chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swollen; Arm redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and 2 days after the vaccination experienced her left arm was swollen and red for a week.  The reporter stated that the redness and swelling occurred below the injection site closer to the elbow. The reporter was also inquiring how common this reaction was, why did it happen, and should she wait longer than two months to receive the second dose. No additional details were provided. Provided medical advice disclaimer. Spoke from PI (package insert) and content. The patient declined permission to contact her HCP (health care professional). The reporter did not consent to follow-up.
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose administered to 3 year old patient; 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 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number n254c, expiry date 23rd November 2023) for prophylaxis.   On 18th February 2022, the patient received Boostrix. On 18th February 2022, unknown after receiving Boostrix, 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: The patient was inadvertently administrated a dose of Boostrix, which led to inappropriate age at vaccine administration. No further events were reported. The reporter agreed to be contacted for follow-up The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: EXPIRED DRUG USED; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Bexsero and Bexsero 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 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 expired a dose of Bexsero, which led to expired vaccine used.  The reporter would like to know if the patient needed to be revaccinated and what were the next steps.  He reported that, he did not have any patient demographic information or contact information and the patient had not experienced any adverse events.  Consent was obtained to contact reporter for follow up questions.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose Bexsero, 2nd dose Trumenba; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th December 2021, the patient received the 2nd dose of TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Pharmacist reported that, the patient was requesting a 2nd dose of Bexsero.  Problem was another pharmacy gave her Trumenba 06th December 2021 which led to interchange of vaccine products. The reporter did not consent to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Incomplete course of vaccination
Clinical narrative: No record of 2nd dose administered; He thinks he got Shingrix shot #2 in July of 2020 but the hospital cannot find a record of this; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1s tdose in January 2020, call center representative failed to ask for exact date of injection, lot and expiry date and route).   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 and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the incomplete course of vaccination and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. The patient thought, he got 2nd dose of Shingrix in July 2020 but the hospital could not find a record of this, so they were advising him to start the whole series over again, which led to incomplete course of vaccination and circumstance or information capable of leading to medication error. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given to a patient with another diluent; given to a patient with another diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 333TE, expiry date 15th April 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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 reporter was Nurse and Clinic Manager. The age at vaccination was unknown. The reporter called in because she reviewed vaccine records and found that a first dose of Shingrix had been given to the patient with another diluent than the one in Shingrix pack. which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. She stated that, she was unsure what solution was used at this point and needed to investigate further from her staff. She stated, if any additional information was uncovered she would call back and provide it. The reporter requested additional guidance on how to proceed after this administration so Medical Information number was provided to her. The reporter did not consent to follow-up.
Age: 12.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: dose on 25Feb2020, not yet received second; adult dose administered to 12 year old; adult dose administered to 12 year old; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HAV (Havrix adult) (batch number K4YAL, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Havrix adult. On an unknown date, the patient received the 2nd dose of Havrix. On 25th February 2020, unknown after receiving Havrix adult and not applicable after receiving Havrix, the patient experienced overdose and adult product administered to child. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the overdose, adult product administered to child and incomplete course of vaccination were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of Havrix. The reporter stated that, an adult dose of Havrix was administered to 12 year old patient, which led to overdose and adult product administered to child. Till the time of reporting, the patient did not receive second/ booster dose of Havrix series, which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022032554:FU1 - Deleted
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in 2019, second dose in 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2019).   On 10th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 10th May 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 self-reported the case. The patient received second dose of Shingrix more than 6 months after the first dose, which led to lengthening of vaccination schedule. The patient did not have the following information: lot/expiry date and dose of Shingrix second dose. The patient did not give a consent to follow-up with HCP (health care professional). Therefore, HCP contact information was not collected.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old male patient who received HAB (Twinrix adult) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th February 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 18th February 2022, unknown after receiving Twinrix adult and Twinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Twinrix adult, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: patient 43 years of age, has a prescription to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 43-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was immunocompetent. Pharmacist reported that, the patient had a prescription to receive Shingrix at the age of 43 years, which led to intercepted drug prescribing error. Shingrix was not administered at the time of reporting. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient receiving 3 doses; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacy student requested information about the patient receiving 3 doses of the Shingrix, which led to extra dose administered.  She did not have any information about the patient. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't had the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter enquired about how to proceed with the 2nd dose of Shingrix. The reporter did not consent to follow up.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: the dose received had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Twinrix and Twinrix 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 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 an expired dose of Twinrix, which led to expired vaccine used. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not yet received second dose; This case was reported by a consumer 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 (received 1st dose on 05th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient got an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 21st February 2022, unknown after receiving Twinrix and Twinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administrated with an expired dose of Twinrix, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd February 2022, unknown after receiving Twinrix and Twinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was given an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash caused by simplex virus; Rash was red; Rash was itchy; Rash consisted of raised bump/ elevation of bumps; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced herpes simplex, red rash, itchy rash and papular rash. On an unknown date, the outcome of the herpes simplex, red rash, itchy rash and papular rash were recovering/resolving.   It was unknown if the reporter considered the herpes simplex, red rash, itchy rash and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in left arm and developed a rash across their chest, underneath both pectorals and above the stomach. The patient reported that  rash was red, itchy, and consisted of raised bumps. The patient reported that  dermatologist reported rash was caused by herpes simplex virus.  The patient reported rash was ongoing, but redness, itch, and elevation of bumps had improved. The reporter consented to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 01/25/2022, 2nd dose on 02/08/2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 72P9H, expiry date 9th April 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 8th February 2022, the patient received the 2nd dose of Shingrix. On 8th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, 11 days after starting the series, earlier than the recommended schedule, which led to shortening of vaccination schedule The reporter stated that, the patient did not experience any know side effects to her knowledge.  No medical intervention needed as of reporting date. The reporter did not consent to follow up.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient got Bexsero instead of Tdap; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, at their clinic, they normally immunize against Meningococcal B starting at age 16 years.  The patient was given Bexsero in error, at the age of 13 years, which led to wrong vaccine administered. The patient was supposed to get Tdap instead of Bexsero.  The reporter stated that, Bexsero was ordered in error in place of TDap vaccine. The reporter enquired, since Bexsero was approved for the patient's age group, could she just give the series now or wait until she was 16 and repeat the series. The reporter wanted to be able to do what was best for her, if she could get the series nor that was fine by her, just unsure if immunity waned and she should get it closer to 16. The reporter was in the process of checking for expiry date but disconnected before providing additional information or follow permission.  Contact information was provided in case of follow up.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of peripheral swelling (swollen left hand) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swollen left hand). At the time of the report, peripheral swelling (swollen left hand) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: not applicable. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Arm is hot to the touch; Red band halfway between elbow and shoulder; Swelling; Pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm is hot to the touch), ERYTHEMA (Red band halfway between elbow and shoulder), SWELLING (Swelling) and PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Arm is hot to the touch), ERYTHEMA (Red band halfway between elbow and shoulder), SWELLING (Swelling) and PAIN (Pain). At the time of the report, FEELING HOT (Arm is hot to the touch) outcome was unknown and ERYTHEMA (Red band halfway between elbow and shoulder), SWELLING (Swelling) and PAIN (Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was provided.  No treatment medications were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test, SARS-CoV-2 test positive, Transient ischaemic attack
Clinical narrative: TRANSIENT ISCHAEMIC ATTACK; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; SARS-COV-2 TEST POSITIVE; MALAISE; This spontaneous report received from a health care professional by a Regulatory Authority (VAERS FDA, US-VAERS-1944320-OGNM-20211224160546) on 24-DEC-2021 and concerned a 58 year old male of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, obesity, and nephrolithiasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total administered on 18-MAR-2021 for an unspecified indication (Dose number in series 1). Drug start period was 265 days. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced symptoms of transient ischaemic attack, confirmed clinical vaccination failure, covid-19 , sars-cov-2 (Severe acute respiratory syndrome coronavirus 2)test positive, malaise, and was hospitalized (date unspecified). Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the malaise, sars-cov-2 test positive, transient ischaemic attack, covid-19 and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000208902. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 22-FEB-2022. The following information was updated and incorporated into the case narrative: product quality complaint investigation result was added.; Sender's Comments: V1:This version is created to update the information regarding Product quality complaint investigation result  was added, This updated information does not change the causality of the previously reported events. 20211255599-covid-19 vaccine ad26.cov2.s- transient ischaemic attack, covid-19, sars-cov-2 test positive, malaise. 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). 20211255599-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: TRANSIENT ISCHAEMIC ATTACK; CONFIRMED CLINICAL VACCINATION FAILURE; COVID-19; SARS-COV-2 TEST POSITIVE; MALAISE; This spontaneous report received from a health care professional by a Regulatory Authority (VAERS FDA, US-VAERS-1944320-OGNM-20211224160546) on 24-DEC-2021 and concerned a 58 year old male of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes, obesity, and nephrolithiasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total administered on 18-MAR-2021 for an unspecified indication (Dose number in series 1). Drug start period was 265 days. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced symptoms of transient ischaemic attack, confirmed clinical vaccination failure, covid-19 , sars-cov-2 (Severe acute respiratory syndrome coronavirus 2)test positive, malaise, and was hospitalized (date unspecified). Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the malaise, sars-cov-2 test positive, transient ischaemic attack, covid-19 and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000208902. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 22-FEB-2022. The following information was updated and incorporated into the case narrative: product quality complaint investigation result was added.; Sender's Comments: V1:This version is created to update the information regarding Product quality complaint investigation result  was added, This updated information does not change the causality of the previously reported events. 20211255599-covid-19 vaccine ad26.cov2.s- transient ischaemic attack, covid-19, sars-cov-2 test positive, malaise. 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). 20211255599-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Inflammation
Clinical narrative: INFLAMMATORY HEART DISEASE; INFLAMMATORY HEART DISEASE; This spontaneous report was received from literature. This report concerned a patient of unspecified age and sex of unspecified race and ethnicity. The patient 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 not reported, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced inflammatory heart disease (cardiac disorder) and inflammatory heart disease (inflammation). The 67 patients identified with inflammatory heart disease, 21 (31.3%) had a SARS-Cov-2 vaccination within the previous 60 days. Overall, 914 611 patients received a SARS-CoV-2 vaccine, resulting in an inflammatory heart disease rate of 2.30 per 100 000 vaccinated patients. The relative risk of inflammatory heart disease for the vaccinated patients compared to the unvaccinated patients was 2.05 times higher rate within the 30-day window and had a trend toward increase in the 60-day window (relative rate 1.63) All vaccinated patients with inflammatory heart disease were treated successfully. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammatory heart disease (cardiac disorder) and inflammatory heart disease (inflammation). The author emphasized that the rate of inflammatory heart disease was greater in a SARS-CoV-2-vaccinated population than the unvaccinated population. This risk is eclipsed by the risk of contracting coronavirus disease 2019 and its associated, commonly severe outcomes. Nevertheless, clinicians and patients should be informed of this risk to facilitate earlier recognition and treatment. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220236455-covid-19 vaccine ad26.cov2.s-inflammatory heart disease (cardiac disorder), inflammatory heart disease (inflammation). 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: SMALL STROKES; This spontaneous report received from a patient via social media via a company representative concerned a 74 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: polio. The patient was previously treated with polio vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was 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 it was reported that, "I took it. No problem. I got polio from the polio vaccine at age 15 and had been advised to never take a flu shot. Didn't until now. 74 years old. Took the chance. So far, so good. Caveat: it did cause 2 or 3 small strokes. All is good" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small strokes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via a company representative concerned a 74-year-old of unspecified sex, race, and ethnicity who experienced cerebrovascular accident after an unspecified duration since vaccination. Patient had medical history of polio after polio vaccination 15-years-ago. No concomitant medications were reported. The patient experienced 2 or 3 small strokes after an unspecified duration of vaccination. No further information was provided. Information is limited in this case, and the occurrence of cerebrovascular accident could represent background incidence of such events in the general population. Therefore, the relationship of cerebrovascular accident to vaccination is considered unclassifiable due to insufficient information.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscular weakness, Pain
Clinical narrative: WHOLE BODY ACHE; JOINT PAIN; WHOLE BODY WEAKNESS/ RIGHT LOWER LEG WEAKNESS; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had four stents and was on unspecified blood thinners. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201A21A, expiry: unknown) dose was not reported, dose number in series 1, 01 total, administered on 04-MAY-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced muscles aches for two months (dose number in series 1). The patient recovered from muscles aches for two months. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, dose number in series 2, 01 total, administered at right arm on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had joint pain, whole body weakness/ right lower leg weakness, severe headache, and whole body ache (dose number in series 2). At the time of report, the patient's ache and weakness spread into the whole body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from whole body weakness/ right lower leg weakness, and whole body ache, and the outcome of joint pain and severe headache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220241253.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SORE ARM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (physician) concerned a 74 year old male.  Initial information was processed along with the additional information received from a regulatory authority on 18-FEB-2021. The patient's weight was 230 pounds, and height was 71 inches. The patient's concurrent conditions included: borderline diabetes controlled with diet, environmental allergy, alcohol user of one glass of wine or whisky once every two weeks, and non smoker. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 043A21A and expiry: 21-JUN-2021) dose was not reported, 1 total, administered in right arm on 07-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s.  The patient received booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number:1855835 expiry: unknown) dose was not reported, 1 total administered in right arm on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient (health care professional reported that he had Covid-19 after he received two doses of the Janssen Covid-19 vaccine (First dose on 07-APR-2021 and Booster dose on 03-DEC-2021). On 15-FEB-2022, He tested positive (fast test /rapid antigen test). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient had suspected clinical vaccination failure. The test was performed by a medical technician at his own clinic. He awaited PCR (Polymerase chain reaction) results. On 13-FEB-2022, the patient had suspected covid-19 infection as symptoms started on same day. On an unspecified date, the patient had sore arm. He felt better and energetic on the day of reported. His oxygen level was over 90 and pulse was over 70. He decided to not take oral antivirals. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and was recovering from suspected covid-19 infection, and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000218079.; Sender's Comments: V0:20220242740-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. No adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835, expiry: 27-APR-2022) dose was not reported, 1 total, administered on 16-FEB-2022 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-FEB-2022, about 10 hours after vaccination, the patient experienced chills, fever, and headache (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on FEB-2022 and had not recovered from headache. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Localised infection, Muscle injury, Pain in extremity, Tissue injury
Clinical narrative: INFECTED/PUFFY/HOLE IN THE LEFT ARM; MUSCLE ARE DAMAGED; TISSUES ARE DAMAGED; WON'T BE ABLE TO USE ARM SAME WAY; ARM HURTING REALLY BAD; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: brain injury in the right frontal lobe, and concurrent conditions included: degenerative disease, iodine allergy, seafood allergy, lyrica allergy, and sulpha antibiotics allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: 29-SEP-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUN-2021, the patient experienced arm hurting really bad. On an unspecified date, the patient experienced infected/puffy/hole in the left arm, muscle are damaged, tissues are damaged, and won't be able to use arm same way. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the infected/puffy/hole in the left arm, arm hurting really bad, muscle are damaged, tissues are damaged and won't be able to use arm same way was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Off label use, Product administered to patient of inappropriate age
Clinical narrative: ANAPHYLAXIS; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This solicited report received from a consumer concerned a 17 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose,1 total, start therapy date were not reported for prophylactic vaccination (coded to inappropriate age at vaccine administration and Off label use). 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 an unspecified date, the patient experienced anaphylaxis. Approximately 8.5 hours after vaccination, patient had developed blisters in mouth and itching all over body, patient took 25mg Benadryl at that time. Shortly after that patient had developed breathing problems (throat closing). Prior to arrival to ED (Emergency department) patient took epinephrine, dexamethasone, acrivastine and NS bolus IV. The patient improved and was sent home from ED (Emergency department) with prednisone 5 days. On an unspecified date the patient visited Emergency department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and the outcome of off label use and inappropriate age at vaccine administration was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and anaphylaxis as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and inappropriate age at vaccine administration, and off label use. Company causality between covid-19 vaccine ad26.cov2.s, and anaphylaxis was related. Company causality between covid-19 vaccine ad26.cov2.s, and inappropriate age at vaccine administration, and off label use was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220243496-COVID-19 VACCINE Ad26.COV2.S- Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MANY PROBLEMS THAT WERE NEVER GOING AWAY; 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. 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, expiry: 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 patient experienced many problems that were never going away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from many problems that were never going away. This report was non-serious. This case, from the same reporter is linked to 20220243873.