Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Somnolence, Therapeutic response unexpected
Clinical narrative: MILD GASTROINTESTINAL (GI) UPSET; JITTERY; SLEEPY; MIGRAINE/HEADACHE; MINIMAL SLEEP; CHILLS; TINGLING TO FEET; NUMBNESS TO FEET; INJECTION SITE SORENESS; HIGH FEVER; NERVOUS SYSTEM DISORDER; FLARE UP; LIGHTS GOT BRIGHT/EUPHORIA/FELT LIKE SHE TOOK AMPHETIMINES; VISION GOT SHARPER MOMENTARILY, SPEEDED UP AND WAS THINKING SHARPER; BODY ACHES; PARCHED DRY THROAT; NEUROPATHIC PAIN; This spontaneous report received from a patient concerned a 72-year-old female. Initial information received on 18-NOV-2021 was processed with additional information received on 22-NOV-2021. This case was reassessed as serious based upon new information received from the patient on 22-NOV-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal stenosis, migraines, neuro inflammatory, penicillin allergy, topical sulpha drugs allergy, nonsmoker, and non-alcohol user. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid, proton pump inhibitors (PPIs) and macrogol.  On an unspecified date, the patient previously received initial covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced citrus taste and throat burning (Captured : 20211159138). The patient received a booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported (dose number in series was 2), 1 total administered on 18-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 18-NOV-2021, evening of injection, the patient experienced sleepy as if she took a tranquilizer, slight chills and achy and by 23:00 the patient experienced fever of 99.3 F (high of fever), body aches, parched dry throat, injection site soreness and minimal sleep. On 18-NOV-2021, the patient also experienced "lights got bright/euphoria," neuropathic pain, tingling to feet, numbness to feet, headache, vision got sharper momentarily, "speeded up" and was "thinking sharper" (therapeutic response unexpected) and felt like she took amphetimines. The patient also experienced neuro inflammatory "flare up" (coded as nervous system disorder, and flare up). Laboratory data included: Body temperature ( not provided) 99.3 F, 100.1 F.  On 20-NOV-2021, the patient experienced migraine and the next day (21-NOV-2021) she experienced mild gastrointestinal (GI) upset and jittery.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nervous system disorder, flare up, lights got bright/euphoria/felt like she took amphetimines, body aches, tingling to feet, and numbness to feet on 18-NOV-2021, vision got sharper momentarily, speeded up and was thinking sharper, parched dry throat, sleepy, migraine/headache, minimal sleep, and chills on 20-NOV-2021, mild gastrointestinal (GI) upset, jittery, and high fever on 21-NOV-2021, and injection site soreness on 22-NOV-2021, and had not recovered from neuropathic pain. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211159138.; Sender's Comments: V0: 20211143069-covid-19 vaccine ad26.cov2.s- nervous system disorder, flare up. 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).