Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Herpes zoster, Lumbar puncture, Meningitis viral
Clinical narrative: MANY BLOOD CLOTS IN RIGHT ARM AND LEFT LEG; VERY SWOLLEN ARM; MENINGITIS VIRAL; BECAME SICKER; SHINGLES; This spontaneous report received from a parent concerned a 24 year old female. Initial information was processed with additional information received on 20-OCT-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included a genetic condition called lymphedema distichiasis (which involves the FOX-C2 gene and is a vascular condition). The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 16-SEP-2021 to right arm for prophylactic vaccination. Concomitant medications included levothyroxine sodium (Synthroid). On 17-SEP-2021, the patient developed a rash and was diagnosed with shingles. On 19-SEP-2021, the patient became sicker. On 20-SEP-2021, at 06:30 AM the patient went to emergency room (ER) and had performed with CT (Computerised tomogram) scan, and was prepared for a spinal tap. The patient was then diagnosed with viral meningitis due to the shingles. On 23-SEP-2021, the patient was released from the hospital with a PICC (peripherally inserted central catheter) line in her right arm and was to receive 2 weeks worth of antibiotic therapy. The patient was hospitalized for 3 days.  On 27-SEP-2021, the patient developed a very swollen arm and due to scheduling complications patient was unable to visit the doctor on (until morning of) 28-SEP-2021. At that time (on 27-SEP-2021), the patient was admitted to hospital and was diagnosed with many blood clots in her right arm. Subsequently, the patient was later diagnosed with blood clots in her left leg as well. 04-OCT-2021, the patient was discharged from the hospital, and was currently taking Eliquis (apixaban) which she will be taking for the next 3 to 6 months. And also reported that, the patient was following up with her hematologist, endocrinologist, and immunologist to determine what could have caused the clots. The reporter directly attributes the clots due to the Janssen COVID-19 vaccine and states that her physician as well states that it probably was due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles, meningitis viral, became sicker, very swollen arm and many blood clots in right arm and left leg was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint number: 90000198195. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as, this record describes an adverse reaction (blood clots) to the product during administration. there was no product quality issue described and does not meet the definition for LOE (lack of effect)) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211038367-Covid-19 vaccine ad26.cov2.s-Meningitis viral ,many blood clots in right arm and left leg ,shingles, became sicker, very swollen arm . 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).