chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Neurological symptom
Clinical narrative: Last fall / unclassified neurological illness after / first dose; Has had some other health issues in the last year; This case was reported by a physician and described the occurrence of neurological symptom in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced neurological symptom and illness. On an unknown date, the outcome of the neurological symptom and illness were unknown.   It was unknown if the reporter considered the neurological symptom and illness to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix in last fall (Fall 2020) and experienced an unclassified neurological illness. The reporter stated that he also had some other health issues in the last year.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given 11 months after the first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient was the reporter.  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, 11months after the 1st dose, which led to lengthening of vaccination schedule. The reporter enquired if the 3rd dose was required for Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: syringe was faulty / caused some of the medication to leak out while injecting / unsure of the actual amount of volume the patient received; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2021, the patient received Shingrix. On 19th June 2021, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, syringe was faulty and caused some of the medication leaked out while injecting and was unsure of the actual amount of volume the patient received, which led to underdose. The reporter was asking if it would be appropriate to re-vaccinate.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: What happens if I miss the second dose?; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was asking what happens if miss the second dose. The health care professional was using chat and able to confirm the product in question was Shingrix, patient or HCP demographics, whether or not the patient was indeed past due for the second dose of Shingrix. This adverse event filed out of the abundance of caution. No additional information to provide.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: mild arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix (the exact date of vaccine was unknown) and experienced mild arm soreness. It was unclear how soon after the vaccine the arm soreness began or when it dissipated. The reporter consented to follow- up. For tolerance of 2nd dose, refer case US2021AMR132546.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR132546:Same reporter
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received a dose of pediatrix Havrix; Adult patient received a dose of pediatrix Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a patient who received HAV (Havrix pediatric) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 17th June 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: The age at vaccination was not reported. The adult patient received a dose of pediatrix Havrix, which led to underdose and adult use of a child product. The Health care professional did not want to provide patient's identifiers and stated that the nurse in charge will proceed administering a second dose of the pediatric Havrix to the adult patient to complete the dose. The reporter consented to follow up.
Age: 72.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 72 years old patient received Menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 72-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Health care professional reported that the 72 years old patient received Menveo, which led to inappropriate age at vaccine administration. No adverse event were detected after vaccination. No patient's or vaccine identifiers were reported. Health care professional provided little details to first line agent and wanted to get contacted by mail with medical information on this matter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / in 2019 / second dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 13th November 2019, from batch number 49Y35 and expiry date 22nd October 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. Till the time reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. This is1 of the 2 cases reported, by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134481:Same reporter. Patient 2 of 2.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / in 2019 / second dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in 2019).   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. No identifiers were provided for the second patient. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccination occurred in unknown facility. The reporter did not consent to follow up. This is1 of the 2 cases reported, by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134479:Same reporter. Patient 1 of 2.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received 1st dose in 2019 and is there today for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On 18th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist stated that, exact date of 1st dose in 2019 was unknown. Pharmacist reported that, on the day of reporting, the patient was there for 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case had been linked with case US2021134503, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134503:same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose in 2019 and is there today for 2nd dose.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date in 2019).   On 18th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose, more than the recommended interval, which led to lengthening of vaccination schedule.  The reporter was not aware of exact date of 1st Shingrix vaccine or Lot and Expiration date. The reporter consented to follow up. The case has been linked with the case US2021134502 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134502:same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: accidentally administered the powder component / with other diluent than supplied (normal saline); accidentally administered the powder component / with other diluent than supplied (normal saline); This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA431A, expiry date 31st October 2021) for prophylaxis.   On 18th June 2021, the patient received Menveo. On 18th June 2021, 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 as follows: The nurse reported that she accidentally administered the patient the powder component of Menveo with other diluent than supplied (normal saline) which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired dose / on the same day of the report. It was meant a first dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HBV (Engerix B) (batch number AN3NC, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th June 2021, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 18th June 2021, unknown after receiving Engerix B and Engerix B 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 reported as follows: On 18th June 2021, patient received 1st dose of Engerix B, which was expired on 3rd June 2021. No further events were reported.  The Health care professional agreed to follow up. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received an early 2nd dose / first dose was administered on 21Feb2021 / 2nd on 10May2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included transplant (Patient had a transplant). Concomitant products included HAV (Havrix).   On 10th May 2021, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 10th May 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received the 2nd dose of Havrix, less than the recommended interval, which led to shortening of vaccination schedule. The reporter mentioned that, no vaccine data was provided. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Biopsy, Body temperature, Chills
Clinical narrative: SEVERE ABDOMINAL PAIN; DIARRHEA; PERSISTENT VOMITING WITH BLOOD COMING OUT; NON BLEEDING GASTRIC ULCER; NON BLEEDING HEMORRHOIDS; COLITIS; ESOPHAGITIS; ACHES; CONGESTED MUCOSA; RASH ON STOMACH; CHILLS; FEELING OF WEAKNESS; HEADACHE; NAUSEA; FEVER; FATIGUE; DIZZINESS; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 15029 Patient couldn't read lot, and expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced dizziness right away after vaccination. Within couple of days she started to had the other symptoms. On 26-MAR-2021, the patient experienced diarrhea. On an unspecified date, the patient experienced severe abdominal pain (seems to be chronic), persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, colitis, esophagitis, congested mucosa, rash on stomach, chills, headache, nausea and fever. Some symptoms were on and off but had persistent aches, feeling of weakness and fatigue. On 02-JUN-2021, the patient was hospitalized and discharged on 04-Jun-2021. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids, Body temperature (NR: not provided) 101, and Colonoscopy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids (was banded in the colonoscopy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from colitis, rash on stomach, persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, esophagitis, diarrhea, severe abdominal pain, aches, dizziness, congested mucosa, chills, feeling of weakness, headache, nausea, fever and fatigue. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210626711-covid-19 vaccine ad26.cov2.s-Diarrhea, Severe abdominal pain, Persistent vomiting with blood coming out, Non bleeding gastric ulcer, Non bleeding hemorrhoids . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Colonoscopy, Diarrhoea, Dizziness, Fatigue
Clinical narrative: SEVERE ABDOMINAL PAIN; DIARRHEA; PERSISTENT VOMITING WITH BLOOD COMING OUT; NON BLEEDING GASTRIC ULCER; NON BLEEDING HEMORRHOIDS; COLITIS; ESOPHAGITIS; ACHES; CONGESTED MUCOSA; RASH ON STOMACH; CHILLS; FEELING OF WEAKNESS; HEADACHE; NAUSEA; FEVER; FATIGUE; DIZZINESS; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 15029 Patient couldn't read lot, and expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced dizziness right away after vaccination. Within couple of days she started to had the other symptoms. On 26-MAR-2021, the patient experienced diarrhea. On an unspecified date, the patient experienced severe abdominal pain (seems to be chronic), persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, colitis, esophagitis, congested mucosa, rash on stomach, chills, headache, nausea and fever. Some symptoms were on and off but had persistent aches, feeling of weakness and fatigue. On 02-JUN-2021, the patient was hospitalized and discharged on 04-Jun-2021. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids, Body temperature (NR: not provided) 101, and Colonoscopy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids (was banded in the colonoscopy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from colitis, rash on stomach, persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, esophagitis, diarrhea, severe abdominal pain, aches, dizziness, congested mucosa, chills, feeling of weakness, headache, nausea, fever and fatigue. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210626711-covid-19 vaccine ad26.cov2.s-Diarrhea, Severe abdominal pain, Persistent vomiting with blood coming out, Non bleeding gastric ulcer, Non bleeding hemorrhoids . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Gastric ulcer, Haematemesis, Haemorrhoids, Headache, Intestinal congestion
Clinical narrative: SEVERE ABDOMINAL PAIN; DIARRHEA; PERSISTENT VOMITING WITH BLOOD COMING OUT; NON BLEEDING GASTRIC ULCER; NON BLEEDING HEMORRHOIDS; COLITIS; ESOPHAGITIS; ACHES; CONGESTED MUCOSA; RASH ON STOMACH; CHILLS; FEELING OF WEAKNESS; HEADACHE; NAUSEA; FEVER; FATIGUE; DIZZINESS; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 15029 Patient couldn't read lot, and expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced dizziness right away after vaccination. Within couple of days she started to had the other symptoms. On 26-MAR-2021, the patient experienced diarrhea. On an unspecified date, the patient experienced severe abdominal pain (seems to be chronic), persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, colitis, esophagitis, congested mucosa, rash on stomach, chills, headache, nausea and fever. Some symptoms were on and off but had persistent aches, feeling of weakness and fatigue. On 02-JUN-2021, the patient was hospitalized and discharged on 04-Jun-2021. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids, Body temperature (NR: not provided) 101, and Colonoscopy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids (was banded in the colonoscopy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from colitis, rash on stomach, persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, esophagitis, diarrhea, severe abdominal pain, aches, dizziness, congested mucosa, chills, feeling of weakness, headache, nausea, fever and fatigue. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210626711-covid-19 vaccine ad26.cov2.s-Diarrhea, Severe abdominal pain, Persistent vomiting with blood coming out, Non bleeding gastric ulcer, Non bleeding hemorrhoids . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oesophagitis, Pain, Pyrexia, Rash
Clinical narrative: SEVERE ABDOMINAL PAIN; DIARRHEA; PERSISTENT VOMITING WITH BLOOD COMING OUT; NON BLEEDING GASTRIC ULCER; NON BLEEDING HEMORRHOIDS; COLITIS; ESOPHAGITIS; ACHES; CONGESTED MUCOSA; RASH ON STOMACH; CHILLS; FEELING OF WEAKNESS; HEADACHE; NAUSEA; FEVER; FATIGUE; DIZZINESS; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 15029 Patient couldn't read lot, and expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced dizziness right away after vaccination. Within couple of days she started to had the other symptoms. On 26-MAR-2021, the patient experienced diarrhea. On an unspecified date, the patient experienced severe abdominal pain (seems to be chronic), persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, colitis, esophagitis, congested mucosa, rash on stomach, chills, headache, nausea and fever. Some symptoms were on and off but had persistent aches, feeling of weakness and fatigue. On 02-JUN-2021, the patient was hospitalized and discharged on 04-Jun-2021. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids, Body temperature (NR: not provided) 101, and Colonoscopy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids (was banded in the colonoscopy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from colitis, rash on stomach, persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, esophagitis, diarrhea, severe abdominal pain, aches, dizziness, congested mucosa, chills, feeling of weakness, headache, nausea, fever and fatigue. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210626711-covid-19 vaccine ad26.cov2.s-Diarrhea, Severe abdominal pain, Persistent vomiting with blood coming out, Non bleeding gastric ulcer, Non bleeding hemorrhoids . 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight was 194 pounds, and height was 72 inch. The patient's concurrent conditions included blood pressure, alcohol user drinks wine 2 per day, cholesterol, and non-smoker, patient had no known allergies. The patient had no 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:043A21A expiry: UNKNOWN) dose was not reported,1 total administered on 01-APR-2021 around 17:00 on left arm for prophylactic vaccination. Concomitant medications included simvastatin for cholesterol. On 05-MAY-2021 at 10:00 and 02-JUN-2021 between 9:00 to 10:00 the patient went through blood test and found out vaccine was not taken based on test(Suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182753 The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210630345-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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 (FEVER); SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 66 year old female of unknown race and ethnicity. The patient's weight was 69.1 kilograms, and height was 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included macitentan for primary pulmonary hypertension, selexipag for primary pulmonary hypertension, and riociguat non-company.  On an unspecified date, the patient experienced covid-19 (fever), and suspected clinical vaccination failure, was hospitalized. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F, and SARS-CoV-2 test (NR: not provided) positive. patient was hospitalized from 03-JUN-2021 to 04-JUN-2021, for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 (fever) and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210115804.; Sender's Comments: V0: 20210630934 -Covid-19 vaccine ad26.cov2.s-Covid-19(Fever). This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210630934 -Covid-19 vaccine ad26.cov2.s-Suspected Clinical vaccination failure .This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Injection site pain
Clinical narrative: CLOTTING PAIN STUFF IN CHEST; THE SHORT ITSELF HURT; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced clotting pain stuff in chest, and the short itself hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clotting pain stuff in chest, and the short itself hurt. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cerebral haemorrhage, Ear haemorrhage, Eye haemorrhage, Gait inability
Clinical narrative: BLEEDING IN BRAIN; COULD NOT SEE WITH HIS EYES; COULD NOT WALK; PAIN IN LEGS; SHARP PAINS THROUGH HEAD; BLEEDING FROM HIS EYES; BLEEDING FROM HIS EARS; SICK; This spontaneous report received from a consumer (patient's sister) concerned a 67-year-old, White, not Hispanic or Latino male patient. The patient's height, and weight were not reported. The patient's past medical history included covid-19. His concurrent conditions included inability to see after he got something sprayed into one of his eyes in jail and wheelchair user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Since the day of the shot, the patient had been sick. On 02-JUN-2021 (about 2-3 days after the vaccination), the patient experienced side effects. He had bleeding in his brain due to which he could see with his eye, could not walk, had so much pain in legs, and sharp pains through his head. The patient was getting worse. On an unspecified date in JUN-2021, the patient had bleeding from his eyes and ears. The patient could not walk at the time of reporting. He had one good eye (not the eye with which he could not see due to bleeding in brain) but could not see from it too as he got something sprayed into it previously. Hence, he lost both eyes and could not see at all at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in brain, could not walk, could not see with his eyes, pain in legs, and sharp pains through head, and the outcome of bleeding from his ears, bleeding from his eyes and sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210632304 - Covid-19 vaccine ad26.cov2.s - BLEEDING IN BRAIN , COULD NOT SEE WITH HIS EYES , BLEEDING FROM HIS EYES . 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Pain in extremity
Clinical narrative: BLEEDING IN BRAIN; COULD NOT SEE WITH HIS EYES; COULD NOT WALK; PAIN IN LEGS; SHARP PAINS THROUGH HEAD; BLEEDING FROM HIS EYES; BLEEDING FROM HIS EARS; SICK; This spontaneous report received from a consumer (patient's sister) concerned a 67-year-old, White, not Hispanic or Latino male patient. The patient's height, and weight were not reported. The patient's past medical history included covid-19. His concurrent conditions included inability to see after he got something sprayed into one of his eyes in jail and wheelchair user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Since the day of the shot, the patient had been sick. On 02-JUN-2021 (about 2-3 days after the vaccination), the patient experienced side effects. He had bleeding in his brain due to which he could see with his eye, could not walk, had so much pain in legs, and sharp pains through his head. The patient was getting worse. On an unspecified date in JUN-2021, the patient had bleeding from his eyes and ears. The patient could not walk at the time of reporting. He had one good eye (not the eye with which he could not see due to bleeding in brain) but could not see from it too as he got something sprayed into it previously. Hence, he lost both eyes and could not see at all at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding in brain, could not walk, could not see with his eyes, pain in legs, and sharp pains through head, and the outcome of bleeding from his ears, bleeding from his eyes and sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210632304 - Covid-19 vaccine ad26.cov2.s - BLEEDING IN BRAIN , COULD NOT SEE WITH HIS EYES , BLEEDING FROM HIS EYES . 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ocrelizumab for multiple sclerosis.  On 29-APR-2021, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. 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: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE FOR WEEKS ALREADY; 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 concurrent conditions included migraine.  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 migraine for weeks already. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine for weeks already. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Disorientation, Headache, Hot flush, Insomnia
Clinical narrative: LOSS OF SLEEP; STRANGE DISORIENTATION IN HEAD; PAIN IN ARM; HEADACHES; CLOUDY HEAD; UNUSUAL LOSS OF ARM USE AND NUMBNESS IN  ARM; RECURRENCE  OF HOT FLASHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received from patient on 16-JUN-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: 2031421A) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches, cloudy head, a recurrence of hot flashes, unusual loss of arm use and numbness, loss of sleep because of the pain in arm. The patient was also making unacceptable and unusual mistakes at work because of the strange disorientation in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, cloudy head, recurrence of hot flashes, unusual loss of arm use and numbness in arm, loss of sleep, pain in arm, and strange disorientation in head. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210633003-Covid-19 vaccine ad26.cov2.s- Cloudy head, Unusual loss of arm use. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Monoplegia, Pain in extremity
Clinical narrative: LOSS OF SLEEP; STRANGE DISORIENTATION IN HEAD; PAIN IN ARM; HEADACHES; CLOUDY HEAD; UNUSUAL LOSS OF ARM USE AND NUMBNESS IN  ARM; RECURRENCE  OF HOT FLASHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with additional information received from patient on 16-JUN-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: 2031421A) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced headaches, cloudy head, a recurrence of hot flashes, unusual loss of arm use and numbness, loss of sleep because of the pain in arm. The patient was also making unacceptable and unusual mistakes at work because of the strange disorientation in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, cloudy head, recurrence of hot flashes, unusual loss of arm use and numbness in arm, loss of sleep, pain in arm, and strange disorientation in head. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210633003-Covid-19 vaccine ad26.cov2.s- Cloudy head, Unusual loss of arm use. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Poor quality product administered, Product storage error, Pyrexia
Clinical narrative: ADMINISTERED A VACCINE THAT HAD BEEN LEFT OUT OF THE REFRIGERATOR FOR 8 HOURS; INCORRECT STORAGE CODITION THAT VACCINE LEFT OUT OF THE REFRIGERATOR FOR 8 HOURS; FEVER; SORE ARM AT SITE OF VACCINATION; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included patient was not hospitalized in the past month and did not disclose any other medical information. the patient had no known allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-JUN-2021, the subject experienced administered a vaccine that had been left out of the refrigerator for 8 hours. On 13-JUN-2021, the subject experienced incorrect storage condition that vaccine left out of the refrigerator for 8 hours. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced sore arm at site of vaccination. Laboratory data included: Body temperature (NR: not provided) 101.1 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-JUN-2021, was recovering from sore arm at site of vaccination, and the outcome of administered a vaccine that had been left out of the refrigerator for 8 hours and incorrect storage condition that vaccine left out of the refrigerator for 8 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 24 HR 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 was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (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 24 hr fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 24 hr fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210633198.