Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: where she got the vaccine it is really big, like the size of an orange, he confirms the swelling is over the injection site on her arm.; her arm is really swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:50 (Lot number: ER8729) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "She has something with her blood" (unspecified if ongoing), notes: She has something with her blood, he thinks low blood, pressure. She has not had anemia. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 15Apr2021, outcome "not recovered", described as "her arm is really swollen"; VACCINATION SITE SWELLING (non-serious) with onset 16Apr2021, outcome "unknown", described as "where she got the vaccine it is really big, like the size of an orange, he confirms the swelling is over the injection site on her arm."  Additional information:  Reporter seriousness for her arm is really swollen: Unspecified. Event: her arm is really swollen was reported as worsened. Reporter is son-in-law of the patient. Caller is calling about the Pfizer, the reason he is calling is on behalf of his mother in law who had the vaccine on Tuesday, her arm is really swollen and she wanted to know what to do if she should go back to the clinic or what to do. He asks if he could get transferred to one of the people to ask a questions about reactions or side effects.  He clarifies the product is the Pfizer COVID vaccine and the patient's first dose was given Tuesday 13Apr2021. He says she first noticed the swelling in her arm 27 hours after the shot, he clarifies it was Thursday the 16Apr2021 when she first noticed the swelling. He says where she got the vaccine it is really big, like the size of an orange, he confirms the swelling is over the injection site on her arm. He says he thinks it is worse, it is going down the arm from where the vaccine was given, instead of going up, it's going down the arm. He confirms it is worsened because it is expanding, it is like 4 inches long and an inch and a half thick, he clarifies an inch and a half wide. She received the injection in the left upper arm. Product details: he sees a number, 70TUV57BFF06, he clarifies it says that is the patient number . he provides the lot number and he does not see any NDC or expiration, only when it was given which was 13Apr2021. Dose: He does not see any dose amount. It only has when she has to get the second dose. Her appointment was at 2:15 but they left early, he thinks it was given at 1:50 PM. Anatomical Location of Administration of Pfizer vaccine considered as suspect. This was her first dose. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: No. Emergency Room?  No, Physician Office?  No. Family Medical History Relevant to AE(s): He mom died of cancer, her sister died of cancer. PSCC Communication: Advised caller Pfizer would refer patient to speak with a physician regarding treatment recommendations. Caller wishes to speak with Medical Information agent. The caller was provided the contact number, option 3, and hours of operation of 8AM-8PM Monday through Friday and 9AM to 3PM Saturday and Sunday, for COVID vaccine calls prior to attempted warm transfer to Medical Information. Due to high call volume caller elects to be placed in the hold queue to continue holding for an agent.  No follow-up attempts are possible. No further information is expected.