Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme abnormal, Hot flush, Hyperhidrosis, Investigation, Nasopharyngitis
Clinical narrative: COVID; Has a lung infection/infection is aspergillus; COVID; COVID Pneumonia; He can't eat; Liver enzymes are up; He can barely walk; Sweating; His temperature gets over 99 degrees; Get so cold; Chills; Violent hot flashes; Shaking; Losing weight; Non-Hodgkin's Lymphoma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Shingles" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure measurement; GLIMEPIRIDE taken for diabetes mellitus. The following information was reported: NON-HODGKIN'S LYMPHOMA (medically significant) with onset Apr2021, outcome "unknown"; WEIGHT DECREASED (non-serious) with onset Apr2022, outcome "unknown", described as "Losing weight"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 PNEUMONIA (medically significant), outcome "unknown" and all described as "COVID Pneumonia"; COVID-19 (hospitalization, medically significant), outcome "recovered", described as "COVID"; ASPERGILLUS INFECTION (hospitalization, medically significant), outcome "unknown", described as "Has a lung infection/infection is aspergillus"; HOT FLUSH (non-serious), outcome "recovered", described as "Violent hot flashes"; TREMOR (non-serious), outcome "unknown", described as "Shaking"; EATING DISORDER (non-serious), outcome "unknown", described as "He can't eat"; HEPATIC ENZYME ABNORMAL (non-serious), outcome "unknown", described as "Liver enzymes are up"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "He can barely walk"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "His temperature gets over 99 degrees"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Get so cold"; CHILLS (non-serious), outcome "recovered". The patient was hospitalized for covid-19, aspergillus infection (start date: 28Feb2022, discharge date: 03Mar2022, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) over 99 degrees, notes: would go up; Hepatic enzyme: (unspecified date) up, notes: Caller states his liver enzymes are up; Diagnosed: (Apr2021) Non-Hodgkin's Lymphoma; (Mar2022) lung infection; SARS-CoV-2 test: (10Apr2022) not testing positive; Weight: (Mar2022) 276 lbs; (Apr2022) 200 lbs. Therapeutic measures were taken as a result of aspergillus infection, hot flush. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Clinical course: The patient was calling in regards to Vfend 200mg tablet. Patient mentioned he is in the hospital for COVID and has a lung infection. Agent reports that the patient was approved for the pro-gram and she was scheduling for his order to be shipped to his home. Agent reports the medication is to treat the infection. Patient confirms details provided by transfer agent. Patient states whatever the pills the doctor had to prescribe. He states he had to call Patient Assis-tance this morning to verify the address. Patient states whatever Pfizer Drug Safety needs. Patient is speaking to someone else in his room and tells the person that he is talking to someone and can't get off this call. Patient Details: Age at event onset: Patient states he was diagnosed with the lung infection 4 weeks ago so he was 72-years-old. Weight: Patient states he was 276 pounds but is now 200 pounds. He states he has lost this weight in the last month. Patient states he is trying to talk to 2 people at once. Patient clarifies that he has been losing weight for a month or 5 to 6 weeks. He states he is losing a half pound to a pound a day be-cause he can't eat. Country: Patient states he hasn't been out of the country. Prescribing HCP details: Patient states he will have to pause and states he couldn't tell Pfizer who his prescribing doctor is for Vfend as he has seen so many doctors. He states he has an Infectious Disease team. Patient states his liver enzymes are up. Event Details: COVID: Patient states he was in the hospital 28Feb2022 and was told he had COVID. He states he stayed in the hospital for 3 days and was sent home. He states he was home about a week but kept getting worse and worse with violent hot flashes and chills. He states that is how the doctors deter-mined he had the infection in his lungs and has been in the hospital ever since. Patient confirms he is still currently in the hospital. Patient states he has received the COVID-19 vaccines and the COVID-19 booster dose. Hospitalization: Patient states he kept getting worse and worse and worse and his wife brought him back to the hospital Saturday night. Patient states his wife withheld has the dates at home. He states he was admitted Sunday, Monday, Tuesday, Wednesday the 28Feb2022. He states the following Saturday his wife brought him back to the hospital. COVID Therapy Dates: Patient states he was told yesterday 10Apr2022 that he is not testing positive for COVID-19 anymore. COVID Outcome: Patient states recovered completely all depends. He states he can barely walk and he was a 276 pound man and now he is 200 pounds.  He will need to regain his strength. Patient states in regards to the recovered completely he doesn't know the answer to that and even the doctors can't tell him. Lung Infection: Patient states he was diagnosed with the lung infection 1 or 2 days after he reentered the hospital the second time. He states the doctor's knew there was another infection and the infection took the doctors a while to find the location. He states by the time the doctors get the samples and take the samples to a lab. Lung infection Outcome: Patient states he will be on the Vfend for the next 3 months. Patient states he is right at the beginning of the lung infection. He states he can't tell one way or another. He states he asked the doctor how does he tell if he is beating this. Patient states he just doesn't know. Hot Flashes: Patient states he was sitting eating breakfast and would get chills and then would grab a sweatshirt to put on. He states he was shaking like he had been left outside on a 30 degree day completely nude. He states then he would take Tylenol then start sweating. He states his temperature would go up and he would receive a couple of Tylenols at the hospital and next thing you would be on fire, then he would be looking for buckets of water to dump on himself. He states then he would get so cold that he couldn't get enough blankets on himself. He states the hot flashes and chills began a few days before his second admission to the hospital. He states he hasn't had any more episodes since his temperature stopped spiking. He states he just has to watch if his temperature gets over 99 degrees and the temperature will lead to the hot flashes and chills. He states if he doesn't take Tylenol then he won't get this violent reaction. He states he went through the series of burning up and then freezing. He states he is not sure if he has recovered completely but the hot flashes and chills have resolved. He states here's the thing the violent hot flashes and chills whatever the Tylenol does to the infection his body goes wild. Patient states he does not have the NDC, Lot number, or Expiration date for the Tylenol that he received in the hospital or at home. He states the Tylenol he took at home was the regular over the counter Tylenol and this Tylenol did the same thing. He states his body felt like his body was on fire. He states if he could have a 5 gallon bucket of water to put on himself, he would have taken the water. Vfend: Patient states he has been on Vfend for 3 or 4 days. He clarifies he has been receiving the Vfend for several days. He states he couldn't even tell Pfizer if he is receiving a pill or if the Vfend is being put in his port. Indication: not provided. Patient clarified COVID diagnosed prior to use of Vfend. No lot number due to product being given in the hospital. Patient states he was diagnosed with Non-Hodgkin's Lymphoma in Apr2021. Product Details: COVID-19 Vaccines: Patient states all of his COVID-19 vaccines were Pfizer. He confirms his first 2 vaccinations and his booster dose. He states he received his first 2 vaccinations last year in Feb2021. He states 6 weeks apart. He states he received the first dose of COVID-19 vaccine in Feb and his second dose of COVID-19 vaccine in Mar2021. He states he received his booster dose of COVID-19 vaccine whenever he was told he could get the booster dose. He states he went right away. Patient states he dose not have exact dates received, NDC, Lot number, or expiration dates for his COVID-19 vaccinations. He states all his vaccination cards are in his desk drawer at home. He states he can have his wife withheld call Pfizer Drug Safety back with the information. Patient asks she can request to speak to and asks what is this call handler's name. Indication: Not provided. Concomitant Medications: Patient states he is also on a drug for chemo to prevent shingles. He states the medication starts with Av and he takes the medication twice a day. Medical Conditions: Patient states nothing besides a worn out 72-year-old body. Test Results: Patient states all he knows is what the doctor's have on record in withheld. He states withheld Hospital. Vaccine Supplemental Form: Patient Age at Time of Vaccination in Years: Patient states he would have been 71-years-old when he received his booster dose of the COVID-19 vaccine. Pfizer Suspect Vaccine and Vaccination Details: Vaccine Lot Number: unknown. Vaccine Lot Expire Date: unknown. Time the Vaccination Was Given: unknown. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Patient states he receives most shots in his left arm. Vaccination Facility Address: Phone: unknown; Patient states here is the sad part, he got a new phone with T-Mobile and he doesn't know how to pull the phone number without disconnecting the call. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Vaccine Name: Pfizer 1st Dose COVID-19 Vaccine Lot Number / Expiry Date: unknown Route, Anatomical Location: unknown No. of Previous Doses: Date: unknown: Age at Immunization if date not available: not provided. Vaccine Name: Pfizer 2nd Dose COVID-19 Vaccine. Lot Number / Expiry Date: unknown. Route, Anatomical Location: unknown. No. of Previous Doses: Date: unknown Age at Immunization if date not available: not provided. Vaccine Name: Pfizer Booster Dose COVID-19 Vaccine: Lot Number / Expiry Date: unknown: Route, Anatomical Location: unknown: No. of Previous Doses: Date: unknown: Age at Immunization if date not available: not provided. Patient states hopefully he will be home in few days and can provide this information. Additional Vaccines Administered on Same Date of the Pfizer Suspect. If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: No. Adverse Event (AE) Details: Provide the time of onset of AE(s): Adverse Event: COVID. Time of Onset: (24-hour clock): unknown. Adverse Event: has a lung infection. Time of Onset: (24-hour clock): unknown. Additional Information: Did any AE(s) require a visit to: Emergency Room? No, Physician Office? No He stated he has to take 4 pills a day: If Yes, which AE(s)? If the patient was hospitalized, how many days was the hospital stay? Patient is currently in the hospital. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination)? None. Family Medical History Relevant to AE(s): No; Patient states the doctor told him this lung infection comes with COVID. Relevant Tests: Unknown. For Lack of Efficacy, request the following information if not included in the initial report. What is the primary infection site? Patient states he would guess the primary infection site would be his lungs. He states the doctor said he probably had COVID-Pneumonia. He states the doctor knew he had another infection. He states that infection is aspergillas. Patient asks does Pfizer Drug Safety know what that is. Patient states he asked the doctor about that and the doctor stated COVID brings that infection. Please specify any secondary site(s) (e.g. empyema): Patient states no, he just knows he tested negative for COVID and now has to fight this virus. Was a culture performed? Unknown; Patient states he has had more blood taken out of him than a gas pump. He states more blood is taken every day. Are there predisposing factors? Patient states not to his knowledge. He states he thought he was vac-cinated and boosted and still wore his mask but got COVID. Patient states when the doctor told him he had COVID, he about fell off the bed. Patient states Pfizer can send an email and he can email the missing information right back. Patient states he just has to wait and see the doctor today and hopefully the doctor can send him enough medication home so he will have the medication till his prescription arrives. Patient states the Vfend won't get to his house till this Friday. Patient asks how far in advance should he order his refills so that he will not run out of medication. Patient states he will take care of the medication refill and will order the Vfend early enough so he doesn't run out. He states he has to take 4 pills a day. Is there a product complaint to report? Yes. Description of Product Complaint: Description of complaint: He was in the hospital 28Feb2022 and was told he had COVID. He has received the COVID-19 vaccines and the COVID-19 booster dose. Call-er states he was told yesterday 10Apr2022 that he is not testing positive for COVID-19 anymore. Product strength and count size dispensed: N/A. Additional lot numbers: unknown. Is a sample of the product available to be returned, if requested (Y/N): N/A. Packaging sealed and intact? N/A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.