Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chillsPatient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; Patient was unable to go to work due to disorientation, confusion, headache, and chills; bronchitis; This is a spontaneous report from a contactable Pharmacist.  A 67-year-old male patient received second dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at 07:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old. Lot number was EL3248. Medical history included Cerebrovascular accident (CVA), Hypertension, Coronary artery disease (CAD), Transient ischaemic attack, Myocardial infarction, migraine induced stroke like symptoms, seizures. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX), atorvastatin calcium (ATORVASTATIN), cetirizine hydrochloride (CETIRIZINE), Clonazepam, Diclofenac sodium, valproate semisodium (Depakote), docusate sodium (COLACE), lansoprazole, lisinopril, metoprolol succinate (TOPROL XL), morniflumate (FLOMAX), tadalafil (CIALIS). The patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 12:30 at single dose in left arm for COVID-19 immunisation at the age of 67-year-old; lot number EL0140. Patient missed worked on 03Feb2021 due to effects from COVID vaccine. Patient was unable to go to work due to disorientation, confusion, headache, and chills on 04Feb2021. The patient's employee health department advised the patient's family to send patient to be seen by emergency department (ED). Per ED note patient had complaint of intermittent confusion and disorientation, and fever. Symptoms started after he received his second Covid vaccine. Patient was alert and oriented when seen by ED physician. Patient described symptoms as coming and going, have been worse when he first wakes up. Patient has a past history of seizures and transient ischemic attack (TIA). Provider admitted making sure he was not having further seizures or TIA. Patient was observed and discharged on 05Feb2021. Per discharging provider the patient had some mild low-grade fever with negative cultures on unknown date. On 03Feb2021, nasal swab resulted negative. Provider unsure if fever due to vaccine or mild case of bronchitis (04Feb2021), patient discharged on a ZITHROMAX pack, antibiotics-one dose of Zosyn, Vancomycin, Rocephin. The patient was treated for the events. The patient recovered from the events. The patient did not have covid-19 prior to vaccination; the patient was tested for covid-19 post vaccination (nasal swab, negative). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever and other reported events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.