chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: the night of the 2nd day, and during the 3rd day I got vicious headaches; I had a heavy nosebleed which left me extremely exhausted for 2 days; I had a heavy nosebleed which left me extremely exhausted for 2 days; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 17:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included alopecia areata. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included malus spp. vinegar extract (APPLE CIDER VINEGAR) for unknown indication and ethinylestradiol/levonorgestrel (ALTAVERA) for birth control; both from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021, the patient underwent COVID test (Nasal swab) and the result was Negative. On 23Jan2021, the patient underwent COVID test (Nasal swab) and the result was Negative. On 10Feb2021, the patient underwent COVID test (Nasal swab) and the result was Negative. On 14Apr2021 at 07:15, the patient experienced heavy nosebleed which left the patient extremely exhausted for 2 days. On 16Apr2021, the night of the 2nd day, and during the 3rd day, the patient experienced vicious headaches and the 3rd day, the patient started feeling better. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely exhausted for 2 days was recovered on 16Apr2021 and of the events heavy nosebleed and vicious headaches was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rash erythematous, SARS-CoV-2 test
Clinical narrative: Vivid red itchy rash over whole body beginning on day 5 following injection. Has not gone away; Extreme fatigue; Low grade fevers; Chills; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 72-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN); on an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 22:00, the patient experienced extreme fatigue, low grade fevers and chills. On 17Apr2021, day 5 following injection, the patient experienced vivid red itchy rash over whole body. 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 been tested for COVID. On 07Apr2021, the patient underwent Sars Cov-2 test (test type: Nasal Swab) and result was negative. The clinical outcome of the events extreme fatigue, low grade fevers, chills and vivid red itchy rash over whole body were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: I got a large rash across most of my body.; Extremely itchy; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 17:45 (at the age of 20-year-old) (Lot Number: EW0151) as dose 1, single for COVID-19 immunization. Medical history included none. The patient did not have any known allergies. The patient's concomitant medication included Vita fusion MultiVites. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced a large rash across most of his body on 16Apr2021 08:00. The patient reported that it started in small spots and then quickly spread across his arms, stomach, back, and legs. It was extremely itchy but not painful. The patient required Doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone and fexofenadine (ALLEGRA). The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Fatigue, Feeling abnormal
Clinical narrative: "I" was very tired; Lethargic; Sleeping pretty much the whole day; Stomach cramping appeared; "I" woke up at 6am with significant chills; Severe abdominal pain; Brain fog; "I" started to experience back muscle cramping which progressed rapidly.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6207) via an unspecified route of administration in the right arm on 06Apr2021 at 13:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 were not reported. On 14Apr2021 at 06:00, in the morning the patient woke up with significant chills, severe abdominal pain and brain fog. On the same day around 11:15, the patient started to experience back muscle cramping which progressed rapidly and at 11:50, the patient was on a virtual meeting and was unable to sit up straight in a chair and had to end the meeting. These effects lasted for approximately 10 hours. On 15Apr2021 at 03:00 in the morning, the patient woke up with similar effects as the previous  day but less pronounced. On the same day at 11:45 the chills, abdominal pain and brain fog subsided a bit. However, stomach cramping appeared. Then 9 hours after waking up all the effects were not evident. On 16Apr2021, the effects slowly dissipated but the patient was very tired, lethargic, sleeping pretty much the whole day. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events back muscle cramping, significant chills, severe abdominal pain, brain fog, stomach cramping, very tired, lethargic, sleeping pretty much the whole day were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Lethargy, Muscle spasms
Clinical narrative: "I" was very tired; Lethargic; Sleeping pretty much the whole day; Stomach cramping appeared; "I" woke up at 6am with significant chills; Severe abdominal pain; Brain fog; "I" started to experience back muscle cramping which progressed rapidly.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6207) via an unspecified route of administration in the right arm on 06Apr2021 at 13:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 were not reported. On 14Apr2021 at 06:00, in the morning the patient woke up with significant chills, severe abdominal pain and brain fog. On the same day around 11:15, the patient started to experience back muscle cramping which progressed rapidly and at 11:50, the patient was on a virtual meeting and was unable to sit up straight in a chair and had to end the meeting. These effects lasted for approximately 10 hours. On 15Apr2021 at 03:00 in the morning, the patient woke up with similar effects as the previous  day but less pronounced. On the same day at 11:45 the chills, abdominal pain and brain fog subsided a bit. However, stomach cramping appeared. Then 9 hours after waking up all the effects were not evident. On 16Apr2021, the effects slowly dissipated but the patient was very tired, lethargic, sleeping pretty much the whole day. The event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events back muscle cramping, significant chills, severe abdominal pain, brain fog, stomach cramping, very tired, lethargic, sleeping pretty much the whole day were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Lethargy, Lymphadenopathy, Pain in extremity
Clinical narrative: Headache; Sore arm; Enlarged lymph node (left armpit); Lethargy; Intense pain in thighs; Hot to touch thighs; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 44-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 BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on 23Mar2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021, the patient experienced headache, sore arm, enlarged lymph node (left armpit), lethargy, intense pain or hot to touch thighs. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, sore arm, enlarged lymph node (left armpit), lethargy, intense pain or hot to touch thighs was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Migraine, Muscle spasms
Clinical narrative: Started having period, haven't had a period in over a year. Horrible cramps, migraine also. Started 3 days after shot.; Started having period haven't had a period in over a year. Horrible cramps; Horrible cramps, migraine also.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm right on 13Apr2021 at 14:00(at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history included blood pressure high, migraines, contraceptive implants and allergy to sulfa. 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. The patient received unspecified medications of  blood pressure, migraine and implant for birth control. On 16Apr2021 at 17:00, 3 days after shot, the patient started having period, horrible cramps and migraine also. The patient reported that she had not have a period in over a year. The adverse events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started having period, horrible cramps and migraine was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstruation was much much heavierthan normal; Menstrual lasted a total of seven (7) days compared to the usual four (4) days; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 16:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 21:00, the patient menstruation period began the day that she took the shot (as per her usual cycle), but it was much much heavier than normal and lasted a total of seven (7) days compared to the usual four (4) days. The events 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstruation was much much heavier than normal and lasted a total of seven (7) days compared to the usual four (4) days was recovered on 16Apr2021, after the duration of 7 days..   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: a rash that felt like the injection site was on fire; a rash that felt like the injection site was on fire; chills; headache; extreme fatigue; Low grade fever/ fever as high as 103.8; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and psoriatic arthritis. 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 cetirizine hydrochloride (ZYRTEC) and vitamin d nos (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient previously took doxycycline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 14Apr2021 at 18:30, the patient experienced low grade fever within 3 hours of second shot. On 15Apr2021, second day, the patient experienced fever as high as 103.8 (unspecified units), chills, headache and extreme fatigue. On 16Apr2021, third day, experienced low grade fever and a rash that felt like the injection site was on fire. On 15Apr2021, the patient underwent body temperature test and the result was as high as 103.8 (unspecified units). The events resulted in a visit to the emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with Ibuprofen (MANUFACTURER UNKNOWN) and anti-nausea medication (unspecified) and diphenhydramine hydrochloride (BENADRYL) cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, fever as high as 103.8, chills ,headache, extreme fatigue, rash that felt like the injection site was on fire was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: a rash that felt like the injection site was on fire; a rash that felt like the injection site was on fire; chills; headache; extreme fatigue; Low grade fever/ fever as high as 103.8; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and psoriatic arthritis. 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 cetirizine hydrochloride (ZYRTEC) and vitamin d nos (MANUFACTURER UNKNOWN), both for an unknown indication from an unknown date and unknown if ongoing. The patient previously took doxycycline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 14Apr2021 at 18:30, the patient experienced low grade fever within 3 hours of second shot. On 15Apr2021, second day, the patient experienced fever as high as 103.8 (unspecified units), chills, headache and extreme fatigue. On 16Apr2021, third day, experienced low grade fever and a rash that felt like the injection site was on fire. On 15Apr2021, the patient underwent body temperature test and the result was as high as 103.8 (unspecified units). The events resulted in a visit to the emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with Ibuprofen (MANUFACTURER UNKNOWN) and anti-nausea medication (unspecified) and diphenhydramine hydrochloride (BENADRYL) cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, fever as high as 103.8, chills ,headache, extreme fatigue, rash that felt like the injection site was on fire was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Hot flush
Clinical narrative: Hot flash; Dizziness; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 15Apr2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was unknown, if the patient was pregnant at the time of this report. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included vitamins (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 18:15, 2 days after vaccination, the patient experienced hot flash, dizziness and diarrhea. The events 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hot flash, dizziness and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: A wave of dizziness; Burning sensations all through my body; Tingling pins and needles feeling; Numbness; Severe weakness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 08Apr2021 at 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included Bi-lateral cochlear implants and congenital deafness. The patient had no known allergies to medications, food, or other products. 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 COVID vaccine. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED), taken for an unknown indication from an unknown date and unknown if ongoing. On 14Apr2021 at 19:45, 6 days after the vaccination, the patient experienced a wave of dizziness, had burning sensations all through her body, tingling pins and needles feeling, with numbness and severe weakness. The patient felt like a wave that overtook from head to feet which required her to call 911 with an ambulance ride to the Emergency Room (ER) and after ruling out several things, the patient believed that it might be a side effect from the vaccine and still had lingering side effects 3 days after visit from ER. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 14Apr2021, the patient underwent COVID-19 rapid test (nasal swab) and the result was negative. The clinical outcome of the events dizziness, burning sensations all through body, tingling pins and needles feeling, numbness and severe weakness were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: A wave of dizziness; Burning sensations all through my body; Tingling pins and needles feeling; Numbness; Severe weakness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 08Apr2021 at 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included Bi-lateral cochlear implants and congenital deafness. The patient had no known allergies to medications, food, or other products. 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 COVID vaccine. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED), taken for an unknown indication from an unknown date and unknown if ongoing. On 14Apr2021 at 19:45, 6 days after the vaccination, the patient experienced a wave of dizziness, had burning sensations all through her body, tingling pins and needles feeling, with numbness and severe weakness. The patient felt like a wave that overtook from head to feet which required her to call 911 with an ambulance ride to the Emergency Room (ER) and after ruling out several things, the patient believed that it might be a side effect from the vaccine and still had lingering side effects 3 days after visit from ER. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 14Apr2021, the patient underwent COVID-19 rapid test (nasal swab) and the result was negative. The clinical outcome of the events dizziness, burning sensations all through body, tingling pins and needles feeling, numbness and severe weakness were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; Arm aching; Chills; This is a spontaneous report from a contactable consumer, the patient. A 72-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 right arm on an unknown date in Mar2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 09Apr2021 at 12:30, the patient experienced diarrhea which started 1 week after receiving first shot, arm aching for 2 days and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 arm aching was recovered on 11Apr2021, after 2 days and the outcome of the events diarrhea and chills was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Pain in both my thumbs; Mild nausea; Runny nose; Extreme tiredness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8739) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin sulfa and hops. 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. The patient did not receive any concomitant medications. On 15Apr2021 at 15:00, the patient experienced pain in both thumbs, mild nausea, runny nose and extreme tiredness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had been tested for COVID-19. On 15Apr2021, the patient underwent PCR test (Nasal Swab: test type) and the result was found to be negative. The clinical outcome of the events pain in both thumbs, mild nausea, runny nose and extreme tiredness were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 32-year-old 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 right arm on 17Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. 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. The patient received unspecified medication within two weeks of vaccination. On 17Apr2021 at 20:30, the patient experienced headache, nausea, stomach cramping, diarrhea, weakness, easily fatigued and tired. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, stomach cramping, diarrhea, weakness, easily fatigued and tired was not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 32-year-old 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 right arm on 17Apr2021 at 15:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. 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. The patient received unspecified medication within two weeks of vaccination. On 17Apr2021 at 20:30, the patient experienced headache, nausea, stomach cramping, diarrhea, weakness, easily fatigued and tired. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, stomach cramping, diarrhea, weakness, easily fatigued and tired was not recovered at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Extremely tired; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second 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 09:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes type 2, anxiety, high blood pressure and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included insulin glargine (LANTUS) (reported as Lantus Solostar), glipizide (MANUFACTURER UNKNOWN), Centrum Silver and lysine (MANUFACTURER UNKNOWN) all taken for unknown indication from unknown date and unknown if ongoing. The patient previously 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 26Mar2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 12:00, the patient experienced sore arm and felt extremely tired. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (MANUFACTURER UNKNOWN) and sleep. 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 sore arm and extremely tired was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Headache
Clinical narrative: Fever 102; Chills; Extreme weakness; Horrible headache; Sick to stomach; This is a spontaneous report from a contactable consumer, the patient. A 88-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 13:15 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin and COVID-19. 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 received unspecified concomitant medications. On an unknown date in Apr2021, the patient experienced fever 102, chills, extreme weakness, horrible headache, sick to her stomach. On an unknown date in Apr2021, the patient underwent body temperature test and the result was found to be 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102, chills, extreme weakness, horrible headache, sick to her stomach was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102; Chills; Extreme weakness; Horrible headache; Sick to stomach; This is a spontaneous report from a contactable consumer, the patient. A 88-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 13:15 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin and COVID-19. 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 received unspecified concomitant medications. On an unknown date in Apr2021, the patient experienced fever 102, chills, extreme weakness, horrible headache, sick to her stomach. On an unknown date in Apr2021, the patient underwent body temperature test and the result was found to be 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102, chills, extreme weakness, horrible headache, sick to her stomach was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pruritus, Eye swelling, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Conjunctivitis in right eye; Conjunctivitis in right eye. Prolonger swelling; Conjunctivitis in right eye. Prolonger swelling, redness; Conjunctivitis in right eye. Prolonger swelling, redness, itching; Tearing; Sensitivity; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications within two weeks of vaccination. On 06Apr2021 at 20:00, the patient experienced conjunctivitis in right eye, prolonger swelling, redness, itching, tearing and sensitivity. The patient reported that currently 7plus days, slowly improving and has not seen a doctor. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events conjunctivitis in right eye, prolonger swelling, redness, itching, tearing and sensitivity was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Conjunctivitis in right eye; Conjunctivitis in right eye. Prolonger swelling; Conjunctivitis in right eye. Prolonger swelling, redness; Conjunctivitis in right eye. Prolonger swelling, redness, itching; Tearing; Sensitivity; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 04Apr2021 at 11:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications within two weeks of vaccination. On 06Apr2021 at 20:00, the patient experienced conjunctivitis in right eye, prolonger swelling, redness, itching, tearing and sensitivity. The patient reported that currently 7plus days, slowly improving and has not seen a doctor. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events conjunctivitis in right eye, prolonger swelling, redness, itching, tearing and sensitivity was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over body (arms, legs, back, buttocks area); This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWOIS 1) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 55-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sulfamethoxazole, trimethoprim (SULFAMETH/TRIMETH), taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EPG955) via an unspecified route of administration in the left arm on18Mar2021 at 12:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00, the patient experienced rash all over body (arms, legs, back, buttocks area). The event 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. The clinical outcome of the event rash all over body (arms, legs, back, buttocks area) was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; Headache; Sore arm where injection was; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 15:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and anxiety. 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 citalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indications, from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 25Mar2021 at 15:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 04:30, the patient experienced fever, chills, body aches, headache, sore arm where injection was and fatigue, lasted a little over 24 hours except for headache which lasted more like 36 hours or so. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 events fever, chills, body aches, headache, sore arm where injection was and fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; Chills; Body aches; Headache; Sore arm where injection was; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 15:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and anxiety. 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 citalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indications, from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 25Mar2021 at 15:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 04:30, the patient experienced fever, chills, body aches, headache, sore arm where injection was and fatigue, lasted a little over 24 hours except for headache which lasted more like 36 hours or so. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 events fever, chills, body aches, headache, sore arm where injection was and fatigue was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: Fever; Chills; Sore throat; Headache; Body ache; Stomach ache; This is a spontaneous report from a contactable consumer, the patient, A 41-year-old non-pregnant female patient received second 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 06:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 cetirizine hydrochloride (ZYRTEC) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. On 16Apr2021 at 15:00, the patient experienced fever, chills, sore throat, headache, body ache and stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, sore throat, headache, body ache and stomach ache was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.