chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: injection site pain.; fever; entire body joint pain; muscle pain; This is a spontaneous report from a contactable other health care professional, the patient. A 60-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration in the left arm on 25Mar2021 at 19.00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included hyperlipidemia. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) 20mg on every other day for an unknown indication and from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200) via an unspecified route of administration in the left arm on 04Mar2021 at 19.00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any vaccines within four weeks prior to the COVID-19 vaccine. On 26Mar2021 at 15:00, the patient experienced injection site pain, fever, entire body joint and muscle pain. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site pain, fever, body joint pain and muscle pain was resolved on  an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nausea, Somnolence
Clinical narrative: initial symptom was severe occipital headache; somnolence; insomnia; mild nausea; chills; injection site soreness; This is a spontaneous report from a contactable physician. A non-pregnant female patient of unknown age patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: #EP6955), intramuscularly in the right arm on 17Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 17:00 (day 2 post vaccination), the patient had an initial symptom of severe occipital headache (reported as patient rarely got headaches), followed by both somnolence and insomnia (reported as not able to fall asleep despite feeling somnolent), mild nausea, chills, and injection site soreness (vaccination site pain). The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The treatment received for the adverse events included paracetamol (TYLENOL). The clinical outcomes of the events severe occipital headache (reported as patient rarely got headaches), followed by both somnolence and insomnia (reported as not able to fall asleep despite feeling somnolent), mild nausea, chills, and injection site soreness were recovered on an unknown date in Mar2021 (reported as within two days).  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: initial symptom was severe occipital headache; somnolence; insomnia; mild nausea; chills; injection site soreness; This is a spontaneous report from a contactable physician. A non-pregnant female patient of unknown age patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: #EP6955), intramuscularly in the right arm on 17Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 17:00 (day 2 post vaccination), the patient had an initial symptom of severe occipital headache (reported as patient rarely got headaches), followed by both somnolence and insomnia (reported as not able to fall asleep despite feeling somnolent), mild nausea, chills, and injection site soreness (vaccination site pain). The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The treatment received for the adverse events included paracetamol (TYLENOL). The clinical outcomes of the events severe occipital headache (reported as patient rarely got headaches), followed by both somnolence and insomnia (reported as not able to fall asleep despite feeling somnolent), mild nausea, chills, and injection site soreness were recovered on an unknown date in Mar2021 (reported as within two days).  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Genital pain, Lymphadenopathy, Rash
Clinical narrative: Left throat lymph node swollen; Rash on right arm partially on left arm and lower legs); Genital sores; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6Z06), via an unspecified route of administration in the left arm on 11Mar2021 at 14:00 (at the age of 30-years-old), as a single for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 14Mar2021, the patient experienced swollen lymph nodes in left throat, rash on right arm (partially on left arm and lower legs) and genital sores. The patient did not receive any treatments for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events swollen lymph nodes, the rash on legs and arms and the genital pain were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Painful swelling in lymph nodes under armpit of the injected arm; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date, and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via an unspecified route of administration in the left arm on unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced painful swelling in lymph nodes under armpit of the injected arm. No therapeutic measures were taken as a result of the event. The clinical outcome of painful swelling in lymph nodes under armpit of the injected arm was recovering.   No follow up attempts are possible; Information about lot number cannot be obtained.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis
Clinical narrative: Diaphoresis; Drop in blood pressure; Feeling of dizziness; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6Q02), via an unspecified route of administration in the left arm on 25Mar2021 at 15:45 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient had allergies to cephalosporin. Prior to 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 medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 15:45, the patient experienced diaphoresis, drop in blood pressure and feeling of dizziness. 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 events. The clinical outcomes of the events diaphoresis, drop in blood pressure and feeling of dizziness was resolved on an unknown date in Mar2021.  No follow up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dyspnoea
Clinical narrative: Feels weak; No appetite; Short of breath/Winded going up and down stairs; This is a spontaneous report from a non-contactable consumer. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 24Mar2021 as a single dose (at the age of vaccination 39-years-old) for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination, it is unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced short of breath (2 days after shot, felt short of breath, after moving equipment, had to sit for 10 mins and just catch breath) and on 28Mar2021, the patient was feeling weak, winded going up and down stairs and did not have appetite. Considered going to hospital for IV fluids. It was unknown if the patient had received any treatment for the reported events. 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. The clinical outcome of the events short of breath/winded going up and down stairs, feels weak and no appetite was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Myalgia, Nausea
Clinical narrative: brain fog; Muscle pain; Nausea; Joint pain; Fatigue; Significant muscle pain at injection site began theday following injection and resolvedwithin 2-3 days.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 22Mar2021 at 15:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included mild PCOS, mild asthma. The patient did not have any known allergies to medications, food, or other products. Concomitant medications included OVASITOL received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced nausea, muscle aches, joint pain, fatigue, brain fog and vaccination site pain. The patient did not receive treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was resolved on an unknown date in Mar2021. The clinical outcome of events, nausea, muscle aches, joint pain, fatigue and brain fog was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: brain fog; Muscle pain; Nausea; Joint pain; Fatigue; Significant muscle pain at injection site began theday following injection and resolvedwithin 2-3 days.; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 22Mar2021 at 15:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included mild PCOS, mild asthma. The patient did not have any known allergies to medications, food, or other products. Concomitant medications included OVASITOL received within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, the patient experienced nausea, muscle aches, joint pain, fatigue, brain fog and vaccination site pain. The patient did not receive treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vaccination site pain was resolved on an unknown date in Mar2021. The clinical outcome of events, nausea, muscle aches, joint pain, fatigue and brain fog was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Vaccination site pain
Clinical narrative: Injection pain site; tiredness; slight headache; nausea; general malaise; This is a spontaneous report received from a contactable health care professional, the patient. A 58-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route administration in the right arm on 27Mar2021 at 10:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to codeine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 09:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Mar2021 at 14:00 the patient experienced injection site pain (vaccination site pain), tiredness, slight headache, nausea and general malaise. The patient underwent lab investigations for COVID-19 with nasal swab test on 11Feb2021 and was tested negative. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, tiredness, slight headache, nausea and general malaise were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: Injection pain site; tiredness; slight headache; nausea; general malaise; This is a spontaneous report received from a contactable health care professional, the patient. A 58-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route administration in the right arm on 27Mar2021 at 10:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to codeine. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 06Mar2021 at 09:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 27Mar2021 at 14:00 the patient experienced injection site pain (vaccination site pain), tiredness, slight headache, nausea and general malaise. The patient underwent lab investigations for COVID-19 with nasal swab test on 11Feb2021 and was tested negative. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, tiredness, slight headache, nausea and general malaise were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Headache, Oxygen saturation
Clinical narrative: her whole right arm started hurting and it was horrible pain; headache; chills; breathing is different; her oxygen will drop down to the seventies and she has to work to get it back up; Sinus draining; has more tightness in her chest; hip started hurting all the way from the left knee to the hip; This is a spontaneous report from a non-contactable consumer (patient).   A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 19Mar2021 at 08:00 (at the age of 59-years-old) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease and was on oxygen 24/7, obesity, asthma and cardiac failure congestive all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021 at 19:00 the patient reported that her whole right arm started hurting and it was horrible pain. She had headache and chills that comes and goes but had no fever in Mar2021. Her breathing was different. She had more tightness in her chest and a nebulizer gave her some relief. She reported that with slightest movement, her oxygen would drop down to seventies and she had to work to get it back up. She increased her oxygen from three to four litters. Her hip started hurting all the way from left knee to hip in Mar2021. She never had hip problems before. She also had sinus draining. She wanted to know if any fatalities had been reported when the study was done on the reports of the fatalities. She stated that she did not think that side effects were supposed to happen on the first shot and asked can this happen on the first shot. She also stated that if it happened on the first shot, it might not happen on the second shot. She asked if Pfizer recommend that she get the second shot stating she was scared of the second shot because the second shot had more virus in it. She stated that the nurse that gave her the shot said the first shot was 60 percentage and the second shot was 90 percentage. She stated that was not true. The patient underwent lab tests and procedures which included oxygen saturation as low in Mar2021. Therapeutic measures were taken, and the patient took two ES Tylenol for pain in arm and her HCP prescribed her prednisone and Dicyclomine for sinus draining. The outcome of the event pain in arm was recovered in Mar201 and for the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: The events abnormal breathing and low oxygen were considered medically significant. This case is being upgraded to serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain in extremity, Respiration abnormal, Sinus congestion
Clinical narrative: her whole right arm started hurting and it was horrible pain; headache; chills; breathing is different; her oxygen will drop down to the seventies and she has to work to get it back up; Sinus draining; has more tightness in her chest; hip started hurting all the way from the left knee to the hip; This is a spontaneous report from a non-contactable consumer (patient).   A 59-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 19Mar2021 at 08:00 (at the age of 59-years-old) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease and was on oxygen 24/7, obesity, asthma and cardiac failure congestive all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021 at 19:00 the patient reported that her whole right arm started hurting and it was horrible pain. She had headache and chills that comes and goes but had no fever in Mar2021. Her breathing was different. She had more tightness in her chest and a nebulizer gave her some relief. She reported that with slightest movement, her oxygen would drop down to seventies and she had to work to get it back up. She increased her oxygen from three to four litters. Her hip started hurting all the way from left knee to hip in Mar2021. She never had hip problems before. She also had sinus draining. She wanted to know if any fatalities had been reported when the study was done on the reports of the fatalities. She stated that she did not think that side effects were supposed to happen on the first shot and asked can this happen on the first shot. She also stated that if it happened on the first shot, it might not happen on the second shot. She asked if Pfizer recommend that she get the second shot stating she was scared of the second shot because the second shot had more virus in it. She stated that the nurse that gave her the shot said the first shot was 60 percentage and the second shot was 90 percentage. She stated that was not true. The patient underwent lab tests and procedures which included oxygen saturation as low in Mar2021. Therapeutic measures were taken, and the patient took two ES Tylenol for pain in arm and her HCP prescribed her prednisone and Dicyclomine for sinus draining. The outcome of the event pain in arm was recovered in Mar201 and for the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: The events abnormal breathing and low oxygen were considered medically significant. This case is being upgraded to serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pain
Clinical narrative: Extreme body ache; Nausea; Extreme tiredness; Feeling unwell; Headche; This is a spontaneous report from a non-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: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 46- years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to acidic fruits/vegetables. Concomitant medications were not reported. Prior to 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 27Mar2021 at 20:00, after 28 hours of vaccination the patient experienced nausea and headache that was not subsided with paracetamol (TYLENOL). The patient also had extreme tiredness and was feeling unwell. On 28Mar2021 (next day), the patient had extreme body aches. The patient received treatment with paracetamol (TYLENOL) for the event of headache and did not receive any treatment for the events nausea, extreme tiredness, feeling unwell and extreme body aches. The clinical outcomes of the events headache, nausea, tiredness, feeling unwell and general body pain were unknown at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Severe pounding headache; Fever; Chills; Body pain; Injection site pain; This is a spontaneous report from a contactable pharmacist. An adult male patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via intramuscularly in the left arm on 25Mar2021 at 14:15, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via intramuscularly in the left arm on 04Mar2021, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination it was unknown that whether the patient was diagnosed with COVID-19. Since vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 03:00, the patient experienced severe pounding headache (lasted until 27Mar2021), fever, chills, body ache and injection site pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events which included treatment with acetaminophen (500mg) on 26Mar2021 and ibuprofen on 27Mar2021. The clinical outcomes of the events severe pounding headache, fever, chills, body ache and injection site pain were starting to resolved on late evening of 27Mar2021 and by morning of 28Mar2021 all the events were fully resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspepsia, Insomnia, Nausea
Clinical narrative: indigestion; coughing; sneezing; body aches; congestion; insomnia; Fever; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and anxiety. The patient received unspecified concomitant medications. The patient previously received lamotrigine (LAMICTAL) and oxcarbazepine (TRILEPTAL) and experienced drug allergy. Prior to 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 27Mar2021, the patient experienced fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia. The clinical outcomes of the events fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Obstruction, Pain, Pyrexia, Sneezing, Vomiting
Clinical narrative: indigestion; coughing; sneezing; body aches; congestion; insomnia; Fever; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and anxiety. The patient received unspecified concomitant medications. The patient previously received lamotrigine (LAMICTAL) and oxcarbazepine (TRILEPTAL) and experienced drug allergy. Prior to 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 27Mar2021, the patient experienced fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia. The clinical outcomes of the events fever, nausea, vomiting, diarrhoea, indigestion, coughing, congestion, sneezing, body aches and insomnia were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Swollen tongue
Clinical narrative: 1day later noted metalic taste in mouth, tongue felt big in her mouth- lasted 10 daysMight have improved with Benadryl 25 mg; tongue felt big in her mouth; This is a spontaneous report from a contactable physician. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot number: unknown); via intramuscular route of administration on 11Mar2021 at 10:45 (at the age 45-year-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus and pollen allergy. Concomitant medications were not reported. It was unknown if the patient had any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 12Mar2021, one day after vaccination, the patient experienced metallic taste in mouth and tongue felt big in her mouth which lasted for 10 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken and included treatment with BENADRYL 25mg. The clinical outcome of the metallic taste and tongue felt big in mouth was recovered on 22Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: Throat swelling; tongue swelling; itchiness of throat; itchiness of lips; Difficulty breathing; Exhaustion; high fever; joint pain; aches; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 37-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 on 22Mar2021 at 10:45 (at the age of 37-years-old) as single dose for COVID-19 immunisation and received the second dose for BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on unknown date as single dose for COVID-19 immunisation. Medical history included COVID-19; the patient had mushroom allergy. Prior to vaccination, on an unknown date the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 22Mar2021 (within 30 minutes of vaccination), the patient experienced aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling, tongue swelling. Therapeutic measure takes as a result all events included treatment with BENADRYL. The clinical outcome of the events aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling and tongue swelling were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Pain, Pharyngeal swelling, Pyrexia, Swollen tongue
Clinical narrative: Throat swelling; tongue swelling; itchiness of throat; itchiness of lips; Difficulty breathing; Exhaustion; high fever; joint pain; aches; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 37-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 on 22Mar2021 at 10:45 (at the age of 37-years-old) as single dose for COVID-19 immunisation and received the second dose for BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on unknown date as single dose for COVID-19 immunisation. Medical history included COVID-19; the patient had mushroom allergy. Prior to vaccination, on an unknown date the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 22Mar2021 (within 30 minutes of vaccination), the patient experienced aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling, tongue swelling. Therapeutic measure takes as a result all events included treatment with BENADRYL. The clinical outcome of the events aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling and tongue swelling were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat swelling; tongue swelling; itchiness of throat; itchiness of lips; Difficulty breathing; Exhaustion; high fever; joint pain; aches; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 37-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 on 22Mar2021 at 10:45 (at the age of 37-years-old) as single dose for COVID-19 immunisation and received the second dose for BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on unknown date as single dose for COVID-19 immunisation. Medical history included COVID-19; the patient had mushroom allergy. Prior to vaccination, on an unknown date the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any vaccine within four weeks prior to the COVID-19 vaccine. On 22Mar2021 (within 30 minutes of vaccination), the patient experienced aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling, tongue swelling. Therapeutic measure takes as a result all events included treatment with BENADRYL. The clinical outcome of the events aches, chills, difficulty in breathing, exhaustion, high fever, itchiness of lips, itchiness of throat, joint pain, throat swelling and tongue swelling were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart started feeling like it was racing on Friday night and has not stopped since.; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in right arm on 23Mar2021 at 11:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The medical history and concomitant medications were reported as no. The patient was not aware if she had any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021, at 21:00, the patient had experienced heart racing. The patient reported that she had the vaccine on Tuesday and her heart started feeling like it was racing on Friday night and had not stopped since. No treatment was received for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of heart racing was not recovered at the time of report.   No follow-up attempts are needed; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose
Clinical narrative: Blood sugar and others; This is a spontaneous report received from a contactable consumer, the patient. A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the left arm on 24Mar2021 as a single dose for COVID-19 immunisation. The patient medical history was reported yes (unspecified). The patient had no known allergies. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 08:00, the patient experienced blood sugar and others (as reported). The clinical outcome of the event blood sugar was unknown at the time of report.    No follow-up attempts are needed; information about lot number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: Soreness in arm administered; Soreness in neck; Soreness in back shoulder blade; Underarm lymph was swollen and hurting; 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: en6204), via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 52-years-old) as a single dose for Covid-19 immunisation. Relevant medical history included allergies to foods (unspecified) and medications (unspecified). Patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced soreness in arm administered from neck to back shoulder blade. The patient reported that this soreness lasted for two days. On an unknown date in Mar2021, a week after, the patient experienced swollen and hurting underarm lymph. Therapeutic measures were taken as a result of swollen and hurting underarm lymph which included treatment with Tylenol. The patient reported that the pain had started to lessen but was still present. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event soreness in arm administered from neck to back shoulder blade was resolved on 18Mar2021. The clinical outcome of the events swollen and hurting underarm lymph was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Pain at site of injection; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old adult 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 left arm on 02Mar2021 at 13:15 (at the age of 49-years-old) for COVID-19 immunisation and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 23Mar2021 at 13:15 (at the age of 49-years-old) for COVID-19 immunisation. The patient had no medical history. Concomitant medications included glycerine monolaurate (MONOLAURIN), vit D (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN),curcuma longa (TURMERIC CURCUMIN), all from an unknown date, for unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not tested with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 02Mar2021 at 14:30, the patient experienced pain at site of injection- approximately 3 days, headache on the day of injection and fatigue. Therapeutic measures taken as a result of adverse events and treatment included with Tylenol. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain at site of injection, headache and fatigue was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: moved to lower back pain; joint pain first day; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included barretts esophagus. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 as a single dose for COVID-19 immunisation. Prior to 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. Since the vaccine, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included pantoprazole (PANTOPRAZOLE) 40mg for unknown indication and from an unknown date. On 24Mar2021 at 08:00, the patient experienced joint pain (first day). Went away and next day moved to lower back pain. Continued and seems to be worsened. The adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of events joint pain and lower back pain was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitching face; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration in shoulder on 13Mar2021, (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not had any allergies to medications, food and other products. Concomitant medications were not reported. Prior to vaccination, the patient did not diagnose 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 14Mar2021, the patient experienced twitching on left side of the face. 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. The patient did not receive treatment for the reported events. The clinical outcome of the event twitching face was not resolved 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: Arthralgia, Back pain, Chest discomfort, Headache, Myalgia
Clinical narrative: Injection site pain; muscle pain; joint pain; tingling; headache; sensitivity to light and sound; chest tightness; body aches; This is a spontaneous report from a non-contactable consumer, patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified administrated in the left arm on 27Mar2021 at 10:45 hours as a single dose for COVID-19 immunisation (at the age of 31-years-old). Medical history not provided. Concomitant medications included metformin (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) for an unknown indication. Previously patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified administrated in the left arm on 4March2021 as a single dose for COVID-19 immunisation (at the age of 31-years-old). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. On 27March2021, at 12:45 hours patient experienced injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches. Prior to vaccination, the patient was not diagnosed with COVID-19. Therapeutic measures were not taken as a result of the event. Clinical outcome of the Injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches was recovering at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained.