chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm redness; Puffiness continue to spread down my arm.; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2023, the patient received Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter's comment: This case was reported by a consumer via interactive digital media  The patient reported that (date of reporting) today was day 6 since Shingrix vaccination, his/her arm redness and puffiness continue to spread down his/her arm. Additional supportive information: Follow-up would not be possible as no contact details were available.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to a 12 year-old; Adult dose given to a 12 year-old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-year-old male patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2023, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 17th January 2023, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were 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: 17-Jan-2023 Reporter's comment: Nurse administered Engerix-B adult dose to 12 year old pediatric patient. Adverse event contains all reported information. The reporter gave consent for safety team follow-up. The reporter consented to follow-up. Additional supportive information: The pediatric patient received an adult dose of Engerix-B, which led to overdose and adult product administered to child.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose given to adult patient; pediatric dose given to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 25N39, expiry date 16th March 2024) for prophylaxis.   On 19th July 2022, the patient received Engerix B 10 mcg 10 ug. On 19th July 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comments: The pharmacist reported pediatric dose given to adult patient. Adverse event contained all reported information.  The reporter consented to follow up.  Additional Supportive Information: The adult patient received Engerix B pediatric dose, which led to underdose and adult use of a child product.
Sex: F
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 female patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 17th January 2023, the patient received Havrix. On 17th January 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: 18-JAN-2023 Reporter's Comment: The pharmacist reported that the patient received expired Havrix vaccine.  The patient was planning to travel.  The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix vaccine, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 3 years ago, never completed the series; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (was vaccinated with the first dose of Shingrix about 3 years ago).   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: 16-JAN-2023 Reporter's comment: The consumer had called up today at the time of reporting and had stated that, he was vaccinated with the first dose of Shingrix about 3 years ago but never had completed the series. The consumer had stated that, he had plans on getting the second dose as soon as possible. The reporter had consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which had led to incomplete course of vaccination. The details provided corresponded to the 1st dose of Shingrix as the 2nd dose was not administered yet.; Sender's Comments:  US-GSK-US2023007570:Same reporter
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient received Twinrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th January 2023, unknown after receiving Twinrix and Twinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's Comments: The pharmacist was looking information on Twinrix because a patient received Twinrix expired dose. There were no adverse effects detected to date (till the time of reporting). The reporter mentioned that, on 16th January 2023, Monday (closed), a colleague left a VM (voicemail) with this concern, but nobody did a follow-up. No other information was provided by the healthcare professional. The reporter consented to follow up by email. Additional Supportive Information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 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 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 2 years ago).   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: 18-JAN-2023 Reporter's comment: The reporter was patient's wife. She stated that her husband received his first dose of Shingrix approximately 2 years ago but was not received his second dose.  The reporter 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.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle aches; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 14th January 2023, 1 days after receiving Shingrix, the patient experienced muscle pain. On 15th January 2023, the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-JAN-2023 Reporter's Comment: The reporter was the patient. The reporter reported that patient received Shingrix vaccine, in an unknown arm.  The day after the Shingrix vaccine she had some muscle aches that was resolved.  The reporter did not consent to follow up. The reporter did not give permission for GlaxoSmithKline to contact HCP.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018, never came back for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix back on 2nd July 2018).   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: 19-JAN-2023 Reporter's Comment: The patient never came back to get the second dose of Shingrix. The reporter unable to provide vaccine lot and expiration details. The reporter called to inquire would the patient need to restart Shingrix series. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash
Clinical narrative: Rash not pruritic on hands and feet; This case was reported by a physician via call center representative and described the occurrence of rash in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2022, the patient received Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 14th April 2022, 2 days after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced rash. On 15th April 2022, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Kinrix and Kinrix Pre-Filled Syringe Device.This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The reporter was a doctor stating that a patient of his got a Kinrix vaccine (not at his clinic) and then 2 days later developed a rash on the soles of her feet and palms of her hands.  The rash was not pruritic and resolved a day later.  The doctor did not have any further information about the vaccine itself or event.  The consent to follow up was granted.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, not completed the series; 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 (1st dose received intramuscularly around 2 years ago in 2021).   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: 19-JAN-2023 Reporter's Comments: The patient had not completed the vaccine series and adverse event (AE) was filed. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Urinary tract infection
Clinical narrative: Urinary Tract Infection/ she currently has a UTI; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 26th September 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 19th January 2023, the patient experienced urinary tract infection. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and urinary tract infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's comments: The caller was the patient and had reported that, she had received her Shingrix vaccine in the left arm. The caller reported that, she only had felt soreness at the injection site that had resolved.  The caller had also mentioned in the call that, she currently had a urinary tract infection (UTI) which she would be starting with antibiotics at the time of reporting. The reporter did not consent to follow-up.  The reporter does not give permission to contact HCP. Additional supportive information:  115 days after receiving Shingrix, the patient experienced urinary tract infection.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 74-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Twinrix and Twinrix 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: 19 January 2023 Reporters comment: The nurse informed that Twinrix was administered to a patient, but such vaccine had expired on 1st January 2023. The Vaccine Administration Facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: As patient received the expired vaccine, which led to expired vaccine used.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received Pediatric dose; Adult received Pediatric dose; This case was reported by a physician via call center representative and described the occurrence of underdose in a adult male patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.       Additional Information: GSK Receipt Date: 19-Jan-2023 Reporter's Comments: The physician reported that an adult patient received pediatric dose of Engerix-B.  The reporter consented to follow up. There was no further details available but agreeable to recontact for additional details. Additional supportive information: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Shingrix (received first dose 4 years ago). 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: 20-JAN-2023. Reporter's Comments: The case was self reported by the patient. The patient did not receive second dose of Shingrix yet. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was linked with case US2023008732, reported by the same reporter. Sender's Comments: US-GSK-US2023008732: same reporter.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Diarrhoea, Dyspepsia
Clinical narrative: COVID-19; SEVERE STOMACH BURNING; DIARRHEA; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered at left arm on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 19 years old. It was unknown whether patient had any adverse events following vaccination with first dose covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Pfizer and BioNTech(tozinameran) (dose number in series 2) ( form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered at left arm on NOV-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. Concomitant medications included Mucinex (guaifenesin). On an unspecified date, the patient experienced covid-19 (dose number in series 2) and received non-company suspect drug Paxlovid for treatment (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered from 04-JAN-2023 to 08-JAN-2023. On 04-JAN-2023 17:00, the patient experienced severe stomach burning, and diarrhea while taking Paxlovid (dose number in series 2). She went a few hours without taking her morning dose and felt relief from the gastrointestinal (GI) symptoms which she experienced. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and for Paxlovid was drug discontinued.  The patient recovered from severe stomach burning, and diarrhea on 08-JAN-2023, and the outcome of covid-19 and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022; No adverse event; 4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) in an 18-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022).    Concomitant product use was not provided by the reporter. It was unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The best used date was reported as 17-Aug-2022. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-700335, US-MODERNATX, INC.-MOD-2023-700086, US-MODERNATX, INC.-MOD-2023-700320 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2023: Significant follow up appended: Patient information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700335:Patient 2 Out of 4 patient information received US-MODERNATX, INC.-MOD-2023-700086:Patient 3 Out of 4 patient information received US-MODERNATX, INC.-MOD-2023-700320:Patient 1 Out of 4 patient information received
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) 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. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-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 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No relevant concomitant medications were reported.  Dose was administered on 01-Dec-2022 from lot number 021H22A, best use by date of 26-Nov-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-685141 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2022: Upon internal review on 24-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685141:Samer Reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by 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. AS7168B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 09-Jan-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. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    No concomitant medication information was provided.  Beyond use date 08-Jan-2023. Administration dates are as follows: 09Jan2023 (2 patients) 10Jan2023 (2 patients) 11Jan3023 (4 patients) 12Jan2023 (4 patients) 13Jan2023 (3 patients). All the patients were 12 years and above, but HCP did not have the information if some of them were below 17 years old.  No treatment medications were provided.  This case contains information for the 02 out of 15 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:MASTER  CASE
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; they should not have gotten a second Bivalent dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7172B and AS7163B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Lot 001M21A) in April 2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (took 3 shots of Pfizer). Past adverse reactions to the above products included No adverse event with Moderna and PFIZER BIONTECH COVID-19 VACCINE.   On 25-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 19-Jan-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose) 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 EXTRA DOSE ADMINISTERED (they should not have gotten a second Bivalent dose).    No concomitant medication were reported.  Reporter and her husband have been taking vaccines all the same dates except for the beginning. They took 3 shots of Pfizer and then in April-2022 they took Moderna for the first time and then 25-sep-2022 they also took Moderna.  When they took it in September they forgot vaccine card. They went with their card so they could enter the 25-Sep-2022 Bivalent shot and were told that they were up for a new shot. They went and took another shot today which was the Bivalent booster on 19-Jan-2023. Reporter said they have taken 6 shots. Caller says the woman at Pharmacy was wrong and they should not have gotten a second Bivalent dose. They were told that they needed another one but they didn't have any spots available so caller got the vaccines at a different location. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-700859 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700859:Female case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021. The patient did not report any side effects.  BUD was reported as 30 Jul 2021.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Best used date was 30-Jul-2021, Patients did not report any side effects.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired device used, No adverse event, Product storage error
Clinical narrative: The patient received vaccine after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED DEVICE USED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (The patient received vaccine after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccines were stored in the fridge on 30-Jun-2021, there were different administration dates, starting on 02-Aug-2021 until 20-Sep-2021 being the last one. Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored; No adverse event; 40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (40 patients received the moderna monovalent vaccines (1st and 2nd doses) after being more than 30 days stored).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication of the patient was not reported.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021.  Best Used Date was reported as 30-Jul-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case ID