Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Nausea, Oxygen saturation decreased, Pruritus
Clinical narrative: itching on both arms; slight nausea; her temperature went up to 101.7; Her oxygen level has been as low as 90...91-93 within the last hour.; felt unwell; slight fever 99.3/she had a higher fever 101.7; developed a cough; she had an elevated heart rate, her average heart rate was usually 59-55 but currently it was in the 90s and low 100s; slight breathlessness/shortness of breath; This is a spontaneous report received from a contactable consumer. This 33-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8727 and expiry date: 31Jul2021) via intramuscular route of administration on 24Mar2021 around 09: 20 or 09:30 on left arm as 1st dose, 0.3 ml single dose for COVID-19 immunization. The patient's medical history included breast cancer from unknown date in 2018 to unknown date in 2018. She was a breast cancer survivor. She had chemo in late 2018. She does not know if that matters. It was in remission, she was a survivor. It was mentioned that the patient received no other products. She had some side effects and she does not know if she needs to be worried about them. It was mentioned that the patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and she did not visit emergency room and physician office. On 24Mar2021, the same day hours after vaccination, she felt slight breathlessness, she had an elevated heart rate, her average heart rate was usually 59-55 but currently it was in the 90s and low 100s just sitting on the couch. On an unknown date she felt unwell, had itching on both arms, had nausea an felt generally out of it, her temperature went up to 101.7 before she took a Tylenol, her oxygen level had been as low as 90...91-93 within the last hour. On 25Mar2021, one day later the patient experienced slight fever 99.3/she had a higher fever 101.7, developed a cough. She took a took a rapid covid test and it was negative. The patient saw number on the paper of the centre where she was vaccinated because she was a patient there and she wanted to make sure or try to find out if this was concerning or should she be going to the emergency room or was this just something that just happens, and she should not worry and just monitor her symptoms. The outcome of slight breathlessness/shortness of breath, itching on both arms, slight nausea, her temperature went up to 101.7, she had an elevated heart rate, her average heart rate is usually 59-55 but currently it was in the 90s and low 100s, Her oxygen level has been as low as 90...91-93 within the last hour and felt unwell was unknown and slight fever 99.3/she had a higher fever 101.7, developed a cough was not recovered  This is a complaint for Lack of Effect of lot ER8727 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. The initial scope of this investigation is limited to ER8727 pending review of lot genealogy to determine other in-scope lots. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. A full investigation will be performed.  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8727 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.