chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Vaccination site bruising
Clinical narrative: Sever bruising at injection site about half a dollar bill size; Aches in joints; Nausea; Headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 11Apr2021 at 15:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic health condition. The patient had known allergies to bee stings. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 13Mar2021 at 15:30 (at the age of 56-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021, the patient experienced severe bruising at injection site about half a dollar bill size, nausea, aches in joints, headache and tiredness. 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 the reported events. The clinical outcomes of severe bruising at injection site about half a dollar bill size, nausea, aches in joints, headache and tiredness were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypokinesia, Thinking abnormal, Tremor
Clinical narrative: Dark thoughts; Constant shaking; Unable to get out of bed; This is a spontaneous report from a non-contactable consumer, the patient. A patient of an unknown gender and age 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 07Apr2021 at 09:30 as a single dose for COVID-19 immunisation. Medical history included chronic back pain and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 15:00, the patient experienced dark thoughts, constant shaking and was unable to get out of bed. 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. The clinical outcome of the events dark thoughts, constant shaking and unable to get out of bed was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Swelling
Clinical narrative: Swollen right armpit; Sore spine area of back; This is a spontaneous report from a contactable consumer, the patient. A 27-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 right arm on 10Apr2021 at 12:00 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had a history of allergy to peanuts and tree nuts. Concomitant medications included paracetamol (TYLENOL) for an unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 12:00, the patient experienced swollen right armpit and sore spine area of back. 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 for the events. The clinical outcome of the events swollen right armpit and sore spine area of back were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Constipation, Decreased appetite, Fatigue
Clinical narrative: chills in arms; tiredness; fever of 101; some nausea; felt unwell; a little constipation; soreness in left arm; not feeling hungry; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and high cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and atorvastatin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have a history of allergies to medications, food or other products. On 10Apr2021 at 01:00, the patient noticed chills in arms, tiredness, had fever of 101, some nausea, felt unwell, a little constipation, soreness in left arm. Also, woke up not feeling hungry, but was able to eat something by 10:00. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events chills in arms, tiredness, had fever of 101, some nausea, felt unwell, a little constipation, soreness in left arm was not recovered at the time of this report and that of feeling hungry was resolved on 10Apr2021 at 10:00 am.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia
Clinical narrative: chills in arms; tiredness; fever of 101; some nausea; felt unwell; a little constipation; soreness in left arm; not feeling hungry; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 12:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and high cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and atorvastatin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have a history of allergies to medications, food or other products. On 10Apr2021 at 01:00, the patient noticed chills in arms, tiredness, had fever of 101, some nausea, felt unwell, a little constipation, soreness in left arm. Also, woke up not feeling hungry, but was able to eat something by 10:00. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events chills in arms, tiredness, had fever of 101, some nausea, felt unwell, a little constipation, soreness in left arm was not recovered at the time of this report and that of feeling hungry was resolved on 10Apr2021 at 10:00 am.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Shortness of breath for a few weeks after minimal physical activities, increased heart rate.; Shortness of breath for a few weeks after minimal physical activities, increased heart rate.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 17Mar2021 at 18:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient previously had Kiwi, avocado and experienced fruit allergy. Concomitant medications taken within two weeks of vaccination included etanercept (ENBREL) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced shortness of breath for a few weeks after minimal physical activities, increased heart rate. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events shortness of breath for a few weeks after minimal physical activities, increased heart rate was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test
Clinical narrative: It started under both arms little red dots, then noticed it on thighs. spreading behind right knee, stomach, and lower abdomen.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high and cholesterol high. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY); pr (unspecified) (MANUFACTURER UNKNOWN) all from unknown date for unknown indications and unknown if ongoing. The patient previously took amoxicillin and experienced drug allergy to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 03Apr2021 at 09:00, the patient experienced little red dots in under both arms, then noticed it on thighs, spreading behind right knee, stomach, and lower abdomen. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with Aller-tec . Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent SARS-CoV-2 test and the result was negative. The clinical outcome of the event little red dots in under both arms, then noticed it on thighs, spreading behind right knee, stomach, and lower abdomen was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; headache; fever; fatigue; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 60-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 10Apr2021 at 13:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ascorbic acid (vitamin C) (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), vitamin b (MANUFACTURER UNKNOWN) and acetylsalicylic acid (baby aspirin) (MANUFACTURER UNKNOWN) all from unknown date for unspecified indication. The patient previously took erythromycin, and experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced body aches, headache, fever, fatigue and sore arm. Therapeutic measures were taken as a result of the events which included treatment with Tylenol from unknown date for unspecified indication and unknown if ongoing. The clinical outcome of the events body aches, headache, fever, fatigue and sore arm was recovering 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: Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Sore arm; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 46-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 an unknown date (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included cerebral palsy and known allergies to bee. Concomitant medications included diazepam (MANUFACTURER UNKNOWN), ibuprofen (ADVIL), multivitamin and vaccinium spp. (CRANBERRY SUPPLEMENT); from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced headache, sore arm and fever. 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 the reported events. The clinical outcomes of headache, sore arm and fever were unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site rash
Clinical narrative: Red rash at injection site and sore throat; Red rash at injection site and sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Apr2021 at 16:30(at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced red rash at injection site and sore throat. 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. The clinical outcome of the event red rash at injection site and sore throat was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Chills, Diplopia, Headache
Clinical narrative: BP at triage was 175/100 / prescribing a diuretic to lower BP as it would reach 180/100; not feeling well; Vomited twice; seeing double; Lower back ache; Fever; Chills; Headache/massive headache; flu-like reaction; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 47-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 (Lot Number: ER8732, unknown expiration; at the age of 47 years old) as dose 2, single for COVID-19 immunisation.  Medical history included GERD, endometriosis, hiatal hernia, allergies to Sulfa, and allergy to PCN. Concomitant medications included fluticasone propionate (FLONASE); cetirizine hydrochloride (CETRIZINE); calcium; and unspecified multivitamins.  The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6204; at the age of 47 years old) on 11Mar2021 at 10:30 am in the left arm for COVID-19 immunization. On 01Apr2021 at 12:00 am (within 24 hours), the patient experienced flu-like reaction (fever, chills, lower back ache, and headache). On 03Apr2021 (close to 48 hours), the patient had a massive headache, seeing double, and vomited twice. On 04Apr2021 (3 days after this episode), the patient went to ER due to not feeling well and BP at triage was 175/100. BP still high after this. The patient went to urgent care on 10Apr2021 (video visit), prescribing a diuretic to lower BP as it would reach 180/100. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient received hydrochlorothiazide 25 mg QD as treatment for blood pressure.  The patient is recovering from the events.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Hypertension and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Influenza like illness, Malaise, Pyrexia, Vomiting
Clinical narrative: BP at triage was 175/100 / prescribing a diuretic to lower BP as it would reach 180/100; not feeling well; Vomited twice; seeing double; Lower back ache; Fever; Chills; Headache/massive headache; flu-like reaction; This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 47-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 01Apr2021 (Lot Number: ER8732, unknown expiration; at the age of 47 years old) as dose 2, single for COVID-19 immunisation.  Medical history included GERD, endometriosis, hiatal hernia, allergies to Sulfa, and allergy to PCN. Concomitant medications included fluticasone propionate (FLONASE); cetirizine hydrochloride (CETRIZINE); calcium; and unspecified multivitamins.  The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6204; at the age of 47 years old) on 11Mar2021 at 10:30 am in the left arm for COVID-19 immunization. On 01Apr2021 at 12:00 am (within 24 hours), the patient experienced flu-like reaction (fever, chills, lower back ache, and headache). On 03Apr2021 (close to 48 hours), the patient had a massive headache, seeing double, and vomited twice. On 04Apr2021 (3 days after this episode), the patient went to ER due to not feeling well and BP at triage was 175/100. BP still high after this. The patient went to urgent care on 10Apr2021 (video visit), prescribing a diuretic to lower BP as it would reach 180/100. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient received hydrochlorothiazide 25 mg QD as treatment for blood pressure.  The patient is recovering from the events.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Hypertension and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Peripheral swelling, Rash erythematous
Clinical narrative: Swollen left arm size of small orange.; Arm burning feel like on fire; Painful; Large red rash; This is a spontaneous report from a contactable consumer, the patient. A 46-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 10Apr2021 at 10:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as no. It was reported that the patient had known allergies to medications, food, or other products. Other medication within two weeks of vaccination was not reported. 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 20Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 08:00, the patient experienced swollen left arm size of small orange. Arm was burning and felt like on fire. The patient also experienced large red rash. It was painful. 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. The clinical outcome of the events swollen left arm size of small orange, arm was burning and felt like on fire, large red rash, painful was not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Ran 101.5-102 temp for about 24 hours; Pounding headache; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6204) via an unspecified route of administration in the left arm on 14Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. The patient had no known allergies to medications, food or other products. Concomitant medications included anastrozole (ARIMIDEX), atorvastatin calcium (LIPITOR), biotin (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and denosumab (PROLIA) injection; all from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient had run 101.5-102 temp for about 24 hours, pounding headache and extreme fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of high temperature, headache and fatigue extreme was recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a burn to skin in the location where the band aid was placed immediately following vaccination shot.; 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: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 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 13Mar2021 (at the age of 42-years-old), as a single dose for COVID-19 immunisation.  On 03Apr2021 at 12:00, the patient experienced burn to her skin in the location where the band aid was placed immediately following her vaccination shot. The burn was in the shape of the band aid. 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 for the events. The clinical outcome of the event burn to her skin in the location where the band aid was placed immediately following her vaccination shot was not recovered 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: vomiting; Headache; Fatigue; fever; chills; diarrhea; extreme exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced headache, fatigue, vomiting, fever, chills, diarrhea and extreme exhaustion for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events headache, fatigue, vomiting, fever, chills, diarrhea and extreme exhaustion were resolved on 08Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; Headache; Fatigue; fever; chills; diarrhea; extreme exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced headache, fatigue, vomiting, fever, chills, diarrhea and extreme exhaustion for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events headache, fatigue, vomiting, fever, chills, diarrhea and extreme exhaustion were resolved on 08Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Ear pain, Fatigue, Headache, Nasal congestion
Clinical narrative: Stuffy nose; left jaw pain; sore arm; lower back pain; bumps in underside tip of tongue; headaches; super tired; earache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE), citalopram (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL) and cobamamide (VITAMIN B12); all from unknown start dates and for unknown indications. 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 right arm on 19Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 17:00 the patient experienced the events stuffy nose, left jaw pain, sore arm, lower back pain, bumps in underside tip of tongue, headaches, super tired and earache. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of stuffy nose, left jaw pain, sore arm, lower back pain, bumps in underside tip of tongue, headaches, super tired and earache were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Tongue disorder
Clinical narrative: Stuffy nose; left jaw pain; sore arm; lower back pain; bumps in underside tip of tongue; headaches; super tired; earache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 09Apr2021 at 13:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE), citalopram (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL) and cobamamide (VITAMIN B12); all from unknown start dates and for unknown indications. 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 right arm on 19Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 17:00 the patient experienced the events stuffy nose, left jaw pain, sore arm, lower back pain, bumps in underside tip of tongue, headaches, super tired and earache. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of stuffy nose, left jaw pain, sore arm, lower back pain, bumps in underside tip of tongue, headaches, super tired and earache were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Soreness at injection site; soreness at injection site and into theback of arm; Headache; Weak; Extreme Fatigue; Nausea; Vomitting; This is a spontaneous report from a contactable healthcare professional. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 30Mar2021 at 16:45 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroidectomy, asthma, COVID-19, sulfonamide allergy and penicillin allergy. Concomitant medications included levothyroxine (LEVOTHYROXINE) and unspecified birth control pills; both from unknown dates for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 06:00, the patient experienced soreness at injection site and into the back of arm, headache, weak, extreme fatigue, nausea and vomiting. The 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 events. The clinical outcome of the events soreness at injection site and into the back of arm, headache, weak, extreme fatigue, nausea and vomiting were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Soreness at injection site; soreness at injection site and into theback of arm; Headache; Weak; Extreme Fatigue; Nausea; Vomitting; This is a spontaneous report from a contactable healthcare professional. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 30Mar2021 at 16:45 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history included thyroidectomy, asthma, COVID-19, sulfonamide allergy and penicillin allergy. Concomitant medications included levothyroxine (LEVOTHYROXINE) and unspecified birth control pills; both from unknown dates for unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 06:00, the patient experienced soreness at injection site and into the back of arm, headache, weak, extreme fatigue, nausea and vomiting. The 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 events. The clinical outcome of the events soreness at injection site and into the back of arm, headache, weak, extreme fatigue, nausea and vomiting were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Very high fever; Very weak; This is a spontaneous report from a contactable consumer, the patient. A 59-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 left arm on 07Apr2021 at 15:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 15:00, 24 hours after vaccination, the patient experienced very high fever and became very weak. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events very high fever and very weak was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea, Paranasal sinus discomfort
Clinical narrative: nausea; parts of head hurt; tight sinuses; some mild rolling heat flash; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ewa80) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient was not allergic to any food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced mild side effects- nausea, parts of head hurt, tight sinuses, some mild rolling heat flash. The patient did not receive any treatment for the event. The clinical outcome of the events nausea, parts of head hurt, tight sinuses and some mild rolling heat flash was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 30Mar2021 at 12:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Apr2021 at 15:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event shingles and included treatment with valacyclovir (VALTREX) and hydrocodone (MANUFACTURER UNKNOWN) on an unknown date. The clinical outcome of the event shingles was recovering 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: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0150), at the age of 50, via an unspecified route of administration, left arm, on Apr 6, 2021, at 16:15, single dose, for COVID-19 immunisation. Medical history reported as none. Concomitant medications included Lo Loestrin Fe (ethinyl-estradiol, ferrous fumarate, norethisterone acetate), started on unknown date; for unknown indication. The patient has no known allergies. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6208), at the age of 50, via an unspecified route of administration, left arm, on Mar 11, 2021, at 16:15, single dose, for COVID-19 immunisation. Prior to the vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 7, 2021 at 12:00, patient experienced nausea, vomited once, exhaustion and headache. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event vomited once recovered on Apr 7, 2021; while that of nausea, exhaustion and headache recovered on an unknown date in Apr 2021. No follow-up attempts needed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: patient has had severe shortness of breath since receiving the vaccine; This is a spontaneous report from a contactable physician. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via intramuscular route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Mar2021 at 16:00, the patient had severe shortness of breath since receiving the vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as the result of event. On an unknown date, the patient underwent o2 sat and the result was normal. On an unknown date, the patient underwent CXR, CT scan, echocardiogram and the result were unspecified for all. On 24Mar2021, the patient underwent nasal swab (COVID-19 test) and the result was negative. The clinical outcome of the event patient had severe shortness of breath since receiving the vaccine was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: The next day the whole area was red and smooth; The next day whole area was red and smooth and very mild itchiness; A patchy bumpy rash around the injection site; A patchy bumpy rash around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 02Apr2021 at 13:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy. The patient had known allergies to food (mushroom). Concomitant medications included womens health vitamins for unknown indication and levocetirizine dihydrochloride (XYZAL) for allergy, on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Apr2021 at 12:00, 1 week and 1 day after vaccine; 8 days after, the patient experienced patchy bumpy rash around the injection site. On 11Apr2021, 9 days after vaccination, next day, the patient experienced whole area was red and smooth and very mild itchiness. 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 event's patchy bumpy rash around the injection site, whole area was red and smooth and very mild itchiness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.