Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Vaccination site pain, Vision blurred
Clinical narrative: Nausea/ She notes her nausea as being "awful"; Severe pain in the arm, really hurts./ injection site pain in her arm; My eyes shortly after getting the vaccine got blurrier/ She has worsening blurry vision; I feel terrible/ I didnt know it was going to be this bad; This is a spontaneous report from a non-contactable consumer (patient) medical team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 07Jul2021 16:30 (Batch/Lot number: Not provided, NDC number: Not provided) as single dose for COVID-19 immunization. The patient had history of cataracts and she was in a car accident 2 weeks ago in Jun2021. Concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced worsening blurry vision, severe nausea and injection site pain in her arm. Reporter seriousness was unspecified. Caller would like to know if the vaccine contains "steroids", and the response was advised caller per attached document and advised that according to the ingredient list, steroids was not listed. Caller stated that she had nausea and would like to know if Ginger Ale would help relieve her symptom. She noted her nausea as being "awful". Caller agreed to transfer to hospital however disconnected before call agent was available to take the call and had the calls merged together. Caller noted having "severe pain in the arm, really hurt. It was not mild". Advised caller per PI; Adverse reactions nausea (1.1 %) as well as Adverse reactions were noted regarding injection site pain. LAB-1457-10.0 Revised: 25Jun2021. Advised caller that Pfizer was unable to make individual treatment recommendations and that her HCP would be the best to provide her with further guidance regarding her symptoms and possible treatment. Consumer calling stating she received a dose of the Pfizer COVID19 Vaccine yesterday 07Jul2021 1630. Caller reported "people said her that arm would be sore". Her question today was were there any reports of the vaccine affecting eyes, she would more specifically like to know since her having a history of cataracts already could the vaccine make it worse. She stated "her eyes shortly after getting the vaccine got blurrier". Caller also asked if there was any information or reported of the "shot affecting her breasts and the way they look". Caller also spoke on having nausea that was "awful" as well as "severe" arm pain. Attempted to transfer caller to hospital call center after calling being a little reluctant to do so initially, she stated "what good would it do". Spoke with hospital nurse. Caller disconnected from the call prior to being connected with hospital to file safety report. Caller declined to provide additional demographics other than her first name, therefore unable to contact caller back for full report. Will Transmit to safety for reported of AE. Advised caller, after review of the Information for Pfizer COVID19 Vaccine, she did not find information regarding blurry vision or visual changes or additional information pertaining to Cataract specifically as she was inquiring. Neither were any notes of breast changes/concerns. Advised as the Prescribing Information did not include all adverse reactions that had been reported or that might occur, please consult doctor/healthcare provider. Furthermore, advised caller that filing a report with hospital could help Pfizer with post authorization studies and data. Advised that she did not have record of fillings made to hospital and chose not to speak on her behalf of side effects, if any, following the vaccine. Caller understood and remained pleasant. Caller stated that she "regrets" getting the Pfizer vaccine because she "felt fine before and now she felt terrible". She proceeded to say "she did not want the MODERNA or the Johnson because she knew the company had been around for a long time. She felt as though she could trust you guys. She did not know it was going to be this bad. Empathized with caller regarding her concerns and referred back to HCP. Caller wanted to know how long her side effects should last and was there anything she could do to feel better. She stated she asked her doctor because she was supposed to pick up her car after she was in a car accident 2 weeks ago. She had to go to the body shop, and she told her HCP she could not even go to pick up her car. Caller stated her provider advised her if she was telling her eyes were blurry and she did not feel well then she should wait for tomorrow. Caller would like to know if agent agreed with HCP advice provided. HCP also advised her that her side effects should be better by 1630 today as it would be 24 hours post vaccination. Advised caller per attached document regarding "in general most side effects resolving within 24-48 hours (1-2 days). Also advised caller that Pfizer was unable to make treatment recommendations regarding individual clients and that her HCP would remain the best source of her medical care plan and directions. Advised that we would recommend she follow the guidance of her HCP and follow their plan of care. She had her first Pfizer Covid 19 vaccine yesterday, 07Jul2021 at 4:30 PM and wanted to report. She now had several side effects. She had worsening blurry vision, severe nausea and injection site pain in her arm. The caller had a history of cataracts. The caller provided no further demographic information other than her name. The caller disconnected prior to completion of transfer. No PQC present. No further information is provided or obtained. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.