chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Heart rate increased, Pain
Clinical narrative: By Tuesday, May 11, I was experiencing chest pain over the area of my heart. On Friday, May 14, I was still having pains, my heart seemed to be beating much more intensely than normal, and I was worri; By Tuesday, May 11, I was experiencing chest pain over the area of my heart. On Friday, May 14, I was still having pains, my heart seemed to be beating much more intensely than normal, and I was worri; By Tuesday, May 11, I was experiencing chest pain over the area of my heart. On Friday, May 14, I was still having pains, my heart seemed to be beating much more intensely than normal, and I was worri; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot number: EW0173) via an unspecified route of administration in Arm Right on 06May2021 14:15 as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Concomitant medication(s) included famotidine (FAMOTIDINE); allopurinol (ALLOPURINOL) was taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient has been tested for COVID-19. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0150) via an unspecified route of administration in Arm left on 15Apr2021 10:15 AM as single dose for covid-19 immunisation. The patient experienced on 11May2021; he was experiencing chest pain over the area of my heart. On Friday, 14May2021, he was still having pains, my heart seemed to be beating much more in-tensely than normal, and he was worried about my health, so he visited an ER. The tests run at the ER showed no signs of heart damage. Since they could not detect any heart damage, he was not sure if he had a side effect from the vaccine, but since there are now articles about heart inflammation occurring 4 days after vaccination. The patient under-went lab tests and procedures which included electrocardiogram: no signs on 14May2021 no signs of heart damage. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: Heartbeats irregular; palpitation; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported; NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 24Apr2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. The patient reported that since she got the second dose, she noticed her heartbeat was irregular. Before it was not that reason but later she felt it almost daily specially in the afternoon time, even during late night-time and sometimes a whole day. She never felt this type of heartbeat irregularly and she felt strong, stronger, and weaker and the timing between was longer. She said it was palpitation. She never had this issue before as she could barely feel her heart beating, it was obvious. She and her husband took the vaccine at the same day and her husband felt the same thing and reported it was not as strong. She had a strong suspect that the events were caused by Pfizer vaccine, so she planned to visit her physician. She wanted to know if the events were reported by lot of people. She asked how to deal with the events. She thinks that she had never contacted covid, and she had never gone through the test. She was wondering as it had been over one month ago. She just felt bothered and nervous. The outcome of both the events was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021640539 same reporter/different patient
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Laboratory test, Myalgia
Clinical narrative: developed diffuse erythematous macular rash to trunk and upper extremities; mild facial swelling; tachycardic; fever/febrile; headache; myalgias; fatigue; This is a spontaneous report from a contactable other healthcare professional. A 17-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172, Expiration date was not reported), via an unspecified route of administration on 30May2021 as dose 2, single (at the age of 17-year-old) for COVID-19 immunization. Patient had no medical history and no known drug allergy (NKDA). Historical vaccine included patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172, Expiration date was not reported), via an unspecified route of administration on 09May2021 as dose 1, single (at the age of 17-year-old) for COVID-19 immunization. The patient's concomitant medications 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 to vaccination. Since the vaccination, patient had not been tested for COVID-19. On 30May2021, since the day of vaccine administration, patient had fever, headache, myalgias and fatigue. On 02Jun2021, 3rd day post vaccine, patient developed diffuse erythematous macular rash to trunk and upper extremities, had mild facial swelling and negative for angioedema, was tachycardic and febrile on exam. Patient had Doctor or other healthcare professional office/clinic visit for all the events. Therapeutic measures were taken as a result of developed diffuse erythematous macular rash to trunk and upper extremities, mild facial swelling, tachycardic, fever, headache, myalgias and fatigue and treatment included steroids and antihistamines for all the events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Swelling face, Tachycardia
Clinical narrative: developed diffuse erythematous macular rash to trunk and upper extremities; mild facial swelling; tachycardic; fever/febrile; headache; myalgias; fatigue; This is a spontaneous report from a contactable other healthcare professional. A 17-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172, Expiration date was not reported), via an unspecified route of administration on 30May2021 as dose 2, single (at the age of 17-year-old) for COVID-19 immunization. Patient had no medical history and no known drug allergy (NKDA). Historical vaccine included patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172, Expiration date was not reported), via an unspecified route of administration on 09May2021 as dose 1, single (at the age of 17-year-old) for COVID-19 immunization. The patient's concomitant medications 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 to vaccination. Since the vaccination, patient had not been tested for COVID-19. On 30May2021, since the day of vaccine administration, patient had fever, headache, myalgias and fatigue. On 02Jun2021, 3rd day post vaccine, patient developed diffuse erythematous macular rash to trunk and upper extremities, had mild facial swelling and negative for angioedema, was tachycardic and febrile on exam. Patient had Doctor or other healthcare professional office/clinic visit for all the events. Therapeutic measures were taken as a result of developed diffuse erythematous macular rash to trunk and upper extremities, mild facial swelling, tachycardic, fever, headache, myalgias and fatigue and treatment included steroids and antihistamines for all the events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate increased, Nausea, Tachycardia
Clinical narrative: Severe nausea and vomiting; Severe nausea and vomiting; heart rate as high as 192; dizziness; severe fatigue; heart rate as high as 192; This is a spontaneous report from a contactable other health care professional (Nurse). A 31-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in right arm on 07Jan2021 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation in hospital. Medical history included polycystic ovarian syndrome from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medications included DULOXETINE taken for an unspecified indication, start and stop date were not reported; VITAMIN D3 taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (ESTARYLLA) taken for an unspecified indication, start and stop date were not reported. The patient previously took mango c and experienced fruit allergy, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK7530), via an unspecified route of administration in left arm on 17Dec2020 (at the age of 31-year-old) as dose 1, single 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. It was reported that the patient experienced Severe nausea and vomiting for 7 days after second Pfizer COVID vaccination. On Jan14 2021, tachycardia, dizziness, and severe fatigue started resulting in 2 hospital trips with a heart rate as high as 192. Currently seeing multiple specialists to try to find a diagnosis. Symptoms improved on medication but still experiencing multiple adverse symptoms. The adverse events resulted in visit of doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart rate increased: 192 (unknown units) on 14Jan2021. The treatment was received for all the events. The outcome of the events was reported as not resolved at the time of reporting.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe nausea and vomiting; Severe nausea and vomiting; heart rate as high as 192; dizziness; severe fatigue; heart rate as high as 192; This is a spontaneous report from a contactable other health care professional (Nurse). A 31-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in right arm on 07Jan2021 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation in hospital. Medical history included polycystic ovarian syndrome from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medications included DULOXETINE taken for an unspecified indication, start and stop date were not reported; VITAMIN D3 taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (ESTARYLLA) taken for an unspecified indication, start and stop date were not reported. The patient previously took mango c and experienced fruit allergy, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK7530), via an unspecified route of administration in left arm on 17Dec2020 (at the age of 31-year-old) as dose 1, single 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. It was reported that the patient experienced Severe nausea and vomiting for 7 days after second Pfizer COVID vaccination. On Jan14 2021, tachycardia, dizziness, and severe fatigue started resulting in 2 hospital trips with a heart rate as high as 192. Currently seeing multiple specialists to try to find a diagnosis. Symptoms improved on medication but still experiencing multiple adverse symptoms. The adverse events resulted in visit of doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart rate increased: 192 (unknown units) on 14Jan2021. The treatment was received for all the events. The outcome of the events was reported as not resolved at the time of reporting.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fear, Feeling cold, Hypoaesthesia, Limb discomfort
Clinical narrative: Very sore arm; Chills/had four blankets and space heater but still shivering uncontrollably; Numbness; Tingling in hands and feet; Hands crapped up into lobster claws ended up at ER; Never was so cold in my life-had four blankets and space heater but still shivering uncontrollably; Very scary experience; This is a spontaneous report from a contactable consumer or other non hcp. A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in the left arm on 07May2021 at 18:00 (at the age of 56-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine; estrogens conjugated, estrogens esterified (MENEST); progesterone and duloxetine. Historical vaccine included bnt162b2 (Lot number: ER8737) dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 18:45 for covid-19 immunisation. On 08May2021 at 18:00, the patient experienced very sore arm, chills/had four blankets and space heater but still shivering uncontrollably, numbness, tingling in hands and feet, hands crapped up into lobster claws ended up at ER, never was so cold in my life-had four blankets and space heater but still shivering uncontrollably and very scary experience. Patient was not dehydrated. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Device timestamp was provided as 04Jun2021. Treatment for the events was given with Tylenol and fluids. Outcome of the events were recovered on an unspecified day in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Very sore arm; Chills/had four blankets and space heater but still shivering uncontrollably; Numbness; Tingling in hands and feet; Hands crapped up into lobster claws ended up at ER; Never was so cold in my life-had four blankets and space heater but still shivering uncontrollably; Very scary experience; This is a spontaneous report from a contactable consumer or other non hcp. A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in the left arm on 07May2021 at 18:00 (at the age of 56-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine; estrogens conjugated, estrogens esterified (MENEST); progesterone and duloxetine. Historical vaccine included bnt162b2 (Lot number: ER8737) dose 1 via an unspecified route of administration, administered in the left arm on 13Apr2021 at 18:45 for covid-19 immunisation. On 08May2021 at 18:00, the patient experienced very sore arm, chills/had four blankets and space heater but still shivering uncontrollably, numbness, tingling in hands and feet, hands crapped up into lobster claws ended up at ER, never was so cold in my life-had four blankets and space heater but still shivering uncontrollably and very scary experience. Patient was not dehydrated. Facility where the most recent COVID-19 vaccine was administered was a pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Device timestamp was provided as 04Jun2021. Treatment for the events was given with Tylenol and fluids. Outcome of the events were recovered on an unspecified day in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Fatigue, Lymphadenopathy
Clinical narrative: Shooting pain up right backside of neck to behind right ear; Shooting pain up right backside of neck to behind right ear; Psoriasis flare ups; Extreme joint pain; Fatigue; Fever; Chills; Swollen lymph nodes in neck.; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0175), dose 2 via an unspecified route of administration, administered in arm left on 01Jun2021 at 15:15 (at the age of 33-years-old) as single for COVID-19 immunisation at hospital. The patient medical history included psoriasis. The patient had no known allergies. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 at 15:15 pm (at the age of 33-years-old) as single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 02Jun2021 at 02:30, the patient experienced shooting pain up right backside of neck to behind right ear, psoriasis flare ups, extreme joint pain, fatigue, fever, chills and swollen lymph nodes in neck. The patient was treated with Ibuprofen for the events. Outcome of all the events was resolved with sequelae in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Psoriasis, Pyrexia
Clinical narrative: Shooting pain up right backside of neck to behind right ear; Shooting pain up right backside of neck to behind right ear; Psoriasis flare ups; Extreme joint pain; Fatigue; Fever; Chills; Swollen lymph nodes in neck.; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0175), dose 2 via an unspecified route of administration, administered in arm left on 01Jun2021 at 15:15 (at the age of 33-years-old) as single for COVID-19 immunisation at hospital. The patient medical history included psoriasis. The patient had no known allergies. The patient's concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0175), dose 1 via an unspecified route of administration, administered in arm left on 11May2021 at 15:15 pm (at the age of 33-years-old) as single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 02Jun2021 at 02:30, the patient experienced shooting pain up right backside of neck to behind right ear, psoriasis flare ups, extreme joint pain, fatigue, fever, chills and swollen lymph nodes in neck. The patient was treated with Ibuprofen for the events. Outcome of all the events was resolved with sequelae in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Nausea
Clinical narrative: felt less tired but still not back to normal; flu-like symptoms; body aches; extremely tired; headaches; nausea; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A 53-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 59267-1000-02 ), via an unspecified route of administration, administered in Arm Left on 19May2021 at 14:30 (Age at vaccination: 53 years ) as dose 1, single for covid-19 immunisation. The patient Medical history and concomitant medications were not reported. Patient did not received other vaccines in 4 weeks. Patient did not received other medications in two weeks. Patient did not have COVID prior vaccination. Patient was tested COVID post vaccination. Patient did not had allergies. The patient experienced extremely tired, headaches, nausea on 21May2021 at 19:00 , flu-like symptoms, body aches on 31May2021, felt less tired but still not back to normal on 06Jun2021. There was no treatment received for the events. The day of her first vaccine, and the day after, she felt fine. For the next three days (21May-23May), she felt extremely tired, had headaches and nausea. 24May-30May, she felt fine. 31May-05Jun very tired with flu-like symptoms of body aches. 06Jun-07Jun felt less tired but still not back to normal. She was supposed to get second vaccine on 09Jun. The patient underwent lab tests and procedures which includ-ed sars-cov-2 test Nasal swab test was negative on 30May2021. The outcome of the event extremely tired, headaches, nausea, flu-like symptoms, body aches, felt less tired but still not back to normal was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: felt less tired but still not back to normal; flu-like symptoms; body aches; extremely tired; headaches; nausea; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A 53-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: 59267-1000-02 ), via an unspecified route of administration, administered in Arm Left on 19May2021 at 14:30 (Age at vaccination: 53 years ) as dose 1, single for covid-19 immunisation. The patient Medical history and concomitant medications were not reported. Patient did not received other vaccines in 4 weeks. Patient did not received other medications in two weeks. Patient did not have COVID prior vaccination. Patient was tested COVID post vaccination. Patient did not had allergies. The patient experienced extremely tired, headaches, nausea on 21May2021 at 19:00 , flu-like symptoms, body aches on 31May2021, felt less tired but still not back to normal on 06Jun2021. There was no treatment received for the events. The day of her first vaccine, and the day after, she felt fine. For the next three days (21May-23May), she felt extremely tired, had headaches and nausea. 24May-30May, she felt fine. 31May-05Jun very tired with flu-like symptoms of body aches. 06Jun-07Jun felt less tired but still not back to normal. She was supposed to get second vaccine on 09Jun. The patient underwent lab tests and procedures which includ-ed sars-cov-2 test Nasal swab test was negative on 30May2021. The outcome of the event extremely tired, headaches, nausea, flu-like symptoms, body aches, felt less tired but still not back to normal was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth./Food, and water are tasting extremely salty, like tin/metal, and marzipan; This is a spontaneous report from a contactable consumer. A 44-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jun2021 09:00 (age at vaccination 44 years) as dose 1, single for covid-19 immunisation. Medical history included Periodic iron deficiency, Bee stings, penicillin allergy. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced metallic taste in mouth /food, and water are tasting extremely salty, like tin/metal, and marzipan on 08Jun2021 12:00. She has brushed my teeth twice. Currently no other symptoms. Drinking plenty of water, (2-3 liters), which is her normal daily routine. The patient did not receive any treatment for reported events. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Neck pain, Pain in extremity
Clinical narrative: Severe Abdominal Pain; excruciating pain in neck; excruciating pain in arms .; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0173 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 07Jun2021 12:00 (at the age of 45 years) as single for covid-19 immunization. The patient concomitant medications were not reported. No other medical history reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0172 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 17May2021 12:00 (at the age of 45 years) as single for covid-19 immunization. Patient had no reported allergies. Patient did not receive any other vaccines within four weeks and other medications in two weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination. patient did not covid tested post vaccination. On 07Jun2021, the patient experienced severe abdominal Pain, excruciating pain in neck and arms. The patient did not receive any treatment for adverse events. The outcome the events was resolving at time of report.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: The next day had a fever of 101; chills; headache; nausea; Extreme exhaustion for 4-5 days following; Missed menstrual cycle (delayed by 3 weeks); Consistent diarrhea for the following month; This is a spontaneous report from a contactable consumer (patient, self-reported). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW162), via an unspecified route of administration, administered in the left arm on 17Apr2021 14:15 (at the age of 31-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was reported as no, and no known allergies were reported. Concomitant medications included famotidine (PEPCID AC), astragalus mongholicus root (ASTRAGALUS ROOT), multivitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in the left arm on 27Mar2021 14:15 (at the age of 31-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. On 18Apr2021 at 05:00, the patient experienced fever of 101, chills, headache, nausea, extreme exhaustion for 4-5 days following, missed menstrual cycle (delayed by 3 weeks), consistent diarrhea for the following month. The patient underwent lab tests and procedures which included body temperature: 101 on unspecified date. Patient did not receive any treatment for adverse events. The outcome of all events was recovered.  This follow-up is being submitted to notify Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Nausea, Pyrexia
Clinical narrative: The next day had a fever of 101; chills; headache; nausea; Extreme exhaustion for 4-5 days following; Missed menstrual cycle (delayed by 3 weeks); Consistent diarrhea for the following month; This is a spontaneous report from a contactable consumer (patient, self-reported). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW162), via an unspecified route of administration, administered in the left arm on 17Apr2021 14:15 (at the age of 31-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was reported as no, and no known allergies were reported. Concomitant medications included famotidine (PEPCID AC), astragalus mongholicus root (ASTRAGALUS ROOT), multivitamin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732), via an unspecified route of administration, administered in the left arm on 27Mar2021 14:15 (at the age of 31-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and covid was not tested post vaccination. On 18Apr2021 at 05:00, the patient experienced fever of 101, chills, headache, nausea, extreme exhaustion for 4-5 days following, missed menstrual cycle (delayed by 3 weeks), consistent diarrhea for the following month. The patient underwent lab tests and procedures which included body temperature: 101 on unspecified date. Patient did not receive any treatment for adverse events. The outcome of all events was recovered.  This follow-up is being submitted to notify Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I received my second Pzifer shot, I had started menstruating for 6 days; This is a spontaneous report from a contactable Other Health Care Professional (patient) reported for herself that a 49-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ew0179), via an unspecified route of administration in left arm on 11May2021 at 09:00 (at the age of 49-years-old) as dose2, single for Covid-19 immunization facilitate at hospital. The patient's medical history included menopause and have not menstruated in 10 years and no known allergies. Concomitant medications were not reported. No other vaccine in four weeks and in two weeks. The patient historical vaccine included first dose of (Pfizer-Biontech Covid-19 Vaccine, solution for injection, lot number: w0161), via an unspecified route of administration in left arm on 20Apr2021 at 09:00 (at the age of 49-years-old) as single dose for Covid-19 immunization. On 31May2021, two weeks after I received my second Pfizer shot, I had started menstruating for 6 days. No covid prior vaccination and no covid tested post vaccination. No treatment received for adverse event. The outcome of the adverse event was recovered on an unknown date.   Follow-Up (14Jul2021 and 28Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Fever (100.4 F); chills; fatigue; nausea; general malaise; This is a spontaneous report from a contactable Consumer. This consumer reported for a 16-year-old male patient that.  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), dose 2 intramuscular, administered in Arm Left on 11Jun2021 17:00 as (Age at the time of vaccination 16-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186),dose 1, intramuscular, administered in Arm Left on 21May2021 at 06:00 pm for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. No covid prior vaccination. No Known allergies ware reported. Other medications in two weeks included Multivitamins. The patient experienced fever (100.4 f), chills, fatigue, nausea, and general malaise on 12Jun2021 10:00. Patient received treatment with Ibuprofen 200 mg (2 tablets) for events. The patient underwent lab tests and procedures which included body temperature: 100.4 fahrenheit on 12Jun2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (100.4 F); chills; fatigue; nausea; general malaise; This is a spontaneous report from a contactable Consumer. This consumer reported for a 16-year-old male patient that.  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), dose 2 intramuscular, administered in Arm Left on 11Jun2021 17:00 as (Age at the time of vaccination 16-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186),dose 1, intramuscular, administered in Arm Left on 21May2021 at 06:00 pm for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. No covid prior vaccination. No Known allergies ware reported. Other medications in two weeks included Multivitamins. The patient experienced fever (100.4 f), chills, fatigue, nausea, and general malaise on 12Jun2021 10:00. Patient received treatment with Ibuprofen 200 mg (2 tablets) for events. The patient underwent lab tests and procedures which included body temperature: 100.4 fahrenheit on 12Jun2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: legs became very swollen, numb at times, and painful.; legs became very swollen, numb at times, and painful.; legs became very swollen, numb at times, and painful.; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 09Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included blood clotting from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that the patient received first dose on 09Jun2021 and one of her legs became very swollen, numb at times, and painful on 10Jun2021. The patient advised they have had blood clotting issues in the past and worried that the vaccine caused another one. The outcome of the events was unknown at the time of reporting. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in both ears; This is a spontaneous report from a contactable pharmacist, Pfizer employee.   A 61-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 17Feb2021 (at the age of 61-years-old) as DOSE 2, SIN-GLE for covid-19 immunization. Medical history included drug hypersensitivity (known allergies: sulfa) from an unknown date and unknown if ongoing. Concomitant medications were not report-ed. The patient previously received historic vaccine as a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 27Jan2021 (at the age of 61-years-old) as DOSE 1, SIN-GLE for covid-19 immunization. Other vaccine in four weeks; covid prior vaccination included none. The patient experienced ringing in both ears started 2 weeks after vaccine 2, on an unspecified date in 2021. Event resulted in Doctor or other healthcare professional office or clinic visit. Therapeutic measures taken included ENT visit, but nothing they could do. It was reported that ENT MD saw nothing that would cause this. Covid was tested on an unspecified date, post vaccination which included sars-cov-2 test (nasal swab) result was negative. Outcome of the event was reported as not resolved.  Information on the lot/batch number had been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, SARS-CoV-2 antibody test, Sensation of foreign body
Clinical narrative: I had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months/Symptoms resumed 4-5 days after 1 dose vaccine; I had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months/Symptoms resumed 4-5 days after 1 dose vaccine; This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, in Left Arm on 22Mar2021 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history included sensation of foreign body from 2020 and ongoing I had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months. Was tx'd with steroid course after laryngoscopy Jun2020 with some improvement but not resolved until Dec2020, pharyngitis from 2020 and ongoing I had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months. Was tx'd with steroid course after laryngoscopy Jun2020 with some improvement but not resolved until Dec2020, covid-19 from Mar2020 to an unknown date I had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months. Was tx'd with steroid course after laryngoscopy Jun2020 with some improvement but not resolved until Dec2020, laryngoscopy from Jun2020 to an unknown date I had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months. Was tx'd with steroid course after laryngoscopy Jun2020 with some improvement but not resolved until Dec2020 , steroid therapy from 2020 to an unknown date I had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months. Was tx'd with steroid course after laryngoscopy Jun2020 with some improvement but not resolved until Dec2020, immunisation from an unknown date and unknown if ongoing. The patient concomitant medication in 4 weeks included varicella zoster vaccine rge (cho) (SHINGRIX) taken for immunisation from 20Feb2021 to 20Feb2021. The patient was not diagnosed covid-19, prior vaccination, Since the vaccination, the patient had not been tested for Covid-19, The patient had no known allergies. On 26Mar2021, the patient stated that she had globus pharyngitis after having Covid Mar2020 which lasting approx 9 months. Was tx'd with steroid course after laryngoscopy Jun2020 with some improvement but not resolved until Dec2020. Symptoms resumed 4-5 days after 1 dose vaccine and have not yet resolved. She has not taken 2nd dose and am concerned re pressure to do so for employment/travel even though my antibody screen remained one full year after illness prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: high my antibody screen remained high one full year after illness prior to vaccine. Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen decreased
Clinical narrative: After "2shots of the vaccine", his "PSA reading went down". "Before, he had high reading of PSA but the numbers dropped significantly from last year; This is a spontaneous report received from Pfizer sponsored program. A contactable male consumer (patient) reported for himself. A 74-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) via an unspecified route of administration on 23Feb2021 (at the age of 74-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on 02Feb2021 (at the age of 74-year-old) (Batch/Lot Number: not reported) for COVID-19 immunization as no reaction on previous exposure to vaccine. Patient reported after the second dose he had tested for PSA, so his PSA is reading after the second shot went down so before he was having high reading of the PSA but although it is better if the numbers are low, he had drop significant live from last year. Consumer stated all right, I just want to point out it not a problem am just finding me out more information whether vaccine does affect the Prostate reading. Query response received and confirmed the patient first name. The clinical outcome of event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever; fatigue; joint pain; nausea; Severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179), dose 2 via an unspecified route of administration, administered in right arm on 11Jun2021 at 17:45 (at the age of 36-year-old) as single for COVID-19 immunisation at pharmacy or drug store. The patient medical history included chronic pain, insomnia and breast cancer. The patient did not had known allergies. Concomitant medications received in two weeks included eszopiclone, ibuprofen, pseudoephedrine hydrochloride (MOTRIN COLD & FLU); oxycodone and pregabalin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0176), dose 1, administered in right arm on 21May2021 at 17:30 (at the age of 36-year-old) as single for COVID-19 immunisation. No past drug events were reported. The patient did not receive any other vaccines in 4 weeks and on same date of vaccine. The patient was not diagnose with COVID prior to vaccination and was not tested for COVID post vaccination. On 12Jun2021 at 14:00, the patient experienced fever, fatigue, joint pain, nausea and severe diarrhoea. No treatment was received for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain
Clinical narrative: On June 4th in the afternoon, experienced a burning sensation in his chest/lungs. It resolved with one dose of ibuprofen administered a few hours later.; On June 4th in the afternoon, experienced a burning sensation in his chest/lungs. It resolved with one dose of ibuprofen administered a few hours later.; This is a spontaneous report from a contactable consumer, the patient. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 15:15 (at the age of 12-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 15:30 (at the age of 12-years-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of 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 04Jun2021 13:00 in the afternoon, the patient experienced a burning sensation in his chest/lungs. it resolved with one dose of ibuprofen administered a few hours later. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient receive treatment with ibuprofen. Outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.