chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Fatigue, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Big lump at injection site; Injectiion site itchy; Injection site sore; warm too touch at injection site; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site lump in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site lump (Verbatim: Big lump at injection site), injection site itching (Verbatim: Injectiion site itchy), injection site pain (Verbatim: Injection site sore), injection site warmth (Verbatim: warm too touch at injection site) and tiredness (Verbatim: tiredness). The outcome of the injection site lump, injection site itching, injection site pain, injection site warmth and tiredness were not reported.   It was unknown if the reporter considered the injection site lump, injection site itching, injection site pain, injection site warmth and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site lump, injection site itching, injection site pain, injection site warmth and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had a big lump at injection site, warm too touch, sore, itchy, tiredness.  Might be it was not right. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: got shingles shots, and even though arm gets so sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of pain in extremity (received dose on an unknown date, for tolerance refer linked case US2024AMR038200).   On an unknown date, the in an unspecified number of patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: got shingles shots, and even though arm gets so sore). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR038200   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a reporter via interactive digital media. The reporter stated that they (reporter himself/ herself and unspecified number of patients) got their Shingles shots and even though their arm gets so sore and that lasted about 3 days for each dose, it was nowhere as bad as the pain from shingles and reporter suggested to get the shots. This case had been linked to the cases US2024AMR038177 and US2024AMR032141 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR038200:same reporter, unspecifoed patient with initial unspecified dose US-GSK-US2024AMR032141:same reporter, different patient US-GSK-US2024AMR038177:Same reporter, different patient US-GSK-US2024AMR032141:same reporter, different patient
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced fatigue (Verbatim: fatigue). The outcome of the fatigue was not resolved.   It was unknown if the reporter considered the fatigue to be related to Arexvy.     It was unknown if the company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient reported that he was experienced diabetic fatigue day after shot nonstop since rising in AM.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Rash, Rash papular
Clinical narrative: raised rash between her clavicle up towards the chin; The pain was unbearable all over my body; This non-serious case was reported by a consumer via call center representative and described the occurrence of raised rash in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In DEC-2023, the patient received Arexvy (intramuscular, right deltoid). In DEC-2023, 12 hrs after receiving Arexvy, the patient experienced raised rash (Verbatim: raised rash between her clavicle up towards the chin) and general body pain (Verbatim: The pain was unbearable all over my body). The patient was treated with acrivastine (Benadryl). In DEC-2023, the outcome of the raised rash and general body pain were resolved.   It was unknown if the reporter considered the raised rash and general body pain to be related to Arexvy.     It was unknown if the company considered the raised rash and general body pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-MAR-2024 and 19-MAR-2024 The reporter was the patient that received her Arexvy vaccine. The reporter was unsure of exact date.  The reporter stated that within 12 hours of receiving the vaccine she developed a raised rash between her clavicle up towards the chin. Reporter stated no itchiness was associated with this reaction. However, reporter stated that the pain was unbearable all over her body. The reporter stated she did take some Benadryl and the symptoms completely subsided within 24 hours.  The reporter stated she had not talked to her healthcare professional but intended to call him at the time of reporting, no information given for the healthcare physician. The reporter was a very understanding and interested in everything she had to say and took some care in making notes about the reaction she had to a vaccine and she just appreciated it that she took it seriously The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received one Hep A vaccine but did not complete the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: patient received one Hep A vaccine but did not complete the series). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-MAR-2024 The pharmacist reported that the male patient received one Hep A vaccine  but did not complete the series, which led to incomplete course of vaccination. The reported that there is no vaccination history for the patient. The pharmacist stated that he/she chose Havrix PFS only because I had to choose an option. The reporter did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose was meant to be taken on March 11th but she hasn't taken the dose yet; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: second dose was meant to be taken on March 11th but she hasn't taken the dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAR-2024 The reporter reported that a patient that took the accelerated Twinrix schedule, her second dose was meant to be taken on 11th March but she had not taken the dose yet which led to incomplete course of vaccination. The patient only received the first dose. The doctor called because he wanted to know if she could still take the dose or needed to have the full schedule again.  Batch number and expiration date not available since first dose was not taken at the facility. The Vaccine Administration Facility was the same as Primary reporter. Consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received 2 Shingrix vaccines on the same day; Wrong vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number B2M9E, expiry date 10-FEB-2026) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 11-JAN-2024, the patient received the 2nd dose of Shingrix (unknown arm). On 11-JAN-2024, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: patient received 2 Shingrix vaccines on the same day) and wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the overdose and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-MAR-2024 The registered pharmacist mentioned that a patient received two doses of Shingrix vaccine on the same day, which led to overdose. The patient was supposed to get dose 1 Shingrix in one arm and another vaccine in the other arm (the pharmacist did not said which one), which led to wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who had 1st Shingrix vaccines greater than 6 months ago; This non-serious case was reported by a pharmacist 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 greater than 6 months ago, from the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who had 1st Shingrix vaccines greater than 6 months ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2024 The pharmacist reported that she was unsure if this was an actual adverse event or not, she had to check but she might had a patient who had 1st Shingrix vaccine greater than 6 months ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient was given a third dose of SHINGRIX in left arm on 21Feb2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TA92, expiry date 29-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-FEB-2024, the patient received the 3rd dose of Shingrix (left arm). On 21-FEB-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient was given a third dose of SHINGRIX in left arm on 21Feb2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 22-MAR-2024 It was reported that a patient was given a third dose of Shingrix which led to extra dose administered. It was given 5 weeks after dose 2. This case is linked with US2024AMR037689, same reporter.; Sender's Comments:  US-GSK-US2024AMR037689:same reporter ,different patient
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient the second Shingrix dose at less time than recommended; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number MG5EJ, expiry date 24-JAN-2026) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: a patient the second Shingrix dose at less time than recommended). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 22-MAR-2024 Pharmacists called and wanted to know if there was information on giving a patient the second Shingrix dose at less time than recommended, the patient received Shingrix second dose with 12 days apart. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: arm pain; soreness; redness; IM injection potentially administered under deltoid muscle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) (batch number 2P5E9, expiry date 18-APR-2026) for prophylaxis.   On 11-MAR-2024, the patient received the 1st dose of Shingrix. On 11-MAR-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: IM injection potentially administered under deltoid muscle). On an unknown date, the patient experienced pain in arm (Verbatim: arm pain), pain (Verbatim: soreness) and erythema (Verbatim: redness). The outcome of the pain in arm, pain, erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm, pain and erythema to be related to Shingrix.     It was unknown if the company considered the pain in arm, pain and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2024 Pharmacist received a called from a patient who was also a nurse over 50 years old, who reported that after Shingrix she got arm pain, soreness and redness.  The patient believes that the vaccine was not administered into her deltoid muscle but was injected below this muscle which led to intramuscular formulation administered by other route. The reporter did not consent to follow-up.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: staff member accidentally administered an expired dose of 20mcg Engerix-B to a patient today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number K9HS5, expiry date 18-MAR-2024) for prophylaxis.   On 22-MAR-2024, the patient received Engerix B 20 ug. On 22-MAR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: staff member accidentally administered an expired dose of 20mcg Engerix-B to a patient today). 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: 22-MAR-2024 Nurse stated an office staff member accidentally administered an expired dose of 20 mcg Engerix-B to a patient today (on the day of reporting) which led to expired vaccine used. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not received 2nd dose till time of contacting; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received only one dose of Twinrix (batch number 2PG39) back on 13th October 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not received 2nd dose till time of contacting). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAR-2024 Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative
Clinical narrative: her antibody of Shingrix was low; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date 20-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number LG2XJ, expiry date 20-SEP-2023) for prophylaxis.   On 10-JAN-2023, the patient received the 2nd dose of Shingrix. On 10-JUL-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced therapeutic response decreased (Verbatim: her antibody of Shingrix was low). The outcome of the therapeutic response decreased was unknown.   Additional Information: GSK Receipt Date: 22-MAR-2024 The reporter called to know if it was possible to give a third dose of Shingrix because a patient had a first and second dose and her doctor said her antibody of Shingrix was low, so he recommended a third dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Cardiac arrest, Condition aggravated, Dizziness, Heart rate increased
Clinical narrative: Cardiac arrest; Heart Arrhythmia /experienced heart pauses every 5 minutes (very bad); Rapid pulse; feel like she was about to pass out; Flu like symptoms; soreness; This serious case was reported by a pharmacist via call center representative and described the occurrence of cardiac arrest in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   Concurrent medical conditions included cardiac arrest and cardiac ablation (Patient with history of cardiac arrest, got heart ablation in the past).   On 21-MAR-2024, the patient received the 1st dose of Shingrix. On 21-MAR-2024, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: soreness). On 22-MAR-2024, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). On 23-MAR-2024, the patient experienced cardiac arrest (Verbatim: Cardiac arrest) (serious criteria GSK medically significant), cardiac arrhythmia (Verbatim: Heart Arrhythmia /experienced heart pauses every 5 minutes (very bad)) (serious criteria GSK medically significant), pulse rapid (Verbatim: Rapid pulse) and felt faint (Verbatim: feel like she was about to pass out). The outcome of the cardiac arrest, pulse rapid, influenza-like symptoms, felt faint and pain were resolving and the outcome of the cardiac arrhythmia was not resolved.   It was unknown if the reporter considered the cardiac arrest, cardiac arrhythmia, pulse rapid, influenza-like symptoms, felt faint and pain to be related to Shingrix.   It was unknown if the company considered the cardiac arrest, cardiac arrhythmia, pulse rapid, influenza-like symptoms, felt faint and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-Mar-2024 The patient had history of heart pauses and had heart ablation procedure, which resolved this prior issue. The patient recently received the Shingles vaccine, the pharmacist believed it was the first dose and then she called the pharmacist concern with symptoms of heart process, that had increased in frequency. First started on Thursday. Thursday was the date she got the shot, Friday she had flue like symptoms and on Saturday she had this heart process almost around every 5 minutes that make her feel like she was about to pass out. She did mention that she had a history of getting a heart ablation because of the heart process. Did not known if symptoms continued.  She had that sensation where she was going to pass out but not after the ablation. The reporter followed up with patient, who reported experiencing heart arrhythmia (heart pauses specifically) She had reported significant improvement but was currently still experiencing these heart pauses, but sporadic in nature and could not determine frequency. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Cardiac arrest; Heart Arrhythmia /experienced heart pauses every 5 minutes (very bad); Rapid pulse; feel like she was about to pass out; Flu like symptoms; soreness; This serious case was reported by a pharmacist via call center representative and described the occurrence of cardiac arrest in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   Concurrent medical conditions included cardiac arrest and cardiac ablation (Patient with history of cardiac arrest, got heart ablation in the past).   On 21-MAR-2024, the patient received the 1st dose of Shingrix. On 21-MAR-2024, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: soreness). On 22-MAR-2024, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). On 23-MAR-2024, the patient experienced cardiac arrest (Verbatim: Cardiac arrest) (serious criteria GSK medically significant), cardiac arrhythmia (Verbatim: Heart Arrhythmia /experienced heart pauses every 5 minutes (very bad)) (serious criteria GSK medically significant), pulse rapid (Verbatim: Rapid pulse) and felt faint (Verbatim: feel like she was about to pass out). The outcome of the cardiac arrest, pulse rapid, influenza-like symptoms, felt faint and pain were resolving and the outcome of the cardiac arrhythmia was not resolved.   It was unknown if the reporter considered the cardiac arrest, cardiac arrhythmia, pulse rapid, influenza-like symptoms, felt faint and pain to be related to Shingrix.   It was unknown if the company considered the cardiac arrest, cardiac arrhythmia, pulse rapid, influenza-like symptoms, felt faint and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-Mar-2024 The patient had history of heart pauses and had heart ablation procedure, which resolved this prior issue. The patient recently received the Shingles vaccine, the pharmacist believed it was the first dose and then she called the pharmacist concern with symptoms of heart process, that had increased in frequency. First started on Thursday. Thursday was the date she got the shot, Friday she had flue like symptoms and on Saturday she had this heart process almost around every 5 minutes that make her feel like she was about to pass out. She did mention that she had a history of getting a heart ablation because of the heart process. Did not known if symptoms continued.  She had that sensation where she was going to pass out but not after the ablation. The reporter followed up with patient, who reported experiencing heart arrhythmia (heart pauses specifically) She had reported significant improvement but was currently still experiencing these heart pauses, but sporadic in nature and could not determine frequency. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I experienced hives after 3 days of receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (I experienced hives after 3 days of receiving the vaccine) in a 43-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna vaccine (Dose 1) on 31-Mar-2021, Moderna vaccine (Dose 2) on 14-Aug-2021 and Moderna vaccine (Dose 3) on 20-Sep-2021. Past adverse reactions to the above products included No adverse event with Moderna vaccine, Moderna vaccine and Moderna vaccine.    On 01-Nov-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 04-Nov-2022,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced URTICARIA (I experienced hives after 3 days of receiving the vaccine). At the time of the report, URTICARIA (I experienced hives after 3 days of receiving the vaccine) had resolved.            No concomitant medications were reported. Patient experienced hives after 3 days of receiving the vaccine. Patient continued to experience hives for 3-4 weeks in various degrees of severity. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-764150 (Patient Link).
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 14 year old son died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (14 year old son died) in a 14-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medication was not reported by reporter.  Dosage text for suspect product was reported as unknown. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728478 (E2B Linked Report).   Reporter did not allow further contact  Company comment: This spontaneous case concerns a 14-year-old, male patient with no medical history information reported, who experienced the unexpected serious fatal (death and medically significant) event of death. Death occurred on an unknown date (reported as 1-JAN-1990 implausible date) The cause of death was not reported. It is unknown if an autopsy was performed. Temporal relationship to a dose of Spikevax NOS is unclear. It was also reported that patient experienced no adverse event. No further information about the events was provided. Considering very limited information available causal association with a dose of Spikevax could not be established and the event is considered as not related. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728478:Same reporter different patient; Reported Cause(s) of Death: Unknown cause of death
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I experienced hives after 3 days of receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (I experienced hives after 3 days of receiving the vaccine) in a 44-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (2nd dose) on 14-Aug-2021, Moderna (3rd  dose) on 20-Sep-2021 and Moderna (1st dose) on 31-Mar-2022. Past adverse reactions to the above products included No adverse event with Moderna, Moderna and Moderna.    On 06-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 09-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URTICARIA (I experienced hives after 3 days of receiving the vaccine). On 08-Nov-2023, URTICARIA (I experienced hives after 3 days of receiving the vaccine) had resolved.            No Concomitant medications provided by the reporter. Patient another booster dose received on 1-Nov-2022. It has been reported that patient continued to experience hives for 3-4 weeks in various degrees of severity. No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-764310 (Patient Link).
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report, with RA Case ID number: was received by a partner on 05-DEC-2023 and forwarded to RA on 06-DEC-2023, from a HCP in the (PRIVACY).   This case was considered non-valid as no patient identifiers were provided.   Due to the nature of the event, the causality between the event " The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   Further information is expected.  Follow-up information was received by the partner on 06-DEC-2023 and forwarded to RA on 06-DEC-2023, from a HCP in the (PRIVACY). The case is maintained as non-serious and non-valid (no patient identifiers)  Due to the nature of the event, the causality between the event "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   Further information is expected.  Follow-up information was received by RA on 20-DEC-2023, from a HCP in the (PRIVACY). The case is maintained as non-serious and non-valid (no patient identifiers were provided -temperature excursion case).  Due to the nature of the event, the causality between the event "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   No further information is expected.  Follow-up information was received by RA on 21-DEC-2023, from a HCP in the (PRIVACY). The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   Companion cases which share same Product Temperature Excursion issue: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005640, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651, MCM-005652.  No further information is expected.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; his non-serious spontaneous safety report was received by agency on 21-DEC-2023, from a Health care professional.  Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.  This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639 MCM-005640, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651 and MCM-005652.  Further information is not expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue (Parent case MCM-005586) with the following companion cases: MCM-005634, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005640, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651, MCM-005652  No further information is expected
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.  Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.  This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005634, MCM-005635, MCM-005637, MCM-005638, MCM-005639 MCM-005640, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651 and  MCM-005652.  Further information is not expected.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.  Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.  This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005638, MCM-005640, MCM-005642, MCM-005645, MCM-005646, MCM-005648, MCM-005649, MCM-005651, MCM-005652, MCM-005639, MCM-005641, MCM-005634, MCM-005636, MCM-005647, MCM-005650, MCM-005643, and MCM-005644.   Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion (Parent case MCM-005586) issue with the following companion cases: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005639, MCM-005640, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651, MCM-005652  No further information is expected
Age: 0.33
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Healthcare professional.  Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.  This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005637, MCM-005638, MCM-005640, MCM-005642, MCM-005645, MCM-005646, MCM-005648, MCM-005649, MCM-005651, MCM-005652, MCM-005641, MCM-005634, MCM-005636, MCM-005647, MCM-005650, MCM-005643, and MCM-005644.   Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by Agency on 21-DEC-2023, from a Health care professional in the country.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion (Parent case MCM-005586) issue with the following companion cases: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651, MCM-005652  No further information is expected
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by UBC on 21-DEC-2023, from a Health care professional.  Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.  This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005640, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651 and  MCM-005652.  Further information is not expected
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue (Parent case MCM-005586) with the following companion cases: MCM-005634, MCM-005435, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005640, MCM-005641, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651, MCM-005652  No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by RA on 21-DEC-2023, from a Health care professional in the (PRIVACY).   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005638, MCM-005640, MCM-005642, MCM-005645, MCM-005646, MCM-005648, MCM-005649, MCM-005651, MCM-005652, MCM-005639, MCM-005641, MCM-005634, MCM-005636, MCM-005650, and MCM-005644.   Further information is not expected.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005638, MCM-005640, MCM-005642, MCM-005645, MCM-005646, MCM-005648, MCM-005649, MCM-005651, MCM-005652, MCM-005639, MCM-005641, MCM-005634, MCM-005636, MCM-005650, and MCM-005643.   Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by RA on 21-DEC-2023, from a Health care professional in the (PRIVACY).   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue (Parent case MCM-005586) with the following companion cases: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005640, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651, MCM-005652  No further information is expected.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by agency on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion (Parent case MCM-005586) issue with the following companion cases: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005640, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005651, MCM-005652  No further information is expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by RA on 21-DEC-2023, from a Health care professional in the (PRIVACY).   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005638, MCM-005640, MCM-005642, MCM-005645, MCM-005646, MCM-005648, MCM-005649, MCM-005651, MCM-005652, MCM-005639, MCM-005641, MCM-005634, MCM-005636, MCM-005650, MCM-005643, and MCM-005644.   Further information is not expected.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion (Parent case MCM-005586) issue with the following companion cases: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005640, MCM-005649, MCM-005650, MCM-005651, MCM-005652  No further information is expected.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion (Parent case MCM-005586) issue with the following companion cases: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005640, MCM-005650, MCM-005651, MCM-005652  No further information is expected.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by Agency on 21-DEC-2023, from a Health care professional in the Country.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion issue with the following cases: MCM-005586, MCM-005635, MCM-005638, MCM-005640, MCM-005642, MCM-005645, MCM-005646, MCM-005648, MCM-005649, MCM-005651, MCM-005652, MCM-005639, MCM-005641, MCM-005634, MCM-005636, MCM-005643, and MCM-005644.   Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Product storage error
Clinical narrative: The customer reported that doses of improperly stored vaccines were potentially administered to patients; This non-serious spontaneous safety report was received by agency on 21-DEC-2023, from a Health care professional.   Due to the nature of the event, the causality between the event; "The customer reported that doses of improperly stored vaccines were potentially administered to patients" and Vaxelis was assessed as not applicable.   This case shares the same Product temperature excursion (Parent case MCM-005586) issue with the following companion cases: MCM-005634, MCM-005635, MCM-005636, MCM-005637, MCM-005638, MCM-005639, MCM-005641, MCM-005642, MCM-005643, MCM-005644, MCM-005645, MCM-005646, MCM-005647, MCM-005648, MCM-005649, MCM-005650, MCM-005640, MCM-005652  No further information is expected.