chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Pain, Pain in extremity, Vertigo, Vomiting
Clinical narrative: Vomiting; nausea; I suffered from a severe episode of vertigo; dizziness; chills; aches; severe headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (Pfizer BioNTech), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 08:45 (Lot Number: 8727) as single dose for COVID-19 immunisation. Medical history included oral allergy syndrome, and allergic to fruits like apples, pears, peaches etc and hazelnuts; and birth control. The patient was not pregnant. Concomitant medications included betamethasone for an unknown indication and ethinylestradiol, ferrous fumarate, norethisterone acetate (TRI LEGEST FE) for birth control. The patient previously took first single dose of BNT162B2 (Pfizer BioNTech) via unknown route of administration in left arm on 06Mar2021 09:15 (lot number: 6205). There were no other vaccines within four weeks. The patient reported outside of chills, aches, and severe headache 14 hours after 2nd injection (lasting 2 days) on 27Mar2021. Patient eventually felt fine - but then 7 days later on 03Apr2021 16:00 (4:00 PM), the following Saturday after the second dose, she suffered from a severe episode of vertigo/dizziness. She never had vertigo before in her life so it was odd. Also vomiting and nausea ensued. Patient landed in the ER. She had been stabilized and had been home since. Nausea and vomiting hasn't returned but the vertigo/dizziness persisted. Patient tried Epley and Foster moves but still dizzy at the time three days later (Tuesday 06Apr2021). Treatment for the events also included IV for rehydration, meclizine, and ondansetron. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. Chills, aches, and severe headache recovered on 29Mar2021, vomiting and nausea recovered on an unspecified date in Apr2021. The outcome of other events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Vomiting; nausea; I suffered from a severe episode of vertigo; dizziness; chills; aches; severe headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (Pfizer BioNTech), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 08:45 (Lot Number: 8727) as single dose for COVID-19 immunisation. Medical history included oral allergy syndrome, and allergic to fruits like apples, pears, peaches etc and hazelnuts; and birth control. The patient was not pregnant. Concomitant medications included betamethasone for an unknown indication and ethinylestradiol, ferrous fumarate, norethisterone acetate (TRI LEGEST FE) for birth control. The patient previously took first single dose of BNT162B2 (Pfizer BioNTech) via unknown route of administration in left arm on 06Mar2021 09:15 (lot number: 6205). There were no other vaccines within four weeks. The patient reported outside of chills, aches, and severe headache 14 hours after 2nd injection (lasting 2 days) on 27Mar2021. Patient eventually felt fine - but then 7 days later on 03Apr2021 16:00 (4:00 PM), the following Saturday after the second dose, she suffered from a severe episode of vertigo/dizziness. She never had vertigo before in her life so it was odd. Also vomiting and nausea ensued. Patient landed in the ER. She had been stabilized and had been home since. Nausea and vomiting hasn't returned but the vertigo/dizziness persisted. Patient tried Epley and Foster moves but still dizzy at the time three days later (Tuesday 06Apr2021). Treatment for the events also included IV for rehydration, meclizine, and ondansetron. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. Chills, aches, and severe headache recovered on 29Mar2021, vomiting and nausea recovered on an unspecified date in Apr2021. The outcome of other events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vomiting; nausea; I suffered from a severe episode of vertigo; dizziness; chills; aches; severe headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (Pfizer BioNTech), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 08:45 (Lot Number: 8727) as single dose for COVID-19 immunisation. Medical history included oral allergy syndrome, and allergic to fruits like apples, pears, peaches etc and hazelnuts; and birth control. The patient was not pregnant. Concomitant medications included betamethasone for an unknown indication and ethinylestradiol, ferrous fumarate, norethisterone acetate (TRI LEGEST FE) for birth control. The patient previously took first single dose of BNT162B2 (Pfizer BioNTech) via unknown route of administration in left arm on 06Mar2021 09:15 (lot number: 6205). There were no other vaccines within four weeks. The patient reported outside of chills, aches, and severe headache 14 hours after 2nd injection (lasting 2 days) on 27Mar2021. Patient eventually felt fine - but then 7 days later on 03Apr2021 16:00 (4:00 PM), the following Saturday after the second dose, she suffered from a severe episode of vertigo/dizziness. She never had vertigo before in her life so it was odd. Also vomiting and nausea ensued. Patient landed in the ER. She had been stabilized and had been home since. Nausea and vomiting hasn't returned but the vertigo/dizziness persisted. Patient tried Epley and Foster moves but still dizzy at the time three days later (Tuesday 06Apr2021). Treatment for the events also included IV for rehydration, meclizine, and ondansetron. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. Chills, aches, and severe headache recovered on 29Mar2021, vomiting and nausea recovered on an unspecified date in Apr2021. The outcome of other events was not recovered.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever at a near constant 38 degrees centigrade.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN3518) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 20-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 known allergies. The patient did not have any other medications taken in two weeks prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 15Mar2021 at 16:30 (at the age of 20-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the patient underwent OTHER(COVID-19) test and the result was negative. On 15Mar2021, the patient underwent OTHER(COVID-19) test and the result was negative. On 29Mar2021, the patient underwent OTHER(COVID-19) test  and the result was negative. On 06Apr2021 at 10:00, the patient experienced fever at a near constant 38 degrees centigrade from 10:00 to around 17:00 to 18:00 the day following the second dose of the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit or emergency visit. The patient received tylenol as a treatment taken for the adverse event.  The clinical outcome of the event fever at a near constant 38 degrees centigrade was recovered on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Pyrexia
Clinical narrative: Fever at a near constant 38 degrees centigrade.; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN3518) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 20-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 known allergies. The patient did not have any other medications taken in two weeks prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 15Mar2021 at 16:30 (at the age of 20-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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the patient underwent OTHER(COVID-19) test and the result was negative. On 15Mar2021, the patient underwent OTHER(COVID-19) test and the result was negative. On 29Mar2021, the patient underwent OTHER(COVID-19) test  and the result was negative. On 06Apr2021 at 10:00, the patient experienced fever at a near constant 38 degrees centigrade from 10:00 to around 17:00 to 18:00 the day following the second dose of the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit or emergency visit. The patient received tylenol as a treatment taken for the adverse event.  The clinical outcome of the event fever at a near constant 38 degrees centigrade was recovered on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Condition aggravated, Musculoskeletal stiffness, Neck pain
Clinical narrative: stiff neck, cannot move head side to side; Pain at base of skull at neck; Felt like head would explode; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on the left arm on 27Mar2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's and ulcerative colitis since age 11. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 06:00, the patient experienced stiff neck, could not move head side to side, pain at base of skull at neck, could not lay down, felt like head would explode. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of stiff neck, pain at base of skull at neck, felt like head would explode were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: stiff neck, cannot move head side to side; Pain at base of skull at neck; Felt like head would explode; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on the left arm on 27Mar2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's and ulcerative colitis since age 11. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 06:00, the patient experienced stiff neck, could not move head side to side, pain at base of skull at neck, could not lay down, felt like head would explode. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of stiff neck, pain at base of skull at neck, felt like head would explode were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Throat irritation, Throat tightness
Clinical narrative: My throat began to tingle and close slightly; My throat began to tingle and close slightly; cough; I also became hoarse.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 (Batch/Lot Number: EW0158) as dose 1, single for covid-19 immunisation. Medical history included asthma, migraines, shellfish allergy and allergy to sulfa drugs. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), and ipratropium bromide. The patient had no other vaccine in four weeks and no covid prior to vaccination. On 08Apr2021 at 13:15, the patient's throat began to tingle and close slightly and she developed a cough, generally experienced when she has an allergic reaction to shellfish. She also became hoarse. This occurred 10 mins after receiving her vaccine (as reported). She had to administer her epipen and the EMT took her to the ER for additional medication. The events resulted in emergency room/department or urgent care and was treated with epipen and an IV of benadryl and prednisone. The patient was not tested for covid post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Pharyngeal paraesthesia, Throat tightness
Clinical narrative: My throat began to tingle and close slightly; My throat began to tingle and close slightly; cough; I also became hoarse.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 (Batch/Lot Number: EW0158) as dose 1, single for covid-19 immunisation. Medical history included asthma, migraines, shellfish allergy and allergy to sulfa drugs. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), and ipratropium bromide. The patient had no other vaccine in four weeks and no covid prior to vaccination. On 08Apr2021 at 13:15, the patient's throat began to tingle and close slightly and she developed a cough, generally experienced when she has an allergic reaction to shellfish. She also became hoarse. This occurred 10 mins after receiving her vaccine (as reported). She had to administer her epipen and the EMT took her to the ER for additional medication. The events resulted in emergency room/department or urgent care and was treated with epipen and an IV of benadryl and prednisone. The patient was not tested for covid post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Immediately after the injection, I experienced a headache and itchiness in my throat. I went over to the nurse's station to ask if my symptoms were normal. The nurse said no and beckon for me to sit down for they can monitor me. While being monitored, I experienced headache, throat itching then throat swelling. I was given some Benadryl but it did not help. It then became hard for me to swallow. I felt a sensation down right side of leg, and I had difficulty breathing, and shortness of breath, and became cold and had chills. The nurse gave me epi-shot and called 9-1-1. I was taken to the ER. I was given another shot of epinephrine, a dose of steroids, and Benadryl and was monitored. I was also given a pain medicine for my headache. The headache was so severe that it felt like someone was banging and pounding my head against the wall non-stop. Since the vaccine, I still have headaches daily and take Tylenol for it.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Dysphagia, Dyspnoea, Feeling cold
Clinical narrative: Immediately after the injection, I experienced a headache and itchiness in my throat. I went over to the nurse's station to ask if my symptoms were normal. The nurse said no and beckon for me to sit down for they can monitor me. While being monitored, I experienced headache, throat itching then throat swelling. I was given some Benadryl but it did not help. It then became hard for me to swallow. I felt a sensation down right side of leg, and I had difficulty breathing, and shortness of breath, and became cold and had chills. The nurse gave me epi-shot and called 9-1-1. I was taken to the ER. I was given another shot of epinephrine, a dose of steroids, and Benadryl and was monitored. I was also given a pain medicine for my headache. The headache was so severe that it felt like someone was banging and pounding my head against the wall non-stop. Since the vaccine, I still have headaches daily and take Tylenol for it.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immediate post-injection reaction, Nausea, Pharyngeal swelling, Pyrexia
Clinical narrative: Immediately after the injection, I experienced a headache and itchiness in my throat. I went over to the nurse's station to ask if my symptoms were normal. The nurse said no and beckon for me to sit down for they can monitor me. While being monitored, I experienced headache, throat itching then throat swelling. I was given some Benadryl but it did not help. It then became hard for me to swallow. I felt a sensation down right side of leg, and I had difficulty breathing, and shortness of breath, and became cold and had chills. The nurse gave me epi-shot and called 9-1-1. I was taken to the ER. I was given another shot of epinephrine, a dose of steroids, and Benadryl and was monitored. I was also given a pain medicine for my headache. The headache was so severe that it felt like someone was banging and pounding my head against the wall non-stop. Since the vaccine, I still have headaches daily and take Tylenol for it.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Throat irritation
Clinical narrative: Immediately after the injection, I experienced a headache and itchiness in my throat. I went over to the nurse's station to ask if my symptoms were normal. The nurse said no and beckon for me to sit down for they can monitor me. While being monitored, I experienced headache, throat itching then throat swelling. I was given some Benadryl but it did not help. It then became hard for me to swallow. I felt a sensation down right side of leg, and I had difficulty breathing, and shortness of breath, and became cold and had chills. The nurse gave me epi-shot and called 9-1-1. I was taken to the ER. I was given another shot of epinephrine, a dose of steroids, and Benadryl and was monitored. I was also given a pain medicine for my headache. The headache was so severe that it felt like someone was banging and pounding my head against the wall non-stop. Since the vaccine, I still have headaches daily and take Tylenol for it.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Headache, Tinnitus
Clinical narrative: pronounced ringing in left ear; Low level headache; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included high BP, cholesterol, benign prostatic hyperplasia (BPH), sleep disorder, hearing loss  and known allergies with certain types of fish. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN), dutasteride (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date . 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 06Apr2021 at 15:00,on second day, the patient experienced somewhat pronounced ringing in left ear associated with 36-hour low level headache. The patient previously had moderate hearing loss in the same ear and a hearing test was already pending with ENT physician. 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 pronounced ringing in left ear and low level headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: pronounced ringing in left ear; Low level headache; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included high BP, cholesterol, benign prostatic hyperplasia (BPH), sleep disorder, hearing loss  and known allergies with certain types of fish. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN), dutasteride (MANUFACTURER UNKNOWN) and clonazepam (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date . 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 06Apr2021 at 15:00,on second day, the patient experienced somewhat pronounced ringing in left ear associated with 36-hour low level headache. The patient previously had moderate hearing loss in the same ear and a hearing test was already pending with ENT physician. 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 pronounced ringing in left ear and low level headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: toe continues to be red and swollen; Moderate/severe pulsing pain in left big toe; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: PFIZER EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included toe injury on Sep2020 about 7 months ago. The patient had no known allergies. Concomitant medications included valaciclovir (VALACYCLOVIR) and PNR (unspecified) for unknown indication on unknown dates. 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 04Apr2021 at 03:30 the patient experienced moderate/severe pulsing pain in left big toe and toe was red and swollen. It was reported that after the first night of extreme pain, the pain had subsided, but the toe continues to be red and swollen, which it was not prior to the vaccine. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events pulsing pain in left big toe and toe continues to be red and swollen were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: toe continues to be red and swollen; Moderate/severe pulsing pain in left big toe; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: PFIZER EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included toe injury on Sep2020 about 7 months ago. The patient had no known allergies. Concomitant medications included valaciclovir (VALACYCLOVIR) and PNR (unspecified) for unknown indication on unknown dates. 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 04Apr2021 at 03:30 the patient experienced moderate/severe pulsing pain in left big toe and toe was red and swollen. It was reported that after the first night of extreme pain, the pain had subsided, but the toe continues to be red and swollen, which it was not prior to the vaccine. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events pulsing pain in left big toe and toe continues to be red and swollen were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Erythema, Pruritus, Urticaria
Clinical narrative: Itching all over body; Rash that would cover torso, inside arms, neck, back, tops of feet; Hives that would cover torso, inside arms, neck, back, tops of feet; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to adhesives and non-severe latex allergy. Concomitant medications included nicotinic acid (NIACIN) for an unknown indication from an unknown date and elderberry supplements for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 16:00 the patient experienced itching all over body and also experienced rash and hives that would cover her torso, inside arms, neck, back, tops of her feet when she was hot, or when she got in the shower. The patient had non-stop itching just a couple of days, shy of 3 weeks after the vaccination.  It would subside a little when taking BENADRYL or ALLEGRA.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with triamcinolone acetonide cream (MANUFACTURER UNKNOWN) and BENADRYL or ALLEGRA. The clinical outcome of the event itching all over body, rash and hives were recovering at the time of report.   No follow-up attempts are needed. No further information is expected. .
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching all over body; Rash that would cover torso, inside arms, neck, back, tops of feet; Hives that would cover torso, inside arms, neck, back, tops of feet; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to adhesives and non-severe latex allergy. Concomitant medications included nicotinic acid (NIACIN) for an unknown indication from an unknown date and elderberry supplements for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 16:00 the patient experienced itching all over body and also experienced rash and hives that would cover her torso, inside arms, neck, back, tops of her feet when she was hot, or when she got in the shower. The patient had non-stop itching just a couple of days, shy of 3 weeks after the vaccination.  It would subside a little when taking BENADRYL or ALLEGRA.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with triamcinolone acetonide cream (MANUFACTURER UNKNOWN) and BENADRYL or ALLEGRA. The clinical outcome of the event itching all over body, rash and hives were recovering at the time of report.   No follow-up attempts are needed. No further information is expected. .
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Injection site pain, Oedema, Peripheral swelling, Stool analysis
Clinical narrative: PALPITATIONS COMMENCED ABOUT ONE WEEK; SWELLING 'TO ALL OVER BODY' LASTED FOR 2 WEEKS; HURTING ALL OVER BODY; PAINFUL RIGHT SHOULDER; PAIN TO LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, non smoker, pain to right shoulder, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 01805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for cardiac, atorvastatin for cholesterol management, infliximab for ulcerative colitis, and mesalazine for ulcerative colitis. On 18-MAR-2021, the subject experienced pain to left arm at injection site. On 21-MAR-2021, the subject experienced palpitations commenced about one week. On 21-MAR-2021, the subject experienced swelling 'to all over body' lasted for 2 weeks. On 21-MAR-2021, the subject experienced hurting all over body. On 21-MAR-2021, the subject experienced painful right shoulder. On 19-APR-2021, Laboratory data included: EKG (NR: not provided) Normal. On 05-JUL-2021, Laboratory data included: X-ray (NR: not provided) Normal shoulder xray. Laboratory data (dates unspecified) included: ECG (NR: not provided) Normal. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations commenced about one week, and swelling 'to all over body' lasted for 2 weeks on 14-MAY-2021, hurting all over body on 16-MAY-2021, and pain to left arm at injection site on 21-MAR-2021, and had not recovered from painful right shoulder. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: PALPITATIONS COMMENCED ABOUT ONE WEEK; SWELLING 'TO ALL OVER BODY' LASTED FOR 2 WEEKS; HURTING ALL OVER BODY; PAINFUL RIGHT SHOULDER; PAIN TO LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, non smoker, pain to right shoulder, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 01805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for cardiac, atorvastatin for cholesterol management, infliximab for ulcerative colitis, and mesalazine for ulcerative colitis. On 18-MAR-2021, the subject experienced pain to left arm at injection site. On 21-MAR-2021, the subject experienced palpitations commenced about one week. On 21-MAR-2021, the subject experienced swelling 'to all over body' lasted for 2 weeks. On 21-MAR-2021, the subject experienced hurting all over body. On 21-MAR-2021, the subject experienced painful right shoulder. On 19-APR-2021, Laboratory data included: EKG (NR: not provided) Normal. On 05-JUL-2021, Laboratory data included: X-ray (NR: not provided) Normal shoulder xray. Laboratory data (dates unspecified) included: ECG (NR: not provided) Normal. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations commenced about one week, and swelling 'to all over body' lasted for 2 weeks on 14-MAY-2021, hurting all over body on 16-MAY-2021, and pain to left arm at injection site on 21-MAR-2021, and had not recovered from painful right shoulder. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Electrocardiogram, Injection site pain, Pain, Palpitations
Clinical narrative: PALPITATIONS COMMENCED ABOUT ONE WEEK; SWELLING 'TO ALL OVER BODY' LASTED FOR 2 WEEKS; HURTING ALL OVER BODY; PAINFUL RIGHT SHOULDER; PAIN TO LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, non smoker, pain to right shoulder, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 01805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for cardiac, atorvastatin for cholesterol management, infliximab for ulcerative colitis, and mesalazine for ulcerative colitis. On 18-MAR-2021, the subject experienced pain to left arm at injection site. On 21-MAR-2021, the subject experienced palpitations commenced about one week. On 21-MAR-2021, the subject experienced swelling 'to all over body' lasted for 2 weeks. On 21-MAR-2021, the subject experienced hurting all over body. On 21-MAR-2021, the subject experienced painful right shoulder. On 19-APR-2021, Laboratory data included: EKG (NR: not provided) Normal. On 05-JUL-2021, Laboratory data included: X-ray (NR: not provided) Normal shoulder xray. Laboratory data (dates unspecified) included: ECG (NR: not provided) Normal. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations commenced about one week, and swelling 'to all over body' lasted for 2 weeks on 14-MAY-2021, hurting all over body on 16-MAY-2021, and pain to left arm at injection site on 21-MAR-2021, and had not recovered from painful right shoulder. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, X-ray
Clinical narrative: PALPITATIONS COMMENCED ABOUT ONE WEEK; SWELLING 'TO ALL OVER BODY' LASTED FOR 2 WEEKS; HURTING ALL OVER BODY; PAINFUL RIGHT SHOULDER; PAIN TO LEFT ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non-alcohol user, non smoker, pain to right shoulder, and type 2 diabetes mellitus, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 01805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for cardiac, atorvastatin for cholesterol management, infliximab for ulcerative colitis, and mesalazine for ulcerative colitis. On 18-MAR-2021, the subject experienced pain to left arm at injection site. On 21-MAR-2021, the subject experienced palpitations commenced about one week. On 21-MAR-2021, the subject experienced swelling 'to all over body' lasted for 2 weeks. On 21-MAR-2021, the subject experienced hurting all over body. On 21-MAR-2021, the subject experienced painful right shoulder. On 19-APR-2021, Laboratory data included: EKG (NR: not provided) Normal. On 05-JUL-2021, Laboratory data included: X-ray (NR: not provided) Normal shoulder xray. Laboratory data (dates unspecified) included: ECG (NR: not provided) Normal. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations commenced about one week, and swelling 'to all over body' lasted for 2 weeks on 14-MAY-2021, hurting all over body on 16-MAY-2021, and pain to left arm at injection site on 21-MAR-2021, and had not recovered from painful right shoulder. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Left face, left underlying chin, and left dorsal hand paresthesias 30 minutes after vaccine #1. Since her vaccination 4/10/21 she's had increasing, multifocal areas of paresthesia around her body including calves, feet, buttocks, abdomen, left thigh, left forearm, groin, R dorsal wrist, R medial forearm, and R posterior upper arm (with continued spread as recently as 7/17).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Miliaria, Paraesthesia
Clinical narrative: Left face, left underlying chin, and left dorsal hand paresthesias 30 minutes after vaccine #1. Since her vaccination 4/10/21 she's had increasing, multifocal areas of paresthesia around her body including calves, feet, buttocks, abdomen, left thigh, left forearm, groin, R dorsal wrist, R medial forearm, and R posterior upper arm (with continued spread as recently as 7/17).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Biopsy skin normal, Paraesthesia
Clinical narrative: Left face, left underlying chin, and left dorsal hand paresthesias 30 minutes after vaccine #1. Since her vaccination 4/10/21 she's had increasing, multifocal areas of paresthesia around her body including calves, feet, buttocks, abdomen, left thigh, left forearm, groin, R dorsal wrist, R medial forearm, and R posterior upper arm (with continued spread as recently as 7/17).
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Muscular weakness, Pyrexia
Clinical narrative: By the 10th day, I could barely walk.  It is now two weeks after the 2nd vaccine, and I can walk only about 700 steps at a time at a pace less than 2 mph.  I previously could; On the 9th day after receiving the 2nd vaccine, my legs became very weak.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 19Apr2021 at 09:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient previously took prednisone (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Concomitant medications taken within two weeks of vaccination included duloxetine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and daily multivitamin (unspecified), all for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 09:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 28Apr2021, the 9th day after receiving the second vaccine, the patient's legs became very weak. On 29Apr2021, by the 10th day, the patient could barely walk. It was two weeks after the 2nd vaccine at the time of report, and the patient could walk only about 700 steps at a time at a pace less than 2 mph. The patient previously could walk over 3 miles at 4 mph. The clinical outcome of the event legs became very weak and could barely walk was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: By the 10th day, I could barely walk.  It is now two weeks after the 2nd vaccine, and I can walk only about 700 steps at a time at a pace less than 2 mph.  I previously could; On the 9th day after receiving the 2nd vaccine, my legs became very weak.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 19Apr2021 at 09:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient previously took prednisone (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Concomitant medications taken within two weeks of vaccination included duloxetine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and daily multivitamin (unspecified), all for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 09:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 28Apr2021, the 9th day after receiving the second vaccine, the patient's legs became very weak. On 29Apr2021, by the 10th day, the patient could barely walk. It was two weeks after the 2nd vaccine at the time of report, and the patient could walk only about 700 steps at a time at a pace less than 2 mph. The patient previously could walk over 3 miles at 4 mph. The clinical outcome of the event legs became very weak and could barely walk was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pruritus, Rash, Skin irritation
Clinical narrative: rash looks like Shingles; Calamine lotion does not reduce irritation; rash appeared on back starting at spine, within a week  it has grown outward from the spine in a band stretching away from spinal cord in one direction; Mild itchiness; This is a spontaneous report from a contactable consumer, the patient. A 39-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 arm right on 26Apr2021 at 11:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included magnesium 1000 mg/day (MANUFACTURER UNKNOWN) and align probiotic from unknown dates taken for unknown indications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Apr2021 at 12:00 (at the age of 39-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 28Apr2021 at 12:00 the patient experienced rash appearing on the back starting at the spine, and within a week it had grown outward from the spine in a band stretching away from spinal cord in one direction, mild itchiness, calamine lotion did not reduce irritation. The events resulted in doctor or other healthcare professional office/clinic visit. Dermatologist office visit was on 04May2021, and determined that the rash looks like shingles. Therapeutic measure was taken as a result of the events rash, mild itchiness, skin irritation and shingles which included treatment with 7 day course of Valtrax. The clinical outcome of the events rash, mild itchiness, skin irritation and shingles was not recovered at the time of this report.   No follow-up attempts needed; information about lot/batch number cannot be obtained.