Sex: U
Vaccine: COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. Smaller break out same 10 days after first shot; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 07Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician (patient) from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscularly, administered in the right arm on 16Feb2021 at 12:00 (Batch/Lot number was not reported) as a single dose, and then dose 2 intramuscularly, administered in in the right arm on 09Mar2021 at 12:00 (Batch/Lot Number: EN6199) as a single dose for COVID-19 immunisation. There were no prior vaccinations. The patient's medical history included hyperimmune from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 26Feb2021 at 12:00, the patient experienced herpes zoster ophthalmic (medically significant); described as: herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. Smaller break out same 10 days after first shot. The event required a visit to a physician office after the second instance of the herpes zoster. On 26Feb2021 at 12:00, the patient experienced herpes zoster ophthalmic which did not require treatment and was recovered with sequel on 10Apr2021 (as reported). On 17Apr2021 at 08:00, the patient had herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. The clinical course was reported as follows: After the first dose, the patient who was hyperimmune, contacted Pfizer to ask if the second COVID vaccine dose should be delayed or reduced due to the "major reactions to the first dose." Upon follow-up information received on 07Jun2021, the patient reported: had a "herpes zoster infection of the trigeminal ophthalmic branch 40 days after the second dose of bnt162b2. Smaller break out same 10 days after first shot. Never experienced zoster before Pfizer vaccine. Second breakout required medication (antiviral) for two weeks." The patient did not undergo lab tests. Therapeutic measures were taken as a result of herpes zoster ophthalmic which included acyclovir for 14 days (for the 17Apr2021 instance). The clinical outcome of the event, herpes zoster ophthalmic, was recovered on 30Apr2021 (as reported).; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported herpes zoster ophthalmic cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.