Age: 28.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Gait inability, Head injury, Hyperhidrosis, Hypersomnia, Hypotension
Clinical narrative: Drug ineffective; he was suffering from COVID symptoms,; he was tested for COVID and came positive; I thought he had died and he was all sweat, he was very disoriented, he could not walk; fainted completely just because of the syncope; he fainted, he hit on his head; he hit up the wall and he tried to grab it because he fainted; face went white, his eyes were open, that he would not respond; we have to get him on an ambulance to the hospital with blood pressure of 80/40; his blood pressure systolic was 80 and diastolic was in 40; he turned white, his lips turned grey, he would not respond for few minutes, he completely got all sweated and that happened three times; he was found to be dehydrated; he has been sleeping a lot since the 23 he was constantly sleeping; he lost his appetite and he is feeling some loss of taste, he feels that things do not taste like they used to taste, that he hardly does have a taste; he was quite catatonic; two hours before I have seen like his foot nails, I had noticed them like grey, not very white; he was very weak; I thought he had died and he was all sweat, he was very disoriented, he could not walk; I thought he had died and he was all sweat, he was very disoriented, he could not walk; I thought he had died and he was all sweat, he was very disoriented, he could not walk; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the parent.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: EW0196) at the age of 28 years as dose 2, single for covid-19 immunisation; ibuprofen (ADVIL [IBUPROFEN]) (Batch/Lot number: unknown) at 200 mg; dextromethorphan hydrobromide, guaifenesin (ROMPE PECHO DM) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, LOT# EW0177), administration date: May2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 23Dec2021, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 23Dec2021, outcome "unknown", described as "he was suffering from COVID symptoms,; he was tested for COVID and came positive"; NEAR DEATH EXPERIENCE (medically significant), HYPERHIDROSIS (non-serious), DISORIENTATION (non-serious), GAIT INABILITY (non-serious) all with onset 23Dec2021, outcome "unknown" and all described as "I thought he had died and he was all sweat, he was very disoriented, he could not walk"; SYNCOPE (medically significant) with onset 23Dec2021, outcome "unknown", described as "fainted completely just because of the syncope"; HEAD INJURY (non-serious) with onset 23Dec2021, outcome "unknown", described as "he fainted, he hit on his head; he hit up the wall and he tried to grab it because he fainted; face went white, his eyes were open, that he would not respond"; HYPOTENSION (non-serious) with onset 23Dec2021, outcome "unknown", described as "we have to get him on an ambulance to the hospital with blood pressure of 80/40; his blood pressure systolic was 80 and diastolic was in 40"; PALLOR (non-serious) with onset 23Dec2021, outcome "unknown", described as "he turned white, his lips turned grey, he would not respond for few minutes, he completely got all sweated and that happened three times"; DEHYDRATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "he was found to be dehydrated"; HYPERSOMNIA (non-serious) with onset 23Dec2021, outcome "unknown", described as "he has been sleeping a lot since the 23 he was constantly sleeping"; DECREASED APPETITE (non-serious) with onset 23Dec2021, outcome "unknown", described as "he lost his appetite and he is feeling some loss of taste, he feels that things do not taste like they used to taste, that he hardly does have a taste"; CATATONIA (non-serious) with onset 23Dec2021, outcome "unknown", described as "he was quite catatonic"; NAIL DISCOLOURATION (non-serious) with onset 23Dec2021, outcome "unknown", described as "two hours before I have seen like his foot nails, I had noticed them like grey, not very white"; ASTHENIA (non-serious) with onset 23Dec2021, outcome "unknown", described as "he was very weak". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (23Dec2021) 80/40; blood test: (unspecified date) normal; computerised tomogram: (unspecified date) unknwon results; oxygen saturation: (unspecified date) 92; sars-cov-2 test: (23Dec2021) positive; (23Dec2021) positive. The action taken for ibuprofen and dextromethorphan hydrobromide, guaifenesin was unknown. Therapeutic measures were taken as a result of covid-19, near death experience, syncope, head injury, hypotension, pallor, dehydration, catatonia, nail discolouration, asthenia, hyperhidrosis, disorientation, gait inability.  Clinical course: The patient had been very ill days before with the lot of cough, aches and nasal congestion and aches in his body in his feet and feeling nausea until this. Just before the patient fainted, he had taken two Advil 200 mg each like ten minutes not before and he had taken a teaspoon of a syrup  the patient mother had purchased, he had taken it like 1 hour before brand name Rompe Pecho. One hour before he felt symptoms that he was nauseous and he was having his lunch he felt nausea he stood up from where he was eating, towards the bathroom to vomit and suddenly the next thing the patient mother heard was something from the wall that fall and it was because he hit up the wall and he tried to grab it because he fainted there in the floor which was his first fainting, then came two others which was 'unreal', the third one was 'unreal'. Well he was taken to the hospital, he was stabilized and arrived like at 01:30 or 2:00, he was discharged seven hours after. The patient was hydrated, he was found to be dehydrated to rehydrate it, so it was the normal saline he has two IV pushed. He was taken to isolation, and they did not put him on any oxygen assistance mechanism. The patient was discharged on the 23Dec2021 having to take Vitamin C 6000 mg, 3000 mg in the morning and 3000 in the afternoon, which he has not taken that many (later pharmacist stated as he was taking only 2000 a day), he has taken less, he was discharged with Azithromycin 500 mg, 3 tablets for to take once for 3 days (pharmacist stated 1 tablet per day for 3 days only). He was also discharged with having to take Dologesic (later pharmacist stated this medication for discomfort and some fever to keep the fever in control) which was having acetaminophen and anti-histaminic, the patient was also discharged with one tablet of Zinc without specifying the dose, he was also recommended to take 'Tussmel' which was really, a mixture for the decongestant and all that and patient mother did not give him that, he was having Tylenol  every 6 hours two 500 mg Tylenol and well he was on fever, he was given the Medrol 4, the Medrol pack which has the 21 tablet the medicine prednisolone 4 mg, Medrol pack (pharmacist confirmed this as  21 tablet that are taken on certain frequency for 6 consecutive days  which are  methylprednisolone 4 mg tablet) and zinc tablet are 50 mg (further not clarified). On 27Dec2021, it was the first day, the patient had hardly a cough because he kept coughing till yesterday (26Dec2021), the patient had cough like four time in the whole day, that was all, he has not have a fever, he feels more energetic, he feels great. But he has been sleeping a lot since the 23 he was constantly sleeping, you know he would wake up, he lost his appetite and he was feeling some loss of taste, he feels that things do not taste like they used to taste, that he hardly does have a taste.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the events of Drug Ineffective, COVID-19,  Near Death experience and syncope and the suspect product of BNT162B2 cannot be completely ruled out. 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.