chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 and 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 and 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 to 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 to 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 to 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; the vaccine was administered while out of recommended range; This spontaneous report was received from a nurse referring to a 4 month old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 15-MAY-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not provided; lot # was 1694410 and expiration date was 19-DEC-2021) 2 milliliter, orally for prophylaxis, which was out of recommended range (product storage error). No additional adverse event was reported.   The administered dose was stored under 89 degree Fahrenheit for 24 hours. The was previous temperature excursion. It was detected by a data logger.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like systems; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, his/her friends experienced flu like symptoms after vaccination.  The reporter was yet to receive the vaccine and was trying to plan a day around it. The reporter wanted to know that how long after receiving the first vaccine might the side effects start and for how long after vaccination might he/she experience side effects. The reporter was advised to refer to his/her health care provider.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I got my shots and my arm hurt so much; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was captured as adult as per vaccine indication. The age at vaccination was not reported. The patient 1st dose of Shingles vaccine and his/her arm hurt so much for days. For tolerance of 2nd dose refer case US2021AMR106809, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106809:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: I got my shots and my arm hurt so much; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2021AMR106774).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. 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 Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient received shingles shot and his/her arm hurt so much for days. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR106774:same reporter
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Incomplete course of vaccination, Wrong product administered
Clinical narrative: received a dose of Engerix-B instead of the dose of Twinrix; received a dose of Engerix-B instead of the dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B, Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination 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 patient received a dose of Engerix B instead of the dose of Twinrix, which led to wrong vaccine administered. Till the time of reporting, the patient did not receive the dose of Twinrix as he was due, which led to incomplete course of vaccination. The reporter did not have patient demographics or lot number and expiration date to provide.  No additional details were provided. The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia, Headache, Heart rate increased, Pruritus, Throat tightness
Clinical narrative: having hives; itching all over; voice changed; throat was feeling closed up / ER Visit Required; headache; fast heartbeat; This case was reported by a consumer via call center representative and described the occurrence of hives in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2021, the patient received the 1st dose of Shingrix. On 13th May 2021, 7 days after receiving Shingrix, the patient experienced hives, generalized pruritus, voice alteration, throat constriction, headache and heartbeats increased. The patient was treated with benadryl (nos) (Benadryl) and triamcinolone. On an unknown date, the outcome of the hives and generalized pruritus were recovering/resolving and the outcome of the voice alteration, throat constriction, headache and heartbeats increased were not recovered/not resolved.   It was unknown if the reporter considered the hives, generalized pruritus, voice alteration, throat constriction, headache and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and approximately 7 days later, the patient reported that his throat was feeling closed up and his voice changed and had itching all over and had hives. The patient also experienced headache and fast heartbeat. The patient went to the emergency room and was given Benedryl and an injection of triamcinolone. The patient noted some improvement in the itching and hives and all other events remain the same. The patient was not hospital overnight. No other contact information was available at time of report, but patient did give permission to contact their doctor. The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: having hives; itching all over; voice changed; throat was feeling closed up / ER Visit Required; headache; fast heartbeat; This case was reported by a consumer via call center representative and described the occurrence of hives in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2021, the patient received the 1st dose of Shingrix. On 13th May 2021, 7 days after receiving Shingrix, the patient experienced hives, generalized pruritus, voice alteration, throat constriction, headache and heartbeats increased. The patient was treated with benadryl (nos) (Benadryl) and triamcinolone. On an unknown date, the outcome of the hives and generalized pruritus were recovering/resolving and the outcome of the voice alteration, throat constriction, headache and heartbeats increased were not recovered/not resolved.   It was unknown if the reporter considered the hives, generalized pruritus, voice alteration, throat constriction, headache and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and approximately 7 days later, the patient reported that his throat was feeling closed up and his voice changed and had itching all over and had hives. The patient also experienced headache and fast heartbeat. The patient went to the emergency room and was given Benedryl and an injection of triamcinolone. The patient noted some improvement in the itching and hives and all other events remain the same. The patient was not hospital overnight. No other contact information was available at time of report, but patient did give permission to contact their doctor. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1: 5/30/2018 / Dose 2:10/31/2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) (batch number 5SB37, expiry date 19th June 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th May 2018).   On 31st October 2020, the patient received the 2nd dose of Shingrix. On 31st October 2020, 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 reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2nd dose of Shingrix later then the recommended interval, which led to lengthening of vaccination schedule. The pharmacist wanted to know if 3rd dose was needed, also the pharmacist was aware of CDC (Centers for Disease Control and Prevention) recommendations. The healthcare professional was not comfortable for giving patient information. The reporter consented to follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: ACCIDENTALLY ADMINISTERED TWO DIFFERENT COVID 19 VACCINES; This spontaneous report received from a health care professional concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1816027, and expiry: UNKNOWN) .5 ml, administered on 07-MAY-2021 10:00 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 07-MAY-2021 10:00, the subject experienced accidentally administered two different covid 19 vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidentally administered two different covid 19 vaccines was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 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, the patient had tested negative for multiple antibody tests (confirmed immunological vaccine failure). According to reporter, the patient received vaccination 10 weeks ago. The reporter believed that the patient did antigen test for immunoglobulin G (IgG) and immunoglobulin M (IgM) .  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179671. The suspected product quality complaint has been confirmed to be not voided, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210529730-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy
Clinical narrative: RARE BLOOD CLOTTING DISORDER; This spontaneous report was received concerning 4 adult female(18-48 years) patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown exp: unknown) frequency one total, 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 within one to three weeks of vaccination, the patient experienced rare blood clotting disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare blood clotting disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210530468;-covid-19 vaccine ad26.cov2.s- Rare blood clots. This event is considered Un assessable. The event 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination complication
Clinical narrative: ITCHING ON ARM; SOME REACTION; RASH ON ARM; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 14-MAY-2021 was received on 14-MAY-2021 and concerned a 69 year old male. The patient's weight was 106.59 kilograms, and height was 185 centimeters. The patient's pre-existing medical conditions included the patient did not had any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced itching on arm. On MAY-2021, the subject experienced some reaction. On MAY-2021, the subject experienced rash on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on arm, rash on arm, and some reaction. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED; This spontaneous report received from a patient via a company representative concerned a 19 year old male of an unknown ethnicity and race. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: Unknown) dose was not reported, 1 total administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On the same day, the patient fainted (syncope) after vaccination. The patient woke up later and did not had to go to the hospital, however someone had to drive patient home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted on 06-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210535593-COVID-19 VACCINE AD26.COV2.S-fainted. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM HURT; This spontaneous report received from a patient and concerned a 42 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurt was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Platelet count decreased
Clinical narrative: LOW PLATELET COUNT; BLACK AND BLUES; This spontaneous report received from a concerned a 6 decade (age of patient (in late 50's early 60's) old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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, consumer called to report that the patient got the vaccine and approximately 10 days later patient had black and blues and low platelet count. Patient was hospitalized and was still hospitalized on the day of reporting. Patient got a steroid and plasma treatment was used to successfully elevate platelets. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the black and blues and low platelet count was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210535373.; Sender's Comments: V0: 20210536558-JANSSEN COVID-19 VACCINE-Low platelet count, black and blues. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAY-2021, the subject experienced partial dose administered. The action taken with covid-19 vaccine  was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased
Clinical narrative: ELEVATED BLOOD SUGAR LEVEL 446; This spontaneous report received from a patient concerned a 72 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included the patient reported that he has 128-138 mg/dL as normal range for blood sugar. The patient was previously treated with prednisone for drug used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, 15 minutes after having lunch the patient experienced elevated blood sugar level 446 mg/dL. She reported that she had meatballs, butter noodles, and angel fruit cake with cabbage, also for beverage had ice-tea with no sugar. Laboratory data included: Blood sugar abnormal (NR: not provided) 446 mg/dL. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood sugar level 446 mg/dL. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210537343-Covid-19 vaccine ad26.cov2.s - Elevated blood sugar level 446. 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: MEDICAL HISTORY.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, SARS-CoV-2 test
Clinical narrative: FEEL STRONG IN THE MORNING; DIFFICULTY SLEEPING; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergy to chloroquine (difficulty sleeping, itching, fast heartbeat). The patient experienced drug allergy when treated with chloroquine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 04-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 17-MAY-2021, the subject experienced difficulty sleeping. On 18-MAY-2021, the subject experienced feel strong in the morning. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty sleeping, and the outcome of feel strong in the morning was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Nausea
Clinical narrative: FELT PAIN IN ALL OF JOINTS; NAUSEA TO THE POINT THAT COULD NOT EAT DINNER; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included back injury, back surgery, previous car accident, and rare case of chicken pox in mouth, and concurrent conditions included herniated disks, nerve damage, and low cholesterol level, and other pre-existing medical conditions included medical anomaly, high pain threshold. 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 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 MAY-2021, the subject experienced felt pain in all of joints. On MAY-2021, the subject experienced nausea to the point that could not eat dinner. On MAY-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea to the point that could not eat dinner, felt pain in all of joints and soreness at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Vasodilatation
Clinical narrative: INNER LEFT ANKLE FELT HOT TO TOUCH; LEFT LEG PAIN; BULGING VEIN ON LEFT LEG; This spontaneous report received from a consumer concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced bulging vein on left leg. On 16-MAY-2021, the subject experienced left leg pain. On 19-MAY-2021, the subject experienced inner left ankle felt hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg pain, bulging vein on left leg, and inner left ankle felt hot to touch. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Product dose omission issue
Clinical narrative: Hospitalized with a major surgery/ Some blood leakage in brain; Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Brain operation in March 2021.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine). The patient was hospitalized on 01-Mar-2021 due to CEREBRAL HAEMORRHAGE. At the time of the report, CEREBRAL HAEMORRHAGE (Hospitalized with a major surgery/ Some blood leakage in brain) and PRODUCT DOSE OMISSION ISSUE (Was in the hospital longer than than expected and has not received the second dose/ Missed second dose of Moderna-covid-19 vaccine) outcome was 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.   No relevant concomitant medications were provided.  Patient had received the first dose of the Moderna Covid-19 vaccine and ended up being hospitalized in March with a major surgery that involved some blood leakage in brain. Patient had essentially missed the second Moderna Covid-19 dose scheduled in mid-March and at the time of reporting patient was about 90 days after receiving the first Moderna Covid-19 vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up received on 11-May-2021 Updated the Reporter, patient information  and serious event added.; 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. However, Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: Hallucination; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (Hallucination) had not resolved.            No concomitant medications were provided.  No treatment drugs were reported.  It was reported that patient refuses to see a doctor and says that everyone else is crazy.  Company comment: Limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09 May 2021 included no new information.; Sender's Comments: Limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebral artery embolism, Product dose omission issue
Clinical narrative: Brain embolism; Missed second dose (51 days since first dose); Feeling a little weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL ARTERY EMBOLISM (Brain embolism) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced CEREBRAL ARTERY EMBOLISM (Brain embolism) (seriousness criteria hospitalization, medically significant and life threatening). On 09-May-2021, the patient experienced ASTHENIA (Feeling a little weak). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (51 days since first dose)). The patient was hospitalized until 08-May-2021 due to CEREBRAL ARTERY EMBOLISM. On 08-May-2021, CEREBRAL ARTERY EMBOLISM (Brain embolism) had resolved. At the time of the report, ASTHENIA (Feeling a little weak) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed second dose (51 days since first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included cholesterol medication, high blood pressure medication, anxiety medication, allergies medication, and medication for brain embolism.  Company comment:This case concerns a 51-year-old male who experienced cerebral artery embolism and asthenia and missed second dose (51 days since first dose) (missed dose).  Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events of cerebral embolism and asthenia, a causal relationship cannot be excluded.  The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 51-year-old male who experienced cerebral artery embolism and asthenia and missed second dose (51 days since first dose) (missed dose).  Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events of cerebral embolism and asthenia, a causal relationship cannot be excluded.  The event of missed dose is assessed as not applicable.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On 07-May-2021, BELL'S PALSY (Bell's Palsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Patient stated, he was given 2 medications of unknown names for treatment of bells palsy and symptoms gone way after a week of taking those meds.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Event start date, stop date and outcome updated. Vaccine given date updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Atrial fibrillation, Hypoaesthesia, Lip swelling, Paraesthesia
Clinical narrative: acute anaphylactic shock; A.fib; blurry vision; swollen lips; Numbing sensation in her hands and lips; tingling sensation in her hands and lips; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (acute anaphylactic shock) and ATRIAL FIBRILLATION (A.fib) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ANAPHYLACTIC SHOCK (acute anaphylactic shock) (seriousness criterion medically significant), ATRIAL FIBRILLATION (A.fib) (seriousness criterion medically significant), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips). At the time of the report, ANAPHYLACTIC SHOCK (acute anaphylactic shock), ATRIAL FIBRILLATION (A.fib), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment for the events included diphenhydramine, metoclopramide, ketorolac, prochlorperazine and prednisone. The patient was advised not to receive the second dose of vaccine by her healthcare provider.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.