Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fibromyalgia, Haemorrhagic diathesis, Sinus headache, Systemic lupus erythematosus
Clinical narrative: DRUG EFFECT INCOMPLETE/LACK OF EFFECT; SINUS HEADACHE; MOSQUITO BITE; FEAR OF FALLING; DEPRESSION WORSENED; FIBROMYALGIA; ARTIFICIAL CROWN INSERTION; DRUG SPECIFIC ANTIBODY PRESENT; BLEEDING TENDENCY; BLOOD VISCOSITY DECREASED; LUPUS ERYTHEMATOSUS; This spontaneous report received from a patient concerned a 58 year old male of unspecified race and ethnicity. Initial information was processed along with the additional information received on 29-JUL-2022. The patient's weight was 132 pounds, and height was 72 inches. The patient's past medical history included: mosquito bite, and rash, and concurrent conditions included: tobacco user (One to five stick a day), stroke, non alcoholic, atrial fibrillation, and penicillin allergy associated manifestation with rash. The patient was previously treated with acetylsalicylic acid,  On an unspecified date, the patient was previously treated with covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, administered 1 in total on 29-OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Age at time of vaccination 59 years old. On an unspecified date, the patient experienced drug effect incomplete/lack of effect, mosquito bite, fear of falling, sleepiness 20 hours sleep and wake up for 3 hours and again sleep for 20 hours), depression worsened, fibromyalgia, sinus headache, artificial crown insertion, and drug specific antibody present (Dose number in series 2). Laboratory data (dates unspecified) included: Bleeding time longer, Drug specific antibody Present. On 2022, the patient experienced lupus erythematosus, and feeling of despair (Dose number in series 2). On JAN-2022, the patient experienced bleeding tendency (tooth bleed), and blood viscosity decreased lot of bleeding due to thin blood) (Dose number in series 2). On 02-JAN-2022, Laboratory data included: Blood test Not reported. Patient was supposed to have a sinus surgery due to sinus headaches but when the physician made a cut on a soft tissue he said his bleeding time was longer so the surgery was cancelled (Dose number in series 2). Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 40mg per 0.4 ml 1 time every 1 week, from an unspecified date to 06-JUN-2022 for moderate to severe chronic plaque psoriasis, rheumatoid arthritis, and hidradenitis suppurativa. Concomitant medications included apixaban, bupropion hydrochloride, duloxetine hydrochloride, and testosterone.  The patient received 2 other doses of non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 3) (form of admin, route of admin, batch number and expiry were not reported), dose was not reported, administered on an unknown date and on 04-APR-2022 for covid-19 vaccination.  It was unknown whether patient had any adverse events following vaccination with elasomeran (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, was not applicable; and treatment with adalimumab was withdrawn on 06-JUN-2022. The patient had not recovered from lupus erythematosus, blood viscosity decreased, fear of falling, bleeding tendency, and fibromyalgia, and the outcome of mosquito bite, drug effect incomplete/lack of effect, depression worsened, artificial crown insertion, sinus headache and drug specific antibody present was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint; Sender's Comments: V0: 20220754496-covid-19 vaccine ad26.cov2.s-lupus erythematosus, sinus headache. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220754496-covid-19 vaccine ad26.cov2.s-bleeding tendency . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event(s) is considered not related.  20220754496-covid-19 vaccine ad26.cov2.s-drug effect incomplete/lack of effect. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.