Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Confusional state, Facial paralysis, Fatigue, Herpes virus infection
Clinical narrative: experienced increasing and moderately severe trigeminal nerve pain on left side of face; increasing fatigue; confusion; Reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose; Reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose; Vision blurred on left eye; photosensitivity; I lid round this was reduced and affected slightly drooping; Heightened response on 07Mar dose; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunization. The patient's relevant medical history was not reported. No known allergies. There were no concomitant medications, also reported as no other medications in two weeks.  No other vaccine in four weeks. No COVID prior vaccination. Vaccination history included: BNT162b2 (First dose, Batch/lot number: WN6201, Anatomical Location: Arm Left), administration date: 14Feb2021, when the patient was 45-year-old, for COVID-19 Immunization, reaction(s): "Regular chills", "fatigue", "fever". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 25Mar2021, outcome "recovered with sequelae", described as "Heightened response on 07Mar dose"; FACIAL PARALYSIS (medically significant) with onset 25Mar2021, outcome "recovered with sequelae", described as "I lid round this was reduced and affected slightly drooping"; HERPES VIRUS INFECTION (non-serious), HERPES ZOSTER (non-serious) all with onset 25Mar2021, outcome "recovered with sequelae" and all described as "Reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose"; VISION BLURRED (non-serious) with onset 25Mar2021, outcome "recovered with sequelae", described as "Vision blurred on left eye"; CONFUSIONAL STATE (non-serious) with onset 25Mar2021, outcome "recovered with sequelae", described as "confusion"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered with sequelae", described as "increasing fatigue"; PHOTOSENSITIVITY REACTION (non-serious) with onset 25Mar2021, outcome "recovered with sequelae", described as "photosensitivity"; TRIGEMINAL NEURALGIA (non-serious) with onset 27Mar2021, outcome "recovered with sequelae", described as "experienced increasing and moderately severe trigeminal nerve pain on left side of face". The events "i lid round this was reduced and affected slightly drooping", "heightened response on 07mar dose", "experienced increasing and moderately severe trigeminal nerve pain on left side of face", "increasing fatigue", "confusion", "reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose", "vision blurred on left eye" and "photosensitivity" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of facial paralysis, condition aggravated, trigeminal neuralgia, fatigue, confusional state, herpes virus infection, herpes zoster, vision blurred, photosensitivity reaction included Valcyclovir. Clinical course was reported as, Regular chills, fatigue, fever etc. from the first dose in February. Heightened response on 07Mar2021 dose. On 27Mar2021, the patient experienced increasing and moderately severe trigeminal nerve pain on left side of face. Patient lid round this was reduced and affected slightly drooping, increasing fatigue and confusion. Reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose. Vision blurred on left eye and photosensitivity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.