chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lethargy, Migraine, Nasal congestion
Clinical narrative: Sore body; fever of 102 for 2 days; chills; sore throat; stuffy nose; migraine; lethargy; injection site is still sore; injection site red and hot to touch; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 11:00 as dose 2, single for COVID-19 immunization. Medical history included depression, migraine and COVID-19. The patient's concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 29Jan2021 11:00 as dose 1, single for COVID-19 immunization. Patient reported that she was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was diagnosed with COVID-19 prior to vaccination and since the vaccination, she does not have COVID-19. On 20Feb2021, patient underwent lab tests and procedures which included body temperature: 102. On 20Feb2021, patient experienced sore body, fever of 102 for 2 days, chills, sore throat, stuffy nose, migraine and lethargy. Even though fever broke after two days, still was experiencing all the other symptoms still. Also, the injection site is still sore, red and hot to touch. The patient did not receive any treatment for the events. Seriousness of the events was reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Sore body; fever of 102 for 2 days; chills; sore throat; stuffy nose; migraine; lethargy; injection site is still sore; injection site red and hot to touch; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 11:00 as dose 2, single for COVID-19 immunization. Medical history included depression, migraine and COVID-19. The patient's concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 29Jan2021 11:00 as dose 1, single for COVID-19 immunization. Patient reported that she was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was diagnosed with COVID-19 prior to vaccination and since the vaccination, she does not have COVID-19. On 20Feb2021, patient underwent lab tests and procedures which included body temperature: 102. On 20Feb2021, patient experienced sore body, fever of 102 for 2 days, chills, sore throat, stuffy nose, migraine and lethargy. Even though fever broke after two days, still was experiencing all the other symptoms still. Also, the injection site is still sore, red and hot to touch. The patient did not receive any treatment for the events. Seriousness of the events was reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: rapid heart rate; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left arm on 20Feb2021 at 16:15 (at the age of 78-years-old) as dose 1, single for COVID-19 immunisation. Medical history included stent placement (he has 3-4 stents put in), bypass surgery in Jul2019, Defibrillator/pacemaker insertion (that was implanted originally back in 2006 or 2007, for which he had the battery changed in it in 2014 maybe). Patient thinks that he was 5 feet 8 inches to 5 feet 9 inches tall, he is shrinking every year. There were no concomitant medications. On 20Feb2021 at 19:00, the patient experienced rapid heart rate. The patient was looking at a list of possible side effects for the vaccine and noticed it stated something about a rapid heartbeat, and that information was lumped in there. He says that after he had his shot which he had about at 04:15PM Saturday afternoon and then he sat there for 15 minutes he didn't experience any side effects at all. He says about 3 hours later after about 07:00 PM his heart took off, and his heart rate was 110 bpm and this lasted probably 3 hours. He says he wondered if this had anything to do with vaccine he got. The patient underwent lab tests which included heart rate: 110 bpm on an unspecified date.  It was unknown if the patient received any treatment for the event. The outcome of the event was recovered on 20Feb2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: ask if it is okay to take antibiotics prescribed by her Urologist for possible bladder infection; This is a spontaneous report from a Pfizer-sponsored program Pfizer Covax US Support. A contactable Female consumer (Patient) of unspecified age reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient asked if it is okay to take antibiotics prescribed by her urologist for possible bladder infection before the schedule of her second dose for Covid-19 vaccine on 26Feb2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: pulse rate had increased; This is a spontaneous report from a contactable consumer (Reported for himself). A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 10:00 (at the age of 47-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing (on medication). Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient previously took neomycin and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 10:45, the patient experienced pulse rate had increased. It was reported that, adverse event was very mild. Approximately 45 minutes after receiving the shot, patient noticed his pulse rate had increased. Normal RHR for patient during day is low 50s, patient fit and a runner. Patient took pulse and it was in 80s. Patient then took it every 5 min or so for another half hour and it began returning to normal. 2 hours after shot, pulse was back to normal RHR. It was not a big deal but it was something patient thought was related to response to the shot. All is well now. Dose 2 scheduled on 25Feb2021. The patient underwent lab tests and procedures which included heart rate: increased (during day is low 50s) and heart rate: 80s on 02Feb2021. No treatment was given for the events. The outcome of the event was resolved on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Discomfort, Dizziness, Fatigue, Glomerular filtration rate
Clinical narrative: dizziness; arm hurting; felt extreme discomfort; nausea; feeling sick; fatigue; headache; rapid pulse; she was in bed 13Feb21 to 15Feb21 feeling sick; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6210 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Feb2021 (age at vaccination: 73 years), as a single dose for COVID-19 immunization. The patient's medical history included diabetic, renal problems, and chronic back problems. Concomitant medications included insulin and dulaglutide (TRULICITY) both for diabetic. The patient experienced side effects such as nausea, headache, fatigue, dizziness, arm hurting the next day. She stated that she also experienced having a rapid pulse yesterday on 16Feb2021 which was a week after getting the vaccine and wanted to know if it's still ok for her to get the 2nd dose since she experienced these side effects and if having a rapid pulse was one of the normal side effects from the vaccine. Also wanted to know if there were any known interactions of the vaccine with insulin or Trulicity since she mentioned that she took Trulicity last Saturday morning and noticed that she experienced a rapid pulse the day after. The patient also felt extreme discomfort and an elevated heart rate and stated she was in bed 13Feb2021 to 15Feb2021 feeling sick. She felt better then was sick again on Sunday. The patient underwent lab tests and procedures which included glomerular filtration rate: 44 on an unspecified date in Dec2020 and heart rate increased: 119 to 120 on 22Feb2021 (Pulse rapid). The patient stated that they did not give her a second dose date. Outcome of the event she was in bed 13Feb21 to 15Feb21 feeling sick was recovered on 15Feb2021 and for all other events, it was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Nausea, Pain in extremity
Clinical narrative: dizziness; arm hurting; felt extreme discomfort; nausea; feeling sick; fatigue; headache; rapid pulse; she was in bed 13Feb21 to 15Feb21 feeling sick; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6210 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Feb2021 (age at vaccination: 73 years), as a single dose for COVID-19 immunization. The patient's medical history included diabetic, renal problems, and chronic back problems. Concomitant medications included insulin and dulaglutide (TRULICITY) both for diabetic. The patient experienced side effects such as nausea, headache, fatigue, dizziness, arm hurting the next day. She stated that she also experienced having a rapid pulse yesterday on 16Feb2021 which was a week after getting the vaccine and wanted to know if it's still ok for her to get the 2nd dose since she experienced these side effects and if having a rapid pulse was one of the normal side effects from the vaccine. Also wanted to know if there were any known interactions of the vaccine with insulin or Trulicity since she mentioned that she took Trulicity last Saturday morning and noticed that she experienced a rapid pulse the day after. The patient also felt extreme discomfort and an elevated heart rate and stated she was in bed 13Feb2021 to 15Feb2021 feeling sick. She felt better then was sick again on Sunday. The patient underwent lab tests and procedures which included glomerular filtration rate: 44 on an unspecified date in Dec2020 and heart rate increased: 119 to 120 on 22Feb2021 (Pulse rapid). The patient stated that they did not give her a second dose date. Outcome of the event she was in bed 13Feb21 to 15Feb21 feeling sick was recovered on 15Feb2021 and for all other events, it was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Throat tightness
Clinical narrative: Tightening of the throat; head discomfort; This is a spontaneous report from non-contactable consumer reported that a 69-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 15Feb2021 at 14:00 as dose number unknown, single for COVID-19 immunisation. Facility type vaccine was other. The patient's medical history included chronic cholangitis. No known allergies. Concomitant medications included levothyroxine (LEVOTHYROXINE), pancreatin (CREON), ursodiol (URSODIOL), sertraline (SERTRALINE), omeprazole (OMEPRA); all were taken for an unknown indication and from an unknown date. No other vaccine in four weeks. On 15Feb2021 at 14:00, the patient experienced tightening of the throat and head discomfort. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested post the vaccination. No treatment received for events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache, Hypokinesia, Illness
Clinical narrative: head like spinning round and round and like the room is spinning really really fast; Getting really really dizzy and it was hard to even move on that first day, I couldn't even turn my head/couldn't move her head, couldn't turn her tv on; Getting really really dizzy and it was hard to even move on that first day, I couldn't even turn my head; Sick; nausea; I couldn't lay down and I couldn't even get any rest without just getting sick all over again; sick stomach/Upset stomach; Headache; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200 and Expiration date and NDC number was unknown), via an unspecified route of administration on 18Feb2021 as dose 1, single (at the age of 73-years-old) for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included moexipril taken for blood pressure measurement, start and stop date were not reported. On 19Feb2021, the day after, the Friday, patient woke up with my head like spinning round and round and like the room was spinning really really fast. Patient was really really dizzy, and it was hard to even move on that first day. Patient stated that it was scary, and patient could not move/turn her head, could not turn her tv on, could not lay down and could not even get any rest without just getting sick all over again. On an unspecified date of 2021, patient experienced nausea and sick stomach/upset stomach. Patient asked if that was normal like she could not lay down to sleep or anything for few days finally, morning she could but she still talks to these other people. But at least patient was able to lay down her head a little bit and get some rest. But she had not been able to do that because she had been so sick and every time, she tries to put any pressure, put her head down to get some, it starts spinning. Patient asked if it was normal and should she receive the second dose, as patient mentioned that she heard that patients had more severe reactions after receiving the second dose. Patient also asked that does the first dose had some antibodies/some protection and would she be able to receive only one dose. Patient was probably 4 foot 9, well let's say 5 feet. Patient used to be 5 foot 2 so she does not know after she get older, but her weight was probably right about a 100 pounds. On an unspecified date of 2021, patient had headache. Patients stated that she does not take treatment for headache, but she does like Tylenol and the Excedrin because she kind of had a headache too and then she took Gaviscon for my upset stomach she took a couple of those. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Vertigo
Clinical narrative: head like spinning round and round and like the room is spinning really really fast; Getting really really dizzy and it was hard to even move on that first day, I couldn't even turn my head/couldn't move her head, couldn't turn her tv on; Getting really really dizzy and it was hard to even move on that first day, I couldn't even turn my head; Sick; nausea; I couldn't lay down and I couldn't even get any rest without just getting sick all over again; sick stomach/Upset stomach; Headache; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200 and Expiration date and NDC number was unknown), via an unspecified route of administration on 18Feb2021 as dose 1, single (at the age of 73-years-old) for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included moexipril taken for blood pressure measurement, start and stop date were not reported. On 19Feb2021, the day after, the Friday, patient woke up with my head like spinning round and round and like the room was spinning really really fast. Patient was really really dizzy, and it was hard to even move on that first day. Patient stated that it was scary, and patient could not move/turn her head, could not turn her tv on, could not lay down and could not even get any rest without just getting sick all over again. On an unspecified date of 2021, patient experienced nausea and sick stomach/upset stomach. Patient asked if that was normal like she could not lay down to sleep or anything for few days finally, morning she could but she still talks to these other people. But at least patient was able to lay down her head a little bit and get some rest. But she had not been able to do that because she had been so sick and every time, she tries to put any pressure, put her head down to get some, it starts spinning. Patient asked if it was normal and should she receive the second dose, as patient mentioned that she heard that patients had more severe reactions after receiving the second dose. Patient also asked that does the first dose had some antibodies/some protection and would she be able to receive only one dose. Patient was probably 4 foot 9, well let's say 5 feet. Patient used to be 5 foot 2 so she does not know after she get older, but her weight was probably right about a 100 pounds. On an unspecified date of 2021, patient had headache. Patients stated that she does not take treatment for headache, but she does like Tylenol and the Excedrin because she kind of had a headache too and then she took Gaviscon for my upset stomach she took a couple of those. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Felt tired; developed a temp of 100.4-102; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for herself that. A female patient of an unspecified age received bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date of Feb2021 the patient experienced felt tired and developed a temp of 100.4-102. The patient underwent lab tests and procedures which included body temperature: 100.4-102 on an unspecified date and sars-cov-2 test on 15Feb2021 and result was negative. The outcome of the events was unknown.   Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Nausea, Neck pain
Clinical narrative: swelling under her injection arm in the lymph nodes; arm soreness/Could not maneuver her arm which was sore; neck was a little painful; swelling under her arm; Not feeling good at all; nausea; pain in the injection arm; Injection was a quite little, felt like a sting and a burn; chills; weakness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program COVAX US support. A 69-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in Left arm on 13Feb2021 (at the age of 69-year-old) as single for vaccination. Medical history included blood pressure, cholesterol from an unknown date and unknown if ongoing, Patient was allergic to squash. Prior Vaccinations (within 4 weeks) and AEs following prior vaccinations was reported as none. Concomitant medications included hydrochlorothiazide, lisinopril 20/25mg once daily, taken for blood pressure and simvastatin taken for cholesterol 40 mg once daily, start and stop date were not reported. On 13Feb2021 the patient experienced chills, weakness and reported that injection was a quite little, felt like a sting and a burn. On 14Feb2021 she had nausea, pain in the injection arm, arm soreness/ she could not 'maneuver' her arm which was sore, side of her neck was a little painful, swelling under her arm, not feeling good at all. On 15Feb2021 she has swelling under her injection arm in the lymph nodes. The patient was administered the first dose of Pfizer COVID-19 Vaccine 13Feb2021. The injection was a quite little, felt like a sting and a burn but it was just quick. That's ok. She had cold chills though the night of 13Feb2021 and onset of sore arm night of 13Feb2021. On 14Feb2021 morning she just was not feeling good at all, could not 'maneuver' her arm which was sore. She was just feeling nauseated but she did not actually bring anything up. On 14Feb2021 night she noticed the side of her neck was a little painful and right under her arm was a painful swelling. She called to ask if these are side effects of the first dose of Pfizer COVID-19 Vaccine, what can she expect with the second dose of Pfizer COVID-19 Vaccine; will effects be the same or worse. On 15Feb2021 morning, when she got up the right under her arm was a painful swelling is there but is not as painful but it's fading out, going away. She is not having the cold chills, not having nausea, not having not feeling good at all today. The rest were kind of better today. The events not required emergency room and physician office. Outcome of the events neck was a little painful and swelling under her arm was resolving and outcome of other events was unknown.   Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Thermal burn, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling under her injection arm in the lymph nodes; arm soreness/Could not maneuver her arm which was sore; neck was a little painful; swelling under her arm; Not feeling good at all; nausea; pain in the injection arm; Injection was a quite little, felt like a sting and a burn; chills; weakness; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program COVAX US support. A 69-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in Left arm on 13Feb2021 (at the age of 69-year-old) as single for vaccination. Medical history included blood pressure, cholesterol from an unknown date and unknown if ongoing, Patient was allergic to squash. Prior Vaccinations (within 4 weeks) and AEs following prior vaccinations was reported as none. Concomitant medications included hydrochlorothiazide, lisinopril 20/25mg once daily, taken for blood pressure and simvastatin taken for cholesterol 40 mg once daily, start and stop date were not reported. On 13Feb2021 the patient experienced chills, weakness and reported that injection was a quite little, felt like a sting and a burn. On 14Feb2021 she had nausea, pain in the injection arm, arm soreness/ she could not 'maneuver' her arm which was sore, side of her neck was a little painful, swelling under her arm, not feeling good at all. On 15Feb2021 she has swelling under her injection arm in the lymph nodes. The patient was administered the first dose of Pfizer COVID-19 Vaccine 13Feb2021. The injection was a quite little, felt like a sting and a burn but it was just quick. That's ok. She had cold chills though the night of 13Feb2021 and onset of sore arm night of 13Feb2021. On 14Feb2021 morning she just was not feeling good at all, could not 'maneuver' her arm which was sore. She was just feeling nauseated but she did not actually bring anything up. On 14Feb2021 night she noticed the side of her neck was a little painful and right under her arm was a painful swelling. She called to ask if these are side effects of the first dose of Pfizer COVID-19 Vaccine, what can she expect with the second dose of Pfizer COVID-19 Vaccine; will effects be the same or worse. On 15Feb2021 morning, when she got up the right under her arm was a painful swelling is there but is not as painful but it's fading out, going away. She is not having the cold chills, not having nausea, not having not feeling good at all today. The rest were kind of better today. The events not required emergency room and physician office. Outcome of the events neck was a little painful and swelling under her arm was resolving and outcome of other events was unknown.   Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: fever; severe body aches; fatigue; This is a spontaneous report from a contactable Other Health Care Professional (HCP) (Patient) via in response to HCP follow-up letter sent in cross reference case. A 53-year-old female patient second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via intramuscular route of administration at left arm on 29Jan2021 13:00 (at the age of 53-year-old) (Lot Number: EJ1685) as single dose for COVID-19 immunisation. Patient Medical history included HBP (hypertension) and concomitant medication included hydrochlorothiazide with a daily dose of 12.5 mg for (HBP) hypertension. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration at left arm (at the age of 53-year-old) on 08Jan2021 08:15 (Lot number: EJ1685) for COVID-19 immunization and experienced headache, myalgia, chills, pyrexia and fatigue on 08Jan2021 at 12:00. On 29Jan2021 13:00, the patient received 2nd dose of vaccine and symptoms started around 30Jan2021, 03:00 (AM) early and developed severe body aches, fatigue, 100-100.2 fever which lasted until 02Feb2021. Fatigue lasted until 03Feb2021. Then all symptoms subside. The patient underwent lab tests and procedures which included body temperature: 100 - 102.2 on 30Jan2021. Patient did not visit the emergency room or physician office for the events. Patient was not admitted in the hospital and did not received any treatment for the events. Patient was not deceased. Outcome of fever and severe body aches recovered on 02Feb2021 and fatigue recovered on 03Feb2021.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: extreme shortness of breath/ongoing minor shortness of breath; This is a spontaneous report from a contactable consumer (patient himself).  A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E19267), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 as DOSE 1, SINGLE (age at vaccination was 71 years old) for covid-19 immunisation. Medical history included hypertension, depression and arthritis, all from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril, bupropion, glucosamine and multi-vit. The patient reported absolutely nothing until four days after, on 21Feb2021 04:00, he had maybe eight hours of extreme shortness of breath, followed by ongoing minor shortness of breath for another day or two. It was reported that the patient did not have Covid prior to vaccination and Covid was not tested post vaccination. The patient did not receive any other vaccination 4 weeks prior of BNT162B2. It was unknown if any treatment was provided. At the time of this report, the outcome of the event was recovering.  Follow-up attempts completed. No further information expected. .
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Immune system disorder, Malaise, Nasopharyngitis
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Jan 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 14, 2021, patient experienced cough and fatigue. On an unspecified date in 2021, patient felt sick. Patient has been sick for two or three days now. Patient didn't know if it was safe to get the COVID-19 vaccine as her immune system was down. Cold started on Sunday. The second dose was scheduled Feb 16, 2021. The outcome of events: unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: severe fatigue; acute headache; malaise; nausea; inability to perform normal duties; Heavy eyelids which resulted in patient having to rest immediately; This is a spontaneous report from a non-contactable other hcp. An adult non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 22Feb2021 08:00 (Batch/Lot number was not reported)as dose number unknown, single for covid-19 immunisation. Medical history included asthma and allergies to medications, food, or other products to Shrimp, levaquin and tequin. The patient concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 10:00, after 2nd hour post vaccine, the patient experienced severe fatigue, acute headache, malaise, nausea, inability to perform normal duties and heavy eyelids which resulted in patient having to rest immediately. Therapeutic measures were taken as a result of the events (Tylenol, extra fluids). The clinical outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: severe fatigue; acute headache; malaise; nausea; inability to perform normal duties; Heavy eyelids which resulted in patient having to rest immediately; This is a spontaneous report from a non-contactable other hcp. An adult non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 22Feb2021 08:00 (Batch/Lot number was not reported)as dose number unknown, single for covid-19 immunisation. Medical history included asthma and allergies to medications, food, or other products to Shrimp, levaquin and tequin. The patient concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Feb2021 10:00, after 2nd hour post vaccine, the patient experienced severe fatigue, acute headache, malaise, nausea, inability to perform normal duties and heavy eyelids which resulted in patient having to rest immediately. Therapeutic measures were taken as a result of the events (Tylenol, extra fluids). The clinical outcome of the events were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: She reported over 102.8 fever with chills and nausea; She reported over 102.8 fever with chills and nausea; She reported over 102.8 fever with chills and nausea; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 17Feb2021 (at the age of 40 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies were reported. The patient had no allergy to medications, food, or other products. The patient did not have Covid prior vaccination and Covid tested post vaccination. No other vaccines were received within four weeks prior to the administration of bnt162b2. The patient previously took bnt162b2 (Batch/Lot Number: unknown) on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medications were not reported. On 20Feb2021, the patient experienced over 102.8 fever with chills and nausea. She said she started experiencing these symptoms 4 days after vaccination. She tested negative for COVID-19. On 21Feb2021, the patient underwent rapid covid test post vaccination with covid test type nasal swab: negative. Treatment received was unknown. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Terrible dizziness; numbness on tips middle 4th and 5 finger on 2/20.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 20Feb2021 08:00 (age at the time of vaccination was 66 years) as dose 1, single for covid-19 immunisation at hospital. Medical history included rheumatoid arthritis, asthma, no spleen born without, allergies to stone crab claws and Azulfadine both from an unknown date and unknown if ongoing. Concomitant medications within 2 weeks of vaccination included methotrexate (METHOTREXATE) 12.5 mg and infliximab (REMICADE) IV 1/12/21 both taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Feb2021 09:15, the patient experienced terrible dizziness and numbness on tips middle 4th and 5 finger on 2/20. Since the vaccination, has the patient has not been tested for COVID-19. It was reported that no treatment was received for the adverse events. The case was non-serious with Seriousness criteria-Results in death/ Seriousness criteria-Life threatening/ Seriousness criteria caused/prolonged hospitalization/Seriousness criteria Disabling /Incapacitating/ Seriousness criteria-Congenital anomaly/birth defect were reported as No. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Intense arm and muscle pain; Intense arm and muscle pain; intense headaches for 3 days. Still have headache, on day 4; This is a spontaneous report from a non-contactable consumer (patient). An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 18Feb2021 at 13:00 hours (Batch/Lot Number: EL9267) as DOSE1, SINGLE for COVID-19 immunisation. The patient's medical history included allergies: sulfa from an unknown date and unknown if ongoing. Concomitant medications included preventative sodium, and hydrochlorothiazide. On 18Feb2021 at 08:00 PM, the patient experienced intense arm and muscle pain, and intense headaches for 3 days. The patient reported that she still has headache, on day 4, rest going away. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the adverse event. The events were non serious and did not result in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. The patient was recovering from the events.  No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I have raised itchy clusters of bumbs on my left arm, left leg, genitals, right ear, and fingers.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 36-year-old) (Batch/Lot Number: EL9264) as dose 2, single for covid-19 immunisation. Medical history included migraine, colitis ulcerative, anxiety and depression. The patient had no known allergies. Concomitant medications included azathioprine (IMURAN [AZATHIOPRINE]) and infliximab (RENFLEXIS [INFLIXIMAB]) taken for an unspecified indication, start and stop date were not reported.The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 15:30 (Batch/Lot Number: EL3302) as dose 1, single for covid-19 immunisation. On 20Feb2021 09:00, the patient experienced raised itchy clusters of bumbs on his left arm, left leg, genitals, right ear, and fingers. They are beginning to puss and are very itchy. It feels like poison ivy, but he have not been any where near the woods this winter. Therapeutic measures were taken as a result of the event (Benadryl). The clinical outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Fatigue, Migraine, Myalgia
Clinical narrative: Extreme joint pain; fever; blurry eyesight; confusion; severe sensitivity to light; migraine headache; sore muscles; extreme tiredness; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: en6200) via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included migraines. The patient had allergies to medications, food, or other products such as Penicillin, pineapple, gold, lanolin, hair dye. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: el8982) via an unspecified route of administration, administered in Arm Left on 25Jan2021 09:15 (at the age of 41-year-old) as single dose for COVID-19 immunization. Since 19Feb2021 04:00, the patient experienced extreme joint pain, fever, blurry eyesight, confusion, severe sensitivity to light, migraine headache, sore muscles, extreme tiredness lasting 3 days. Joint pain subsided after 30 hours. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered with sequelae in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, Vision blurred
Clinical narrative: Extreme joint pain; fever; blurry eyesight; confusion; severe sensitivity to light; migraine headache; sore muscles; extreme tiredness; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: en6200) via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included migraines. The patient had allergies to medications, food, or other products such as Penicillin, pineapple, gold, lanolin, hair dye. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: el8982) via an unspecified route of administration, administered in Arm Left on 25Jan2021 09:15 (at the age of 41-year-old) as single dose for COVID-19 immunization. Since 19Feb2021 04:00, the patient experienced extreme joint pain, fever, blurry eyesight, confusion, severe sensitivity to light, migraine headache, sore muscles, extreme tiredness lasting 3 days. Joint pain subsided after 30 hours. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was recovered with sequelae in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in armpit of left arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in arm left on 20Feb2021 11:30 (at the age of 59-year-old) at dose 2, single for covid-19 immunisation. Medical history included penicillin allergy. Concomitant medications included losartan (LOSARTAN); simvastatin (SIMVASTATIN); ibuprofen (IBUPROFEN); mometasone furoate (FLONASE [MOMETASONE FUROATE]) (medications the patient received within 2 weeks of vaccination) all drugs taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in arm left on an unspecified date in Jan2021 14:30 at dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Feb2021 09:00 the patient experienced swollen lymph node in armpit of left arm. Patient did not receive treatment for the adverse event. Outcome of the event was resolving.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Illness
Clinical narrative: I was a little sick from the chest with cough; Cough; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. During the call the patient stated, who got the first dose of the pfizer vaccine and they told to wait two weeks. But to get the second dose, but it turns out that when went to get the second dose the patient was a little sick from the chest with cough (occurred on 12Feb2021). The nurse told to wait, to consult with the doctor to see if could put it back on, and felt better today who went to put it on the second dose but there was nothing, and everyone has left here. The outcome of events was recovering.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: numbness in fingers and hands on the right side where she received the vaccine,; Arm was extremely sore; bad headache; This is a spontaneous report from a contactable consumer, the patient.  A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration on 20Feb2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. The patient stated that, yesterday evening, on 21Feb2021, she developed numbness in fingers and hands on the right side where she received the vaccine, and one of her fingers felt like rubber, basically had no control over it. On an unspecified date in Feb2021, her arm was extremely sore and she had a bad headache all day, laid down early. She reported that she could not pick up phone in the middle of the night. The outcome of the events was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.