Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Blood test, Fall, Hallucination, auditory, Mobility decreased
Clinical narrative: Slipped on steps/fall; blood clot from pfizer shot or fall/had a clot on hip; Hip hurt; Delirium after surgery/unable to speak /did not even remember; hearing voices; Psoriasis came back all over back; Could not even touch the nose or rub the legs; Levels of ammonia in liver very high; This is solicited report. (manufacturer control number: 21K-163-3935590-00).  A contactable consumer (patient) reported that a 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly on 15Jun2021 (vaccination age was 53 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Citrate free (40 mg); subcutaneously from 2021 (Batch/Lot number was not reported) to 2021, at Citrate Free; subcutaneously from 2021 (Batch/Lot number was not reported) to an unspecified date, at Citrate Free, all for Plaque psoriasis.  Medical history included smoked and he had quit now, Paranoid schizophrenia, psoriasis from an unknown date and ongoing. The patient's concomitant medications were not reported. On 15Jun2021, patient slipped on the steps and had the Pfizer shot at the same time. And in Jun2021, patient had blood clot in his hip. His hip hurt and it was unbearable. He had hip surgery for blood clot on his hip. After surgery he woke up with delirium in 2021 and was like that for about three weeks. He was unable to speak because of it. He did not even remember that he smoked and he had quit now because he did not remember he smoked. He was put in a nursing home and they drugged him and took him off his Humira. Now his psoriasis had come back all over his back. He was back home now and took one shot and his hands already looked better. When he was in the nursing home, they drugged him and he could not even touch his nose or rub his leg when the physician checked him. He was hearing voices and was sent to the hospital and they got him fixed up. Blood work was done and he put on the right medications. Physician took him off whatever psych medication they had put him on at the nursing home and he was all better. When he was in the nursing home on those psych medication, his levels of ammonia in his liver, were very high. They fixed him up at the hospital when he was sent there, then they sent him back to nursing home and within a week he could not talk anymore. He went back and they gave him the right medication again and checked all his levels. Now he was so much better and was at home. On 30Sep2021, the patient's sister called to report an issue with a Humira shipment they received. The patient's niece was the one present when the issue was encountered. When she opened the box, there was only one pen inside instead of two. Unspecified psych medications were considered as suspect. Seriousness criteria was provided as hospitalized and medical significant. The patient underwent lab tests and procedures which included Levels of ammonia in liver were very high in 2021, blood test: unknown results in 2021, scan: blood clot in Jun2021. The action taken in response to the event(s) for adalimumab was unknown. Treatment was received for blood clot, delirium and psoriasis had come back. The outcome of delirium after surgery, psoriasis came back all over back was not recovered. The outcome for other events was reported as recovering. The reporter's causality for the event(s) of Clot blood and Pain in hip to bnt162b2 was possible; the causality of other events to bnt162b2 was not provided.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate