chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sedation, Vomiting
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Dizziness, Hot/Cold extremities, Pain @ injection site Narrative:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Myalgia Leg muscle cramps, abdominal cramps, injection arm pain. Narrative:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever fatigue Narrative:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, aches Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache, Myalgia, NauseaVomiting, Chills, fatigue Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, Chills, fatigue Narrative:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Impaired work ability
Clinical narrative: Dizziness, Fatigue Narrative: missed work and several days fatigue following second dose
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Headache, Myalgia, Fever, congestion Narrative:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache fatigue, chills, myalgias Narrative:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Headache, Myalgia & Arthralgia Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Dizziness, Headache, Arthralgia, Fever, NauseaVomiting, chills, urinary frequency Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Pyrexia, Vomiting
Clinical narrative: Dizziness, Headache, Arthralgia, Fever, NauseaVomiting, chills, urinary frequency Narrative:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Impaired work ability, Pyrexia
Clinical narrative: Headache, Fever, weakness Narrative:  missed work following the second dose due to symptoms
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Headache, Myalgia, Arthralgia, chills, fatigue, numbness/tingling Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Headache, Myalgia, Arthralgia, chills, fatigue, numbness/tingling Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Myalgia, Fever & NauseaVomiting Narrative:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Myalgia fatigue Narrative:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Nausea, Pain, Pain in extremity
Clinical narrative: Headache, NauseaVomiting, Reports shooting pain in left arm. Swelling @ injection site Narrative:  Reports shooting pain down left arm, nausea, head ache.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, NauseaVomiting, Reports shooting pain in left arm. Swelling @ injection site Narrative:  Reports shooting pain down left arm, nausea, head ache.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Headache, NauseaVomiting, chill,s fatigue Narrative:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, Fever, Chills Narrative:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Myalgia, Arthralgia, Fever chills, extreme tiredness Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, fatigue, chills, burning eyes, nasal congestion Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Headache, Myalgia, fatigue, chills, burning eyes, nasal congestion Narrative:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache fatigue, H/a sore arm Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache arm pain, fatigue Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pruritus, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, UrticariaPruritus, FATIGUE, "TREMORS" ON 3rd DAY Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urticaria
Clinical narrative: Headache, Myalgia, Fever, UrticariaPruritus, FATIGUE, "TREMORS" ON 3rd DAY Narrative:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: Headache, Myalgia, Fever, congestion fatigue Narrative:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Dizziness, Headache, NauseaVomiting, FATIGUE Narrative:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability
Clinical narrative: Headache fatigue Narrative:  missed work following second dose due to symptoms
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: Myalgia, NauseaVomiting, fatigue Narrative:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Headache shortness of breath, chest pain fatigue Narrative:  was seen at the ED a day after vaccinated; treated with Zofran, Toradol and Benadryl. Has hx of asthma.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest discomfort, Chills, Cough
Clinical narrative: Headache, Arthralgia, CoughWheeze, NauseaVomiting, Stomach pain, chest tightness, fatigue, chills Narrative:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting, Wheezing
Clinical narrative: Headache, Arthralgia, CoughWheeze, NauseaVomiting, Stomach pain, chest tightness, fatigue, chills Narrative:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema multiforme, Headache, Pain in extremity, Pruritus
Clinical narrative: Headache, Arthralgia, Fever, Tachypnea, ErythemaMultiform, UrticariaPruritus, L arm pain Narrative:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachypnoea, Urticaria
Clinical narrative: Headache, Arthralgia, Fever, Tachypnea, ErythemaMultiform, UrticariaPruritus, L arm pain Narrative:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Pyrexia
Clinical narrative: Headache, Fever, fatigue Narrative:  missed work following the second dose due to the above symptoms
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever FATIGUE Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia
Clinical narrative: Dizziness & Tachycardia Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, Chills Narrative:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache
Clinical narrative: Headache Anxiety Narrative:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Fever malaise, right side chest wall pain Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Headache, Myalgia, sore arm Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Pyrexia
Clinical narrative: Myalgia, Fever, Diarrhea, NauseaVomiting, chills, Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Myalgia, Fever, Diarrhea, NauseaVomiting, chills, Narrative:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: Dizziness, Headache, chills Narrative:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills, fatigue, body aches Narrative:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperglycaemia, Insulin therapy, Myalgia
Clinical narrative: Headache, Myalgia, NauseaVomiting, Hyperglycemia(insulin dependent), fatigue Narrative:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, Hyperglycemia(insulin dependent), fatigue Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache, Myalgia, Fever, injection site discomforts (right arm red, hot, swollen and painful, c/o insomnia Narrative:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Insomnia, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, injection site discomforts (right arm red, hot, swollen and painful, c/o insomnia Narrative:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache, Myalgia, chills Narrative:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, Rash, NauseaVomiting, FATIGUE Narrative:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: Headache, Myalgia, Fever, Rash, NauseaVomiting, FATIGUE Narrative:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, Fatigue, chills Narrative:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, Myalgia, Fever, NauseaVomiting, Fatigue, chills Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Impaired work ability
Clinical narrative: Dizziness & Headache Narrative:  missed one day of work following second dose due to the above symptoms
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Myalgia
Clinical narrative: Headache & Myalgia Narrative:  missed one day of work following second dose due to symptoms
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache chills Narrative:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Arthralgia, Fever, Chills Narrative:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: NauseaVomiting Chills Narrative:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, left arm- vaccine arm hurt Narrative:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, Chills Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache, Fever, fatigue Narrative:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Nausea, Vomiting
Clinical narrative: Headache, NauseaVomiting, fatigue Narrative:  missed work following second dose due to above symptoms
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Nausea, Pain
Clinical narrative: Headache, Fever, NauseaVomiting, Chills, and Body aches, back pain Narrative:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, Chills, and Body aches, back pain Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, arm pain, chills Narrative:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Fever, NauseaVomiting, chills Narrative:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, nausea Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Brain fog, Headache, Myalgia, Nausea
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, BrainFog Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, BrainFog Narrative:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Dizziness, Influenza like illness
Clinical narrative: Agitation, Dizziness, Flu like symptoms. Narrative:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea & NauseaVomiting Narrative:
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 yo patient given FluBlok.  FluBlok indicated for 18years and older.  No side effects or adverse events.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Facial paresis, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: bell's palsy; right sided mouth weakness; numbness; tingling; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot number: EH9899) on 23Dec2020 12:30 via an unspecified route of administration in the right arm at a single dose, and second dose (lot number: EJ1686) via an unspecified route of administration in the left arm on 10Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included allergies to Penicillin, Shingles (three times in 2014, 2015 and 2017), anxiety, depression, and ovarian Cyst. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). On an unspecified date, after the first injection, the patient experienced noticeable right sided mouth weakness, numbness and tingling which resolved within 3 hrs. On 10Jan2021 04:00, after the second injection, the patient experienced worse right sided mouth weakness, numbness and tingling that is still in effect. It was also reported that the patient experienced bells palsy on an unspecified date. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment for the event includes high dose prednisone and acylovir for bells palsy. The patient underwent COVID test post vaccination via nasal swab (PCR) reported as on 29Nov2020 and was negative. The outcome of the events facial paresis, hypoaesthesia and paraesthesia was recovered on an unspecified date while the outcome of the event facial paralysis was unknown.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy/facial paresis cannot be excluded, considering the plausible temporal relationship. 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: bell's palsy; right sided mouth weakness; numbness; tingling; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot number: EH9899) on 23Dec2020 12:30 via an unspecified route of administration in the right arm at a single dose, and second dose (lot number: EJ1686) via an unspecified route of administration in the left arm on 10Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included allergies to Penicillin, Shingles (three times in 2014, 2015 and 2017), anxiety, depression, and ovarian Cyst. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). On an unspecified date, after the first injection, the patient experienced noticeable right sided mouth weakness, numbness and tingling which resolved within 3 hrs. On 10Jan2021 04:00, after the second injection, the patient experienced worse right sided mouth weakness, numbness and tingling that is still in effect. It was also reported that the patient experienced bells palsy on an unspecified date. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment for the event includes high dose prednisone and acylovir for bells palsy. The patient underwent COVID test post vaccination via nasal swab (PCR) reported as on 29Nov2020 and was negative. The outcome of the events facial paresis, hypoaesthesia and paraesthesia was recovered on an unspecified date while the outcome of the event facial paralysis was unknown.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy/facial paresis cannot be excluded, considering the plausible temporal relationship. 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Headache, Hypertension
Clinical narrative: BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15.  On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg.  Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course.  However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors.  The case will be reassessed should additional information become available.  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.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: 12/29/2020   Soreness at site, headache ,  chills  fever 100.4-102 rectally /Tylenol
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Nausea, Swelling of eyelid
Clinical narrative: About 5 min after the immunization, the patient developed headache, nausea and some dizziness.   Left the clinic and noticed some eyelid swelling and took some benadryl.    The swelling didn't resolve so she presented to the ED.    She was also found to be hypertensive in the ED and required treatment for both the swelling in her eyes and the hypertension.  All symptoms resolved in about 90 min and the patient was discharged home without incident
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: 8 hours following administration of Pfizer-BioNTech COVID19 vaccination, patient developed generalized hives and dyspnea.  She was treated in a local ED with epinephrine, IV solumedrol, and Benadryl.  She was discharged with a 5-day course of oral prednisone. On January 3rd, she experienced mild flushing, chest tightness, mild facial edema, and hives.  She was treated with IV fluids and an extension of prednisone. On January 5th, she developed mild pruritic, but no hives.  This was treated with hydroxyzine.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Face oedema, Flushing, Pruritus
Clinical narrative: 8 hours following administration of Pfizer-BioNTech COVID19 vaccination, patient developed generalized hives and dyspnea.  She was treated in a local ED with epinephrine, IV solumedrol, and Benadryl.  She was discharged with a 5-day course of oral prednisone. On January 3rd, she experienced mild flushing, chest tightness, mild facial edema, and hives.  She was treated with IV fluids and an extension of prednisone. On January 5th, she developed mild pruritic, but no hives.  This was treated with hydroxyzine.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: 8 hours following administration of Pfizer-BioNTech COVID19 vaccination, patient developed generalized hives and dyspnea.  She was treated in a local ED with epinephrine, IV solumedrol, and Benadryl.  She was discharged with a 5-day course of oral prednisone. On January 3rd, she experienced mild flushing, chest tightness, mild facial edema, and hives.  She was treated with IV fluids and an extension of prednisone. On January 5th, she developed mild pruritic, but no hives.  This was treated with hydroxyzine.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Chills, Feeling hot, Groin pain, Headache
Clinical narrative: Myalgias  several  hours later . Evening worsened myalgias, shivering, "burning up", no fever,  headache, back pain, palpitations, left axillary lymph nodes pain,  next day "peach pit size",  this has improved .  bilateral inguinal pain "a week for symptoms to resolve"
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Palpitations
Clinical narrative: Myalgias  several  hours later . Evening worsened myalgias, shivering, "burning up", no fever,  headache, back pain, palpitations, left axillary lymph nodes pain,  next day "peach pit size",  this has improved .  bilateral inguinal pain "a week for symptoms to resolve"
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Palpitations
Clinical narrative: Myalgias  several  hours later . Evening worsened myalgias, shivering, "burning up", no fever,  headache, back pain, palpitations, left axillary lymph nodes pain,  next day "peach pit size",  this has improved .  bilateral inguinal pain "a week for symptoms to resolve"
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Heart rate increased, Myalgia
Clinical narrative: Temp 100.6-100.1. Soreness>flu shot, nausea, Chills, elevated  HR 110, muscle ache, fatigue, weakness
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Temp 100.6-100.1. Soreness>flu shot, nausea, Chills, elevated  HR 110, muscle ache, fatigue, weakness
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Temp 100.6-100.1. Soreness>flu shot, nausea, Chills, elevated  HR 110, muscle ache, fatigue, weakness
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe multi joint pain never in same place.   The joints I didnt have where neck,  rt ankle or left elbow
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Severe multi joint pain never in same place.   The joints I didnt have where neck,  rt ankle or left elbow
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Borrelia test negative, Facial paralysis, Facial paresis, Hypoaesthesia
Clinical narrative: Reports who had COVID vaccine shot on 1/4/2021 and notice same day right sided facial weakness. She went to ER and diagnoses Bell's Palsy.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paresis
Clinical narrative: Reports who had COVID vaccine shot on 1/4/2021 and notice same day right sided facial weakness. She went to ER and diagnoses Bell's Palsy.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Eye swelling, Facial pain
Clinical narrative: Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapula region and complained of not feeling well.  Per ED note, mild facial swelling, no evidence of any other symptoms, given Benadryl, Steroids and Pepcid, monitored for 4 hours and discharged.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypersensitivity, Hypertension, Neck pain
Clinical narrative: Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapula region and complained of not feeling well.  Per ED note, mild facial swelling, no evidence of any other symptoms, given Benadryl, Steroids and Pepcid, monitored for 4 hours and discharged.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Malaise, Swelling face
Clinical narrative: Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapula region and complained of not feeling well.  Per ED note, mild facial swelling, no evidence of any other symptoms, given Benadryl, Steroids and Pepcid, monitored for 4 hours and discharged.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Approximately 10-15 minutes after injection patient experienced a pins and needles sensation to bilateral feet and hands. The sensation eventually radiated up to the bilateral elbows and knees. patient continued to experience residual of that the sensation for about 2 weeks. most of the sensation has dissipated on its own.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: Approximately 10-15 minutes after injection patient experienced a pins and needles sensation to bilateral feet and hands. The sensation eventually radiated up to the bilateral elbows and knees. patient continued to experience residual of that the sensation for about 2 weeks. most of the sensation has dissipated on its own.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Chest X-ray, Chills, Culture urine, Full blood count, Headache
Clinical narrative: fever; headache; chill; The patient developed fever; The patient developed headache; The patient developed chill; The patient developed pain at the injection site; This spontaneous report was received from a patent's mother and refers to a 26 year old male patient. The patient's concurrent conditions included asthma and sulfa allergy.  The patient's medical history included pneumonia in 2009.  On 28-DEC-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # T-020638, injected in the arm (dose, expiration date and route were not reported) for prophylaxis.Concomitant therapies included montelukast sodium (SINGULAIR).     On 28-DEC-2020, the patient developed a fever (pyrexia), headache, chills and pain at the injection site. These symptoms lasted for "a few days". However, approximately 3 days later in January 2021, the symptoms of fever, headache and chills returned. The patient reached out to physician and was treated with acetaminophen (TYLENOL) for fever and headache. On unspecified date, complete blood count, chest x-ray, 2 COVID-19 tests, and mono test were performed, and no results were provided.  At the time of the report, the patient was recovering from pyrexia, headache and chills. On unknown date, the patient recovered from injection site pain.  The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  Lot number T-020638 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent(PNEUMOVAX23) . Lot number T-020638  does not match any Company product as confirmed by Lot Verification team.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Metabolic function test, Mononucleosis heterophile test, Photophobia, Pyrexia, Swelling
Clinical narrative: fever; headache; chill; The patient developed fever; The patient developed headache; The patient developed chill; The patient developed pain at the injection site; This spontaneous report was received from a patent's mother and refers to a 26 year old male patient. The patient's concurrent conditions included asthma and sulfa allergy.  The patient's medical history included pneumonia in 2009.  On 28-DEC-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # T-020638, injected in the arm (dose, expiration date and route were not reported) for prophylaxis.Concomitant therapies included montelukast sodium (SINGULAIR).     On 28-DEC-2020, the patient developed a fever (pyrexia), headache, chills and pain at the injection site. These symptoms lasted for "a few days". However, approximately 3 days later in January 2021, the symptoms of fever, headache and chills returned. The patient reached out to physician and was treated with acetaminophen (TYLENOL) for fever and headache. On unspecified date, complete blood count, chest x-ray, 2 COVID-19 tests, and mono test were performed, and no results were provided.  At the time of the report, the patient was recovering from pyrexia, headache and chills. On unknown date, the patient recovered from injection site pain.  The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  Lot number T-020638 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent(PNEUMOVAX23) . Lot number T-020638  does not match any Company product as confirmed by Lot Verification team.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Tenderness, Urine analysis
Clinical narrative: fever; headache; chill; The patient developed fever; The patient developed headache; The patient developed chill; The patient developed pain at the injection site; This spontaneous report was received from a patent's mother and refers to a 26 year old male patient. The patient's concurrent conditions included asthma and sulfa allergy.  The patient's medical history included pneumonia in 2009.  On 28-DEC-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # T-020638, injected in the arm (dose, expiration date and route were not reported) for prophylaxis.Concomitant therapies included montelukast sodium (SINGULAIR).     On 28-DEC-2020, the patient developed a fever (pyrexia), headache, chills and pain at the injection site. These symptoms lasted for "a few days". However, approximately 3 days later in January 2021, the symptoms of fever, headache and chills returned. The patient reached out to physician and was treated with acetaminophen (TYLENOL) for fever and headache. On unspecified date, complete blood count, chest x-ray, 2 COVID-19 tests, and mono test were performed, and no results were provided.  At the time of the report, the patient was recovering from pyrexia, headache and chills. On unknown date, the patient recovered from injection site pain.  The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  Lot number T-020638 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent(PNEUMOVAX23) . Lot number T-020638  does not match any Company product as confirmed by Lot Verification team.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Chest X-ray, Chills, Full blood count, Headache, Injection site pain
Clinical narrative: fever; headache; chill; The patient developed fever; The patient developed headache; The patient developed chill; The patient developed pain at the injection site; This spontaneous report was received from a patent's mother and refers to a 26 year old male patient. The patient's concurrent conditions included asthma and sulfa allergy.  The patient's medical history included pneumonia in 2009.  On 28-DEC-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # T-020638, injected in the arm (dose, expiration date and route were not reported) for prophylaxis.Concomitant therapies included montelukast sodium (SINGULAIR).     On 28-DEC-2020, the patient developed a fever (pyrexia), headache, chills and pain at the injection site. These symptoms lasted for "a few days". However, approximately 3 days later in January 2021, the symptoms of fever, headache and chills returned. The patient reached out to physician and was treated with acetaminophen (TYLENOL) for fever and headache. On unspecified date, complete blood count, chest x-ray, 2 COVID-19 tests, and mono test were performed, and no results were provided.  At the time of the report, the patient was recovering from pyrexia, headache and chills. On unknown date, the patient recovered from injection site pain.  The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  Lot number T-020638 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent(PNEUMOVAX23) . Lot number T-020638  does not match any Company product as confirmed by Lot Verification team.
Age: 26.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Mononucleosis heterophile test, Pyrexia
Clinical narrative: fever; headache; chill; The patient developed fever; The patient developed headache; The patient developed chill; The patient developed pain at the injection site; This spontaneous report was received from a patent's mother and refers to a 26 year old male patient. The patient's concurrent conditions included asthma and sulfa allergy.  The patient's medical history included pneumonia in 2009.  On 28-DEC-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # T-020638, injected in the arm (dose, expiration date and route were not reported) for prophylaxis.Concomitant therapies included montelukast sodium (SINGULAIR).     On 28-DEC-2020, the patient developed a fever (pyrexia), headache, chills and pain at the injection site. These symptoms lasted for "a few days". However, approximately 3 days later in January 2021, the symptoms of fever, headache and chills returned. The patient reached out to physician and was treated with acetaminophen (TYLENOL) for fever and headache. On unspecified date, complete blood count, chest x-ray, 2 COVID-19 tests, and mono test were performed, and no results were provided.  At the time of the report, the patient was recovering from pyrexia, headache and chills. On unknown date, the patient recovered from injection site pain.  The relationship between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  Lot number T-020638 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent(PNEUMOVAX23) . Lot number T-020638  does not match any Company product as confirmed by Lot Verification team.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes (Visible and tender) in left axilla; swollen lymph nodes (Visible and tender) in left axilla; This is a spontaneous report from a contactable nurse (patient).  A 27-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on 04Jan2021 at 7:00 PM at a single dose on the left arm for COVID-19 immunization.  Medical history included allergies to shellfish, nuts and sulfa drugs. The patient has not had COVID-19 prior to vaccination. Concomitant medication included vitamin d3 (manufacturer unknown), macrogol 3350 (MIRALAX), ibuprofen (manufacturer unknown) and unspecified multivitamins. The patient did not have other vaccines in four weeks. The patient experienced swollen lymph nodes (visible and tender) in left axilla on 11Jan2021. The patient did not receive any treatment for the event. The patient has not recovered from the event. The patient has not been tested for COVID-19 post vaccination.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chills, Fatigue, Full blood count, Lymphadenopathy
Clinical narrative: Anaphylaxis; itching; slight rash on upper chest; nausea; hives; sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 10Jan2021 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, hypothyroidism, Meniere's disease, asthma, anaphylaxis, and known allergies to cantaloupe and pineapple. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included levothyroxine, montelukast, lorazepam, and fish oil. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and ciprofloxacin and experienced allergies. The patient was given first dose of BNT162B2 on 20Dec2020 (lot number: EH9899, brand: Pfizer) on left arm at 11:30 AM for COVID-19 immunization. No other vaccines in four weeks. On 12Jan2021 11:00, the patient experienced anaphylaxis. During 1st 24hrs, patient just had sore arm, then started itching but just slight rash on upper chest, then 36 hrs, nausea and increased itching; and 48 hrs itching got intense and went quickly into hives. IV SoluMedrol, IV fluids, Pepcid and Benadryl were administered as treatment for the events. It was reported that the adverse events resulted in Emergency room/department or urgent care. The patient has not been tested for COVID-19 post vaccination. The patient is recovering from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylaxis with individual symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the 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.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: Anaphylaxis; itching; slight rash on upper chest; nausea; hives; sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 10Jan2021 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, hypothyroidism, Meniere's disease, asthma, anaphylaxis, and known allergies to cantaloupe and pineapple. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included levothyroxine, montelukast, lorazepam, and fish oil. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and ciprofloxacin and experienced allergies. The patient was given first dose of BNT162B2 on 20Dec2020 (lot number: EH9899, brand: Pfizer) on left arm at 11:30 AM for COVID-19 immunization. No other vaccines in four weeks. On 12Jan2021 11:00, the patient experienced anaphylaxis. During 1st 24hrs, patient just had sore arm, then started itching but just slight rash on upper chest, then 36 hrs, nausea and increased itching; and 48 hrs itching got intense and went quickly into hives. IV SoluMedrol, IV fluids, Pepcid and Benadryl were administered as treatment for the events. It was reported that the adverse events resulted in Emergency room/department or urgent care. The patient has not been tested for COVID-19 post vaccination. The patient is recovering from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylaxis with individual symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the 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.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Nausea, Pain in extremity, Pruritus, Rash
Clinical narrative: Anaphylaxis; itching; slight rash on upper chest; nausea; hives; sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 10Jan2021 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, hypothyroidism, Meniere's disease, asthma, anaphylaxis, and known allergies to cantaloupe and pineapple. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included levothyroxine, montelukast, lorazepam, and fish oil. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and ciprofloxacin and experienced allergies. The patient was given first dose of BNT162B2 on 20Dec2020 (lot number: EH9899, brand: Pfizer) on left arm at 11:30 AM for COVID-19 immunization. No other vaccines in four weeks. On 12Jan2021 11:00, the patient experienced anaphylaxis. During 1st 24hrs, patient just had sore arm, then started itching but just slight rash on upper chest, then 36 hrs, nausea and increased itching; and 48 hrs itching got intense and went quickly into hives. IV SoluMedrol, IV fluids, Pepcid and Benadryl were administered as treatment for the events. It was reported that the adverse events resulted in Emergency room/department or urgent care. The patient has not been tested for COVID-19 post vaccination. The patient is recovering from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylaxis with individual symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the 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.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Anaphylaxis; itching; slight rash on upper chest; nausea; hives; sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 10Jan2021 11:00 at a single dose on left arm for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, hypothyroidism, Meniere's disease, asthma, anaphylaxis, and known allergies to cantaloupe and pineapple. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included levothyroxine, montelukast, lorazepam, and fish oil. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and ciprofloxacin and experienced allergies. The patient was given first dose of BNT162B2 on 20Dec2020 (lot number: EH9899, brand: Pfizer) on left arm at 11:30 AM for COVID-19 immunization. No other vaccines in four weeks. On 12Jan2021 11:00, the patient experienced anaphylaxis. During 1st 24hrs, patient just had sore arm, then started itching but just slight rash on upper chest, then 36 hrs, nausea and increased itching; and 48 hrs itching got intense and went quickly into hives. IV SoluMedrol, IV fluids, Pepcid and Benadryl were administered as treatment for the events. It was reported that the adverse events resulted in Emergency room/department or urgent care. The patient has not been tested for COVID-19 post vaccination. The patient is recovering from the events.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset anaphylaxis with individual symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  Severe allergic reaction is the known risk for the 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.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: The vaccine was given to me. Within 5 minutes my throat felt strange so I went get water. I went pale and blood pressure was 205/198 along with tachycardia. Spent hours in E.R.