chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had vaccine and still got shingles/Suspected vaccination failure; Still got shingles, eight weeks now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In December 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine and still got shingles, eight weeks now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Partial event onset date was captured based upon reported information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot but still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 years after receiving 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.     Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: This case was reported by a patient's child via interactive digital media. The patient got the Shingles shot but still got shingles might be 5 years later. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: More prominent,severe flu like reactions; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt date: 03-Feb-2023. Reporter's Comment: The pharmacist for a retail pharmacy chain mentioned that she would get reports about a cluster of patients who had more severe flu like reaction after getting vaccinated with Shingrix.  She wondered if it was specific to a certain lot because the reports always seem to come in clusters. She did not have any details but said she would keep track in the future and report specifics in the future. The reporter said there was a cluster of patients, in probing her she said she thought it was 2-4 patients who reported more severe flu like reactions (more severe than she normally heard from patients). The reporter did not have specific patients to share, but she knew that all the patients were older than 50 years of age (approved age for Shingrix), but she did not have specifics ages. The reporter did not consent to follow up. Additional Supportive Information: The case is linked with case US2023AMR018990, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR018990:Same reporter.
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.     On an unknown date, the patient received the 2nd dose of Shingrix and COVID-19 BOOSTER. On an unknown date, more than 2 years 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 Information: tareceipt date: 3-Feb-2023 Reporter's comment: The patient received the 2nd dose of Shingrix vaccine in 2019 just before COVID began. The patient had second occurrence of Shingles in 2022, 1 year later receiving a COVID booster. The reporter clarified to be sure that it was Shingrix (not Zostavax) that the patient received and whether he had previously reported it. It was definitely Shingrix, he said, and commented that it was never reported.  The reporter was happy for it to be reported and willing to provide any additional information, should any be needed.  The reporter commented that 3 independent seasoned clinicians confirmed the diagnosis to be shingles as he was very much an advocate of Shingrix (and still was) for his patients.  The reporter was surprised at the reoccurrences but believe them both to be true, fairly mild cases of shingles. Lots numbers were not available but the information was complete, per the form. The reporter consented to follow-up. Additional supportive information: It was unknown if the reporter considered the shingles to be related to Covid-19 booster. As 1 year later Covid-19 booster the patient had second occurrence of shingles therefore Covid-19 booster was coded as suspect in this case.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Insomnia, Pain, Pyrexia
Clinical narrative: Extreme weakness; Feverish; Lots of aches and pains; Some dizziness; Severe SE reaction, could not sleep; This case was reported by a consumer and described the occurrence of difficulty sleeping in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2020).   On 28th January 2023, the patient received the 1st dose of Shingles vaccine. In January 2023, less than a week after receiving Shingles vaccine, the patient experienced difficulty sleeping and dizziness. On an unknown date, the patient experienced weakness, fever and pain. On an unknown date, the outcome of the difficulty sleeping and dizziness were recovered/resolved and the outcome of the weakness, fever and pain were unknown.   It was unknown if the reporter considered the difficulty sleeping, weakness, fever, pain and dizziness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 03-FEB-2023 Reporter Comment: The reporter reported that, the patient had the 1st dose shingles vaccine and had a severed side effects reaction to it. The patient could not sleep the first 3 days.  The patient felt extreme weakness and feverish. lots of aches and pains. Some dizziness occurred the first 2 days. The patient had shingles in 2020. The patient wondering if getting the next vaccine will be similar, or worse, is it safe to get the 2nd dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot on 06May2022, too late to get 2nd; This case was reported by a consumer via call center representative 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 on 6th May 2022).   On an unknown date, the patient did not receive 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: GSK Receipt Date: 3-Feb-2023  Reporter's comment: The patient stated that he/she had difficulty in getting the information even after requesting it several times. The patient wanted to know if it was too late to get the second dose and how he/she should handle it.  The patient did not want to get 3 shots. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 10 months since 1st vaccine, should I start over; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose 10 months prior to the reporting date).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 3-Feb-2023 Reporter's comment: The patient asked that what if it had been 10 months since his/her first Shingrix vaccine, he/she should start over with the first one again. The patient was asking for someone else and just want a direction. The representative stated that please note that GlaxoSmithKline had not done any studies on the Shingrix second dose beyond six months from the first dose. However, center of drug control and prevention (CDC) had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients did not need to restart the vaccine series. If your second Shingrix vaccine was later than six months after receiving the first Shingrix vaccine, please consult with your healthcare provider about guidance and your individual situation. Because patient care was individualized, a healthcare provider should always be consulted to evaluate your health and provide guidance to you based on your medical history. They as a pharmaceutical manufacturer, did not provide medical advice or guidance. If your healthcare provider needs additional information about their medications, they may contact the GlaxoSmithKline medical information department. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, 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: Feeling abnormal, Pain, Pain in extremity, Product storage error, Pyrexia
Clinical narrative: Felt lousy; Intense arm pain; Aches; Possible fever,; 2nd shot may have been compromised due to temperature issues; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose was received on 15 June 2022 and she also had experienced pain and fever, kindly refer this case - US2023AMR018964) and Covid vaccine with an associated reaction of pain in extremity. Additional patient notes included Shingles does not run in her family.   On 24th October 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad, pain in arm, pain, fever and incorrect storage of drug. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling bad, pain in arm, pain, fever and incorrect storage of drug were unknown.   It was unknown if the reporter considered the feeling bad, pain in arm, pain and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR018964   Additional Information: GSK Receipt Date: 03-FEB-2023 and 06-FEB-2023 Reporter's comments: The reporter had stated that, she had received two doses of the shingles vaccine. With both shots, she experienced significant side effects as intense arm pain, aches and a possible fever. The side effects for the second shot were a little worse than the first.  A month or so ago she was notified that her second shot might had been compromised due to temperature issues. They had advised her to take a third shot and were not interested in addressing her questions/concerns. She had asked, if it does the presence of virtually identical side effects indicated that there was a good chance, if the second shot was effective. She had asked, if it was it too late to take another shot.  She had asked that, was it safe to take a third shot and If she were to take it, then could she expect better, same or worse side effects. She said that, she never took her temperature to confirm if she had a fever, but she just felt lousy. She said the arm pain from Shingrix was not a big deal. She mentioned that she had experienced a sore arm when she had gotten a Covid vaccine. The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023018204, which was reported by same reporter. The reporter was notified that her second shot might had been compromised due to temperature issues, which le to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023AMR018964:Same reporter US-GSK-US2023018204:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: Intense arm pain; Aches; Possible fever, not confirmed; Felt lousy; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID vaccine with an associated reaction of pain in extremity (experienced a sore arm when she had gotten a Covid vaccine).   On 15th June 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, pain, fever and feeling bad. On an unknown date, the outcome of the pain in arm, pain, fever and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm, pain, fever and feeling bad to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2023AMR018960   Additional Information: GSK Receipt Date: 03-FEB-2023 and 06-FEB-2023 Reporter's Comments: The case was self reported by the patient. The reporter reported that shingles did not run in her family. The patient received first dose of Shingles vaccine an experienced significant side effects as intense arm pain, aches and a possible fever. The patient asked did the presence of virtually identical side effects indicate that there was a good chance the second shot was effective. The patient asked was it toll late to take another shot, was it safe to take a third shot, if she were to take it could she expect better, same or worse side effects. The patient indicated that her Shingrix side effects were bad, but not horrible. The patient had been warned that Shingrix could cause side effects and said that she never took her temperature to confirm if she had a fever, but she just felt lousy. The patient reported that the arm pain from Shingrix was not big deal. Additional Supportive Information: For tolerance of 2nd dose, refer case US2023AMR018960. This case was linked with US2023018204 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR018960:Same reporter US-GSK-US2023018204:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like reactions, less severe flu like symptoms; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   The reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt date: 03-Feb-2023. Reporter's Comment: The health care provider was a regional pharmacy leader and handles adverse reactions from many pharmacy retails stores. The reporter for a retail pharmacy chain mentioned that she would get reports about a cluster of patients who had more severe flu like reaction after getting vaccinated with Shingrix.  She wondered if it was specific to a certain lot because the reports always seem to come in clusters. She did not have any details but said she would keep track in the future and report specifics in the future. The reporter said there was a cluster of patients, in probing her she said she thought it was 2 to 4 patients who reported more severe flu like reactions (more severe than she normally hears from patients). The reporter did not have specific patients to share, but she knew that all the patients were older than 50 years of age (approved age for Shingrix), but she did not have specifics ages. The reporter did not consent to follow up. Additional Supportive Information: The case is linked with case US2023017292, reported by same reporter.; Sender's Comments:  US-GSK-US2023017292:Same reporter.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix 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 Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/ source case
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body pain; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th February 2023, the patient received the 2nd dose of Shingles vaccine. On 8th February 2023, 1 days after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 08-Feb-2023. Reporter's Comment: This case was reported by patient via interactive digital media. Patient stated that he/she had body pain. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Ear discomfort, Feeling abnormal, Skin warm
Clinical narrative: Skin really hot to the touch, still warm, hot today; Was pretty bad, felt like he needed to stretch; Ears are burning; This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2023, the patient received the 2nd dose of Shingrix (intramuscular). In February 2023, less than a day after receiving Shingrix, the patient experienced skin warm, feeling bad and burning sensation. The patient was treated with ibuprofen. On an unknown date, the outcome of the skin warm, feeling bad and burning sensation were recovering/resolving.   The reporter considered the skin warm, feeling bad and burning sensation to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The case was self reported by the patient but there were two reporters. The patient and his fiancee were both on the line.  The patient received second dose of Shingrix yesterday (the day before reporting) into right deltoid and his skin got really hot to touch and it was still warm now and last night it was pretty bad and the patient felt like he needed to stretch. They did not take his temperature to see if he had a fever but he did take Ibuprofen and warm skin involved his whole body and he was still hot today but not like last night and his ears were burning because they were hot and the patient was getting better today. The reporter did not have the lot number of the administered vaccine. The reporter consented to follow up. Additional Supportive Information: Event outcome for all event was captured as recovering conservatively as per the last sentence from the narrative and event causality captured as yes.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 8 YO received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd February 2023, unknown after receiving Kinrix and Kinrix 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 Information: Gsk receipt date: 3-Feb-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Kinrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Injection site pain
Clinical narrative: pain upper left chest area, chest is sore; hard to take deep breath; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2023, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st January 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On 1st February 2023, the patient experienced chest pain and difficulty breathing. On an unknown date, the outcome of the injection site pain, chest pain and difficulty breathing were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, chest pain and difficulty breathing to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The reporter was the patient/RN (Registered nurse ). The reporter reported adverse reactions after receiving her Shingrix in the left arm.  The reporter reported pain at the injection site and pain in the upper left chest area (at the bra line).  The reporter reported it was hard to take a deep breath because the chest was sore. The reporter did not give permission to contact healthcare professional because she did not have the healthcare professional name and phone number with her. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both doses in 2018, then Shingles in 2022/ Suspected vaccination failure; Shingles outbreak, currently has shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2018, the patient received the 2nd dose of Shingrix. On 28th May 2018, the patient received the 1st dose of Shingrix. In September 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The patient was self-reported this case The patient reported that she received both the doses of Shingrix vaccine in 2018. The reporter stated that after received Shingrix vaccine in September 2022 she experienced an outbreak of shingles and also currently had a case of shingles. The reporter did consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2018, 2nd 30Jan2023; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number XY225, expiry date 27th May 2024) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix in 2018).   On 30th January 2023, the patient received the 2nd dose of Shingrix. On 30th January 2023, 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 Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter consented to follow up.  Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The case had been linked to US2023019041, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023019041:Same reporter / female Case
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Forgot to get dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2022).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter was a patients husband. The reporter reported that his wife received 1st dose of Shingrix vaccine in January 2022. The reporter stated that he does not know the exact date or location site of injection. The reporter stated that they moved and forgot to get the second dose The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2023019046 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023019046:Same reporter.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 28-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The nurse reported that a patient received an expired dose of Havrix. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old female patient who received HAV (Havrix) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 7th February 2023, the patient received Havrix. On 7th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The medical assistant called to ask for information regarding the administration of an expired dose of Havrix to a patient.  The Vaccine was administered on 7th Feb 2023. The reporter asked how to proceed with this patient. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Shingrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number C3455, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (first dose was received on 3rd November 2022).   On 6th February 2023, the patient received the 2nd dose of Shingrix. On 6th February 2023, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-Feb-2023 Reporter comment: The nurse reported that the patient was administered a dose of Shingrix vaccine, which had an expiration date of 3rd February 2023. At the time of reporting, dose had not been repeated.  The reporter consented to follow up.  Additional supportive information: The patient was received an expired second dose of Shingrix, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Product availability issue, Rhinorrhoea
Clinical narrative: RHINORRHEA; PRODUCT AVAILABILITY ISSUE; This spontaneous report received from a health care professional concerned a 74 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rhinorrhea, and product availability issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rhinorrhea and product availability issue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Schizophrenia
Clinical narrative: schizophrenia; cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) and SCHIZOPHRENIA (schizophrenia) in an adult male patient who received TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form at an unspecified frequency. In August 2022, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SCHIZOPHRENIA (schizophrenia) (seriousness criterion medically significant). The patient died in August 2022. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, SCHIZOPHRENIA (schizophrenia) outcome was unknown.            No concomitant medication information was reported. It was reported that, patient died of a cardiac arrest ,on the streets, some time in Aug 2022. No treatment medication information was reported. It was reported that a few weeks ago and one of the things she had mentioned during that call was that her son died this past summer, but she stated it had nothing to do with the Moderna COVID-19 vaccine. In fact, her son had received the Pfizer vaccine and was living in another state at the time of vaccination. He was living with her when he had the cardiac arrest and she again claims that it had nothing at all to do with any vaccines. Now, she is getting emails with Moderna thinking that the cardiac arrest was caused by the Moderna vaccine when her son didn't even receive the Moderna COVID-19 vaccine.    This case was linked to US-MODERNATX, INC.-MOD-2023-704428, US-MODERNATX, INC.-MOD-2023-704425 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2023: Significant follow up information included patients demographics (date of birth) and narrative updated. Patient did not receive Moderna suspect hence case classification changed into tracking only.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704425:Husband case US-MODERNATX, INC.-MOD-2023-704428:Wife case; Reported Cause(s) of Death: cardiac arrest
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nasopharyngitis, Pyrexia
Clinical narrative: cold; felt dizzy for short period; chills; Felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), DIZZINESS (felt dizzy for short period), CHILLS (chills) and PYREXIA (Felt feverish) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (aspirin).   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), DIZZINESS (felt dizzy for short period), CHILLS (chills) and PYREXIA (Felt feverish). At the time of the report, NASOPHARYNGITIS (cold), DIZZINESS (felt dizzy for short period), CHILLS (chills) and PYREXIA (Felt feverish) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  It was reported that after 2nd primary dose felt dizzy for short period, vaccine was taken March 13,2021. Felt feverish/cold chills after taking booster shots, boosters were take November 13, 2021; August 10, 2022; and September 10 2022.   This case was linked to (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 21-Dec-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    Concomitant and treatment medications were not reported.  Company comment: This spontaneous case concerns a 49-year-old, female patient with maternal exposure during pregnancy with no relevant reported medical history, who experienced the unexpected non-serious event of Maternal exposure during pregnancy with No adverse event that occurred in context to the administration of third dose of mRNA-1273 bivalent BA.4-5 vaccine. Last menstrual period and estimated date of delivery were not provided. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, and treatment received were available for review. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 bivalent BA.1 vaccine is not affected by this report.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: Wrong vaccine administured; No adverse event; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), WRONG PRODUCT ADMINISTERED (Wrong vaccine administured) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong vaccine administured) and NO ADVERSE EVENT (No adverse event). On 02-Dec-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong vaccine administured) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and WRONG PRODUCT ADMINISTERED (Wrong vaccine administured).    Concomitant and treatment medications were not reported.  Company Comment: This spontaneous case concerns a 48-year-old female patient with no medical history reported, who experienced non serious unexpected Maternal exposure during pregnancy with No adverse event that occurred in association with second dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine. Additionally, Wrong product administered was also noted as non- serious unexpected event. No further details on Last menstrual period/Expected date of delivery, gestation period, lab test results were available. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.      Reporter did not allow further contact
Age: 42.0
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 42-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid vaccine. Past adverse reactions to the above products included No adverse reaction with Pfizer Covid vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported.  The patient was a nurse. The patient had the Pneumococcal 20 vaccine Prevnar 20 last Wednesday and today as reported woke up and the injection site has little bit of blotchiness with some small bump like almost like a little tiny rash and was wondering if it seemed like the red injection site dermatitis type thing with this vaccine. Patient did have this with Moderna COVID Vaccine and had that like COVID arm but  did not had it with the Pfizer version of the COVID vaccine. It was a week out from that, so patient was thinking something more like a delayed reaction.  No treatment products reported.   Reporter did not allow further contact
Age: 59.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs) and NO ADVERSE EVENT (no adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs).    No concomitant medications were reported.   It was reported that the dose was drawn up in a syringe on 06-Feb-2023 and was administered on 07-Feb-2023.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709074 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709074:(same reporter)