chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: double dose of fluzone quad with no adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who received double dose of Influenza quadrival A-B vaccine [Fluzone Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Sep-2022, the patient received a dose 1 of Influenza quadrival A-B vaccine, suspension for injection (lot UT7683JA; Expiry date. 30-Jun-2023) via intramuscular route in the right arm  and  on 31-Oct-2022 she also received a dose 2 of the same vaccine (lot UT7683JA; Expiry date. 30-Jun-2023) via intramuscular route in the right arm for immunization double dose of fluzone quad with no adverse event (extra dose administered).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Autoimmune disorder, Neuralgia
Clinical narrative: autoimmune problem of nerve pain throughout her body/autoimmune symptoms were worsening; autoimmune symptoms were worsening; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced autoimmune problem of nerve pain throughout her body/autoimmune symptoms were worsening after receiving vaccine Influenza Vaccine.  The patient's past vaccination(s) included COVID-19 VACCINE  (did not respond well to the COVID vaccine and it caused the autoimmune problem of nerve pain throughout her body). The patient's past medical history, medical treatment(s) and family history were not provided.    On an unknown date, , the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed autoimmune problem of nerve pain throughout her body/autoimmune symptoms were worsening (neuralgia) (condition aggravated) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient was inadvertently given the fluzone hd, with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 62 year old male patient who was inadvertently given the Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect Influenza Quadrival A-B High Dose HV Vaccine at a dose of 0.7 ml (lot UJ918AD, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for immunization.  On an unknown date the patient was inadvertently given the fluzone hd, with no reported adverse event (product administered to patient of inappropriate age) (same day latency).   Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inappropriate administration of ACTHIB to a patient after it had expired with no reported adverse event; Initial information was received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported inappropriate administration of hib (prp/t) vaccine [ACT-HIB] after it had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect hib (prp/t) vaccine powder and solvent for solution for injection (lot UJ584AAA, expiry date - 16-Oct-2022) via unknown route in unknown administration site (strength, dose, frequency: unknown) for Immunization.  On an unknown date the patient reported a non-serious event of inappropriate administration of hib (prp/t) vaccine after it had expired with no reported adverse event (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, UNK
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong product administered
Clinical narrative: 4 month old was given quadracel instead of pentacle (1 ml instead of 0.5ml) with no reported adverse event; 4 month old was given quadracel instead of pentacle (1 ml instead of 0.5ml) with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4-month-old female patient who was given DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (1 ml instead of 0.5ml) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation..  On 01-Nov-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation, dose, route: unknown) (lot number: C5916AA and expiry date: unknown) via intramuscular route in the left thigh for prophylactic vaccination and on the same day 4 month old was given quadracel instead of pentacle (1 ml instead of 0.5ml) with no reported adverse event (extra dose administered), (wrong product administered) (latency same day).   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for both events    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of ACTHIB was administered with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), both for Immunization.  On 01-Nov-2022, the patient received 0.5 mL of Booster (dose 4) of suspect HIB (PRP/T) VACCINE (lot UJ594AAA and expiry date: 26-Oct-2022) via intramuscular route in the left thigh for prophylactic immunization.  On 01-Nov-2022, (latency: same day) an expired dose of acthib was administered with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 8-year old receives quadracel with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old and unknown gender patient who was administered with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 8 year old patient who received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry: unknown) (product administered to patient of inappropriate age) (dose, formulation and strength: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event 8-year old receives quadracel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurses gave her an expired dose of FLUZONE QIV NP with no reported adverse event; Initial information received  on 03-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 58 years old female patient who reported nurses gave her an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 03-Nov-2022, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (lot UT7384KA; expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 03-NOV-2022 the patient reported a non-serious event nurses gave her an expired dose of INFLUENZA QUADRIVAL A-B VACCINE with no reported adverse event (expired product administered).  Action taken: not applicable.   At time of reporting, the outcome was Not Recovered / Not Resolved for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: given an expired ACTHIB vaccine,with no reported adverse event; Initial information received on 04-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was given an expired acthib (HIB (PRP/T) VACCINE) vaccine,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 03-Nov-2022, the patient received a first dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot UJ600AAB, expiration date: 29-Oct-2022 via intramuscular route in the left thigh as Immunization    On 03-NOV-2022 the patient was given an expired acthib vaccine,with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  A nurse looked at the actual powder component which expires on 30Nov2022. This was realized after the injection. Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (given an expired ACTHIB vaccine,with no reported adverse event).  At time of reporting, the outcome was Unknown for the event     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Discomfort; Arm pain; The student nurse aimed very high on my shoulder/thinks that Fluad was administered to high/ Near the shoulder; This spontaneous case was received on 25-Oct-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-05011) and concerned a 74-year-old, male patient.  The patient's medical history and concomitant medication were not reported.  On an unspecified day in Oct-2022, between 16-Oct-2022 and 22-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4; dose: 0.5 ml, route of administration, anatomical location: not reported) for prevention of influenza disease. The batch number was not reported. As it was reported that the student nurse administered Fluad to high on patient shoulder (explicitly coded as 'Vaccine administered at inappropriate site').  On unspecified date in Oct-2022, between 16-Oct-2022 and 22-Oct-2022, after vaccine administration, the patient experienced discomfort and pain in the arm. The patient had to take ibuprofen for the arm pain.  On an unspecified date, reported as three days after onset, the patient recovered from the event of discomfort.  The outcome of the event of pain in arm was unknown.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 74-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As it was reported that the student nurse administered Fluad to high on patient shoulder (explicitly coded as 'Vaccine administered at inappropriate site'). An unknown amount of tie after vaccination the patient developed discomfort and pain in arm. Causality for vaccine administered at inappropriate site is assessed as not related. Causality for the remaining events could not be ruled out and is assessed as possibly related.; Reporter's Comments: .; Sender's Comments: A 74-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. As it was reported that the student nurse administered Fluad to high on patient shoulder (explicitly coded as 'Vaccine administered at inappropriate site'). An unknown amount of tie after vaccination the patient developed discomfort and pain in arm. Causality for vaccine administered at inappropriate site is assessed as not related. Causality for the remaining events could not be ruled out and is assessed as possibly related.
Age: 90.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Hypersensitivity, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Bad injection site reaction (arm got red); Bad injection site reaction (arm got red); Hypersensitivity; This spontaneous case was received on 26-Oct-2022 from other healthcare professional via Communications (reference number: SEQW22-05058) and concerned a 90-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date in 2022, an unspecified amount of time after receiving Flucelvax Quadrivalent, the patient experienced bad injection reaction/hypersensitivity (arm got red).  At the time of reporting, the outcome of the events was not reported.  The reporter assessed the events of hypersensitivity, vaccination site erythema and vaccination site reaction as related to Flucelvax Quadrivalent, as it was reported that the patient had bad reaction to the Flucelvax.  The case was assessed as non-serious.  Company comment: The events of hypersensitivity, vaccination site erythema and vaccination site reaction are assessed as related to Flucelvax Quadrivalent due to plausible temporal relationship.; Reporter's Comments: The reporter assessed the events of hypersensitivity, vaccination site erythema and vaccination site reaction as related to Flucelvax Quadrivalent, as it was reported that the patient had bad reaction to the Flucelvax.; Sender's Comments: The events of hypersensitivity, vaccination site erythema and vaccination site reaction are assessed as related to Flucelvax Quadrivalent due to plausible temporal relationship.
Age: 78.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Excruciate pain on the rigth hip that extends to bellow the rigth knee/Pain had an intensity of 8-9; This spontaneous case was received on 01-Nov-2022 from consumer via Communications (reference number: SEQW22-05290) with name of the vaccine reported by a pharmacist, and concerned a 78-year-old, male patient.  The patient's concurrent conditions included high blood pressure, high cholesterol, high triglycerides, and chronic obstructive pulmonary disease (COPD). The patient's past medical procedures included two hip replacement, one knee replacement (right knee). The patient's historical conditions included a stroke. The patient's concomitant medications included albuterol for chronic obstructive pulmonary disease and unspecified medications for high blood pressure, high cholesterol, and high triglycerides.  On 24-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration, anatomical location, and dose: not reported) for prevention of influenza disease. The batch number was not reported.  On Wednesday, 26-Oct-2022, two days after receiving Fluad Quadrivalent, the patient started to feel an excruciate pain on the right hip that extended to bellow the right knee (hip and knee were both artificial). The patient stated that his pain, on a scale from 0 (no pain) -10 (extreme), had an intensity of 8-9.  On unspecified date in 2022, the patient went to emergency care and there it was prescribed Robaxin (methocarbamol) and prednisone.  At the time of initial reporting, the patient had not recovered from the event.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: The event of 'arthralgia' is assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The event of 'arthralgia' is assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Started to feel itchy; Welts all over her body; This spontaneous case was received on 01-Nov-2022 from other healthcare professional via Med Communications (reference number: SEQW22-05304) and concerned a 67-year-old, female patient.  The patient's concurrent condition included possibly allergy to Fentanyl. The patient's concomitant medications were not reported.  On 22-Nov-2010, the patient was vaccinated with Fluvirin (influenza vaccine inact sag 3v; dose: reported as 0.5 ml; route of administration: intramuscular, and anatomical location: not reported) for prevention of influenza disease. The batch number reported was U3719AA and expiry date was 13-Jun-2011.  On the same date, at night, after receiving Fluvirin, the patient experienced itchy and welts all over body. The patient visited doctor and it was prescribed with some medications.  On an unspecified date in Nov-2010, the patient recovered from the events. As it was reported that symptoms disappeared after a few days.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The events of hives and welts are assessed as possibly related to Fluvirin due to plausible temporal relationship.; Sender's Comments: The events of hives and welts are assessed as possibly related to Fluvirin due to plausible temporal relationship.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs/no PQCs.; HCP called in and reported that an expired dose of VARIVAX was administered on 10/31/2022. Caller did not report any temperature excursion.; This spontaneous report was received from a nurse referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 31-OCT-2022, the patient was vaccinated with a expired second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1742084 has been verified to be a valid lot number with expiration date reported and established as 05-OCT-2022) (dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis (expired product administered). There was not any temperature excursion reported. No additional adverse events were reported.; Sender's Comments:  US-009507513-2211USA000204:
Age: 0.25
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Crying, Irritability, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Fluarix administred at 3month old; Crying; Fever; Irritability; This case was reported by a consumer via other manufacturer and described the occurrence of crying in a 3-month-old male patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included flu seasonal tiv dresden pre-filled syringe device (Fluarix Pre-Filled Syringe Device) injection syringe for prophylaxis and INFLUENZA VACCINE INACT (FLUZONE QUADRIVALENT) for prophylaxis.   Additional patient notes included Race   On an unknown date, the patient received Fluarix, Fluarix Pre-Filled Syringe Device and FLUZONE QUADRIVALENT .5 ml. On 28th September 2022, less than a month after receiving Fluarix and Fluarix Pre-Filled Syringe Device, the patient experienced crying, fever and irritability. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the crying, fever and irritability were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   The reporter considered the crying, fever and irritability to be related to Fluarix and Fluarix Pre-Filled Syringe Device.   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: 01-NOV-2022 Reporter's Comments: The reporter reported that the patient was crying, had fever and irritability while receiving vaccine Fluarix and fluzone quadrivalent. The patient's past medical history, medical treatment, vaccination and family history were not provided. On 28th September 2022 the patient was crying, fever and irritability. It was not reported, if the patient received a corrective treatment for the event. Additional Supportive Information: The patient received Fluarix at 3 months of age, which led to Inappropriate age at vaccine administration. The reporter considered the crying, fever and irritability to be related to FLUZONE QUADRIVALENT.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: patients who received 2 doses and ENGERIX-B and never got 3rd dose.; This case was reported by a nurse via other manufacturer and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st and 2nd dose received on an unknown date.).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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 :01-NOV-2022 Reporters comment: The nurse reported that the several s patients received 2 doses and ENGERIX-B and did not received 3rd dose.  No additional adverse event reported.  No PQC reported.  No further information was provided. Additional Supportive information: Till the time of reporting, the patients did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. This case has been linked to the US2022158108 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022158108:same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) 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 WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    Concomitant medications were not reported.   The patient received Moderna Covid-19 vaccine monovalent instead of the bivalent dose for their booster dose. This happened  because the monovalent vaccine with the purple border is labeled booster doses.   Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion).    No concomitant product was reported.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures. Patient received the vaccine after a temperature excursion. Storage condition at the time of the excursion was frozen. Temperature was unknown and only manual recording of temperature was done twice a day. Vials were within unbroken cartons and were of the size 2.5 ml and 5.5 ml. The vials were returned to the freezer and were still frozen.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion).    Concomitant product use was not provided by the reporter.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures.  Patient received the vaccine after a temperature excursion. Storage condition at the time of the excursion was frozen. Temperature was unknown and only manual recording of temperature was done twice a day.  Vials were within unbroken cartons and were of the size 2.5 ml and 5.5 ml.  The vials were returned to the freezer and were still frozen.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the vaccination after a temperature excursion; Patient received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion).    No concomitant medication was reported.  No treatment medication was reported. The facility had a temperature excursion in the freezer. RA was not recording the temperatures and needed a viability letter from Moderna about further steps to be done.  The vial was stored in the freezer nad the vaccine was still frozen. The vial size was 2.5 ml or 5.5 ml.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: received the vaccination after a temperature excursion; received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (received the vaccination after a temperature excursion).    No concomitant medication were reported.  The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures At the time of the excursion vaccine was in frozen storage. Unbroken Cartons with vial size of 2.5 mL and 5.5 mL . Maximum or minimum temperatures reached was unknown, only had manual twice a day recording. The Excursion duration was Unknown. The vials were Returned to the freezer at the time of reporting. Upon visual inspection vaccine state change was still frozen. No treatment information was provided by the reporter.