Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Eye infection, Feeling abnormal, Headache, Herpes zoster
Clinical narrative: blood platelets increased to over 800; had the worst headache; did an angiogram on her head thinking it could be anything and everything was clear; it was so bad.; the eyes were infected with it; Pain; Shingles; It even got in her eyes it was a lot of mess; This is a spontaneous report from a contactable nurse (patient, self-reported). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7533 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 16Apr2021 (age at vaccination: 67 years), as a single dose for COVID-19 immunization at hospital. They even kept her after administering the vaccine until 9:28 am. She went that morning for the first dose. No further details provided. The patient's medical history included ongoing high platelets. Concomitant medications were not reported. Historical vaccine included hepatitis shot (but that was 8 weeks later not 4 weeks, it was months before getting the Covid shot), via an unspecified route of administration, on an unspecified date for immunization. The patient reported that she received first dose of Pfizer Covid vaccine 16Apr2021 and was scheduled to receive second dose 14May2021 but developed Shingles. The patient reported she had shingles for months and then her blood platelets increased to over 800 on an unspecified date. For the past three weeks patient reported seeing hematologist to get platelets down. The patient wanted to know could she receive the second dose of Pfizer Covid vaccine, was there an issue with waiting long to get second dose, and if increased platelets would effect receiving second dose. When vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine should only be administered as an intramuscular injection. The patient reported that shortly after the first one on 06May2021, she broke out with shingles on her face and was told didn't come for the second vaccine. It was really bad and for 2 months it's been an ongoing problem with the shingles. It even got in her eyes it was a lot of mess on an unspecified date in May2021 and wanted to know if she could get the second shot. She has looked on the CDC website after getting the shingles and still taking the eye drops for her eyes. Her platelets spiked up to 800. The people were talking about blood clots with possible side effects with the vaccine. She went to the Hematologist for her high platelets, but she has had history of high platelets before getting the vaccine and was on medication and it spiked. Platelets had been 500 and now it's up to 800 and now it's down. The doctor had put her on 3 of the Hydroxyurea 500mg and was scheduled to see her in 2 more weeks. She thought her platelets were down and the shingles was resolved, and everything were resolved. Later clarified she was put on steroid drops for her eyes after she was diagnosed with shingles and given 3 prescriptions of Acyclovir because it was so bad. She was having a senior moment when trying to recall name of medication given for shingles. Later provides medication given was Acyclovir. She had 3 prescriptions of that it was also given in the emergency room and she took that, and the family practice provider told her to keep taking it because she still had bad break outs and her ophthalmologist also told her to keep taking it and gave her more because the eyes were infected with it. Unable to provide NDC, Lot, or expiry for any Acyclovir prescription and steroid drop. It was the worse thing she every had. Had been to the emergency room twice and has never been to the emergency room ever and she was almost 70. She ended up going there because of the shingles and pain and she had the worst headache on an unspecified date. They did an angiogram on her head thinking it could be anything and everything was clear on an unspecified date. Stated things with shingles started on 06May2021 and she went to the emergency room on 07May2021. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Clarified again, that her condition with the high platelets were diagnosed several years ago, about 4 years before she received the Covid vaccine and it has nothing to do with the shot. She also had been on the Hydroxyurea before the Covid vaccine, since 2018. Finished up the previous bottle the Hydroxyurea and the most recent bottle she provides the discard after date of 28May2022 from the orange (Pharmacy name) pharmacy bottle. Again, mentioned after the shingles, even though the platelets had been stable in past, they spiked. She had been takin the Hydroxyurea 500mg 1 capsule daily and that kept the levels stable and now she was taking 3 capsules daily to try to get the platelet count back in line because it could cause high risk for stroke and blood clots. Unable to provide NDC, Lot, or expiry for bottle when taking 1 capsule daily of Hydroxyurea. Stated even the news says it could cause high risk of stroke and blood counts with high platelets and that was her main concern. Thinks high platelet count could have been caused by shingles. No further details provided. On 07May2021, the patient experienced pain. The events required a visit to emergency room and physician office visit. It was reported that relatedness of drug to all reaction(s)/event(s) by global introspection method of assessment were unrelated. There was a Product Complaint and description of Product complaint included after the shingles, even though the platelets had been stable in past, they spiked. She had been takin the Hydroxyurea 500mg 1 capsule daily and that kept the levels stable and now she is taking 3 capsules daily to try to get the platelet count back in line. Unable to provide NDC, Lot, or expiry for bottle when taking 1 capsule daily of Hydroxyurea. Was diagnosed with shingles and given 3 prescriptions of Acyclovir and steroid eye drops because it was so bad. Unable to provide NDC, Lot, or expiry for any Acyclovir prescription and steroid drop. Product strength and count size dispensed: 500mg. Additional lot numbers: n/a, Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided. Outcome of the events was shingles was recovered on an unspecified date in 2021 and it even got in her eyes it was a lot of mess was not recovered. Outcome of the events blood platelets increased to over 800, had the worst headache, and pain was recovering and for all other events, it was unknown.  Information about lot and batch number was requested.; Sender's Comments: Based on known mechanism of action of the drugs, the events of (thrombocytosis, herpes zoster, ophthalmic herpes, pain and headache are assessed as not related to Suspect drug and more likely due patient medical history of thrombocytosis.