Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Hyperhidrosis, Malaise
Clinical narrative: Headache; Sweating; pain and redness at injection site/arm was sore and swollen; palpate a bump at the injection site/arm was sore and swollen; redness at injection site/Arm was red; Feeling bad like I caught Covid again; Cough; feeling ill; Arm was itching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0198; Expiration Date: 21Jun2021) via an unspecified route, administered in Right Arm on 25May2021 at 11:00 (58-year-old at vaccination) as dose 1, single for Covid-19 immunization. Vaccination facility type was reported as Pharmacy and not military facility. The patient's medical history included chronic obstructive pulmonary disease (COPD) from 2020 and ongoing, supraventricular tachycardia (SVT) from 2018 and ongoing, covid-19 from 04May2021 to May2021, She was diagnosed with Covid-19 on 04May2021.  The patient reported that she had recovered from her Covid-19 infection about 2 weeks after it began. She reported that she was a person with underlying health conditions. The patient's Family Medical History Relevant to AE(s): She reported that her mom's family from her mom's father has heart problems, so all of them died young from heart problems.  She reported that her mother was young, and her grandfather was young when they died, they were in their 50's. The patient's concomitant medications included prednisone acetate taper taken for pneumonia from May2021 to May2021, a week before receiving the first dose of the Covid-19 vaccine; metoprolol succinate taken for supraventricular tachycardia from 2018 and ongoing; hydrochlorothiazide taken for supraventricular tachycardia from 2018 and ongoing; famotidine (FAMOTIDINE ACID REDUCER) taken for supraventricular tachycardia; benzonatate taken for cough from 2018 and ongoing. The patient was not related to any study or programme. No additional vaccines administered on same date of the Pfizer Suspect or 4 weeks of vaccination. She reported that she wasn't taken any vaccine since she was a little girl. The patient had no AE(s) following prior vaccination. She had Covid on 04May2021 and was told to wait 90 days before getting the Covid-19 vaccine. She reported that, she went to take the Covid-19 vaccine, it was 14 days after getting over the infection. The patient stated that she received her first dose of the Pfizer BioNTech Covid-19 vaccine on 25May2021, and reports that she felt fine that day. On 26May2021 (the next day after dose of vaccination), she started feeling sick/ feeling ill, had headache, was sweating some, which lasted about 4 days.  Also states she had pain and redness at injection site, and she can still palpate a bump at the injection site. She stated that her arm was sore and swollen. She reported that she could still saw a little bit that it's still swollen but she had to look closely.  She reported that she could still felt soreness on her arm when she rubs it. With her the Covid-19 shot in her arm had gotten red, and of course it was going to be sore.  She reported that now it's gone down, but it's still sore if she rubs across her arm, it was still feeling sore. She reported that it had gotten better over time. She also developed cough after getting the vaccine. She had gone back to the doctor because her coughing came back. She reported that her doctor put her on prednisone again and said that the cough had to be from the Covid-19 shot. He had to give her Prednisone again to get rid of the same symptoms from the Covid-19 shot. She reported that she was still taking those for the week and would be done with those on Sunday, 04Jul2021.  She reported that she was having an appointment to go back to her doctor next Thursday, 08Jul2021. She reported that the cough she had before receiving the Covid-19 vaccine had cleared up. She reported that she was on Prednisone the week prior for pneumonia that came from Covid. She reported that she was on Prednisone for that for the duration. She reporter that her cough was getting better. She reported that Benzonatate 200 mg are supposed to help her stop coughing, but they don't do anything, and she still coughs. She reported that Benzonatate sample was available to be returned if required. She was feeling bad like she caught covid again. She reported that she felt that for 3 days off the Covid-19 shot. She reported that she was feeling back for about 4 days. On an unknown date in May2021, the patient's arm was itching. She reported that her arm was itching, but the itching came may be 5-6 days after the Covid-19 shot.  She reported that it was like mosquito bite type itching.  She reported that she was trying to keep herself from scratching and just kept putting alcohol on the area that was itchy.She was diagnosed with Covid-19 (on 04May2021), she went ahead and got the first dose because her doctor told her she didn't have to wait 90 days. She though if she got the vaccine too soon and what caused it and was it an allergic reaction. She was fearful of getting her second dose.   At one point, she stated that if she had an allergic reaction to the first dose (or any medication), why would she get a second dose.  Said a doctor wouldn't give a medication a second time if somebody was allergic to it. She just wanted to confirm if she can receive the vaccine with a prior or current Covid-19 diagnosis. She was informed that these interim considerations stated mRNA vaccines, including the Pfizer BioNTech COVID-19 vaccine, can safely be given to persons with a history of a prior COVID-19 infection. The vaccine should be offered even if you had symptoms or no symptoms of COVID-19 infection.  These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation.  Pfizer was independent of these recommendations.  Please be sure to discuss any questions about receiving the Pfizer-BioNTech COVID-19 vaccine and if you have COVID-19 or develop COVID-19 after receiving the first dose with your vaccination provider, doctor, or other health care professional and she was also suggested that Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer the patient to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The patient's healthcare provider knows them health situation and had access to information that can better help inform this decision.  She mentioned that her second dose was scheduled for 07Jul2021 and she took her first dose on 25Jun2021. She was advised to that Pfizer recommends 21 days apart to complete series of both doses.She reported that she was having an issue with pneumonia and her physician put her on prednisone. She reported that she took that for the duration and went to take another Covid test in between (in May2021) that came back negative. She reported that her physician told her that she should be fine to take the Covid-19 shot and the She went in on 25May2021 to get it. She queried that if it was because she didn't wait enough days between her Covid infection and getting the Covid-19 vaccine.  She reported that they did suggest for her to wait 90 days after the infection, but her physician said it would be ok.  She stated that she guessed her physician was afraid of her being out there. She reported that she really doesn't want to get the second dose of the Covid-19 vaccine.  She reported that she did take one Covid-19 shot but she was now hesitant to do the second.  She reported that after the first dose of the Covid-19 vaccine, she was feeling bad and couldn't do anything for 3 days. She reported that headache lasted about 4 days, sweating lasted about 2 days. The patient had not reported any investigation assessment. The patient reported that adverse events did not resulted to visit emergency room but, she visited physician office for cough. The patient received prednisone as treatment medication for cough. The outcome of the events headache, feeling bad like she caught Covid again was recovered on 30May2021, sweating on 28May2021, arm was itching, redness at injection site/Arm was red on unknown date in Jun2021 and the outcome of the events cough, pain at injection site/arm was sore and swollen was recovering and unknown for feeling ill.; Sender's Comments: Linked Report(s): PFIZER INC- similar report from same reporter