Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Dyspnoea, Fatigue, Fear of death
Clinical narrative: congestive heart failure exacerbated; Atrial Fibrillation; however these symptoms were exacerbated after having the 1st dose; The patient stated that she know that if she got a covid vaccine she may die because of her heart and lungs.; flutter; shortness of breath exacerbated; chest pain/ chest pain exacerbated; racing heartbeat at times exacerbated; abdominal pain/ cramping in abdomen/ belly pain; diarrhea; tired; headache; stomach was queasy; rash; itching; This is a spontaneous report received from a contactable consumer via medical information team. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration in the right arm, on 04Jun2021 (at the age of 72-year-old), as a single dose for COVID-19 immunisation. Medical history included ongoing congestive heart failure, ongoing atrial fibrillation, ongoing flutter and does experience shortness of breath (ongoing), ongoing chest pain, and racing heartbeat at times (ongoing). Concomitant medications included Warfarin   sodium (COUMADIN). On 04Jun2021 after vaccination, when the patient by reaching to home experienced itching and rash that initially was on her left arm and knuckles and moved to her right arm where she got the vaccine. Those symptoms have since resolved with no further concerns. A couple hours after the administration of the vaccine, the patient experienced severe pain in her chest. It was reported that the pain was an 11 on a scale of 1 to 10, and her heart was really racing. The patient had shortness of breath, which she had with her problems, but it was a little more. The patient stated that she has a history of congestive heart failure, with Atrial Fibrillation and flutter and does experience shortness of breath, chest pain, and racing heartbeat at times however these symptoms were exacerbated after having the 1st dose administered. The patient stated her symptoms almost put her in the Emergency Room but she held off on going and chose to wait her symptoms out. It calmed down so the patient did not go to the emergency room. Later, on the patient had a chest pain but not as severe. It was reported that in the morning and over the weekend it was minor. The patient started cramping in her abdomen and had diarrhea at night and had it again on Saturday and she had some yesterday (06Jun2021). This morning (07Jun2021) the patient had it and then around 2:00 she started having belly pain/abdominal pain and diarrhea. The patient wanted to know if there were any contraindications with receiving the Pfizer COVID19 vaccine in conjunction with Coumadin use. Response was provided for the same as: When vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine should only be administered as an intramuscular injection. Also reported that there was no contraindication listed upon the package insert for patients receiving blood thinners and getting the COVID19 vaccine as well as provided information regarding use with blood thinners. It was reported that one provider advised her to not get the vaccine, however her cardiologist recommended her to get the vaccine due to risks vs benefits. However, the patient was waiting call back from her Cardiologist regarding her chest pain and racing heart symptoms at that time. The patient wants to make sure the physician doesn't want to see her. The patient was overall not felt well and was fatigued as well and she wanted to know if those symptoms are commonly seen or have they been reported. She also stated that she gets tired easily due to heart congestion but she was feeling more tired than usual. Patient does not usually get headaches and also got a headache on Friday after getting her COVID19 vaccine. The patient wanted to know how long her side effects may last because already she was scheduled dental procedure tomorrow (08Jun2021) wants to make sure everything was okay, and also she wanted to know more information regarding the reported cases of Myocarditis. The patient was more concerned and worried about getting the second dose because with the first dose she experienced events and she stated that her second dose was scheduled on the 25Jun2021. It was reported that when the patient's husband visited for vaccination, they asked whether he was on blood thinner. But the patient was mentioning that she (his wife) was on blood thinner coumadin, however they did not ask her regarding the blood thinners. Even the patient had not informed about the blood thinners to them. The patient queried about whether they give a different type of vaccine for blood thinners or its okay to take normal vaccine. The patient stated that she know that if she got a covid vaccine she may die because of her heart and lungs. It was reported that her stomach was queasy. The events congestive heart failure exacerbated, Atrial Fibrillation, however these symptoms were exacerbated after having the 1st dose were assessed as medically significant. The outcome of the events was unknown.  Follow-up attempts are needed; Information on the lot/batch number has been requested.