chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient by a Business partner (Pfizer Inc., US-JNJFOC-20210714002) on 02-JUL-2021 was received on 12-JUL-2021 and concerned multiple patients. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sars-cov-2 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious.; Sender's Comments: V1 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Oedema peripheral
Clinical narrative: NOT BEING ABLE TO BREATH; RIGHT LEG AND FOOT VERY SWOLLEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. 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-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced not being able to breath. On JUL-2021, the subject experienced right leg and foot very swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not being able to breath, and right leg and foot very swollen. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE/NUMBNESS OF LEFT SIDE OF BODY/INABILITY TO WALK; This spontaneous report received from a patient concerned a 44 year old. 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 reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-JUN-2021, the patient woke up with numbness in left side of the body. The patient visited emergency room and diagnosed with stroke, and was hospitalized in intensive care unit (ICU) (date unspecified). The patient also experienced inability to walk after the stroke and visited physician's office and currently in rehabilitation. The number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke/numbness of left side of body/inability to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210716287-Covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 21 year old male. 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: 202A21A and expiry: not reported) 0.5 ml, at a frequency of 1 total, administered on 27-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, at the end of Jun or start of Jul, patient got fully developed Covid-19 with all the symptoms including cough and diarrhea. Covid-19 infection were clinically confirmed by the PCR test and Nasal test. Both test results were positive. On an unspecified date, patient was positive for Covid-19 (coded as Confirmed covid-19 infection). Exact date of tests were not reported. It is reported that, test were performed within the last week and half (at the end of Jun or start of Jul). Patient went to the urgent care and was in the quarantine. On an unspecified date, the patient experienced confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000185403. The suspected product quality complaint has been confirmed to be Void: N based on the PQC evaluation/investigation performed.; Sender's Comments: V0:- 20210722298- covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 49 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUL-2021, the subject experienced confirmed covid 19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the subject experienced confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was non-serious. This report was associated with product quality complaint Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Pyrexia
Clinical narrative: SOME LOSE  BOWELS; SEVERE CHILLS; FEVER/HOT; SWEATS; This spontaneous report received from a patient concerned a 70 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, and multiple neurological issues, and other pre-existing medical conditions included .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 13:15 for prophylactic vaccination. Concomitant medications included ivermectin. On 22-JUN-2021, the subject experienced sweats. On 22-JUN-2021, the subject experienced severe chills. On 22-JUN-2021, the subject experienced fever/hot. On 23-JUN-2021, the subject experienced some lose bowels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever/hot, severe chills, and sweats, and the outcome of some lose bowels was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age race and ethnic origin. 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, frequency 1 total, 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 08-JUL-2021, the patient and her daughter were tested covid-19 positive (suspected clinical vaccination failure and suspected covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210718648.; Sender's Comments: V0:20210720833- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 65 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: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced headache. On 11-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and had not recovered from headache. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ONE DOSE WAS INADVERTENTLY ADMINISTERED THIS MORNING FROM PUNCTURED VIAL THAT WAS LEFT  IN REFRIGERATOR YESTERDAY; THE VIAL WAS LEFT IN THE FRIDGE PUNCTURED FOR AROUND 12 HOURS; This spontaneous report received from a pharmacist concerned a 30 year old male. 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: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced the vial was left in the fridge punctured for around 12 hours. On 09-JUL-2021, the subject experienced one dose was inadvertently administered this morning from punctured vial that was left in refrigerator yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the vial was left in the fridge punctured for around 12 hours and one dose was inadvertently administered this morning from punctured vial that was left in refrigerator yesterday was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Eating disorder, Hypersomnia, Illness, Pain in extremity
Clinical narrative: SUSPECTED COVID-19 INFECTION; DOING A LOT OF SLEEPING; EXTREME LOWER BACK PAIN; COULD NOT EAT; PAIN IN THE ARM; SHE WAS REALLY SICK; This spontaneous report received from a patient via a company representative concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, alcohol user, and nonsmoker, 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) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced she was really sick. On 28-JUN-2021, the subject experienced extreme lower back pain. On 28-JUN-2021, the subject experienced could not eat. On 28-JUN-2021, the subject experienced pain in the arm. On JUL-2021, the subject experienced doing a lot of sleeping. On 01-JUL-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme lower back pain, could not eat, and pain in the arm, and the outcome of suspected covid-19 infection, doing a lot of sleeping and she was really sick was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; DOING A LOT OF SLEEPING; EXTREME LOWER BACK PAIN; COULD NOT EAT; PAIN IN THE ARM; SHE WAS REALLY SICK; This spontaneous report received from a patient via a company representative concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, alcohol user, and nonsmoker, 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) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced she was really sick. On 28-JUN-2021, the subject experienced extreme lower back pain. On 28-JUN-2021, the subject experienced could not eat. On 28-JUN-2021, the subject experienced pain in the arm. On JUL-2021, the subject experienced doing a lot of sleeping. On 01-JUL-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme lower back pain, could not eat, and pain in the arm, and the outcome of suspected covid-19 infection, doing a lot of sleeping and she was really sick was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Poor quality sleep, Venous injury
Clinical narrative: SAFENA VEIN DAMAGED; CONSTANT PAIN; VERY LITTLE SLEEP FOR FEW DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient was healthy and had no previous conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-JUL-2021 immediately after vaccination, the patient felt pain in the left leg and her veins began to feel inflamed, the inflammation began to show in the foot and developed upwards. On an unspecified date in JUL-2021, the patient experienced constant pain and very little sleep for few days until then the patient visited the physician's office and was told that the patient had her safena vein damaged for which she had to undergo unspecified treatment and potentially surgery. The patient reported that her leg was just fine prior to the vaccine and that the treatment would last for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very little sleep for few days, safena vein damaged and constant pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210722944-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  venous injury-This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Vertigo
Clinical narrative: NUMBNESS IN THE ARM; MINOR INJECTION SITE PAIN; VERTIGO; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 JUN-2021, the subject experienced vertigo. On an unspecified date, the subject experienced numbness in the arm, and minor injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo on JUN-2021, and the outcome of minor injection site pain and numbness in the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210726264.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: CURED CHRONIC BRONCHITIS, TEN YEAR LONG COUGH (ESPECIALLY MORNINGS) FADED AWAY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced cured chronic bronchitis, ten year long cough (especially mornings) faded away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cured chronic bronchitis, ten year long cough (especially mornings) faded away was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: 3 BRUISED TOES; This spontaneous report received from a patient via a company representative concerned a 66 year old male. 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 16-JUN-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced 3 bruised toes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 3 bruised toes. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Contusion, Limb mass
Clinical narrative: LITTLE BLOOD SPOT UNDER SKIN ON RIGHT ARM; A LUMP AND POOL OF BLOOD INSIDE BEND OF RIGHT ARM TO THE RIGHT SIDE; FRESH BRUISING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced little blood spot under skin on right arm, a lump and pool of blood inside bend of right arm to the right side, and fresh bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little blood spot under skin on right arm, a lump and pool of blood inside bend of right arm to the right side, and fresh bruising. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a parent concerned a 32 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 reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced headache. On 11-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and fever. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Epistaxis, Pyrexia
Clinical narrative: NOSE BLEED; FEVER OF 38.5 CELCIUS 101.3F; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was 69 kilograms, and height was 66 centimeters. The patient's past medical history included iron deficiency, and concurrent conditions included non alcohol user, non smoker, and sulfa allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received acne medication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced nose bleed. On 09-JUL-2021, the subject experienced fever of 38.5 Celsius 101.3f. Laboratory data included: Body temperature (NR: not provided) 99.5, 101.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 09-JUL-2021, and had not recovered from fever of 38.5 Celsius 101.3f. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lethargy, Myalgia
Clinical narrative: LETHARGY; COLD CHILLS; SORE ARM; NAUSEA; MUSCLE ACHE; HEADACHE; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. 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-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced lethargy. On 06-JUL-2021, the subject experienced cold chills. On 06-JUL-2021, the subject experienced sore arm. On 06-JUL-2021, the subject experienced nausea. On 06-JUL-2021, the subject experienced muscle ache. On 06-JUL-2021, the subject experienced headache. On 06-JUL-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and the outcome of nausea, cold chills, muscle ache, headache, lethargy and injection site soreness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: LETHARGY; COLD CHILLS; SORE ARM; NAUSEA; MUSCLE ACHE; HEADACHE; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. 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-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced lethargy. On 06-JUL-2021, the subject experienced cold chills. On 06-JUL-2021, the subject experienced sore arm. On 06-JUL-2021, the subject experienced nausea. On 06-JUL-2021, the subject experienced muscle ache. On 06-JUL-2021, the subject experienced headache. On 06-JUL-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and the outcome of nausea, cold chills, muscle ache, headache, lethargy and injection site soreness was not reported. This report was non-serious.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer concerned a 13 year old male. 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 subject experienced inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BAD 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 08-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up was requested for this case. No concomitant medications were reported.  On 08-JUL-2021, the subject experienced bad fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER 8 HOURS LATER; 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 subject experienced fever 8 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 8 hours later. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: WEIGHT LOSS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. 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 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced weight loss. Laboratory data (dates unspecified) included: Weight (NR: not provided) weight loss from 136 pounds to 125 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weight loss. This report was non-serious. This case, from the same reporter is linked to 20210724253.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: JOINTS PAIN; EXTREME EXHAUSTION; 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 15-MAY-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 an unspecified date, the subject experienced joints pain, and extreme exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme exhaustion, and joints pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NICE FEVER LAST NIGHT; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced nice fever last night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nice fever last night was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER PEAKING AT 40'C; This spontaneous report received from a patient via a company representative concerned multiple patients.  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 28-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-JUN-2021, the subject experienced fever peaking at 40'c. Laboratory data included: Body temperature (NR: not provided) 40'C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever peaking at 40'c was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Headache
Clinical narrative: SHORTNESS OF BREATH; CONGESTION; SORE THROAT; RUNNY NOSE; VOMITING; DIARRHEA; COUGH; CHILLS; LEFT ARM PAIN; NAUSEA; 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 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shortness of breath. On 10-JUL-2021, the subject experienced congestion. On 10-JUL-2021, the subject experienced sore throat. On 10-JUL-2021, the subject experienced runny nose. On 10-JUL-2021, the subject experienced vomiting. On 10-JUL-2021, the subject experienced diarrhea. On 10-JUL-2021, the subject experienced cough. On 10-JUL-2021, the subject experienced chills. On 10-JUL-2021, the subject experienced left arm pain. On 10-JUL-2021, the subject experienced nausea. On 10-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cough, shortness of breath, nausea, vomiting, diarrhea, headache, runny nose, congestion, left arm pain, and sore throat. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, Sinus congestion
Clinical narrative: SHORTNESS OF BREATH; CONGESTION; SORE THROAT; RUNNY NOSE; VOMITING; DIARRHEA; COUGH; CHILLS; LEFT ARM PAIN; NAUSEA; 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 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shortness of breath. On 10-JUL-2021, the subject experienced congestion. On 10-JUL-2021, the subject experienced sore throat. On 10-JUL-2021, the subject experienced runny nose. On 10-JUL-2021, the subject experienced vomiting. On 10-JUL-2021, the subject experienced diarrhea. On 10-JUL-2021, the subject experienced cough. On 10-JUL-2021, the subject experienced chills. On 10-JUL-2021, the subject experienced left arm pain. On 10-JUL-2021, the subject experienced nausea. On 10-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cough, shortness of breath, nausea, vomiting, diarrhea, headache, runny nose, congestion, left arm pain, and sore throat. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SHORTNESS OF BREATH; CONGESTION; SORE THROAT; RUNNY NOSE; VOMITING; DIARRHEA; COUGH; CHILLS; LEFT ARM PAIN; NAUSEA; 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 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shortness of breath. On 10-JUL-2021, the subject experienced congestion. On 10-JUL-2021, the subject experienced sore throat. On 10-JUL-2021, the subject experienced runny nose. On 10-JUL-2021, the subject experienced vomiting. On 10-JUL-2021, the subject experienced diarrhea. On 10-JUL-2021, the subject experienced cough. On 10-JUL-2021, the subject experienced chills. On 10-JUL-2021, the subject experienced left arm pain. On 10-JUL-2021, the subject experienced nausea. On 10-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, cough, shortness of breath, nausea, vomiting, diarrhea, headache, runny nose, congestion, left arm pain, and sore throat. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Pain
Clinical narrative: VACCINE GAVE ALMOST ALL THE  REACTIONS; EVERYTHING HURT; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 09-JUL-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 09-JUL-2021, the subject experienced vaccine gave almost all the reactions. On 09-JUL-2021, the subject experienced everything hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine gave almost all the reactions and everything hurt was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE  CAN SCREAM); WEAKNESS; This spontaneous report received from a patient concerned a 60 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: 207A21A expiry: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting ( nothing comes out). On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (feels she can scream). On 09-JUL-2021, the subject experienced weakness. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting (nothing comes out), headache (feels she can scream), weakness and hand soreness was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE  CAN SCREAM); WEAKNESS; This spontaneous report received from a patient concerned a 60 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: 207A21A expiry: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting ( nothing comes out). On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (feels she can scream). On 09-JUL-2021, the subject experienced weakness. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting (nothing comes out), headache (feels she can scream), weakness and hand soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Oesophagogastric fundoplasty
Clinical narrative: CONSTANT BURPING/ BURPING EVERY FEW  SECONDS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problems, and gerd (gastrooesophageal reflux disease), and other pre-existing medical conditions included patient currently took medications and had some medical conditions but nothing serious. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-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 MAR-2021, the subject experienced constant burping/ burping every few seconds. On 04-MAY-2021, Laboratory data included: Nissen fundoplication (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant burping/ burping every few seconds. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Grip strength decreased, Hypersomnia, Inflammation
Clinical narrative: LOST THE ABILITY TO GRIP ANYTHING WITH LEFT HAND; BACK VERY PAINFUL; OFTEN SLEEPING MUCH MORE THAN I NORMALLY DO; INFLAMMATION; 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: Unk) 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 subject experienced lost the ability to grip anything with left hand, back very painful, often sleeping much more than i normally do, and inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost the ability to grip anything with left hand, back very painful, often sleeping much more than i normally do and inflammation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: QUARTER SIZE LUMP AT INJECTION SITE; SWELLING AT INJECTION SITE (ABOUT A DIAMETER OF BASEBALL); This spontaneous report received from a patient concerned a 64 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: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the subject experienced quarter size lump at injection site. On 07-JUL-2021, the subject experienced swelling at injection site (about a diameter of baseball). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling at injection site (about a diameter if baseball) on JUL-2021, and was recovering from quarter size lump at injection site. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Contusion, Diarrhoea, Dyspepsia, Fatigue
Clinical narrative: STOMACH PAIN; DIARRHEA; BURNING FEELING IN STOMACH; HEADACHE; FATIGUE; MILD REDDISH BRUISE ON RIGHT HAND; RIGHT CALF A LITTLE SWOLLEN VERY MINUTE; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous gastric issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced right calf a little swollen very minute. On 06-JUL-2021, the subject experienced mild reddish bruise on right hand. On 06-JUL-2021, the subject experienced fatigue. On 07-JUL-2021, the subject experienced stomach pain. On 07-JUL-2021, the subject experienced diarrhea. On 07-JUL-2021, the subject experienced burning feeling in stomach. On 07-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild reddish bruise on right hand, and fatigue, and had not recovered from right calf a little swollen very minute, stomach pain, diarrhea, burning feeling in stomach, and headache. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oedema peripheral
Clinical narrative: STOMACH PAIN; DIARRHEA; BURNING FEELING IN STOMACH; HEADACHE; FATIGUE; MILD REDDISH BRUISE ON RIGHT HAND; RIGHT CALF A LITTLE SWOLLEN VERY MINUTE; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous gastric issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced right calf a little swollen very minute. On 06-JUL-2021, the subject experienced mild reddish bruise on right hand. On 06-JUL-2021, the subject experienced fatigue. On 07-JUL-2021, the subject experienced stomach pain. On 07-JUL-2021, the subject experienced diarrhea. On 07-JUL-2021, the subject experienced burning feeling in stomach. On 07-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild reddish bruise on right hand, and fatigue, and had not recovered from right calf a little swollen very minute, stomach pain, diarrhea, burning feeling in stomach, and headache. This report was non-serious.