Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: She was been down for over a week, the Covid symptoms; weakness of bones; nauseous; headaches; she missed the 2nd dose; Tested positive for COVID; Tested positive for COVID; sick; This is a spontaneous report from a Pfizer Sponsored Program. Two contactable consumers (patient's husband and patient herself) reported that a 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Mar2021, the patient tested positive for COVID, sick, she missed the 2nd dose, weakness of bones, nauseous, headaches, serious side effects and she was been down for over a week, the COVID symptoms on an unspecified date. He does not have any adverse reaction at all. The report was received as, he does not have any adverse reaction at all.  The reason for call is not for him personally.  It is for his fiance.  For the first dose, he had his dose on 14Mar2021.  Prior to that first dose, 3 weeks before that, is when he had first dose.  She and him went together for first dose.  She has one dose and had to go back to her hometown for a family emergency and was not able to go for second dose.  In the interim, she got a COVID test and she tested positive.  She did not come for second shot or they would have gone together.  What does she have to do after testing positive and missing her second dose? He was going to have her call directly.  He said she has all the information about what they used and what protocol for test she took. Reporter stated, "Well I have a situation. My wife and I on 7Feb2021 got our 1st dose. In the interim she had to go out of town to her family and she tested positive after her 1st dose. My question is, I went and had my 2nd dose on 14Mar2021. I got mine, but she didn't get hers. She would like to know, how long she had wait before she gets the 2nd dose." Reporter stated, "Since I have you on the phone you can get the side effects. She had serious side effects. She was been down for over a week, the Covid symptoms. She is not asthmatic. She had weakness of bones, nauseous, headaches no fever or coughs but all the other symptoms." She may be taking thyroid medications. That's all I know. Reporter stated, "I hope I don't have to go on hold for another 2 hours and 45 minutes." The doctor's don't know. She is recovering. I already spoke with the safety team and reported this.: Spoke from attached document and emailed as requested Spoke from (LAB- 1457-6.0 Revised: 25Feb2021) under section 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA "The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19." Therapeutic measures were taken as a result of she was been down for over a week, the COVID symptoms, sick, weakness of bones, nauseous, headaches and serious side effects with reported as, she is taking some vitamins. The patient underwent lab tests and procedures which included COVID-19 test: positive on 14Mar2021. The outcome of events was recovering.  Information on the lot/batch number has been requested.