Sex: M
Vaccine: COVID19
Symptoms: Drooling, Dysphagia, Swelling face, Tremor
Clinical narrative: EXTRAPYRAMIDAL EFFECT (TREMORS); FACIAL SWELLING; EXCESSIVE DROOLING; INABILITY TO SWALLOW; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight was 140 pounds, and height was 68 inches. The patient's past medical history included: psychotic episode (patient's parents were unsure if it was from marijuana, he had this episode or from mental breakdown), and aggressive behaviour (patient showed aggressive behaviour with the hospital staff. They tried to give him medication but was uncooperative thus he was sent to mental facility and he got discharged on 08-JUL-2021). The patient received haloperidol decanoate (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from JUL-2021 to JUL-2021 for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: unknown) dose was not reported, 1 total, administered on 08-JUL-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, patient's mother noticed he was having tremors, so she asked medical doctor to stop haloperidol decanoate, so they discontinued the haloperidol decanoate and pushed fluids to get it out of his system. On 27-JUL-2021, tremors got worse, so his parents took him to the emergency room. On 28-JUL-2021, the patient was discharged (as per his mother, the discharge note stated extrapyramidal effect and they also suggested to visit psychological medical doctor.). On 01-AUG-2021, the patient was not able to swallow, and the tremors were really bad. His parents were got panicked and they again took him to the emergency room. On 02-Aug-2021 around 17:00, he got discharged. Psychologist gave him lorazepam and another medication via intravenous (IV) and his tremors stopped. When patient came home, the tremors reoccurred again (full body tremor which occurred all day). On an unspecified date, his mother also stated that he experienced excessive drooling and facial swelling. The patient also took diazepam, but it was not working. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with haloperidol decanoate was withdrawn on JUL-2021. The patient had not recovered from facial swelling, and extrapyramidal effect (tremors), and the outcome of inability to swallow and excessive drooling was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210815258-Covid-19 vaccine ad26.cov2.s- Inability to swallow, Extrapyramidal effect (tremors). 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). V0:20210815258-Haldol (haloperidol decanoate unspecified)-Inability to swallow. 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). V0:20210815258-Haldol (haloperidol decanoate unspecified)- Extrapyramidal effect (tremors). This event(s) is labeled per RSI and is therefore considered potentially related.