chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Tiredness; Nausea; Headache; Fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's hypothyroidism and allergic to penicillin family of medicines, allergic to eggs, dairy (cow's milk), tomatoes (food allergy), wheat (allergy to grains) and soy. Concomitant medications included levothyroxine sodium (SYNTHROID) and montelukast (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in left arm on 05Mar2021 at 14:45 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 26Mar2021 at 20:30, the patient experienced pain, redness, swelling in arm at injection site began about 1-3 hours after injection. Tiredness, nausea, headache, fever, chills, muscle aches began in that order about 8-11 hours after injection and lasted for about 12 hours. After which, only pain and swelling in arm at injection side as well as tiredness, headache and muscle aches remained and lasted for approximately two days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events the events redness, nausea, fever, chills recovered on 27Apr2021 at 08:30; while that of the events pain and swelling in arm at injection side as well as tiredness, headache and muscle aches were recovered on 28Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Tiredness; Nausea; Headache; Fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's hypothyroidism and allergic to penicillin family of medicines, allergic to eggs, dairy (cow's milk), tomatoes (food allergy), wheat (allergy to grains) and soy. Concomitant medications included levothyroxine sodium (SYNTHROID) and montelukast (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in left arm on 05Mar2021 at 14:45 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 26Mar2021 at 20:30, the patient experienced pain, redness, swelling in arm at injection site began about 1-3 hours after injection. Tiredness, nausea, headache, fever, chills, muscle aches began in that order about 8-11 hours after injection and lasted for about 12 hours. After which, only pain and swelling in arm at injection side as well as tiredness, headache and muscle aches remained and lasted for approximately two days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events the events redness, nausea, fever, chills recovered on 27Apr2021 at 08:30; while that of the events pain and swelling in arm at injection side as well as tiredness, headache and muscle aches were recovered on 28Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Pain, redness, swelling in arm at injection site began about 1-3 hours after injection.; Tiredness; Nausea; Headache; Fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 26Mar2021 at 12:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's hypothyroidism and allergic to penicillin family of medicines, allergic to eggs, dairy (cow's milk), tomatoes (food allergy), wheat (allergy to grains) and soy. Concomitant medications included levothyroxine sodium (SYNTHROID) and montelukast (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in left arm on 05Mar2021 at 14:45 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 26Mar2021 at 20:30, the patient experienced pain, redness, swelling in arm at injection site began about 1-3 hours after injection. Tiredness, nausea, headache, fever, chills, muscle aches began in that order about 8-11 hours after injection and lasted for about 12 hours. After which, only pain and swelling in arm at injection side as well as tiredness, headache and muscle aches remained and lasted for approximately two days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome for the events the events redness, nausea, fever, chills recovered on 27Apr2021 at 08:30; while that of the events pain and swelling in arm at injection side as well as tiredness, headache and muscle aches were recovered on 28Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle ache; Muscle spasms; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 11:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 02Apr2021 at 17:00, the patient experienced fever, chills, muscle ache, muscle spasms and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events fever, chills, muscle ache, muscle spasms and extreme fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Itching rash in different areas on the hand and arm; Itching rash in different areas on the same arm as the injection site, but different locations.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153,) via an unspecified route of administration on 15Apr2021 at 09:00 (at the age of 54-years-old) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included rosacea, vitamin deficiency and nonrelated but hearing. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole sodium (NEXIUM), multiple vitamin supplements (MANUFACTURER UNKNOWN) and other unspecified medication; all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient experienced itching rash in different areas on the hand and arm on the same arm as the injection site, but different locations. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itching rash in different areas on the hand and arm on the same arm as the injection site, but different locations was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash pruritic, Vaccination site rash
Clinical narrative: Itching rash in different areas on the hand and arm; Itching rash in different areas on the same arm as the injection site, but different locations.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153,) via an unspecified route of administration on 15Apr2021 at 09:00 (at the age of 54-years-old) as 0.3 mL, single dose for COVID-19 immunisation. Medical history included rosacea, vitamin deficiency and nonrelated but hearing. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole sodium (NEXIUM), multiple vitamin supplements (MANUFACTURER UNKNOWN) and other unspecified medication; all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient experienced itching rash in different areas on the hand and arm on the same arm as the injection site, but different locations. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itching rash in different areas on the hand and arm on the same arm as the injection site, but different locations was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Right inside forearm rash (hives).; Right inside forearm rash (hives).; This is a spontaneous report from a contactable consumer, the patient. A 28-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 18Apr2021 at 08:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included citalopram (MANUFACTURER UNKNOWN); taken for unknown indication on an unknown date and unknown if ongoing. 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 19Apr2021 at 03:00, the patient experienced right inside forearm rash (hives). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right inside forearm rash (hives) was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Oversensing, Pain, Photophobia
Clinical narrative: Fever and chills started 12 hours after injection.; Fever and chills started 12 hours after injection.; Nausea; Headache; Loss of appetite; Sensitivity to noise; Body soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 21Apr2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN) and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified multi vitamin medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021, 16 hours after injection, the patient experienced total body soreness, nausea and headache. On 22Apr2021, the patient experienced loss of appetite and sensitivity to noise. On 22Apr2021 at 04:00, 12 hours after injection, the patient experienced fever and chills. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events total body soreness, nausea, headache, loss of appetite, sensitivity to noise, fever and chills were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever and chills started 12 hours after injection.; Fever and chills started 12 hours after injection.; Nausea; Headache; Loss of appetite; Sensitivity to noise; Body soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 21Apr2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN) and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified multi vitamin medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021, 16 hours after injection, the patient experienced total body soreness, nausea and headache. On 22Apr2021, the patient experienced loss of appetite and sensitivity to noise. On 22Apr2021 at 04:00, 12 hours after injection, the patient experienced fever and chills. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events total body soreness, nausea, headache, loss of appetite, sensitivity to noise, fever and chills were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Oversensing
Clinical narrative: Fever and chills started 12 hours after injection.; Fever and chills started 12 hours after injection.; Nausea; Headache; Loss of appetite; Sensitivity to noise; Body soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 21Apr2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN) and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified multi vitamin medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021, 16 hours after injection, the patient experienced total body soreness, nausea and headache. On 22Apr2021, the patient experienced loss of appetite and sensitivity to noise. On 22Apr2021 at 04:00, 12 hours after injection, the patient experienced fever and chills. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events total body soreness, nausea, headache, loss of appetite, sensitivity to noise, fever and chills were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and chills started 12 hours after injection.; Fever and chills started 12 hours after injection.; Nausea; Headache; Loss of appetite; Sensitivity to noise; Body soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 21Apr2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had history of known allergies to penicillin (MANUFACTURER UNKNOWN) and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified multi vitamin medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 31Mar2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021, 16 hours after injection, the patient experienced total body soreness, nausea and headache. On 22Apr2021, the patient experienced loss of appetite and sensitivity to noise. On 22Apr2021 at 04:00, 12 hours after injection, the patient experienced fever and chills. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events total body soreness, nausea, headache, loss of appetite, sensitivity to noise, fever and chills were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph nodes in the left neck area; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 32-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0162) via an unspecified route of administration in the left arm on 21Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's known allergies were reported as not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The concomitant medications were not reported. On 01Apr2021, the patient experienced enlarged lymph nodes in the left neck area. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event enlarged lymph nodes in the left neck area was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: throbbing pains in my legs, and thighs.; throbbing pains in my legs, and thighs. It is constant, and I can't sleep at times.; Headaches; Fatigue; The pain is pulsing at time.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 13Apr2021(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 the patient experienced throbbing pains in her legs, and thighs and it was constant, and she could not sleep at times and the pain was pulsing at times she also had headaches and fatigue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event throbbing pains in her legs, and thigh, can't sleep, headaches and fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Insomnia, Pain
Clinical narrative: throbbing pains in my legs, and thighs.; throbbing pains in my legs, and thighs. It is constant, and I can't sleep at times.; Headaches; Fatigue; The pain is pulsing at time.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 13Apr2021(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 the patient experienced throbbing pains in her legs, and thighs and it was constant, and she could not sleep at times and the pain was pulsing at times she also had headaches and fatigue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event throbbing pains in her legs, and thigh, can't sleep, headaches and fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Erythema multiforme
Clinical narrative: I broke out with a rash in my inner thighs on both side 3 days after the 1st shot, than it spread to my arms neck and hands; This is a spontaneous report from a contactable consumer, the patient. A 58-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 left arm on 16Apr2021 at 09:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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. Concomitant medications included levothyroxine sodium (SYNTHROID) and atorvastatin (MANUFACTURER UNKNOWN) both for unknown indications on unknown dates and unknown if ongoing. The patient had no known allergies. On 19Apr2021 at 14:00, 3 days after the first shot, the patient broke out with a rash in his inner thighs on both side, then it spread to his arms, neck and hands. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the reported event and included treatment with a prescription medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: I broke out with a rash in my inner thighs on both side 3 days after the 1st shot, than it spread to my arms neck and hands; This is a spontaneous report from a contactable consumer, the patient. A 58-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 left arm on 16Apr2021 at 09:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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. Concomitant medications included levothyroxine sodium (SYNTHROID) and atorvastatin (MANUFACTURER UNKNOWN) both for unknown indications on unknown dates and unknown if ongoing. The patient had no known allergies. On 19Apr2021 at 14:00, 3 days after the first shot, the patient broke out with a rash in his inner thighs on both side, then it spread to his arms, neck and hands. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the reported event and included treatment with a prescription medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site reaction, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in armpit and groin; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 08:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Apr2021 at 09:00, the patient experienced swollen lymph nodes in armpit and groin. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in armpit and groin was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in armpit and groin; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 08:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Apr2021 at 09:00, the patient experienced swollen lymph nodes in armpit and groin. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in armpit and groin was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Ear pain, Hypoacusis, Tinnitus
Clinical narrative: Tinnitus; Ear pain; Muffled hearing; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 27Mar2021 at 10:45 hours (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to Sulfa based antibiotics and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19, on an unknown date. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 four days following the first vaccine, the patient experienced tinnitus, ear pain, and muffled hearing. The events tinnitus, ear pain, and muffled hearing resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus, ear pain and muffled hearing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Hypoacusis, Tinnitus
Clinical narrative: Tinnitus; Ear pain; Muffled hearing; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 27Mar2021 at 10:45 hours (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to Sulfa based antibiotics and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19, on an unknown date. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 four days following the first vaccine, the patient experienced tinnitus, ear pain, and muffled hearing. The events tinnitus, ear pain, and muffled hearing resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus, ear pain and muffled hearing was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: i was covid positive after being fully immunized; i was covid positive after being fully immunized; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid positive after being fully immunized and was not contacted by anyone for follow up on unspecified date. All events are medically significant. The patient underwent lab tests and procedures which included COVID positive: positive on unspecified date. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: i was covid positive after being fully immunized; i was covid positive after being fully immunized; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid positive after being fully immunized and was not contacted by anyone for follow up on unspecified date. All events are medically significant. The patient underwent lab tests and procedures which included COVID positive: positive on unspecified date. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Dyskinesia, Electric shock sensation, Heart rate increased
Clinical narrative: All over myoclonus; Large jerks involving head, back, legs, feet, and stomach and small fast twitches all over body including face twitching; large jerks involving head, back, legs, feet, and stomach; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8734) via an unspecified route of administration on 05Apr2021 at 18:45 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. Concomitant medications were none. The patient did not have any known allergies. On 08Apr2021 at 22:00 the patient experienced all over myoclonus, large jerks involving head, back, legs, feet, and stomach, and small fast twitches all over body including face twitching. The patient visited a doctor or other healthcare professional office/clinic in response to the events. The patient received treatment with anti-seizure medication. The outcomes of myoclonus and twitching were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle contractions involuntary, Muscle spasms, Muscle twitching, Pain in extremity
Clinical narrative: All over myoclonus; Large jerks involving head, back, legs, feet, and stomach and small fast twitches all over body including face twitching; large jerks involving head, back, legs, feet, and stomach; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8734) via an unspecified route of administration on 05Apr2021 at 18:45 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. Concomitant medications were none. The patient did not have any known allergies. On 08Apr2021 at 22:00 the patient experienced all over myoclonus, large jerks involving head, back, legs, feet, and stomach, and small fast twitches all over body including face twitching. The patient visited a doctor or other healthcare professional office/clinic in response to the events. The patient received treatment with anti-seizure medication. The outcomes of myoclonus and twitching were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Muscle twitching, Myoclonus
Clinical narrative: All over myoclonus; Large jerks involving head, back, legs, feet, and stomach and small fast twitches all over body including face twitching; large jerks involving head, back, legs, feet, and stomach; This is a spontaneous report from a contactable consumer (patient). This 30-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8734) via an unspecified route of administration on 05Apr2021 at 18:45 (at the age of 30-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. Concomitant medications were none. The patient did not have any known allergies. On 08Apr2021 at 22:00 the patient experienced all over myoclonus, large jerks involving head, back, legs, feet, and stomach, and small fast twitches all over body including face twitching. The patient visited a doctor or other healthcare professional office/clinic in response to the events. The patient received treatment with anti-seizure medication. The outcomes of myoclonus and twitching were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Itching, swelling, redness, warmth at vaccine location; Itching, swelling, redness, warmth at vaccine location; Itching, swelling, redness, warmth at vaccine location; Itching, swelling, redness, warmth at vaccine location; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received povidone-iodine (BETADINE) and experienced drug allergy. On 22Apr2021 at 13:45, beginning day 9, the patient experienced itching, swelling, redness, warmth at vaccine location. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching, swelling, redness, warmth at vaccine location were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itching, swelling, redness, warmth at vaccine location; Itching, swelling, redness, warmth at vaccine location; Itching, swelling, redness, warmth at vaccine location; Itching, swelling, redness, warmth at vaccine location; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 13Apr2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received povidone-iodine (BETADINE) and experienced drug allergy. On 22Apr2021 at 13:45, beginning day 9, the patient experienced itching, swelling, redness, warmth at vaccine location. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching, swelling, redness, warmth at vaccine location were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Blood test, Headache, Heart rate irregular, Palpitations
Clinical narrative: Headache; ringing in both ears; racing heart; tingling both hands; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 04Mar2021 at 10:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. On 26Mar2021 at 03:00, the patient experienced headache, ringing in both ears, racing heart, and tingling in both hands. These events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, ringing in both ears, racing heart, and tingling in both hands were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Headache; ringing in both ears; racing heart; tingling both hands; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 04Mar2021 at 10:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. On 26Mar2021 at 03:00, the patient experienced headache, ringing in both ears, racing heart, and tingling in both hands. These events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, ringing in both ears, racing heart, and tingling in both hands were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.