Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Investigation, Respiratory disorder
Clinical narrative: Giving her feelings of going to die intermittently/she was feeling like she was going to die; respiratory issues; Her sugars are swinging; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 60-year-old female patient received BNT162b2 (BNT162B2), as dose number unkn own, 0.3ml single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "asthma" (unspecified if ongoing), notes: not taking her asthma medication properly and they adjusted her medications. Concomitant medication(s) included: LEVEMIR; NOVOLOG; VICTOZA; ASPIRIN [ACETYLSALICYLIC ACID]; FLONASE [MOMETASONE FUROATE]. The following information was reported: FEELING ABNORMAL (non-serious) with onset Feb2022, outcome "unknown", described as "Giving her feelings of going to die intermittently/she was feeling like she was going to die"; BLOOD GLUCOSE FLUCTUATION (non-serious) with onset Feb2022, outcome "unknown", described as "Her sugars are swinging"; RESPIRATORY DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "respiratory issues". The events "giving her feelings of going to die intermittently/she was feeling like she was going to die", "respiratory issues" and "her sugars are swinging" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller said that the patient is reporting that the vaccine is giving her feelings of going to die intermittently. Caller said that the patient started in Mar2022 with some respiratory issues. She was an asthma patient and was not taking her asthma medication properly and they adjusted her medications. Then the patient thought she might have tuberculosis and had a chest x-ray that was negative. Then the patient thought she was having chest pain. The caller said that she did a EKG in the office and it was fine. Now she is saying that she thinks her symptoms are caused by the vaccine. The patient is Bipolar and under therapy and not a particularly well controlled diabetic. The patient has a anxiety disorder. She believes that the patient is not controlling her diabetes the way she could. She has some swings in her blood sugars and that can make you feel funny. She works in a free clinic. Caller said that they did a D-Dimer that was negative, and the caller does not believe it is a blood clot. The patient's sugars are swinging and she believes that is the problem. The caller has maintained it is not the Vaccine, and she thinks it is the uncontrolled diabetes and the patient has sleep apnea. She thinks she has drop in her blood sugar at night, but can't get the patient to understand that. Caller said that you can overtreat diabetes as well as undertreat it. Caller provided the patient's BMI as 28.3, and said that it is not bad. Events: The patient would not give the caller dates about when her symptoms started. The patient was very vague. The patient won't tell anyone about her symptoms and said that she was going to report everything on VAERS. One day the patient said she was feeling like she was going to die. Caller said that in one day the patient blood sugar drop was from 272 to 111 in one day. Caller said that will make you feel bad. The patient wont tell her this. The patient did not look like she was in any distress when she said that she was going to die.  The patient's heart rate was not up and the patient was not sweating, she looked fine. She is a mental health patient. The only way to get the patient to get over this is to go through a report and not have this cause for concern. The caller said that they read stuff on the internet about it and the caller would like the patient to stop googling information off of the internet. The caller said that she told the patient there is no side effects from the vaccine. She told the patient Covid was worse than any side effects that the patient would get from the vaccine. The caller said that the pharmacist told the patient her symptoms could be from the vaccine, even the though that she told the patient it was not. The patient also said that she was told that the government keeps the side effects a secret. Vaccination Facility Type: Pharmacy. Vaccine not Administered at Facility. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. AEs not require a visit to: Emergency Room, require a visit to Physician Office. The caller thinks this all started in Feb2022 with increased secretions. None other vaccines within four weeks prior to the first administration date of the suspect vaccine. No AE following prior vaccinations. The patient will have to provide the medications as the mental health changes the medication all of the time. Caller said that she has the patient on Levemir, NovoLog, Victoza, aspirin and Flonase. The caller believes the product is safe and finds it impossible to trust people who don't belive that the vaccines are safe. Relatedness of drug to reaction(s)/event(s), Source of assessment: Primary Source Reporter, Method of assessment: Introspection, Result of Assessment: No; Relatedness of drug to reaction(s)/event(s), Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Result of Assessment: No. The events were reported as non-serious.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.