Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin D dimer, Fraction of inspired oxygen, Glomerular filtration rate, Haemoglobin
Clinical narrative: Unknown, was given for hypoxia twice a day; Caller says that the patient was diagnosed with ARDs; Shortness of breath; COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a contactable other hcp. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Feb2021 as dose 2, single for covid-19 immunisation. Medical history included hypertension, diabetes, coronary artery disease, CABG, hyperlipidaemia, high cholesterol. Concomitant medications included pravastatin (PRAVASTATIN) taken for blood cholesterol increased, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; carvedilol (CARVEDILOL) taken for hypertension, start and stop date were not reported. The patient previously took bnt162b2 dose 1 on Jan2021 for covid-19 immunization. The patient experienced covid-19 pcr test positive on 15Jul2021, shortness of breath on 17Jul2021, unknown, was given for hypoxia twice a day on an unspecified date, caller says that the patient was diagnosed with ards on an unspecified date with outcome of unknown. The patient was hospitalized for shortness of breath, unknown, was given for hypoxia twice a day, caller says that the patient was diagnosed with ards from 17Jul2021 to an unknown date. Patient stated, this patient was hospitalized, Seriousness: Medically significant. He says that the patient had tested positive 15Jul as an outpatient, then came to the hospital 17Jul2021 and was admitted, and then was an ICU transfer on 24Jul2021 when he was admitted his needs for oxygen increased, so they transferred him Med-Surg to the ICU 24Jul2021. patient was diagnosed with ARDs, his PF ratio was 94. Caller denies that patient had any cardiovascular, gastrointestinal, vascular, renal, cerebrovascular, haematological including no DIC no thrombocytopenia. Reporter denies patient had any dermatological or neurological systems affected. This patient had gotten worse since he was admitted but had stable since transfer to the ICU. Patient had symptomatic COVID after receiving both doses of Pfizer COVID-19 vaccine. Caller says he works in the ICU and they have three patients that were just admitted with COVID after having the Pfizer COVID-19 vaccine. He says there could be waning of immunity and he wanted to get a third dose. He says that they haven't tested their antibodies, and all but one of those patients are over 65 and have multiple comorbidities. He says one of those patients was 49 and had an increased BMI, which he wants to say it was a BMI of 45. He says that patient was an undiagnosed diabetic when they came into the hospital, with an A1C 6.5 which was right there on the threshold. Caller says that one of the patients was 79. Caller is only able to complete most of a report for the first patient who is 65 before he had to end the call. NDC/LOT/EXP and dates given for Pfizer COVID-19 vaccinations of his patients is unknown. Further details in additional context. The patient underwent lab tests and procedures which included angiogram was extensive bilateral ground glass opacities but no pulmonary embolism, blood creatinine was normal, fibrin d dimer was 4.4, fraction of inspired oxygen was 100%, glomerular filtration rate was normal, haemoglobin was 14 or 16, oxygen saturation was 96 % , pao2/fio2 ratio was 94, platelet count was greater than 200, respiratory rate was 30 breaths/minute, sars-cov-2 test positive: positive on 15Jul2021 , urine analysis was unkown result(they were clean with no ketones, leucoesterase, or nitrites on that), white blood cell count was 12.6, x-ray was multifocal opacities. Patient received treatment of Dexamethasone 10mg IV the patient was started on high dose steroids, 10mg of Dexamethasone IV, NDC/LOT/EXP: Unknown, was given for hypoxia twice a day for 5 days, then they will taper it for 5 days after that to 10mg daily IV. Patient received Remdesivir, NDC/LOT/EXP: Unknown, for the indication of active COVID infection. patient received 5 doses of this. Dose/Strength: Unknown, the normal dosage, since the infectious disease doctor orders it, for 5 days IV, one dose daily. Convalescent plasma: Caller says that on 21Jul the patient was given one unit FFP or convalescent plasma, which they get theirs form the Blood Bank. Indication was Unknown, he was guessing that they thought he didn't have enough antibodies, and those tests are still pending. Azithromycin, NDC/LOT/EXP: Unknown, and Rocephin, NDC/LOT/EXP: Unknown, as antibiotics that were stopped after he didn't have Procalcitonin levels. He says that the Azithromycin was started 17Jul2021 when he was admitted, then the Rocephin started July 24Jul2021 with his ICU transfer. He says that the Azithromycin was stopped after 5 days, and they started Rocephin which they stopped yesterday once Procal came back negative. the dose for Azithromycin was 500mg IV once a day and the Rocephin was one gram IV daily. The outcome of event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The possibility of COVID-19, drug ineffective, dyspnoea, hypoxia, and ARDS, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination 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.,Linked Report(s) : US-PFIZER INC-202100957229 same reporter, different patient, same drug, similar events