chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Oximeter marked the first number as 85 something; She wasn't feeling well; Temperature was 100.4/ she felt like fever; Chills; This is a spontaneous report from a contactable consumer. The consumer reported for a female patient (daughter) of an unspecified age that she received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiry date were reported as unknown) via an unspecified route of administration on 09Feb2021 at 12:30 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Feb2021 at 12:30, the patient got vaccinated with the Pfizer vaccine. On 10Feb2021, in the morning she didn't felt good, her temperature was 100.4, she felt like fever, chills and oximeter showed the first number as something like 85. She was completely fine before the vaccine. The consumer wanted to know if that was a problem with the vaccine or the patient needs to be taken to emergency room. The patient underwent lab tests and procedures which included body temperature as 100.4 and oxygen saturation as 85 on 10Feb2021. The outcome of all the events was unknown.  Information on Lot /Batch Number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Oximeter marked the first number as 85 something; She wasn't feeling well; Temperature was 100.4/ she felt like fever; Chills; This is a spontaneous report from a contactable consumer. The consumer reported for a female patient (daughter) of an unspecified age that she received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiry date were reported as unknown) via an unspecified route of administration on 09Feb2021 at 12:30 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Feb2021 at 12:30, the patient got vaccinated with the Pfizer vaccine. On 10Feb2021, in the morning she didn't felt good, her temperature was 100.4, she felt like fever, chills and oximeter showed the first number as something like 85. She was completely fine before the vaccine. The consumer wanted to know if that was a problem with the vaccine or the patient needs to be taken to emergency room. The patient underwent lab tests and procedures which included body temperature as 100.4 and oxygen saturation as 85 on 10Feb2021. The outcome of all the events was unknown.  Information on Lot /Batch Number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Fatigue, Influenza
Clinical narrative: chills; uncontrollably shakes; nauseous; fatigue; That night started to vomit; fever (101 degree temp); shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 17:00 (Batch/Lot Number: EN5138) as SINGLE DOSE for covid-19 immunisation. Medical history included heart Cond, RA (Rheumatoid arthritis) and allergies. The patient's concomitant medications included unspecified medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. First shot on 2/9 at 5pm. 24 hours later on 10Feb2021 05:00 PM chills, fever (101 degree temp), shortness of breath, uncontrollably shakes, nauseous, fatigue. Symptoms continued for the next 48 hrs and went to the local clinic. The patient was tested for covid and the flu. Both were negative. Prescribed nausea med. That night started to vomit and continued for the next 50 hours off and on. Fever broke at around 9 am on 2/15. The patient visited to emergency room/department or urgent care. Therapeutic measures were taken as a result of events. The outcome of the events were recovered on 2021.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Tremor, Vomiting
Clinical narrative: chills; uncontrollably shakes; nauseous; fatigue; That night started to vomit; fever (101 degree temp); shortness of breath; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 17:00 (Batch/Lot Number: EN5138) as SINGLE DOSE for covid-19 immunisation. Medical history included heart Cond, RA (Rheumatoid arthritis) and allergies. The patient's concomitant medications included unspecified medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. First shot on 2/9 at 5pm. 24 hours later on 10Feb2021 05:00 PM chills, fever (101 degree temp), shortness of breath, uncontrollably shakes, nauseous, fatigue. Symptoms continued for the next 48 hrs and went to the local clinic. The patient was tested for covid and the flu. Both were negative. Prescribed nausea med. That night started to vomit and continued for the next 50 hours off and on. Fever broke at around 9 am on 2/15. The patient visited to emergency room/department or urgent care. Therapeutic measures were taken as a result of events. The outcome of the events were recovered on 2021.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Diarrhoea, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night sweats; They are wondering did they get COVID from the shot or should they have been tested before they got the shot; This is a spontaneous report from a contactable consumer reported for a male patient via medical information team.  A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration in the upper left arm on 18Feb2021 at 16:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma growing up as a child. It was an underlying medical condition and high blood pressure. No investigation assessment was not provided. Concomitant medication included Metoprolol for high blood pressure and one other but doesn't know the name of the other one. Patient also took a water pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Consumer reported that patient received first dose of COVID vaccine on 18Feb2021. He had symptoms ever since. The reporter wanted to know did he get COVID from the shot or should he have been tested before he got the shot and how long would the side effects could last. The reporter clarified patient symptoms as lost sense of smell, stuffy nose, hot and cold sweats, diarrhea one day, night sweats and headache on an unknown date in Feb2021. She mentioned that she finds it strangely coincidental that they received the shot and then "all of the sudden they can't smell". The vaccination card given to him was in the car. The reporter doesn't have it on hand to provide lot number. It was given on the same date and at the same time as consumer, so probably the same lot number she received. Consumer's lot number was EN6200. No adverse events resulted in physician's office visit nor emergency Room. The events were assessed as non-serious. The clinical outcome of events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Suspected COVID-19
Clinical narrative: lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night sweats; They are wondering did they get COVID from the shot or should they have been tested before they got the shot; This is a spontaneous report from a contactable consumer reported for a male patient via medical information team.  A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration in the upper left arm on 18Feb2021 at 16:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma growing up as a child. It was an underlying medical condition and high blood pressure. No investigation assessment was not provided. Concomitant medication included Metoprolol for high blood pressure and one other but doesn't know the name of the other one. Patient also took a water pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Consumer reported that patient received first dose of COVID vaccine on 18Feb2021. He had symptoms ever since. The reporter wanted to know did he get COVID from the shot or should he have been tested before he got the shot and how long would the side effects could last. The reporter clarified patient symptoms as lost sense of smell, stuffy nose, hot and cold sweats, diarrhea one day, night sweats and headache on an unknown date in Feb2021. She mentioned that she finds it strangely coincidental that they received the shot and then "all of the sudden they can't smell". The vaccination card given to him was in the car. The reporter doesn't have it on hand to provide lot number. It was given on the same date and at the same time as consumer, so probably the same lot number she received. Consumer's lot number was EN6200. No adverse events resulted in physician's office visit nor emergency Room. The events were assessed as non-serious. The clinical outcome of events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Cough, Pyrexia
Clinical narrative: I lost my sense of smell; The fever and cough that was expected on Saturday; The fever and cough that was expected on Saturday; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809 and Expiration date was unknown), via an unspecified route of administration on an unspecified date in 2021 as unknown dose number, single dose for COVID-19 immunisation. Medical history included Epilepsy, PTSD and traumatic brain injury all from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMICTAL) taken at a dose of 100 mg; venlafaxine taken at a dose of 150 mg; levonorgestrel (SKYLA) (Intrauterine device) at an unknown dose. Patient stated, she got the Pfizer vaccine on Wednesday and today she lost sense of smell (01Mar2021) and wanted to make sure is that any bit of normal or should she go tested. Stated, the smell was today. The fever and cough that was expected on Saturday (unspecified date in 2021). Patient received treatment for events over the counter thing like Advil and Cough drops and some nasal decongestion. Consumer further stated vaccination date: It was 26. Therapeutic measures were taken as a result of lost my sense of smell, the fever and cough that was expected on Saturday. There was no investigation assessment. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Said has no sense of smell; This is a spontaneous report via Pfizer Sponsored Program. A non-contactable consumer (patient) reported a female patient of an unspecified age received first dose of BNT162B2(Covid-19 Vaccine: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient just had 1st dose of covid vaccine. Said her side effects are different from ones listed in pamphlet. Said has no sense of smell. The clinical outcome of the said has no sense of smell was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Nervousness, Tremor
Clinical narrative: felt a "rush" and shakiness as if I just had a cup of coffee; felt a "rush" and shakiness as if I just had a cup of coffee; felt nervous; This is a spontaneous report from a contactable consumer (patient's himself). A 56-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm (Batch/Lot number unknown) on 06Mar2021 at 09:30 AM at the age of 56-year old as single dose for Covid-19 immunization and alprazolam (XANAX) 0.25 mg two hours before the vaccine (06Mar2021 at 07:30 AM) Relevant medical history included high blood pressure. Concomitant medications were not reported. The patient reported that he was very relaxed and calm and had taken less than 0.25 mg of alprazolam two hours prior. In less than two minutes after receiving the injection he felt a "rush" and shakiness as if he just had a cup of coffee. He was not short of breath and had no other symptoms. The patient tried to remain calm. The symptoms subsided in less than 30 seconds. He still felt nervous but may have been out of concern after the "rush" feeling. The site monitor approximately 8 mins. after the injection asked him how he was doing. He told him he was shaky but may have been nervous. He said he was free to leave. The patient took alprazolam that morning because he had prior Emergency Medical experience and was aware of potential anaphylaxis. The outcome of the events was recovered.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: chest feeling heavy like she was swelling up with fluid; chest feeling heavy like she was swelling up with fluid; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced chest feeling heavy like she was swelling up with fluid on an unspecified date. Reporter stated that, "after receiving her first injection of the Pfizer-BioNTech COVID-19 vaccine and then afterwards, while still at the vaccination site, she experienced her chest feeling heavy like she was swelling up with fluid. She did not need any treatment and before she left, the vaccination site told her to go to the emergency room if she started to experience trouble breathing or any symptoms that might indicate anaphylaxis. She does plan to consult with her physician about getting the second injection or not because of what she experienced. She inquired should she get second injection since she had a reaction after the first". Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Infection, Sensory disturbance
Clinical narrative: Clipped toenails. Didn't have a reaction. Noticed sensitivity; Slight infection; Touch sensitivity; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced clipped toenails. Didn't have a reaction. Noticed sensitivity, slight infection, touch sensitivity on an unspecified date. Patient stated three or four days ago clipped toenails. Didn't had a reaction. Noticed sensitivity. No bleeding and he didn't had any touch sensitivity. Slight infection two days. Putting on Neosporin. Touch sensitivity was there. Would you indicate that I keep the appointment? No pre existing conditions. Potential AE. The outcome of the events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: Vaccine was administered in right arm. Experienced mild pain for about 24 hours; I did experience itching on my lower back, buttocks, and back of both legs for about 36 hours. No rash but a moderate itching sensation; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration, administered in arm right on 04Mar2021 at 12:45 (PM) (at the age of 64-year-old) as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took flu vaccination (annual flu vaccination) and experienced mild pain. No other vaccine in four weeks and no treatment received. No covid prior vaccination and did not tested covid post vaccination. The patient known allergies were none. The patient got vaccine in right arm and experienced mild pain on an unspecified date Mar2021 (for about 24 hours) similar to that of the annual flu vaccination, itching on his lower back, buttocks, and back of both legs for about 36 hours. No rash but a moderate itching sensation. Outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Appetite disorder, Confusional state, Fatigue
Clinical narrative: very tired; still can't function; My urine stream became half of what it normally is; severe stomach pains/ pains around outside of stomach; Pain in right kidney; Chills/hot; Hands shaky; Slight confusion; Couldn't eat; Couldn't sleep or sit for more than 10 minutes at a time due to pain; Couldn't sleep or sit for more than 10 minutes at a time due to pain; bloat; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EN6199) via unspecified route of administration in left arm, as single dose on an 06Mar2021 16:45 for COVID-19 immunization (at the age of 68-years). The patient medical history and concomitant medications were not reported. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 06Mar2021 22:00, patient started to get severe stomach pains, couple hours after, patient got pains outside of stomach, pain in right kidney, chills/hot, handy shaky, slight confusion, could not eat, drank water and could not sleep or sit for more than 10 minutes at a time due to pain. Patient started to bloat. Less severe on Monday 08Mar2021 and finally slept a full night from 7 pm to 3 am Monday into Tuesday. Patient stated that symptoms have decreased but still could not function and was very tired yet at 10 am Tuesday (09Mar2021). Patient stated that urine stream became half of what it normally was. Patient had been drinking lots of water, had some crackers, had five teaspoons of broth last night and finally ate a bowl of oatmeal. The events resulted to visit doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of, my urine stream became half of what it normally is. The outcome of all the events was recovering except urine stream became half of what it normally was, which was recovered on 08Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Impaired work ability, Insomnia, Pain, Renal pain
Clinical narrative: very tired; still can't function; My urine stream became half of what it normally is; severe stomach pains/ pains around outside of stomach; Pain in right kidney; Chills/hot; Hands shaky; Slight confusion; Couldn't eat; Couldn't sleep or sit for more than 10 minutes at a time due to pain; Couldn't sleep or sit for more than 10 minutes at a time due to pain; bloat; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EN6199) via unspecified route of administration in left arm, as single dose on an 06Mar2021 16:45 for COVID-19 immunization (at the age of 68-years). The patient medical history and concomitant medications were not reported. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 06Mar2021 22:00, patient started to get severe stomach pains, couple hours after, patient got pains outside of stomach, pain in right kidney, chills/hot, handy shaky, slight confusion, could not eat, drank water and could not sleep or sit for more than 10 minutes at a time due to pain. Patient started to bloat. Less severe on Monday 08Mar2021 and finally slept a full night from 7 pm to 3 am Monday into Tuesday. Patient stated that symptoms have decreased but still could not function and was very tired yet at 10 am Tuesday (09Mar2021). Patient stated that urine stream became half of what it normally was. Patient had been drinking lots of water, had some crackers, had five teaspoons of broth last night and finally ate a bowl of oatmeal. The events resulted to visit doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of, my urine stream became half of what it normally is. The outcome of all the events was recovering except urine stream became half of what it normally was, which was recovered on 08Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Urine output decreased
Clinical narrative: very tired; still can't function; My urine stream became half of what it normally is; severe stomach pains/ pains around outside of stomach; Pain in right kidney; Chills/hot; Hands shaky; Slight confusion; Couldn't eat; Couldn't sleep or sit for more than 10 minutes at a time due to pain; Couldn't sleep or sit for more than 10 minutes at a time due to pain; bloat; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EN6199) via unspecified route of administration in left arm, as single dose on an 06Mar2021 16:45 for COVID-19 immunization (at the age of 68-years). The patient medical history and concomitant medications were not reported. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 06Mar2021 22:00, patient started to get severe stomach pains, couple hours after, patient got pains outside of stomach, pain in right kidney, chills/hot, handy shaky, slight confusion, could not eat, drank water and could not sleep or sit for more than 10 minutes at a time due to pain. Patient started to bloat. Less severe on Monday 08Mar2021 and finally slept a full night from 7 pm to 3 am Monday into Tuesday. Patient stated that symptoms have decreased but still could not function and was very tired yet at 10 am Tuesday (09Mar2021). Patient stated that urine stream became half of what it normally was. Patient had been drinking lots of water, had some crackers, had five teaspoons of broth last night and finally ate a bowl of oatmeal. The events resulted to visit doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of, my urine stream became half of what it normally is. The outcome of all the events was recovering except urine stream became half of what it normally was, which was recovered on 08Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Increased upper airway secretion, Malaise, Nasal congestion
Clinical narrative: headache; feeling unwell; fever; chills; cold symptoms and nose keeps swelling up with snot; mucus at back of throat; mucus at back of throat and nose"; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received second dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 06Mar2021 (Age at Vaccination 66-year-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included anaphylactic reaction from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  On 08Mar2021, the patient experienced yesterday some headache; feeling unwell; fever; chills and today cold symptoms and her "nose keeps swelling up with snot" or "mucus at back of throat and nose". Reporter is asking if these symptoms are part of the vaccine, she had an anaphylactic reaction to some medicine before, but this was different. She mentioned is worried about the different mask legislation of states. She seeking information on the need to continue using mask even after vaccination. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: headache; feeling unwell; fever; chills; cold symptoms and nose keeps swelling up with snot; mucus at back of throat; mucus at back of throat and nose"; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old female patient received second dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 06Mar2021 (Age at Vaccination 66-year-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included anaphylactic reaction from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  On 08Mar2021, the patient experienced yesterday some headache; feeling unwell; fever; chills and today cold symptoms and her "nose keeps swelling up with snot" or "mucus at back of throat and nose". Reporter is asking if these symptoms are part of the vaccine, she had an anaphylactic reaction to some medicine before, but this was different. She mentioned is worried about the different mask legislation of states. She seeking information on the need to continue using mask even after vaccination. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling hot, Pain, Pyrexia
Clinical narrative: Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; fever; pain; Feels so bad; This is a spontaneous report received from a contactable consumer. A male (Age: 62, unit: Unknown) patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in arm on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after first dose of vaccine he had a reaction. He has a ball on his arm, inflammation under the arm like a big baseball ball, it is very red and hot. It was on the same arm that he got the vaccine. It was also reported that he feels so bad but this was the worst symptom. She stated the ball is under the arm next to the breast and confirmed it was the armpit. She said he has fever and pain and everything but she was worried about the ball on his arm that is very inflamed and asked if it was normal. Outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; Ball on arm, inflammation under arm like a big baseball ball,very red,hot,on same arm that he got vaccine, ball is under arm next to breast, confirmed it was armpit,ball on arm that is very inflamed; fever; pain; Feels so bad; This is a spontaneous report received from a contactable consumer. A male (Age: 62, unit: Unknown) patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in arm on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after first dose of vaccine he had a reaction. He has a ball on his arm, inflammation under the arm like a big baseball ball, it is very red and hot. It was on the same arm that he got the vaccine. It was also reported that he feels so bad but this was the worst symptom. She stated the ball is under the arm next to the breast and confirmed it was the armpit. She said he has fever and pain and everything but she was worried about the ball on his arm that is very inflamed and asked if it was normal. Outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Tremor
Clinical narrative: flushed; face turned really red within a few minutes after receiving the vaccine; terrible trembling; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 Vaccine, Lot number was not reported), via an unspecified route of administration on 21Feb2021 as 1st dose, single dose for covid-19 immunisation. Medical history included autoimmune disorder from an unknown date and unknown if ongoing, cutaneous lupus erythematosus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The caller stated that she became very flushed and her face turned really red within a few minutes after receiving the vaccine (21Feb2021). She also states that later that evening (21Feb2021) she started to have "terrible trembling" and then the symptoms got better. The patient stated, "I don't think it had anything to do with the vaccine itself, I think it was because I have lupus and anything that I put into my body causes me to have a reaction." She had spoken with her HCP and they told her that she may not build any antibodies since she has an autoimmune disorder. Caller clarified that she was not on any immune suppressants for her condition. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: shortness of breath; chills; body aches; low energy; Numbness in her mouth and tongue; Electricity feeling through the legs; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 06Mar2021 as 1st dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received her first dose of the Pfizer-BioNTech COVID-19 vaccine on Saturday (06Mar2021). About 5 minutes after the injection while at the vaccination site, she experienced shortness of breath. Later on after leaving the vaccination site, she began to experience chills, body aches, low energy, numbness in her mouth and tongue, and electricity feeling through the legs. She reports her energy is better now but she continues to experience the other side effects. She reports the shortness of breath comes and goes and lasts about an hour when she was experiencing it. Patient mentioned she heard about some women who experienced swollen lymph nodes after receiving the covid-19 vaccine and it affected their mammograms, and some even had a biopsy done because of the test results. Patient asked should she get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: shortness of breath; chills; body aches; low energy; Numbness in her mouth and tongue; Electricity feeling through the legs; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 06Mar2021 as 1st dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received her first dose of the Pfizer-BioNTech COVID-19 vaccine on Saturday (06Mar2021). About 5 minutes after the injection while at the vaccination site, she experienced shortness of breath. Later on after leaving the vaccination site, she began to experience chills, body aches, low energy, numbness in her mouth and tongue, and electricity feeling through the legs. She reports her energy is better now but she continues to experience the other side effects. She reports the shortness of breath comes and goes and lasts about an hour when she was experiencing it. Patient mentioned she heard about some women who experienced swollen lymph nodes after receiving the covid-19 vaccine and it affected their mammograms, and some even had a biopsy done because of the test results. Patient asked should she get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchial hyperreactivity, Chest discomfort, Cough, Respiratory tract irritation
Clinical narrative: chest tightening/ feeling of fullness in my lungs; cough; feels scratchy in my lungs; Reactive Airway Disease/Asthma; Reactive Airway Disease/Asthma; This is a spontaneous report from a contactable consumer (patient). A 63-year-old (Adult 18-64 Years) non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 09Mar2021 at 11:30 (at the age of 63 years), as a single dose for COVID-19 immunisation. There was no other vaccine in four weeks. The patient's medical history was reported as Migraine disease, Fibromyalgia, Collagenous Colitis, Asthma. Concomitant medications was not reported. Other medications in two weeks was reported as Clonopam, Flexeril, Imitrex. Known allergies which includes many antibiotics, metals, latex, adhesives, molds. Prior vaccination, the patient had no covid. Post vaccination, the patient had not tested for covid. On 09Mar2021 at 02:30 PM, Patient stated that within 2 hrs of injection, felt chest tightening and a feeling of fullness in my lungs. The patient had a minor cough and tightness in the chest at bedtime. Today, my cough is more prevalent, and it feels scratchy in my lungs. It was not unbearable but is not one of the listed side-effects. The patient do suffer from Reactive Airway Disease/Asthma. The patient received treatment for adverse events which includes using my nebulizer and inhalers. Outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Heart rate, Heart rate increased, Investigation
Clinical narrative: 10 min had fast heart beat/Had spells of rapid heart rate on and off. Ended up going to ER 4 days after due to rapid heart rate; rush of heat to head; her face stayed red 45 min; This is a spontaneous report from a contactable Consumer. A 75-year-old female Consumer (patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 02Mar2021 at (at the age of 75-years-old) at single dose for COVID-19 immunization.Medical history included single kidney, hypo thyroid, cancer to both previous, childhood illnesses, acid reflux. Known allergies to Sulfa, Levaquin, seasonal allergies, adheasive, neosporin. Concomitant drugs included Levothyroxin 50 micograms, Qnoll 100mgs, Zertec 10mgs, melatonin 5mlgs, colase 100 mgs, folodadine 20mgs. After the vaccine administration on 02Mar2021 the patient had rush of heat to head - 10 min had fast heart beat maybe 30 sec then felt ok. She waited another 7 min. She told nurse she was ok nurse said they could leave. After home her face stayed red 45 min after. Had spells of rapid heart rate on and off. Ended up going to ER 4 days after due to rapid heart rate. At the ER received tests and will have to wear halter monitor for 24 hrs. The outcome of the events was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Nausea
Clinical narrative: Headache; Nausea; Lethargy; This is a spontaneous report received from a non-contactable consumer (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via unspecified route of administration in left arm on 09Mar2021 02:00 PM (at the age of 54-year-old) as 2nd dose, single dose for COVID-19 immunisation. Vaccine facility type was reported as workplace clinic. The patient's medical history was not reported. No COVID prior vaccination was reported. The patient's concomitant medications within 2 weeks included atorvastatin (LIPITOR) 40 mg, from unspecified date at 40 mg, daily. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 10Mar2021 10:00 AM the patient experienced headache, nausea, and lethargy. No treatment was received due to the events. The patient was not tested for COVID post vaccination. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Night sweats, Pyrexia
Clinical narrative: Headache; Fever; Chills; Sweating all night; This is a spontaneous report received from a contactable consumer (patient's parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6202), on 04Mar2021 (at the age of 27-year-old) as unknown, single dose for COVID-19 immunisation. Vaccine facility type was reported as workplace clinic. The patient's medical history included known allergies: seasonal allergies, mold, dust, and mites. No COVID prior vaccination was reported. No concomitant medications in two weeks were reported. Patient did not receive other vaccines in four weeks. On 05Mar2021 the patient had headache, fever, chills and sweating all night. Patient was treated due to the events with paracetamol (TYLENOL). Patient was not tested for COVID post vaccination. The outcome of the events was recovered with sequel (reported as recovered with lasting effect).  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Burning sensation, Feeling hot, Oral pruritus, Pruritus
Clinical narrative: Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; lump in throat; 2 asthma flare-ups; face swollen; itching on face, head and around eyes; itching on face, head and around eyes; Occasional waves of feeling very warm; burning feeling around elbows; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 07Mar2021 13:30, at 62 years of age, (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included contrast media allergy, asthma, hypertension, hypothyroidism, glucose tolerance impaired (pre-diabetic) and allergy to erythromycin, cefaclor (CECLOR), penicillin, cefalexin (KEFLEX), neosporine, polysporin, sulfa drugs, eggs, tree nuts, peanuts, fish, shellfish, mushrooms, mustard, chocolate, some melons, raw apples (rashes of hives reactions). The patient didn't receive any other vaccine in the four weeks previous to COVID-19 vaccine. The patient received unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested from COVID-19 post vaccination. On 07Mar2021 at 13:45 the patient experienced itching of tongue, mouth and throat, sometimes lump in throat, 2 asthma flare-ups, face swollen, itching on face, head and around eyes, occasional waves of feeling very warm and burning feeling around elbows. The patient began treatment with famotidine (PEPCID) and diphenydramine hydrochloride (BENADRYL), contacted Doctor's office, then went to ER the day before this report. The physician assistant in ER prescribed 20 mg prednisone daily for 5 days. At the time of the report the reported events had not resolved yet.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensation of foreign body, Swelling face, Throat irritation, Tongue pruritus
Clinical narrative: Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; Itching of tongue, mouth, throat; lump in throat; 2 asthma flare-ups; face swollen; itching on face, head and around eyes; itching on face, head and around eyes; Occasional waves of feeling very warm; burning feeling around elbows; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 07Mar2021 13:30, at 62 years of age, (Batch/Lot Number: EN6205) as single dose for COVID-19 immunization. Medical history included contrast media allergy, asthma, hypertension, hypothyroidism, glucose tolerance impaired (pre-diabetic) and allergy to erythromycin, cefaclor (CECLOR), penicillin, cefalexin (KEFLEX), neosporine, polysporin, sulfa drugs, eggs, tree nuts, peanuts, fish, shellfish, mushrooms, mustard, chocolate, some melons, raw apples (rashes of hives reactions). The patient didn't receive any other vaccine in the four weeks previous to COVID-19 vaccine. The patient received unspecified concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested from COVID-19 post vaccination. On 07Mar2021 at 13:45 the patient experienced itching of tongue, mouth and throat, sometimes lump in throat, 2 asthma flare-ups, face swollen, itching on face, head and around eyes, occasional waves of feeling very warm and burning feeling around elbows. The patient began treatment with famotidine (PEPCID) and diphenydramine hydrochloride (BENADRYL), contacted Doctor's office, then went to ER the day before this report. The physician assistant in ER prescribed 20 mg prednisone daily for 5 days. At the time of the report the reported events had not resolved yet.  No follow-up attempts are possible. No further information is expected.