chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: feeling really weak; feeling so run down; real bad headache; aches and pains; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis and asthma both were ongoing. There were no concomitant medications. The patient reported 10 minutes after receiving the COVID-19 Vaccine on 12Jan2021 he developed a real bad headache. He said his headache was followed by aches and pains, nausea, and some diarrhea. Clarified by Saturday, 16Jan2021, his symptoms had mostly cleared up. He was feeling really weak on 13Jan2021. His doctor checked him over on his 13Jan2021 appointment. He said his doctor told him there had been a lot of reports of side effects from the COVID-19 Vaccine. He said his doctor wanted him to just keep an eye on if any symptoms got worse. He said from 13Jan2021 his headaches were starting to go away, and were less frequent. He said from 13Jan2021 he was still feeling pretty achy, and had occasional diarrhea. He said by 16Jan2021 his headache, ache, pain, nausea, and diarrhea had resolved. He said he was still feeling really weak. He said he was feeling really run down on 13Jan2021, so went to his doctor again on 19Jan2021, and was given a B12 shot. He was told to stay home from work on 20Jan2021. Reported he went back to work on 21Jan2021, and 22Jan2021. He said he was told by his boss that he needed to report his side effects from the COVID-19 Vaccine. Reported he was scheduled to receive his second COVID-19 Vaccine shot on 02Feb2021. He asked if he should go for his second vaccine dose or should he wait. Reported he did not have any blood work performed when he went to the doctor on 13Jan2021 and 19Jan2021. The facility where the vaccine was administered was in a Public Health Department. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events resulted to a physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events headache, aches and pain, nausea, and diarrhea on 16Jan2021; feeling really weak in Jan2021 and outcome of the other event was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: feeling really weak; feeling so run down; real bad headache; aches and pains; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231) via an unspecified route of administration on the right arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis and asthma both were ongoing. There were no concomitant medications. The patient reported 10 minutes after receiving the COVID-19 Vaccine on 12Jan2021 he developed a real bad headache. He said his headache was followed by aches and pains, nausea, and some diarrhea. Clarified by Saturday, 16Jan2021, his symptoms had mostly cleared up. He was feeling really weak on 13Jan2021. His doctor checked him over on his 13Jan2021 appointment. He said his doctor told him there had been a lot of reports of side effects from the COVID-19 Vaccine. He said his doctor wanted him to just keep an eye on if any symptoms got worse. He said from 13Jan2021 his headaches were starting to go away, and were less frequent. He said from 13Jan2021 he was still feeling pretty achy, and had occasional diarrhea. He said by 16Jan2021 his headache, ache, pain, nausea, and diarrhea had resolved. He said he was still feeling really weak. He said he was feeling really run down on 13Jan2021, so went to his doctor again on 19Jan2021, and was given a B12 shot. He was told to stay home from work on 20Jan2021. Reported he went back to work on 21Jan2021, and 22Jan2021. He said he was told by his boss that he needed to report his side effects from the COVID-19 Vaccine. Reported he was scheduled to receive his second COVID-19 Vaccine shot on 02Feb2021. He asked if he should go for his second vaccine dose or should he wait. Reported he did not have any blood work performed when he went to the doctor on 13Jan2021 and 19Jan2021. The facility where the vaccine was administered was in a Public Health Department. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events resulted to a physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No relevant tests done. The patient recovered from the events headache, aches and pain, nausea, and diarrhea on 16Jan2021; feeling really weak in Jan2021 and outcome of the other event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Hepatic enzyme increased, Liver function test, Myalgia
Clinical narrative: myalgia; joint pain; 103 F fever for 6 days; elevated liver enzymes; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the 2nd dose of the vaccine on 12Jan2021 and had myalgia, joint pain, and 103 F fever for 6 days (Jan2021). The patient also had an elevated liver enzymes (Jan2021) and a negative hepatitis serology result. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Serology test
Clinical narrative: myalgia; joint pain; 103 F fever for 6 days; elevated liver enzymes; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the 2nd dose of the vaccine on 12Jan2021 and had myalgia, joint pain, and 103 F fever for 6 days (Jan2021). The patient also had an elevated liver enzymes (Jan2021) and a negative hepatitis serology result. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Night sweats
Clinical narrative: Significant chills; Spiked a fever (100 F at peak); Night sweats; Joint/muscle aches; Joint/muscle aches; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported), intramuscularly on the left arm on 19Jan2021 (18:00) at a single dose for COVID-19 immunization at the public health clinic. Medical history included diabetes type II, asthma, high cholesterol and sulfa allergy. Concomitant medications included metformin, montelukast, finasteride, atorvastatin, cetirizine and fluticasone propionate (FLUTICASON). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported), intramuscularly on the left arm on 28Dec2020 (when the patient was 38 years old) for COVID-19 immunization. On 20Jan2021 (06:00), the patient had joint/muscle aches. On 20Jan2021 (19:30), the patient had significant chills for "about 15 minutes"; had spiked a fever (100 F at peak); and had night sweats. The patient had not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021 for 'joint aches', 'significant chills' and 'night sweats'; was recovered on 21Jan2021 for 'spiked a fever'; and was recovering for 'muscle aches'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Significant chills; Spiked a fever (100 F at peak); Night sweats; Joint/muscle aches; Joint/muscle aches; This is a spontaneous report from a contactable healthcare professional (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported), intramuscularly on the left arm on 19Jan2021 (18:00) at a single dose for COVID-19 immunization at the public health clinic. Medical history included diabetes type II, asthma, high cholesterol and sulfa allergy. Concomitant medications included metformin, montelukast, finasteride, atorvastatin, cetirizine and fluticasone propionate (FLUTICASON). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported), intramuscularly on the left arm on 28Dec2020 (when the patient was 38 years old) for COVID-19 immunization. On 20Jan2021 (06:00), the patient had joint/muscle aches. On 20Jan2021 (19:30), the patient had significant chills for "about 15 minutes"; had spiked a fever (100 F at peak); and had night sweats. The patient had not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021 for 'joint aches', 'significant chills' and 'night sweats'; was recovered on 21Jan2021 for 'spiked a fever'; and was recovering for 'muscle aches'. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report from a non-contactable consumer. An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 for COVID-19 immunization. The most recent COVID-19 vaccine was administered in a hospital facility. On an unspecified date, the patient experienced chills. Therapeutic measures were taken as a result of the event which included ibuprofen (ADVIL). The event was considered non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Pain
Clinical narrative: Temperature of 102; body aches; chills; headache; This is a spontaneous report from a contactable nurse (patient herself).  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported.  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 hasn't been tested for COVID-19. the patient was not pregnant. Concomitant medication included celecoxib (CELEXA) and vitamin D.  The patient previously took stadol and experienced allergies. Patient previously received the first dose of bnt162b2 (lot number: EJI1686) on 29Dec2020 via intramuscular in the right arm for covid-19 immunization and experienced Right sided supraclavicular lymph node enlargement and pain.  On 20Jan2021 01:00, 24 hours after the vaccine administration, the patient had a temperature of 102 body aches, chills and headache. The outcome of events was reported as "recovering". The patient did not receive any treatment for the events. the events were considered as non-serious.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Myalgia, Peripheral swelling
Clinical narrative: have a situation on my arm. it is swollen, hot, and the size of 2 o3 half dollars put together; have a situation on my arm. it is swollen, hot, and the size of 2 o3 half dollars put together; headache; tiredness; muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. It was reported that the patient had a situation on her arm, it was swollen, hot and the size of 2 "o3 half dollars" put together on 14Jan2021. It was also reported that the patient experienced headache, tiredness  and muscle pain on 14Jan2021. Outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Dizziness, Nausea, Vaccination site pain
Clinical narrative: Stomach hurt/stomach pain; feels like throwing up/Nausea/feels nauseous/sick to her stomach; some pain after inoculation in her arm at the site; dizzy; This is a spontaneous report received from a contactable consumer. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), intramuscular in the left arm, on 21Jan2021 13:00, at 0.3 mL, single, for COVID-19 immunization. Medical history included "kashi disease" which the reporter further explained as a rare disease that affects shape of red blood cells and has to do with spleen; and brittle bones (pending clarification). Concomitant medications included an unspecified infusion which the patient has to go to every other week (also reported as every two weeks) for "kashi disease" and unspecified medications for brittle bones (pending clarification). The patient did not have any other recent vaccinations. On 21Jan2021, the patient had some pain after inoculation in her arm at the site, was a bit dizzy and had stomach issues which started at night. The patient started feeling "stomach hurt"/stomach pain or sick to her stomach on 21Jan2021 at around 23:00 (reported as "11:00PM-12:00PM"), experienced nausea/felt nauseous, stomach pain, and felt like throwing up. The patient still has that in the morning of 22Jan2021. It was reported that they were not treating the stomach pain with anything. The patient's dizziness went away. The reporter wanted to know if the patient would get the same side effects after the second shot. It was also reported that they check the patient's blood once a month doing labs, results were unknown. The outcome of dizziness was resolved on an unspecified date; "stomach hurt/stomach pain" and nausea were not recovered; and vaccination site pain was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Joint effusion
Clinical narrative: right knee was swollen like there is "water on his knee"; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Jan2021 11:00 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received the COVID-19 vaccine yesterday at 11AM (21Jan2021). This morning (22Jan2021), he woke up and his right knee was swollen like there is "water on his knee". He doesn't know any other problems that may have caused it aside from the vaccine. He was wondering if this is a side effect of the vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenitis, Lymphadenopathy, Ultrasound scan
Clinical narrative: large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm; large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm; fatigue; This is a spontaneous report from a contactable consumer reporting for a female patient (daughter). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown) via an unspecified route of administration in the right arm on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date via unspecified route of administration in the right arm at single dose for covid-19 immunization. She received both shots (first and second dose) in the same arm. The reporter stated that patient (daughter) took her second shot (Covid-19 Vaccine by Pfizer) on unspecified date (reported as "this past Tuesday") and the next morning she woke up with a large inflamed swollen lymph nodes under her arm; upper arm but certainly it's in her armpit side. Reporter wanted to know how long the lymph nodes will just take swollen. The event was further described as extremely swollen large lymph node under the right arm. This happened on unspecified date, reported as the night patient received the vaccine (also reported as occurred the next morning). She did have additional side effects such as fatigue but no fever, no diarrhea, no upset stomach. Fatigue to the point she couldn't go to work on the day after receiving the vaccine. The fatigue passed but not the swollen lymph nodes. Patient went to see the doctor and said it could be a possible side effect of the vaccine or something else. Ultrasound was performed on unspecified date with unknown results. No treatment was received for the event (not at this time) but patient has been to physician.  The outcome of the event "large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm" was not recovered. Outcome of the event fatigue was recovered on unspecified date.   Information about lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen axillary lymph on left arm; low grade fever (daily average: 97.3. For 24 hours following injection was 99.8); Significant lethargy; "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4176), via an unspecified route of administration in the left arm on 20Jan2021 at 07:00 at a single dose in the hospital for covid-19 immunization. Medical history included hyperlipidaemia, depressive disorder, chronic anxiety disorder, hypertensive, allergies to PCN (anaphylactic) and sulfa (allergic). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin (LIPITOR [ATORVASTATIN]), escitalopram oxalate (LEXAPRO), losartan, and Mg/Ca supplement. The patient experienced swollen axillary lymph on left arm, "railroad spike" headaches that correlate with the right parietal and right occipital lasting approx 30 hours, low grade fever (daily average: 97.3. For 24 hours following injection was 99.8), and significant lethargy on an unspecified date. The patient did not receive treatment for the events. Outcome of the event headache was recovered and for other events was reported as recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Vaccination site pain
Clinical narrative: feeling like I had the flu without the high fever; had a very bad headache; soreness in the arm where I received the shot; This is a spontaneous report from a contactable consumer reported for self. This 65-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL8982) at single dose in right arm on 20Jan2021 at 10:30 AM for COVID-19 immunization. Medical history included hypothyroidism. Allergies to medications, food, or other products were unknown. Concomitant medications included duloxetine; levothyroxine; montelukast; trazodone. 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 had not been tested for COVID-19. Patient felt fine the day she received the vaccine, with only soreness in the arm where she received the shot. The next day at 11:00 AM, she started feeling like she had the flu without the high fever. The worse symptom was that she had a very bad headache. These symptoms were continuing 48 hours after the vaccine was administered. She was generally very healthy, had a very active life, and didn't get headaches. She was rarely sick. She just didn't seem to be feeling any better. Seriousness was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. There was no treatment received for the adverse events. The adverse events was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 antibody test positive, SARS-CoV-2 test positive
Clinical narrative: covid test came back positive; covid test came back positive; This is a spontaneous report from a contactable other hcp (patient). The patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 17Dec2020 (first dose) and 07Jan2021 (second dose) at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported "I am a healthcare professional and I have had both doses of the vaccine (17Dec and 07Jan). I was scheduled for surgery this past Wednesday but it was cancelled as my covid test came back positive. I have no symptoms. I was advised to get antibody testing. This showed I have antibodies for both IgG and IgM. I was still told I cannot have the surgery. " The outcome of the events was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: headache; chills; muscle ache; Fatigue; pain at injection site; This is a spontaneous report from a contactable consumer.   A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration left arm single dose on 21Jan2021 10:00 for covid-19 immunisation. No other vaccine was received in four weeks.  Medical history included renal cancer (currently no evidence of disease), migraine with aura, irritable bowel syndrome, attention deficit hyperactivity disorder, cyclothymic disorder. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), Hemp-derived CBD/CBG, magnesium, polycarbophil calcium (FIBER). The patient had allergy to clindamycin and azithromycin. The patient experienced headache on 21Jan2021 13:00, chills on 21Jan2021 13:00, muscle ache on 21Jan2021 13:00, fatigue on 21Jan2021 13:00, pain at injection site on 21Jan2021 13:00.  No treatment administered. The events outcome was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: minor discomfort on the injection site; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included ongoing discomfort on her lower back/back pain (prior to getting the shot).  Concomitant medications included levothyroxine sodium (SYNTHROID), rosuvastatin calcium (CRESTOR), ibuprofen (ADVIL) for discomfort on her lower back and naproxen for discomfort on her lower back.  The patient reported that she received her first dose of COVID-19 vaccine on Sunday. The patient experienced minor discomfort on the injection site on 17Jan2021, she barely noticed it. She had no other side effects. She does experience back pain, but this was prior to getting the shot and the pain is still the same as it always has been. She took two Advil on 22Jan2021 and asked if it will have an impact on the efficacy of her vaccination. She usually takes Advil or naproxen, as needed, for discomfort on her lower back (not associated to the COVID-19 vaccine). Prior to the shot he didn't take anything, no Advil or ibuprofen. The patient recovered from the event on 18Jan2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus
Clinical narrative: feeling itchy; itch could possibly be from dry skin; This is a spontaneous report from a contactable consumer.   A 75-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown, via an unspecified route of administration single dose on 17Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced feeling itchy on Jan2021, itch could possibly be from dry skin on Jan2021. The outcome was unknown.    Information on Lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: headache; nausea; fatigue; site injection pain, red and swollen; site injection pain, red and swollen; site injection pain, red and swollen; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiry date unknown), intramuscular on the left arm on 12Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome. Concomitant medications included metformin, vitamin D [vitamin D NOS], and unspecified birth control. Patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 14Jan2021, the patient experienced headache, nausea, fatigue, injection site pain, red and swollen. Outcome of the events was recovered with sequelae. The events were reported as non-serious. No treatment was received for the adverse events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: headache; nausea; fatigue; site injection pain, red and swollen; site injection pain, red and swollen; site injection pain, red and swollen; This is a spontaneous report from a contactable healthcare professional (patient). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiry date unknown), intramuscular on the left arm on 12Jan2021 15:30 at a single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome. Concomitant medications included metformin, vitamin D [vitamin D NOS], and unspecified birth control. Patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 14Jan2021, the patient experienced headache, nausea, fatigue, injection site pain, red and swollen. Outcome of the events was recovered with sequelae. The events were reported as non-serious. No treatment was received for the adverse events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypersensitivity, Lacrimation increased, Sneezing, Upper-airway cough syndrome
Clinical narrative: Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat and sneezing; Allergies and nasal drip in back of throat and sneezing; Eyes watering; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 20Jan2021 at 08:40 at 0.3 mL, single on arm left for covid-19 immunisation. Medical history included high blood pressure diagnosed for a while.  Historical vaccine included flu shot for immunization and experienced allergies. Concomitant medication included hydrochlorothiazide/lisinopril and ascorbic acid/ betacarotene/ biotin/ calcium/ chromium/ colecalciferol/ copper/ folic acid/ iodine/ iron/ lycopene/ magnesium/ manganese/ nicotinamide/ pantothenic acid/ phosphorus/ phytomenadione/ potassium/ pyridoxine hydrochloride/ retinol/ riboflavin/ selenium/ vitamin b1 nos/ vitamin b12 nos/ vitamin e nos/ xantofyl/ zinc (CENTRUM SILVER). Patient had the first Pfizer vaccine on Wednesday, 20Jan2021 at about 8:40AM, yesterday (22Jan2021) she started with allergies and nasal drip in back of throat, eyes watering and sneezing around 10 AM. Stated that this was normal for her to have these allergies this time of the year. Caller reports Temperature of 99.8, "not feverish", no nausea. Caller wanted to know if she was contagious because of the vaccine, if it was possible the vaccine triggered her allergies. States she was just wanting to know if she was able to go to work tomorrow. Caller said "the first time i got the flu shot, it triggered my allergies real bad". Patient was treated symptoms with diphenhydramine hydrochloride (BENADRYL) and stated it got better with the diphenhydramine hydrochloride. Outcome of the events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his wife experiencing some pain in her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some pain in arm on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Rash
Clinical narrative: fatigue; chills; headache; a rash from her face to her waist; fever; pain at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 53-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported), via an unspecified route of administration on 20Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten sensitivity; she develops a rash when she eats gluten. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was either EJ7685 or EJ1685, expiry date: not reported), via an unspecified route of administration on 30Dec2020 at a single dose on right deltoid for COVID-19 immunization and experienced pain at injection site; patient was 53-year-old at the time of vaccination. The patient received the second dose of the COVID vaccine on 20Jan2021. On 21Jan2021, she experienced fatigue, fever, chills, headache, which have resolved. However, on 21Jan2021 later in the evening she broke out in a rash. She reported that she is gluten sensitive. She asked if there is any gluten involved in the 2nd dose and if they do grow anything for the serum that might be gluten contained. The patient also experienced pain at injection site with second dose on 21Jan2021. She experienced fever, chills, headache and fatigue. She has a rash from her face to her waist. She has a gluten sensitivity and develops a rash when she eats gluten. She didn't see it on the information sheet. She is wondering if any aspect of the vaccine was grown containing grain. She will be seeing her doctor on Monday. She has a fever where she takes her temperature on the skin that is elevated with the rash. She does not have a fever on the areas that she does not have a rash. She noticed the rash late on 21Jan2021. She had a long sleeve on during the day. She still has chills at night. The patient reported the events as non-serious. Outcome of the event fatigue was recovered on 22Jan2021, of headache was recovered on an unspecified date, in Jan2021 of chills and pain at injection site was recovering, while outcome of other events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fatigue; chills; headache; a rash from her face to her waist; fever; pain at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 53-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: not reported), via an unspecified route of administration on 20Jan2021 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten sensitivity; she develops a rash when she eats gluten. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was either EJ7685 or EJ1685, expiry date: not reported), via an unspecified route of administration on 30Dec2020 at a single dose on right deltoid for COVID-19 immunization and experienced pain at injection site; patient was 53-year-old at the time of vaccination. The patient received the second dose of the COVID vaccine on 20Jan2021. On 21Jan2021, she experienced fatigue, fever, chills, headache, which have resolved. However, on 21Jan2021 later in the evening she broke out in a rash. She reported that she is gluten sensitive. She asked if there is any gluten involved in the 2nd dose and if they do grow anything for the serum that might be gluten contained. The patient also experienced pain at injection site with second dose on 21Jan2021. She experienced fever, chills, headache and fatigue. She has a rash from her face to her waist. She has a gluten sensitivity and develops a rash when she eats gluten. She didn't see it on the information sheet. She is wondering if any aspect of the vaccine was grown containing grain. She will be seeing her doctor on Monday. She has a fever where she takes her temperature on the skin that is elevated with the rash. She does not have a fever on the areas that she does not have a rash. She noticed the rash late on 21Jan2021. She had a long sleeve on during the day. She still has chills at night. The patient reported the events as non-serious. Outcome of the event fatigue was recovered on 22Jan2021, of headache was recovered on an unspecified date, in Jan2021 of chills and pain at injection site was recovering, while outcome of other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: numbness to her knees/feeling soft bilaterally and symmetrically/ wearing tights; weakness in her legs; This is a spontaneous report from a contactable physician (patient's daughter). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Medical history included hernia, and herniated disc in her cervical spine, but she was fine prior. The patient's concomitant medications were not reported. On 13Jan2021, her mom started to experience numbness to her knees and it was described as "feeling soft bilaterally and symmetrically"; the feeling was described as "wearing tights", the patient also had a little weakness in her legs. On 16Jan2021, the symptoms were at its worst and on 18Jan2021, her mom started to feel better. Her mom was taking Motrin and Ibuprofen. She didn't have any other symptoms. It was symmetrical and bilateral on both legs. The Physician wanted to know if this has been seen in any other patients and was it safe to get the second vaccine. The outcome of the events was recovering. Information on the Lot/Batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product use issue
Clinical narrative: Lymph Nodes in armpits; COVID-19 vaccine was administered on the same date as the other vaccine; This is a spontaneous report from a contactable consumer (patient himself). A 74-year-old male patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 17Jan2021 at 07:45 at a single dose for COVID-19 immunization. The first dose of another vaccine (unspecified trade name; reported product: "Phizer," lot number and expiration date were unknown) was also administered on the same date on 17Jan2021, via an unspecified route of administration on the left arm at unknown dosage and frequency for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history was not reported. Concomitant medication included morniflumate (FLOMAX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 at 07:45, the patient experienced lymph nodes in armpits, which was considered as non-serious. COVID-19 vaccine was administered on the same date as the other vaccine on 17Jan2021. The patient did not receive any treatment for the adverse event "lymph nodes in armpits." The patient was not recovered from the event lymph nodes in armpits.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; This is a spontaneous report from a contactable consumer (patient's spouse). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 in 2020 wherein the reporter and the patient had it last year. The patient's concomitant medications were not reported. The patient experienced fever with outcome of recovering. She already took TYLENOL to treat her fever. It was queried if the patient can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The patient was a nurse, she got the Pfizer vaccine yesterday on 21Jan2021, that at 3am this morning (22Jan2021), she had a 101 degree temperature, a 100 degree temperature at 8AM and a while ago it was 99.9 degrees at around 9:30 this morning. The reporter wanted to known if these were expected and what they should do. The reporter mentioned that his wife's case was not so bad, states that he himself was in the unit for some weeks. The patient also had fatigue 22Jan2021 with outcome of not recovered.  Information about Lot/Batch has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of BNT162B2 (lot number: EL1283 and expiry date was unknown), via an unspecified route of administration in the left arm on 10Jan2021 08:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included asthma. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot no. and expiry date were unknown) in the left arm on 21Dec2020 12:00 PM for Covid-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Jan2021 at 08:30 AM, the patient experienced severe headache for 12 days, nausea, body aches, severe prolonged fatigue, swollen underarms, fever for 7 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included fluids and analgesics round the clock. The patient underwent laboratory test which included Covsars2 swab/nasal swab on 13Jan2021 and the result was negative. The events recovered with sequelae.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling
Clinical narrative: Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of BNT162B2 (lot number: EL1283 and expiry date was unknown), via an unspecified route of administration in the left arm on 10Jan2021 08:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included asthma. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot no. and expiry date were unknown) in the left arm on 21Dec2020 12:00 PM for Covid-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Jan2021 at 08:30 AM, the patient experienced severe headache for 12 days, nausea, body aches, severe prolonged fatigue, swollen underarms, fever for 7 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included fluids and analgesics round the clock. The patient underwent laboratory test which included Covsars2 swab/nasal swab on 13Jan2021 and the result was negative. The events recovered with sequelae.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller stated that she tested positive for the Covid Virus after she received her first dose of the vaccine; Caller stated that she tested positive for the Covid Virus after she received her first dose of the vaccine; This is a spontaneous report from a contactable consumer reporting for the mother. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller, calling on behalf of mother, wanted to know if she should receive her second vaccine today while positive for the Covid Virus. Caller stated that she tested positive for the Covid Virus after she received her first dose of the vaccine. The outcome of the events was unknown.  Information on lot number/batch number has been requested.