chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: lyophilized portion of the vaccine was diluted with a sterile liquid; lyophilized portion of the vaccine was diluted with a sterile liquid; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date 30th June 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The case was reported by Medical assistant. The age at vaccination was not reported. The patient received Menveo vaccine which had been reconstituted lyophilized portion of the vaccine was diluted with a sterile liquid, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported at the time of the call. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / on 1/27/2020 / never received the second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago on 27th January 2020, batch number 4ME42, expiry date 14th November 2021).   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 nurse stated that, they plan to administer second Shingrix dose on the day of reporting but, but till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: SICK AS A DOG FOR ENTIRE MONTH OF APRIL; AWFUL; 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 APR-2021, the subject experienced sick as a dog for entire month of april. On APR-2021, the subject experienced awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick as a dog for entire month of april and awful was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Facial paralysis, Fatigue, Memory impairment
Clinical narrative: SLIGHT DROOP ON RIGHT SIDE OF FACE; TWO NOSEBLEEDS EACH ON A SEPARATE DAY; SLIGHT MEMORY ISSUES; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: Unknown) dose was not reported, with frequency 1 total administered on 28-JUN-2021 to left arm for prophylactic vaccination. Concomitant medications included amlodipine/olmesartan and gabapentin for hypertension. On 29-JUN-2021, the patient stated that the next day he felt tiredness. On JUL-2021, that roughly a week to two weeks ago (roughly ten days he added) his son noticed a slight droop on the right side of his face. He observed in the mirror that there was a slight difference at this time. Currently he reported that his son still notices a slight difference. On JUL-2021, He also stated that last week he experienced two nosebleeds each on a separate day and several days apart and he felt he had slight memory issues. Consumer has made an appointment to see his health care provider and will be seeing him on 23-JUL-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight droop on right side of face, and the outcome of two nosebleeds each on a separate day, slight memory issues and tiredness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210747736 -Covid-19 vaccine ad26.cov2.s -slight droop on right side of face. 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Application site pain, Contusion, Fatigue, Myalgia, Oedema peripheral
Clinical narrative: RIGHT LEG BRUISING ON HAMSTRING; SWOLLEN AREA ABOVE THE ANKLE; TENDER TO TOUCH; RIGHT LEG PAIN IN HAMSTRING; ACHEYNESS/MUSCULAR TYPE ACHEYNESS IN HIS ONE LEG OR ARM; MILD FATIGUE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 140 pounds, and height was 70 inches. The patient's concurrent conditions included alcohol use, non-smoker, and penicillin (hives) allergy, and other pre-existing medical conditions included the patient had no medical history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced swollen area above the ankle. On JUL-2021, the subject experienced tender to touch. On JUL-2021, the subject experienced right leg pain in hamstring. On JUL-2021, the subject experienced acheyness/muscular type acheyness in his one leg or arm. On JUL-2021, the subject experienced mild fatigue. On 21-JUL-2021, the subject experienced right leg bruising on hamstring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acheyness/muscular type acheyness in his one leg or arm, and mild fatigue on JUL-2021, and had not recovered from right leg pain in hamstring, right leg bruising on hamstring, swollen area above the ankle, and tender to touch. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: RIGHT LEG BRUISING ON HAMSTRING; SWOLLEN AREA ABOVE THE ANKLE; TENDER TO TOUCH; RIGHT LEG PAIN IN HAMSTRING; ACHEYNESS/MUSCULAR TYPE ACHEYNESS IN HIS ONE LEG OR ARM; MILD FATIGUE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 140 pounds, and height was 70 inches. The patient's concurrent conditions included alcohol use, non-smoker, and penicillin (hives) allergy, and other pre-existing medical conditions included the patient had no medical history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 03-JUL-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced swollen area above the ankle. On JUL-2021, the subject experienced tender to touch. On JUL-2021, the subject experienced right leg pain in hamstring. On JUL-2021, the subject experienced acheyness/muscular type acheyness in his one leg or arm. On JUL-2021, the subject experienced mild fatigue. On 21-JUL-2021, the subject experienced right leg bruising on hamstring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acheyness/muscular type acheyness in his one leg or arm, and mild fatigue on JUL-2021, and had not recovered from right leg pain in hamstring, right leg bruising on hamstring, swollen area above the ankle, and tender to touch. This report was non-serious.
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 49 year old male. The patient's weight was not reported and height was 75 inches. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the patient experienced suspected covid-19 infection (delta variant). Laboratory data included: COVID-19 virus test (NR: not provided) infected with the Delta Variant. On 18-JUL-2021, the patient experienced suspected clinical vaccination failure. The patient was admitted to a local hospital last week (20-JUL-2021) due to a covid infection. Patient was hospitalized for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected clinical vaccination failure, and the outcome of suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000187200.; Sender's Comments: V0: 20210752840-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 20210752840-COVID-19 VACCINE AD26.COV2.S-Suspected COVID 19 infection. 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: Eye inflammation
Clinical narrative: EYE INFLAMMATION; This spontaneous report received from a consumer concerned a 55 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-JUL-2021, the subject experienced eye inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eye inflammation. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/VERY SICK; This spontaneous report received from a patient concerned a 5 decade old female. Initial information was processed along with the additional information received on 26-JUL-2021 and 27-JUL-2021. 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, 1 total administered on 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 23-JUL-2021, the patient felt very sick with covid-19 infection which was clinically proven (suspected clinical vaccination failure and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection/very sick and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187073.; Sender's Comments: V0: 20210753056-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a parent concerned a 22 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick on 10-APR-2021. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Arthropod bite, Bedridden, Eating disorder symptom
Clinical narrative: MUSCLE LOSS TO THE ARMS AND SHOULDERS; BITES MARKS TO THE INSIDE OF THE  THIGHS; NUMBING SENSATION TO BOTH LEGS FROM TOP OF CALF TO BOTTOM OF QUADS AND PAIN WORSEN AND SPREAD EVERY DAY; DIFFICULTY EATING DUE TO ABDOMINAL DISTENTION; SEVERE PAIN TO BOTH SIDES OF THE ABDOMEN AND IT IS PAINFUL TO TOUCH; DISTENDED ABDOMEN; NUMBNESS AND TINGLING TO UPPER BODY, UP TO NECK AND DOWN TO THE ANKLES.; FELT LIKE "PINS AND NEEDLES IN ALL ORGANS"; CURLED UP IN THE BED; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced general body aches. On 18-MAY-2021, the subject experienced felt like pins and needles in all organs. On 18-MAY-2021, the subject experienced curled up in the bed. On 08-JUN-2021, the subject experienced severe pain to both sides of the abdomen and it is painful to touch. On 08-JUN-2021, the subject experienced distended abdomen. On 08-JUN-2021, the subject experienced numbness and tingling to upper body, up to neck and down to the ankles. On 08-JUN-2021, the subject experienced numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day. On 08-JUN-2021, the subject experienced difficulty eating due to abdominal distention. On 03-JUL-2021, the subject experienced bites marks to the inside of the thighs. On 06-JUL-2021, Laboratory data included: Laboratory test abnormal (NR: not provided) Elevated liver enzymes, diagnosed with ascites, and Sonogram (NR: not provided) Free fluid in the abdomen. On 09-JUL-2021, the subject experienced muscle loss to the arms and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from curled up in the bed on 19-MAY-2021, and bites marks to the inside of the thighs on 09-JUL-2021, recovered with sequelae from felt like pins and needles in all organs on 19-MAY-2021, and had not recovered from general body aches, severe pain to both sides of the abdomen and it is painful to touch, distended abdomen, numbness and tingling to upper body, up to neck and down to the ankles., muscle loss to the arms and shoulders, numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day, and difficulty eating due to abdominal distention. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test abnormal, Muscle atrophy, Pain, Paraesthesia
Clinical narrative: MUSCLE LOSS TO THE ARMS AND SHOULDERS; BITES MARKS TO THE INSIDE OF THE  THIGHS; NUMBING SENSATION TO BOTH LEGS FROM TOP OF CALF TO BOTTOM OF QUADS AND PAIN WORSEN AND SPREAD EVERY DAY; DIFFICULTY EATING DUE TO ABDOMINAL DISTENTION; SEVERE PAIN TO BOTH SIDES OF THE ABDOMEN AND IT IS PAINFUL TO TOUCH; DISTENDED ABDOMEN; NUMBNESS AND TINGLING TO UPPER BODY, UP TO NECK AND DOWN TO THE ANKLES.; FELT LIKE "PINS AND NEEDLES IN ALL ORGANS"; CURLED UP IN THE BED; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced general body aches. On 18-MAY-2021, the subject experienced felt like pins and needles in all organs. On 18-MAY-2021, the subject experienced curled up in the bed. On 08-JUN-2021, the subject experienced severe pain to both sides of the abdomen and it is painful to touch. On 08-JUN-2021, the subject experienced distended abdomen. On 08-JUN-2021, the subject experienced numbness and tingling to upper body, up to neck and down to the ankles. On 08-JUN-2021, the subject experienced numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day. On 08-JUN-2021, the subject experienced difficulty eating due to abdominal distention. On 03-JUL-2021, the subject experienced bites marks to the inside of the thighs. On 06-JUL-2021, Laboratory data included: Laboratory test abnormal (NR: not provided) Elevated liver enzymes, diagnosed with ascites, and Sonogram (NR: not provided) Free fluid in the abdomen. On 09-JUL-2021, the subject experienced muscle loss to the arms and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from curled up in the bed on 19-MAY-2021, and bites marks to the inside of the thighs on 09-JUL-2021, recovered with sequelae from felt like pins and needles in all organs on 19-MAY-2021, and had not recovered from general body aches, severe pain to both sides of the abdomen and it is painful to touch, distended abdomen, numbness and tingling to upper body, up to neck and down to the ankles., muscle loss to the arms and shoulders, numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day, and difficulty eating due to abdominal distention. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: MUSCLE LOSS TO THE ARMS AND SHOULDERS; BITES MARKS TO THE INSIDE OF THE  THIGHS; NUMBING SENSATION TO BOTH LEGS FROM TOP OF CALF TO BOTTOM OF QUADS AND PAIN WORSEN AND SPREAD EVERY DAY; DIFFICULTY EATING DUE TO ABDOMINAL DISTENTION; SEVERE PAIN TO BOTH SIDES OF THE ABDOMEN AND IT IS PAINFUL TO TOUCH; DISTENDED ABDOMEN; NUMBNESS AND TINGLING TO UPPER BODY, UP TO NECK AND DOWN TO THE ANKLES.; FELT LIKE "PINS AND NEEDLES IN ALL ORGANS"; CURLED UP IN THE BED; GENERAL BODY ACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced general body aches. On 18-MAY-2021, the subject experienced felt like pins and needles in all organs. On 18-MAY-2021, the subject experienced curled up in the bed. On 08-JUN-2021, the subject experienced severe pain to both sides of the abdomen and it is painful to touch. On 08-JUN-2021, the subject experienced distended abdomen. On 08-JUN-2021, the subject experienced numbness and tingling to upper body, up to neck and down to the ankles. On 08-JUN-2021, the subject experienced numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day. On 08-JUN-2021, the subject experienced difficulty eating due to abdominal distention. On 03-JUL-2021, the subject experienced bites marks to the inside of the thighs. On 06-JUL-2021, Laboratory data included: Laboratory test abnormal (NR: not provided) Elevated liver enzymes, diagnosed with ascites, and Sonogram (NR: not provided) Free fluid in the abdomen. On 09-JUL-2021, the subject experienced muscle loss to the arms and shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from curled up in the bed on 19-MAY-2021, and bites marks to the inside of the thighs on 09-JUL-2021, recovered with sequelae from felt like pins and needles in all organs on 19-MAY-2021, and had not recovered from general body aches, severe pain to both sides of the abdomen and it is painful to touch, distended abdomen, numbness and tingling to upper body, up to neck and down to the ankles., muscle loss to the arms and shoulders, numbing sensation to both legs from top of calf to bottom of quads and pain worsen and spread every day, and difficulty eating due to abdominal distention. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: VOMITING; COVID-19 VIRUS TEST POSITIVE; BODY ACHES; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have any symptoms related to covid, only the secondary symptoms. 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 vomiting, covid-19 virus test positive, body aches, fever, and nausea. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, body aches, fever, and nausea, and the outcome of covid-19 virus test positive was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; COVID-19 VIRUS TEST POSITIVE; BODY ACHES; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have any symptoms related to covid, only the secondary symptoms. 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 vomiting, covid-19 virus test positive, body aches, fever, and nausea. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, body aches, fever, and nausea, and the outcome of covid-19 virus test positive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient did not develop any antibody (negative antibody) (suspected immunological vaccine failure). The patient received antibody testing and the results were inconclusive. The test results were sent for reevaluation as recommended by the physician and the results were inconclusive again. The patient spoke to the hematologist and was told that the patient needed to be revaccinated. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210754967-Covid-19 vaccine ad26.cov2.s-suspected immunological vaccine 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN AFTER FROZEN; VACCINE ACCIDENTALLY STORED IN FREEZER FOR APPROXIMATELY 4 TO 5 DAYS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,and batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given after frozen, and vaccine accidentally stored in freezer for approximately 4 to 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after frozen and vaccine accidentally stored in freezer for approximately 4 to 5 days was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 0.3 ML DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 63 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 0.3 ml dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 0.3 ml dose of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: FELT SHITTY; JOINT PAINS; FEVERISH WITHOUT A FEVER; INJECTION SITE ACHES; 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: 212C21A expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced felt shitty. On JUL-2021, the subject experienced joint pains. On JUL-2021, the subject experienced feverish without a fever. On JUL-2021, the subject experienced injection site aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt shitty, feverish without a fever, joint pains and injection site aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pyrexia, Rash
Clinical narrative: ELEVATED HEART RATE; RASH ON THIGH; PERSISTENT FEVER; This spontaneous report received from a consumer 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. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced elevated heart rate, rash on thigh, and persistent fever. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on thigh, elevated heart rate and persistent fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Increased upper airway secretion, Pharyngeal disorder, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: SARS-COV-2 TEST POSITIVE; DRAINAGE IN THROAT; CONGESTION IN THROAT; CONGESTION IN SINUS AND NOSE; This spontaneous report received from a parent concerned a 34 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, and mold allergy. 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 26-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021, the subject experienced drainage in throat. On 26-APR-2021, the subject experienced congestion in throat. On 26-APR-2021, the subject experienced congestion in sinus and nose. On 19-JUL-2021, the subject experienced sars-cov-2 test positive. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) POSITIVE. On 21-JUL-2021, Laboratory data included: COVID-19 PCR test positive (NR: not provided) POSITIVE, and COVID-19 rapid POC test positive (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drainage in throat, congestion in throat, and congestion in sinus and nose on 03-MAY-2021, and the outcome of sars-cov-2 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; 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 and has been requested. No concomitant medications were reported.  On 15-JUL-2021, the subject experienced covid-19 test positive. 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 covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000187269.; Sender's Comments: V0-Medical Assessment Comment is not required as per standard procedures, as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Nausea, Neck pain
Clinical narrative: NECK PAIN; NAUSEA; HEADACHE; FUNCTIONAL MOVEMENT DISORDER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy. 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 28-MAR-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 25-JUN-2021, the subject experienced functional movement disorder. On an unspecified date, the subject experienced neck pain, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, neck pain, nausea and functional movement disorder was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain
Clinical narrative: SWEATING; BODY ACHES; HEADACHE; This spontaneous report received from a consumer concerned a 27 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 25-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUL-2021, the subject experienced sweating. On 25-JUL-2021, the subject experienced body aches. On 25-JUL-2021, the subject experienced headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, sweating, and body aches. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 178 pounds, and height was 64 inches. The patient's concurrent conditions included high blood pressure, non-alcohol user, non-smoker, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number, 043A21A, and expiry, unknown) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. Patient was unsure about the anatomical site of vaccination, but thinks it was the left arm. Patient was 49 years at the time of vaccination. No concomitant medications were reported.  On 16-JUL-2021, the patient's physician performed the IgG antibody test (SARs COV2 Ab. IgG Spike-S Semi initial QN) which came back negative (confirmed immunological vaccine failure). Physician recommended that she gets vaccinated again but the patient was not sure if she should get another shot. Laboratory data included, SARS-CoV-2 IgG antibody test (NR, not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210755788-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: SLEEPINESS; SORE ARM; CHILLS; BODY WEAKNESS; 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 23-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 JUL-2021, the subject experienced sleepiness. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced chills. On JUL-2021, the subject experienced body weakness. On JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, chills, body weakness, fever and sleepiness was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Influenza like illness, Injection site discolouration, Muscle spasms, Pain in extremity
Clinical narrative: GOLF SIZE LIGHT PINK MARKING  AT THE INJECTION SITE; QUARTER SIZE BRUISING WITH YELLOW SPOT ON THE LEFT ARM, UNDER RIGHT NIPPLE AND BROWN SPOT ON CHEST AND ON LEFT THIGH; CRAMPING OF THE NECK, FINGERS AND TOES; ARM HURT; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and poison oak allergy, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. patient stated that, he sometimes bruises but it is minor and did not have any medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced flu-like symptoms. On 08-JUL-2021, the subject experienced arm hurt. On 11-JUL-2021, the subject experienced cramping of the neck, fingers and toes. On 22-JUL-2021, the subject experienced quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. On 26-JUL-2021, the subject experienced golf size light pink marking at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and cramping of the neck, fingers and toes on 11-JUL-2021, and arm hurt on 10-JUL-2021, was recovering from golf size light pink marking at the injection site, and had not recovered from quarter size bruising with yellow spot on the left arm, under right nipple and brown spot on chest and on left thigh. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Granuloma, Viral infection
Clinical narrative: NODULE/GRANULOMA MEASURING 1CM ON HER RIGHT SIDE OF PIRIFORM FOSSA; VIRAL ILLNESS; This spontaneous report received from a physician concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no allergies or medical history, had no fillers or toxins in the past, and does routinely use other products or medications. the patient was not ill in the month prior to treatment. the patient has not had any dental procedures in the last 6-12 months. The patient was previously treated with influenza vaccine for prophylactic vaccination. 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: hyaluronic acid ( batch number: 18481 expiry: 31-AUG-2022, form of admin, route of admin, and were not reported) .2 ml, frequency was not reported, from 12-APR-2021, .2 ml, frequency was not reported, from 12-APR-2021, and .6 ml, frequency was not reported, from 12-APR-2021 for an unspecified indication. No concomitant medications were reported. On 18-JUN-2021, the subject experienced viral illness. On 02-JUL-2021, the subject experienced nodule/granuloma measuring 1cm on her right side of piriform fossa. Treatment medications (dates unspecified) included: vorhyaluronidase alfa. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with hyaluronic acid was not reported. The patient had not recovered from nodule/granuloma measuring 1cm on her right side of piriform fossa, and the outcome of viral illness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210757030 and 20210756804.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Insomnia, Myalgia
Clinical narrative: INSOMNIA; CHILLS; MINOR MUSCLE SORENESS FROM THE INJECTION SITE; 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 insomnia, chills, and minor muscle soreness from the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor muscle soreness from the injection site, chills and insomnia was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: CHILLS; ARM SORENESS; This spontaneous report received from a patient via a company representative concerned a 71 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210757030 and 20210756561.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a consumer 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious. This case, from the same reporter is linked to 20210756561 and 20210756804.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Restless legs syndrome
Clinical narrative: HEADACHE; FATIGUE; RANDOM NAUSEA; RESTLESS LEG SYNDROME; 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 21-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 JUL-2021, the subject experienced restless leg syndrome. On JUL-2021, the subject experienced fatigue. On JUL-2021, the subject experienced random nausea. On 25-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 headache, and the outcome of fatigue, restless leg syndrome and random nausea was not reported. This report was non-serious.