Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: SARS-COV-2 TEST NEGATIVE; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; SARS-COV-2 TEST POSITIVE; ABDOMINAL DISCOMFORT; AGEUSIA; ANOSMIA; EAR CONGESTION; SINUS CONGESTION; SENSORY LOSS; SNEEZING; LACRIMATION INCREASED; NASAL CONGESTION; RHINORRHOEA; PAIN; CHILLS; FATIGUE; NAUSEA; PYREXIA; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1749362) concerned a 55 year old female. Initial information was processed along with additional information received on 12-OCT-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to venomous bite like spider or bee bite. The patient had no current illness. The patient experienced drug allergy when treated with pseudoephedrine hydrochloride for product use for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609) dose was not reported, 1 total, administered on 25-MAR-2021 in left arm for product use for unknown indication. Concomitant medication included magnesium used for unknown indication.  On 25-MAR-2021, 8 hours after the vaccine, the patient experienced low-grade temperature, chills, nausea, body aches, and fatigue which lasted for 24 hours. On 09-SEP-2021, the patient experienced COVID symptoms (low-grade temperature, chills, nausea, body aches, and fatigue) same way the symptoms started after getting the vaccine which lasted for 24 hours too. The patient also had runny nose, low grade temperature for 4 days. On 09-SEP-2021 ,the patient got a COVID-19 virus test which came positive and contacted her physician. The homeopathic physician provided natural remedies for treating COVID. On 09-SEP-21, the patient experienced watery eyes, loss of taste and smell, fatigue, irritable stomach, sneezing and congestion in nose, sinuses, and ears. On 23-SEP-2021, the patient again had COVID-19 virus test which came negative. The patient still had stomach issues. The patient visited physician's office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rhinorrhoea on 13-SEP-2021, and pain, chills and nausea on 26-MAR-2021, had not recovered from pyrexia, abdominal discomfort, ageusia, anosmia, Covid-19 , ear congestion, fatigue, lacrimation increased, nasal congestion, sars-cov-2 test negative, sars-cov-2 test positive, sensory loss, sinus congestion, and sneezing, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197208 The suspected product quality complaint has been confirmed to be undetermined. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from a regulatory authority on 05-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1 Additional information in this version updates of Product quality complaint investigation result. This updated information does not change the previously assessed causality of event.   20211017493-Covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS