chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer who heard about a male patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose and start therapy date were not reported, 1 total, administered 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, the patient experienced blood clot from the vaccine. This was not confirmed if it was the Janssen Covid-19 vaccine which the person received, it was just implied. The action taken with covid-19 vaccine was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210827109- Covid-19 vaccine-  Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspepsia, Eye pain, Feeling hot
Clinical narrative: SWOLLEN CALVES AND FEET; FEELING HOT AT CALVES AND FEET; HEARTBURN; ABOUT A 5/10 PAIN OVER EYES; 8/10 PAIN; TIGHTNESS ON CHEST; CHEST PAIN; HEADACHE; This spontaneous report received from a patient 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 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced swollen calves and feet. On 12-AUG-2021, the patient experienced feeling hot at calves and feet. On 12-AUG-2021, the patient experienced heartburn. On 12-AUG-2021, the patient experienced about a 5/10 pain over eyes. On 12-AUG-2021, the patient experienced 8/10 pain. On 12-AUG-2021, the patient experienced tightness on chest. On 12-AUG-2021, the patient experienced chest pain. On 12-AUG-2021, the patient experienced headache. Laboratory data included: Pain scale (NR: not provided) 5/10 PAIN OVER EYES, 8/10 PAIN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, swollen calves and feet, feeling hot at calves and feet, heartburn, about a 5/10 pain over eyes, 8/10 pain, tightness on chest, and chest pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Oedema peripheral, Pain, Pain assessment
Clinical narrative: SWOLLEN CALVES AND FEET; FEELING HOT AT CALVES AND FEET; HEARTBURN; ABOUT A 5/10 PAIN OVER EYES; 8/10 PAIN; TIGHTNESS ON CHEST; CHEST PAIN; HEADACHE; This spontaneous report received from a patient 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 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced swollen calves and feet. On 12-AUG-2021, the patient experienced feeling hot at calves and feet. On 12-AUG-2021, the patient experienced heartburn. On 12-AUG-2021, the patient experienced about a 5/10 pain over eyes. On 12-AUG-2021, the patient experienced 8/10 pain. On 12-AUG-2021, the patient experienced tightness on chest. On 12-AUG-2021, the patient experienced chest pain. On 12-AUG-2021, the patient experienced headache. Laboratory data included: Pain scale (NR: not provided) 5/10 PAIN OVER EYES, 8/10 PAIN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, swollen calves and feet, feeling hot at calves and feet, heartburn, about a 5/10 pain over eyes, 8/10 pain, tightness on chest, and chest pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 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, expiry: 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. No concomitant medications were reported. On an unspecified date, the patient experienced chills, massive headache, and fever that wouldn't quit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and massive headache, and had not recovered from fever that wouldn't quit. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: DOSES THAT WERE ADMINISTERED MORE THAN 6 HOURS AFTER THE VIAL WAS FIRST PUNCTURED/ SUBSEQUENT DOSES WERE ADMINISTERED SEVERAL DAYS LATER; VACCINE WAS STORED MORE THAN 6 HOURS AFTER THE VIAL WAS FIRST PUNCTURED; This spontaneous report received from a pharmacist 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced doses that were administered more than 6 hours after the vial was first punctured/ subsequent doses were administered several days later, and vaccine was stored more than 6 hours after the vial was first punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the doses that were administered more than 6 hours after the vial was first punctured/ subsequent doses were administered several days later and vaccine was stored more than 6 hours after the vial was first punctured was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Chest discomfort, Computerised tomogram, Dizziness, Eye movement disorder
Clinical narrative: CAN NOT MOVE HIS EYES (LIKE SOMEONE PUT FINGER IN  HIS EYES); BLURRED VISION; FEELING OF ELEPHANT ON HIS HEART; SENSITIVE TO ANY SOUND; CAN NOT SPEAK (LOSING HIS VOICE); SENSITIVE TO LIGHT (CAN'T USE COMPUTER); FEELING DIZZY; FEELING TIRED; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: stomach pain, headache, and increased blood pressure, and other pre-existing medical conditions included: The patient initially visited the ER on 07-Mar-2021 for symptoms of headache, bloated head, high blood pressure and stomach hurting but all this was before receiving the vaccine. The ER stated he was normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced can not move his eyes (like someone put finger in his eyes). On 07-MAR-2021, the patient experienced blurred vision. On 07-MAR-2021, the patient experienced feeling of elephant on his heart. On 07-MAR-2021, the patient experienced sensitive to any sound. On 07-MAR-2021, the patient experienced can not speak (losing his voice). On 07-MAR-2021, the patient experienced sensitive to light (can't use computer). On 07-MAR-2021, the patient experienced feeling dizzy. On 07-MAR-2021, the patient experienced feeling tired. On 07-MAR-2021, the patient experienced headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not move his eyes (like someone put finger in his eyes), blurred vision, feeling tired, feeling of elephant on his heart, sensitive to any sound, can not speak (losing his voice), headache, sensitive to light (can't use computer), and feeling dizzy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperacusis, Magnetic resonance imaging, Photophobia
Clinical narrative: CAN NOT MOVE HIS EYES (LIKE SOMEONE PUT FINGER IN  HIS EYES); BLURRED VISION; FEELING OF ELEPHANT ON HIS HEART; SENSITIVE TO ANY SOUND; CAN NOT SPEAK (LOSING HIS VOICE); SENSITIVE TO LIGHT (CAN'T USE COMPUTER); FEELING DIZZY; FEELING TIRED; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: stomach pain, headache, and increased blood pressure, and other pre-existing medical conditions included: The patient initially visited the ER on 07-Mar-2021 for symptoms of headache, bloated head, high blood pressure and stomach hurting but all this was before receiving the vaccine. The ER stated he was normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced can not move his eyes (like someone put finger in his eyes). On 07-MAR-2021, the patient experienced blurred vision. On 07-MAR-2021, the patient experienced feeling of elephant on his heart. On 07-MAR-2021, the patient experienced sensitive to any sound. On 07-MAR-2021, the patient experienced can not speak (losing his voice). On 07-MAR-2021, the patient experienced sensitive to light (can't use computer). On 07-MAR-2021, the patient experienced feeling dizzy. On 07-MAR-2021, the patient experienced feeling tired. On 07-MAR-2021, the patient experienced headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not move his eyes (like someone put finger in his eyes), blurred vision, feeling tired, feeling of elephant on his heart, sensitive to any sound, can not speak (losing his voice), headache, sensitive to light (can't use computer), and feeling dizzy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: CAN NOT MOVE HIS EYES (LIKE SOMEONE PUT FINGER IN  HIS EYES); BLURRED VISION; FEELING OF ELEPHANT ON HIS HEART; SENSITIVE TO ANY SOUND; CAN NOT SPEAK (LOSING HIS VOICE); SENSITIVE TO LIGHT (CAN'T USE COMPUTER); FEELING DIZZY; FEELING TIRED; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: stomach pain, headache, and increased blood pressure, and other pre-existing medical conditions included: The patient initially visited the ER on 07-Mar-2021 for symptoms of headache, bloated head, high blood pressure and stomach hurting but all this was before receiving the vaccine. The ER stated he was normal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced can not move his eyes (like someone put finger in his eyes). On 07-MAR-2021, the patient experienced blurred vision. On 07-MAR-2021, the patient experienced feeling of elephant on his heart. On 07-MAR-2021, the patient experienced sensitive to any sound. On 07-MAR-2021, the patient experienced can not speak (losing his voice). On 07-MAR-2021, the patient experienced sensitive to light (can't use computer). On 07-MAR-2021, the patient experienced feeling dizzy. On 07-MAR-2021, the patient experienced feeling tired. On 07-MAR-2021, the patient experienced headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not move his eyes (like someone put finger in his eyes), blurred vision, feeling tired, feeling of elephant on his heart, sensitive to any sound, can not speak (losing his voice), headache, sensitive to light (can't use computer), and feeling dizzy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Malaise, Nausea
Clinical narrative: JAW PAIN; EAR ACHE; FELT SICK; CHILLS; VERY BAD HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight was 157 pounds, and height was 68 inches. The patient's concurrent conditions included: arrhythmias, food allergy, pollen allergy, non alcoholic, non smoker, antibiotic allergy, and erythromycin allergy, and other pre-existing medical conditions included: Patient is not pregnant at the time of vaccination. The patient had no history of drug abuse or Illicit drug usage. The patient experienced drug allergy when treated with epinephrine for heart issues. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced jaw pain. On 24-MAR-2021, the patient experienced ear ache. On 24-MAR-2021, the patient experienced felt sick. On 24-MAR-2021, the patient experienced chills. On 24-MAR-2021, the patient experienced very bad headache. On 24-MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from jaw pain, ear ache, felt sick, chills, very bad headache, and nausea on 26-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: JAW PAIN; EAR ACHE; FELT SICK; CHILLS; VERY BAD HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight was 157 pounds, and height was 68 inches. The patient's concurrent conditions included: arrhythmias, food allergy, pollen allergy, non alcoholic, non smoker, antibiotic allergy, and erythromycin allergy, and other pre-existing medical conditions included: Patient is not pregnant at the time of vaccination. The patient had no history of drug abuse or Illicit drug usage. The patient experienced drug allergy when treated with epinephrine for heart issues. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced jaw pain. On 24-MAR-2021, the patient experienced ear ache. On 24-MAR-2021, the patient experienced felt sick. On 24-MAR-2021, the patient experienced chills. On 24-MAR-2021, the patient experienced very bad headache. On 24-MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from jaw pain, ear ache, felt sick, chills, very bad headache, and nausea on 26-MAR-2021. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Nausea, Palpitations
Clinical narrative: HEART IS BEATING FASTER THAN NORMAL; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 152.5 pounds, and height was 66 inches. The patient's concurrent conditions included: hypothyroidism, anxiety, ragweed allergy, morphine allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 15:05 for prophylactic vaccination. Concomitant medications included lorazepam for anxiety. On 13-AUG-2021, the patient experienced heart is beating faster than normal. On 13-AUG-2021, the patient experienced nausea. On 13-AUG-2021, the patient experienced tiredness. Laboratory data included: Heart rate (NR: not provided) 80 to 90 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart is beating faster than normal, nausea, and tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Pyrexia, Somnolence
Clinical narrative: BAD FLU; FEELING LIKE CRAP; FEELING LIKE SLEEPING; HIGH 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) 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 patient experienced bad flu, feeling like crap, feeling like sleeping, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad flu, feeling like crap, feeling like sleeping, and high fever. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest pain, Chills, Dizziness
Clinical narrative: HEADACHE/MILD COMES AND GOES HEADACHE; LIGHT-HEADED FEELINGS; PAIN; UNABLE TO SLEEP; BLURRED VISION; SLIGHT CHEST PAIN; NECK PAIN; CANNOT MOVE; HOT FLASHES; COULD NOT WALK; COULD NOT STAND WITHOUT ASSISTANCE; CHILLS; INTENSE JOINT PAINS IN THE GROINS, KNEES, ANKLES, ELBOWS; FATIGUE; WEAKNESS/SEVERELY WEAK; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy, Patient was not diagnosed with COVID previously. 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 12-AUG-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced light-headed feelings. On 12-AUG-2021, the patient experienced pain. On 12-AUG-2021, the patient experienced unable to sleep. On 12-AUG-2021, the patient experienced blurred vision. On 12-AUG-2021, the patient experienced slight chest pain. On 12-AUG-2021, the patient experienced neck pain. On 12-AUG-2021, the patient experienced cannot move. On 12-AUG-2021, the patient experienced hot flashes. On 12-AUG-2021, the patient experienced could not walk. On 12-AUG-2021, the patient experienced could not stand without assistance. On 12-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced intense joint pains in the groins, knees, ankles, elbows. On 12-AUG-2021, the patient experienced fatigue. On 12-AUG-2021, the patient experienced weakness/severely weak. On 13-AUG-2021, the patient experienced headache/mild comes and goes headache. Treatment medications (dates unspecified) included: melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight chest pain, and headache/mild comes and goes headache, and the outcome of light-headed feelings, weakness/severely weak, fatigue, blurred vision, chills, intense joint pains in the groins, knees, ankles, elbows, neck pain, cannot move, hot flashes, could not walk, could not stand without assistance, unable to sleep and pain was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Gait inability, Headache, Hot flush
Clinical narrative: HEADACHE/MILD COMES AND GOES HEADACHE; LIGHT-HEADED FEELINGS; PAIN; UNABLE TO SLEEP; BLURRED VISION; SLIGHT CHEST PAIN; NECK PAIN; CANNOT MOVE; HOT FLASHES; COULD NOT WALK; COULD NOT STAND WITHOUT ASSISTANCE; CHILLS; INTENSE JOINT PAINS IN THE GROINS, KNEES, ANKLES, ELBOWS; FATIGUE; WEAKNESS/SEVERELY WEAK; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy, Patient was not diagnosed with COVID previously. 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 12-AUG-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced light-headed feelings. On 12-AUG-2021, the patient experienced pain. On 12-AUG-2021, the patient experienced unable to sleep. On 12-AUG-2021, the patient experienced blurred vision. On 12-AUG-2021, the patient experienced slight chest pain. On 12-AUG-2021, the patient experienced neck pain. On 12-AUG-2021, the patient experienced cannot move. On 12-AUG-2021, the patient experienced hot flashes. On 12-AUG-2021, the patient experienced could not walk. On 12-AUG-2021, the patient experienced could not stand without assistance. On 12-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced intense joint pains in the groins, knees, ankles, elbows. On 12-AUG-2021, the patient experienced fatigue. On 12-AUG-2021, the patient experienced weakness/severely weak. On 13-AUG-2021, the patient experienced headache/mild comes and goes headache. Treatment medications (dates unspecified) included: melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight chest pain, and headache/mild comes and goes headache, and the outcome of light-headed feelings, weakness/severely weak, fatigue, blurred vision, chills, intense joint pains in the groins, knees, ankles, elbows, neck pain, cannot move, hot flashes, could not walk, could not stand without assistance, unable to sleep and pain was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Movement disorder, Neck pain, Pain, Vision blurred
Clinical narrative: HEADACHE/MILD COMES AND GOES HEADACHE; LIGHT-HEADED FEELINGS; PAIN; UNABLE TO SLEEP; BLURRED VISION; SLIGHT CHEST PAIN; NECK PAIN; CANNOT MOVE; HOT FLASHES; COULD NOT WALK; COULD NOT STAND WITHOUT ASSISTANCE; CHILLS; INTENSE JOINT PAINS IN THE GROINS, KNEES, ANKLES, ELBOWS; FATIGUE; WEAKNESS/SEVERELY WEAK; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy, Patient was not diagnosed with COVID previously. 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 12-AUG-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced light-headed feelings. On 12-AUG-2021, the patient experienced pain. On 12-AUG-2021, the patient experienced unable to sleep. On 12-AUG-2021, the patient experienced blurred vision. On 12-AUG-2021, the patient experienced slight chest pain. On 12-AUG-2021, the patient experienced neck pain. On 12-AUG-2021, the patient experienced cannot move. On 12-AUG-2021, the patient experienced hot flashes. On 12-AUG-2021, the patient experienced could not walk. On 12-AUG-2021, the patient experienced could not stand without assistance. On 12-AUG-2021, the patient experienced chills. On 12-AUG-2021, the patient experienced intense joint pains in the groins, knees, ankles, elbows. On 12-AUG-2021, the patient experienced fatigue. On 12-AUG-2021, the patient experienced weakness/severely weak. On 13-AUG-2021, the patient experienced headache/mild comes and goes headache. Treatment medications (dates unspecified) included: melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight chest pain, and headache/mild comes and goes headache, and the outcome of light-headed feelings, weakness/severely weak, fatigue, blurred vision, chills, intense joint pains in the groins, knees, ankles, elbows, neck pain, cannot move, hot flashes, could not walk, could not stand without assistance, unable to sleep and pain was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Gait disturbance, Headache, Hypokinesia
Clinical narrative: FEELING UNWELL/SOUNDED UNWELL; INTENSE HEADACHE; TROUBLE WALKING; FELT A BIT FUNNY; CAN HARDLY GET OUT OF BED; PAIN ALL OVER THE BODY (ARMS, LEGS, BACK, FEET); GETTING REALLY HOT AND COLD (CHILLS); This spontaneous report received from a patient concerned a 54 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, intramuscular, batch number: Unknown) dose was not reported, administered on 14-AUG-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-AUG-2021, the patient experienced trouble walking. On 14-AUG-2021, the patient experienced felt a bit funny. On 14-AUG-2021, the patient experienced can hardly get out of bed. On 14-AUG-2021, the patient experienced pain all over the body (arms, legs, back, feet). On 14-AUG-2021, the patient experienced getting really hot and cold (chills). On 14-AUG-2021, the patient experienced intense headache. On 15-AUG-2021, the patient experienced feeling unwell/sounded unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from getting really hot and cold (chills), trouble walking, can hardly get out of bed, pain all over the body (arms, legs, back, feet), and intense headache, and the outcome of felt a bit funny and feeling unwell/sounded unwell was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: FEELING UNWELL/SOUNDED UNWELL; INTENSE HEADACHE; TROUBLE WALKING; FELT A BIT FUNNY; CAN HARDLY GET OUT OF BED; PAIN ALL OVER THE BODY (ARMS, LEGS, BACK, FEET); GETTING REALLY HOT AND COLD (CHILLS); This spontaneous report received from a patient concerned a 54 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, intramuscular, batch number: Unknown) dose was not reported, administered on 14-AUG-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-AUG-2021, the patient experienced trouble walking. On 14-AUG-2021, the patient experienced felt a bit funny. On 14-AUG-2021, the patient experienced can hardly get out of bed. On 14-AUG-2021, the patient experienced pain all over the body (arms, legs, back, feet). On 14-AUG-2021, the patient experienced getting really hot and cold (chills). On 14-AUG-2021, the patient experienced intense headache. On 15-AUG-2021, the patient experienced feeling unwell/sounded unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from getting really hot and cold (chills), trouble walking, can hardly get out of bed, pain all over the body (arms, legs, back, feet), and intense headache, and the outcome of felt a bit funny and feeling unwell/sounded unwell was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Influenza like illness, Nausea, Paraesthesia
Clinical narrative: RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP TRIED TO PUT WEIGHT ON IT AND COLLAPSED; NAUSEOUS; TINGLING FINGER TIPS, HANDS AND FEET; FINGER TIPS FEELING LITTLE NUMB/RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included: marijuana use, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient takes birth control but was perfectly healthy. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced flu-like symptoms. On 11-AUG-2021, the patient experienced tingling finger tips, hands and feet. On 11-AUG-2021, the patient experienced finger tips feeling little numb/right arm feels like it was completely asleep. On 13-AUG-2021, the patient experienced nauseous. On 14-AUG-2021, the patient experienced right arm feels like it was completely asleep tried to put weight on it and collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, had not recovered from tingling finger tips, hands and feet, finger tips feeling little numb/right arm feels like it was completely asleep, and right arm feels like it was completely asleep tried to put weight on it and collapsed, and the outcome of nauseous was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes, Blood test, Chest discomfort, Dizziness, Headache
Clinical narrative: RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP TRIED TO PUT WEIGHT ON IT AND COLLAPSED; NAUSEOUS; TINGLING FINGER TIPS, HANDS AND FEET; FINGER TIPS FEELING LITTLE NUMB/RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included: marijuana use, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient takes birth control but was perfectly healthy. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced flu-like symptoms. On 11-AUG-2021, the patient experienced tingling finger tips, hands and feet. On 11-AUG-2021, the patient experienced finger tips feeling little numb/right arm feels like it was completely asleep. On 13-AUG-2021, the patient experienced nauseous. On 14-AUG-2021, the patient experienced right arm feels like it was completely asleep tried to put weight on it and collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, had not recovered from tingling finger tips, hands and feet, finger tips feeling little numb/right arm feels like it was completely asleep, and right arm feels like it was completely asleep tried to put weight on it and collapsed, and the outcome of nauseous was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Thyroid function test
Clinical narrative: RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP TRIED TO PUT WEIGHT ON IT AND COLLAPSED; NAUSEOUS; TINGLING FINGER TIPS, HANDS AND FEET; FINGER TIPS FEELING LITTLE NUMB/RIGHT ARM FEELS LIKE IT WAS COMPLETELY ASLEEP; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included: marijuana use, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient takes birth control but was perfectly healthy. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced flu-like symptoms. On 11-AUG-2021, the patient experienced tingling finger tips, hands and feet. On 11-AUG-2021, the patient experienced finger tips feeling little numb/right arm feels like it was completely asleep. On 13-AUG-2021, the patient experienced nauseous. On 14-AUG-2021, the patient experienced right arm feels like it was completely asleep tried to put weight on it and collapsed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, had not recovered from tingling finger tips, hands and feet, finger tips feeling little numb/right arm feels like it was completely asleep, and right arm feels like it was completely asleep tried to put weight on it and collapsed, and the outcome of nauseous was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Influenza like illness, Nausea, Paraesthesia
Clinical narrative: Tingling in hands, arms, and feet. Weakness in right arm. Dizziness, headache, chest tightness.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes, Blood test, Chest discomfort, Dizziness, Headache
Clinical narrative: Tingling in hands, arms, and feet. Weakness in right arm. Dizziness, headache, chest tightness.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Thyroid function test
Clinical narrative: Tingling in hands, arms, and feet. Weakness in right arm. Dizziness, headache, chest tightness.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: METAL STICKING TO INJECTION SITE; This spontaneous report received from a consumer concerned a 43 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced metal sticking to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of metal sticking to injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210830364 and 20210830487.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: BRUISING; NUMBNESS IN LEFT SIDE; TINGLING IN LEFT SIDE; WEAKNESS; HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known drug abuse or illicit drug usage, alcohol usage or smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 24-OCT-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021, the patient experienced bruising. On 04-AUG-2021, the patient experienced numbness in left side. On 04-AUG-2021, the patient experienced tingling in left side. On 04-AUG-2021, the patient experienced weakness. On 04-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in left side, weakness, headache, bruising, and numbness in left side. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sensory disturbance
Clinical narrative: METAL STUCK AT INJECTION SITE; SORE ARM; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's past medical history included: opioid dependency, and concurrent conditions included: cigarette smoker, and alcohol use, and other pre-existing medical conditions included: The patient had no known allergies. Patient reported drug abuse for heroin then fentanyl on and off for 9 years. Patient reported that no taking fentanyl from 1 month ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included clonidine for drug used for unknown indication, and quetiapine fumarate for sleep disorder therapy.  On 12-AUG-2021, the patient experienced sore arm. On 14-AUG-2021, the patient experienced metal stuck at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and metal stuck at injection site. This report was non-serious. This case, from the same reporter is linked to 20210830342.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Skin adhesion
Clinical narrative: METAL STUCK AT INJECTION SITE; SORE ARM; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's past medical history included: opioid dependency, and concurrent conditions included: cigarette smoker, and alcohol use, and other pre-existing medical conditions included: The patient had no known allergies. Patient reported drug abuse for heroin then fentanyl on and off for 9 years. Patient reported that no taking fentanyl from 1 month ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Concomitant medications included clonidine for drug used for unknown indication, and quetiapine fumarate for sleep disorder therapy.  On 12-AUG-2021, the patient experienced sore arm. On 14-AUG-2021, the patient experienced metal stuck at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and metal stuck at injection site. This report was non-serious. This case, from the same reporter is linked to 20210830342.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Sinus congestion
Clinical narrative: COLD; BODY ACHES; CONGESTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 rapid antigen test, and 'regular' nasal swab test, and concurrent conditions included: alcohol user, non smoker, dry cough, and light headache, and other pre-existing medical conditions included: Patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced cold. On 13-AUG-2021, the patient experienced body aches. On 13-AUG-2021, the patient experienced congestion. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold, body aches, and congestion. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: ACHINESS; HEADACHE; TIRED; INJECTION SITE RED; INJECTION SITE PAIN; INJECTION SITE WARM; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. 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, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced injection site warm. On 05-AUG-2021, the patient experienced injection site red. On 05-AUG-2021, the patient experienced injection site pain. On 06-AUG-2021, the patient experienced achiness. On 06-AUG-2021, the patient experienced headache. On 06-AUG-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, and headache on 11-AUG-2021, was recovering from tired, and had not recovered from injection site warm, injection site red, and injection site pain. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHINESS; HEADACHE; TIRED; INJECTION SITE RED; INJECTION SITE PAIN; INJECTION SITE WARM; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. 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, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced injection site warm. On 05-AUG-2021, the patient experienced injection site red. On 05-AUG-2021, the patient experienced injection site pain. On 06-AUG-2021, the patient experienced achiness. On 06-AUG-2021, the patient experienced headache. On 06-AUG-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, and headache on 11-AUG-2021, was recovering from tired, and had not recovered from injection site warm, injection site red, and injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned an 18 year old male of unspecified ethnic origin and race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported 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, the patient experienced suspected immunological vaccine failure. It was reported that patient recently had titers checked and was found to be negative for antibodies. On an unspecified date, Laboratory data included: titer test (antibody test) (NR: not provided) negative for antibodies. The action taken with covid-19 vaccine was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210830464-Covid-19 vaccine -SUSPECTED IMMUNOLOGICAL VACCINE 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
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: SWEATING; LEG WARM TO TOUCH; MUSCLE BULGING DUE TO THE CONTRACTIONS; FREEZING; ON AND OFF HEADACHE; FEVER; SEVERE LEFT LEG CRAMP; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: leg cramps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced severe left leg cramp. On 14-AUG-2021, the patient experienced sweating. On 14-AUG-2021, the patient experienced freezing. On 14-AUG-2021, the patient experienced leg warm to touch. On 14-AUG-2021, the patient experienced muscle bulging due to the contractions. On 14-AUG-2021, the patient experienced on and off headache. On 14-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, severe left leg cramp, sweating, freezing, leg warm to touch, on and off headache, and muscle bulging due to the contractions. This report was non-serious.