chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Influenza like illness, Lymphadenopathy, Magnetic resonance imaging head
Clinical narrative: POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Thrombosis, Ultrasound scan
Clinical narrative: POSSIBLE BLOOD CLOT ISSUE; ELEVATED HEART RATE (OVER 100 AT REST); KIDNEY PAIN; NO APPETITE; FLU LIKE SYMPTOMS; SWOLLEN GLANDS IN NECK; SERIOUS BRAIN FOG; DIARRHEA; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 total, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021 after getting vaccination, the patient experienced elevated heart rate of over 100 at rest for four days. On an unspecified date in JUN-2021 after vaccination, the patient also experienced shortness of breath, headache, kidney pain, diarrhea, no appetite, flu-like symptoms, swollen glands in neck, aches and pains and had severe fatigue. On 14-JUN-2021, after four days of vaccination, the patient heart rate decreased to a healthier range but shortness of breath, headache, swollen glands, extreme fatigue and diarrhea continued. The patient also had serious brain fog. On 21-JUN-2021, after 11 days of vaccination, the patient had a severe shortness of breath and the patient's PCP (primary care physician) directed patient to visit an emergency room in a hospital. The patient took blood test and showed an elevated d-dimer indicating possible blood clot issue. The patient could not perform lung CT (computed tomography) or angiography due to a severe allergy to contrast dye. The patient also had an MRI (magnetic resonance imaging) of brain and ultra sound of the legs and the results were normal. The patient was on day 16 post vaccination at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate (over 100 at rest) on 14-JUN-2021, had not recovered from flu like symptoms, swollen glands in neck, possible blood clot issue, serious brain fog, and diarrhea, and the outcome of shortness of breath, kidney pain and no appetite was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210660381-Covid 19 Vaccine ad26.cov2.s-Possible blood Clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder dilatation, Body temperature, Dysstasia, Mobility decreased, Multiple sclerosis
Clinical narrative: USING WHEELCHAIR; FEEL LIKE COMPLETELY FULL BLADDER; URINATES 5 OR 6 TIMES IN THE LAST HOUR; SLUGGISH; MULTIPLE SCLEROSIS; PROBLEMS STANDING UP; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and no alcohol user, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient had no any side effect from a previous vaccine in the past. he had cold as a cucumber and temperature is in normal range. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 24-JUN-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced multiple sclerosis, experienced problems standing up and sluggish. On 26-JUN-2021, the subject experienced feel like completely full bladder, urinates 5 or 6 times in the last hour, using wheelchair. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Normal. Treatment medications (dates unspecified) included: fampridine, and teriflunomide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggish, had not recovered from problems standing up, feel like completely full bladder, and urinates 5 or 6 times in the last hour, and the outcome of using wheelchair and multiple sclerosis was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660422-COVID-19 VACCINE AD26.COV2.S-Multiple sclerosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Sluggishness
Clinical narrative: USING WHEELCHAIR; FEEL LIKE COMPLETELY FULL BLADDER; URINATES 5 OR 6 TIMES IN THE LAST HOUR; SLUGGISH; MULTIPLE SCLEROSIS; PROBLEMS STANDING UP; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and no alcohol user, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. patient had no any side effect from a previous vaccine in the past. he had cold as a cucumber and temperature is in normal range. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 24-JUN-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced multiple sclerosis, experienced problems standing up and sluggish. On 26-JUN-2021, the subject experienced feel like completely full bladder, urinates 5 or 6 times in the last hour, using wheelchair. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Normal. Treatment medications (dates unspecified) included: fampridine, and teriflunomide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggish, had not recovered from problems standing up, feel like completely full bladder, and urinates 5 or 6 times in the last hour, and the outcome of using wheelchair and multiple sclerosis was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210660422-COVID-19 VACCINE AD26.COV2.S-Multiple sclerosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity, Peripheral swelling
Clinical narrative: SWOLLEN LEFT LEG; LEG PAIN; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight was 285 pounds, and height was 178 centimeters. The patient's concurrent conditions included high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies and no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-JUN-2021, the subject experienced swollen left leg. On 17-JUN-2021, the subject experienced leg pain. Laboratory data included: Pain scale (NR: not provided) 8/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen left leg, and leg pain. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous pregnancy report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced maternal exposure during pregnancy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of maternal exposure during pregnancy was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Headache, Post-traumatic neck syndrome, Road traffic accident, SARS-CoV-2 antibody test
Clinical narrative: CAR ACCIDENT; WHIPLASH INJURY; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 76-year-old  female. The patient's height, and weight were not reported. The patient's past medical history included measles, and chicken pox. On 20-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced headache on the day of vaccination. Treatment medications included: paracetamol. The reporter stated she was involved in car accident after 1-2 month of vaccination. The patient mentioned she received stem cell injections to treat whip lash injury following accident. On an unspecified date the patient reported that she had Covid-19 antibody test drawn by her primary care physician which came negative. On 24-JUN-2021, the patient had another lab test COVID IGG test, and the results came negative on 25-Jun-2021(confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, and the outcome of confirmed immunological vaccine failure, car accident and whiplash injury was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210660662- covid-19 vaccine ad26.cov2.s - Confirmed Immunological failure. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CAR ACCIDENT; WHIPLASH INJURY; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 76-year-old  female. The patient's height, and weight were not reported. The patient's past medical history included measles, and chicken pox. On 20-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the patient experienced headache on the day of vaccination. Treatment medications included: paracetamol. The reporter stated she was involved in car accident after 1-2 month of vaccination. The patient mentioned she received stem cell injections to treat whip lash injury following accident. On an unspecified date the patient reported that she had Covid-19 antibody test drawn by her primary care physician which came negative. On 24-JUN-2021, the patient had another lab test COVID IGG test, and the results came negative on 25-Jun-2021(confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-MAR-2021, and the outcome of confirmed immunological vaccine failure, car accident and whiplash injury was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210660662- covid-19 vaccine ad26.cov2.s - Confirmed Immunological failure. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Adnexa uteri pain, Back pain, Nausea
Clinical narrative: ABDOMINAL PAIN,  CRAMPS LIKE KIDNEY PAIN OR LIKE CRAMPING THAT COMES  PREMENSTRUAL; PAIN OVER THE OVARY; BACK PAIN THAT IT IS ON THE RIGHT SIDE IS THE MOST; NAUSEA; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced abdominal pain, cramps like kidney pain or like cramping that comes premenstrual. On 25-JUN-2021, the subject experienced pain over the ovary. On 25-JUN-2021, the subject experienced back pain that it is on the right side is the most. On 25-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain that it is on the right side is the most, and the outcome of abdominal pain, cramps like kidney pain or like cramping that comes premenstrual, nausea and pain over the ovary was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned an  male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose was not reported, on an unspecified date in MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in JUN-2021, the patient was diagnosed with Covid-19 and was sick for few days. Patient experienced suspected clinical vaccination failure. He was on rest at time of reporting. He was well with no medical condition. It was not known how he was diagnosed with Covid and which test was used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184096 The suspected product quality complaint has been confirmed to be non voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20210660759-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chest X-ray, Chest discomfort, Dyspnoea, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH, LABORED BREATHING COULD NOT LIE IN SUPINE POSITION; TIGHTNESS IN CHEST; SWELLING IN LEFT ARM, PALM, RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; REDNESS IN LEFT PALM, RIGHT HAND, LEFT AND RIGHT SOLE; ITCHY IN LEFT PALM, ARM,RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; TIP OF TONGUE REDNESS; WEIRD FEELING ON TONGUE-TINGLING; LEFT ARM PAIN/ACHY COULD NOT MAKE A FIST; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 119 pounds, and height was 64 inches. The patient's past medical history included autogenic dental bone graft, and concurrent conditions included hypothyroidism, non-smoker, penicillin allergy, and abstains from alcohol, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. The patient experienced drug allergy when treated with clindamycin, and minocycline hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium.  On 14-MAR-2021, the subject experienced shortness of breath, labored breathing could not lie in supine position. On 14-MAR-2021, the subject experienced tightness in chest. On 14-MAR-2021, the subject experienced swelling in left arm, palm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced redness in left palm, right hand, left and right sole. On 14-MAR-2021, the subject experienced itchy in left palm, arm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced tip of tongue redness. On 14-MAR-2021, the subject experienced weird feeling on tongue-tingling. On 14-MAR-2021, the subject experienced left arm pain/achy could not make a fist. On JUN-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Ultrasound Doppler (NR: not provided) Negative blood clots. On 08-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 16-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 17-JUN-2021, Laboratory data included: Antibody test (NR: not provided) low by 4%. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in left arm, palm, right hand, sole of foot right and left, redness in left palm, right hand, left and right sole, itchy in left palm, arm,right hand, sole of foot right and left, tip of tongue redness, weird feeling on tongue-tingling, and left arm pain/achy could not make a fist on 15-JUN-2021, and had not recovered from shortness of breath, labored breathing could not lie in supine position, and tightness in chest. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palmar-plantar erythrodysaesthesia syndrome, Paraesthesia oral, Peripheral swelling, Polymerase chain reaction, Pruritus
Clinical narrative: SHORTNESS OF BREATH, LABORED BREATHING COULD NOT LIE IN SUPINE POSITION; TIGHTNESS IN CHEST; SWELLING IN LEFT ARM, PALM, RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; REDNESS IN LEFT PALM, RIGHT HAND, LEFT AND RIGHT SOLE; ITCHY IN LEFT PALM, ARM,RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; TIP OF TONGUE REDNESS; WEIRD FEELING ON TONGUE-TINGLING; LEFT ARM PAIN/ACHY COULD NOT MAKE A FIST; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 119 pounds, and height was 64 inches. The patient's past medical history included autogenic dental bone graft, and concurrent conditions included hypothyroidism, non-smoker, penicillin allergy, and abstains from alcohol, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. The patient experienced drug allergy when treated with clindamycin, and minocycline hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium.  On 14-MAR-2021, the subject experienced shortness of breath, labored breathing could not lie in supine position. On 14-MAR-2021, the subject experienced tightness in chest. On 14-MAR-2021, the subject experienced swelling in left arm, palm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced redness in left palm, right hand, left and right sole. On 14-MAR-2021, the subject experienced itchy in left palm, arm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced tip of tongue redness. On 14-MAR-2021, the subject experienced weird feeling on tongue-tingling. On 14-MAR-2021, the subject experienced left arm pain/achy could not make a fist. On JUN-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Ultrasound Doppler (NR: not provided) Negative blood clots. On 08-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 16-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 17-JUN-2021, Laboratory data included: Antibody test (NR: not provided) low by 4%. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in left arm, palm, right hand, sole of foot right and left, redness in left palm, right hand, left and right sole, itchy in left palm, arm,right hand, sole of foot right and left, tip of tongue redness, weird feeling on tongue-tingling, and left arm pain/achy could not make a fist on 15-JUN-2021, and had not recovered from shortness of breath, labored breathing could not lie in supine position, and tightness in chest. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tongue erythema, Ultrasound Doppler
Clinical narrative: SHORTNESS OF BREATH, LABORED BREATHING COULD NOT LIE IN SUPINE POSITION; TIGHTNESS IN CHEST; SWELLING IN LEFT ARM, PALM, RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; REDNESS IN LEFT PALM, RIGHT HAND, LEFT AND RIGHT SOLE; ITCHY IN LEFT PALM, ARM,RIGHT HAND, SOLE OF FOOT RIGHT AND LEFT; TIP OF TONGUE REDNESS; WEIRD FEELING ON TONGUE-TINGLING; LEFT ARM PAIN/ACHY COULD NOT MAKE A FIST; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 119 pounds, and height was 64 inches. The patient's past medical history included autogenic dental bone graft, and concurrent conditions included hypothyroidism, non-smoker, penicillin allergy, and abstains from alcohol, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. The patient experienced drug allergy when treated with clindamycin, and minocycline hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium.  On 14-MAR-2021, the subject experienced shortness of breath, labored breathing could not lie in supine position. On 14-MAR-2021, the subject experienced tightness in chest. On 14-MAR-2021, the subject experienced swelling in left arm, palm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced redness in left palm, right hand, left and right sole. On 14-MAR-2021, the subject experienced itchy in left palm, arm, right hand, sole of foot right and left. On 14-MAR-2021, the subject experienced tip of tongue redness. On 14-MAR-2021, the subject experienced weird feeling on tongue-tingling. On 14-MAR-2021, the subject experienced left arm pain/achy could not make a fist. On JUN-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and Ultrasound Doppler (NR: not provided) Negative blood clots. On 08-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 16-JUN-2021, Laboratory data included: PCR (NR: not provided) Negative. On 17-JUN-2021, Laboratory data included: Antibody test (NR: not provided) low by 4%. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in left arm, palm, right hand, sole of foot right and left, redness in left palm, right hand, left and right sole, itchy in left palm, arm,right hand, sole of foot right and left, tip of tongue redness, weird feeling on tongue-tingling, and left arm pain/achy could not make a fist on 15-JUN-2021, and had not recovered from shortness of breath, labored breathing could not lie in supine position, and tightness in chest. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: BODY ACHES; DULL HEADACHE; FEVER; HEAD CONGESTION WORSENED; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 147 pounds, and height was 67 inches. The patient's past medical history included hyperthyroidism, and concurrent conditions included allergic to chocolate and caffeine, head congestion, migraines, and allergic to some antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced body aches. On 25-JUN-2021, the subject experienced dull headache. On 25-JUN-2021, the subject experienced fever. On 25-JUN-2021, the subject experienced head congestion worsened. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, dull headache, fever, and head congestion worsened. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Hypersomnia, Somnolence
Clinical narrative: REACTIONS; SLEEPY; SLEPT A LOT; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced reactions, sleepy, and slept a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy, reactions and slept a lot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Muscle spasms, Nodule, Pain in extremity
Clinical narrative: EXTREMELY LARGE  BRUISE 5 INCH LONG ON FOREARM; BUMP NODULE PEA SIZE; CRAMPING IN LEGS; SORE ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 09-JUL-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, benazepril for blood pressure, and metformin for diabetes. On 25-JUN-2021, the subject experienced extremely large bruise 5 inch long on forearm. On 25-JUN-2021, the subject experienced bump nodule pea size. On 25-JUN-2021, the subject experienced cramping in legs. On 25-JUN-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extremely large bruise 5 inch long on forearm, bump nodule pea size, sore arm, and cramping in legs. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Dizziness, Dry mouth, Feeling abnormal
Clinical narrative: SWEATING; DIZZINESS; DRY MOUTH; BONES HURT; GOOD FOR NOTHING; BRAIN IS FLOATING AROUND; FREEZING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNWON) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included buprenorphine hydrochloride/naloxone hydrochloride.  On 24-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced sweating. On 25-JUN-2021, the subject experienced dizziness. On 25-JUN-2021, the subject experienced dry mouth. On 25-JUN-2021, the subject experienced bones hurt. On 25-JUN-2021, the subject experienced good for nothing. On 25-JUN-2021, the subject experienced brain is floating around. On 25-JUN-2021, the subject experienced freezing. On 25-JUN-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, headache, sweating, dizziness, dry mouth, bones hurt, good for nothing, brain is floating around, and fever. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feelings of worthlessness, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: SWEATING; DIZZINESS; DRY MOUTH; BONES HURT; GOOD FOR NOTHING; BRAIN IS FLOATING AROUND; FREEZING; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNWON) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included buprenorphine hydrochloride/naloxone hydrochloride.  On 24-JUN-2021, the subject experienced headache. On 25-JUN-2021, the subject experienced sweating. On 25-JUN-2021, the subject experienced dizziness. On 25-JUN-2021, the subject experienced dry mouth. On 25-JUN-2021, the subject experienced bones hurt. On 25-JUN-2021, the subject experienced good for nothing. On 25-JUN-2021, the subject experienced brain is floating around. On 25-JUN-2021, the subject experienced freezing. On 25-JUN-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, headache, sweating, dizziness, dry mouth, bones hurt, good for nothing, brain is floating around, and fever. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: BRONCHITIS; This spontaneous report received from a health care professional concerned a 71 year old female. The patient's weight was 86 kilograms, and height was 148 centimeters. The patient's concurrent conditions included no tobacco use, and abstains from alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021, the subject experienced bronchitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bronchitis was not reported. This report was non-serious. This case, involving the same patient is linked to 20210405798.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: DIARRHEA; SORE ARM; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 170 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included no known allergies and patient does not abuse drug or have illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-JUN-2021, the subject experienced sore arm. On 26-JUN-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, and sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hypokinesia, Pain
Clinical narrative: TIRED; ACHY; SHAKES; COULD NOT  MOVE; CHILLS; ZERO ENERGY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-JUN-2021 13:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 20-JUN-2021, the subject experienced achy. On 20-JUN-2021, the subject experienced shakes. On 20-JUN-2021, the subject experienced could not move. On 20-JUN-2021, the subject experienced chills. On 20-JUN-2021, the subject experienced zero energy. On 21-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, achy, zero energy, shakes, and could not move, and had not recovered from tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TIRED; ACHY; SHAKES; COULD NOT  MOVE; CHILLS; ZERO ENERGY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-JUN-2021 13:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 20-JUN-2021, the subject experienced achy. On 20-JUN-2021, the subject experienced shakes. On 20-JUN-2021, the subject experienced could not move. On 20-JUN-2021, the subject experienced chills. On 20-JUN-2021, the subject experienced zero energy. On 21-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, achy, zero energy, shakes, and could not move, and had not recovered from tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: SHIVERING/TEETH CHATTERING; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced shivering/teeth chattering, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering/teeth chattering, nausea, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever. This report was non-serious.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Purpura, Rash
Clinical narrative: RASH OF BLOOD COMING TO SURFACE OF SKIN; RASH ON ARMS AND FOOT; ALLERGIC REACTION TWICE; This spontaneous report received from a patient via a company representative concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced rash of blood coming to surface of skin. On JUN-2021, the subject experienced rash on arms and foot. On JUN-2021, the subject experienced allergic reaction twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction twice, rash of blood coming to surface of skin and rash on arms and foot was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eructation, Feeling abnormal, Headache, Pyrexia
Clinical narrative: BRAIN FOG; STOMACHACHE; NOXIOUS BURPS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced brain fog, stomachache, noxious burps, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, brain fog, stomachache and noxious burps was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: MILD NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced mild nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Lethargy, Pyrexia
Clinical narrative: LETHARGIC; CHILLS; FEVER; FELT WEAK; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lethargic, chills, fever, felt weak, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, chills, fever, felt weak, and tiredness. This report was non-serious.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: SORE BODY; SORE ARM; This spontaneous report received from a patient concerned an 85 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the subject experienced sore body. On JUN-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and sore body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown,expiry:unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram head, Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAY-2021 11:30 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included ibuprofen, paracetamol, prednisone, and tramadol.  On 15-MAY-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Brain CT (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.