chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First / vaccine in / 6/26/2018 / Second dose / not yet received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 26th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacy Intern reported that, till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination. The lot number and expiration date were unknown for 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 08Jan2020 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 08th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient was late for the 2nd dose of Shingrix, which led to incomplete course of vaccination. No further information reported.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: was vaccinated on June7th with a Pediarix / exposed for 20 min to a 11.7F.; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 8-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number AZ472, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 5th June 2021, from 10:15 to 10:35, the Pediarix vaccine exposed for 20 min to a 11.7 degree F. The health care professional (HCP) reported that patient was vaccinated with a this exposed Pediarix vaccine, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertently given two doses / 20 days apart.  First dose / administered on 28Jul2020 / second dose / administered 14Aug2020; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 81-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Boostrix).   On 14th August 2020, the patient received Boostrix. On 14th August 2020, unknown after receiving Boostrix and 17 days after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received boostrix 20 days apart after earlier dose,which led to shortening of the schedule. The reporter did not locate lot and expiration date for the dose administered on 14Aug2020 The reporter was not aware of the patient experiencing any ill effects after dosing. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for drug used for unknown indication. On 28-MAY-2021, the subject experienced inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea
Clinical narrative: DIARRHEA; ABDOMINAL PAIN/ABDOMINAL CRAMPING; ABDOMINAL DISTENTION; This spontaneous report received from a patient concerned a 54 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 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced diarrhea. On 08-JUN-2021, the subject experienced abdominal pain/abdominal cramping. On 08-JUN-2021, the subject experienced abdominal distention. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, abdominal pain/abdominal cramping, and abdominal distention. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Brain death, Fall, Incorrect dose administered
Clinical narrative: BRAIN ANEURYSM; BRAIN DEAD; BLOOD CLOT; FALL; NEEDLE BROKE OFF THE SYRINGE; NEEDLE BROKE OFF THE SYRINGE UNSURE OF THE FULL VOLUME THAT WAS INJECTED; This spontaneous report received from a consumer concerned a 57 year old White Hispanic/Latino male.. The patient's height, and weight were not reported. The patient's concurrent conditions included blind, diabetes, cancer, congestive heart failure, and penicillin allergy.  Nurse came to patients house to administer the vaccine due to patient disability, patient usually does have a home aid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:  Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Upon administering the vaccine, the needle broke off the syringe, unsure of the full volume that was injected. On 21-MAY-2021 patient experienced dizziness, vomiting, and fall. Blood pressure and sugar was fine after the wife had checked it (BP 120/75, glucose 112). They called the ambulance because the symptoms were unrelenting and a headache began on 21-MAY-2021. Patient required and emergency surgery to relieve pressure on the brain, drilling of the skull where ultimately patient was pronounced brain dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of brain aneurysm due to blood clot and brain dead on 25-MAY-2021, and the outcome of fall, blood clot, needle broke off the syringe, needle broke off the syringe unsure of the full volume that was injected was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210708201-COVID-19 VACCINE AD26.COV2.S-Brain Aneurysm, Brain Dead, Blood Clot, Fall. 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).; Reported Cause(s) of Death: BRAIN ANEURYSM DUE TO BLOOD CLOT
Sex: M
Vaccine: COVID19
Symptoms: Intracranial aneurysm, Needle issue, Thrombosis
Clinical narrative: BRAIN ANEURYSM; BRAIN DEAD; BLOOD CLOT; FALL; NEEDLE BROKE OFF THE SYRINGE; NEEDLE BROKE OFF THE SYRINGE UNSURE OF THE FULL VOLUME THAT WAS INJECTED; This spontaneous report received from a consumer concerned a 57 year old White Hispanic/Latino male.. The patient's height, and weight were not reported. The patient's concurrent conditions included blind, diabetes, cancer, congestive heart failure, and penicillin allergy.  Nurse came to patients house to administer the vaccine due to patient disability, patient usually does have a home aid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:  Unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Upon administering the vaccine, the needle broke off the syringe, unsure of the full volume that was injected. On 21-MAY-2021 patient experienced dizziness, vomiting, and fall. Blood pressure and sugar was fine after the wife had checked it (BP 120/75, glucose 112). They called the ambulance because the symptoms were unrelenting and a headache began on 21-MAY-2021. Patient required and emergency surgery to relieve pressure on the brain, drilling of the skull where ultimately patient was pronounced brain dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of brain aneurysm due to blood clot and brain dead on 25-MAY-2021, and the outcome of fall, blood clot, needle broke off the syringe, needle broke off the syringe unsure of the full volume that was injected was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210708201-COVID-19 VACCINE AD26.COV2.S-Brain Aneurysm, Brain Dead, Blood Clot, Fall. 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).; Reported Cause(s) of Death: BRAIN ANEURYSM DUE TO BLOOD CLOT
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; WRONG PRODUCT ADMINISTERED; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a physician concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was a healthy individual. 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 an unspecified date, the subject experienced inappropriate age at vaccine administration, wrong product administered, and off label use in unapproved age group. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration, wrong product administered and off label use in unapproved age group was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Confusional state, Electrocardiogram, Eye disorder
Clinical narrative: FAINTED; PUKE/ VOMITING; RETCHING; CONFUSED OR COULD NOT FIGURE OUT; FELT HOT; SWEATING PROFUSELY; COULD NOT HOLD BODY WEIGHT; COULD NOT OPEN EYES; URINATED; LETHARGIC; LOW BLOOD PRESSURE; FELT FREEZING COLD; FELT SICK AND DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 155 pounds, and height was 62 inches. The patient's concurrent conditions included little alcohol user, and non-smoker. The patient had no known allergies. She was not pregnant at the time of report. She had no drug abuse or illicit drug usage. The patient was healthy and not taking any medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202/ZA21A, expiry: unknown) dose was not reported, 1 total, administered on 28-JUN-2021 at left arm for prophylactic vaccination. (The patient was not sure about 3rd letter of batch number as 2' or Z'). No concomitant medications were reported.  On 28-JUN-2021, within 30 second after receiving vaccine the patient did not feel good. She asked for water to her son while waiting she fainted. She urinated. She woke up after a while, felt confused or could not figure out what was going on. She was lethargic. She felt so hot' for 30 minutes. She was sweating profusely.  She sat down on the floor and felt sick, retching several times and finally vomiting/ puke. She could not hold her body weight and could not open eyes. Patient was taken to the hospital via ambulance. In ambulance patient received IV anti-nausea medication. In emergency room (ER) bloodwork up and electrocardiogram (ECG) was done and both were normal and she had really low blood pressure (did not recall the exact measurements). She felt freezing cold and needed warm blankets until her body temperature finally regulated, an hour later. After 3-4 hours she felt better and went home. She has not sought any further medical care after this occurrence. She was hospitalized for 3 hours. She was feeling better at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, puke/ vomiting, retching, confused or could not figure out, felt hot, sweating profusely, could not hold body weight, could not open eyes, urinated, low blood pressure, felt freezing cold, and felt sick and did not feel good on 28-JUN-2021, and lethargic on 29-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210708856-COVID-19 VACCINE AD26.COV2.S-Fainted, Puke / vomiting, Retching. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Hypotension, Lethargy
Clinical narrative: FAINTED; PUKE/ VOMITING; RETCHING; CONFUSED OR COULD NOT FIGURE OUT; FELT HOT; SWEATING PROFUSELY; COULD NOT HOLD BODY WEIGHT; COULD NOT OPEN EYES; URINATED; LETHARGIC; LOW BLOOD PRESSURE; FELT FREEZING COLD; FELT SICK AND DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 155 pounds, and height was 62 inches. The patient's concurrent conditions included little alcohol user, and non-smoker. The patient had no known allergies. She was not pregnant at the time of report. She had no drug abuse or illicit drug usage. The patient was healthy and not taking any medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202/ZA21A, expiry: unknown) dose was not reported, 1 total, administered on 28-JUN-2021 at left arm for prophylactic vaccination. (The patient was not sure about 3rd letter of batch number as 2' or Z'). No concomitant medications were reported.  On 28-JUN-2021, within 30 second after receiving vaccine the patient did not feel good. She asked for water to her son while waiting she fainted. She urinated. She woke up after a while, felt confused or could not figure out what was going on. She was lethargic. She felt so hot' for 30 minutes. She was sweating profusely.  She sat down on the floor and felt sick, retching several times and finally vomiting/ puke. She could not hold her body weight and could not open eyes. Patient was taken to the hospital via ambulance. In ambulance patient received IV anti-nausea medication. In emergency room (ER) bloodwork up and electrocardiogram (ECG) was done and both were normal and she had really low blood pressure (did not recall the exact measurements). She felt freezing cold and needed warm blankets until her body temperature finally regulated, an hour later. After 3-4 hours she felt better and went home. She has not sought any further medical care after this occurrence. She was hospitalized for 3 hours. She was feeling better at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, puke/ vomiting, retching, confused or could not figure out, felt hot, sweating profusely, could not hold body weight, could not open eyes, urinated, low blood pressure, felt freezing cold, and felt sick and did not feel good on 28-JUN-2021, and lethargic on 29-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210708856-COVID-19 VACCINE AD26.COV2.S-Fainted, Puke / vomiting, Retching. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Retching, Syncope, Urinary incontinence, Vomiting
Clinical narrative: FAINTED; PUKE/ VOMITING; RETCHING; CONFUSED OR COULD NOT FIGURE OUT; FELT HOT; SWEATING PROFUSELY; COULD NOT HOLD BODY WEIGHT; COULD NOT OPEN EYES; URINATED; LETHARGIC; LOW BLOOD PRESSURE; FELT FREEZING COLD; FELT SICK AND DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 155 pounds, and height was 62 inches. The patient's concurrent conditions included little alcohol user, and non-smoker. The patient had no known allergies. She was not pregnant at the time of report. She had no drug abuse or illicit drug usage. The patient was healthy and not taking any medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202/ZA21A, expiry: unknown) dose was not reported, 1 total, administered on 28-JUN-2021 at left arm for prophylactic vaccination. (The patient was not sure about 3rd letter of batch number as 2' or Z'). No concomitant medications were reported.  On 28-JUN-2021, within 30 second after receiving vaccine the patient did not feel good. She asked for water to her son while waiting she fainted. She urinated. She woke up after a while, felt confused or could not figure out what was going on. She was lethargic. She felt so hot' for 30 minutes. She was sweating profusely.  She sat down on the floor and felt sick, retching several times and finally vomiting/ puke. She could not hold her body weight and could not open eyes. Patient was taken to the hospital via ambulance. In ambulance patient received IV anti-nausea medication. In emergency room (ER) bloodwork up and electrocardiogram (ECG) was done and both were normal and she had really low blood pressure (did not recall the exact measurements). She felt freezing cold and needed warm blankets until her body temperature finally regulated, an hour later. After 3-4 hours she felt better and went home. She has not sought any further medical care after this occurrence. She was hospitalized for 3 hours. She was feeling better at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, puke/ vomiting, retching, confused or could not figure out, felt hot, sweating profusely, could not hold body weight, could not open eyes, urinated, low blood pressure, felt freezing cold, and felt sick and did not feel good on 28-JUN-2021, and lethargic on 29-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210708856-COVID-19 VACCINE AD26.COV2.S-Fainted, Puke / vomiting, Retching. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: FAINTED; PUKE/ VOMITING; RETCHING; CONFUSED OR COULD NOT FIGURE OUT; FELT HOT; SWEATING PROFUSELY; COULD NOT HOLD BODY WEIGHT; COULD NOT OPEN EYES; URINATED; LETHARGIC; LOW BLOOD PRESSURE; FELT FREEZING COLD; FELT SICK AND DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 155 pounds, and height was 62 inches. The patient's concurrent conditions included little alcohol user, and non-smoker. The patient had no known allergies. She was not pregnant at the time of report. She had no drug abuse or illicit drug usage. The patient was healthy and not taking any medication regularly. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202/ZA21A, expiry: unknown) dose was not reported, 1 total, administered on 28-JUN-2021 at left arm for prophylactic vaccination. (The patient was not sure about 3rd letter of batch number as 2' or Z'). No concomitant medications were reported.  On 28-JUN-2021, within 30 second after receiving vaccine the patient did not feel good. She asked for water to her son while waiting she fainted. She urinated. She woke up after a while, felt confused or could not figure out what was going on. She was lethargic. She felt so hot' for 30 minutes. She was sweating profusely.  She sat down on the floor and felt sick, retching several times and finally vomiting/ puke. She could not hold her body weight and could not open eyes. Patient was taken to the hospital via ambulance. In ambulance patient received IV anti-nausea medication. In emergency room (ER) bloodwork up and electrocardiogram (ECG) was done and both were normal and she had really low blood pressure (did not recall the exact measurements). She felt freezing cold and needed warm blankets until her body temperature finally regulated, an hour later. After 3-4 hours she felt better and went home. She has not sought any further medical care after this occurrence. She was hospitalized for 3 hours. She was feeling better at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, puke/ vomiting, retching, confused or could not figure out, felt hot, sweating profusely, could not hold body weight, could not open eyes, urinated, low blood pressure, felt freezing cold, and felt sick and did not feel good on 28-JUN-2021, and lethargic on 29-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210708856-COVID-19 VACCINE AD26.COV2.S-Fainted, Puke / vomiting, Retching. 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: U
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: CHEST PAIN; DIFFICULTY BREATHING; FELT BAD IN BODY; DIZZINESS; WEAKNESS; STRANGE HEADACHE; This spontaneous report received from a patient concerned an adult of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced chest pain. On 12-MAY-2021, the subject experienced difficulty breathing. On 12-MAY-2021, the subject experienced felt bad in body. On 12-MAY-2021, the subject experienced dizziness. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021, the subject experienced strange headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange headache, chest pain, difficulty breathing, dizziness, weakness, and felt bad in body. This report was non-serious.; Sender's Comments: V0;Medical assessment comment not required as per standard operating procedures, as case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: CHEST PAIN; DIFFICULTY BREATHING; FELT BAD IN BODY; DIZZINESS; WEAKNESS; STRANGE HEADACHE; This spontaneous report received from a patient concerned an adult of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced chest pain. On 12-MAY-2021, the subject experienced difficulty breathing. On 12-MAY-2021, the subject experienced felt bad in body. On 12-MAY-2021, the subject experienced dizziness. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021, the subject experienced strange headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange headache, chest pain, difficulty breathing, dizziness, weakness, and felt bad in body. This report was non-serious.; Sender's Comments: V0;Medical assessment comment not required as per standard operating procedures, as case was assessed as non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Hyperhidrosis, Nausea, Pain of skin
Clinical narrative: SWEATING; STOMACH ACHE; STING ON THE RIGHT SIDE OF FACE; NAUSEA PREVENTED FROM EATING ANYTHING; NAUSEA; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included aches every day due to history of arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: UNKNOWN) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced sweating. On 01-JUL-2021, the subject experienced stomach ache. On 01-JUL-2021, the subject experienced sting on the right side of face. On 01-JUL-2021, the subject experienced nausea prevented from eating anything. On 01-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting on the right side of face on 01-JUL-2021, was recovering from sweating, nausea, and stomach ache, and the outcome of nausea prevented from eating anything was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Groin pain, Pain, Pain in extremity
Clinical narrative: ACHES; GROIN PAIN; THIGH PAIN AND LEG PAIN; CHILLS; SHOULDER PAIN; 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 was not reported, administered on 04-MAY-2021 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 aches, groin pain, thigh pain and leg pain, chills, and shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, groin pain, thigh pain and leg pain and shoulder pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dependence on respirator, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: ON A VENTILATOR; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient via a company representative concerned a 64 year old male of unknown ethnic origin and race. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included exposure to covid-19. 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, one total, administered on 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 JUN-2021, The patient was hospitalized in intensive care unit, after infectious disease experts confirmed patient had a different variant of COVID-19. On JUN-2021, patient thought he had allergies and on next day patient said that may had getting a cold. Patient stated that he was in contact with someone who tested positive. Patient was breathing with the help of a ventilator. 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 on a ventilator, suspected clinical vaccination failure and suspected variant covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210713171-covid-19 vaccine ad26.cov2.s - suspected variant COVID 19, patient on ventilator. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210713171- covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: Feeling hot
Clinical narrative: WARM SENSATION TO THE ENTIRE UPPER ARM AND GOES DOWN TO THE ELBOW; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight was 145 pounds, and height was 65 inches. The patient's past medical history included uterine cancer, and uterine surgery, and concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient has the allergy of certain anesthesia's due to insufficient levels of enzymes dibucaine and pseudo-cholinesterase, and reported that she almost died on the operating table due to that. the patient did not have any history of drug abuse or illicit drug use. patient take estrogen replacement. The patient experienced drug allergy when treated with cinchocaine, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 20-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced warm sensation to the entire upper arm and goes down to the elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from warm sensation to the entire upper arm and goes down to the elbow. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PERISHED APPROX 9 WEEKS POST INJECTION OF YOUR PRODUCT; This spontaneous report received from a company representative via social media and concerned a male patient 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, route of admin not reported, batch number not reported, expiry not reported frequency one total, dose, therapy start date were not reported administered 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 perished approximately 9 weeks (2021) post injection and cause of death was unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210713544-covid-19 vaccine ad26.cov2.s -Perished approx. 9 weeks post injection of your product. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
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 concerned a 4 decade old male of unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose,1 total, start therapy date was in either April or May for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-JUN-2021, the patient experienced suspected covid-19 infection. The patient had experienced symptoms additional to testing positive and had contacted physician concerning the symptoms. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The type of test performed was unknown. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000185108.; Sender's Comments: 20210713582-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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder symptom, Full blood count, Headache, Migraine with aura
Clinical narrative: SYSTEMIC PAIN; DIFFICULTY EATING DUE TO NAUSEA; FEVER; MIGRAINE WITH AURA/ NEUROLOGICAL EYE TWITCHING/ HEADACHE/ RUNNY NOSE/ FLASHING LIGHT/ BLUE SPOTS/RINGING IN EAR (TINNITUS)/PAIN IN EYE/ NAUSEA/PAIN IN CHEEK; MIGRAINE WITH AURA/ NEUROLOGICAL EYE TWITCHING/ HEADACHE/ RUNNY NOSE/ FLASHING LIGHT/ BLUE SPOTS/RINGING IN EAR (TINNITUS)/PAIN IN EYE/ NAUSEA/PAIN IN CHEEK; CHILLS; HEADACHE/STABBING HEADACHE BEHIND THE EYE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine with onset at age 16, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient was having allergies but wishes not to disclose 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus) /pain in eye/ nausea/pain in cheek. On 20-MAR-2021, the subject experienced migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus) /pain in eye/ nausea/pain in cheek. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache/stabbing headache behind the eye. On 20-MAR-2021, the subject experienced difficulty eating due to nausea. On 20-MAR-2021, the subject experienced fever. On 23-JUN-2021, the subject experienced systemic pain. Treatment medications included: ketorolac tromethamine. On 29-JUN-2021, treatment medications included: topiramate. Laboratory data (dates unspecified) included: Complete blood count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, headache/stabbing headache behind the eye on 03-APR-2021, and systemic pain on 23-JUN-2021, and had not recovered from difficulty eating due to nausea, migraine with aura/ aura neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus)/pain in eye/ nausea/pain in cheek, and migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus)/pain in eye/ nausea/pain in cheek. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine without aura, Myalgia, Pyrexia
Clinical narrative: SYSTEMIC PAIN; DIFFICULTY EATING DUE TO NAUSEA; FEVER; MIGRAINE WITH AURA/ NEUROLOGICAL EYE TWITCHING/ HEADACHE/ RUNNY NOSE/ FLASHING LIGHT/ BLUE SPOTS/RINGING IN EAR (TINNITUS)/PAIN IN EYE/ NAUSEA/PAIN IN CHEEK; MIGRAINE WITH AURA/ NEUROLOGICAL EYE TWITCHING/ HEADACHE/ RUNNY NOSE/ FLASHING LIGHT/ BLUE SPOTS/RINGING IN EAR (TINNITUS)/PAIN IN EYE/ NAUSEA/PAIN IN CHEEK; CHILLS; HEADACHE/STABBING HEADACHE BEHIND THE EYE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine with onset at age 16, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient was having allergies but wishes not to disclose 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus) /pain in eye/ nausea/pain in cheek. On 20-MAR-2021, the subject experienced migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus) /pain in eye/ nausea/pain in cheek. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headache/stabbing headache behind the eye. On 20-MAR-2021, the subject experienced difficulty eating due to nausea. On 20-MAR-2021, the subject experienced fever. On 23-JUN-2021, the subject experienced systemic pain. Treatment medications included: ketorolac tromethamine. On 29-JUN-2021, treatment medications included: topiramate. Laboratory data (dates unspecified) included: Complete blood count (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, headache/stabbing headache behind the eye on 03-APR-2021, and systemic pain on 23-JUN-2021, and had not recovered from difficulty eating due to nausea, migraine with aura/ aura neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus)/pain in eye/ nausea/pain in cheek, and migraine with aura/ neurological eye twitching/ headache/ runny nose/ flashing light/ blue spots/ringing in ear (tinnitus)/pain in eye/ nausea/pain in cheek. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION /ANOTHER VARIANT; 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. The patient's concurrent conditions included ldl (low density lipoprotein), and triglycerides, and other pre-existing medical conditions included normally in good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported)at a frequency of 1 total, dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination.  Concomitant medications included eicosapentaenoic acid ethyl ester for ldl, and triglycerides, and fenofibrate for ldl, and triglycerides.  On 03-JUL-2021, the subject experienced suspected clinical vaccination failure and suspected covid-19 infection / another variant. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection / other variant, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210713929-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous report received from a consumer 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 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 fever. On 06-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Dyspnoea, Pyrexia
Clinical narrative: CRAZY DREAMS; SHORT OF BREATH; HIGH FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced abnormal dreams, short of breath, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, abnormal dreams and short of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Myalgia, Pyrexia, Sneezing
Clinical narrative: SICK; VOMITING; DIARRHEA; SNEEZING; MUSCLE ACHES; FEVER; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821267, and expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced fever. On 04-JUL-2021, the subject experienced sneezing. On 04-JUL-2021, the subject experienced muscle aches. On 05-JUL-2021, the subject experienced vomiting. On 05-JUL-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, diarrhea, muscle aches, and sneezing, and had not recovered from fever, and sick. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SICK; VOMITING; DIARRHEA; SNEEZING; MUSCLE ACHES; FEVER; This spontaneous report received from a consumer concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821267, and expiry: UNKNOWN) dose was not reported, administered on 27-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced fever. On 04-JUL-2021, the subject experienced sneezing. On 04-JUL-2021, the subject experienced muscle aches. On 05-JUL-2021, the subject experienced vomiting. On 05-JUL-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, diarrhea, muscle aches, and sneezing, and had not recovered from fever, and sick. This report was non-serious.