Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Malaise, Pruritus, Stress
Clinical narrative: she does not feel well; Illness; weak, does not have energy; stressful; she itches from head to toe; This is a spontaneous report received from a contactable consumer. This 61-year-old consumer (patient) reported that she received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number; EN6207, Expiration date: not provided) via an unspecified route of administration on 18Mar2021 12:00 and second dose on 08-APR-2021 11:30 (Lot number: EW0150) both as a single dose for COVID-19 immunisation. Patient medical history included Metformin 500mg once per day for type 2 diabetes and began taking it 5-6 years ago, Valsartan 80mg for high blood pressure and takes it once per day and began it about the same time of 5-6 years ago, Allopurinol 300mg as needed and began taking it about 4 years ago for gout. No family history was reported. No Relevant tests were reported. No additional vaccines were administered on Same Date of the Pfizer Suspect product administered. No other medication taken within 4 weeks Prior to vaccination. No Investigation Assessment was provided. On 18Apr2021, the patient experienced itches from head to toe. She had a reaction to the Pfizer Vaccine and has been stressing since 18Mar2021 and stated that she went to the HCP because she had a reaction to the vaccine and the HCP gave her a Zpack and she felt a little better. She went back to take the 2nd dose of the Pfizer Vaccine on 08Apr2021, and she itches from head to toe and talked to her pharmacist and they said it was ok to take the 2nd dose of the Pfizer Vaccine. Patient said that she reacted to something she taken or ate, and she does not know what it is and today she does not feel well and stressful today. She stated the itching began the day she took the Pfizer Vaccine and she had to sit for 15 minutes and the itching started that night and that was why she went to HCP and the itching is about the same, she stated the Pfizer vaccine made her so sick and does not know if it was affecting her organs and she can't stop itching. No further details provided by the caller. Other medication given by her HCP was Hydroxyzine 25mg and suggested to take one, three times per day but does not take it three per day because it made her sleepy and she took one of the Hydroxyzine already. She said Hydroxyzine was in an orange pharmacy bottle and does not have a lot number, expiry date or NDC. She said, she had no lot numbers, expiry dates or NDC for the Zpack and threw it away when she finished taking it. Her HCP also gave her Montelukast Sodium 10mg and she took it once per day by mouth and was almost finished and does not know when she began taking it and it was in an orange pharmacy bottle. Caller states she was calling to ask Pfizer to let her know something and she was weak, does not have energy and does not know what was in the Pfizer Vaccine; states they gave her a paper with the components of the vaccine listed on it and she does not know what prompted her to have a reaction to it. Caller states the purpose of this call was nothing; states she just needed to know what to do about this reaction and about the itching; states she saw her HCP already and couldn't stop itching and went to the HCP, but the itching is still there. Reporter seriousness was unspecified for she itches from head to toe. Patient was not hospitalized due to event occurred. Patient visited the HCP office due to AE occurred. The outcome of the event pruritus was not recovered and outcome was unknown for the other events (Malaise, asthenia, stress, and illness).  Caller was provided with the report reference number, contact information and hours of operation for Covid Line and timings of working hours. Description of complaint: Vaccine Supplemental Form completed in additional context. States the itching began the day she took the Pfizer Vaccine and she had to sit for 15 minutes and the itching started that night and that's why she went to HCP and the itching was about the same. Caller states she was calling to ask Pfizer to let her know something and she was weak, does not have energy and does not know what is in the Pfizer Vaccine, states they gave her a paper with the components of the vaccine listed on it and she does not know what prompted her to have a reaction to it. Caller states the HCP gave her was Hydroxyzine 25mg and suggested to one, three times per day but does not take it three per day because it makes her sleepy and she has taken one of the Hydroxyzine already and stated that Hydroxyzine was in an orange pharmacy bottle and does not have a lot number, expiry date or NDC.  No follow-up attempts are needed. No further information is expected.