chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Blood work came back with a low white blood cell count of 3.1; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any other medications in two weeks. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced rashes. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, unknown) via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. 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 an unknown date in 2021, the patient blood work came back with a low white blood cell count of 3.1(unspecified units). The patient never ever had a low white blood cell and the patient gets her blood tested twice per year. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blood work came back with a low white blood cell count of 3.1 was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: About a week after my first vaccination shot, I had an oral herpe breakout (bottom lip).; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on May2021 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. The facility in which the vaccination was administered was a hospital. Medical history included seasonal allergy from known Seasonal allergies, lactose intolerance from Known allergies, anxiety, depression from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride, phentermine resin and vitamins. Prior to vaccination, it was unknown whether 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 23May2021 19:00 about a week after her first vaccination shot the patient experienced an oral herpes breakout. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection Lot Number: EW0178) dose 2 via an unspecified route of administration in the left arm on 02JUN2021 at 14:15 (at the age of 38-year-old) as a single dose for COVID-19 immunization. The event did not result in doctor office visit, emergency room. Therapeutic measures were taken as a result of event and included treatment with docosanol 10%. The clinical outcome of the event was resolved on an unspecified date of 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Lymphadenopathy, Muscle tightness, Pain
Clinical narrative: swollen tonsil; collar bone lymph node swollen; muscle tension in left arm, shoulder, and side of neck.; Severe pain and muscletension in left arm, shoulder, and sideof neck.; mild fever; irritability; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Jun2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, sulfonamide allergy and fruit allergy (Bananas). Concomitant medications were not reported. The patient previously took aspirin (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 12May2021 (at the age of 37-years-old) 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 vaccination. On 03Jun2021, the patient experienced swollen tonsil, collar bone lymph node swollen, severe pain and muscle tension in left arm, shoulder, and side of neck. Mild fever, irritability, fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with muscle relaxants. The clinical outcome of the events swollen tonsil, collar bone lymph node swollen, severe pain and muscle tension in left arm, shoulder, and side of neck. Mild fever, irritability, fatigue was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tonsillar hypertrophy
Clinical narrative: swollen tonsil; collar bone lymph node swollen; muscle tension in left arm, shoulder, and side of neck.; Severe pain and muscletension in left arm, shoulder, and sideof neck.; mild fever; irritability; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Jun2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, sulfonamide allergy and fruit allergy (Bananas). Concomitant medications were not reported. The patient previously took aspirin (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 12May2021 (at the age of 37-years-old) 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 vaccination. On 03Jun2021, the patient experienced swollen tonsil, collar bone lymph node swollen, severe pain and muscle tension in left arm, shoulder, and side of neck. Mild fever, irritability, fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with muscle relaxants. The clinical outcome of the events swollen tonsil, collar bone lymph node swollen, severe pain and muscle tension in left arm, shoulder, and side of neck. Mild fever, irritability, fatigue was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Discomfort, Dysgeusia, Eye pruritus, Nausea
Clinical narrative: Metal taste in tongue 15 minutes after injection; Itchy eyes; Itchy skin; Runny nose; Nausea; caffeine-like mental excitedness mixed with body feeling very heavy; caffeine-like mental excitedness mixed with body feeling very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included allergy to red wine. Concomitant medications were not reported. The patient previously took TYLENOL and BENADRYL on unknown date for unknown indication and experienced drug allergy. 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 an unknown date in 2021, the patient experienced metal taste in tongue 15 minutes after injection, itchy eyes, itchy skin, runny nose, nausea, caffeine-like mental excitedness mixed with body feeling very heavy. 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. The clinical outcome of the events metal taste in tongue 15 minutes after injection, itchy eyes, itchy skin, runny nose, nausea, caffeine-like mental excitedness mixed with body feeling very heavy was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rhinorrhoea
Clinical narrative: Metal taste in tongue 15 minutes after injection; Itchy eyes; Itchy skin; Runny nose; Nausea; caffeine-like mental excitedness mixed with body feeling very heavy; caffeine-like mental excitedness mixed with body feeling very heavy; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included allergy to red wine. Concomitant medications were not reported. The patient previously took TYLENOL and BENADRYL on unknown date for unknown indication and experienced drug allergy. 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 an unknown date in 2021, the patient experienced metal taste in tongue 15 minutes after injection, itchy eyes, itchy skin, runny nose, nausea, caffeine-like mental excitedness mixed with body feeling very heavy. 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. The clinical outcome of the events metal taste in tongue 15 minutes after injection, itchy eyes, itchy skin, runny nose, nausea, caffeine-like mental excitedness mixed with body feeling very heavy was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: 4 days after first dose started getting frequent and severe heart palpitations at night lasting 4 - 8 hours.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191 and expiration date was no reported), first dose via an unspecified route of administration, administered in Arm Left on 27May2021 11:15 (at the age of 38 years) as single for covid-19 immunisation. Medical history included gastroesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen (MANUFACTURER UNKNOWN) and acetaminophen (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 31May2021 the patient experienced 4 days after first dose started getting frequent and severe heart palpitations at night lasting 4 - 8 hours. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oral herpes, Pain in jaw, Swelling face
Clinical narrative: Cold sores around the mouth; swollen lymph under chin; Swollen and pain on chin; Swollen and pain on chin; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 at 20:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medication included amoxicillin (AMOXICILLIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28May2021, the patient experienced swollen and pain on chin, swollen lymph under chin and cold sores around the mouth. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events Cold sores around the mouth, pain on chin, swollen on chin and swollen lymph under chin were not resolved at the time of this report.  The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Period started  the week got the vaccine. It normally lasts 5-7 days, but it hasn't stopped since.; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included ibuprofen (ADVIL), pseudoephedrine hydrochloride; cetirizine hydrochloride (ZYRTEC D 12HR), fluoxetine (MANUFACTURER UNKNOWN) capsule PO 20mg; all from unknown dates for unspecified indications. On 16Mar2021, the patient received meningococcal vaccine B rfHbpA/fHpB (MEN-B (TRUMENBA) PFS) vaccine in the right arm within four weeks of 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 11Apr2021, the patient experienced period started the week she got the vaccine.It normally lasts 5-7 days but it hasn't stopped since. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event period started the week she got the vaccine, it normally lasts 5-7 days but it hasn't stopped since was not resolved at the time of reporting. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167), via an unspecified route of administration on 01May2021 at 10:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Nausea, Pain
Clinical narrative: Rash on both legs from top of feet about 8 inches up the leg; fatigue; muscle soreness; fever for 1.5 days/ fever (a bit over 101); nausea; achiness; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0176), intramuscular in left arm on 03Jun2021 15:15 (at the age of 12-years-old) as dose 2, single for COVID-19 immunization. Medical history included urticaria pigmentosa from 2010 (started to present in the summer of 2010, when he was 1.5years old. It has nearly completely gone away. No flare ups for few years/getting better over the last 3 years). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0169), intramuscular in left arm on 13May2021 15:00 as dose 1, single for COVID-19 immunization. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any known allergies. The patient experienced rash on both legs from top of feet about 8 inches up the leg on 05Jun2021 10:13, fatigue, muscle soreness, fever for 1.5 days/ fever (a bit over 101), nausea and achiness on 05Jun2021. The patient called physician and mentioned over the phone about rash on both legs from top of feet about 8 inches up the leg. The patient was treated with Benadryl for 2 days. It was reported that rash came 1.5 days after shot and lasted about a day. Outcome of all events was resolved on 06Jun2021.  Comments: Got his vaccine at 03:15 PM on 03Jun2021. The morning of 05Jun2021 around 10 AM, alerted me to the rash on his ankles over about 1.5 days, it got worse later spread to feet and up to knee and then eventually went away. He also had the usual side effect of fever (a bit over 101), achiness, fatigue, and nausea. Withheld is a 12-years-old. The nurse kept in touch with me over the phone and had me give him Benadryl. She was going to home to have him go to the emergency room (ER), until pointed at that he has urticaria pigmentosa.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on both legs from top of feet about 8 inches up the leg; fatigue; muscle soreness; fever for 1.5 days/ fever (a bit over 101); nausea; achiness; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0176), intramuscular in left arm on 03Jun2021 15:15 (at the age of 12-years-old) as dose 2, single for COVID-19 immunization. Medical history included urticaria pigmentosa from 2010 (started to present in the summer of 2010, when he was 1.5years old. It has nearly completely gone away. No flare ups for few years/getting better over the last 3 years). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0169), intramuscular in left arm on 13May2021 15:00 as dose 1, single for COVID-19 immunization. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any known allergies. The patient experienced rash on both legs from top of feet about 8 inches up the leg on 05Jun2021 10:13, fatigue, muscle soreness, fever for 1.5 days/ fever (a bit over 101), nausea and achiness on 05Jun2021. The patient called physician and mentioned over the phone about rash on both legs from top of feet about 8 inches up the leg. The patient was treated with Benadryl for 2 days. It was reported that rash came 1.5 days after shot and lasted about a day. Outcome of all events was resolved on 06Jun2021.  Comments: Got his vaccine at 03:15 PM on 03Jun2021. The morning of 05Jun2021 around 10 AM, alerted me to the rash on his ankles over about 1.5 days, it got worse later spread to feet and up to knee and then eventually went away. He also had the usual side effect of fever (a bit over 101), achiness, fatigue, and nausea. Withheld is a 12-years-old. The nurse kept in touch with me over the phone and had me give him Benadryl. She was going to home to have him go to the emergency room (ER), until pointed at that he has urticaria pigmentosa.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal faeces
Clinical narrative: Major change in bowel function; Stools became Messy, sticky and smelly, totally uncharacteristic of my prior functioning; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in right arm on 01Mar2021 (at the age of 75-year-old) as single dose for COVID-19 immunization. Medical history of the patient included Prostate cancer 2006. No other medications/concomitant within two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took Penicillin on an unspecified date and experienced allergy. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9808) via an unspecified route of administration in right arm on 08Feb2021 as single dose for COVID-19 immunization. On 04Mar2021, three days after receiving second dose of vaccination, patient experienced major change in bowel function, stools became messy, sticky, and smelly, totally uncharacteristic of his prior functioning. Condition was persisting for 3 months. AE resulted in visit to Doctor or other healthcare professional office/clinic visit. Patient tried various supplements with no change. Outcome of the events were not resolved.  Follow-Up (15Jul2021, 30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: Appetite lost; This is a spontaneous report from a contactable consumer, the patient. A 64-years-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 04Jun2021 at 15:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergy. 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 05Jun2021, at 04:00 the patient experienced appetite lost. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event appetite lost was unknown at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenopathy
Clinical narrative: Lymph nodes under right armpit is very swollen; Ankles became swollen; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Jun2021 at 13:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy (makeup) and fruit allergy (Mango). The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in May2021 at 13:00 (at the age of 57-years-old) 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 vaccination. On an unknown date in Jun2021, the patient experienced lymph nodes under right armpit was very swollen, also noticed the day she had the shot, both her ankles became swollen as well. That had subsided, but swollen lymph nodes remained. Including in the back of her head. The patient did not receive any treatment for the events. The clinical outcome of the event lymph nodes under right armpit was not recovered. While that of ankles became swollen was recovered on an unknown date in Jun2021.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast swelling, Breast tenderness, Feeling abnormal, Hypomenorrhoea
Clinical narrative: Period seemed to stop immediately (3days instead of typical 4-5 days); Hormonal warning symptoms that period is coming, changes notice in body right before period comes; Swollen tender breasts; Swollen tender breasts; Back pain; Feel like crying easily without provocation-completely connected to hormones; This is a spontaneous report from a contactable consumer, the patient. A 42-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 24May2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine 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 tested for COVID-19. On 24May2021, the patient had period seemed to stop immediately (3days instead of typical 4-5 days), hormonal warning symptoms that period was coming, changes noticed in body right before period comes, swollen breasts, tender breasts, back pain and feel like crying easily without provocation-completely connected to hormones. It was reported that the period had not started again yet. Thankfully, it just felt like it was about to. 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 outcome of period seemed to stop immediately (3days instead of typical 4-5 days), hormonal warning symptoms that period is coming, changes notice in body right before period comes, swollen breasts, tender breasts, back pain and feel like crying easily without provocation-completely connected to hormones was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Premenstrual syndrome
Clinical narrative: Period seemed to stop immediately (3days instead of typical 4-5 days); Hormonal warning symptoms that period is coming, changes notice in body right before period comes; Swollen tender breasts; Swollen tender breasts; Back pain; Feel like crying easily without provocation-completely connected to hormones; This is a spontaneous report from a contactable consumer, the patient. A 42-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 24May2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccine 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 tested for COVID-19. On 24May2021, the patient had period seemed to stop immediately (3days instead of typical 4-5 days), hormonal warning symptoms that period was coming, changes noticed in body right before period comes, swollen breasts, tender breasts, back pain and feel like crying easily without provocation-completely connected to hormones. It was reported that the period had not started again yet. Thankfully, it just felt like it was about to. 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 outcome of period seemed to stop immediately (3days instead of typical 4-5 days), hormonal warning symptoms that period is coming, changes notice in body right before period comes, swollen breasts, tender breasts, back pain and feel like crying easily without provocation-completely connected to hormones was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: 3 days after 2nd shot both legs knee on down front and back started to swell up. Feet and ankles as well.; 3 days after 2nd shot both legs knee on down front and back started to swell up. Feet and ankles as well.; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 17May2021 at 12:00 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. Concomitant medication included VITAMINS NOS Other medications in two weeks. Historical Vaccine included bnt162b2 as 1st dose for covid-19 immunization (at the age of 59 years-old).  The patient received no other vaccine in four weeks. On an unspecified date, the patient experienced 3 days after 2nd shot both legs knee on down front and back started to swell up. feet and ankles as well. Facility type vaccine was public Health Clinic/Administration facility. It was reported that 3 days after 2nd shot both legs knee on down front and back started to swell up. Feet and ankles as well. Continue to be swollen for up to two weeks and 4 days. The patient was going for an appointment to see his doctor. The patient reported it was is outrageous as it was known about this issue. Ae resulted in Doctor or other healthcare professional office/clinic visit. treatment was received Unknown. Patient was not covid prior vaccination. Patient did not test for covid post vaccination. Outcome of the events were not recovered.   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Right atrial enlargement
Clinical narrative: Mild right atrial enlargement; This is a spontaneous report from a contactable other hcp (patient). A 67-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration in the left arm on 17Feb2021 11:00 (at the age of 67 years old) as dose number unknown, single for COVID-19 immunisation. The facility in which vaccination administered was other. Medical history included nephrectomy, transurethral bladder resection from 2020 (prior EKGs (3) in 2020 required for pre-op exams for bladder scrapping (2) and for right nephrectomy did not show any abnormal findings), contrast media allergy, iodized contrast dye allergy, Penicillin allergy, ureteric cancer, bladder cancer. Concomitant medications included amlodipine at 2.5 mg daily, diazepam dose unknown as needed for an unspecified indication. No other vaccines were given 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested COVID-19. On May2021 the patient experienced mild right atrial enlargement. The patient underwent lab tests and procedures on an unspecified date of 2020 which included electrocardiogram resulted did not show any abnormal findings. On May2021 which included electrocardiogram resulted right atrial enlargement. The events did not result in doctor office, emergency room or urgent care. No therapeutic measures were taken for the reported event. No treatment was given. The clinical outcome of the events was unknown.   Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from a Pfizer sponsored Program Pfizer.com - General Company Information. A patient of un-specified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tinnitus. Patient further stated that vaccine gave me tinnitus. Was perfectly healthy. The clinical outcome of the events was reported as unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Itchy red bumpy rash all over body; Itchy red bumpy rash all over body; Itchy red bumpy rash all over body; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 15May2021 at 12:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22May2021, the patient experienced itchy, red and bumpy rash all over body. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy, red and bumpy rash was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site hypoaesthesia, Musculoskeletal stiffness, Vaccination site bruising
Clinical narrative: Soreness at injection site; injection site become raised; Tiredness; shoulder pain; left side of neck felt stiff; bruise at injection site; injection site  become white; injection site numb to touch; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 29May2021 at 11:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosis spondylitis. The patient previously took Gluten and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sulfasalazine (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE), sulindac (MANUFACTURER UNKNOWN), zingiber officinale (GINGER) and iron (MANUFACTURER UNKNOWN); all from an unknown date for  unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021, the patient experienced soreness at injection site, later in the day injection site became raised and white and numb to touch. On 29May2021, 7 hours after injection, the patient had tiredness and shoulder pain (felt like it needed to pop, could not lie on it). On 29May2021, the patient experienced left side of neck stiff (woke up in the middle of the night because of pain) and bruise at injection site. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events.   Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of soreness at injection site, injection site become raised and white and numb to touch, tiredness, shoulder pain, neck stiff and bruise at injection site was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Soreness at injection site; injection site become raised; Tiredness; shoulder pain; left side of neck felt stiff; bruise at injection site; injection site  become white; injection site numb to touch; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 29May2021 at 11:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included ankylosis spondylitis. The patient previously took Gluten and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sulfasalazine (MANUFACTURER UNKNOWN), naproxen sodium (ALEVE), sulindac (MANUFACTURER UNKNOWN), zingiber officinale (GINGER) and iron (MANUFACTURER UNKNOWN); all from an unknown date for  unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021, the patient experienced soreness at injection site, later in the day injection site became raised and white and numb to touch. On 29May2021, 7 hours after injection, the patient had tiredness and shoulder pain (felt like it needed to pop, could not lie on it). On 29May2021, the patient experienced left side of neck stiff (woke up in the middle of the night because of pain) and bruise at injection site. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events.   Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of soreness at injection site, injection site become raised and white and numb to touch, tiredness, shoulder pain, neck stiff and bruise at injection site was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortage of breath; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26May2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no known allergies to food, medication or other products. Concomitant medications were not reported. 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 14Apr2021, the patient experienced shortage of breath. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shortage of breath and included treatment with unspecified medications from an unspecified date in 2021 and unknown if ongoing. The clinical outcome of the event shortage of breath was not resolved at the time of this report.  Information on lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via intramuscular route of administration in the left arm on 05Jun2021 at 14:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to shellfish. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via intramuscular route of administration in the left arm on 14May2021 at 12:30 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jun2021 at 10:00, the patient experienced headache. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event headache was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer. A 14-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0217) via intramuscular route of administration in the left arm on 05Jun2021 at 14:45 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications in two weeks of vaccine. The patient had no known allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0217) via intramuscular route of administration in the left arm on 14May2021 at 13:45 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021 at 10:45, the patient experienced fatigue. No therapeutic measures were taken a result of the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue 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: Alopecia
Clinical narrative: Hair loss, Significant hair fall that comes in sections when smoothed, brushed, washed; This is a spontaneous report from a contactable consumer, the patient. A 35-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 17May2021 at 13:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19 prior to vaccination. 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 vaccine. On 23May2021, the patient experienced hair loss, significant hair fall that comes in sections when smoothed, brushed and washed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event hair loss was not recovered.   No follow up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Extreme neck/ shoulder muscle stiffness; Extreme neck/shoulder muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0176) via an unspecified route of administration in the right arm on 20May2021 at 17:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included ankylosing spondylitis, degenerative disc disease, chronic iridocyclitis and allergy to (Sulfa, Neomycin, Neosporin). Concomitant medications included tramadol (MANUFACTURER UNKNOWN) 50 mg one a day and B3 (MANUFACTURER UNKNOWN) one a day, both on an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, the patient experienced extreme neck/shoulder muscle pain/stiffness. No therapeutic measures were taken as a result of the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme neck/shoulder muscle pain/stiffness were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.