chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event on patient; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager regarding a 13-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger) (Product storage error). There were no additional adverse events (AEs) reported in the patient.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event on patient; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager regarding a 13-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, 1 dose, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger) (Product storage error). There were no additional adverse events (AEs) reported in the patient.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager, referring to a 13-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 04-FEB-2023, the patient was vaccinated one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot numbers and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023, administered for prophylaxis (administration sites, and routes of administration were not provided).  The doses of vaccines experienced 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 min. Total time: 25 mins. Temperatures were reported as 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). Excursions were not noted until after the fact due to employee error of cleaning data logger more than once a day. There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: a patient got an extra dose of Rotarix; inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number yl9yn, expiry date 20-APR-2025) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 20th December 2022 by oral route, batch number 5279E, expiry date 25th February 2024). Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX).   On 21-APR-2023, the patient received the 3rd dose of Rotarix lyophilized formulation (oral). On 21-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: a patient got an extra dose of Rotarix) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the extra dose administered and inappropriate age at vaccine administration 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: 09-MAY-2023 The reporter was a practice administrator stating that a patient got an extra dose of Rotarix.  They received their first 2 vaccines in the appropriate time frame and then got a 3rd dose of Rotarix.  The reporter was consented to follow up. The patient received 3rd dose of Rotarix, which led to Extra dose administered. The patient received 3rd dose of Rotarix at 6 month of age, which led to Inappropriate age at vaccine administration. This case was identified as duplicate of case US2023066939. All future correspondence would be added in case US2023066941, which stands as case of record for this patient and the case US2023066939 would be deleted.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Kinrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 10-MAY-2023, the patient received Kinrix. On 10-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix was administered to a patient). 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: 10-May-2023 The reporter consented to follow-up via email. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix instead of the recommeded Dtap-IPV; Kinrix + Underage administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22-MAR-2023) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix instead of the recommeded Dtap-IPV) and inappropriate age at vaccine administration (Verbatim: Kinrix + Underage administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 10-May-2023 No date of administration was gathered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Kinrix instead of the recommended Dtap-IPV vaccine at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: should restart the SHINGRIX series, due to being two months late for the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on September 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: should restart the SHINGRIX series, due to being two months late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-May-2023 The consumer who wishes to remain anonymous asking if she should restart the Shingrix series, due to being two months  late for the 2nd dose. Spoken as per package insert and content, gave medical disclaimer, referred to health care professional offered after call survey. The reporter did not consent to follow-up. 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: she have never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 22nd September 2022). Additional patient notes included the patient was immunocompetent.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she have never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-May-2023 No lot number information available at the moment of the call. The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Bone marrow transplant
Clinical narrative: Bone Marrow Transplant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of bone marrow transplant in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix, the patient experienced bone marrow transplant (Verbatim: Bone Marrow Transplant). The outcome of the bone marrow transplant was unknown.   It was unknown if the reporter considered the bone marrow transplant to be related to Shingrix.     It was unknown if the company considered the bone marrow transplant to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2023 The pharmacist reported that patient received Shingrix series approximately in 2021 and then had a bone marrow transplant September 2022.  Pharmacist does not know the indication for the transplant.  The Shingrix series was not administered at her facility, so the pharmacist did not have any records with the dates of administration or lot number information, she just knew the patient said he had the series about a year before the transplant.  The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Administration of Menveo reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA766A, expiry date 31-DEC-2023) for prophylaxis.   On 10-MAY-2023, the patient received Menveo. On 10-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Administration of Menveo reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The nurse reported that the administration of Menveo reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component.  The healthcare professional (HCP) asked how to proceed with this patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received Menveo which was reconstituted using sterile water instead of the MenCYW-135 liquid conjugate vaccine component, which led to wrong solution used in drug reconstitution.
Age: 76.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric Havrix dose to adult patient; Pediatric Havrix dose to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 76-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 06-MAY-2023, the patient received Havrix. On 06-MAY-2023, an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: Pediatric Havrix dose to adult patient) and adult use of a child product (Verbatim: Pediatric Havrix dose to adult patient). The outcome of the underdose and adult use of a child product 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: 10-MAY-2023 The pharmacist reported that a pediatric dose of Havrix was administered to an adult patient. The reporter consented to follow up via email. The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient was administered Bexsero instead of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 06-MAY-2023, the patient received Bexsero. On 06-MAY-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Patient was administered Bexsero instead of Menveo). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAY-2023 The registered pharmacist reported that a patient was administered Bexsero on Saturday instead of Menveo.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received Bexsero instead of Menveo, which led to wrong vaccine administered.
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient received a three days expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired drug administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 10-MAY-2023, the patient received Kinrix. On 10-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired drug administered (Verbatim: patient received a three days expired dose of Kinrix). The outcome of the expired drug administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-May-2023 A nurse reported that a 4 years old patient received a 3 days expired dose of Kinrix, which led to expired dose administered. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: SHINGRIX vaccine via the Subcutaneous route; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number C9Z43, expiry date 08-JUL-2024) for prophylaxis.   On 10-MAY-2023, the patient received Shingrix (subcutaneous, left arm) .5 ml. On 10-MAY-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: SHINGRIX vaccine via the Subcutaneous route). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 31-Mar-2023 Health care professional called to report an adult female received the Shingrix vaccine via the subcutaneous route on Wednesday, 10th May 2023, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T543J, expiry date 25-JAN-2025) for prophylaxis.   On 05-MAY-2023, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug 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: 31-Mar-2023 Pharmacist reports clinic experienced a temperature excursion with Kinrix vaccines on 4th May 2023 that lasted 45 minutes and reached a low temperature of -0.8 degree C.  On 5th May 2023 a dose of Kinrix was administered to 4 year old female patient.   At the time of reporting, the dose had not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: clinic experienced a temperature excursion with Kinrix vaccines; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T543J, expiry date 25-JAN-2025) for prophylaxis.   On 05-MAY-2023, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: clinic experienced a temperature excursion with Kinrix vaccines). The outcome of the incorrect storage of drug 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: 11-May-2023 Pharmacist reports clinic experienced a temperature excursion with Kinrix vaccines on 4th May 2023 that lasted 45 minutes and reached a low temperature of -0.8 degree C.  On 5th May 2023 a dose of Kinrix was administered to 4 year old female patient.   At the time of reporting, the dose had not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received Kinrix vaccine, which experienced temperature excursion, which led to incorrect storage of drug. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo dose that was reconstituted using sterile water instead of the supplied meningococcal CYW 135; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA794a, expiry date 31-JAN-2024) for prophylaxis.   On 04-MAY-2023, the patient received Menveo. On 04-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo dose that was reconstituted using sterile water instead of the supplied meningococcal CYW 135) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter called and asked for information about a Menveo dose that was reconstituted using sterile water instead of the supplied meningococcal CYW 135 (MenCYW-135) liquid conjugate vaccine component.  The reporter asked for guidance on this situation.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Menveo dose was reconstituted using sterile water instead of the supplied meningococcal CYW 135 which lead to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient got a 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number 477X5, expiry date 27-MAY-2024) for prophylaxis.   On 11-MAY-2023, the patient received the 3rd dose of Shingrix. On 11-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient got a 3rd dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter stated that a patient got a 3rd dose of Shingrix.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.  The patient administered 3rd dose of Shingrix which lead to Extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 24May2019 and is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24 May 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose of Shingrix on 24May2019 and is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-MAY-2023 HCP stated patient received her 1st dose at a different pharmacy location (not address listed for HCP). HCP did not have the patient's date of birth. HCP agreed to follow-up via postal mail. Till the time of reporting patient did not receive 2nd dose, which led to incomplete course of vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the Shingrix adjuvant to consumer; administered only the Shingrix adjuvant to consumer; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-MAY-2023, the patient received Shingrix. On 12-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the Shingrix adjuvant to consumer) and inappropriate dose of vaccine administered (Verbatim: administered only the Shingrix adjuvant to consumer). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-MAY-2023 The reporter reported that the patient administered only the Shingrix adjuvant. The reporter was consented to follow up. The patient administered only the Shingrix adjuvant, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was given just the adjuvant portion of Shingrix; patient was given just the adjuvant portion of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-MAY-2023, the patient received Shingrix. On 12-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was given just the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient was given just the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-MAY-2023 The reporter reported that the patient was given just the adjuvant portion of Shingrix and not reconstituted first with the antigen.  The pharmacist had no further information concerning the patient or vaccine itself. The reporter was consented to follow up. The patient received just the adjuvant portion of Shingrix and not reconstituted first with the antigen, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Burning feeling on skin, upper back area; This non-serious case was reported by a consumer and described the occurrence of burning sensation skin in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included blood pressure high and cholesterol. Concomitant products included amlodipine and rosuvastatin.  On 02-MAY-2023, the patient received Shingrix. On 03-MAY-2023, 1 days after receiving Shingrix, the patient experienced burning sensation skin (Verbatim: Burning feeling on skin, upper back area). The outcome of the burning sensation skin was not resolved.  It was unknown if the reporter considered the burning sensation skin to be related to Shingrix.  It was unknown if the company considered the burning sensation skin to be related to Shingrix.  Additional Information: GSK Receipt Date: 05-MAY-2023 This report was submitted by public reporting reference via the online direct entry reporting system.  The reporter had self-reported for himself and had burning feeling on skin on upper back area day after getting the vaccine but no sign of any rash. The Skin appeared to be normal. The symptoms was not treated. The reporter had consented to follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair started falling out; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (hair started falling out) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Back surgery (about 4 years ago). Concurrent medical conditions included Allergy. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ALOPECIA (hair started falling out). At the time of the report, ALOPECIA (hair started falling out) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Claritin she was taking this at the time her hair was falling out, takes when her allergies were flaring up. Allergy Drops (unknown name) will likely have to start using again in the summer.  Patient was 46 when her hair started falling out. Doctors are saying that patient are getting alopecia from wearing wigs and people are saying it was due to things without vitamin d and iron. If Patient had regular alopecia, she would have bald spots. She was so mad about her hair. She cries about all day about her hair. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723206 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2023: Live follow up- QE number updated. Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723206: Bivalent case.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute disseminated encephalomyelitis, Biopsy brain
Clinical narrative: acute disseminated encephalomyelitis; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis) in a 69-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis) (seriousness criterion medically significant). At the time of the report, ACUTE DISSEMINATED ENCEPHALOMYELITIS (acute disseminated encephalomyelitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy brain: revealed nonspecific meningoencephalitis.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Healthy patient presented with acute fever, confusion, and later progressive weakness after receiving the first dose of the mRNA-1273 (Moderna) severe acute respiratory syndrome coronavirus 2 vaccine. Considering the progressive deterioration of the patient, despite being on multiple immunosuppressive agents, a brain biopsy was obtained, which revealed nonspecific meningoencephalitis.  In this case, author highlighted the need for a regulatory framework to assist clinicians and patients with coverage of treatment for acute disseminated encephalomyelitis. The use of intravenous immunoglobulin in conjunction with glucocorticoids seems to be an effective treatment option.  Company Comment: This is a literature non-study case concerning a 69-year-old or 52 year old (the information is discrepant in the source document) male patient with no reported medical history, who experienced the serious (medically significant) unexpected event acute disseminated encephalomyelitis.  The event occurred after receiving the first dose of mRNA-1273 vaccine (vaccination and event dates were not reported). The patient presented with acute fever, confusion, and later progressive weakness after receiving the first dose of the mRNA-1273 (Moderna) severe acute respiratory syndrome coronavirus 2 vaccine. Considering the progressive deterioration of the patient, despite being on multiple immunosuppressive agents, a brain biopsy was obtained, which revealed nonspecific meningoencephalitis.  Relevant diagnostic tests included Biopsy of brain that revealed nonspecific meningoencephalitis. No concomitant and treatment medication were reported for the event. At the time of the report, the event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2, VARZOS
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; no adverse event; They kept a vial in the fridge for an extra 4 days.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They kept a vial in the fridge for an extra 4 days.), PRODUCT STORAGE ERROR (Dose administered after 30-day 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. 011H22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   On 09-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient received dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 09-May-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 (They kept a vial in the fridge for an extra 4 days.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They kept a vial in the fridge for an extra 4 days.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (They kept a vial in the fridge for an extra 4 days.) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 04-May-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 04-May-2023) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-May-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 (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 04-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 04-May-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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 30-Mar-2023 and was administered on 04-May-2023).    No concomitant medications were provided. It was administered within 5 days of the expiration of the beyond-use-date, which was 29-Apr-2023.  The vial size was 2.5 ml.  The vial was initially stored in the refrigerator on 30-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.) 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)) (batch no. AS7140C) 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 (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration 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 (A patient received 1 dose of Moderna Bivalent beyond manufacturer's expiration date.).    No concomitant medications were reported.  No treatment medications were reported.
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: No adverse event; They accidentally gave her a yellow box instead of the blue one with grey label.; The HCP determined that it was a lower-than-authorized dose given from incorrect product; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.), UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product) and NO ADVERSE EVENT (No adverse event) in a 10-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (0.25ml dose of monovalent Moderna) on 13-Apr-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 11-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 11-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.) and UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.), UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product) 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 WRONG PRODUCT ADMINISTERED (They accidentally gave her a yellow box instead of the blue one with grey label.) and UNDERDOSE (The HCP determined that it was a lower-than-authorized dose given from incorrect product).    Concomitant drugs were not reported.  It was reported that the vial was with a pink cap with yellow label. The HCP confirmed that the parents of the patient did not report any adverse reaction experienced by the patient.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Rash papular
Clinical narrative: Chronic spontaneous urticaria; pruritic eruption papules; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria) and RASH PAPULAR (pruritic eruption papules) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria) and RASH PAPULAR (pruritic eruption papules). The patient was treated with OMALIZUMAB at an unspecified dose and frequency. At the time of the report, CHRONIC SPONTANEOUS URTICARIA (Chronic spontaneous urticaria) and RASH PAPULAR (pruritic eruption papules) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash
Clinical narrative: granuloma annulare; After patient got the Moderna vaccination the second one, she developed a really bad rash that looks like ringworm almost it was all over her body; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GRANULOMA ANNULARE (granuloma annulare) and RASH (After patient got the Moderna vaccination the second one, she developed a really bad rash that looks like ringworm almost it was all over her body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 prophylaxis.     Patient had no previous allergies. No prior health conditions.  Concomitant products included PREDNISONE for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GRANULOMA ANNULARE (granuloma annulare) and RASH (After patient got the Moderna vaccination the second one, she developed a really bad rash that looks like ringworm almost it was all over her body). At the time of the report, GRANULOMA ANNULARE (granuloma annulare) and RASH (After patient got the Moderna vaccination the second one, she developed a really bad rash that looks like ringworm almost it was all over her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had rash doctor after doctor and don't know what it was. It was all over her body except her face and back. It's on her legs, arm and chest. It was not hot, does not itched and did not hurt. Not warm to the touch. Reaction started about a couple of months later after the second dose. Patient told caller the rash was flat, not raised. Caller said they could give it a name Granuloma Annulare but no idea how to get rid of it. Caller says her sister has been to a dermatologist but it won't go away. No treatment information was reported.