chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Moderate hives head to toe x 7 days; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3248) via an unspecified route of administration administered in left arm on 21Jan2021 at 18:00 (at 59 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included multivitamin, calcium, magnesium, zinc, and vitamin D3, all from unspecified date for unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER5730) via an unspecified route of administration administered in left arm on 31Dec2020 at 15:45 (at 59 years old) as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient experienced moderate hives head to toe x 7 days on 23Jan2021 at 18:00. The event resulted in physician office and emergency room visit. The event was considered medically significant. Treatment for the event included methylprednisolone sodium succinate (SOLU MEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) via intravenous twice. Outcome of the event was recovered on unspecified date.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on reported event cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint effusion, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: joint effusion/knee filled back up with fluid again; severe right knee pain; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (non-pregnant) received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ3249), intramuscular, administered in the right arm, on 21Jan2021 16:00 (at the age of 40-years) as single dose for COVID-19 immunisation. The patient was vaccinated at the workplace clinic. Medical history included arthritis, insomnia, Lyme disease, and chronic dry eye. The patien has no known allergies. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks but had other vaccine in two weeks. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), intramuscular, administered in the right arm, on 30Dec2020 11:30 (at the age of 40-years) for COVID-19 immunisation. 48 hours after her second Pfizer COVID vaccine, on 23Jan2021 at 04:00 PM, she woke up with severe right knee pain. She had to lift her leg off the bed. Three days later, she had it looked at by an orthopedic PA and was told that she had a joint effusion and if it doesn't get better to come back in 2 weeks. After 2 weeks, she then had to get a joint aspiration and they pulled out 36 ml's out of her right knee. Her knee didn't get better after that, so an MRI was done (on unspecified date in 2021), and it showed that her knee filled back up with fluid again. She is now being referred to (institution name) for a recurrent joint effusions s/p Pfizer COVID vaccine. She will have to fly for that appointment. Prior to vaccine, she didn't fall or have any trauma to her knee. The patient was tested for COVID via nasal swab post vaccination, had negative results on 12Jan2021, 17Jan2021, 26Jan2021, and 09Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. Treatments received were knee arthrocentesis and PRP injection. The outcome of the events was not recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, Palpitations
Clinical narrative: palpitations; chest pain; high heart rate; This is a spontaneous report from a contactable other HCP. This Other HCP (patient) reported for herself that a 38-years-old female (Non-pregnant) patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL3248), (at the age of 38-years-old) via intramuscular route of administration in right arm on 01Feb2021 at 15:15 as dose 1, single for COVID-19 immunisation. Vaccine was facilitated in hospital. The patient's medical history and concomitant medications were not reported. She had no known allergies. Neither other vaccine in four weeks nor other medications in two weeks were received by patient. On 01Feb2021 at 15:15, the patient experienced palpitations, chest pain and high heart rate. Patient visited emergency room and physician office due to events. Neither prior vaccination nor post vaccination, patient tested for covid. The patient did not received treatment for adverse event. The outcome of the adverse events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Dysgeusia, Fatigue, Headache
Clinical narrative: headache; chills; sore muscles all over; sore throat with redness; sore throat with redness; sore arm; metallic taste still present; sore; fatigue; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6204) via an unspecified route of administration, administered in right arm on 16Mar2021 at 12:00 (at 43 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included meloxicam, triamterene, omeprazole, estradiol, and zolpidem; all from unspecified date for unspecified indication. The patient did not have COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination. The patient experienced sore and fatigue, both on 16Mar2021 at 12:00. The patient had metallic taste still present on 25Mar2021. The patient also had headache, chills, sore muscles all over, sore throat with redness, sore throat with redness, and sore arm; all on 26Mar2021. The events resulted in physician office and emergency room visit. The events were considered medically significant. The course of event was reported as follows: The patient reported that day after the first shot, she was sore and fatigued. Then 9 days after started with a metallic taste. On Day 10, severe headache, chills, fatigue, sore arm, sore muscles all over, sore throat with redness. All lasted for 48 hours. At the time of report, metallic taste still present and the patient was still recovering from the side effects. In 10 days after getting shot, 3 doctor visits, 2 rapid test (both were negative), negative flu test, negative strep test, intravenous (IV) with 2 bags of fluids meds, a third covid shot and blood work. The doctor sent off to have checked and awaiting on those results to come back at the time of report. The patient also added "I was told 16 strands that the test were testing for and it's believed I have one of those strands. With a negative result I've missed so much already what is my employer doesn't pay me?" (as reported). Three nasal swabs (rapid) on unspecified dates were negative. On 23Mar2021, blood test (regular test) was performed (pending results). On 26May2021, nasal swab (rapid) was negative. On 27Mar2021, blood test (rapid) was negative. Treatment received included IV with 2 bags with ibuprofen and nausea medications. Outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Myalgia, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: headache; chills; sore muscles all over; sore throat with redness; sore throat with redness; sore arm; metallic taste still present; sore; fatigue; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6204) via an unspecified route of administration, administered in right arm on 16Mar2021 at 12:00 (at 43 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included meloxicam, triamterene, omeprazole, estradiol, and zolpidem; all from unspecified date for unspecified indication. The patient did not have COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination. The patient experienced sore and fatigue, both on 16Mar2021 at 12:00. The patient had metallic taste still present on 25Mar2021. The patient also had headache, chills, sore muscles all over, sore throat with redness, sore throat with redness, and sore arm; all on 26Mar2021. The events resulted in physician office and emergency room visit. The events were considered medically significant. The course of event was reported as follows: The patient reported that day after the first shot, she was sore and fatigued. Then 9 days after started with a metallic taste. On Day 10, severe headache, chills, fatigue, sore arm, sore muscles all over, sore throat with redness. All lasted for 48 hours. At the time of report, metallic taste still present and the patient was still recovering from the side effects. In 10 days after getting shot, 3 doctor visits, 2 rapid test (both were negative), negative flu test, negative strep test, intravenous (IV) with 2 bags of fluids meds, a third covid shot and blood work. The doctor sent off to have checked and awaiting on those results to come back at the time of report. The patient also added "I was told 16 strands that the test were testing for and it's believed I have one of those strands. With a negative result I've missed so much already what is my employer doesn't pay me?" (as reported). Three nasal swabs (rapid) on unspecified dates were negative. On 23Mar2021, blood test (regular test) was performed (pending results). On 26May2021, nasal swab (rapid) was negative. On 27Mar2021, blood test (rapid) was negative. Treatment received included IV with 2 bags with ibuprofen and nausea medications. Outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, SARS-CoV-2 test, Streptococcus test
Clinical narrative: headache; chills; sore muscles all over; sore throat with redness; sore throat with redness; sore arm; metallic taste still present; sore; fatigue; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6204) via an unspecified route of administration, administered in right arm on 16Mar2021 at 12:00 (at 43 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history. The patient had no known allergies. Concomitant medications included meloxicam, triamterene, omeprazole, estradiol, and zolpidem; all from unspecified date for unspecified indication. The patient did not have COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination. The patient experienced sore and fatigue, both on 16Mar2021 at 12:00. The patient had metallic taste still present on 25Mar2021. The patient also had headache, chills, sore muscles all over, sore throat with redness, sore throat with redness, and sore arm; all on 26Mar2021. The events resulted in physician office and emergency room visit. The events were considered medically significant. The course of event was reported as follows: The patient reported that day after the first shot, she was sore and fatigued. Then 9 days after started with a metallic taste. On Day 10, severe headache, chills, fatigue, sore arm, sore muscles all over, sore throat with redness. All lasted for 48 hours. At the time of report, metallic taste still present and the patient was still recovering from the side effects. In 10 days after getting shot, 3 doctor visits, 2 rapid test (both were negative), negative flu test, negative strep test, intravenous (IV) with 2 bags of fluids meds, a third covid shot and blood work. The doctor sent off to have checked and awaiting on those results to come back at the time of report. The patient also added "I was told 16 strands that the test were testing for and it's believed I have one of those strands. With a negative result I've missed so much already what is my employer doesn't pay me?" (as reported). Three nasal swabs (rapid) on unspecified dates were negative. On 23Mar2021, blood test (regular test) was performed (pending results). On 26May2021, nasal swab (rapid) was negative. On 27Mar2021, blood test (rapid) was negative. Treatment received included IV with 2 bags with ibuprofen and nausea medications. Outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Migraine, Nausea
Clinical narrative: Migraine all around my head; Dizziness to the point of falling down; Dizziness to the point of falling down; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 08Mar2021 13:30 (at the age of 53 years old) (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 13:30 (at the age of 54 years old) (Batch/Lot number was not reported), both as single dose for covid-19 immunization. Medical history included panhypopituitarism, hypothyroidism, bipolar 1, others. The patient had unspecified known allergies. The patient's concomitant medications in two weeks were reported as yes. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. The patient experienced dizziness to the point of falling down, migraine all around my head, extreme nausea on 29Mar2021 13:45, which were resulted in emergency room/department or urgent care. These events happened with both shots. The patient went to ER both times Treatment for events included migraine cocktail. Nothing for dizziness or nausea. The outcome of event was recovered with lasting effects.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Decreased appetite, Diarrhoea, Feeding disorder
Clinical narrative: Hot flashes; Cold sweats; Dilated pupils; Inability to eat; Nerve pain; Loss of appetite; Nausea; Diarrhea; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 14:00(at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included sertraline hydrochloride (ZOLOFT), lamotrigine (LAMICTAL), mitragyna speciosa (KRATOM) and paracetamol, oxycodone hydrochloride (PERCOCET). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19 and not since the vaccination, the patient was not tested positive for COVID-19. On same day 28Mar2021 at 19:00, after five hours of vaccination, the patient experienced loss of appetite , nausea, diarrhea, nerve pain, joint pain, hot flashes, cold sweats, dilated pupils, inability to eat but no fever. The event resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event loss of appetite, nausea, diarrhea, nerve pain, joint pain, hot flashes, cold sweats, dilated pupils, inability to eat was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Mydriasis, Nausea, Neuralgia
Clinical narrative: Hot flashes; Cold sweats; Dilated pupils; Inability to eat; Nerve pain; Loss of appetite; Nausea; Diarrhea; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Mar2021 at 14:00(at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications included sertraline hydrochloride (ZOLOFT), lamotrigine (LAMICTAL), mitragyna speciosa (KRATOM) and paracetamol, oxycodone hydrochloride (PERCOCET). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19 and not since the vaccination, the patient was not tested positive for COVID-19. On same day 28Mar2021 at 19:00, after five hours of vaccination, the patient experienced loss of appetite , nausea, diarrhea, nerve pain, joint pain, hot flashes, cold sweats, dilated pupils, inability to eat but no fever. The event resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event loss of appetite, nausea, diarrhea, nerve pain, joint pain, hot flashes, cold sweats, dilated pupils, inability to eat was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea; tired; This is a spontaneous report from a contactable other health care professional, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via intramuscular route in the right arm on 04Mar2021 at 17:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received morphine (MANUFACTURER UNKNOWN) for an unknown indication and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks prior to the COVID vaccine. On 05Mar2021 at 16:30, the patient experienced nausea and was tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events nausea and tired. The clinical outcomes of the events nausea and tiredness was resolved on unknown date in Mar2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Localized injection site pain.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 08:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and environmental allergies. Concomitant medications included testosterone (ANDROGEL), salbutamol (ALBUTEROL), montelukast (MANUFACTURER UNKNOWN) and fluticasone (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications received within 2 weeks of vaccination. The patient had no known allergies to Allergies to medications, food, or other products. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 16:00, the patient experienced localized vaccination site pain which peaked about 12 hours after vaccination and almost completely subsided by 24 hours. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event localized vaccination site pain was recovered on 01Apr2021.   No follow-up attempts are needed. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GR8737), via an unspecified route of administration in the left arm on 31Mar2021 at 17:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 03Mar2021 at 17:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included diabetes. The patient had no known allergies to medications, food or other products. The patient received unspecified concomitant medication for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unspecified date in 2021, the patient experienced metallic taste in mouth. The adverse event did not result in a doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. The patient did not receive any treatment for the event experienced. The clinical outcome of the event metallic taste in mouth was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site pain
Clinical narrative: Pain/soreness in lymph nodes in armpit of left arm(injection arm) 12 hours after injection.; Moderate soreness around injection site; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the upper left arm on 29Mar2021 at 15:15 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, obesity and pre-diabetes. The patient was allergic to tree nuts. Concomitant medications included cetirizine hydrochloride (ZYRTEC), phentermine hydrochloride (PHENTERAMINE), levothyroxine and liothyronine (NP THYROID) and multivitamin (MANUFACTURER UNKNOWN). The patient previously took codeine experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 30Mar2021 at 06:00, the patient experienced pain/soreness in lymph nodes in armpit of left arm (injection arm) 12 hours after injection which remained painful after 2.5 days, and moderate soreness around injection site. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for pain/soreness in lymph nodes in armpit of left arm and moderate soreness around injection site. The clinical outcomes of the events pain/soreness in lymph nodes in armpit of left arm and moderate soreness around injection site were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Covid arm red spots; Onset of fever 101.7; Chills; extreme headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP). The patient was allergic to penicillin, sulfa and nickel. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and amlodipine besylate (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 08Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021 at 17:30, the patient experienced chills, extreme headache and fatigue. On 29Mar2021 at 18:00, 5 hours after the vaccination, the patient had onset of fever 101.7 lasting 37 hours even with paracetamol (TYLENOL). On 01Apr2021 (reported as day 4), the patient had covid arm red spots. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure taken as a result of the event onset of fever 101.7 included treatment with paracetamol (TYLENOL). The patient did not receive any treatment for the events chills, extreme headache, fatigue and covid arm red spots. The clinical outcomes of the events onset of fever 101.7, chills, extreme headache, fatigue and covid arm red spots were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Covid arm red spots; Onset of fever 101.7; Chills; extreme headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 29Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP). The patient was allergic to penicillin, sulfa and nickel. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and amlodipine besylate (MANUFACTURER UNKNOWN), for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 08Mar2021 at 15:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021 at 17:30, the patient experienced chills, extreme headache and fatigue. On 29Mar2021 at 18:00, 5 hours after the vaccination, the patient had onset of fever 101.7 lasting 37 hours even with paracetamol (TYLENOL). On 01Apr2021 (reported as day 4), the patient had covid arm red spots. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure taken as a result of the event onset of fever 101.7 included treatment with paracetamol (TYLENOL). The patient did not receive any treatment for the events chills, extreme headache, fatigue and covid arm red spots. The clinical outcomes of the events onset of fever 101.7, chills, extreme headache, fatigue and covid arm red spots were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm the day after; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 25Mar2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 26Mar2021, the patient experienced sore arm the day after vaccination. The clinical outcome of the event sore arm was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Hot flush, Lymphadenopathy
Clinical narrative: Lump was noticed; Swollen lymph node noticed in left armpit, soreness in the area; Swollen lymph node noticed in left armpit; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 08:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient had no known allergies to medications, food or other products. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), salbutamol (ALBUTEROL) and ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), all from unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6955), via an unspecified route of administration in the left arm on 04Mar2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced swollen lymph node noticed in left armpit, soreness in the area began about 2 days post 2nd shot (25Mar2021), lump was noticed 6 days post 2nd shot (29Mar2021) but could've been present sooner. Still present as of 01Apr2021, 9 days post 2nd shot. Only other side effect was hot flashes throughout the first day post-2nd shot which lasted one day. No adverse effects from 1st shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of swollen lymph node, soreness in the area and lump were not recovered while that of hot flashes was recovered on 25Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Anything I eat / drink taste like I'm chewing on aluminum foil / metallic aftertaste; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er873cl) via an unspecified route of administration in the left arm on 31Mar2021 at 17:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy with sulfa drug (BACTRIM). The patient received an unspecified prescribed medication within two weeks of vaccination. 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 31Mar2021 at 22:00, about 4 hours after receiving dose, anything the patient ate/ drank tasted like she was chewing on aluminum foil / metallic aftertaste. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the event metallic taste was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Throbbing headache; Fatigue; Chills; Muscle pain; Joint pain; Back pain; Soreness on left arm where injection occurred; Limited mobility on left arm where injection occurred; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 09.00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit-hyperactivity disorder (ADHD). The patient had no known allergies to medications, food or other products. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) for birth control, alprazolam (XANAX) 1mg and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALLXR) 30mg from unknown date for unknown indication received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 17Mar2021 at 21.00,12 hours after first dose of vaccine, the patient experienced throbbing headache, fatigue, chills, muscle pain, joint pain, back pain, soreness and limited mobility on left arm where injection occurred and mild fever persisted for approximately 4 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of throbbing headache, fatigue, chills, muscle pain, joint pain, back pain, soreness and limited mobility on left arm where injection occurred, mild fever were recovered on 21Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Throbbing headache; Fatigue; Chills; Muscle pain; Joint pain; Back pain; Soreness on left arm where injection occurred; Limited mobility on left arm where injection occurred; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 09.00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit-hyperactivity disorder (ADHD). The patient had no known allergies to medications, food or other products. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) for birth control, alprazolam (XANAX) 1mg and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALLXR) 30mg from unknown date for unknown indication received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 17Mar2021 at 21.00,12 hours after first dose of vaccine, the patient experienced throbbing headache, fatigue, chills, muscle pain, joint pain, back pain, soreness and limited mobility on left arm where injection occurred and mild fever persisted for approximately 4 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of throbbing headache, fatigue, chills, muscle pain, joint pain, back pain, soreness and limited mobility on left arm where injection occurred, mild fever were recovered on 21Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pain in jaw, Paraesthesia, Paraesthesia oral
Clinical narrative: numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; jaw ache to the right side of my jaw; This is a spontaneous report from a contactable nurse, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in left arm on 27Mar2021 at 12:00 (age at vaccination was 52 years) as a single dose for COVID-19 immunisation. The patient medical history included history of anaphylaxis. The patient was allergic to latex, bananas and melons. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Mar2021 at 12:30, starting 20-30 minutes after injection, the patient began to feel numbness and tingling to her lips and the right side of her face. When she returned home, she took a BENADRYL with some relief. However, since then the face and lip tingling had persisted intermittently and she had a jaw ache to the right side of her jaw. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Mar2021, the patient underwent abbott binax nasal swab test for COVID-19 and the report was negative. The clinical outcome of the events numbness and tingling to lips and the right side of face and jaw ache to the right side of jaw was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; numbness and tingling to my lips and the right side of my face; jaw ache to the right side of my jaw; This is a spontaneous report from a contactable nurse, the patient. A 52-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in left arm on 27Mar2021 at 12:00 (age at vaccination was 52 years) as a single dose for COVID-19 immunisation. The patient medical history included history of anaphylaxis. The patient was allergic to latex, bananas and melons. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 27Mar2021 at 12:30, starting 20-30 minutes after injection, the patient began to feel numbness and tingling to her lips and the right side of her face. When she returned home, she took a BENADRYL with some relief. However, since then the face and lip tingling had persisted intermittently and she had a jaw ache to the right side of her jaw. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Mar2021, the patient underwent abbott binax nasal swab test for COVID-19 and the report was negative. The clinical outcome of the events numbness and tingling to lips and the right side of face and jaw ache to the right side of jaw was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Only half of dose was injected.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 30Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and multivitamin (MANUFACTURER UNKNOWN) both taken from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, at the time of vaccine administration, the patient noticed that only half of dose was injected, when the patient arrived, they had 3 doses left and threw two away, when attempted to administer it would not go in, the needle was replaced and attempted again but only about half went in. The clinical outcome of the event vaccine under dose was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Extreme exacerbation of existing joint pain in right hip, lower back and right shoulder approximately 10 days after initial vaccination on 15Mar2021.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via an unspecified route of administration in the left arm on 15Mar2021 at 11:30 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, joint pain in right hip, lower back and right shoulder and COVID-19 (which was diagnosed prior to the vaccination). Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication. The patient previously took INDOCIN for an unspecified indication and experienced drug allergy. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, approximately 10 days after initial vaccination, the patient experienced extreme exacerbation of existing joint pain in right hip, lower back and right shoulder. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room or department or urgent care. The patient had self-administered ALEVE as a treatment for the reported event. The clinical outcome of the event joint pain was not recovered at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Swelling
Clinical narrative: Significant swelling in axilla; discomfort in axilla; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 29Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no allergies to medications, food, or other products. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN) 15 mg weekly, folic acid (MANUFACTURER UNKNOWN) 1 mg daily and ibuprofen (MANUFACTURER UNKNOWN)  from an unknown date and  for an unknown indication. 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 30Mar2021, the patient experienced significant swelling and discomfort in axilla, it did not seem to be associated with lymph nodes. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the event swelling in axilla and discomfort in axilla was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.