Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Chest X-ray abnormal, Cough, Ear infection
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; SARS-COV-2 TEST POSITIVE; CHEST X-RAY ABNORMAL; NIGHT SWEATS; RHINORRHOEA; PYREXIA; COVID-19; COUGH; EAR INFECTION; PNEUMONIA; NEURALGIA; PAIN IN EXTREMITY; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System)  concerned a 64 year old female with an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included lung cancer about 8 years ago and concurrent conditions included chronic obstructive pulmonary disease (COPD), asthma, allergy to antibiotics, and mushrooms allergy. The patient received Covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin not reported, batch number: 203A21A expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 to left arm for an unknown indication. Concomitant medications included levothyroxine and vitamins for drug used for unknown indication.  The patient reported that probably about a couple days after receiving the vaccine she got a sore arm and she felt like it hit her nerve and went up to neck. On 09-APR-2021, the patient developed neuralgia, pain in extremity. She was fine for a while and then on 14-SEP-2021, she developed Covid-19 (confirmed clinical vaccination failure) and ended up having pneumonia. With it she had a runny nose, ear infection, night sweats with (high fever) pyrexia , rhinorrhea and then the bacterial pneumonia with a cough. On SEP-2021 patient tested for chest X-ray, which (Abnormal) found pneumonia and on 14-SEP-2021, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test was positive. She visited physician office. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19, chest x-ray abnormal, cough, ear infection, neuralgia, night sweats, pain in extremity, pneumonia, pyrexia, rhinorrhoea, and sars-cov-2 test positive, 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: 90000200121. The suspected product quality complaint has been confirmed to be Void: N: the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the regulatory authority evaluation/investigation performed.  Additional information received from Regulatory authority department on 03-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:This follow-up version updates- Regulatory Authority investigation result.This updated information does not change the prior assessed causality of reported events.   20211061605- Covid-19 vaccine ad26.cov2.s- Pneumonia. This event(s) is considered unassessable. The event(s) 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(s).  20211061605-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