Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, SARS-CoV-2 test, Suspected COVID-19, Throat irritation, Vaccination failure
Clinical narrative: SCRATCHY THROAT; LITTLE CHILLS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 59 year old female of unspecified ethnicity. Initial information was processed along with the additional information received on 07-MAR-2022. The patient's height, and weight were not reported. The patient's past medical history included: In 2019, the patient got covid-19, received an antibody infusion in JAN-2020 and had no other illness at that time, and concurrent conditions included: high blood pressure, alcohol user, non-smoker, and sciatic nerve. The patient had no known allergies.  The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin was not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced scratchy throat and had tested positive in a PCR (polymerase chain reaction) test which indicated suspected covid-19 infection (mild), and suspected clinical vaccination failure (dose number in series: 1). On 08-DEC-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm for prophylactic vaccination. Concomitant medications included paracetamol (Tylenol) and other anti-inflammatory drugs for sciatic nerve. On 31-DEC-2021, few weeks after receiving the booster vaccination, the patient had taken a covid-19 virus home rapid test which was positive, and had scratchy throat which indicated suspected covid-19 infection, and suspected clinical vaccination failure (dose number in series: 2). The patient's entire family had tested positive. On 02-MAR-2022, the patient was exposed to a peer who had tested positive for covid-19 and the patient experienced scratchy throat, and little chills (dose number in series: 2). The patient had not taken a test for covid-19. The patient stated that she had covid-19 three times so far. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure, scratchy throat and little chills was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000220543. This case, involving the same patient is linked to 20220314408 (dose number in series: 1).; Sender's Comments: V0: 20220312273- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.