Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Throat irritation, Throat tightness
Clinical narrative: shortness of breath; throat tightening; hives on the anterior chest and face; throat began to be dry; began sounding like I was snoring; face is flushed; I could not swallow; anaphylaxis; This is a spontaneous report from a contactable physician via US FDA (VAERS Number: 906970). A 30-year-old female patient received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm (also reported as: Deltoid, unknown which side) on 22Dec2020 09:15 at 30-years-old at a single dose for COVID-19 immunization in a hospital. Medical history included ongoing anaphylaxis to bee pollens (Pertinent Details: Anaphylaxis) and ongoing allergy to wasp venom (Pertinent Details: Anaphylaxis); al from an unknown date; Allergy to insect bite/sting/Yellow jacket from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported; the patient was not taking any medications prior to the event. The patient previously took hepatitis b vaccine (MANUFACTURER UNKNOWN) localized side effect from an unknown date to an unknown date; and epinephrine (EPIPEN) and experienced allergies from an unknown date to an unknown date.  On 22Dec2020 at 09:15, the patient experienced anaphylaxis (medically significant, life threatening); throat began to be dry, began sounding like I was snoring, face is flushed, I could not swallow at 09:18; shortness of breath, throat tightening, hives on the anterior chest and face at 09:28 (medically significant, life threatening). The patient experienced throat tightening, difficulty breathing/swallowing secretions, and hives 13 minutes after vaccine administration (as reported). The adverse event did require a visit to the emergency room (ER), and physician office (ER and physician specialty follow-up due to novel reaction to a novel vaccine). The physician saw the patient two hours after the vaccination and the symptoms (except tickle in throat) had resolved. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination. The clinical course was reported as follows: On 22Dec2020 at 09:15 (as reported), the patient got the vaccine and she went to sit in the waiting area. at 9:18, throat began to be dry, and she tried to take paracetamol (TYLENOL) with some water. The patient could not swallow the water at all. She began sounding like she was snoring. At 9:28, the patient developed throat tightening, shortness of breath, hives on the anterior chest after receiving COVID-19 Pfizer vaccine. Doctor saw the patient and she had hives on her chest and face. They gave the patient an epinephrine (EPIPEN) (also reported as adrenaline) within 10 minutes of getting the vaccine. The patient also received some diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL) and famotidine (PEPCID). After that, she was kept for about 5 hours in the ER. Her vitals were taken: blood pressure measurement (BP) was 140/90. The patient received further anaphylaxis treatment to complete IX including H1 and H2 inhibitors and steroids. The patient was observed for 3 hours with no further symptoms. The patient was not hospitalized or admitted to an intensive care unit. The physician reported that the primary organ involvement was "respiratory", and clarified if the patient experienced the following symptoms: Bilateral wheeze/bronchospasm: Yes (patient reported); Stridor: Unknown; Upper airway swelling: Yes (patient reported); Dry cough: Yes; Sensation of throat closure: Yes; Reduced central pulse volume: Unknown; Dermatological/Mucosal: Yes; Generalized urticaria (hives): Yes Anterior chest and face.  Treatment included epinephrine (EPIPEN), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), methylprednisolone sodium succinate (SOLU-MEDROL) was given in the emergency department (ED). Per the discharge summary, the patient was discharged with a prescription for a steroid dose PAK, epinephrine (EPIPEN); and a referral to an allergy immunologist physician, and the recommendation not to take the second dose per CDC recommendations at the time. After released, she woke up with hives on chest, and her face was flushed. She took her prescribed steroid and a diphenhydramine hydrochloride. The clinical outcome of the event, anaphylaxis, was recovered on 22Dec2020. The physician reported that the Pfizer vaccine had a causal effect to the adverse event.   Follow-up (20Jan2021): New information reported from a contactable physician includes: medical history, suspect vaccine (dosing details), reaction data (added the event anaphylaxis, and removed the associated symptoms as events), and clinical course.   This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.