chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: She said every thing hurt( she had muscle pain); Swelling; Rash is itchy/ Rash of her right arm/Itchiness; Arm Hardness; hotness in arm/ rash is hot; hotness in arm; spent the next couple of days in bed; she experienced shivering; Feeling cold; Redness just below the injection site; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   The patient's past medical history included shingles (had 2 episodes of Shingles when she was in her 30's). Previously administered products included Zostavax (1st dose received in 8th December 2014).   On 18th February 2022, the patient received the 1st dose of Shingrix .5 ml. On 18th February 2022, less than a day after receiving Shingrix, the patient experienced shivering, feeling cold, erythema and pain in arm. On 19th February 2022, the patient experienced muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased. On an unknown date, the outcome of the shivering, erythema, swelling, itchy rash, induration, heat rash and extremities hot feeling of were not recovered/not resolved and the outcome of the feeling cold, pain in arm, muscle pain and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the shivering, feeling cold, erythema, pain in arm, muscle pain, swelling, itchy rash, induration, heat rash, extremities hot feeling of and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in right deltoid and that night she experienced shivering, feeling cold, a sore arm, and redness just below the injection site.  The following day she said every thing hurt( she had muscle pain), and that she spent the next couple of days in bed.  The patient also noticed a rash, itchiness, swelling, hotness, and hardness of her right arm. The patient had measured the size of her rash and stated it was 3 inches in diameter, but it had increased yesterday on 21st February 2022) to 4 inches across and 5 inches in length. On the day of reporting she stated that she no longer had pain, and she felt better, but the the rash continues and it was hot and itchy around the edges. She had not yet measured the size of the rash but stated that it was almost wrapping around her arm Gave medical advice disclaimer. Spoke per content. Spoke per PI (package insert). Referred to health care professional.  The reporter consented to follow-up with HCP (health care Professional). The reporter consented to follow-up.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatic steatosis, Hepatitis B surface antibody negative, Inappropriate schedule of product administration, Laboratory test, Liver function test increased
Clinical narrative: fatty liver; Titers for Hepatitis B nonreactive; (Liver Function Tests) were elevated; 1st dose SEP2011, 2nd in JUN2012, 3rd in MAY2013; This case was reported by a nurse via call center representative and described the occurrence of fatty liver in a 19-month-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and HEPATITIS B VACCINE (batch number 0491AA, expiry date unknown) for prophylaxis.   On 27th September 2011, the patient received the 1st dose of Hepatitis B vaccine. On 9th May 2013, the patient received the 3rd dose of Hepatitis B vaccine. On 27th June 2012, the patient received the 2nd dose of HEPATITIS B VACCINE. On 9th May 2013, not applicable after receiving Hepatitis B vaccine and unknown after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On 27th October 2021, the patient experienced raised liver function tests. On 30th December 2021, the patient experienced therapy non-responder. On an unknown date, the patient experienced fatty liver. On an unknown date, the outcome of the fatty liver, raised liver function tests, therapy non-responder and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fatty liver and raised liver function tests to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was unknown. Licensed Vocational Nurse (LVN) reported that, the patient completed a Hepatitis B series when she was younger. The brand for 1st dose and 3rd dose was unknown, the 2nd dose from Pfizer (Lot 0491AA). The patient received 2nd and 3rd dose later than the recommended interval, which led to lengthening of vaccination schedule. On 27th October 2021, the patient had lab tests on and her LFTs (Liver Function Tests) were elevated. Specialist retested her on 30th December 2021, however, the reporter did not have results of retest. Titers for Hepatitis B were done on 30-Dec-2021 as well and came back nonreactive, which led to therapy non-responder. When clarifying about patient's overall health, the reporter stated that, the reason why they came down was she had a fatty liver. The reporter consented to follow up. No additional information shared. No details regarding manufacturer of 1st and 3rd dose of Hep B.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Therapy non-responder
Clinical narrative: fatty liver; Titers for Hepatitis B nonreactive; (Liver Function Tests) were elevated; 1st dose SEP2011, 2nd in JUN2012, 3rd in MAY2013; This case was reported by a nurse via call center representative and described the occurrence of fatty liver in a 19-month-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and HEPATITIS B VACCINE (batch number 0491AA, expiry date unknown) for prophylaxis.   On 27th September 2011, the patient received the 1st dose of Hepatitis B vaccine. On 9th May 2013, the patient received the 3rd dose of Hepatitis B vaccine. On 27th June 2012, the patient received the 2nd dose of HEPATITIS B VACCINE. On 9th May 2013, not applicable after receiving Hepatitis B vaccine and unknown after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On 27th October 2021, the patient experienced raised liver function tests. On 30th December 2021, the patient experienced therapy non-responder. On an unknown date, the patient experienced fatty liver. On an unknown date, the outcome of the fatty liver, raised liver function tests, therapy non-responder and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fatty liver and raised liver function tests to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was unknown. Licensed Vocational Nurse (LVN) reported that, the patient completed a Hepatitis B series when she was younger. The brand for 1st dose and 3rd dose was unknown, the 2nd dose from Pfizer (Lot 0491AA). The patient received 2nd and 3rd dose later than the recommended interval, which led to lengthening of vaccination schedule. On 27th October 2021, the patient had lab tests on and her LFTs (Liver Function Tests) were elevated. Specialist retested her on 30th December 2021, however, the reporter did not have results of retest. Titers for Hepatitis B were done on 30-Dec-2021 as well and came back nonreactive, which led to therapy non-responder. When clarifying about patient's overall health, the reporter stated that, the reason why they came down was she had a fatty liver. The reporter consented to follow up. No additional information shared. No details regarding manufacturer of 1st and 3rd dose of Hep B.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st shot in Dec 2020, 2nd until Feb 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th December 2020, batch number KG52X, expiry date 28th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had received his 1st shot of Shingrix and did not come back to get 2nd dose until the date of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: possible 3rd dose to be administered; received in 2019 and Shingrix in 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number DP2D3, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in 2019).   On 22nd February 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On 22nd February 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the drug dose administration interval too long and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for 3rd dose. The patient received an unknown shingles vaccineas 1st dose and a dose of Shingrix was given the day before reporting, which led to lengthening of vaccination schedule. After the case was closed, the health care professional spoke with Medical information agent and stated that a possible 3rd dose to be administered in 2 months, which was circumstance or information capable of leading to medication error. It was not clear if the patient had prescription for 3rd dose or will erroneously receive it. The reporter consented to follow up.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 33-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 22nd February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd 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 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 pharmacy technician reported that, the patient received a dose of Twinrix that had expired on 8th February 2022, which led to expired vaccine used. The reporter consented to follow up.
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: administered Rotarix intramuscularly; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number M4ar7, expiry date 6th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 23rd February 2022, the patient received Rotarix lyophilized formulation (intramuscular). On 23rd February 2002, the patient started Rotarix Oral Applicator Device. On 23rd February 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device and unknown after starting Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 patient was administered Rotarix intramuscularly, which led to inappropriate route of vaccination. The reporter consented to follow up with email follow-up.
Age: 45.0
Sex: M
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 45-year-old male patient who received HAB (Twinrix) (batch number 93KF5, expiry date 20th 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 2nd 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 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 patient received an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old female patient who received HBV (Engerix B) (batch number 5L27A, expiry date 11th February 2022) for prophylaxis.   On 24th February 2022, the patient received Engerix B (intramuscular). On 24th February 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received Engerix B in right deltoid. The patient inadvertently received an expired dose of Engerix-B, which led to expired vaccine used. The reporter consented to follow up. No further details were provided on call.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Ulcerative keratitis
Clinical narrative: Corneal Ulcer, coronary ulcer; This case was reported by a other health professional via sales rep and described the occurrence of corneal ulcer in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2022, the patient received the 1st dose of Shingrix (intramuscular). On 16th February 2022, 1 days after receiving Shingrix, the patient experienced corneal ulcer (serious criteria GSK medically significant). On an unknown date, the outcome of the corneal ulcer was unknown.   It was unknown if the reporter considered the corneal ulcer to be related to Shingrix.  Additional details were provided as follows: The reporter reported the patient received her Shingrix vaccine in (unknown arm) and the corneal ulcer (coronary ulcer) developed in unknown eye. The reporter reported that the patient received treatment from her eye doctor and then reported it to the GlaxoSmithKline representative's healthcare professional .  No further information was known. The reporter consented to follow up.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 4th dose February 24th 2022, 3rd dose January 27th 2022; patient (DOB 21-APR-2021) received 4th dose February 2022, 3rd January 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 10-month-old male patient who received Hib (Hiberix) (batch number IP244, expiry date 21st March 2023) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis.   On 24th February 2022, the patient received the 4th dose of Hiberix. On 27th January 2022, the patient received the 3rd dose of Hiberix. On 27th January 2022, not applicable after receiving Hiberix and unknown after receiving Hiberix, the patient experienced inappropriate age at vaccine administration. On 24th February 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received 3rd dose of Hiberix at the age of 9 months, which led to inappropriate age at vaccine administration. The patient received 4th dose of Hiberix earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3RD DOSE OF SHINGRIX WAS GIVEN; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th January 2021) and Shingrix (received 2nd dose on 26th July 2021).   On 18th February 2022, the patient received the 3rd dose of Shingrix. On 18th February 2022, 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 patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose greater than two years ago, has not received third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) 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.   Previously administered products included Twinrix (received 2nd dose, greater than two years ago from the date of reporting).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 applicable for this report. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete vaccination schedule. Pharmacist did not have dates of the first doses, nor lot number and expiration date information.   The pharmacist did not have patient information other than gender. The reporter consented to follow up. The reporter gave permission for follow up but declined to provide email address or mailing address.
Sex: U
Vaccine: HEP
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: unknown amount ran down a newborn patient's leg; unknown amount ran down a newborn patient's leg; unknown amount ran down; This case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a neonate patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 24th February 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the inadvertent exposure to vaccine, exposure via skin contact and accidental underdose were 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 pharmacist reported that an unknown amount of Engerix-B ran down a newborn patient's leg when a nurse was administering the vaccine, which led to inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. The reporter did not consent to follow-up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received Adjuvant of Shingrix only(without the Lyophilized Antigen Component); received Adjuvant of Shingrix only(without the Lyophilized Antigen Component); This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number B7FL2, expiry date 17th April 2023) for prophylaxis.   On 11th February 2022, the patient received Shingrix. On 11th February 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received adjuvant of Shingrix only without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. The reporter mentioned that did not care being contacting by safety.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Havrix instead of Hep B; new borm administrated with Havrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-day-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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 Havrix instead of Hepatitis B vaccine at the age of 5 days, which led to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up. No lot number and expiration date provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient had a case of shingles in the evening after first dose of Shingrix was administered. The reporter did not want to give information about patient. No further information was reported. The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: Administered shingrix via gluteus maximus instead of deltoid; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 21st February 2022, the patient received Shingrix. On 21st February 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient received Shingrix via gluteus maximus instead of deltoid, which led to intramuscular formulation administered by other route. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in year 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. At the time of reporting, the patient wanted to complete schedule. Lot number and expiration date of 1st dose was not provided since patient didi not get the vaccine in at the facility. The reporter did not consent to follow up.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: extra dose on the same day; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number h9fm5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 24th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 inadvertently received an extra dose of Kinrix, which led to extra dose administered.  No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered 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 stated that "I was forced to get this vaccine and yet I still got covid twice. What good is a vaccine that lets you still get the sicknesses. Why make something that really does not work mandatory. If you want to impress me make a vaccine that works." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000217268. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received on 24-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: Case was considered as valid since it was received from JNJ managed page.; Sender's Comments: V1:Follow up information in this version updated : Product quality complaint investigation result. Upon review following information was amended: Case was considered as valid since it was received from JNJ managed page. The follow up information does not change the causality of the previous reported event.   20220229986- 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.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via Social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered 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, after receiving vaccine the patient experienced sick coded as suspected clinical vaccination failure, and suspected covid-19 infection and tested positive for Covid-19. The reporter stated that "it's sad! I'm not Vaxed my family is. my daughter got covid a month ago then my husband tested positive 2 days later he gave the test to me I tested positive I had no symptoms they both got sick. we've been at home for 16 days now and I feel great except I'm going crazy, tomorrow I'm going grocery shopping so stay away". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality complaint: 90000217267. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220230287.  Additional information received from Complaint Vigilance department on 24-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was amended: Case validity changed from invalid to valid.; Sender's Comments: V1: Additional information received is regarding product quality complaint investigation result and Case validity changed from invalid to valid. The follow up information received does not alter the assessment of prior company causality of previously reported event. : 20220230241-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via social media via a company representative concerned a 64-year-old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, dose number in series 01, 01 total, was administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 01).  The patient additionally received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, dose number in series 02, 01 total, was administered on an unspecified date 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 (reporter's buddy) experienced suspected covid-19 infection and had suspected clinical vaccination failure (Dose number in series 2). As per the reporter, "My buddy got his shots and still died when he got coronavirus disease (COVID-19)". On an unspecified date, the patient died from suspected covid-19 infection. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported and suspected covid-19 infection was fatal. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000218432.; Sender's Comments: V0: 20220248641-COVID-19 VACCINE AD26.COV2.S-suspected covid-19 infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220248641-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: MYOCARDITIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media concerned an 18 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: extremely healthy before shot. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Dose number in series 1). On an unspecified date, the patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered 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, following administration of covid-19 vaccine ad26.cov2.s, the patient was tested positive (suspected clinical vaccination failure) and got sick (suspected covid-19 infection). The patient also had myocarditis (Dose number in series 2). Laboratory data (dates unspecified) included: coronavirus disease (COVID-19) virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000218634. This case, from the same reporter is linked to 20220250720, 20220251028 and 20220251156.; Sender's Comments: V0: 20220250507-covid-19 vaccine ad26.cov2.s-Myocarditis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220250507-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: HEART ATTACK; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned 2 adult patients of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: extremely healthy before shot. The patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patients additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (unspecified manufacturer) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered 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, following administration of covid-19 vaccine ad26.cov2.s, both patient had heart attack from the shots, they were tested positive (suspected clinical vaccination failure) and got sick (suspected covid-19 infection) (Dose number in series 2). Laboratory data (dates unspecified) included: coronavirus disease (COVID-19) virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000218635. The suspected product quality complaint has been confirmed to be voided (did not describe any product quality complaint) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220250720, 20220250507 and 20220251028.; Sender's Comments: V0: 20220251156- covid-19 vaccine ad26.cov2.s-Heart attack. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. .20220251156- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Mother is the vaccinee. BABY DIED; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer in social media via a company representative concerned multiple patients of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The patient was gravida1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, 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 had vaccine exposure during pregnancy and baby died. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a spontaneous abortion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine exposure during pregnancy and baby died was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220251162-Covid-19 vaccine ad26.cov2.s-Baby died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220251162-Covid-19 vaccine ad26.cov2.s-Vaccine exposure during pregnancy. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance
Clinical narrative: UNSPECIFIED LOCALIZED DISCOMFORT; DIFFICULTY IN WALKING; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: osteoarthritis on her right leg. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown) dose was not reported, 1 total administered on 29-APR-2021 to left arm for prophylactic vaccination.  On an unspecified date, the patient experienced some unspecified localized discomfort/felt the muscular discomfort on her left leg and spread all over her body when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient recovered from some unspecified localized discomfort/muscular discomfort on left leg and spread all over body, and had not recovered from muscular burning sensation (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 221D21A, and expiry: Unknown) dose was not reported, 1 total administered on 21-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient stated after booster shot discomfort came back again (dose number in series 2). It had not subsided since and she had to take 2 extra strength Tylenol and Aleve to be able to walk. Patient stated, that while walking, she had to stop due to the discomfort (dose number in series 2). The patient was concerned regarding polyethylene glycol but was informed that Janssen vaccine did not contain polyethylene glycol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified localized discomfort, and difficulty in walking (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220253476 (series 1).
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia
Clinical narrative: LOCALISED DISCOMFORT; MUSCULAR BURNING SENSATION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced localised discomfort, and muscular burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscular burning sensation and localised discomfort was not reported. This report was non-serious. This case, from the same reporter is linked to 20220260749.