Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, Dizziness, Fatigue, Immunisation
Clinical narrative: rash on her arm below the injection site; rash is from the injection site to her elbow and it was itchy.skin is blotchy in various places from the rash.; from the injection site to her elbow and it was itchy.; Low Grade Fever 99; booster; Aches; Chills; Lightheaded; Black and Blue Around Injection Site, at least an inch wide; Felt tired; tenderness under her arm in the nodes and that was quite painful; tenderness under her arm in the nodes and that was quite painful; swollen lymph nodes under the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 10:30 (Lot number: FH8030) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Lot No. EN6206), administration date: 22Mar2021, when the patient was 70 years old, for Covid-19 immunization, reaction(s): "Rash"; Bnt162b2 (Dose 2, single, Lot No. ER2613, AE Treatment: Zyrtec twice a day), administration date: 12Apr2021, when the patient was 70 years old, for Covid-19 immunization, reaction(s): "Rash", "I couldn't lift my arms up", "I had injection site discomfort", "Fatigue", "Headache", "Chills", "Low grade fever"; Shingrix (The patient had taken the Shingrix shot 4 years ago with the reaction "Rash"., ), reaction(s): "Rash"; Shingrix (Caller states that this reaction was back in Feb2019., ), reaction(s): "reaction".  The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:30, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 18Nov2021, outcome "recovered", described as "Aches"; CHILLS (non-serious) with onset 18Nov2021, outcome "recovered", described as "Chills"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovered", described as "Low Grade Fever 99"; DIZZINESS (non-serious) with onset 18Nov2021, outcome "recovered", described as "Lightheaded"; VACCINATION SITE BRUISING (non-serious) with onset 18Nov2021, outcome "recovered", described as "Black and Blue Around Injection Site, at least an inch wide"; FATIGUE (non-serious) with onset 18Nov2021, outcome "recovered", described as "Felt tired"; TENDERNESS (non-serious), PAIN (non-serious) all with onset Nov2021, outcome "recovering" and all described as "tenderness under her arm in the nodes and that was quite painful"; VACCINATION SITE RASH (non-serious) with onset 20Nov2021, outcome "recovering", described as "rash on her arm below the injection site; rash is from the injection site to her elbow and it was itchy.skin is blotchy in various places from the rash."; PRURITUS (non-serious) with onset 20Nov2021, outcome "recovering", described as "from the injection site to her elbow and it was itchy."; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovering", described as "swollen lymph nodes under the arm". The events "aches", "chills", "low grade fever 99", "lightheaded", "black and blue around injection site, at least an inch wide", "felt tired", "tenderness under her arm in the nodes and that was quite painful", "rash on her arm below the injection site; rash is from the injection site to her elbow and it was itchy.skin is blotchy in various places from the rash.", "from the injection site to her elbow and it was itchy.", "tenderness under her arm in the nodes and that was quite painful" and "swollen lymph nodes under the arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that she received the booster injection about 10:30 a.m. EST 18Nov2021 and a couple of hours later, she took the band aid off and the injection site was black and blue. Caller states of all of her injections never has she seen them black and blue. Caller states it was at last an inch wide black and blue mark. She also felt tired that day, in the evening, and she had to go to bed at 9pm because she was tired, achy and had chills. And also she was lightheaded a few hours after the injection. On 19Nov2021 she was pretty bad, she was running a low grade fever of 99 and then on Saturday 20Nov2021, she noticed in the morning a huge rash on her arm below the injection site. The rash has improved and calmed down. Caller states it is from the injection site to her elbow and it was itchy. Caller states her skin is blotchy in various places from the rash. Caller states she doesn't have severe allergies. Caller states she does know people that had rashes but not as severe as hers and they just say oh it will go away, but they shouldn't take it so lightly, if they are by themselves and they go into anaphylactic shock, they won't wake up. Caller states on 18Nov2021 or 19Nov2021 (as reported) she started to realize the swollen tender lymph nodes, on the night of her injection when she was trying to sleep on her left side and she felt a tenderness under her arm in the nodes and that was quite painful and thought it was strange, but it has calmed down and was subsiding. She hadn't seen a rash noted on side effects but in the article she read, it mentioned the lymph nodes in a specific paragraph about swollen lymph nodes. The article was about the Pfizer Covid Vaccine Booster, and it listed all of the vaccine side effects. It says swollen lymph nodes are seen more frequently with the booster then after the primary two dose series. It also noted most of the side effects are not a result of the vaccine but indicated they are a result of an immune system response, meaning if a person is a healthy person, as she is, they will have a stronger response, is that true she wanted to know. Caller states no doctors have any information on this.  Caller states she had previous reactions to Shingrix like a rash from this one. Caller states, she had rash for all 3, but with this one had a huge black and blue mark at the injection site that developed a couple hours after she got it. Pharmacist left her with black and blue mark and it has subsided now, but the rash is still there but calmer. Caller states swollen lymph nodes is what she have under the arm. Caller asks if the ingredients for the vaccine are similar to Shingrix ingredients? 4 years ago she had a severe reaction to part 1 of the Shingrex shot. Caller states she had a huge rash, 4 times the size of what she got with the Pfizer. Caller states she went to a dermatologist and they had not seen anything like that, it covered her entire arm. Caller states they had to give her a topical steroid cream. Caller states they took pictures. Caller states the rash came up 2 weeks after the injection, part 1. Caller states she called the pharmacist and he said oh well it must be something else because they were going by the side effects listed and said it couldn't be that. Caller states the dermatologist took a picture and showed a picture to the Infectious Disease specialist and he said he was seeing patients react more than 10 days after the vaccine and he thought it was from the vaccine. Caller states it took another 2 weeks after started the steroid cream to go away. Caller states later on she saw a doctor friend and showed him the pictures and his wife is queen of allergies and they both looked at the pics and he said do not take part 2 because she could get a worse reaction and she could go in to anaphylactic shock, so she didn't take part 2. Caller states the rash was lumpy, hot and red and all over her arm from the injection site to her elbow. She had now received an email, and it looks suspicious, states it is from GSK, Glasgow Smith Klein, states they will be sending a request for follow up about her reaction to their product Shingrix. There is an attachment on the email with third party instructions. Caller wants to know if Pfizer let GSK know about her reaction to the Shingrix and if that email is safe to open. Does not want to open the PDF attached in the email on her phone and have it blow up her phone. They don't give a phone number in the email, any questions to call the Medical Information department. Caller states that this reaction was back in Feb2019. No additional Vaccines Administered on Same Date of the Pfizer Suspect. AE did not require for Emergency Room visit. No prior Vaccinations (within 4 weeks), No family Medical History Relevant to AE(s) and no relevant Tests.  Follow-up attempts completed. No further information is expected.