chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Feeling abnormal, Hypertension
Clinical narrative: ELEVATED BLOOD PRESSURE; SINUS INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; JOINT PAIN; FEVER; FEELING BAD; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker and high blood pressure (currently on high blood pressure medication for 10 years), and other pre-existing medical conditions included the patient had no known 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: 1808609, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-MAR-2021 into right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced an hour or two of slightly elevated fever (did not get temperature) and just felt bad. On 02-AUG-2021, the patient experienced bad headache, fever, coughing, general weakness, he was not eating, could not get out of bed (for 2 and half days), low level of oxygen (suspected covid-19 infection and suspected clinical vaccination failure) . On 02-AUG-2021, the patient experienced sinus infection and joint pain. On 04-AUG-2021, at 11:00, the patient went to the emergency room and tested positive for covid-19. As per the patient, he has received regeneron infusion and his blood pressure was elevated. Laboratory data included: Oxygen saturation (NR: not provided) low. The patient stated that he wants to talk to someone from JNJ and because the fact that he trusted JNJ and now here he was sick even after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus infection, joint pain, elevated blood pressure, suspected covid-19 infection, fever and the outcome of feeling bad and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210807550 and 20210808196.; Sender's Comments: V0: 20210807871-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS. 20210807871--Suspected COVID-19 infection, elevated blood pressure. 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia, SARS-CoV-2 test, Sinusitis, Suspected COVID-19
Clinical narrative: ELEVATED BLOOD PRESSURE; SINUS INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; JOINT PAIN; FEVER; FEELING BAD; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker and high blood pressure (currently on high blood pressure medication for 10 years), and other pre-existing medical conditions included the patient had no known 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: 1808609, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-MAR-2021 into right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced an hour or two of slightly elevated fever (did not get temperature) and just felt bad. On 02-AUG-2021, the patient experienced bad headache, fever, coughing, general weakness, he was not eating, could not get out of bed (for 2 and half days), low level of oxygen (suspected covid-19 infection and suspected clinical vaccination failure) . On 02-AUG-2021, the patient experienced sinus infection and joint pain. On 04-AUG-2021, at 11:00, the patient went to the emergency room and tested positive for covid-19. As per the patient, he has received regeneron infusion and his blood pressure was elevated. Laboratory data included: Oxygen saturation (NR: not provided) low. The patient stated that he wants to talk to someone from JNJ and because the fact that he trusted JNJ and now here he was sick even after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus infection, joint pain, elevated blood pressure, suspected covid-19 infection, fever and the outcome of feeling bad and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210807550 and 20210808196.; Sender's Comments: V0: 20210807871-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS. 20210807871--Suspected COVID-19 infection, elevated blood pressure. 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: ELEVATED BLOOD PRESSURE; SINUS INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; JOINT PAIN; FEVER; FEELING BAD; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker and high blood pressure (currently on high blood pressure medication for 10 years), and other pre-existing medical conditions included the patient had no known 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: 1808609, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-MAR-2021 into right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 26-MAR-2021, the patient experienced an hour or two of slightly elevated fever (did not get temperature) and just felt bad. On 02-AUG-2021, the patient experienced bad headache, fever, coughing, general weakness, he was not eating, could not get out of bed (for 2 and half days), low level of oxygen (suspected covid-19 infection and suspected clinical vaccination failure) . On 02-AUG-2021, the patient experienced sinus infection and joint pain. On 04-AUG-2021, at 11:00, the patient went to the emergency room and tested positive for covid-19. As per the patient, he has received regeneron infusion and his blood pressure was elevated. Laboratory data included: Oxygen saturation (NR: not provided) low. The patient stated that he wants to talk to someone from JNJ and because the fact that he trusted JNJ and now here he was sick even after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus infection, joint pain, elevated blood pressure, suspected covid-19 infection, fever and the outcome of feeling bad and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210807550 and 20210808196.; Sender's Comments: V0: 20210807871-COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS. 20210807871--Suspected COVID-19 infection, elevated blood pressure. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Muscular weakness, Pallor
Clinical narrative: LOSS OF BLOOD; LEGS STARTED BUCKLING; PALE OR YELLOW; This spontaneous report received from a consumer concerned a 73 year old female with unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included anemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced loss blood. On JUN-2021, the patient was pale or yellow. On JUL-2021, the patient experienced legs started buckling. Patient went to see her PCP, from there patient went to emergency room and had 2 pints of blood administered. Patient had a repeat transfusion with 2 pints and now patient was on the way to the emergency room as doctor recommended for patient to have another 2 pints. Patient was getting treated for anemia in every 6 months.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pale or yellow, and loss of blood, and the outcome of legs started buckling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210810877-covid-19 vaccine ad26.cov2.s -loss of blood . 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: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: PAIN; FATIGUE; LOW GRADE 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 pain, fatigue, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, pain and low grade fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; 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 was not reported, administered on 04-AUG-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 05-AUG-2021, the patient experienced chills. On 05-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Sinus congestion, Tinnitus
Clinical narrative: SWOLLEN SINUSES BOTH SIDES WERE AFFECTED; SWOLLEN LYMPH NODE IN THE CLAVICLE ON THE RIGHT SIDE BETWEEN THE SHOULDER AND NECK; RINGING IN EARS, HIGH PITCHED, SOUNDS LIKE LETTING OFF STEAM ON A LOW LIGHT KETTLE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 135 pounds, and height was 64 inches. The patient's concurrent conditions included: penicillin allergy, non alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient was taking vitamins occasionally. The patient was having allergies to namycin and mycin's. The patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with prednisone for drug use of unknown indication, drug allergy when treated with levofloxacin, and prochlorperazine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: 18-AUG-2021) dose was not reported, administered on 05-AUG-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced swollen sinuses both sides were affected. On 05-AUG-2021, the patient experienced swollen lymph node in the clavicle on the right side between the shoulder and neck. On 05-AUG-2021, the patient experienced ringing in ears, high pitched, sounds like letting off steam on a low light kettle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen sinuses both sides were affected on 07-AUG-2021, and had not recovered from ringing in ears, high pitched, sounds like letting off steam on a low light kettle, and swollen lymph node in the clavicle on the right side between the shoulder and neck. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHE; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included: heart attack 2 years ago. 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 04-AUG-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 05-AUG-2021, the patient experienced fever. On 05-AUG-2021, the patient experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and muscle ache. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased activity, Eye disorder, Eye pain, Headache
Clinical narrative: BLURRED VISION; LEFT EYE HAS BEEN ACHY; LEFT EYE HAS BEEN SENSITIVE; PERSISTENT HEADACHE/DULL HEADACHE RIGHT BEHIND FOREHEAD; DULL ACHE IN LEGS /PAIN IN LEGS; CHILLS; FEVER; HASN'T BEEN ACTIVE; SWELLING IN LEGS; PURPLEISH LARGE PATCH ABOUT SIZE OF NICKEL OR QUARTER ON BOTH SHINS UNDER THE SKIN/ WORSE WHEN STANDING; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: varicose veins, dark spots on right shin, and tiny bit of blurriness in left eye regardless as an underlying issue. 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 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced swelling in legs. On 30-JUL-2021, the patient experienced purpleish large patch about size of nickel or quarter on both shins under the skin/ worse when standing. On 30-JUL-2021, the patient experienced hasn't been active. On 30-JUL-2021, the patient experienced dull ache in legs /pain in legs. On 30-JUL-2021, the patient experienced chills. On 30-JUL-2021, the patient experienced fever. On 02-AUG-2021, the patient experienced blurred vision. On 02-AUG-2021, the patient experienced left eye has been achy. On 02-AUG-2021, the patient experienced left eye has been sensitive. On 02-AUG-2021, the patient experienced persistent headache/dull headache right behind forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache/dull headache right behind forehead, blurred vision, left eye has been achy, and left eye has been sensitive, and the outcome of fever, swelling in legs, purpleish large patch about size of nickel or quarter on both shins under the skin/ worse when standing, chills, dull ache in legs /pain in legs and hasn't been active was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin discolouration, Vision blurred
Clinical narrative: BLURRED VISION; LEFT EYE HAS BEEN ACHY; LEFT EYE HAS BEEN SENSITIVE; PERSISTENT HEADACHE/DULL HEADACHE RIGHT BEHIND FOREHEAD; DULL ACHE IN LEGS /PAIN IN LEGS; CHILLS; FEVER; HASN'T BEEN ACTIVE; SWELLING IN LEGS; PURPLEISH LARGE PATCH ABOUT SIZE OF NICKEL OR QUARTER ON BOTH SHINS UNDER THE SKIN/ WORSE WHEN STANDING; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: varicose veins, dark spots on right shin, and tiny bit of blurriness in left eye regardless as an underlying issue. 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 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced swelling in legs. On 30-JUL-2021, the patient experienced purpleish large patch about size of nickel or quarter on both shins under the skin/ worse when standing. On 30-JUL-2021, the patient experienced hasn't been active. On 30-JUL-2021, the patient experienced dull ache in legs /pain in legs. On 30-JUL-2021, the patient experienced chills. On 30-JUL-2021, the patient experienced fever. On 02-AUG-2021, the patient experienced blurred vision. On 02-AUG-2021, the patient experienced left eye has been achy. On 02-AUG-2021, the patient experienced left eye has been sensitive. On 02-AUG-2021, the patient experienced persistent headache/dull headache right behind forehead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache/dull headache right behind forehead, blurred vision, left eye has been achy, and left eye has been sensitive, and the outcome of fever, swelling in legs, purpleish large patch about size of nickel or quarter on both shins under the skin/ worse when standing, chills, dull ache in legs /pain in legs and hasn't been active was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, SARS-CoV-2 test, Sinus headache, Tinnitus
Clinical narrative: ACUTE SINUS HEADACHE; SINUS PRESSURE ON BRIDGE OF NOSE/EARS; LOUD RINGING ON BILATERAL EARS; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, the patient experienced acute sinus headache. On 26-JUL-2021, the patient experienced sinus pressure on bridge of nose/ears. On 26-JUL-2021, the patient experienced loud ringing on bilateral ears. On AUG-2021, treatment medications included: alprazolam, and prednisone. On 04-AUG-2021, Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from loud ringing on bilateral ears, and had not recovered from acute sinus headache, and sinus pressure on bridge of nose/ears. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Gait disturbance, SARS-CoV-2 test
Clinical narrative: BRAIN FOG; SHORTNESS OF BREATH; COULD BARELY WALK; EXTREME FATIGUE; This spontaneous report received from a patient 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 was not reported, administered on 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 AUG-2021, the patient experienced brain fog. On AUG-2021, the patient experienced shortness of breath. On AUG-2021, the patient experienced could barely walk. On AUG-2021, the patient experienced extreme fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme fatigue, brain fog, shortness of breath and could barely walk was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: BELOW 18 YEARS OLD GOT THE JNJ COVID 19 VACCINE; OFF LABEL USE; 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 below 18 years old got the JNJ covid 19 vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and below 18 years old got the JNJ covid 19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Nightmare, Pain
Clinical narrative: NIGHTMARES; SLEPT A LOT; BODY HURT A LOT; THE ARM THAT GOT INJECTED KIND OF HURT TO MOVE; FEVER; REALLY TIRED/FELT FATIGUED FOR LIKE A WEEK; HEAD HURT A LOT; 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: 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 nightmares, slept a lot, body hurt a lot, the arm that got injected kind of hurt to move, fever, really tired/felt fatigued for like a week, and head hurt a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body hurt a lot, really tired/felt fatigued for like a week, and head hurt a lot, and the outcome of fever, nightmares, slept a lot and the arm that got injected kind of hurt to move was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: NIGHTMARES; SLEPT A LOT; BODY HURT A LOT; THE ARM THAT GOT INJECTED KIND OF HURT TO MOVE; FEVER; REALLY TIRED/FELT FATIGUED FOR LIKE A WEEK; HEAD HURT A LOT; 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: 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 nightmares, slept a lot, body hurt a lot, the arm that got injected kind of hurt to move, fever, really tired/felt fatigued for like a week, and head hurt a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body hurt a lot, really tired/felt fatigued for like a week, and head hurt a lot, and the outcome of fever, nightmares, slept a lot and the arm that got injected kind of hurt to move was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: MEDICATION ADMINISTRATION ERROR/DOSE WERE WITHDRAWN FROM AN EXPIRED VIAL; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known medical history. 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 06-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-AUG-2021, the patient experienced medication administration error/dose were withdrawn from an expired vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication administration error/dose were withdrawn from an expired vial was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity
Clinical narrative: ALLERGY SYMPTOMS; This spontaneous report received from a patient 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 was not reported, administered on 12-MAY-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced allergy symptoms. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergy symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dehydration, Feeling abnormal, Headache
Clinical narrative: ACHES; DEHYDRATION; A BAD FEELING; CHILLS; FEVER; HEADACHE; LOW 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, 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 aches, dehydration, a bad feeling, chills, fever, headache, and low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, headache, chills, low energy, dehydration and a bad feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHES; DEHYDRATION; A BAD FEELING; CHILLS; FEVER; HEADACHE; LOW 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, 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 aches, dehydration, a bad feeling, chills, fever, headache, and low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, headache, chills, low energy, dehydration and a bad feeling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Poor quality product administered, Product storage error, Pyrexia
Clinical narrative: VIAL WAS WASTED 6 HOURS AFTER THE PUNCTURE; VIAL WASTED FOR 6 HOURS AFTER THE PUNCTURE WAS ADMINISTERED; FEVER 103 DEGREES; This spontaneous report received from a pharmacist concerned a 19 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: 204A21A expiry: 07-AUG-2021) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported.  On AUG-2021, the patient experienced fever 103 degrees. Laboratory data included: Body temperature (NR: not provided) 103 DEGREES. On 05-AUG-2021, the patient experienced vial was wasted 6 hours after the puncture. On 05-AUG-2021, the patient experienced vial wasted for 6 hours after the puncture was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103 degrees, vial was wasted 6 hours after the puncture and vial wasted for 6 hours after the puncture was administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK A DAY; This spontaneous report received from a consumer 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: 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 sick a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick a day. This report was non-serious. This case, from the same reporter is linked to 20210815700 and 20210815667.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: DIARRHEA; SEVERE FATIGUE; FEVER 103 F AND 100 F; MUSCLE ACHES; WORSE HEADACHE; BAD CHILLS; This spontaneous report received from a consumer concerned a 58 year old male. The patient's weight was 210 pounds, and height was 68 inches. The patient's past medical history included: neck pain, and concurrent conditions included: blood pressure, alcohol use, smoker, and cholesterol, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042821A, expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced bad chills. On 04-AUG-2021, the patient experienced severe fatigue. On 04-AUG-2021, the patient experienced fever 103 f and 100 f. On 04-AUG-2021, the patient experienced muscle aches. On 04-AUG-2021, the patient experienced worse headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 05-AUG-2021, the patient experienced diarrhea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 103 f and 100 f, had not recovered from severe fatigue, and muscle aches, and the outcome of bad chills, worse headache and diarrhea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815409.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: DIARRHEA; SEVERE FATIGUE; FEVER 103 F AND 100 F; MUSCLE ACHES; WORSE HEADACHE; BAD CHILLS; This spontaneous report received from a consumer concerned a 58 year old male. The patient's weight was 210 pounds, and height was 68 inches. The patient's past medical history included: neck pain, and concurrent conditions included: blood pressure, alcohol use, smoker, and cholesterol, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042821A, expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced bad chills. On 04-AUG-2021, the patient experienced severe fatigue. On 04-AUG-2021, the patient experienced fever 103 f and 100 f. On 04-AUG-2021, the patient experienced muscle aches. On 04-AUG-2021, the patient experienced worse headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 05-AUG-2021, the patient experienced diarrhea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 103 f and 100 f, had not recovered from severe fatigue, and muscle aches, and the outcome of bad chills, worse headache and diarrhea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210815409.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Sensory disturbance
Clinical narrative: DIFFICULTY SWALLOWING; LITTLE PINCH IN THE LEG AND UNDER THE BREAST; NUMBNESS IN LEFT SIDE OF NECK AND EAR; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug user. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced little pinch in the leg and under the breast. On 04-AUG-2021, the patient experienced numbness in left side of neck and ear. On 07-AUG-2021, the patient experienced difficulty swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in left side of neck and ear, little pinch in the leg and under the breast, and difficulty swallowing. This report was non-serious.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; VACCINE GIVEN TO 15 YEAR OLD PATIENT; This spontaneous report received from a health care professional concerned a 15 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known drug allergies, no known medications and no known medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number:1820095 expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced off label use. On 06-AUG-2021, the patient experienced vaccine given to 15 year old patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine given to 15 year old patient was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; THE VIAL WAS  PUNCTURED AT 9:30 AM AND THE PATIENT RECEIVED THE DOSE AT 6:08  PM; This spontaneous report received from a pharmacist concerned a 34 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A,expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 18:08 for prophylactic vaccination. No concomitant medications were reported. On 06-AUG-2021, the patient experienced out of specification product use. On 06-AUG-2021, the patient experienced the vial was punctured at 9:30 am and the patient received the dose at 6:08 pm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and the vial was punctured at 9:30 am and the patient received the dose at 6:08 pm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: OUTSIDE THE RECOMMENDED 6 HOUR WINDOW PUNCTURED VACCINE WAS ADMINISTERED TO PATIENT (BUT VIAL WAS IN REFRIGERATOR); This spontaneous report received from a pharmacist 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 was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUL-2021, the patient experienced outside the recommended 6 hour window punctured vaccine was administered to patient (but vial was in refrigerator). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of outside the recommended 6 hour window punctured vaccine was administered to patient (but vial was in refrigerator) was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: LOSS OF SMELL; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight was 165 pounds, and height was 70 inches. The patient's concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had No known allergies, no drug abuse or illicit drug usage and patient did not take any medication. 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 18-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the patient experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of smell. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; ARM SORENESS; SUPER NAUSEOUS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 chills, arm soreness, super nauseous, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from super nauseous, and the outcome of fever, chills and arm soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold, Pain, Pyrexia
Clinical narrative: BODY ACHES; DIZZINESS; FELT SO COLD; FEVER; This spontaneous report received from a patient concerned a 53 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 was not reported, administered on 05-AUG-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-AUG-2021, the patient experienced body aches. On 06-AUG-2021, the patient experienced dizziness. On 06-AUG-2021, the patient experienced felt so cold. On 06-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, and dizziness, and the outcome of felt so cold was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic migraine
Clinical narrative: OPTICAL MIGRAINE (EACH TIME THE MIGRAINES LASTED ABOUT 10 TO 15 MINUTES); This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraine headaches, and concurrent conditions included: social drinker, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and the patient was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced optical migraine (each time the migraines lasted about 10 to 15 minutes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from optical migraine (each time the migraines lasted about 10 to 15 minutes). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Red blood cells urine, Renal disorder, Visual impairment, White blood cells urine
Clinical narrative: KIDNEY ISSUES; VISION ISSUES; WHITE BLOOD CELLS IN URINE; RED BLOOD CELLS IN URINE; This spontaneous report received from a parent concerned a 32 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, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced vision issues. On APR-2021, the patient experienced white blood cells in urine. On APR-2021, the patient experienced red blood cells in urine. On an unspecified date, the patient experienced kidney issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vision issues, red blood cells in urine, white blood cells in urine and kidney issues was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: INTERMITTENT TINGLING IN LEGS; NUMBNESS IN EXTREMITIES; PAIN IN CALVES; SEVERE ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the patient experienced severe arm pain at injection site. On 25-JUL-2021, the patient experienced intermittent tingling in legs. On 25-JUL-2021, the patient experienced numbness in extremities. On 25-JUL-2021, the patient experienced pain in calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe arm pain at injection site, and had not recovered from intermittent tingling in legs, numbness in extremities, and pain in calves. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: SORE THROAT; STUFFY NOSE; SNEEZING; COUGHING; FEELING HOT; HEADACHE; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on JUL-2021 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 sore throat, stuffy nose, sneezing, coughing, feeling hot, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, stuffy nose, sneezing, coughing, headache and feeling hot was not reported. This report was non-serious.