VAERS 1368678
JANSSEN · COVID19 (COVID19 (JANSSEN)) · Charge 202A21AHRSA
- Staat
- WA
- Alter
- 43,0
- Geschlecht
- M
- Eingang
- 01.07.2021
- Impfdatum
- -
- Beginn
- 29.05.2021
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- IM / LA
Symptomtext
CONFIRMED COVID-19 INFECTION; STOMATITIS; CONTUSION; RASH; FATIGUE; SARS-COV-2 TEST POSITIVE; PLATELET COUNT DECREASED; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1368678); concerned a 43-year-old male. The patient's height, and weight were not reported. The patient had no known drug allergies, had no current illness and had no other known comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21AHRSA, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAY-2021 in left arm for prophylactic vaccination. Concomitant medications included ibuprofen. On 29-MAY-2021, the patient was admitted to hospital with a platelet count 0 (platelet count decreased). Patient was presented with fatigue, mouth sores (stomatitis) and body rash and extensive bruising (contusion). Patient was also tested positive for covid-19. Patient was hospitalized for 7 days. Laboratory data included: Platelet count (NR: not provided) Decreased (0), and SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This report was associated with product quality complaint: 90000182747. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed. Additional information was received from Regulatory Authority on 22-JUN-2021. The following information was updated and incorporated into the case narrative: Added product quality complaint investigational resolution and narrative updated accordingly.; Sender's Comments: V1: Additional information updated include product quality complaint investigational resolution. This updated information does not alter the causality of previously reported events. 20210624567-Covid-19 vaccine ad26.cov2.s-Contusion, confirmed covid-19 infection, sars-cov-2 test positive, fatigue, platelet count decreased, rash and stomatitis. This events are considered unassessable. The events 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 events.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Fatigue
- Hospital-Tage
- 7,0
- Labordaten
- Test Date: 20210529; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive; Test Date: 20210529; Test Name: Platelet count; Result Unstructured Data: 0
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Comments: Patient had no known drug allergies,had no current illness and had no other known comorbidities.
- Andere Medikamente
- IBUPROFEN
- Allergien
- -
- Vorherige Impfungen
- -