chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Vaccination failure
Clinical narrative: rash on sacral area; Suspected vaccination failure; rash was shingles.; Itching rash; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24-AUG-2023, the patient received the 2nd dose of Shingrix (left deltoid). On 20-JUN-2023, the patient received the 1st dose of Shingrix. On 20-JUL-2023, not applicable after receiving Shingrix and 30 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: Itching rash). In SEP-2023, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: rash was shingles.). On 25-SEP-2023, the patient experienced rash (Verbatim: rash on sacral area).  The patient was treated with antipruritics nos (Anti-Itch Cream (Medication Unknown)). The outcome of the vaccination failure was not reported and the outcome of the shingles and itchy rash were unknown and the outcome of the rash was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix. It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK receipt date: 27-SEP-2023 The reporter was a customer who stated that he was out of the country recently.   When he returned from his trip he received his first Shingrix vaccine and 1 month after his first dose of Shingrix he developed a rash on sacral area, described as bottom of spine tail bone area.   The patient was not evaluated by his physician and did not report rash to his physician.   He treated rash with an OTC anti-itch cream and states the rash was shingles.   The patient then stated that he received his second dose of Shingrix and reported approximately 1 month after second dose of Shingrix he again had the itching rash on his sacral area and he believed the recurring rash was shingles.   The reporter did not see his physician after return of rash and again treated himself with an OTC anti-itch cream. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. Consent to follow up was obtained. The reporter did not had his physicians information and stated that he will call back with the information.  The reporter would like to be contacted via email with any correspondence from Safety Team.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: was reconstituted with saline; received one vial of the vaccine which was reconstituted with saline; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 26-SEP-2023, the patient received Menveo (intramuscular, left deltoid). On 26-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: was reconstituted with saline) and inappropriate dose of vaccine administered (Verbatim: received one vial of the vaccine which was reconstituted with saline).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 Father of the patient reported that the patient received a Menveo (2-vial formulation) vaccine at the local health department yesterday (day before reporting). The Health Department contacted the reporter on reporting day to inform that his son (patient) received one vial of the vaccine which was reconstituted with saline. He did not receive the 2nd vial of vaccine. The patient received only one vial of Menveo reconstituted with saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Pain in the injected arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of patients 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 pain in arm (Verbatim: Pain in the injected arm).  The outcome of the pain in arm was resolved (duration 2 days).   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 27-Sept-2023 According to the pharmacist a few random patients (quantity unknown) had been in the pharmacy to report that pain in the injected arm after receiving Arexvy, that resolved after 2 days.  No identifiers provided or other information. The reporter consented to follow-up. The case was linked with the case US2023133480, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023133480:1st report
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: Hospitalization; Some type of cancer; This serious case was reported by a pharmacist via call center representative and described the occurrence of hospitalization in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dementia.   On 17-MAR-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hospitalization (Verbatim: Hospitalization) (serious criteria hospitalization) and cancer (Verbatim: Some type of cancer) (serious criteria GSK medically significant). The outcome of the hospitalization was unknown and the outcome of the cancer was not reported.   It was unknown if the reporter considered the hospitalization and cancer to be related to Shingrix.     It was unknown if the company considered the hospitalization and cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2023 The reporter mentioned that the patient might had been in the hospital around the time she was supposed to get the 2nd dose.  The reporter stated that he believed she had some type of cancer and slight dementia.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first dose of Shingrix back on 9/25/2019 and the second dose on 9/14/2023 and the physician recommended a third dose to this patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number FY793, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th Sep 2019).   On 14-SEP-2023, the patient received the 2nd dose of Shingrix. On 14-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the first dose of Shingrix back on 9/25/2019 and the second dose on 9/14/2023 and the physician recommended a third dose to this patient.).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date 27 Sep 2023 A pharmacist mentioned that a patient received the first dose of Shingrix back on 25th September 2019 and the second dose on 14th September 2019  and the physician recommended a third dose to this patient. The pharmacist asked if the patient needed a third dose or needed to restart the series. The patient received 2nd dose late than recommended interval which led to lengthening of vaccination schedule.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: LPN states an expired dose of Infanrix was administered to a patient yesterday; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (expiry date 16-SEP-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 4th dose of Infanrix. On 26-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: LPN states an expired dose of Infanrix was administered to a patient yesterday).  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: 27-SEP-2023 The reporter was a licensed practical nurse. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received expired dose of Infanrix, which led to expired vaccine used.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient was administered with BOOSTRIX and the vaccine had expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MR5RK, expiry date 21-SEP-2023) for prophylaxis.   On 25-SEP-2023, the patient received Boostrix (left deltoid). On 25-SEP-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Patient was administered with BOOSTRIX and the vaccine had expired).  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: 28-SEP-2023 Reporter was a Medical Assistant. The reporter called on reporting day to seek guidance. The reporter consented to follow up. The patient was administered with Boostrix, and the vaccine had expired, which led to expired vaccine used.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: 3 year old patient was inadvertently administered a third dose of Havrix today on 9/28/23; 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 2-year-old male patient who received HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   Previously administered products included Havrix (received the first dose on 13-OCT-2021) and Havrix (received the second dose on 14-OCT-2022).   On 28-SEP-2023, the patient received the 3rd dose of Havrix. On 28-SEP-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: 3 year old patient was inadvertently administered a third dose of Havrix today on 9/28/23).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter was Medical Assistant. The reporter called to inquire how to proceed and what to look for. The reporter explained the first dose was never recorded so they thought the patient only received one dose. Then healthcare professional noticed the first dose was administered after this extra dose was given in error. The reporter did not consent to follow-up. The patient received the 3rd dose of Havrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: mistakenly given the adjuvant only rather than reconstituted Shingrix; mistakenly given the adjuvant only rather than reconstituted Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: mistakenly given the adjuvant only rather than reconstituted Shingrix) and inappropriate dose of vaccine administered (Verbatim: mistakenly given the adjuvant only rather than reconstituted Shingrix).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 A long-term care facility patient was mistakenly given the adjuvant only rather than reconstituted Shingrix for her first dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional plans to correct this error by giving a properly reconstituted vaccine but till the time of reporting the patient had not yet received a properly reconstituted dose. Nothing else was reported. The reporter consented to follow up. Follow up with reporter/pharmacist or HCP (primary care HCP).
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Odynophagia, Suspected COVID-19
Clinical narrative: VERY DIFFICULT TO SWALLOW; VERY PAINFUL TO SWALLOW; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer by other manufacturer concerned a patient of unspecified age and 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 not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for covid-19 prophylaxis. Non-company suspect drugs included: nirmatrelvir/ritonavir ( batch number: GF3895 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose and frequency were not reported from 20-SEP-2023 for suspected covid-19 infection. No concomitant medications were reported. On 2023, the patient experienced suspected covid-19 infection. On 21-SEP-2023 23:00, the patient experienced very difficult to swallow, and very painful to swallow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from very difficult to swallow, and very painful to swallow, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: The patient complains of feeling unexpectedly poorly for 5 to 10 days.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (The patient complains of feeling unexpectedly poorly for 5 to 10 days.) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 002A21M) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (two years ago).    On 27-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (The patient complains of feeling unexpectedly poorly for 5 to 10 days.). At the time of the report, FEELING ABNORMAL (The patient complains of feeling unexpectedly poorly for 5 to 10 days.) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient complains of feeling unexpectedly poorly for 5 to 10 days. No other side effects. The patient received her second Moderna Covid-19 on 27Mar2021 lot number 002B21A expiration date is not known. The patient received in her right arm. The patient did not complain of any adverse reactions. The patient received her first Moderna Covid-19 vaccine booster dose on 26Oct2021 lot number 026D21A expiration date is not known. Patient received in her right arm. The patient not had adverse reactions. The patient received her next booster dose as a Pfizer vaccine on 04Apr2022. The patient received her next booster on 02Sep2022 as a Moderna vaccine lot number AS7143C expiration date not known, and the patient received in right arm no side effects for this vaccine. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742771, US-MODERNATX, INC.-MOD-2023-743475 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742771:Spikevax 2023-2024 (same patient) US-MODERNATX, INC.-MOD-2023-743475:
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chest discomfort, Feeling cold, Feeling of body temperature change, Headache
Clinical narrative: weak; chilled and very cold and then felt hot; headache; problems with chest; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), CHEST DISCOMFORT (problems with chest), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (year ago). Concurrent medical conditions included Dust allergy and Allergy. Concomitant products included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE for an unknown indication.    On 29-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced CHEST DISCOMFORT (problems with chest). On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ASTHENIA (weak), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache). The patient was treated with GUAIFENESIN (MUCINEX) for Chest discomfort, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In 2023, HEADACHE (headache) had resolved. At the time of the report, ASTHENIA (weak) and CHEST DISCOMFORT (problems with chest) had not resolved and FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient got the Moderna vaccine in the morning and got very sick the same evening. This was the third day and patient were still very sick. Patient had problems with her chest. Patient could only get out of bed for a short period of time. Patient was weak which was why patient went back to bed. Patient took Mucinex for her chest, but it not helped. Patient used a whole big box of Kleenex it just runs out of her. Patient was not a person who takes pills, but it was so bad that patient had and it did help. Patient called the pharmacy and they said if patient was not better by tomorrow then patient should go to the emergency room (ER) since it was the weekend and there were no doctors available. Patient never had problems before, but this time patient was sick. Patient had no problems with the influenza and pneumonia shot patient got. Patient was chilled and was very cold and then patient was hot.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Mobility decreased
Clinical narrative: weak; chilled and very cold and then felt hot; headache; problems with chest; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak), CHEST DISCOMFORT (problems with chest), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (year ago). Concurrent medical conditions included Dust allergy and Allergy. Concomitant products included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE for an unknown indication.    On 29-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced CHEST DISCOMFORT (problems with chest). On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ASTHENIA (weak), FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) and HEADACHE (headache). The patient was treated with GUAIFENESIN (MUCINEX) for Chest discomfort, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In 2023, HEADACHE (headache) had resolved. At the time of the report, ASTHENIA (weak) and CHEST DISCOMFORT (problems with chest) had not resolved and FEELING OF BODY TEMPERATURE CHANGE (chilled and very cold and then felt hot) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient got the Moderna vaccine in the morning and got very sick the same evening. This was the third day and patient were still very sick. Patient had problems with her chest. Patient could only get out of bed for a short period of time. Patient was weak which was why patient went back to bed. Patient took Mucinex for her chest, but it not helped. Patient used a whole big box of Kleenex it just runs out of her. Patient was not a person who takes pills, but it was so bad that patient had and it did help. Patient called the pharmacy and they said if patient was not better by tomorrow then patient should go to the emergency room (ER) since it was the weekend and there were no doctors available. Patient never had problems before, but this time patient was sick. Patient had no problems with the influenza and pneumonia shot patient got. Patient was chilled and was very cold and then patient was hot.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    Concomitant medication was not reported. Treatment medication was not reported.  This case was for the 2nd patient out of 10 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; The patients are all adults the patients have not reported other side effects; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) outcome was unknown.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient received Moderna vaccine that had thawed out and then refroze. The patient did not report other side effects.  Treatment information was not provided.  This case contains information for the 3rd patient out of 10 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; The patients are all adults the patients have not reported other side effects; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    No relevant concomitant medications were reported. No treatment medication reported.   This case was for the 5th patient out of 10 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze), PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze).    No concomitant medications were reported. It was reported as unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patients have not reported other side effects.  No treatment medications were reported.  This case contains information for the 06 of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    Concomitant medication was not reported. Treatment medication was not reported.  This case was for the 7th patient out of 10 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    This case contains information for the 8th of 10 patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Patient did not have information about previous COVID-19 vaccination doses.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  10 patients received Moderna vaccine that had thawed out and then refroze. All the patients were adults. The patients did not report other side effects.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    This case contains information for the 9th of 10 patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Patient did not have information about previous COVID-19 vaccination doses.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  10 patients received Moderna vaccine that had thawed out and then refroze. All the patients were adults. The patients did not report other side effects.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE from 09-Oct-2022 to an unknown date and VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER H) for an unknown indication.    On 09-Oct-2022, 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 PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) 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.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743088, US-MODERNATX, INC.-MOD-2023-743016 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743088:bivalent case US-MODERNATX, INC.-MOD-2023-743016:bivalent case
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Chills, Influenza like illness, Malaise, Myalgia
Clinical narrative: like having the flu; not feeling well; fatigue; muscle pain; joint pain; chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (like having the flu), MALAISE (not feeling well), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 30-Sep-2023 at 3:00 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced INFLUENZA LIKE ILLNESS (like having the flu), MALAISE (not feeling well), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (like having the flu), MALAISE (not feeling well), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Live Follow up received contains no new information.
Sex: M
Vaccine: UNK
Symptoms: Nervous system disorder, Rash
Clinical narrative: neurological problems; rashes; This spontaneous case was reported by a physician and describes the occurrence of NERVOUS SYSTEM DISORDER (neurological problems) and RASH (rashes) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (neurological problems) and RASH (rashes). At the time of the report, NERVOUS SYSTEM DISORDER (neurological problems) and RASH (rashes) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: No adverse event; Administered vaccine that had been stored incorrectly; Administered vaccine that had been stored incorrectly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that had been stored incorrectly), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that had been stored incorrectly) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that had been stored incorrectly) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that had been stored incorrectly). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that had been stored incorrectly), POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that had been stored incorrectly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Administered vaccine that had been stored incorrectly) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that had been stored incorrectly).    No concomitant medications were reported.  It was reported that the reporter attended an event and an acquaintance (45-50 years) mentioned that he had received the COVID-19 2023-2024 formulation a few weeks ago. He reported no adverse events associated with the vaccine but stated that two days after receipt of the vaccine he got to know that the vaccine had been stored incorrectly and invited him to repeat the vaccination.   No treatment medications were provided.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (two years ago).    On 09-May-2023, 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. In June 2023, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had resolved.        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.   Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742771, US-MODERNATX, INC.-MOD-2023-742800 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742771:Master case (Spikevax 2023-2024 (same patient)) US-MODERNATX, INC.-MOD-2023-742800: