Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Limb discomfort, Peripheral swelling, Vaccination site swelling, Vascular test
Clinical narrative: She had a swelling in the injection site on both doses and both sites.; arm started swelling, puffing up/she still has puffiness in the right arm; couldn't lift that arm; This is a spontaneous report from a contactable consumer(patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry Date: unknown, NDC number: 59267-1000-1), via an unspecified route of administration, administered in Right arm on 09Apr2021 at 09:45 in the morning (at the age of 62-years-old) as dose 1, 0.3 ml single for covid-19 immunization. Patient medical history (including any illness at time of vaccination) was acid reflux from an unknown date, allergies from an unknown date. She had to stay a little while because she has allergies to everything. There were no concomitant medications. Investigation Assessment was Yes. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine were none. Prior Vaccinations (within 4 weeks) If applicable, list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were none. AE(s) following prior vaccinations were none. family medical history relevant to AE(s) were not provided.   It was reported that she had her 1st dose of the vaccine on her right arm last 08Apr2021 and got her 2nd dose on her left arm last 30Apr2021. She had a swelling in the injection site on both doses and both sites. It was reported that ever since she received the Pfizer shot at (withheld) in Apr, the first shot was at the beginning of Apr, her first shot was put in her right arm, her arm started swelling, puffing up on 09Apr2021. She had to stay a little while because she has allergies to everything. It started puffing up and the nurse was massaging it. She could not lift that arm on an unspecified date in Apr2021, she had to take two Tylenol and ice it. she still has puffiness in the right arm on 09Apr2021. She has seen vascular medicine twice to rule out, and there no blood clots, right side and left side, she had an echogram of her heart, and they ruled out no fluid on her heart. Patient Details: Ethnicity: That is probably why she is having an adverse reaction; she is mixed but states she is (Withheld). Reporter asked why her mother, who is 86 years old got it and nobody else got. She told her doctor that she was going to call the CDC and she said she should. They have done every test she can think of and she has seen a rheumatologist, and they said its not in her joints and everybody thinks its a side effect from the vaccine, but she has not ever had swelling in her arms before, and all of a sudden one is bigger than the other. She's on the fourth floor. She was looking through all the papers, and her girlfriend was saying she signed something and she could not remember so she just found all these papers, the VAX sheet for caregivers, emergency release of Pfizer BioNTech Covid 19 to prevent, she just found that sheet and thats where she got the number, through (specialty facility). She did talk to her doctor prior to taking it. She has allergic reactions she thinks it was anesthesia, just had in October and she had that with shellfish, the contrast, so she has allergic reactions and they told her what this was made up of and gave her the ingredients and at one time they thought she had celiac, but thats not it, her stomach where she can't eat everything, She can't lay flat, she has to be raised up, head has to be elevated, acid reflux, so she talked to the gastroenterologist, she was calling all doctors before she got the shot and they said its okay for her to get the shot because it's made up of stuff like jello. Pfizer BioNTech Covid 19 vaccine: Indication: Well, supposedly to protect her from the COVID 19, it says that Pfizer is supposed to be 96-97%, isn't that what Pfizer was supposed to be? That is what Covid is supposed to be, but 97% protective of getting the virus and it says that having this vaccination will prevent her, now she has heard some people have died even after getting the vaccination, buy they claim it is supposed to help her if she did contract it and she wouldn't be that severely impacted. She also took it because of her age, she rather be safe than sorry, that was the main reason, to be safe than sorry because of her age, shes 62, she got the vaccination. Her primary doctor said that her antibodies, when they injected it within her, her antibodies know something foreign was injected in her and she guesses its fighting and thats why its swelling. Time of Onset of AE(s) was not provided. AE(s) required a visit to Physician Office but did not require Emergency Room, she was going to since nobody could figure out where its coming from but thank god she did not. The patient underwent lab tests and procedures which included echocardiogram: ruled out, no fluid on her heart on an unspecified date in Jul2021, Vascular (vascular test): The first one was in Jun2021 at a lab, community radiology, that was the first one on unspecified date in Jun2021, they did the left arm and said no blood clot, then 23Jul2021 she had another done at vascular medicine and they looked at both arms to do a comparison and there was no blood clot. Reporter seriousness for arm started swelling, puffing up and couldn't lift that arm was unspecified. The outcome of event, arm started swelling, puffing up/she still has puffiness in the right arm was not recovered and for other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.