follow up attempts have been made. The batch number for covid-19 vaccine ad26.cov2.s has not been provided. Concomitant medications included ascorbic acid (Vitamin-C), curcuma longa rhizome (Turmeric extract), ergocalciferol (Vitamin-D), selenium, tocopherol (Vitamin-E) and Super Omega 3's, all for an unknown indication. On 01-MAY-2021 (reported as about a month after she received vaccination), she started to experience tingling, cold feelings (paraesthesia) in her feet and hands, her feet felt that they were breaking a cold sweat (peripheral coldness), it was very mild about 2 on a scale from 1-10. She noticed a lump on top of her right foot. The lump was diagnosed as a ganglion cyst (synovial cyst). Since 01-MAY-2021, she had peripheral neuropathy in feet and hands, and it spread to her legs and arms. The patient was diagnosed with a heart murmur (cardiac murmur). The doctor did not think that her symptoms were from the vaccine, when she first went to her doctor, so she had been waiting for things to clear up. The patient had another appointment with her doctor next week to discuss her symptoms. The patient was not aware if the vaccine was related to her symptoms. The patient never had either issue before or within the first 12 hours after the vaccination. It was reported that she felt so sick for about an hour like her blood was boiling in the body (feeling hot) and malaise. The patient stated that, the laboratory test would be done in the week of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac murmur, feeling hot, malaise, neuropathy peripheral, peripheral coldness, paraesthesia and synovial cyst was not reported. This report was serious (Other Medically Important Condition).  Additional information was received on 28-SEP-2021. All required follow-up attempts have been made. The Batch number for covid-19 vaccine ad26.cov2.s has not been provided; Sender's Comments: V1: Follow up information received in the current version is regarding all required follow-up attempts have been made. This updated information does not change the prior causality assessment of reported event.   20210751100-COVID-19 VACCINE Ad26.COV2.S-Neuropathy Peripheral. This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.