Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: headache for a few days; soreness of the site of the shot, sore arm/ I still have some tenderness at the site; soreness of the site of the shot, sore arm; hot flashes and night sweats; hot flashes and night sweats; tired a little achy; tired a little achy; This is a spontaneous report received from a contactable reporter (Patient or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure, For which I am intruded for.; "COPD" (unspecified if ongoing), notes: Verbatim: COPD, I take an inhaler occasionally; "Acid reflux (esophageal)" (unspecified if ongoing), notes: Verbatim: Acid reflux (esophageal), I do take medication for acid reflux; "AFib" (unspecified if ongoing), notes: Verbatim: AFib; "Macular degeneration" (unspecified if ongoing), notes: Verbatim: Macular degeneration. Concomitant medication(s) included: VERAPAMIL taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension; XARELTO taken for atrial fibrillation; OMEPRAZOLE taken for gastrooesophageal reflux disease; FAMOTIDINE taken for gastrooesophageal reflux disease; MELATONIN; CALCIUM D3. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache for a few days"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "soreness of the site of the shot, sore arm/ I still have some tenderness at the site"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "soreness of the site of the shot, sore arm"; HOT FLUSH (non-serious), HYPERHIDROSIS (non-serious), outcome "recovered" and all described as "hot flashes and night sweats"; FATIGUE (non-serious), PAIN (non-serious), outcome "recovered" and all described as "tired a little achy".  Additional information: Concomitant medication included Glutenex 20 mg, Daily for macular degeneration, Multivitamins. Additional Information for Concomitant Products Xarelto: Patient stated, she had AFib and they prescribed me the blood thinner Xarelto. Patient stated, she just spoke with someone and connected me, she was just telling them side effects from the vaccine. What happened was she had we safe paper and she lost it. The thing where you go on site, and she know you guys are trying to track people how they responded to the vaccine. She took all the information, but she still connected me with you. Patient stated, "She connected me with you to tell you my side effects. She does not know whether she is supposed to. When probed for events: Patient stated, she had no fever. She had a headache for a few days, soreness of the site of the shot, sore arm. Actually, she had hot flashes and night sweats but again no fever, tired a little achy but nothing really bad. In fact, she actually back on doing her exercises and other stuffs. To her it seems they were like pretty mild. When paraphrased the concern: Patient stated, yes. She took it easy when she heard about it. She took it kind of easy for few days because she heard about it because she heard about, some people can have side effects. When probed the first-time patient called Pfizer Drug Safety: Patient stated, she had called earlier today but we got cut off, so she had called again. (Hence captured as initial report). Start date: Patient stated, "Saturday, 13Mar2021. Yeah, she goes to back 23Apr2021 for the second dose. That would be 13Mar2021 and side effects lasted about three days. She started side effects on 13Mar2021, the day she of the shot (Further not confirmed)." Ongoing: Patient stated, Yeah, they are pretty much gone. Yeah, it might. she still had a little bit of tenderness at the site of shot. The other side effects are gone. Indication: Patient stated, Because of the covid. She wants to you know trying for insidious. She was at high risk. She does have underlying factors (Intent: History)." Medical History: Patient stated, she was not definitely overweight, so she guesses that was not consider as comorbidity. Lab test: Patient stated, "Actually they got it ordered down for me, but she have not had the lab work done. Verbatim and Event Description: Got the first dose of vaccine last 13Mar2021, and the second dose was scheduled on 03Apr2021, and she wants to know the exact time of her second dose appointment. (name) experienced arm sore, headache, hot flashes after she received the first dose. Reporter hung up so no transfer of call happened, and Manual AE Form was created. Reporter had previously called but got disconnected. She had been experiencing some side effects. she got first dose. She had a headache, sore arm, muscle ache, night sweats, and hot flashes. Her arm is still a bit sore.  No follow-up attempts are possible. No further information is expected.