Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Laboratory test abnormal, Loss of consciousness, Lymphocyte count
Clinical narrative: ABNORMAL LABWORK; LOW LYMPHOCYTES; HIGH NEUROCYTES; LOSS OF CONSCIOUSNESS; VASOVAGAL EVENT; ALMOST CONVULSIVE; PROFUSE VOMITING; DISORIENTED; FELT VERY STRANGE; CHILLS; EXTREME FATIGUE; STRANGE HEADACHE ON RIGHT SIDE OF HEAD; This spontaneous report was received from a 54-year-old female patient. The patient's weight was 140 pounds, and height was 62 inches. The patient's concurrent conditions included type 2 diabetes mellitus, fibromyalgia, social alcohol drinker, seasonal allergy, and coronavirus disease (covid-19). The patient had covid in NOV-2020, from which she got severe neurologic effects, and was still not fully recovered from covid and continued to experience severe vertigo, ringing in ears, and taste and smell have still not fully returned at the time of reporting. The patient does not smoke, had no drug abuse/illicit drug use and no drug allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered on left arm on 08-MAY-2021 for prophylactic vaccination. It was unknown if the product was stored in appropriate temperature conditions and if it was properly stored from receipt to administration. No concomitant medications were reported.  On 08-MAY-2021, following vaccination, the patient at first felt totally fine, however, after 4 to 4.5 hours, the patient felt everything was going black and she passed out (loss of consciousness) and vomited profusely. She was out cold for about five minutes and woke up shaking with extreme chills and was almost convulsive following which an ambulance was called. The patient woke up in the back of the ambulance and told the emergency medical technicians (EMTs) that she was vaccinated and the EMTs said it was just a vasovagal event. The patient was taken to the emergency room (ER) and the ER doctor told the same thing. The patient's blood was taken and she was given intravenous (IV) fluids. The patient felt very strange, similar to what she felt at the time she got covid but it was milder. The patient felt disoriented, extreme fatigue, and a strange headache on the right side of head. At the hospital that day, a computed tomogram (CAT) scan was done but, it was clear. The patient was then released on the same day. On 09-MAY-2021, the bloodwork results came and was very alarming (abnormal lab work; detailed results not provided). The patient then reached out to her healthcare professional (HCP) for lab review and they were very concerned about the results. Her lymphocytes were low and 'neurocytes' were high (as reported), 'everything was off'. The patient was asked to wait for few days for more lab tests be taken during that time. The patient was told if it gets better it would be vaccine-related and if it does not it could be leukemia. Her disorientation, fatigue, and headache lasted for about 5 days until around 13-MAY-2021. The blood work started to return to normal after a few more days, and the HCP confirmed it was vaccine-related. The patient stated that her research showed that the adverse events could be a result of her covid, and not vaccine-related. All of her adverse events went on within the first week following the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, vasovagal event, almost convulsive, profuse vomiting, and chills on 08-MAY-2021, and disoriented, felt very strange, extreme fatigue, strange headache on right side of head, abnormal labwork, low lymphocytes, and high neurocytes on 13-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210730727-Covid-19 vaccine ad26.cov2.s-Loss of consciousness, Vasovagal event, Almost convulsive, Profuse vomiting, Disoriented, Felt very strange. 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). V0: 20210730727-Covid-19 vaccine ad26.cov2.s-Chills ,Extreme fatigue, Strange headache on right side of head. This event(s) is labeled per RSI and is therefore considered potentially related.