Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Vaccination site pain, Vomiting
Clinical narrative: Pain at the site got injection/pain was from her elbow to her shoulder to the site area; Arm is swollen; throw up; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Aug2021 13:00 (Lot number: EW0167) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Multivitamin" (ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol (ongoing); CENTRUM FOR WOMEN taken for vitamin supplementation (ongoing); OMEGA-3 [OMEGA-3 NOS]; VITAMIN D3; MELATONIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Pain at the site got injection/pain was from her elbow to her shoulder to the site area"; PERIPHERAL SWELLING (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Arm is swollen"; NAUSEA (non-serious) with onset Aug2021, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 17Aug2021, outcome "not recovered", described as "throw up".  Additional information: Dates for Pain at the site got injection: (From: 17Aug2021 To: Ongoing). Reporter seriousness for Pain at the site got injection: Unspecified. Dates for Arm is swollen: (From: 17Aug2021 To: Ongoing). Reporter seriousness for Arm is swollen: Unspecified. Dates for Nausea: (From: Unspecified To: Ongoing). Reporter seriousness for Nausea: Unspecified. Other Products: Yes. Dates for Concomitant Products Crestor: (Start: Unspecified Stop: Ongoing). Dates for Concomitant Products Centrum: (Start: Unspecified Stop: Ongoing). Why was the patient taking Concomitant Products Centrum (Verbatim): Multivitamin. Dates for Concomitant Products Omega-3: (Start: Unspecified Stop: Unspecified). Dates for Concomitant Products Vitamin D3: (Start: Unspecified Stop: Unspecified). Dates for Concomitant Products Melatonin: (Start: Unspecified Stop: Unspecified). Investigation Assessment: No. Additional Context: Caller on the line calling about the Pfizer COVID-19 Vaccine. Reporter Details: She mentioned she works in a pharmacy, a pharmacy technician. She commented she was not going to work today. Patient Details: Weight: It fluctuates, it was like Withheld, generally Withheld. Event Details: She got the vaccine on 17Aug2021, two days ago. The area site where she got the shot, has pain in the site area down to elbow. The arm is swollen at the site injection area. She was also having some nauseation, nausea. She eats something, lays down and it's like it goes away somewhat, but within a couple hours sit comes back. Pain at the site got injection: Started to notice it the same day she got the shot. She got the shot around 1 PM and she came home around 6 PM. Her arm was already sore from the prick. She went to sleep and woke up around 8PM.  The pain was from her elbow to her shoulder to the site area. She did not take anything for it. She was told not to take anything. She was told to wait to see what type of effects would occur. She noticed the pain around 8PM because she had gone to sleep and she had woken up with the pain. Nausea: She noticed at 12:00 Midnight. She had gone to sleep earlier. The vaccine had also made her tired. She was sleeping and woke up with the pain in the area. She sat up, drunk some water, and started to feel the nauseation. She laid back down. It was still there around 1-2AM. She ate something because she though this feeling was because she did not eat anything for dinner. She ate something, went back to sleep, and woke up yesterday morning to call the doctor and supervisor to tell what was going on. The nauseation feeling was there again so she laid down. At 12:30 PM she got up, ate. It was like every time she ate the nauseation would come, she would lay down, go to sleep. The nausea is not anything that makes her feel like she wants to throw up. It comes and goes. She was just trying to chime in to see what is going with what is going on with her body. Treatment: She has been resting at home in bed. She would sit up a couple hours. After eating she would start to feel the nauseation and she would lay down to sleep. Product Details: Confirmed this was her first dose. Indication captured as provided. Other Conditions: Mentioned she is 60 years old. She has a history of different things. Each thing she has medical attention to. It has not been resolved, but she does not know how to put it. She stated she does not have heart failure or cancer. VACCINE SUPPLEMENTAL FORM: Patient Details: Patient Last Name: Withheld. First Name: Withheld. Address: See reporter details. City: See reporter details. State: See reporter details. Country: See reporter details. Zip Code: See reporter details. Phone: See reporter details. Patient Age at Time of Vaccination: 60 years. Pfizer Suspect Vaccine and Vaccination Details: Vaccine Lot Number: EW0167. Vaccine Lot Expire Date: UNKNOWN. Time the Vaccination Was Given: 13:00. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Arm Right. For country Only: Vaccination Facility Type: Withheld. Vaccine Administered at private Facility? No. Vaccination Facility Address: Facility Name: Withheld. Address: Withheld. History of all previous immunization with the Pfizer vaccine considered as suspect: None, this was the first dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Adverse Event (AE) Details: Provide the time of onset of AE(s): See additional context. Did any AE(s) require a visit to: Emergency Room? No. Physician Office? No. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination)? See additional context. Family Medical History Relevant to AE(s): Relevant Tests: None.  Follow-up attempts are completed. No further information is expected.