chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Skin tightness, Varicella virus test negative, Vertebral lesion
Clinical narrative: 3/1 and 3/25/21 patient received COVID19 vaccines (Pfizer)  3/8/21 developed a shingles rash over the lower part of the LEFT breast, wrapping around the back Prior hx chicken pox, first time episode of shingles -- > 7  Days of oral valacyclovir. States her vesicular rashes were all scabbed over within 2 weeks of treatment.  3/28 Left finger, toe, and lower breast tingling that progressed over time to impact her entire left arm, leg, and trunk from breast level down; torso tightness in the same distribution of her shingles rash By 4/9, tingling had risen up the left leg to the groin -- > MRI cervical spine on 4/9 noncontrast showed C3 and C7-T1 lesions -- > MRI C/T/L spine on 4/14 with enhancing lesions at multiple cervical and thoracic levels -- > LP on 4/14 with borderline OCB; HSV and VZV negative. (Cells/glucose/protein: 3/77/29) -- > MRI brain 4/15 with 'nonspecific' T2/FLAIR hyperintense lesions. Received IV acyclovir for 6 days 4/14-4/20 -- > Received IV acyclovir for 6 days 4/14-4/20, then 4/20-4/22/21 IV solumedrol X 3 days without noticeable improvement  MRI brain and cervical spine with and without contrast done July 16, 2021 showed no new lesions and resolution of enhancement.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electric shock sensation, Headache, Joint stiffness, Pain, Pain in extremity
Clinical narrative: spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 26Mar2021 at 13:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included possibly latex allergy. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VIT D), vitamin b complex (VIT B COMPLEX) and COQ10 all for unknown indication and from unknown date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in left arm on 05Mar2021 at 13:15 as a single dose for COVID-19 immunisation.  The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been diagnosed with COVID-19. On 26Mar2021 at 13:45 the patient experienced About 30 minutes after receiving the 2nd dose, she felt a stiffening, tightness and shock-like pain in 3 of the fingers on her right hand. Pain seemed to start in knuckle and travel to the finger tips. Pain was worse with movement of the fingers. Pain continued in severity the rest of the day, and she took Tylenol that evening for pain. Pain has continued to a lesser degree in general, but the shooting pain does reoccur with movement on some occasions daily. Pain in the knuckle had appeared to have moved to the joints between the knuckle and fingertips and radiated towards the fingertips. The patient did notice pain in the top joint of the index finger and noticed a swelling in at least the 4th knuckle as she no longer can get a commonly worn ring on that finger. It had been 10 days since she got 2nd vaccine, and reoccurring pain continued, mostly moderate pain with movement. She did not have any of these symptoms prior to second vaccine. The patient also experienced a throbbing headache on 2nd day. The patient received Tylenol as a  treatment drug for the events of  pain in fingers, shooting pain, joint pain, pain upon movement . The clinical outcome of the events stiff fingers, pain in fingers, shooting pain, joint pain and pain upon movement was recovering and the clinical outcome of the events swelling and throbbing headache was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 26Mar2021 at 13:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included possibly latex allergy. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VIT D), vitamin b complex (VIT B COMPLEX) and COQ10 all for unknown indication and from unknown date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in left arm on 05Mar2021 at 13:15 as a single dose for COVID-19 immunisation.  The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been diagnosed with COVID-19. On 26Mar2021 at 13:45 the patient experienced About 30 minutes after receiving the 2nd dose, she felt a stiffening, tightness and shock-like pain in 3 of the fingers on her right hand. Pain seemed to start in knuckle and travel to the finger tips. Pain was worse with movement of the fingers. Pain continued in severity the rest of the day, and she took Tylenol that evening for pain. Pain has continued to a lesser degree in general, but the shooting pain does reoccur with movement on some occasions daily. Pain in the knuckle had appeared to have moved to the joints between the knuckle and fingertips and radiated towards the fingertips. The patient did notice pain in the top joint of the index finger and noticed a swelling in at least the 4th knuckle as she no longer can get a commonly worn ring on that finger. It had been 10 days since she got 2nd vaccine, and reoccurring pain continued, mostly moderate pain with movement. She did not have any of these symptoms prior to second vaccine. The patient also experienced a throbbing headache on 2nd day. The patient received Tylenol as a  treatment drug for the events of  pain in fingers, shooting pain, joint pain, pain upon movement . The clinical outcome of the events stiff fingers, pain in fingers, shooting pain, joint pain and pain upon movement was recovering and the clinical outcome of the events swelling and throbbing headache was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 26Mar2021 at 13:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included possibly latex allergy. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VIT D), vitamin b complex (VIT B COMPLEX) and COQ10 all for unknown indication and from unknown date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in left arm on 05Mar2021 at 13:15 as a single dose for COVID-19 immunisation.  The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been diagnosed with COVID-19. On 26Mar2021 at 13:45 the patient experienced About 30 minutes after receiving the 2nd dose, she felt a stiffening, tightness and shock-like pain in 3 of the fingers on her right hand. Pain seemed to start in knuckle and travel to the finger tips. Pain was worse with movement of the fingers. Pain continued in severity the rest of the day, and she took Tylenol that evening for pain. Pain has continued to a lesser degree in general, but the shooting pain does reoccur with movement on some occasions daily. Pain in the knuckle had appeared to have moved to the joints between the knuckle and fingertips and radiated towards the fingertips. The patient did notice pain in the top joint of the index finger and noticed a swelling in at least the 4th knuckle as she no longer can get a commonly worn ring on that finger. It had been 10 days since she got 2nd vaccine, and reoccurring pain continued, mostly moderate pain with movement. She did not have any of these symptoms prior to second vaccine. The patient also experienced a throbbing headache on 2nd day. The patient received Tylenol as a  treatment drug for the events of  pain in fingers, shooting pain, joint pain, pain upon movement . The clinical outcome of the events stiff fingers, pain in fingers, shooting pain, joint pain and pain upon movement was recovering and the clinical outcome of the events swelling and throbbing headache was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 26Mar2021 at 13:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included possibly latex allergy. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VIT D), vitamin b complex (VIT B COMPLEX) and COQ10 all for unknown indication and from unknown date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in left arm on 05Mar2021 at 13:15 as a single dose for COVID-19 immunisation.  The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been diagnosed with COVID-19. On 26Mar2021 at 13:45 the patient experienced About 30 minutes after receiving the 2nd dose, she felt a stiffening, tightness and shock-like pain in 3 of the fingers on her right hand. Pain seemed to start in knuckle and travel to the finger tips. Pain was worse with movement of the fingers. Pain continued in severity the rest of the day, and she took Tylenol that evening for pain. Pain has continued to a lesser degree in general, but the shooting pain does reoccur with movement on some occasions daily. Pain in the knuckle had appeared to have moved to the joints between the knuckle and fingertips and radiated towards the fingertips. The patient did notice pain in the top joint of the index finger and noticed a swelling in at least the 4th knuckle as she no longer can get a commonly worn ring on that finger. It had been 10 days since she got 2nd vaccine, and reoccurring pain continued, mostly moderate pain with movement. She did not have any of these symptoms prior to second vaccine. The patient also experienced a throbbing headache on 2nd day. The patient received Tylenol as a  treatment drug for the events of  pain in fingers, shooting pain, joint pain, pain upon movement . The clinical outcome of the events stiff fingers, pain in fingers, shooting pain, joint pain and pain upon movement was recovering and the clinical outcome of the events swelling and throbbing headache was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphthous ulcer, Blood test, Decreased appetite, Oropharyngeal pain, Physical examination
Clinical narrative: Aphthous ulcer in mouth and gums; Sore throat; This is a spontaneous report from a contactable physician. A 17-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 7533) via intramuscular route in the left arm on 16Apr2021 at 13:30 (at the age of 17-years-old), as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within 2 weeks prior to the COVID vaccine. The patient's past drug was reported as peanuts. 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 vaccination within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 13:30, the patient experienced aphthous ulcers in mouth and gums and sore throat. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events aphthous ulcers in mouth and gums and sore throat and included treatment with prednisone and listerine. The clinical outcome of the events aphthous ulcers and sore throat were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphthous ulcer, Oropharyngeal pain
Clinical narrative: Aphthous ulcer in mouth and gums; Sore throat; This is a spontaneous report from a contactable physician. A 17-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP 7533) via intramuscular route in the left arm on 16Apr2021 at 13:30 (at the age of 17-years-old), as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within 2 weeks prior to the COVID vaccine. The patient's past drug was reported as peanuts. 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 vaccination within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 13:30, the patient experienced aphthous ulcers in mouth and gums and sore throat. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events aphthous ulcers in mouth and gums and sore throat and included treatment with prednisone and listerine. The clinical outcome of the events aphthous ulcers and sore throat were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Pruritus
Clinical narrative: INABILITY TO SLEEP/SLEEPLESSNESS; SHORTNESS OF BREATH ATTACKS; BRUISES ON ARMS AND LEGS THAT SHOW UP OUT OF NOWHERE/ BRUISING  BEGAN ON THE LOWER LIMBS AND SPREADING UPWARD; BITTERNESS IN MOUTH; LOSS OF APPETITE; WEIGHT LOSS; DIFFICULTY HOLDING THINGS; FATIGUE/UNABLE TO DO ANY ACTIVITY; CHEST PAIN; NUMBNESS IN ARMS AND LEGS/ NUMBNESS  BEGAN ON THE LEFT HAND AND SPREAD TO THE RIGHT SIDE; PAIN IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sjorgen syndrome, familial mediterranean fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and the patient had no known allergies. the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chest pain. On 13-MAR-2021, the subject experienced numbness in arms and legs (numbness began on the left hand and spread to the right side). On 13-MAR-2021, the subject experienced pain in arms and legs. On 17-MAR-2021, the subject experienced inability to sleep/sleeplessness. On 17-MAR-2021, the subject experienced shortness of breath attacks. On 17-MAR-2021, the subject experienced bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward). On 17-MAR-2021, the subject experienced bitterness in mouth. On 17-MAR-2021, the subject experienced loss of appetite. On 17-MAR-2021, the subject experienced weight loss. On 17-MAR-2021, the subject experienced difficulty holding things. On 17-MAR-2021, the subject experienced fatigue/unable to do any activity. On 16-JUN-2021, Laboratory data included: Blood test (NR: not provided) Ruled out clots. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inability to sleep/sleeplessness, fatigue/unable to do any activity, shortness of breath attacks, bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward), difficulty holding things, chest pain, bitterness in mouth, loss of appetite, and weight loss, and the outcome of numbness in arms and legs (numbness began on the left hand and spread to the right side) and pain in arms and legs was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Contusion, Decreased appetite, Dysgeusia
Clinical narrative: INABILITY TO SLEEP/SLEEPLESSNESS; SHORTNESS OF BREATH ATTACKS; BRUISES ON ARMS AND LEGS THAT SHOW UP OUT OF NOWHERE/ BRUISING  BEGAN ON THE LOWER LIMBS AND SPREADING UPWARD; BITTERNESS IN MOUTH; LOSS OF APPETITE; WEIGHT LOSS; DIFFICULTY HOLDING THINGS; FATIGUE/UNABLE TO DO ANY ACTIVITY; CHEST PAIN; NUMBNESS IN ARMS AND LEGS/ NUMBNESS  BEGAN ON THE LEFT HAND AND SPREAD TO THE RIGHT SIDE; PAIN IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sjorgen syndrome, familial mediterranean fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and the patient had no known allergies. the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chest pain. On 13-MAR-2021, the subject experienced numbness in arms and legs (numbness began on the left hand and spread to the right side). On 13-MAR-2021, the subject experienced pain in arms and legs. On 17-MAR-2021, the subject experienced inability to sleep/sleeplessness. On 17-MAR-2021, the subject experienced shortness of breath attacks. On 17-MAR-2021, the subject experienced bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward). On 17-MAR-2021, the subject experienced bitterness in mouth. On 17-MAR-2021, the subject experienced loss of appetite. On 17-MAR-2021, the subject experienced weight loss. On 17-MAR-2021, the subject experienced difficulty holding things. On 17-MAR-2021, the subject experienced fatigue/unable to do any activity. On 16-JUN-2021, Laboratory data included: Blood test (NR: not provided) Ruled out clots. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inability to sleep/sleeplessness, fatigue/unable to do any activity, shortness of breath attacks, bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward), difficulty holding things, chest pain, bitterness in mouth, loss of appetite, and weight loss, and the outcome of numbness in arms and legs (numbness began on the left hand and spread to the right side) and pain in arms and legs was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Hypoaesthesia, Insomnia, Muscular weakness
Clinical narrative: INABILITY TO SLEEP/SLEEPLESSNESS; SHORTNESS OF BREATH ATTACKS; BRUISES ON ARMS AND LEGS THAT SHOW UP OUT OF NOWHERE/ BRUISING  BEGAN ON THE LOWER LIMBS AND SPREADING UPWARD; BITTERNESS IN MOUTH; LOSS OF APPETITE; WEIGHT LOSS; DIFFICULTY HOLDING THINGS; FATIGUE/UNABLE TO DO ANY ACTIVITY; CHEST PAIN; NUMBNESS IN ARMS AND LEGS/ NUMBNESS  BEGAN ON THE LEFT HAND AND SPREAD TO THE RIGHT SIDE; PAIN IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sjorgen syndrome, familial mediterranean fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and the patient had no known allergies. the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chest pain. On 13-MAR-2021, the subject experienced numbness in arms and legs (numbness began on the left hand and spread to the right side). On 13-MAR-2021, the subject experienced pain in arms and legs. On 17-MAR-2021, the subject experienced inability to sleep/sleeplessness. On 17-MAR-2021, the subject experienced shortness of breath attacks. On 17-MAR-2021, the subject experienced bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward). On 17-MAR-2021, the subject experienced bitterness in mouth. On 17-MAR-2021, the subject experienced loss of appetite. On 17-MAR-2021, the subject experienced weight loss. On 17-MAR-2021, the subject experienced difficulty holding things. On 17-MAR-2021, the subject experienced fatigue/unable to do any activity. On 16-JUN-2021, Laboratory data included: Blood test (NR: not provided) Ruled out clots. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inability to sleep/sleeplessness, fatigue/unable to do any activity, shortness of breath attacks, bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward), difficulty holding things, chest pain, bitterness in mouth, loss of appetite, and weight loss, and the outcome of numbness in arms and legs (numbness began on the left hand and spread to the right side) and pain in arms and legs was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Weight decreased
Clinical narrative: INABILITY TO SLEEP/SLEEPLESSNESS; SHORTNESS OF BREATH ATTACKS; BRUISES ON ARMS AND LEGS THAT SHOW UP OUT OF NOWHERE/ BRUISING  BEGAN ON THE LOWER LIMBS AND SPREADING UPWARD; BITTERNESS IN MOUTH; LOSS OF APPETITE; WEIGHT LOSS; DIFFICULTY HOLDING THINGS; FATIGUE/UNABLE TO DO ANY ACTIVITY; CHEST PAIN; NUMBNESS IN ARMS AND LEGS/ NUMBNESS  BEGAN ON THE LEFT HAND AND SPREAD TO THE RIGHT SIDE; PAIN IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sjorgen syndrome, familial mediterranean fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and the patient had no known allergies. the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chest pain. On 13-MAR-2021, the subject experienced numbness in arms and legs (numbness began on the left hand and spread to the right side). On 13-MAR-2021, the subject experienced pain in arms and legs. On 17-MAR-2021, the subject experienced inability to sleep/sleeplessness. On 17-MAR-2021, the subject experienced shortness of breath attacks. On 17-MAR-2021, the subject experienced bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward). On 17-MAR-2021, the subject experienced bitterness in mouth. On 17-MAR-2021, the subject experienced loss of appetite. On 17-MAR-2021, the subject experienced weight loss. On 17-MAR-2021, the subject experienced difficulty holding things. On 17-MAR-2021, the subject experienced fatigue/unable to do any activity. On 16-JUN-2021, Laboratory data included: Blood test (NR: not provided) Ruled out clots. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inability to sleep/sleeplessness, fatigue/unable to do any activity, shortness of breath attacks, bruises on arms and legs that show up out of nowhere (bruising began on the lower limbs and spreading upward), difficulty holding things, chest pain, bitterness in mouth, loss of appetite, and weight loss, and the outcome of numbness in arms and legs (numbness began on the left hand and spread to the right side) and pain in arms and legs was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Eye swelling, Fatigue, Headache
Clinical narrative: Incessant sneezing; Swelling in face; Sinus congestion; Hives around patient body; Extreme nausea; Body aches; Fever of up to 102; Headache; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 31Mar2021 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021 at 18:00, the patient experienced fever of up to 102 (body temperature was 102(unspecified units)), body aches, headache and extreme nausea (incapable of holding down everything including water). On 04Apr2021, the patient experienced incessant sneezing, swelling in face, sinus congestion and hives around body. No therapeutic measures were taken as a result of reported events. The clinical outcome of fever of up to 102, body aches, headache and extreme nausea was not recovered. The clinical outcome of the swelling in face and hives around body was lasting about 12 hours i.e. recovered on an unspecified time on 04Apr2021; while that of incessant sneezing and sinus congestion was recovered on 05Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nasal congestion, Nausea, Pain, Pyrexia
Clinical narrative: Incessant sneezing; Swelling in face; Sinus congestion; Hives around patient body; Extreme nausea; Body aches; Fever of up to 102; Headache; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 31Mar2021 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021 at 18:00, the patient experienced fever of up to 102 (body temperature was 102(unspecified units)), body aches, headache and extreme nausea (incapable of holding down everything including water). On 04Apr2021, the patient experienced incessant sneezing, swelling in face, sinus congestion and hives around body. No therapeutic measures were taken as a result of reported events. The clinical outcome of fever of up to 102, body aches, headache and extreme nausea was not recovered. The clinical outcome of the swelling in face and hives around body was lasting about 12 hours i.e. recovered on an unspecified time on 04Apr2021; while that of incessant sneezing and sinus congestion was recovered on 05Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sneezing, Swelling, Swelling face, Urticaria, Vomiting
Clinical narrative: Incessant sneezing; Swelling in face; Sinus congestion; Hives around patient body; Extreme nausea; Body aches; Fever of up to 102; Headache; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 31Mar2021 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021 at 18:00, the patient experienced fever of up to 102 (body temperature was 102(unspecified units)), body aches, headache and extreme nausea (incapable of holding down everything including water). On 04Apr2021, the patient experienced incessant sneezing, swelling in face, sinus congestion and hives around body. No therapeutic measures were taken as a result of reported events. The clinical outcome of fever of up to 102, body aches, headache and extreme nausea was not recovered. The clinical outcome of the swelling in face and hives around body was lasting about 12 hours i.e. recovered on an unspecified time on 04Apr2021; while that of incessant sneezing and sinus congestion was recovered on 05Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Incessant sneezing; Swelling in face; Sinus congestion; Hives around patient body; Extreme nausea; Body aches; Fever of up to 102; Headache; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 31Mar2021 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021 at 18:00, the patient experienced fever of up to 102 (body temperature was 102(unspecified units)), body aches, headache and extreme nausea (incapable of holding down everything including water). On 04Apr2021, the patient experienced incessant sneezing, swelling in face, sinus congestion and hives around body. No therapeutic measures were taken as a result of reported events. The clinical outcome of fever of up to 102, body aches, headache and extreme nausea was not recovered. The clinical outcome of the swelling in face and hives around body was lasting about 12 hours i.e. recovered on an unspecified time on 04Apr2021; while that of incessant sneezing and sinus congestion was recovered on 05Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus congestion, Sneezing, Swelling face, Urticaria
Clinical narrative: Incessant sneezing; Swelling in face; Sinus congestion; Hives around patient body; Extreme nausea; Body aches; Fever of up to 102; Headache; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 31Mar2021 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 31Mar2021 at 18:00, the patient experienced fever of up to 102 (body temperature was 102(unspecified units)), body aches, headache and extreme nausea (incapable of holding down everything including water). On 04Apr2021, the patient experienced incessant sneezing, swelling in face, sinus congestion and hives around body. No therapeutic measures were taken as a result of reported events. The clinical outcome of fever of up to 102, body aches, headache and extreme nausea was not recovered. The clinical outcome of the swelling in face and hives around body was lasting about 12 hours i.e. recovered on an unspecified time on 04Apr2021; while that of incessant sneezing and sinus congestion was recovered on 05Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient hospitalized with positive COVID  Sepsis secondary to COVID
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient hospitalized with positive COVID  Sepsis secondary to COVID
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; A sore arm at site of injection on the first dose; The first dose is "compromised (may not have been kept at the proper temperature); The first dose is "compromised (may not have been kept at the proper temperature); This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; Lot Number: EL9269), dose 1 via an unspecified route of administration on 15Feb2021 (at the age of 74 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus, NASH cirrhosis and hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported that she received the Pfizer-BioNTech COVID-19 Vaccine first dose a week ago on 15Feb2021. Patient stated that she received a call this morning from the Hospital, told her that the first dose is "compromised (may not have been kept at the proper temperature)" and that is the reason she is scheduled for another dose this Thursday 24th. Just 10 days later. She also mentioned that she had a sore arm at site of injection on the first dose. They said it was compromised because it was not properly handled or refrigerated. If she get another number 1 vaccine, that will be 2 first vaccines she will have had. She reported receiving a "compromised" Pfizer vaccine dose, along with 81 other people who received the same "compromised" doses. She stated the vaccine was not kept at proper temperatures and the CDC advised them to get another dose of the vaccine. She received her second Pfizer Covid vaccine dose on 25Feb2021 (10 days later) and had been experiencing side effects since 28Feb2021. She reported "severe headache, back and neck pain, nausea, diarrhea, weak, tired, on 9th day of this and still not feeling well. Her MD had a feeling there was too much vaccine given in a short period of time, which could cause antibodies to be high. Her MD gave her a Covid antibody spike test, results back today showed that the spike was 9.3 and normal is 1.0 on an unknown date. She wanted to know how serious this could be because she was concerned that the first dose still had some efficacy and now she had received another dose too soon. She wanted to know if she was in any danger with her antibody number being so high. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Poor quality product administered, Product temperature excursion issue, SARS-CoV-2 antibody test
Clinical narrative: Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; A sore arm at site of injection on the first dose; The first dose is "compromised (may not have been kept at the proper temperature); The first dose is "compromised (may not have been kept at the proper temperature); This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; Lot Number: EL9269), dose 1 via an unspecified route of administration on 15Feb2021 (at the age of 74 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus, NASH cirrhosis and hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported that she received the Pfizer-BioNTech COVID-19 Vaccine first dose a week ago on 15Feb2021. Patient stated that she received a call this morning from the Hospital, told her that the first dose is "compromised (may not have been kept at the proper temperature)" and that is the reason she is scheduled for another dose this Thursday 24th. Just 10 days later. She also mentioned that she had a sore arm at site of injection on the first dose. They said it was compromised because it was not properly handled or refrigerated. If she get another number 1 vaccine, that will be 2 first vaccines she will have had. She reported receiving a "compromised" Pfizer vaccine dose, along with 81 other people who received the same "compromised" doses. She stated the vaccine was not kept at proper temperatures and the CDC advised them to get another dose of the vaccine. She received her second Pfizer Covid vaccine dose on 25Feb2021 (10 days later) and had been experiencing side effects since 28Feb2021. She reported "severe headache, back and neck pain, nausea, diarrhea, weak, tired, on 9th day of this and still not feeling well. Her MD had a feeling there was too much vaccine given in a short period of time, which could cause antibodies to be high. Her MD gave her a Covid antibody spike test, results back today showed that the spike was 9.3 and normal is 1.0 on an unknown date. She wanted to know how serious this could be because she was concerned that the first dose still had some efficacy and now she had received another dose too soon. She wanted to know if she was in any danger with her antibody number being so high. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; A sore arm at site of injection on the first dose; The first dose is "compromised (may not have been kept at the proper temperature); The first dose is "compromised (may not have been kept at the proper temperature); This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; Lot Number: EL9269), dose 1 via an unspecified route of administration on 15Feb2021 (at the age of 74 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus, NASH cirrhosis and hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported that she received the Pfizer-BioNTech COVID-19 Vaccine first dose a week ago on 15Feb2021. Patient stated that she received a call this morning from the Hospital, told her that the first dose is "compromised (may not have been kept at the proper temperature)" and that is the reason she is scheduled for another dose this Thursday 24th. Just 10 days later. She also mentioned that she had a sore arm at site of injection on the first dose. They said it was compromised because it was not properly handled or refrigerated. If she get another number 1 vaccine, that will be 2 first vaccines she will have had. She reported receiving a "compromised" Pfizer vaccine dose, along with 81 other people who received the same "compromised" doses. She stated the vaccine was not kept at proper temperatures and the CDC advised them to get another dose of the vaccine. She received her second Pfizer Covid vaccine dose on 25Feb2021 (10 days later) and had been experiencing side effects since 28Feb2021. She reported "severe headache, back and neck pain, nausea, diarrhea, weak, tired, on 9th day of this and still not feeling well. Her MD had a feeling there was too much vaccine given in a short period of time, which could cause antibodies to be high. Her MD gave her a Covid antibody spike test, results back today showed that the spike was 9.3 and normal is 1.0 on an unknown date. She wanted to know how serious this could be because she was concerned that the first dose still had some efficacy and now she had received another dose too soon. She wanted to know if she was in any danger with her antibody number being so high. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood count, Diarrhoea, Fatigue
Clinical narrative: Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; Only just had my first one on February 15 and they want to give me my second one this Thursday which is the 24th. Just 10 days later; A sore arm at site of injection on the first dose; The first dose is "compromised (may not have been kept at the proper temperature); The first dose is "compromised (may not have been kept at the proper temperature); This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; manufacturer: Unspecified; NDC number, UPC number and Expiry Date: Unknown; Lot Number: EL9269), dose 1 via an unspecified route of administration on 15Feb2021 (at the age of 74 years) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus, NASH cirrhosis and hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported that she received the Pfizer-BioNTech COVID-19 Vaccine first dose a week ago on 15Feb2021. Patient stated that she received a call this morning from the Hospital, told her that the first dose is "compromised (may not have been kept at the proper temperature)" and that is the reason she is scheduled for another dose this Thursday 24th. Just 10 days later. She also mentioned that she had a sore arm at site of injection on the first dose. They said it was compromised because it was not properly handled or refrigerated. If she get another number 1 vaccine, that will be 2 first vaccines she will have had. She reported receiving a "compromised" Pfizer vaccine dose, along with 81 other people who received the same "compromised" doses. She stated the vaccine was not kept at proper temperatures and the CDC advised them to get another dose of the vaccine. She received her second Pfizer Covid vaccine dose on 25Feb2021 (10 days later) and had been experiencing side effects since 28Feb2021. She reported "severe headache, back and neck pain, nausea, diarrhea, weak, tired, on 9th day of this and still not feeling well. Her MD had a feeling there was too much vaccine given in a short period of time, which could cause antibodies to be high. Her MD gave her a Covid antibody spike test, results back today showed that the spike was 9.3 and normal is 1.0 on an unknown date. She wanted to know how serious this could be because she was concerned that the first dose still had some efficacy and now she had received another dose too soon. She wanted to know if she was in any danger with her antibody number being so high. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.