Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: soreness at the vaccination site; This is a spontaneous report from a contactable (Patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation; ibuprofen, phenylephrine hcl (IBUPROFEN, PHENYLEPHRINE HCL), route of administration, start and stop date, batch/lot number and dose were not reported for pain. Medical history included scoliosis from an unknown date and unknown if ongoing patient stated I do have pain issues due to scoliosis. The patient concomitant medications were not reported. The patient experienced soreness at the vaccination site on an unspecified date. It was reported Caller was asking Is it okay to take multivitamins and supplements, as well as hormones (progesterone and estradiol) with the vaccine Caller mentioned she is taking hormones regularly. Patient received Response: mentioned no information found on multivitamins and hormones and referred to HCP for guidance. It was reported that Caller asked for how long after getting the Pfizer-BioNTech COVID-19 Vaccine can you take a shower, can Caller take the band-aid off or no. Caller received Response: mentioned no information found specifically on timeframe before taking a shower, but advised caller based on professional judgement: mentioned It would be okay to take a shower after immunization, with or without the band-aid on, and referred to HCP for further guidance. It was reported that caller asking What else should know; other tips before going to get the shot. Caller received Response: Spoke per the Pfizer-BioNTech COVID-19 EUA Fact Sheet for Recipients and Caregivers what should you mention to your vaccination provider before you get the pfizer-biontech covid-19 vaccine. It was reported that Caller seeking guidance on taking anti-inflammatory and the vaccine. Clarified question, caller seeking information on taking medications like ibuprofen or Tylenol. Caller received Response: Spoke from attached document and referred to HCP for further guidance. It was reported that caller asking Question Is there any information on taking Tylenol or Ibuprofen after the vaccine. She had a Pfizer Covid 19 vaccine on Sunday, and she had no symptoms, she mentions she have pain issues due to scoliosis. After 40 hours of receiving the vaccine she was took some ibuprofen due to pain from his other issues. Is it still better pre or post. It was reported that his sister took Tylenol that same day due to pain in her arm, the Soreness. Caller received Response: Spoke from the attached document. Spoke from the PI LAB-1457-6.0 Revised: 25 February 2021: 6.1 Clinical Trials Experience, Table 4: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose  Participants 56 Years of Age and Older  Reactogenicity Subset of the Safety Population. Stated the PI does not state which medications were administered in the clinical trial however it does say how many people took the medications. It was reported that Dates for Soreness at the vaccination site, patient had pain in arm not only in the vaccination site but two or three inches away from it going towards the inside of arm. It was reported that Three weeks ago patient got my first dose of Pfizer and it was very uneventful, and everything was fine. It was reported that patient had a typical soreness at the vaccination site just for one night and everything was great, today patient had second dose and as far. she feels okay but it's unusual it is different from the first time, so she little concern as she has pain in arm, not only in the vaccination site but two or three inches away from it going towards the inside of my arm. It was reported that When paraphrased the above concern, consumer stated, the pain was different this time. You know the vaccination site off course it is going to be soreness, but the soreness is also in two or three inches away from the vaccination site going towards the inside of arm. She wants to know is this a concern or normal or what. Reporter seriousness for Soreness at the vaccination site Unspecified. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.