chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - High pitch whine; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 11:30(at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included abdominal hernia. Concomitant medications included vitamin d nos (VITAMIN D) and ascorbic acid (VITAMIN C) from an unknown date for unknown indication. The patient previously took Codeine and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 14:00 the patient experienced Tinnitus - High pitch whine. The patient did not receive any treatment for the event. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event Tinnitus - High pitch whine was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Rash, Urticaria
Clinical narrative: Hives all over my body, which turned into welts; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 03Apr2021 at 08:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety from an unspecified date, COVID-19 on an unspecified date. Other medications in two weeks included bupropion hydrochloride (WELLBUTRIN), montelukast sodium (SINGULAIR), and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient underwent a COVID-19 virus test on an unspecified date, the result of which was positive. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies. On 03Apr2021 at 10:30 the patient experienced hives all over her body. The hives, which turned into welts appeared on knees, elbows, medial elbows, feet bottom and top, medial knees, groin and inner thighs, wrists, hands, armpits, and shoulders. Patient received treatment for the events which included Prednisone and hydroxyzine. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events hives was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Hives all over my body, which turned into welts; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 03Apr2021 at 08:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety from an unspecified date, COVID-19 on an unspecified date. Other medications in two weeks included bupropion hydrochloride (WELLBUTRIN), montelukast sodium (SINGULAIR), and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient underwent a COVID-19 virus test on an unspecified date, the result of which was positive. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies. On 03Apr2021 at 10:30 the patient experienced hives all over her body. The hives, which turned into welts appeared on knees, elbows, medial elbows, feet bottom and top, medial knees, groin and inner thighs, wrists, hands, armpits, and shoulders. Patient received treatment for the events which included Prednisone and hydroxyzine. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The clinical outcome of the events hives was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: severe headache; nausea; chills; body aches; body aches/joint pain; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWo150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 12:30 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 03Apr2021, side effects took place approximately 12 hours after injection at 03:00, the patient experienced severe headache, nausea, chills, body aches/joint pain and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of severe headache, nausea, chills, body aches/joint pain and dizziness and included treatment with acetaminophen, 1000mg every 12 hours for 36 hours. The clinical outcome of the events headache, nausea, chills, body aches/joint pain and dizziness was recovered on an unknown date of Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: severe headache; nausea; chills; body aches; body aches/joint pain; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWo150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 12:30 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 03Apr2021, side effects took place approximately 12 hours after injection at 03:00, the patient experienced severe headache, nausea, chills, body aches/joint pain and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of severe headache, nausea, chills, body aches/joint pain and dizziness and included treatment with acetaminophen, 1000mg every 12 hours for 36 hours. The clinical outcome of the events headache, nausea, chills, body aches/joint pain and dizziness was recovered on an unknown date of Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea
Clinical narrative: severe headache; nausea; chills; body aches; body aches/joint pain; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWo150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 12:30 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 03Apr2021, side effects took place approximately 12 hours after injection at 03:00, the patient experienced severe headache, nausea, chills, body aches/joint pain and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of severe headache, nausea, chills, body aches/joint pain and dizziness and included treatment with acetaminophen, 1000mg every 12 hours for 36 hours. The clinical outcome of the events headache, nausea, chills, body aches/joint pain and dizziness was recovered on an unknown date of Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: severe headache; nausea; chills; body aches; body aches/joint pain; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWo150) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 12:30 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. On 03Apr2021, side effects took place approximately 12 hours after injection at 03:00, the patient experienced severe headache, nausea, chills, body aches/joint pain and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of severe headache, nausea, chills, body aches/joint pain and dizziness and included treatment with acetaminophen, 1000mg every 12 hours for 36 hours. The clinical outcome of the events headache, nausea, chills, body aches/joint pain and dizziness was recovered on an unknown date of Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on neck which has spread to face; itching on neck which has spread to face; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 30Mar2021 at 09:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not available. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), cyanocobalamin (B12) and cholecalciferol (VIT D3) started on an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 06:00, the patient experienced a rash on the neck which has spread to the face and itching on the neck which has spread to the face. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Therapeutic measures were taken as a result of rash on the neck which has spread to the face and itching on the neck which has spread to the face included treatment with methylprednisolone 4mg and Benadryl. The clinical outcome of the event rash on the neck which has spread to the face and itching on the neck which has spread to the face was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse effects, but received an undiluted dose of vaccine; Overdose; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-03) via an unspecified route of administration in the arm right on 05Apr2021 at 10:00(at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 10:00 the patient experienced no adverse effects, but received an undiluted dose of vaccine. Patient did not receive any treatment.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: No adverse effects, but received an undiluted dose of vaccine; Overdose; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-03) via an unspecified route of administration in the arm right on 05Apr2021 at 10:00(at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Patient did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 10:00 the patient experienced no adverse effects, but received an undiluted dose of vaccine. Patient did not receive any treatment.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram head normal, Ear pain, Headache, Hepatic enzyme increased
Clinical narrative: Severe headache; Left ear pain radiating to neck; Left ear lid was swollen; Neck swollen; Red neck; left ear lid was red; Enlargement of lymph nodes on the left side of the neck it lasted for 2 weeks; Ringing of both ears; Body pain; This is a spontaneous report from a contactable healthcare professional, a nurse. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 52-yeas-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high and hypersensitivity lung disease. The patient previously received sulfa (MANUFACTURER UNKNOWN) and penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Concomitant medications included insulin glargine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), Mutivitamines (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the left arm on 08Feb2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 after the first day of second dose of vaccine, the patient experienced body pain and again after one week. On 09Mar2021 the patient experienced severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red, enlargement of lymph nodes on the left side of the neck which lasted for two weeks, then intolerable pain, medication for a week followed by intermittent pain with and without pain medications (duexis and gabapentin). Took omicef for the first week then levaquin for next week with antiviral (aclovior) and ringing of both ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received pain medications/ antibiotics, antivirals for the adverse events. On an unknown date, the patient underwent computed tomography of the head and the result was negative, underwent aspartate aminotransferase (AST) investigation and the result was increased liver enzyme aspartate aminotransferase and underwent abdominal ultrasound (Abd) and the result was pending. On 12Mar2021, the patient underwent rapid COVID-19 virus test and the result was negative.  The clinical outcome of the events body pain, severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red,  enlargement of lymph nodes and  ringing of both ears was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Neck pain, Pain, Tinnitus, Ultrasound abdomen
Clinical narrative: Severe headache; Left ear pain radiating to neck; Left ear lid was swollen; Neck swollen; Red neck; left ear lid was red; Enlargement of lymph nodes on the left side of the neck it lasted for 2 weeks; Ringing of both ears; Body pain; This is a spontaneous report from a contactable healthcare professional, a nurse. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 52-yeas-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high and hypersensitivity lung disease. The patient previously received sulfa (MANUFACTURER UNKNOWN) and penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Concomitant medications included insulin glargine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), Mutivitamines (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the left arm on 08Feb2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 after the first day of second dose of vaccine, the patient experienced body pain and again after one week. On 09Mar2021 the patient experienced severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red, enlargement of lymph nodes on the left side of the neck which lasted for two weeks, then intolerable pain, medication for a week followed by intermittent pain with and without pain medications (duexis and gabapentin). Took omicef for the first week then levaquin for next week with antiviral (aclovior) and ringing of both ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received pain medications/ antibiotics, antivirals for the adverse events. On an unknown date, the patient underwent computed tomography of the head and the result was negative, underwent aspartate aminotransferase (AST) investigation and the result was increased liver enzyme aspartate aminotransferase and underwent abdominal ultrasound (Abd) and the result was pending. On 12Mar2021, the patient underwent rapid COVID-19 virus test and the result was negative.  The clinical outcome of the events body pain, severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red,  enlargement of lymph nodes and  ringing of both ears was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aspartate aminotransferase, Computerised tomogram head, Ear pain, Ear swelling, Erythema
Clinical narrative: Severe headache; Left ear pain radiating to neck; Left ear lid was swollen; Neck swollen; Red neck; left ear lid was red; Enlargement of lymph nodes on the left side of the neck it lasted for 2 weeks; Ringing of both ears; Body pain; This is a spontaneous report from a contactable healthcare professional, a nurse. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 52-yeas-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high and hypersensitivity lung disease. The patient previously received sulfa (MANUFACTURER UNKNOWN) and penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Concomitant medications included insulin glargine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), Mutivitamines (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the left arm on 08Feb2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 after the first day of second dose of vaccine, the patient experienced body pain and again after one week. On 09Mar2021 the patient experienced severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red, enlargement of lymph nodes on the left side of the neck which lasted for two weeks, then intolerable pain, medication for a week followed by intermittent pain with and without pain medications (duexis and gabapentin). Took omicef for the first week then levaquin for next week with antiviral (aclovior) and ringing of both ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received pain medications/ antibiotics, antivirals for the adverse events. On an unknown date, the patient underwent computed tomography of the head and the result was negative, underwent aspartate aminotransferase (AST) investigation and the result was increased liver enzyme aspartate aminotransferase and underwent abdominal ultrasound (Abd) and the result was pending. On 12Mar2021, the patient underwent rapid COVID-19 virus test and the result was negative.  The clinical outcome of the events body pain, severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red,  enlargement of lymph nodes and  ringing of both ears was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Pain, SARS-CoV-2 test, Swelling
Clinical narrative: Severe headache; Left ear pain radiating to neck; Left ear lid was swollen; Neck swollen; Red neck; left ear lid was red; Enlargement of lymph nodes on the left side of the neck it lasted for 2 weeks; Ringing of both ears; Body pain; This is a spontaneous report from a contactable healthcare professional, a nurse. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 52-yeas-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high and hypersensitivity lung disease. The patient previously received sulfa (MANUFACTURER UNKNOWN) and penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Concomitant medications included insulin glargine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), Mutivitamines (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the left arm on 08Feb2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 after the first day of second dose of vaccine, the patient experienced body pain and again after one week. On 09Mar2021 the patient experienced severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red, enlargement of lymph nodes on the left side of the neck which lasted for two weeks, then intolerable pain, medication for a week followed by intermittent pain with and without pain medications (duexis and gabapentin). Took omicef for the first week then levaquin for next week with antiviral (aclovior) and ringing of both ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received pain medications/ antibiotics, antivirals for the adverse events. On an unknown date, the patient underwent computed tomography of the head and the result was negative, underwent aspartate aminotransferase (AST) investigation and the result was increased liver enzyme aspartate aminotransferase and underwent abdominal ultrasound (Abd) and the result was pending. On 12Mar2021, the patient underwent rapid COVID-19 virus test and the result was negative.  The clinical outcome of the events body pain, severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red,  enlargement of lymph nodes and  ringing of both ears was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Ultrasound abdomen
Clinical narrative: Severe headache; Left ear pain radiating to neck; Left ear lid was swollen; Neck swollen; Red neck; left ear lid was red; Enlargement of lymph nodes on the left side of the neck it lasted for 2 weeks; Ringing of both ears; Body pain; This is a spontaneous report from a contactable healthcare professional, a nurse. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an intramuscular route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 52-yeas-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure high and hypersensitivity lung disease. The patient previously received sulfa (MANUFACTURER UNKNOWN) and penicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Concomitant medications included insulin glargine (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), Mutivitamines (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an intramuscular route of administration in the left arm on 08Feb2021 at 12:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 after the first day of second dose of vaccine, the patient experienced body pain and again after one week. On 09Mar2021 the patient experienced severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red, enlargement of lymph nodes on the left side of the neck which lasted for two weeks, then intolerable pain, medication for a week followed by intermittent pain with and without pain medications (duexis and gabapentin). Took omicef for the first week then levaquin for next week with antiviral (aclovior) and ringing of both ears. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received pain medications/ antibiotics, antivirals for the adverse events. On an unknown date, the patient underwent computed tomography of the head and the result was negative, underwent aspartate aminotransferase (AST) investigation and the result was increased liver enzyme aspartate aminotransferase and underwent abdominal ultrasound (Abd) and the result was pending. On 12Mar2021, the patient underwent rapid COVID-19 virus test and the result was negative.  The clinical outcome of the events body pain, severe headache, left ear pain radiating to neck, left ear lid/neck swollen and red,  enlargement of lymph nodes and  ringing of both ears was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Dizziness; Site soreness; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 11:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. Concomitant medications included cetirizine hydrochloride (ZYRTEC),  pseudoephedrine hydrochloride (SUDAFED), montelukast sodium (MONTELUKAST), sertraline (MANUFACTURER UNKNOWN) and norethisterone, ethinyl estradiol(NORTREL), all from an unknown date and for unspecified indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 15:00, the patient experienced site soreness(vaccination site pain), headache, extreme nausea and dizziness which lasted about 36 hours. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event site soreness, headache, extreme nausea and dizziness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea, Vaccination site pain
Clinical narrative: Dizziness; Site soreness; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 11:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. Concomitant medications included cetirizine hydrochloride (ZYRTEC),  pseudoephedrine hydrochloride (SUDAFED), montelukast sodium (MONTELUKAST), sertraline (MANUFACTURER UNKNOWN) and norethisterone, ethinyl estradiol(NORTREL), all from an unknown date and for unspecified indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 15:00, the patient experienced site soreness(vaccination site pain), headache, extreme nausea and dizziness which lasted about 36 hours. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event site soreness, headache, extreme nausea and dizziness was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Injection site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypertension, prediabetes, anxiety, depression, attention deficit hyperactivity disorder (ADHD) and COVID-19. The patient had known allergies to dust, mold and cat dander. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN) all taken from an unknown date for unknown indications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 20:00, the patient experienced injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea were resolving at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypertension, prediabetes, anxiety, depression, attention deficit hyperactivity disorder (ADHD) and COVID-19. The patient had known allergies to dust, mold and cat dander. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN) all taken from an unknown date for unknown indications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 20:00, the patient experienced injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea were resolving at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypertension, prediabetes, anxiety, depression, attention deficit hyperactivity disorder (ADHD) and COVID-19. The patient had known allergies to dust, mold and cat dander. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN) all taken from an unknown date for unknown indications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 20:00, the patient experienced injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea were resolving at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hypertension, prediabetes, anxiety, depression, attention deficit hyperactivity disorder (ADHD) and COVID-19. The patient had known allergies to dust, mold and cat dander. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN) all taken from an unknown date for unknown indications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 03Apr2021 at 20:00, the patient experienced injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events injection site pain (vaccination site pain), tiredness, headache, muscle pain, joint pain, chills, fever and nausea were resolving at the time of this report.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspepsia, Pruritus, Urticaria
Clinical narrative: Itching around wrists, under breasts, armpits, in between legs, and back of legs; hair and head, and wrists started itching.; Itching around wrists, under breasts, armpits, in between legs, and back of legs, then it turned into hives; hives all over body; Severe heartburn; Pressure in chest; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the arm left on 28Mar2021 at 08:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included hives. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (ADVIL) reportedly might have taken 1 or 2 in the 2 weeks prior vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 11:00 hours, one day after the vaccination, the patient began noticing itching around wrists, under breasts, armpits, in between legs, and back of legs, then it turned into hives. On the same day, the patient also felt severe heartburn, but took TUMS and it went away. The patient was not sure if it was related to vaccination but felt like pressure in chest. The hives and itching went away at night but came back on 30Mar2021. The itching and hives continued for 4 days, again went away at night then back the next day, the hives were all over body. The patient had hives before, but were not like this. The patient took a over the counter (OTC) medication ZYRTEC on day 5, hives and itching completely stopped. Then on 05Apr2021, one week and one day after vaccine, patient's hair and head and wrists started itching. The hives and itching were back, but not as bad this time, and patient took a ZYRTEC right away to prevent hives and itching, which seemed like it was working. The adverse events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care.  The patient also received treatment for pressure in chest. The clinical outcomes of the events severe heartburn, pressure in chest, itching around wrists, under breasts, armpits, in between legs, and back of legs which turned to hives, hair and head and wrists started itching and hives all over body were resolving at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Dizziness, Heart rate increased
Clinical narrative: rapid intermittent resting heart beat (95 - 120 bpm); This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 18Mar2021 at 09:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medications included loratadine (CLARITIN), triamcinolone acetonide (NASACORT), metformin (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALACYCLOVIR) and fluticasone propionate, salmeterol xinafoate (ADVAIR); all for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 19:00, the patient experienced rapid intermittent resting heart beat (95 - 120 bpm). The patient underwent lab tests and procedures which included heart rate on18Mar2021 and the result was 95 - 120 beats per minute. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event heart beat increased was recovered on 23Mar2021.   No follow-up attempts are needed. No further information is expected.