Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactoid reaction, Chest pain, Cough, Dyspnoea, Injection site pain
Clinical narrative: continuous dry cough; chest pains; Anaphylactic type reaction; shortness of breath with audible wheezing/she felt like her airway was closing/onset shortness of breath that worsened; shortness of breath with audible wheezing; throat was closing; some injection site soreness; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date: Mar2021, NDC number: 59267100001), intramuscular on 16Dec2020 at around 1400 (1400-1500) at 0.3 mL, single for COVID-19 prophylaxis. Vaccine location was Left Deltoid. The COVID-19 vaccine was administered at Hospital. Medical history included ongoing diabetes, ongoing Anaphylactic type reaction, and ongoing depression, the patient also had a allergy to Shellfish, corticosteroids and steroids. Concomitant medications included metformin for Diabetes, fluoxetine hydrochloride (PROZAC) for Depression, propranolol, all of them were ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported anaphylaxis to the flu vaccine in the past. The patient experienced anaphylactic type reaction on 16Dec2020. Pharmacist seriousness for Anaphylactic type reaction: Life threatening and Relatedness of drug to reaction was provided as Related. The pharmacist that was calling about the Covid-19 Vaccine. The pharmacist reported that they were administering the vaccine at the hospital and they had an anaphylactic type reaction with an employee. The pharmacist clarified that the patient was given the vaccine on 16Dec2020 around 1400. She went shopping and a couple of hours later she started having chest pains, shortness of breath with audible wheezing 2-3 hours after administration. The pharmacist reported that the patient's throat was closing. It was reported that the patient had nothing to eat or drink since being vaccinated. The patient reported to the ER at the hospital. She was given Benadryl, Pepcid, Epinephrine, and breathing treatments, 3 doses of the Duoneb nebulizer, Magnesium, and 2 liters of fluids. All of this was given between 1730-1830. The patient was observed for another 90 minutes. The pharmacist said that the ER noted no return of symptoms, no tachycardia, and no required oxygen. The pharmacist said that the patient was made aware that her symptoms may come and go over a few days.  She was discharged from the ER 16Dec2020 and told to come back if her symptoms returned or worsened. The pharmacist said that the patient was allergic to steroids and no steroids were given. On 17Dec2020, the patient had a Telehealth visit for follow up and while she was on the phone with the Telehealth visit, she reported anaphylaxis to the flu vaccine in the past. The pharmacist said that the patient did not tell them at the hospital when receiving the Covid-19 Vaccine that she had in the past had a anaphylactic reaction to the flu vaccine in the past. The pharmacist said that the patient has a allergy to Shellfish and corticosteroids. While on the Telehealth visit, she had new onset shortness of breath that worsened and again said that she felt like her airway was closing. The provider she was talking to made her report to a different hospital at the time that was closer to her house. She reported back to the ER at her local hospital and was treated for shortness of breath, continuous dry cough, and chest pain. While at the ER, they gave her Epinephrine, Benadryl, Pepcid, Ativan and fluids, and another breathing treatment of Duoneb. The pharmacist said that the patient had a follow up office visit, via Telehealth, on 18Dec2020. Today she was seen to see if she was still having symptoms and for follow up. They reported that the patient had no shortness of breath,  no itching of throat, no chest pain, no throat swelling, no dizziness, no hyper/hypotension,  and no confusion. The pharmacist said that the patient did report some injection site soreness (in Dec2020), but no erythema and no nodule. All of the events required a visit to Emergency room and Physician Office. The outcome of the event Anaphylactic type reaction was recovered on 17Dec2020, the outcome of the events Chest pain, shortness of breath, Wheezing, and throat was closing was recovered on an unknown date in Dec2020, the outcome of the other events was unknown.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Life threatening anaphylaxis with shortness of breath, dry cough, throat closing and chest pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product 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.