chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Breast pain, Discomfort, Musculoskeletal pain
Clinical narrative: Pains in my breasts; Pains under the armpits; Pains under the shoulder blades; Pains in my back; This case was reported by a consumer via interactive digital media and described the occurrence of breast pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced breast pain, axillary pain, shoulder blade pain and back pain. On an unknown date, the outcome of the breast pain, axillary pain, shoulder blade pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the breast pain, axillary pain, shoulder blade pain and back pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received shingles vaccine. The patient stated that after received Shingles vaccine he/she experienced pain in his/her breast, under the armpits, under the shoulder blades and in his/her back and stated that he/she going for a year with these discomforts and he/she just do not see the end of this. The patient stated that he/she begged for the mercy and sometimes he/she thought that he does not love he/she. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: May have received a third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comments: The health care professional reported that he/she had a patient who thought that he may had received a third dose of the Shingrix vaccine by mistake (from different providers) and asked that what precautions should he take. Additional Supportive Information: The patient received the third dose of Shingrix vaccine by mistake, which had led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Could have been given after temprature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Feb-2023 Reporter's comment:  The medical assistant reported that the Shingrix vaccines were exposed to 31.1 F and they could had been given to one or more patients.  The reporter had no idea when or if the vaccines was administered after the temperature excursion.  The reporter consent to follow up via email. Additional supportive information:  The Shingrix vaccines were exposed to 31.1F, which led to Incorrect storage of drug.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion was administered; only the liquid portion was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30th September 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Feb-2023 Reporter's comment: The nurse told that this event was discovered because a vial of Menveo was left alone in the fridge, so they were not sure about when this dose was administered, or to whom it was administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient inadvertently administered only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Feb-2023 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 2 doses in 2018, 3rd dose this year; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received two doses of Shingrix in 2018).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 20-Feb-2023 Reporter's comment: The reporter did not provide information about Shingrix doses (lot number/exp date/ date of administration). The reporter consented to follow-up. Additional supportive information: The patient received the third dose of Shingrix this year, which led to extra dose administered.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injection site swelling, Nausea, Peripheral swelling
Clinical narrative: Swelling at the injections site; Swelling of the arm; Fever 103 °F; Dizziness; Vomiting; Generalized weakness, went to ER; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced nausea. On 17th February 2023, the patient experienced injection site swelling, swelling arm, fever, dizziness, vomiting and weakness generalized. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site swelling, swelling arm and weakness generalized were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the dizziness, nausea and vomiting were unknown.   It was unknown if the reporter considered the injection site swelling, swelling arm, fever, dizziness, nausea, vomiting and weakness generalized to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The patient was self-reported this case. The reporter stated that after received Shingrix vaccine the patient experienced swelling at the injections site, swelling of the arm, fever of 103 degrees Fahrenheit, dizziness, nausea, vomiting, and generalized weakness. The patient stated that she was seen at the emergency department and received Steroids and Antibiotics as a treatment for this events. The reporter did consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Swelling at the injections site; Swelling of the arm; Fever 103 °F; Dizziness; Vomiting; Generalized weakness, went to ER; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced nausea. On 17th February 2023, the patient experienced injection site swelling, swelling arm, fever, dizziness, vomiting and weakness generalized. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site swelling, swelling arm and weakness generalized were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the dizziness, nausea and vomiting were unknown.   It was unknown if the reporter considered the injection site swelling, swelling arm, fever, dizziness, nausea, vomiting and weakness generalized to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The patient was self-reported this case. The reporter stated that after received Shingrix vaccine the patient experienced swelling at the injections site, swelling of the arm, fever of 103 degrees Fahrenheit, dizziness, nausea, vomiting, and generalized weakness. The patient stated that she was seen at the emergency department and received Steroids and Antibiotics as a treatment for this events. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix given after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-FEB-2023 Reporter's comment: A pharmacist requested information about the thermostability of Shingrix after being exposed to 31 degree Fahrenheit. After being told that Shingrix should not be exposed to 31 degree Fahrenheit, they stated that a many doses had been administered to many patients, without giving specific details.  When asked for information about patients and specific vaccine details, they stated that it would not be needed to create an adverse event report as their corporate team already did do.  They did not gave any specific information. The reporter did not consent to follow-up. Additional supportive information: The Shingrix vaccine was exposed to 31 degree Fahrenheit, which led to incorrect storage of drug.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received HAV (Havrix 720) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Feb-2023 The registered nurse stated that Havrix was administered to a patient on the day of reporting and it expired on 03 February 2023.  The vaccine administration facility was the same as primary reporter. The reporter asked please follow up via postal. Additional supportive information: The patient was administered an expired dose of Havrix 720, which led to expired vaccine used.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number T57F3, expiry date 15th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: The reporter was a physician. The reporter reported that the 18 months old patient received an expired dose of Havrix vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: leaked and an underdose was given; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 8th October 2023) for prophylaxis.   On 20th February 2023, the patient received the 2nd dose of Shingrix. On 20th February 2023, unknown after receiving Shingrix, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  The patient went to receive the 2nd dose of Shingrix, but the vaccine leaked and an underdose was administered. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received 2nd dose of Shingrix, but the vaccine leaked, which led to underdose.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   On 22nd February 2023, the patient received Havrix. On 22nd February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Nurse reported an expired dose of Havrix was given to a patient.  the reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: the patient received Havrix on 22nd February 2023, which was already expired on 16th February 2023.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Over a year late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Pharmacist states that some patients were over a year late with getting their 2nd dose of Shingrix.  She states that they either weren't told that they need to get a 2nd dose or they forgot. The reporter consented to follow up via postal. HCP did not have an exact number of patient or demographics currently.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date 4 years before date of reporting.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Reporter was the patient, who states that she and her husband received their first dose of Shingrix 4 years ago and had not yet received their second doses.  Did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023029938:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose 4 years before date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Reporter was the patient's wife, who states that she and her husband received their first dose of Shingrix 4 years ago and had not yet received their second doses.  Did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023029939:Same reporter
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd February 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-FEB-2023 Reporter's comment:  The reporter reported that an expired dose of Havrix was administered to a patient.  The reporter consented to follow up via email. Additional supportive information. The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2 doses years ago and a dose in Nov 9th; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 20-year-old male patient who received HBV (Engerix B) (batch number 25K4M, expiry date 2nd June 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (in 2015 or 2016, patient had received 2 doses of the same vaccine).   On 9th November 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 9th November 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   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: 23-FEB-2023 Reporter's comments: Patient mentioned that in 2015 or 2016 received 2 doses of the same vaccine but did not finish the schedule either. Pharmacist reported that Engerix B was administered on 9th November (year not mentioned) and patient did not comeback for the another dose until today (Feb 23rd 2023). The reporter consented to follow up. Additional supportive information: The patient had received the third dose later than the recommended interval, which had led to lengthening of vaccination schedule. Based on the structured field date, the vaccination date was captured conservatively and AI was raised to confirm the same.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure, Suspected COVID-19
Clinical narrative: HEART FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, race, ethnicity and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient also received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and had heart failure (Dose number in series 2). Patient's doctor said it was because of the Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and heart failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000272571.; Sender's Comments: V0- 20230256240- Heart failure- Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome
Clinical narrative: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; This spontaneous report received from a consumer via social media concerned a 33 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 4 decade old. No concomitant medications were reported.  On an unspecified date (post 12 days of vaccination), the patient experienced blood clots (vaccine-induced immune thrombotic thrombocytopenia) and had been in a long-term care facility. The reporter stated "Pls contact this 33-year-old, otherwise healthy male, who presented with blood clots (VITT) 12 days after receiving  J and J covid vaccine. He was now in a LONG TERM CARE FACILITY. YOU DISABLED HIM and many like him" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine induced immune thrombotic thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230258720-vaccine induced immune thrombotic thrombocytopenia. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 other patients received Moderna Bivalent vaccine past it's beyond use date.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 other patients received Moderna Bivalent vaccine past it's beyond use date.).    Concomitant medication was not provided.   Treatment information was not provided.  This case contains information for the first out of 2 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712104, US-MODERNATX, INC.-MOD-2023-712526 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2023: Follow-up information received includes patient details, vaccine details (lot number) and new event (expired vaccine used) were added. Report type from invalid to spontaneous, and I-narrative supplement were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712104:Same reporter(Monovalent Dose) US-MODERNATX, INC.-MOD-2023-712526:Patient 2
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, Device connection issue, No adverse event
Clinical narrative: needle of the syringe was not secured and some of the vaccine leaked; needle of the syringe was not secured and some of the vaccine leaked; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked), DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked), DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked), DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (needle of the syringe was not secured and some of the vaccine leaked) and DEVICE CONNECTION ISSUE (needle of the syringe was not secured and some of the vaccine leaked).    No concomitant medications were reported.  Reporter confirmed that vaccine was not related to Moderna Clinical Trial.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: patients received Moderna Bivalent vaccine past it's beyond use date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received Moderna Bivalent vaccine past it's beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received Moderna Bivalent vaccine past it's beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received Moderna Bivalent vaccine past it's beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patients received Moderna Bivalent vaccine past it's beyond use date).    No concomitant medication were reported. Nurse Manager was not aware of any other Adverse Reactions. No treatment information was provided by the reporter.  This case contains information for the 3rd out of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712104, US-MODERNATX, INC.-MOD-2023-712108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712104:(Document) Monovalent case US-MODERNATX, INC.-MOD-2023-712108:Patient 1
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose administered after manufacturer date of expiry; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Concomitant product use was not provided by the reporter. Patient received vaccine at 01:04 PM . It has been reported that  vaccine had been frozen with no known temperature excursion before being thawed on 24-Feb-2023 for administration. Vial  did not go any temperature excursions. Individual vials or unbroken cartons were 4. Vial size was 5. Date the vial was initially stored in the refrigerator was 24-Feb-2023. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712705 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Live follow up has been appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .).    Concomitant medication was not provided.  No side effects were reported by the patients. Treatment information was not provided.  This case contains information for the 2nd patient out of 4 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712814, US-MODERNATX, INC.-MOD-2023-712821 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712814:Patient 1 case US-MODERNATX, INC.-MOD-2023-712821:Patient 3 case US-MODERNATX, INC.-MOD-2023-712822:Patient 4 case
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Nausea; Super tired; very very sore left arm; Body aches; Very severe headache; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea), FATIGUE (Super tired), PAIN IN EXTREMITY (very very sore left arm), MYALGIA (Body aches) and HEADACHE (Very severe headache) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient reported no other health issues.  Concurrent medical conditions included Cholesterol blood excessive. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol blood excessive.    On 21-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced NAUSEA (Nausea), FATIGUE (Super tired), PAIN IN EXTREMITY (very very sore left arm), MYALGIA (Body aches), HEADACHE (Very severe headache) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) on 23-Feb-2023 for Headache, at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and FATIGUE (Super tired) had not resolved, PAIN IN EXTREMITY (very very sore left arm), MYALGIA (Body aches) and HEADACHE (Very severe headache) outcome was unknown and VOMITING (Vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees Fahrenheit.     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.   Patient had never received another vaccine within 4 weeks of any of the Moderna Covid-19 vaccines.  It was reported that the patient was still very nauseous and very tired, however, patient was able to hold down some chicken broth and noodle soup as the patient could not keep food down for 24 hours.   This case was linked to MOD-2023-712853 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Nausea; Super tired; very very sore left arm; Body aches; Very severe headache; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea), FATIGUE (Super tired), PAIN IN EXTREMITY (very very sore left arm), MYALGIA (Body aches) and HEADACHE (Very severe headache) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient reported no other health issues.  Concurrent medical conditions included Cholesterol blood excessive. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol blood excessive.    On 21-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced NAUSEA (Nausea), FATIGUE (Super tired), PAIN IN EXTREMITY (very very sore left arm), MYALGIA (Body aches), HEADACHE (Very severe headache) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) on 23-Feb-2023 for Headache, at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and FATIGUE (Super tired) had not resolved, PAIN IN EXTREMITY (very very sore left arm), MYALGIA (Body aches) and HEADACHE (Very severe headache) outcome was unknown and VOMITING (Vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees Fahrenheit.     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.   Patient had never received another vaccine within 4 weeks of any of the Moderna Covid-19 vaccines.  It was reported that the patient was still very nauseous and very tired, however, patient was able to hold down some chicken broth and noodle soup as the patient could not keep food down for 24 hours.   This case was linked to MOD-2023-712853 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: AE identified; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (AE identified) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022,  after starting , the patient experienced IMMUNISATION REACTION (AE identified). At the time of the report, IMMUNISATION REACTION (AE identified) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023; No adverse event; Booster Bivalent dose administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date), PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (lot number: 206A21A) on 14-May-2021 and COVID-19 VACCINE JANSSEN (lot number: 213D21A) on 12-Nov-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and COVID-19 VACCINE JANSSEN.    On 20-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date), PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date) and PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14-Jan-2023 and administered on 20-Feb-2023).    No concomitant medications were reported.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not report any side effects after receiving initial booster dose of Moderna COVID-19 vaccine, Bivalent.   No treatment medications were reported.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients) and NO ADVERSE EVENT (No adverse event) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 24-Feb-2023 at 1:02 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 24-Feb-2023 at 1:02 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 30-Oct-2022, was administered to patients).    Concomitant medication was not provided.   It was reported that the vaccine was frozen with no known temperature excursion before being thawed. The vial was initially stored in refrigerator on 24-Feb-2023. The vial did not undergo any temperature excursion. Treatment information was not provided.   This case was linked to C-INT-0002940, US-MODERNATX, INC.-MOD-2023-712705, US-MODERNATX, INC.-MOD-2023-712700, US-MODERNATX, INC.-MOD-2023-712708, US-MODERNATX, INC.-MOD-2023-712760, US-MODERNATX, INC.-MOD-2023-712765, US-MODERNATX, INC.-MOD-2023-712766, US-MODERNATX, INC.-MOD-2023-712708 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2023: Non significant live follow up received: Vaccination time added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712705: US-MODERNATX, INC.-MOD-2023-712760: US-MODERNATX, INC.-MOD-2023-712765: US-MODERNATX, INC.-MOD-2023-712766: