chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Bronchitis, Rash, Skin disorder
Clinical narrative: Multiple outbreaks of a painful rash, skin issues and bronchitis; Multiple outbreaks of a painful rash, skin issues and bronchitis; Multiple outbreaks of a painful rash, skin issues and bronchitis; Information has been received regarding a case in litigation from a lawyer and referred to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 24-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of a painful rash, skin issues and bronchitis. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered all the events to be disability.
Age: 77.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired MMRlI administered; This spontaneous report was received from a licensed practical nurse and refers to a 77-year-old male patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 15-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHa)) (M-M-R II) lot # S014807, expiration date 13-MAY-2021 (formulation, dose, route of administration, anatomical location were not reported) for prophylaxis.
Age: 72.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Product storage error; Patient received Proquad; Received Varivax and Proquad; This spontaneous report was received from a medical assistant and refers to a 72 years old male. The patient´s concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 10-JUN-2021, 11-JUN-2021 and 14-JUN-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T022314, expiration date 30-JUN-2022 and and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot number T037954, expiration date 09-MAY-2022 (dose and route were not reported) for prophylaxis.  The temperature involved was 6.8 grades F for 50 minutes. A data logger was involved.
Sex: F
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: allergy to the MMR vaccine; This spontaneous report was received from a female patient of unknown age, who was referring to herself via Pfizer. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (reported as MMR vaccine manufactured by Merck Pharmaceuticals) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, she developed allergy to the vaccine and at the time of the report, the patient still has the allergy.  The patient considered the event to be related to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II).
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: they received first dose of GARDASIL in 2013 and second dose of GARDASIL in 2015; No additional adverse events reported.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2013 (at the age of 12 or 13 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date in 2015, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. Patient did not receive vaccine at recommended intervals per the prescribing information. No further information provided. No additional adverse events reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chills, Dizziness, Electrocardiogram
Clinical narrative: Loss of consciousness; Back pain; Dizziness; Nasopharyngitis; Chills; Nausea; This case was received via  FDA VAERS (Reference number: 1198122) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID in October 2020) in October 2020.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), BACK PAIN (Back pain), DIZZINESS (Dizziness), NASOPHARYNGITIS (Nasopharyngitis), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), BACK PAIN (Back pain), DIZZINESS (Dizziness), NASOPHARYNGITIS (Nasopharyngitis), CHILLS (Chills) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood test: unknown (Inconclusive) unknown. On 03-Apr-2021, Electrocardiogram: 03-apr-2021 (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was received FDA VAERS (Reference number: 1198122) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    Other Meds :  Symptom Text : The patient had experienced Severe back pain starting at 5pm on April 2, 2021. Frequent urination throughout the night, cold chills. April 3, 2021, 4:50am got up to use the bathroom and had extreme nausea and lightheadedness. Passed out and seized up. EMS arrived, BP 80's/50's and low grade fever. Put in chair to transport me downstairs and passed out and seized up again. Threw up. Transported to ER and still weak and severe back pain. Was given something for nausea. Two bags of fluid. EKG, blood work, and urine test. Left ER around 10 am. No Concomitant medication was not provided. No Treatment medication was not provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nasopharyngitis, Nausea
Clinical narrative: Loss of consciousness; Back pain; Dizziness; Nasopharyngitis; Chills; Nausea; This case was received via  FDA VAERS (Reference number: 1198122) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID in October 2020) in October 2020.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), BACK PAIN (Back pain), DIZZINESS (Dizziness), NASOPHARYNGITIS (Nasopharyngitis), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), BACK PAIN (Back pain), DIZZINESS (Dizziness), NASOPHARYNGITIS (Nasopharyngitis), CHILLS (Chills) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood test: unknown (Inconclusive) unknown. On 03-Apr-2021, Electrocardiogram: 03-apr-2021 (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was received FDA VAERS (Reference number: 1198122) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    Other Meds :  Symptom Text : The patient had experienced Severe back pain starting at 5pm on April 2, 2021. Frequent urination throughout the night, cold chills. April 3, 2021, 4:50am got up to use the bathroom and had extreme nausea and lightheadedness. Passed out and seized up. EMS arrived, BP 80's/50's and low grade fever. Put in chair to transport me downstairs and passed out and seized up again. Threw up. Transported to ER and still weak and severe back pain. Was given something for nausea. Two bags of fluid. EKG, blood work, and urine test. Left ER around 10 am. No Concomitant medication was not provided. No Treatment medication was not provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Thrombosis
Clinical narrative: Cerebrovascular accident; Thrombosis; This case was received via FDA VAERS (Reference number: 1321745) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and THROMBOSIS (Thrombosis) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criteria hospitalization, disability, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria hospitalization, disability, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and THROMBOSIS (Thrombosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Computerised tomogram: blood clot (abnormal) Blood clot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient suffered a blot clot on may 11th and a stroke.  No treatment information were reported.  Action taken with the drug in response to events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.  Event terms, onset dates and outcomes captured per Health Authority reporting.  Events seriousness per overall case assessment by Authority and per IME list
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Toxic encephalopathy
Clinical narrative: This regulatory authority case was reported by an other health care professional and describes the occurrence of TOXIC ENCEPHALOPATHY (Toxic encephalopathy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced TOXIC ENCEPHALOPATHY (Toxic encephalopathy) (seriousness criteria hospitalization and medically significant). At the time of the report, TOXIC ENCEPHALOPATHY (Toxic encephalopathy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient presented to the emergency department and was subsequently hospitalized with toxic encephalopathy within 6 weeks of receiving COVID vaccination.   Treatment information was not provided.  Very limited information regarding this event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Antibody test positive, Influenza like illness, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Flu-Like Symptoms; Initial Report Received on 26-Mar-2021, 29-Mar-2021, 30-Mar-2021, and 11-May-2021.  A nurse practitioner reported that a 26 year-old patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced flu-like symptoms.   No relevant medical history was reported.   No relevant concomitant medications were reported.  On an unspecified date in Jan-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, site not reported).  On an unspecified date, after the first dose of HEPLISAV-B, the patient experienced flu-like symptoms for 10 days and had a full recovery. Laboratory tests for COVID-19 and Streptococcus were negative.  Four weeks after the first dose of HEPLISAV-B vaccine, Hepatitis B surface antibody was greater than 600 mIU.  The patient was reported to have completed the series of HEPLISAV-B vaccine.   Additional information was requested.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Antibody test positive, Influenza like illness, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Flu-Like Symptoms; Initial Report Received on 26-Mar-2021, 29-Mar-2021, 30-Mar-2021, and 11-May-2021.  A nurse practitioner reported that a 54 year-old patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced flu-like symptoms.   No relevant medical history was reported.   No relevant concomitant medications were reported.  On an unspecified date in Dec-2020, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, site not reported).  On an unspecified date, after the first dose of HEPLISAV-B, the patient experienced flu-like symptoms for 10 days and had a full recovery. Laboratory tests for COVID-19 and Streptococcus were negative.  Four weeks after the first dose of HEPLISAV-B vaccine, Hepatitis B surface antibody was greater than 600 mIU.  The patient was reported to have completed the series of HEPLISAV-B vaccine.   Additional information was requested.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Second Dose was Engerix; Initial Report Received on 11-May-2021  A pharmacist reported that a 24 year-old man (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported.   No relevant concomitant medications were reported.  On an unspecified date in Apr-2021, the patient received the first dose of HEPLISAV-B from a health care professional (Lot #, expiration date, NDC #, route, and site not reported).   On 10-May-2021, about a month after the first dose, the patient came into the pharmacy for the second dose and was given Engerix. It was not realized that the patient received HEPLISAV-B from the health care professional for the first dose until after the second dose (Engerix) was given. No adverse reactions were reported.   No additional information was reported.  Company The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder, Viral titre
Clinical narrative: Did not respond to two doses of Heplisav-B; Patient Is On Dialysis; Initial Report Received on 08-Jun-2021 and 17-Jun-2021  A nurse reported that an 81 year-old male (race and ethnicity not provided) did not respond to two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history reported included dialysis and no known allergies.  No relevant concomitant medications were reported.    On 08-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot #934599, expiration date 22-Feb-2022 and NDC # not reported), route and site not specified.   On 10-Nov-2020, the patient received the second dose of HEPLISAV-B (Lot #934259, expiration date 25-Sep-2021 and NDC # not reported) route and site not specified.  On 07-Jan-2021, 92 days after having received the first injection, and 59 days after having received the second injection, a titer was drawn which read 1.3 (units not provided).  On 03-Jun-2021, 239 days after having received the first injection, 206 days after having received the second injection, a second titer was drawn, and the results were 3.1.  Company Comment:  The company assessed the events as non-serious. The safety and effectiveness of Heplisav-B have not been established in adults on hemodialysis. For patients undergoing hemodialysis, higher vaccine dosages or an increased number of doses are recommended. Protective levels of antibody developed in 67%-86% (median 64%) of adult hemodialysis patients who received 3-4 doses of current approved vaccines in various dosages and schedules.; Sender's Comments: The company assessed the events as non-serious. The safety and effectiveness of Heplisav-B have not been established in adults on hemodialysis. For patients undergoing hemodialysis, higher vaccine dosages or an increased number of doses are recommended. Protective levels of antibody developed in 67%-86% (median 64%) of adult hemodialysis patients who received 3-4 doses of current approved vaccines in various dosages and schedules.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had both vaccinations, old one and the new improved- still got shingles/ Suspected vaccination failure; I had both vaccinations, old one and the new improved- still got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (old vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient had both vaccinations, old one and the new improved and still got shingles. The reporter had shingles but thought it was not as bad as it would have been if had not taken the vaccine. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Rash erythematous
Clinical narrative: a rash has developed /  have a hot, red rash; have a hot; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2021, the patient received the 2nd dose of Shingrix. On 16th June 2021, 1 days after receiving Shingrix, the patient experienced red rash and feeling hot. On an unknown date, the outcome of the red rash and feeling hot were unknown.   It was unknown if the reporter considered the red rash and feeling hot to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for herself/himself. The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced a hot and red rash. The patient asked if he/she should notify to doctor or not.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: now feeling much better; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovering/resolving.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for herself/himself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix 3 days ago and was now feeling much better. The patient enquired was it safe to have an intense gym workout today or do the patient need rest following the vaccine for a specific period. The patient enquired about exercise after Shingrix vaccine. The pharmacist had replied that there was nothing specific in the prescription information regarding exercise restrictions, beacause patient care was individualized, a healthcare provider should always be consulted to evaluate your health and provide guidance to you based on your medical history. The reporter did not provided the details and asked if he/she can resume exercise today and stated that he/she could contact doctor.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose / (expiration date: June 5th,2021) on June 8th, 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 97NL3, expiry date 5th June 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 8th June 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 provided as follows: On 8th June 2021, the patient received Boostrix which was expired on 5th June 2021. Patient initial was not provided. The reporter consented to follow up.
Age: 64.0
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 consumer concerned a 64 year old male. The patient's weight was 210 pounds, and height was 193.04 centimeters. 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) 1 total, dose was not reported, administered on left deltoid on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the patient was getting sicker and sicker, and performed COVID-19 antigen test and was negative. On 12-JUN-2021, the patient experienced breakthrough infection and tested positive for COVID-19 antigen test (nasal swab) (suspected covid-19 infection, 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 case is associated with Product quality complaint number: 90000182630 The suspected product quality complaint has been confirmed to be void n (meet product quality complaint criteria) based on the PQC (product quality complaint) evaluation/investigation performed.; Sender's Comments: V0:20210627620-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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vomiting
Clinical narrative: THROWING UP; WEAK BODY; FATIGUE; This spontaneous report received from a parent concerned a 47 year old female. The patient's weight was 95 pounds, and height was 60 inches. The patient's concurrent conditions included alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergy 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: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced throwing up. On 29-MAY-2021, the subject experienced weak body. On 29-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up, fatigue, and weak body. This report was non-serious. This case, from the same reporter is linked to 20210627858.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical conditions and had no known allergies.The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced high fever. On 12-JUN-2021, the subject experienced brain fogs. On 12-JUN-2021, the subject experienced lower back pain. On 13-JUN-2021, the subject experienced not acting normally. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain on 13-JUN-2021, and high fever on 12-JUN-2021, and had not recovered from brain fogs, and not acting normally. This report was non-serious. This report was associated with a product quality complaint: 90000182718. The suspected product quality complaint has been confirmed to be voided (does not meet pqc criteria). based on the PQC evaluation/investigation performed.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: ADMINISTERED 1 DOSE OF COVID-19 JOHNSON AND JOHNSON VACCINE AS FIRST DOSE AND THEN ADMINISTERED 1 DOSE OF PFIZER COVID-19 VACCINE AS SECOND DOSE BY MISTAKE; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 24-MAR-2021, the subject experienced administered 1 dose of covid-19 johnson and johnson vaccine as first dose and then administered 1 dose of pfizer covid-19 vaccine as second dose by mistake. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered 1 dose of covid-19 johnson and johnson vaccine as first dose and then administered 1 dose of pfizer covid-19 vaccine as second dose by mistake was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN WITH IMPROPER STORAGE CONDITION; OUT OF SPECIFICATIONS PRODUCT USE; This spontaneous report received from a health care professional 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given with improper storage condition, and out of specifications product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given with improper storage condition and out of specifications product use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 11-JUN-2021, the subject experienced suspected covid-19 infection. Laboratory data included: Laboratory test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182971 The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: VOMITING; COLD CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, cold chills, headache, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, cold chills, nausea and vomiting was not reported. This report was non-serious. This case, from the same reporter is linked to 20210630836.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: LEG PAIN; HEADACHE; DIZZINESS; NECK PAIN; FEVER; This spontaneous report received from a parent concerned a 21 year old male. The patient's weight was 130 pounds, and height was 68 inches. 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. no drug abuse or illicit drug usage. medical history the family had a history of vein issues, and the mother had blood clots before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced neck pain. On 11-JUN-2021, the subject experienced fever. On 12-JUN-2021, the subject experienced dizziness. On 12-JUN-2021, the subject experienced headache. On 13-JUN-2021, the subject experienced leg pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-JUN-2021, and had not recovered from dizziness, headache, leg pain, and neck pain. 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
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: GIVEN VACCINE OUTSIDE OF TEMPERATURE EXCURSION; VACCINES DRAWN FROM A VIAL AND LEFT OUT IN ROOM TEMPERATURE FOR A MAXIMUM OF 3 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced given vaccine outside of temperature excursion. On 01-JUN-2021, the subject experienced vaccines drawn from a vial and left out in room temperature for a maximum of 3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the given vaccine outside of temperature excursion and vaccines drawn from a vial and left out in room temperature for a maximum of 3 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210633324.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Disorientation, Fatigue, Gait disturbance
Clinical narrative: SEVERE DIARRHEA (8-10 EPISODES PER DAY); FATIGUE (MEDIUM TO HIGH SEVERITY); LOW GRADE FEVER; DISORIENTED (MEDIUM TO HIGH SEVERITY); SHUFFLING FEET AND UNSTEADY (NEEDED TO HOLD ON TO STUFF TO PREVENT FALLING); This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 180 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. the patient was healthy as a horse. patient did not had diagnostic data available'. The patient experienced reaction to a flu vaccine when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2008, the subject experienced reaction to a flu vaccine. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-MAY-2021, the subject experienced disoriented (medium to high severity). On 01-MAY-2021, the subject experienced shuffling feet and unsteady (needed to hold on to stuff to prevent falling). On 01-MAY-2021, the subject experienced low grade fever. On 02-MAY-2021, the subject experienced severe diarrhea (8-10 episodes per day). On 02-MAY-2021, the subject experienced fatigue (medium to high severity). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea (8-10 episodes per day) on 10-MAY-2021, disoriented (medium to high severity), and shuffling feet and unsteady (needed to hold on to stuff to prevent falling) on 03-MAY-2021, fatigue (medium to high severity) on 15-MAY-2021, and low grade fever on 08-MAY-2021. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: SEVERE DIARRHEA (8-10 EPISODES PER DAY); FATIGUE (MEDIUM TO HIGH SEVERITY); LOW GRADE FEVER; DISORIENTED (MEDIUM TO HIGH SEVERITY); SHUFFLING FEET AND UNSTEADY (NEEDED TO HOLD ON TO STUFF TO PREVENT FALLING); This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 180 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. the patient was healthy as a horse. patient did not had diagnostic data available'. The patient experienced reaction to a flu vaccine when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2008, the subject experienced reaction to a flu vaccine. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-MAY-2021, the subject experienced disoriented (medium to high severity). On 01-MAY-2021, the subject experienced shuffling feet and unsteady (needed to hold on to stuff to prevent falling). On 01-MAY-2021, the subject experienced low grade fever. On 02-MAY-2021, the subject experienced severe diarrhea (8-10 episodes per day). On 02-MAY-2021, the subject experienced fatigue (medium to high severity). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea (8-10 episodes per day) on 10-MAY-2021, disoriented (medium to high severity), and shuffling feet and unsteady (needed to hold on to stuff to prevent falling) on 03-MAY-2021, fatigue (medium to high severity) on 15-MAY-2021, and low grade fever on 08-MAY-2021. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: SEVERE DIARRHEA (8-10 EPISODES PER DAY); FATIGUE (MEDIUM TO HIGH SEVERITY); LOW GRADE FEVER; DISORIENTED (MEDIUM TO HIGH SEVERITY); SHUFFLING FEET AND UNSTEADY (NEEDED TO HOLD ON TO STUFF TO PREVENT FALLING); This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 180 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. the patient was healthy as a horse. patient did not had diagnostic data available'. The patient experienced reaction to a flu vaccine when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2008, the subject experienced reaction to a flu vaccine. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-MAY-2021, the subject experienced disoriented (medium to high severity). On 01-MAY-2021, the subject experienced shuffling feet and unsteady (needed to hold on to stuff to prevent falling). On 01-MAY-2021, the subject experienced low grade fever. On 02-MAY-2021, the subject experienced severe diarrhea (8-10 episodes per day). On 02-MAY-2021, the subject experienced fatigue (medium to high severity). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea (8-10 episodes per day) on 10-MAY-2021, disoriented (medium to high severity), and shuffling feet and unsteady (needed to hold on to stuff to prevent falling) on 03-MAY-2021, fatigue (medium to high severity) on 15-MAY-2021, and low grade fever on 08-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRÉ SYNDROME; This spontaneous report received from a patient concerned a patient of unspecified age, sex, 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: Unknown and expiry: unknown) dose was not reported of frequency 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the patient was diagnosed with guillain-barré syndrome, and has been hospitalized multiple times since April or May 2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain-barré syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This spontaneous report concerns a patient of unspecified age/sex/race/ethnicity was diagnosed with Guillain-Barré Syndrome (GBS) after an unspecified duration from receiving Janssen COVID-19 vaccine.  It was reported that the patient have been hospitalized multiple times.  No other details reported.  The information available precludes a complete and meaningful assessment.  The information regarding other potential etiologies is  insufficient, and the occurrence of her symptoms could represent background incidence of such events in the general population. Considering the temporal relationship, the events are assessed to have an indeterminate relationship with vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Paraesthesia
Clinical narrative: SENSATION OF TINGLING ON RIGHT KNEE; MILD PAIN BEHIND HER RIGHT KNEE; TIREDNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known drug allergies and no known ongoing conditions. 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 13-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-JUN-2021, the subject experienced tiredness. On 15-JUN-2021, the subject experienced sensation of tingling on right knee. On 15-JUN-2021, the subject experienced mild pain behind her right knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 14-JUN-2021, and had not recovered from sensation of tingling on right knee, and mild pain behind her right knee. This report was non-serious.; Sender's Comments: V0: 20210634511-covid-19 vaccine ad26.cov2.s-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE LEFT ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and abstains from alcohol, and other pre-existing medical conditions included patient had no known allergies, no significant medical history and no drug abuse or illicit drug usage. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride. On 14-MAR-2021, the subject experienced sore left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore left arm on 16-MAR-2021. This report was non-serious.