Sex: U
Vaccine: COVID19
Symptoms: Painful respiration, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: I am not really good with Tylenol because I hallucinate; I cannot move; Fever; I cannot even breathe in, I have a COPD. So, when I inhale that I have the inhaler (Unspecified Inhaler) it is so painful for inhale in that left side; I cannot even breathe in, I have a COPD. So, when I inhale that I have the inhaler (Unspecified Inhaler) it is so painful for inhale in that left side; I cannot even breathe in, I have a COPD. So, when I inhale that I have the inhaler (Unspecified Inhaler) it is so painful for inhale in that left side; big swollen red in the injection site; big swollen red in the injection site; pain went to my side under the rib area and then the shoulder; pain went to my side under the rib area and then the shoulder; pain went to my side under the rib area and then the shoulder; I am really uncomfortable; I cannot even raise my arm; I am not feeling good though; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; paracetamol (TYLENOL), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HALLUCINATION (medically significant), outcome "unknown", described as "I am not really good with Tylenol because I hallucinate"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "I cannot move"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DYSPNOEA (non-serious), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), PAINFUL RESPIRATION (non-serious), outcome "unknown" and all described as "I cannot even breathe in, I have a COPD. So, when I inhale that I have the inhaler (Unspecified Inhaler) it is so painful for inhale in that left side"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "big swollen red in the injection site"; PAIN (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "pain went to my side under the rib area and then the shoulder"; DISCOMFORT (non-serious), outcome "unknown", described as "I am really uncomfortable"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "I cannot even raise my arm"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good though". The action taken for paracetamol was unknown. Clinical course: When probed if the Nurse (Consumer) was okay: Nurse stated, "No, that was why wanted to call you guys because have this, different side effect of this injection (Confirmed as Pfizer-BioNTech COVID-19 Vaccine). The nurse had this Pfizer. But had Pfizer BioNTech COVID-19 Vaccine. The patient had a fever, patient cannot even breathe in, had a COPD. So, when patient inhale that have the inhaler (Further clarification unknown hence captured as Unspecified Inhaler) it was so painful for inhale in that left side have the left side arm was injected and was fine the first day and the second day had that big swollen red in the injection site and then pretty soon the pain went to my side under the rib area and then the shoulder and then fever. Cannot move and then said do not know what was going on? Patient did not even go to service today. So, patient took Tylenol but not really good with Tylenol because patient hallucinate. So, patient do not really take pain pill (Further clarification Unknown. Hence, not captured in tab). So, was really uncomfortable. Patient cannot even raise arm. So, said was listening to the literature before we talked and said that had a different, it did mentioned the things that am feeling right now. So, that was why patient want to report it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided and temporal relationship, the causal association between the event hallucination and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.