chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: 4 vx given after delayed delivery due to inclimate weather; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 age at vaccination was not reported. One to 2 years old patient received dose of Havrix pediatric from a shipment that had delayed delivery due to inclimate weather from 3rd February 2022 till 7th February 2022 but was still showing a good temperature tag alert in the box upon delivery to office.The Glaxosmithkline agreed to return and replace these vaccines on 9th February 2022 due to this longer than normal delivery window even though tag alert was still showing ok after 5 days in transit with this delivery on 7th February 2022. The reporter stated that, on 16th March 2022, learned from the GSK Vaccine Service Center that these 4 Havrix pediatric doses were not returned with rest of claim, and confirmed from the pediatric office on 17th March 2022 that these vaccines were administered to patient around the second week of February. The office was not extremely concerned due to good Glaxosmithkline temperature tag alert upon delivery. No adverse events or patient issues were reported after administration. There seems to be some internal Glaxosmithkline confusion with the temperature tag alerts after 4 days in transit. No evidence given that there was any temperature excursion during delayed delivery to compromise vaccine stability. The reporter consented to follow up. This case was one of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR049425:Same reporter. US-GLAXOSMITHKLINE-US2022AMR049480:Same reporter. US-GLAXOSMITHKLINE-US2022AMR049479:Same reporter. US-GLAXOSMITHKLINE-US2022AMR049479:Same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: 4 vx given after delayed delivery due to inclimate weather; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. In February 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 age at vaccination was not reported. One to 2 years old patient received dose of Havrix pediatric from a shipment that had delayed delivery due to inclimate weather from 3rd February 2022 till 7th February 2022 but was still showing a good temperature tag alert in the box upon delivery to office.The Glaxosmithkline agreed to return and replace these vaccines on 9th February 2022 due to this longer than normal delivery window even though tag alert was still showing ok after 5 days in transit with this delivery on 7th February 2022. The reporter stated that, on 16th March 2022, learned from the GSK Vaccine Service Center that these 4 Havrix pediatric doses were not returned with rest of claim, and confirmed from the pediatric office on 17th March 2022 that these vaccines were administered to patient around the second week of February. The office was not extremely concerned due to good Glaxosmithkline temperature tag alert upon delivery. No adverse events or patient issues were reported after administration. There seems to be some internal Glaxosmithkline confusion with the temperature tag alerts after 4 days in transit. No evidence given that there was any temperature excursion during delayed delivery to compromise vaccine stability. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR049401:Same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: 4 vx given after delayed delivery due to inclimate weather; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 age at vaccination was not reported. One to 2 years old patient received dose of Havrix pediatric from a shipment that had delayed delivery due to inclimate weather from 3rd February 2022 till 7th February 2022 but was still showing a good temperature tag alert in the box upon delivery to office.The Glaxosmithkline agreed to return and replace these vaccines on 9th February 2022 due to this longer than normal delivery window even though tag alert was still showing ok after 5 days in transit with this delivery on 7th February 2022. The reporter stated that, on 16th March 2022, learned from the GSK Vaccine Service Center that these 4 Havrix pediatric doses were not returned with rest of claim, and confirmed from the pediatric office on 17th March 2022 that these vaccines were administered to patient around the second week of February. The office was not extremely concerned due to good Glaxosmithkline temperature tag alert upon delivery. No adverse events or patient issues were reported after administration. There seems to be some internal Glaxosmithkline confusion with the temperature tag alerts after 4 days in transit. No evidence given that there was any temperature excursion during delayed delivery to compromise vaccine stability. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR049480:Same reporter. US-GLAXOSMITHKLINE-US2022AMR049425:Same reporter. US-GLAXOSMITHKLINE-US2022AMR049401:Same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: 4 vx given after delayed delivery due to inclimate weather; This case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a infant patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In February 2022, the patient received Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 age at vaccination was not reported. The 1 to 2 years old patient received dose of Havrix pediatric from a shipment that had delayed delivery due to inclimate weather from 3rd February 2022 till 7th February 2022 but was still showing a good temperature tag alert in the box upon delivery to office. The GlaxoSmithKline Direct service center agreed to return and replace these vaccines on 9th February 2022 due to this longer than normal delivery window even though tag alert was still showing ok after 5 days in transit with this delivery on 7th February 2022. The reporter stated that, on 16th March 2022, learned from the GlaxoSmithKline Vaccine Service Center that these 4 Havrix pediatric doses were not returned with rest of claim, and confirmed from the pediatric office on 17th March 2022 that these vaccines were administered to patient around the second week of February. The office was not extremely concerned due to good GlaxoSmithKline temperature tag alert upon delivery. No Adverse events or patient issues were reported after administration. There seems to be some internal GlaxoSmithKline confusion with the temperature tag alerts after 4 days in transit. No evidence given that there was any temperature excursion during delayed delivery to compromise vaccine stability. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR049401:Same reporter. US-GLAXOSMITHKLINE-US2022AMR049479:Same reporter. US-GLAXOSMITHKLINE-US2022AMR049425:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after second vaccination/ Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles after 2nd dose of Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Last summer I got the shot and got shingles; Got shingles; Pain / Bothering me bad; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles several years ago).   On an unknown date, the patient received Shingles vaccine. In October 2021, less than 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling bad and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, feeling bad and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles several years ago. The patient stated that the pain was bad.  The patient received shingles vaccine last summer. In October 2021, the patient got shingles. It was still bothering him/her bad. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not provided. Note: From the narrative it was not clear if the patient had pain for previous shingles episode or it was occurred after vaccination, hence coded as history and event conservatively.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: got vaccine for shingles, had shingles/ suspected vaccination failure; shingles; COVID; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that he/she got the vaccine for shingles and COVID and experienced shingles twice and also had COVID. The patient stated that he/she was not sure about these vaccines. It was unknown if the reporter considered the shingles and covid-19 to be related to covid-19 vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were not provided. Note: From the narrative it was not clear if the patient received covid vaccine before or after shingles vaccine hence covid vaccine considered as suspect and covid-19 added as event conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient got first dose more than a year ago didn´t get the 2nd; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose more than a year ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. The patient got first dose of Shingrix more than a year ago, the reporter enquired if patient need to restart series get 2 doses now. Till the time of reporting patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 2019, 2nd dose on 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th May 2019).   On 27th December 2021, the patient received the 2nd dose of Shingrix. On 27th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. No lot number and expiration date provided. The pharmacist student reported that, the patient received a second dose of shingrix outside recommended schedule, which led to lengthening of vaccination schedule.  No known side effect was reported. The reporter consented to follow up. No patient's identifiers were provided. No Lot number and expiration date provided
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Anxiety, Dyspnoea, Feeling abnormal, Injection site pain, Malaise
Clinical narrative: I felt like I was hit by a truck; Shortness of breath; anxiety; chest palpitations; side effects, tenderness at injection site; felt really sick for about 36 hours; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 7th December 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season. On 8th December 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell. In December 2021, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness, feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell to be related to Shingrix. It was unknown if the reporter considered the feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by the nurse herself. The patient was now due for second dose of Shingrix this month and she was worried because she reported side effects from dose 1. The patient stated that she received dose of Shingrix in right arm and a flu shot (did not know name) in the left arm.  She stated that she had tenderness at the injection site with Shingrix .  The patient mentioned the next day, she felt like she was hit by a truck. She stated that she had shortness of breath, anxiety, chest palpitations, and felt really sick for about 36 hours. The patient was referred to health care professional and medical information department phone number was provided. Spoke per content.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Palpitations
Clinical narrative: I felt like I was hit by a truck; Shortness of breath; anxiety; chest palpitations; side effects, tenderness at injection site; felt really sick for about 36 hours; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 7th December 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season. On 8th December 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell. In December 2021, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness, feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell to be related to Shingrix. It was unknown if the reporter considered the feeling abnormal, shortness of breath, anxiety, palpitation and feeling unwell to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by the nurse herself. The patient was now due for second dose of Shingrix this month and she was worried because she reported side effects from dose 1. The patient stated that she received dose of Shingrix in right arm and a flu shot (did not know name) in the left arm.  She stated that she had tenderness at the injection site with Shingrix .  The patient mentioned the next day, she felt like she was hit by a truck. She stated that she had shortness of breath, anxiety, chest palpitations, and felt really sick for about 36 hours. The patient was referred to health care professional and medical information department phone number was provided. Spoke per content.
Age: 12.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient received 1 dose; 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 12-year-old female 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.   On an unknown date, the patient received the 1st 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 inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 reported were as follows: The reporter stated that, the patient had no prior immunization history and needed catch up vaccines. The reporter was unaware that Twinrix was for 18 plus years old and the patient who was 12 years of age, received 1 dose of Twinrix, which led to inappropriate age at vaccine administration. The patient was doing fine and denied side effects. The reporter asked if this immunization was still able to be counted toward her vaccine history or not. The reporter was following the CDC (Center for Disease Control) catch up plan. The reporter consented to follow up. No further details provided in email.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: was administered 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 19-month-old patient who received DTPa (Infanrix) (batch number unknown, expiry date 31th January 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Infanrix and Infanrix 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 was administered an expired dose of the infanrix vaccine, which led to expired vaccine used. The reporter consented to follow up. Note: There was discrepancy in expiry date of vaccine captured as reported in narrative.
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received a Hiberix and Pediarix dose out of indication; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received Hib (Hiberix) (batch number J4F4M, expiry date 21st March 2023) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 5nn259, expiry date 5th October 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received Hiberix, Pediarix and Pediarix Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Hiberix, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 age at vaccination was unknown, (it could be 10 or 11 years). The Health care professional reported that the patient received a Hiberix and Pediarix dose out of indication, which led to inappropriate age at vaccine administration. The reporter consented to follow up. The case has been linked with the cases US2022047762 and US2022047763 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022047762:Same reporter US-GLAXOSMITHKLINE-US2022047759:same reporter - FU1 - DELETED  US-GLAXOSMITHKLINE-US2022047764:same reporter - FU - DELETED US-GLAXOSMITHKLINE-US2022047763:same reporter
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in right foot; Tingling sensation in his right foot; This case was reported by a consumer via call center representative and described the occurrence of numbness in feet in a 56-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included anxiety (Patient takes Klonopin for anxiety) and pre-diabetes. Concomitant products included clonazepam (Klonopin).   On 15th March 2022, the patient received the 1st dose of Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. In March 2022, less than a week after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced numbness in feet and tingling sensation. On an unknown date, the outcome of the numbness in feet and tingling sensation were not recovered/not resolved.   It was unknown if the reporter considered the numbness in feet and tingling sensation to be related to Boostrix and Boostrix Pre-Filled Syringe Device. 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 caller was a patient self. The patient takes Klonopin for anxiety, and he was pre diabetic. The patient received the Boostrix vaccine on 15th March, 2022 from the pharmacy at his deltoid area of his left arm. The patient stated that, since receiving the vaccine he had experienced numbness and a tingling sensation in his right foot. The patient inquired if that was normal and was provided with the medical advice disclaimer and spoke from Package Insert. The patient was  referred to Health care Professional and was offered number to Medical Information for caller to provide to Health care Professional. Health care Professional details were provided. No additional details were provided by the reporter. The patient consented to follow up and provided permission to contact his Health care Professional.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Only 1st dose was administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 19th June 2021, Lot number: k2c04, Expiry date: 11 November 2022).   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 reported as follows: The age at vaccination was not applicable. Till the time of reporting the patient had not received her 2nd dose, which led to incomplete course of vaccination. The patient was late for the second dose of Shingrix as only the first dose was administered. No adverse event was reported.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: received Shingrix stored in the freezer. Pt is immunocompromised; This case was reported by a nurse via call center representative and described the occurrence of product storage error in a adult female patient who received Herpes zoster (Shingrix) (batch number XX474, expiry date 26th June 2023) for prophylaxis.   Concurrent medical conditions included immunocompromised (patient was immunocompromised).   On 17th March 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product storage error. On an unknown date, the outcome of the product storage error was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccination which was accidentally stored in the freezer for 4 to 5 hours at negative 19.3 Degree F, which led to product storage error. The reporter gave consent to follow up.
Age: 24.0
Sex: M
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 concerned a 24 year old male . 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 administration was not reported, batch number: 1808609 and expiry: 06-DEC-2021) dose was not reported, 01 total was administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms of Covid-19 (suspected covid-19 infection) and had suspected clinical vaccination failure. 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 the Regulatory Authority: 90000222232.; Sender's Comments: V0: 20220334117-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: Vaccination site pain
Clinical narrative: SORE INJECTION SITE FOR A COUPLE OF DAYS; This spontaneous report received from a consumer (wife) via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had not contracted Covid19. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection and route of administration was not reported and batch number: unknown, expiry: unknown) dose was not reported, dose number in series 1, 01 total was administered on an unspecified date in JUN-2021 for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, he had mild sniffle between the two shots (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection and route of administration was not reported and batch number: unknown, expiry: unknown) dose was not reported, dose number in series 2, 01 total was administered on an unspecified date in JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medication included influenza vaccine for prophylactic vaccination. It was reported that he obtained flu shots each year. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient had sore injection site for a couple of days (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore injection site for a couple of days. This report was non-serious. This case, involving the same patient is linked to 20220341258. This case, from the same reporter is linked to 20220336438.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Rhinorrhoea
Clinical narrative: ONLY HAD ONE DAY OF BEING LETHARGIC FROM THE FIRST SHOT; MILD SNIFFLE; 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 previously received influenza vaccine (Flu shot) for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient experienced lethargic for 1 day from the first shot (Dose number in series 1). Patient had never contracted Covid 19. Patient worked at an ammo assembly manufacturing plant. Patient's employers did not have any type of shutdown due to Covid. Patient continued to go out in public with social distancing and masks if the business required them. Patient continued short trips on days off. Patient reported, between the two shots, she had only mild sniffle during this entire pandemic (Dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on JAN-2022 for prophylactic vaccination.  Patient did not experience any adverse event after booster vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from only had one day of being lethargic from the first shot, and the outcome of mild sniffle was not reported. This report was non-serious. This case, from the same reporter is linked to 20220336317.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Thrombosis with thrombocytopenia syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; This spontaneous report was received from literature: concerned a multiple patients (around 143 with guillain barre syndrome and about 3.2 with vaccine induced immune thrombotic thrombocytopenia) of unspecified race and ethnicity. The objective of this study was to describe COVID-19 Variants and Vaccine Benefits-Risks Balance. 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, 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 experienced guillain barre syndrome and vaccine induced immune thrombotic thrombocytopenia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the guillain barre syndrome and vaccine induced immune thrombotic thrombocytopenia was not reported. In summary, currently, vaccination is considered as the best strategy to protect people from COVID-19 and prevent severe illness and death. There are few proved vaccine mild side effects and the possibility of very rare serious events of coagulopathy. However, vaccines have proved efficacious and safe and hopefully, be able to eradicate the devastating COVID19 pandemic. Nevertheless, rapidly progressing updates of the era of COVID-19 pandemic are being continuously monitored. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220336932-Covid-19 vaccine ad26.CoV-2.s- Guillain barre syndrome, vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Colitis, Feeding disorder, Weight, Weight decreased
Clinical narrative: UNABLE TO EAT; LOST 20 POUNDS WEIGHT; HAIR LOSS; FELT LIKE COLITIS; This spontaneous report received from a patient concerned a 65 year old female of unspecified race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with 2 doses of covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered 1 total on 09-MAR-2021, and the second dose was administered on an unspecified date, for prophylactic vaccination which is an off label use, and inappropriate schedule of vaccine administered (Dose number in series was 1).  On SEP-2021, the patient experienced covid-19 infection (diarrhea and vomiting). On an unspecified date, the patient experienced unable to eat, lost 20 pounds weight, hair loss, and felt like colitis occurred shortly after vaccine injection (Dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, administered 1 in total on 15-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced unable to eat, lost 20 pounds weight, hair loss, and felt like colitis occurred shortly after vaccine injection (Dose number in series was 2). Laboratory data (dates unspecified) included: Weight (NR: not provided) lost 20 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the unable to eat, lost 20 pounds weight, hair loss and felt like colitis was not reported. This report was non-serious. This case, involving the same patient is linked to 20220335284.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood testosterone, Blood testosterone increased, Menstruation irregular
Clinical narrative: HIGH TESTOSTERONE LEVELS; IRREGULAR PERIODS; This spontaneous report received from a parent concerned an 18 year old The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on left arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced irregular periods within two months after receiving the vaccine (Dose number in series 1). The patient received booster dose of non-company suspect Moderna vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered in OCT-2021 (after 6 months of J and J vaccine) for prophylactic vaccination.  On 01-DEC-2021, the patient experienced high testosterone levels. Lab test reported unusually high testosterone levels (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from irregular periods, and high testosterone levels. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: MILD SNIFFLE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had never contracted covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included influenza vaccine for prophylactic vaccination. On an unspecified date, the patient experienced mild sniffle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild sniffle was not reported. This report was non-serious. This case, involving the same patient is linked to 20220336317. This case, from the same reporter is linked to 20220336438.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: BAD REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the patient experienced bad reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction to the vaccine was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: JOINT PAIN; This spontaneous report received from a consumer concerned a 54 year old female. 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 (dose number in series 1), (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered on an unspecified date in MAR-2021 for prophylactic vaccination. On an unspecified date after vaccination, the patient was tired (dose number in series 1). The patient received booster of covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination in DEC-2021, the patient experienced joint pain (dose number in series 2). The patient had not contacted her doctor about her adverse effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20220341319 (dose number in series 1).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: FEVER 101F; RUNNY NOSE, THICK DISCHARGE FROM NOSE; SORE THROAT; COUGH; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 10-JUL-2022) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2022, the patient experienced runny nose, thick discharge from nose, sore throat, and cough. On 21-MAR-2022, the patient experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F, and COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose, thick discharge from nose, sore throat, cough, and fever 101f. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: FEVER 101F; RUNNY NOSE, THICK DISCHARGE FROM NOSE; SORE THROAT; COUGH; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 10-JUL-2022) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2022, the patient experienced runny nose, thick discharge from nose, sore throat, and cough. On 21-MAR-2022, the patient experienced fever 101f. Laboratory data included: Body temperature (NR: not provided) 101 F, and COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from runny nose, thick discharge from nose, sore throat, cough, and fever 101f. This report was non-serious.