Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation, Vaccination failure
Clinical narrative: not feeling hungry/ lack of appetitite; a little bit of diarrhea; cramps; a Level 8 low back pain; sore throat; head cold symptoms/ Stuffy head/ head congestion; shoulder pain; sore throat was severe but is now just scratchy; muscle pain in shoulders and neck; muscle pain in shoulders and neck; tested positive for covid; tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: EW0175, Expiration Date: 30Nov2021) at the age of 61 years as dose 2, single and administration date 19Aug2021 (Lot number: EW0175, Expiration Date: 31Aug2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: years ago. Concomitant medication(s) included: SYMBICORT taken for asthma; ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma. Vaccination history included: Flu shot (flu shot); Pneumonia shot (pneumonia shot). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Feb2022, outcome "unknown" and all described as "tested positive for covid"; BACK PAIN (non-serious) with onset 10Feb2022, outcome "not recovered", described as "a Level 8 low back pain"; OROPHARYNGEAL PAIN (non-serious) with onset 09Feb2022, outcome "recovering", described as "sore throat"; NASOPHARYNGITIS (non-serious) with onset 09Feb2022, outcome "recovering", described as "head cold symptoms/ Stuffy head/ head congestion"; ARTHRALGIA (non-serious) with onset 09Feb2022, outcome "recovering", described as "shoulder pain"; DECREASED APPETITE (non-serious), outcome "recovered", described as "not feeling hungry/ lack of appetitite"; DIARRHOEA (non-serious), outcome "recovered", described as "a little bit of diarrhea"; MUSCLE SPASMS (non-serious), outcome "recovered", described as "cramps"; THROAT IRRITATION (non-serious) with onset 09Feb2022, outcome "recovering", described as "sore throat was severe but is now just scratchy"; NECK PAIN (non-serious), MYALGIA (non-serious) all with onset 09Feb2022, outcome "recovering" and all described as "muscle pain in shoulders and neck". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Feb2022) negative; (08Feb2022) negative; (09Feb2022) positive, notes: went to urgent care for the other two test and was negative. Therapeutic measures were taken as a result of vaccination failure, covid-19, back pain, oropharyngeal pain, nasopharyngitis, arthralgia, decreased appetite, throat irritation, neck pain, myalgia.  Clinical information: The female patient, 62, was prescribed Paxlovid by her doctor yesterday. She was asthmatic and takes Symbicort and Albuterol (Ventolin) so her pulmonologist prescribed it to her, but he stated she was the first patient he had prescribed it for. She was calling to get more information about the pill because she could not read the box of the Paxlovid box of the Prescribing Information. She and her daughter had received both doses of the Pfizer BioNTech Covid 19 vaccine and was scheduled to receive the booster on the 15th, but she tested positive Wednesday. She was vaccinated with Pfizer. Reported verbatim: She developed a sore throat, head cold symptoms, shoulder pain, not feeling hungry/ lack of appetite, a little bit of diarrhea and cramps, and a Level 8 low back pain. She has been taking Advil, Tylenol, and throat lozenges- her sore throat was severe but was now just scratchy. Most of the symptoms had subsided except for that lower back pain, it was extremely painful and thought it was a symptom of covid. She thought that she was less sick, had less symptoms, so maybe that was a positive of getting the vaccine. Caller stated her 1st symptom was an extremely severe sore throat, then head cold symptoms, and bad muscle pain in her shoulder and neck. Yesterday she started to feel better. The sore throat but the stuffy head was still there. Her main Complaint today is extreme, like level 7 or 8 on a pain scale, pain in her lower back. It is extremely painful. Caller states that she has called her doctor because she doesn't know what to take for it other than Advil. Last night before bed it started in the lower back this morning it is miserable, shoulder pain is still there but the lower back pain overrides it. Sore throat: it was still there, but she can swallow without difficulty, it was mild. Indication: Personal response, states her elderly neighbor was in the ICU and died from Covid and the caller and caller's husband were exposed to the neighbor and she did not want to take the chances. Woke up with the sore throat, head congestion and shoulder pain on Wednesday morning, 09Feb2022. Then last night, 10Feb2022 after dark 630pm-7:00pm the back pain started, she didn't sleep very well. She tried to get out of bed. Felt like she took a really bad fall off a horse, her boyfriend had Covid too, he recovered real quick. She states he is 75% better. At this time Caller was asked about treatment she stated that she used OTC products. Declined to provide NDC, Lot or expiry. Pfizer Suspect Vaccine: 1st Covid Vaccine. Time given: noonish, before 2:00pm, she remembered she went with her daughter. For 2nd Covid Dose, Time was reported as about noonish, before 2:00pm. No emergency room or physician office visit was required. No family history, no prior vaccinations. Stated she didn't think so, but she can't be positive. She got the flu shot and the pneumonia shot but she does not know for sure when. She was schedule to have the booster on 15Feb2022, but caller tested positive for Covid on Wednesday and agent felt she should report that as lack of efficacy.   Follow up attempts are completed. No further information is expected.