chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Tension
Clinical narrative: Headache started the next day, persisted for about 3 days. Have also noticed increased incidence of headaches over past 3 weeks. Tension and migraine. Last migraine yesterday. (Now 3 weeks out from vaccine) I do not have any significant headache history. Only usually have headaches from caffeine withdrawal, which has not been an issue these weeks.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Delirium, Dysarthria, Gait disturbance, Heart rate increased, Neuralgia
Clinical narrative: low grade fever, tongue felt swollen, delirious, could not walk, nerve pain throughout body (especially hands, down legs, feet), speech was slurred, fast heart rate,
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: low grade fever, tongue felt swollen, delirious, could not walk, nerve pain throughout body (especially hands, down legs, feet), speech was slurred, fast heart rate,
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of "lost ten pounds", "his brain was little cloudy" and "tested positive for covid" was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: his brain was still a little cloudy; tested positive for covid; tested positive for covid; lost 10 pounds; energy level changed drastically; weak; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 09:00 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertensive and diabetic, both ongoing. Concomitant medication included metformin for diabetic and olmesartan medoxomil (BENICAR) for hypertensive. There were no prior vaccinations within 4 weeks. The patient received the covid vaccine first dose on 21Dec2020 and started developing covid symptoms on the 27Dec2020. He was tested positive for covid on the 28Dec2020. The patient wanted to know what is next. He patient stated that it has been 10 days and he wanted to know if he is still contagious. He is scheduled to get the second dose on 11Jan2021. He wonders if he can get the second dose or does have to start the process over again. He works in a doctor's office. He is a technician. While providing height and weight he commented it has changed drastically. He later clarified it was his weight that changed drastically. He lost ten pounds. His weight and energy level changed drastically, and this was after getting the COVID Vaccine. His symptoms started the weekend after taking the vaccine. He had COVID symptoms. He later clarified and stated they all started on 27Dec2020. He clarified his symptoms as: body aches and fever. The body aches and fever started the night of 27Dec2020 and recovered from 08Jan2021. He was unable to provide an exact time of onset. These have resolved, but at the time of report he was just weak. He had a COVID test done on 28Dec2020 he tested positive. He confirmed he has not had a follow-up COVID test done afterwards. The patient also mentioned that his brain was still a little cloudy since an unspecified date. The patient had not recovered from the event weak; while outcome of "lost ten pounds", "his brain was little cloudy" and "tested positive for covid" was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for covid-19; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 24Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient received the first dose of vaccine on 24Dec2020 and tested positive for COVID-19 on 11Jan2021. She was scheduled for second dose on 14Jan2021. The patient was asking if she can get her second dose as scheduled or wait and recommendation for 2nd dose, if needing to extend past 3 week mark for quarantine after testing positive. Outcome of the events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Moderate vertigo
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Left supraclavicular  and axillary lymphadenopathy, still present
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Peripheral swelling
Clinical narrative: nausea; chills; arm is swollen; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 11Jan2021 11:30 in the left deltoid at single dose for COVID-19 immunization, administered in the hospital. Medical history included birth control. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 23Dec2020 administered in the left deltoid. Her arm was swollen as she noticed this morning (12Jan2021) when she woke up, about 07:00. She placed ice on it and the swelling had gone down a little. Nausea and chills started around 09:30 this morning. The outcome of the event arm was swollen was recovering; while outcome of the events nausea and chills was not recovered.  Information on batch/lot number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: stated that he was scheduled for his second vaccine and tested positive for Coronavirus the same day; stated that he was scheduled for his second vaccine and tested positive for Coronavirus the same day; This is a spontaneous report from a contactable physician. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose (first COVID vaccine) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for the second dose on 06Jan2021 and tested positive for Coronavirus the same day. He started showing symptoms on 03Jan2021 and wanted to know, since he could not do the second Covid vaccine, because he is in quarantine and when he can get it. His quarantine ends on Friday and hopes to do it on that day. Clarified that it was 04Jan2021 that he was scheduled for the second dose and tested positive for the Coronavirus the same day and not 06Jan2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 04Jan2021. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between suspect BNT162B2 and reported event cannot be excluded.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 10 minutes after receiving the vaccine, my left hand went numb.  The numbness started at my wrist and went all the way to my fingertips.  Approximately 20 minutes after receiving the vaccine, my left food went numb.  My hand was still numb at this time.  Approximately 25 minutes after receiving the vaccine, part of the left side of my face was slightly numb.  The facial numbness started at the edge of my left eye and went straight down to my chin and over to the left all the way to my ear lined up near the earlobe.  My hand and foot were still  numb at this time.  Approximately 35 minutes after receiving the vaccine, all of the numbness went away.  At approximately 3:00 a.m. on 1/16/2021, I woke up with a splitting headache and the chills so severe that my teeth were actually chattering and banging into each other.  Later, I woke up overheated with the sweats.  At 9:00 a.m. on 01/16/2021, I had symptoms that were flu-like.  I was dizzy, light-headed, and nauseous as well.    For the remainder of the day, I felt flu-ish, had generalized fatigue, my headache continued, and my left arm near the injection site was extremely sore.  On 01/17/2021, I was still suffering from a severe headache and had generalized fatigue.  My left arm near the injection site was still extremely sore and was now also red in color.        To combat the headache, it required both ibuprofen and acetaminophen simultaneously.  One medication on it's own was not enough.  By 01/18/2021, my headache was gone as was my body aches.  The only lingering effect on this day was a sore arm at the injection site that was still red in color.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Injection site erythema, Injection site pain, Nausea
Clinical narrative: 10 minutes after receiving the vaccine, my left hand went numb.  The numbness started at my wrist and went all the way to my fingertips.  Approximately 20 minutes after receiving the vaccine, my left food went numb.  My hand was still numb at this time.  Approximately 25 minutes after receiving the vaccine, part of the left side of my face was slightly numb.  The facial numbness started at the edge of my left eye and went straight down to my chin and over to the left all the way to my ear lined up near the earlobe.  My hand and foot were still  numb at this time.  Approximately 35 minutes after receiving the vaccine, all of the numbness went away.  At approximately 3:00 a.m. on 1/16/2021, I woke up with a splitting headache and the chills so severe that my teeth were actually chattering and banging into each other.  Later, I woke up overheated with the sweats.  At 9:00 a.m. on 01/16/2021, I had symptoms that were flu-like.  I was dizzy, light-headed, and nauseous as well.    For the remainder of the day, I felt flu-ish, had generalized fatigue, my headache continued, and my left arm near the injection site was extremely sore.  On 01/17/2021, I was still suffering from a severe headache and had generalized fatigue.  My left arm near the injection site was still extremely sore and was now also red in color.        To combat the headache, it required both ibuprofen and acetaminophen simultaneously.  One medication on it's own was not enough.  By 01/18/2021, my headache was gone as was my body aches.  The only lingering effect on this day was a sore arm at the injection site that was still red in color.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 10 minutes after receiving the vaccine, my left hand went numb.  The numbness started at my wrist and went all the way to my fingertips.  Approximately 20 minutes after receiving the vaccine, my left food went numb.  My hand was still numb at this time.  Approximately 25 minutes after receiving the vaccine, part of the left side of my face was slightly numb.  The facial numbness started at the edge of my left eye and went straight down to my chin and over to the left all the way to my ear lined up near the earlobe.  My hand and foot were still  numb at this time.  Approximately 35 minutes after receiving the vaccine, all of the numbness went away.  At approximately 3:00 a.m. on 1/16/2021, I woke up with a splitting headache and the chills so severe that my teeth were actually chattering and banging into each other.  Later, I woke up overheated with the sweats.  At 9:00 a.m. on 01/16/2021, I had symptoms that were flu-like.  I was dizzy, light-headed, and nauseous as well.    For the remainder of the day, I felt flu-ish, had generalized fatigue, my headache continued, and my left arm near the injection site was extremely sore.  On 01/17/2021, I was still suffering from a severe headache and had generalized fatigue.  My left arm near the injection site was still extremely sore and was now also red in color.        To combat the headache, it required both ibuprofen and acetaminophen simultaneously.  One medication on it's own was not enough.  By 01/18/2021, my headache was gone as was my body aches.  The only lingering effect on this day was a sore arm at the injection site that was still red in color.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body height, International normalised ratio, International normalised ratio increased
Clinical narrative: INR levels went up to 3.9; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. An 87-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELI283, unknown expiration), via an unspecified route of administration on 11Jan2021 at a single dose as the patient wanted to take it to be on the safe side.  Medical history included ongoing diabetes.  Concomitant medication included ongoing linagliptin (TRADJENTA) for diabetes. It was reported that the patient received the vaccine yesterday (11Jan2021). On 12Jan2021, his INR levels went up to 3.9 and is usually in the 2.2 - 2.3 range. The patient had no reaction today (12Jan2021), but he did have to go get his INR levels checked. The reporter wanted to know if this is due to the COVID vaccine. They are wondering if the vaccine could have anything to do with the jump in his numbers. He doesn't have a prescribing doctor. He set up an appointment in the next town over to get the vaccine. He is having another INR check next Wednesday. Besides that, he doesn't feel any different. He has had no reactions. He just decided he wanted to take it to be on the safe side down the road. The patient underwent blood tests and procedures which included blood tests: unknown results on unspecified date and height: lost a couple of inches. Outcome of the event was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Pain
Clinical narrative: Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea on 11Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient did not have COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Within 15 mins, fever, chills, fatigue, body and joint pain, diarrhea on 11Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient did not have COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13248), via an unspecified route of administration on right arm on 11Jan2021 08:30AM at a single dose for COVID-19 immunization at workplace clinic. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medication included zinc and melatonin in two weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on right arm on 23Dec2020 7:45AM. The patient did not receive other vaccine in four weeks. The patient was not pregnant and was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site pain, joint pain, mild fever, headache, nausea and diarrhea on 12Jan2021 10:00AM. The events were reported as non-serious. The patient did not receive treatment for the adverse events. The outcome of events was recovering. The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13248), via an unspecified route of administration on right arm on 11Jan2021 08:30AM at a single dose for COVID-19 immunization at workplace clinic. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medication included zinc and melatonin in two weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on right arm on 23Dec2020 7:45AM. The patient did not receive other vaccine in four weeks. The patient was not pregnant and was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site pain, joint pain, mild fever, headache, nausea and diarrhea on 12Jan2021 10:00AM. The events were reported as non-serious. The patient did not receive treatment for the adverse events. The outcome of events was recovering. The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Product administered to patient of inappropriate age
Clinical narrative: This event was not an adverse event, however, it was an invalid dose because the patient was less than 18 years of age when she received her first dose of the Moderna COVID vaccine. Patient did state she experienced some light dizziness about 5 minutes after she was given the vaccine and that this has happened before with the influenza vaccine. She also stated that she did not have anything to eat or drink at all that morning so she may have been experiencing weakness from that as well.  It resolved within 10-15 minutes and patient was fine to go home per other healthcare providers.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Migraine, Myalgia
Clinical narrative: headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea
Clinical narrative: Chills, nausea, headache, loss of appetite
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio decreased
Clinical narrative: he went to check his INR numbers and it went down to 1.3 from 3.3 two weeks ago./INR dropped significantly; This is a spontaneous report from a contactable consumer. A 75-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot BK7231, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included patient was on ongoing blood thinner (thrombosis). Concomitant medication included ongoing warfarin (COUMADIN) as blood thinner for the last 14 years. Patient received the first shot of the vaccine yesterday, 11Jan2021. Today, 12Jan2021, he went to check his INR numbers, got his INR drawn and it dropped significantly; it went down to 1.3 from 3.3 two to three weeks ago (date unspecified). His normal values were 3.0 - 3.5 (dates unspecified) as he was on coumadin as a blood thinner. He was asking if there were any drug interactions with warfarin and the vaccine. Patient did not have the exact units of measurement and stated hi second vaccination is scheduled for 01Feb2021. Therapeutic measure was taken as a result of the event reported. The outcome of the event INR numbers/went down/dropped significantly was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia, Pain
Clinical narrative: Pain at injection site (moderate to severe); general malaise (moderate); body/muscle aches (mild-moderate); body/muscle aches (mild-moderate); headache (mild); chills (mild); This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL1284; expiration date not provided), via an unspecified route of administration on 11Jan2021 10:15 at a single dose at left arm for COVID-19 immunisation. Medical history included premature ventricular contraction and sulfonamide allergy. The patient received the first dose of BNT162B2 on 21Dec2021. Concomitant medication included escitalopram and famotidine. The patient experienced pain at injection site (moderate to severe), general malaise (moderate), body/muscle aches (mild-moderate), headache (mild), chills (mild) on 11Jan2021. No treatment information was received. The patient underwent lab tests and procedures which included SARS-COV-2 test which showed negative result on 01Jun2020. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Pain at injection site (moderate to severe); general malaise (moderate); body/muscle aches (mild-moderate); body/muscle aches (mild-moderate); headache (mild); chills (mild); This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL1284; expiration date not provided), via an unspecified route of administration on 11Jan2021 10:15 at a single dose at left arm for COVID-19 immunisation. Medical history included premature ventricular contraction and sulfonamide allergy. The patient received the first dose of BNT162B2 on 21Dec2021. Concomitant medication included escitalopram and famotidine. The patient experienced pain at injection site (moderate to severe), general malaise (moderate), body/muscle aches (mild-moderate), headache (mild), chills (mild) on 11Jan2021. No treatment information was received. The patient underwent lab tests and procedures which included SARS-COV-2 test which showed negative result on 01Jun2020. The outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Mild pain in arm shortly following injection of vaccine. Approximately 9 hours later, rapid onset of flu-like symptoms occured including: full body aches, fatigue, headache, and mild nausea. Advil was taken roughtly every 6 hours while side effects persisted. Late at night the following day 1/20/21, symptoms became more mild and normal activity was resumed. Advil or tylenol was still being taken at this time. All ailments ceased by mid day on 1/21/21.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild pain in arm shortly following injection of vaccine. Approximately 9 hours later, rapid onset of flu-like symptoms occured including: full body aches, fatigue, headache, and mild nausea. Advil was taken roughtly every 6 hours while side effects persisted. Late at night the following day 1/20/21, symptoms became more mild and normal activity was resumed. Advil or tylenol was still being taken at this time. All ailments ceased by mid day on 1/21/21.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Migraine, Vaccination site pain, Vertigo
Clinical narrative: migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches, headache, nausea, vomiting, chills, fatigue, arm tenderness
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Body aches, headache, nausea, vomiting, chills, fatigue, arm tenderness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Neck pain
Clinical narrative: Exercised following injection. Noticed mildly sore arm within several hours. Much worse that night to the point that I was unable to lift things. Next day it was on/off pain, with very intense pain when it came on to the point that I was unable to lift or do things. On Sunday (next day), pain seemed to radiate from the shoulder up through my left neck to the cranium area. Monday (today) this evening - pain so intense that I was screaming and sobbing. Husband (also MD) had to medicate me as I was laying on bed screaming unable to move or roll over. He had to manually lift me. Significant pain in left neck (trapezius) area on inhales, near injection site. Pain has been getting worse each night.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Exercised following injection. Noticed mildly sore arm within several hours. Much worse that night to the point that I was unable to lift things. Next day it was on/off pain, with very intense pain when it came on to the point that I was unable to lift or do things. On Sunday (next day), pain seemed to radiate from the shoulder up through my left neck to the cranium area. Monday (today) this evening - pain so intense that I was screaming and sobbing. Husband (also MD) had to medicate me as I was laying on bed screaming unable to move or roll over. He had to manually lift me. Significant pain in left neck (trapezius) area on inhales, near injection site. Pain has been getting worse each night.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Nasal congestion, Rash erythematous
Clinical narrative: Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Rash
Clinical narrative: Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Large reactive axillary lymphadenopathy; First dose: 17Nov2020, second dose: 07Jan2021; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on left arm on 07Jan2021 16:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EJ165) for COVID-19 immunization on 17Nov2020 18:45 at left arm and tested positive for COVID test/Nasal Swab on 27Dec2020. The patient experienced large reactive axillary lymphadenopathy on 08Jan2021 that resulted in emergency room/department or urgent care. The patient took a CT scan as treatment with unknown results. The outcome of the event was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: had a massive headache; nausea; throwing up for a couple of hours; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient had the vaccine yesterday on 11Jan2021 at 12:00. Then by 3:30pm on 11Jan2021, patient had a massive headache, nausea, and throwing up for a couple of hours. She saw nausea as a side effect, but not the others. She also didn't think there were side effects really after the first shot. The patient asked if these are reported side effects after first dose and what about 2nd dose? Should there be any issues after the 2nd dose?. She is an ophthalmic tech. She doesn't have a prescribing doctor. She got it with the (health department name) for healthcare workers. The nausea stopped last night (recovered) at 10PM on 11Jan2021, and her headache stopped (recovered) at 9 am this morning on 12Jan2021. The patient also recovered from the event 'throwing up' on 11Jan2021.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: I received my shot at about 7:30PM Friday Jan 22, about 8 hours after that my shoulder had pain where I received the shot and had started to get a headache.   4 hours later awoke with extreme headache with pain in my joints,  also this is when diarrhea started.  Took Aleve and tried going back to bed an hour or so later chills started and couldn't sleep with the pain and diarrhea.  Kept trying to sleep but was difficult with these problems a couple hours later tried stretching and doing a little stretch and flex to see if this would help but it did not.  So approximately 18 hours after the shot the diarrhea was done (nothing left in me) I was dehydrated and consumed water constantly.  A couple hours after this I did not have anymore chills but my head felt like a balloon that was being over inflated and was going to pop.  By this time my sister was at my house keeping an eye on me, I had called her earlier.  I couldn't really feel the pain where I received my shop because of the pain in all my joints (shoulders, knees, hands etc.) but the worst was my neck and head.  Slept rough during the night drinking large quantities of water all night.  Started feeling a bit better mid morning the next day, got appetite back but was extremely fatigued and pretty much napped in bed until 6pm Sunday the 24th.  That's when I started feeling normal again eating like a pig and still couldn't get enough water in me.   Now I'm scared about getting the 2nd dose of Moderna in a month. Thank you t
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Sleep disorder
Clinical narrative: I received my shot at about 7:30PM Friday Jan 22, about 8 hours after that my shoulder had pain where I received the shot and had started to get a headache.   4 hours later awoke with extreme headache with pain in my joints,  also this is when diarrhea started.  Took Aleve and tried going back to bed an hour or so later chills started and couldn't sleep with the pain and diarrhea.  Kept trying to sleep but was difficult with these problems a couple hours later tried stretching and doing a little stretch and flex to see if this would help but it did not.  So approximately 18 hours after the shot the diarrhea was done (nothing left in me) I was dehydrated and consumed water constantly.  A couple hours after this I did not have anymore chills but my head felt like a balloon that was being over inflated and was going to pop.  By this time my sister was at my house keeping an eye on me, I had called her earlier.  I couldn't really feel the pain where I received my shop because of the pain in all my joints (shoulders, knees, hands etc.) but the worst was my neck and head.  Slept rough during the night drinking large quantities of water all night.  Started feeling a bit better mid morning the next day, got appetite back but was extremely fatigued and pretty much napped in bed until 6pm Sunday the 24th.  That's when I started feeling normal again eating like a pig and still couldn't get enough water in me.   Now I'm scared about getting the 2nd dose of Moderna in a month. Thank you t
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: feeling off along with some headache; feels kind of off; This is a spontaneous report from a contactable other healthcare professional (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose for COVID-19 immunization. The patient 's medical history and concomitant medications were not reported. The patient was administered with first dose of bnt162b2 on an unspecified date for COVID-19 immunization and experienced sore arm. The patient received the second injection yesterday (11Jan2021). With the first one, the patient didn't feel any side effects other than a sore arm. He received the second vaccine yesterday at about 3pm. Last night, everything was fine. This morning (12Jan2021) at about 9 a.m., he started getting a little bit of a headache. He just felt kind of off. He thought that it was one of the side effects. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: Throat scratchiness; Cough; This is a spontaneous report from a non-contactable healthcare professional reporting for a patient. A 24-year-old female patient received the first dose of bnt162b2 (BNT162B2, Pfizer, lot number: EH9899) and second dose (lot number: EK9231); both via an unspecified route of administration on an unspecified date at a single dose for COVID-19. Medical history and concomitant medications were not reported. During her 15-minute waiting period after the injection, the patient began to experience throat scratchiness and cough. The patient denied difficulty breathing, difficulty swallowing, throat tightness, dizziness and facial swelling. Treatment included antihistamines: diphenhydramine (BENADRYL) 25 mg oral. The patient denied any symptoms on discharge. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong metallic  taste in mouth; This is a spontaneous report received from a contactable nurse (who is also patient). A 36-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration in right arm, on 12Jan2021 11:00, at single dose, for COVID-19 immunization, in the hospital. There were no medical history and concomitant medications. The patient has no known allergies. The patient is not pregnant. The patient did not have COVID-19 prior to vaccination and did not receive other vaccines in four weeks. The patient experienced strong metallic taste in mouth on 12Jan2021 11:30. No treatment was given for the event. The patient was not tested for COVID-19 post vaccination. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: mild fever, body-aches, headaches