Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus
Clinical narrative: Pain to left breast into right leg then left leg and shot back up into her heart area, then would shoot into her head; Shoulders and back achy and tense; Shoulders and back achy and tense; Stiffness; Arm swollen and red from site of injection to elbow for a week; Arm itching; Arm heated; This is a spontaneous report from a contactable consumer (patient. Self-reported). A 71-Years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0162, NDC 59267-1000-1, and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 19Apr2021 at 12:00 PM, as a single dose, 0.3 mL, for COVID-19 immunization at hospital. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8732, NDC 59267-1000-1, and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 29Mar2021 at 12:00, as a single dose, 0.3 mL, for COVID-19 immunization at hospital. The patient stated both hands started itching at some point the evening of 29Mar2021, beginning around midnight, between midnight and 5 am on 30Mar2021 and described as kind of itch that was internally itching and couldn't scratch, it was inside of her itching. It fully resolved by the time she woke up on 30Mar2021. The patient taking Pfizer COVID vaccine because she didn't want to live like she lived for a year and wanted to be healthy and normal for grandchildren. The patient's medical history included history of breast cancer (from Sep2006) and she completed 6 rounds of chemo and 37 days of radiation and finished in Aug2007 and right mastectomy on 13Oct2006 (also had chemo and radiation) and she had 3 surgeries in 3 weeks and had 27 lymph nodes removed. The patient stated she had heart damage from chemo and radiation, she had congestive heart failure which was reaction to Herceptin which started in Dec2006. She only had half of it and didn't take it for a year. She didn't die from breast cancer, but that's her history. She was one of the first patients to have a cardiologist going through chemo because it was a new drug then, been with the cardiologist for 15 years. Caller states she previously had echos done monthly between chemo that was every 3 weeks to check the ejection fraction. Ejection fraction at some point started showing she was in trouble and he called the oncologists and said the Herceptin was done. They stopped it and she was told she had congestive heart failure, heart damage, but it was reversed now, and she still had that tagged on her. Caller adds it's a mandate now for men and women who were on Herceptin to have an echo or doppler done. The patient did not receive any vaccine prior vaccinations (within 4 weeks). The patient did not have any adverse event prior vaccinations. Concomitant medications included carvedilol (COREG) for heart at slower pace and had been on it 14 years, and Lisinopril had been taking 14 years for kept blood pressure low due to chemo and radiation. The patient reported that on 19Apr2021 at 12:10, she experienced arm swollen and red from site of injection to elbow for a week and lasted a week until the following Monday. The patient clarified swelling lasted a week, but not the itching which only lasted that first day on 19Apr2021. The patient also had arm itching and arm heated on 19Apr2021 at 12:10. She had shoulders and back achy and tense which occurred from noon until 22:00 on 20Apr2021. The patient added that the pain she felt was like a cartoon, didn't know how to explain it, was weird very odd and forceful, and stated it hurt. She stated she was worried about her heart. The patient had pain like a bullet went through her and entered her left chest wall and like a ricochet reaction on 20Apr2021 at 18:00. She stated first it hit her left side, then go down into her upper thigh, go to her right leg, her left leg, her right leg; Pain to left breast into right leg then left leg and shot back up into her heart area, then would shoot into her head which started around 18:00 on 20Apr2021. It would do a round and would stop and do it again maybe 10, 20, 30 minutes later then do it again. It would do the whole body. She went to bed and when she woke up it was gone on 21Apr2021. The patient also had stiffness. The patient stated she had family members that won't do this, they thought it was conspiracy and that's what she had to deal with. She didn't think it was and thought COVID was very real. The patient stated that this was in the past, but she wanted to report her reaction to her second COVID shot. She also stated it was very odd and hadn't talked to anyone who has had this and thought she would tell Pfizer. The patient stated the symptoms started almost 24 hours to the minute, actually while driving and it started in shoulders and back kind of like achy and tense like you've been driving for a long time. She got to her destination, and it seemed like every time she would get out and walk for a while, she felt better and got to her destination. It was like a bullet went through her and entered her left chest wall and like a ricochet reaction. First it hit her left side go down into her upper thigh, go to her right leg, her left leg, her right leg. The patient clarified that the stiffness in her body started 24 hours after, but the ricochet started about another 6 hours after that, after she arrived at her destination. The patient described symptoms in shoulder and back as really tense and sudden. She had a mastectomy and only had one breast on the left side like it shot through and was painful, put her on the floor. She had a high pain tolerance and went to left breast into right leg then left leg and shot back up into her heart area, then would shoot into her head. The patient stated when she had surgeries, she didn't take drugs, Tylenol knocks her out. She was not a user of pain meds. She clarified she was not saying it literally knocks her out, Tylenol was like a big pain med for her and stated Tylenol for some people was what they do daily, but it puts her to sleep. She also stated that all of her life when queried about dates of use when this occurred, and she did not have any specific product available for documentation of lot number or anything related to this. The patient stated Aleve gave her for hives and this occurred when it first came out, but she was not sure when that was and confirmed she did not have the bottle of Aleve available. The patient reported there were certain things she couldn't take. She wanted to add that when she went to bed that night, she told husband if she dies tonight make sure to do an autopsy. Husband said he needed to take her to the hospital, and she stated she really thought it was just from the COVID shot and she didn't think the hospital could do anything. She just wanted to bed and woke up and she was fine, she did not go to the hospital. The events did not require a visit to emergency room or physician office. No treatment was reported for events except for bed. The patient had a doppler echo which was scheduled on 21Jun2021 and which was a yearly echo done for heart function. The patient stated she hope this helped and might be someone else has had this, she was not the only nut case. She was concerned about the talk of possible booster and was a little leary about booster after that one experience, that was a concern. She didn't want to make a bad choice and not did it; this was her real concern. The patient confirmed she would like to know if there was any more information about other reports of this or about the booster. Outcome of the events arm swollen and red from site of injection to elbow for a week and arm heated was resolved on Apr2021. Outcome of the event arm itching was resolved on 19Apr2021, shoulders and back achy and tense, and stiffness was resolved on 20Apr2021, and pain to left breast into right leg then left leg and shot back up into her heart area, then would shoot into her head was resolved on 21Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.