Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: sore arm; developed a big red spot on her left arm/she got a great big red spot that stayed on her arm and it was sore; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6205, expiration date was not reported), via an unspecified route of administration administered in left arm on 04Mar2021 13:20 (at the age of 72-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Lynparza (Batch/lot number:NA0190, Dosage text:150mg, takes two tablets in the morning and two, tablets at night by mouth, Pharmaceutical form(Dosage form) :tablets, Lynparza manufacturer: Optima, NDC number of Lynparza: 00310-0679-12 Expiry Date of Lynparza: Jan 2024) for ovarian cancer stage iii from 04Nov2020, metoprolol (metoprolol 50mg) for blood pressure, simvastatin (Simvastatin for cholesterol 40mg once per day by mouth) for cholesterol, venlafaxine (venlafaxine 37.5mg twice per day) for depression. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL9266, expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Feb2021 as dose 1, single for covid-19 immunization. Patient age at the time of vaccination was 72 years. No additional vaccines administered on same date of the pfizer suspect. No prior vaccinations were received within 4 weeks. It was reported that, a 72-year-old female consumer said she already had both doses of the Pfizer-BioNTech Covid-19 Vaccine. She said she had a sore arm again and developed a big red spot on her left arm after her 2nd dose. She said these symptoms have already subsided and lasted for about 3 days. She said that her main concern is that she is currently taking a cancer management treatment, Lynparza. She said she has been on this medication prior to receiving the vaccine. She said it takes away some of her immune system and wants to know how it could affect the vaccine's efficacy or if she has to stay isolated. Patient had the 1st dose of the Pfizer COVID vaccine on 11Feb2021 and the 2nd dose on 04Mar2021 states the patient is taking three medications and the medication is Lynparza and she is taking four tablets of Lynparza as cancer maintenance pill and it is 150mg and she takes it 12 hours apart and the last one she took was today. The patient took the Lynparza in between the Pfizer COVID vaccines and has taken it since a while back and he heard her say she stopped it today. She stated her questions are does she need to wear a mask now that she has had the Pfizer COVID vaccine and also does the Lynparza affect the efficacy of the Pfizer COVID vaccine. She states she had a big surgery in September 2020 and they wanted her to wait to heal from that before starting the Lynparza and she began taking it on 04Nov2020. She states the ovarian cancer had spread and the Lynparza is supposed to give her maintenance therapy and she has the kind of cancer that comes back and within a year and a half if she was not on the Lynparza, her cancer would come back that fast so being on the Lynparza is giving her an extra year and a half. She asks if taking the Lynparza would lessen the Pfizer Vaccine immunization protection; states is it still wise to wear masks even though she has had the Pfizer vaccine. She declined to provide further contact information for her HCP and said she did not know if ok for consent for contacting the HCP. States for the Pfizer COVID vaccine, the 1st dose lot is EL9266 and the 2nd dose has lot EN6205 and her patient card has no expiry date or NDC written on it. States she got the Pfizer COVID vaccine because they did not want covid and are old and the HCP told her it would not be good if she got covid and it would probably his her pretty hard and her husband also has health issues too and so they were wanting the COVID vaccine and her HCP agreed with them. States she has been on other medicaitons for a while and takes a blood pressure medication Metoprolol 50mg, takes Simvastatin for cholesterol 40mg once per day by mouth, takes a mild antidepressant Venlafaxine 37.5mg twice per day; states she was on other blood pressure medications since 1979 and she was on and off of them since then and some of the blood pressure medications she was on just kind of quit working and it was many years ago and she has no names, dosages or lots, expiry dates or NDC numbers to provide. She states she sees her HCP on the 3rd next month and was seeing him once per month and how sees the HCP every 5 weeks. States her HCP said there is not enough information yet and he did not know if the Lymparza which lowers the immune system somewhat could have an affect on the Pfizer COVID vaccine. She states she had a really sore arm with both doses of the Pfizer COVID Vaccine and for a few days could not lay on her left side and the 2nd dose she got a great big red spot that stayed on her arm and it was sore but this is all cleared up and was there for just a few days and she had nothing bad. She states she wondering because she found out about her ovarian cancer in Mar2020 just before the virus began regarding covid and she had chemo and all that and was isolated and could not be anywhere because chemo takes all the immune system away and she has some immune system but it is lowered due to the Lymparza. States the HCP told her no crowds and told her that this month and she can see people though; states she was diagnosed with ovarian cancer on 10Mar2020 and she does not know the name or lot number of her chemotherapy she had at that time. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.