Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Tenderness
Clinical narrative: I have a low voice; red hot tender swelling in the left arm/Large 3 inch diameter swollen red hot spot on left arm; Red hot tender swelling in the left arm/Large 3 inch diameter swollen red hot spot on left arm; Red hot tender swelling in the left arm/Large 3 inch diameter swollen red hot spot on left arm; she was also lethargic/I was real lethargic, could barely get up and walk around; flu like symptoms/had flu symptoms/felt like she had the flu; feels achy/Whole body aches/ached all over; All night long I was like trying to sleep; Toss and turn; Tender sore left arm; I just had the regular symptoms just a little tender, no swelling, no redness/Tender sore left arm; she felt so crappy; It was swollen and it is red and it is hot and has a bump on it at the shot site on my left arm/Large three inch red-hot, swollen tender lump on my arm; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EN6199, expiration date unknown), via an intramuscular route of administration, administered in arm left on 11Mar2021 at 18:50 (at the age of 63-years-old) as single dose for covid-19 immunization at Clinic at a Recreation center. Medical history included seasonal allergies all around year, she had adverse reaction to wasp sting, swelled up and lips puffed up and was having trouble breathing and took Benadryl and was better after that and no further details provided, and all were from an unknown date and unknown if ongoing. There were no concomitant medications. Family history included sister had asthma. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect. It was reported that after she received first dose of vaccine, she had just a normal soreness and not red, not heated. On 12Mar2021 at 08:00, she had normal symptoms just a little tender sore left arm and it did not hurt that bad and it only hurt for a few days and no swelling, no redness, none other than that and then on Friday on 19Mar2021, during the night, all night long she was like trying to sleep and was toss and turn she just felt like she had the flu, she had no temperature and her whole body was achy and she just ached all over, and this continued into Saturday morning and she was real lethargic and could barely get up and walk around and she did not realize it because she was trying to sleep, she noticed it on 20Mar2021 at 06:00 and she took the Excedrin at 11:00 because she had things to do on 20Mar2021 and after she took it, she felt ok (self-medicated). On Sunday, on 21Mar2021 at 08:00, she had a large red about 3-inch in diameter circle hard swollen red-hot spot on her left arm and has a bump on it at the shot site on her left arm and it was still there, and they disappeared way after the shot, and it has continued until today and she would like to know if she needs to see anyone about this. Her next shot was due on 01Apr2021. There was no prescriber for the vaccine. She further mentioned that the body aches improved because she took Excedrin on Saturday but on Sunday was when her arm swelled up and had the red spot and she thought the body aches and lethargy were significant after she had the reaction on her arm. She could not figure out why she felt so crappy and had low voice, and she did not know what was causing it. Reporter stated that she did not have this kind of reaction until two weeks after the shot and as long as when the symptoms started, and would it be just today and yesterday which was a large three-inch red swollen, hot tender lump on her arm on an unknown date of Mar2021. The events were not resulted in emergency room or physician's office. The seriousness for the events of generalized aching, erythema, peripheral swelling and feeling hot was reported as medically significant and for other events as non-serious. The patient was recovering from the events of generalized aching, lethargy, Pain in arm, Tenderness and was not recovered from the events of redness, swollen arm and feeling hot, tenderness, pain in arm and outcome was unknown for the events of flu like symptoms, feeling sick, sleep restless, upper extremity mass and voice lowered. The events tender sore left arm, whole body ache, lethargic, large 3 inch diameter swollen red hot spot on left arm was reported as related to vaccine.