Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Dyspnoea, Peak expiratory flow rate
Clinical narrative: severe asthma attack; Short of breath; chest is really tight; coughing (non-stop); This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:30 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high risk has asthma" (unspecified if ongoing), notes: just know she needs to get it every year; is high risk has asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: DYSPNOEA (medically significant) with onset 06Oct2023 at 07:30, outcome "not recovered", described as "Short of breath"; CHEST DISCOMFORT (medically significant) with onset 06Oct2023 at 07:30, outcome "not recovered", described as "chest is really tight"; COUGH (medically significant) with onset 06Oct2023 at 07:30, outcome "recovered" (Oct2023), described as "coughing (non-stop)"; ASTHMA (medically significant) with onset 06Oct2023 at 07:30, outcome "unknown", described as "severe asthma attack". The patient underwent the following laboratory tests and procedures: Peak expiratory flow rate: (Oct2023) 250, notes: Normal peak flow meter for her 400-450. Therapeutic measures were taken as a result of asthma, dyspnoea, chest discomfort, cough. Clinical Course: Chest was really tight was reported as worsened. Caller stated that she called about the Pfizer Covid vaccine. Stated that she typically knew people having anaphylactic reactions according to the Pfizer site was 1-4 hours after the vaccine. She was not having a reaction. Today she woke up and had a severe asthma attack that she could not control. She took 50mg of Benadryl and used her albuterol rescue inhaler several times which did not touch it. Called her allergist and he prescribed Prednisone 20mg today, 10mg tomorrow and then 5mg. Took 20mg of Prednisone this morning and it did not help at all. Called him back and was told to take another Prednisone 10mg and used her albuterol nebulizer. She took 25mg of Benadryl and used her rescue inhaler several more times which did not touch it. Around 12:30 she took 10mg of Prednisone for total of 30mg and albuterol. Helped just a touch. She was not coughing non-stop but her chest was still tight and she was feeling short of breath. It had been an hour since she took albuterol and prednisone. She stated this happened 19 hours later. Pollen count was low and she did not do anything different. Only thing different was the Covid vaccine. She had the Pfizer vaccine four times recently. This was unusual. She was not full blown anaphylaxis; could not get her asthma under control. Since she was having such a reaction this time, she wanted to know if she should get it next year or it would be advised not to get it next year or treat with an antihistamine prior to getting it. She stated the Pfizer site in one spot said not to get it but it was not in reference to anaphylaxis. She would take another 10mg of Prednisone this afternoon and if it did not work, she would use her epi-pen. Normal peak flow meter for her 400-450 and hers this morning was 250 and if less than that it told to go to the emergency room so that is why she was taking prednisone was because it was so bad this morning. Stated that her weight was so high because she was on and off cortisone and prednisone injections. Patient had severe asthma attack, short of breath, chest was tight and coughing (non-stop) which started at 7:30 am today. Treatment: For asthma, started 50mg Benadryl then used Albuterol 80mg rescue inhaler twice that did not help. Manufacturer was PRIVACY, Formulated powder that was distributed when used the inhaler breathe it in. Dose was two puffs prn. For short of breath, just took another 10mg of Prednisone because her chest was so tight. For chest tightness, used albuterol rescue inhaler one albuterol nebulizer and used to last 10mg of Prednisone she had and if that did not work she was supposed to go to the emergency room. For coughing, took 30mg Prednisone and Albuterol nebulizer treatment between 12:35-1:00. Coughing stopped at 1:00, outcome provided as the coughing suppressed, still have shortness of breath and chest tightness.   Causality Assessment: Global Introspection method assessment of the causal relationship by Primary Source Reporter of the BNT162b2 with reported events asthma, coughing, short of breath and chest discomfort: Yes.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Considering the plausible temporal association and as the event is expected as per the safety profile of the drug, the causality of the events  asthma, coughing, short of breath and chest discomfort cannot be ruled out and hence assessed as suspected with the drug. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.