Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Nausea
Clinical narrative: 15 hours after vaccine vomited/Vomiting; 12 hours after vaccine experienced chills; swelling; fever; nausea; headache; Lymphadenopathy with considerable swelling and tenderness evident in ipsilate; Patient recived dose 1 on 08Jan2021 and dose 2 on 25jan2021; Respiratory distress; Generalized pruritus without skin rash; This is a spontaneous report received from a contactable other-healthcare professional (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: EL3246, Expiry date: Not reported) via an unspecified route of administration in the left arm on 25Jan2021 at 17:15 (at the age of 25-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included environmental allergies to pollen, mold and dust from an unknown date. No history of Anaphylaxis. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: EL3246, Expiry date: not reported) via an unspecified route of administration in left arm on 08Jan2021 at 17:45 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. On 26Jan2021 at 05:15, 12 hours after second vaccination, the patient experienced chills, fever, nausea, headache, swelling, and lymphadenopathy with considerable swelling and tenderness evident in ipsilateral axillary and supraclavicular lymph nodes. Patient 15 hours after vaccine at 08:15, vomited or had vomiting. Fever, chills, and headache persisted from 12-32 hours after vaccination. On an unspecified date in 2021, after vaccination, patient experienced Respiratory distress and Generalized pruritus without skin rash. It was reported that, Swelling was only seen in ipsilateral super clavicular lymph nodes. No anaphylactic reaction occurred. The patient did not require medical intervention. Patient had no emergency department visit, no hospitalization and not admitted to intensive care unit as result of events. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information was expected.  Follow-up (29Mar2021): This is a follow-up spontaneous report from a contactable consumer. This 25-years-old female consumer (patient) reported that, New information includes: Added Medical history (Allergies), New events, Event details, and Clinical information.  No follow-up attempts are possible; No further information was expected.; Sender's Comments: Based on the available information in the case, the causal association between the event respiratory distress and the suspect drug BNT162B2 cannot be excluded.  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.