chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received the product FLUZONE QUADRIVALENT HIGH DOSE, but the patient is less than 65 years old, with no reported adverse event; Initial information received on 30-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old male patient who received the product fluzone quadrivalent high dose(INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE), but the patient is less than 65 years old, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2022, the patient received a  dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ895AC, expiration date:30-Jun-2023 via intramuscular route in the left deltoid as Immunization  On 30-SEP-2022 the patient received the product fluzone quadrivalent high dose, but the patient is less than 65 years old, with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received the product FLUZONE QUADRIVALENT HIGH DOSE, but the patient is less than 65 years old, 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 guidelines. 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: RAB
Symptoms: No adverse event, Routine immunisation schedule incomplete
Clinical narrative: now a day behind on 2nd dose of the rabies vaccine. AE due to her now being off the administration schedule with no reported AE; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult female patient who was behind on the 2nd dose of the rabies vaccine. Adverse event due to her now being off the administration schedule with no reported Adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2022, the patient received a standard Dose 1 of suspect RABIES (HDC) VACCINE (Strength: standard) (Frequency: once) (lot number: not reported but has been requested) via unknown route in unknown administration site for Immunization.  On an unknown date the patient who was behind on the 2nd dose of the rabies vaccine. Adverse event due to her now being off the administration schedule with no reported Adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (routine immunisation schedule incomplete) (unknown latency).  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  At time of reporting, the outcome was 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 guidelines. 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: administering act-hib to a patient but the diluent portion of the act-hib was expired with no reported adverse event; Initial information received on 03-Oct-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 had received hib (prp/t) vaccine [Act-Hib] but the diluent portion of the Act-Hib was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient had received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection total (Lot # UJ575AA Expiration Date (Product): 07-OCT-2022 Lot # UJ575AA Expiration Date (Diluent): 20-SEP-2022) (dose, strength unknown) via unknown route in unknown administration site for Immunization but the diluent portion of the act-hib was expired with no reported adverse event (expired product administered) (latency same day).  Action: 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.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: there is leakage between the needle and syringe and probably half of the vaccine was leaked on the arm with no reported adverse event; Initial information received  on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 62 years old female patient for whom there was leakage between the needle and syringe and probably half of the vaccine was leaked on the arm with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received approximately 0.25 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7689NA and expiry date: 30-Jun-2023) (formulation and strength not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  On 03-Oct-2022, (latency: same day) there was leakage between the needle and syringe and probably half of the vaccine was leaked on the arm with no reported adverse event (incorrect dose administered) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, "medical assistant reports that she tried to give FLUZONE QUADRIVALENT in prefilled syringe to a patient but there is leakage between the needle and syringe and probably half of the vaccine was leaked on the arm".   Action taken 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.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: patient was administered expired fluzone quad (with no reported adverse event); Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves adult male patient who was administered expired 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-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at dose of 0.5 mL, once (1x) (formulation., strength: standard) (lot UJ705AB and expiry date: 30-Jun-2022)  via intramuscular route in the right deltoid for immunization which was expired with no reported adverse event expired product administered) (latency: same day).  Action taken was not applicable.  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: 4.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of vaccine post temperature excursion with no adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient for whom reporter reported administration of vaccine post temperature excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL]   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) for Immunisation; and measles vaccine live (Enders-Edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (Wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Immunisation.  HCP office inquiring about the stability of vaccines after a temperature excursion and reporting adverse events for patients who received doses post excursion.  Unopened Products: DAPTACEL, TUBERSOL, ACTHIB, IPOL, VAXELIS, MENQUADFI Opened Products: TUBERSOL and IPOL Cause: Power outage. Max/Low Temperature reached: 54.3 degrees Fahrenheit Duration out of recommended range: 2 hours and 45 minutes  On 29-Sep-2022, the patient received dose 4 of suspect IPV (VERO) at a dose of 0.5 ml (milliliter) total once Suspension for injection (lot V1A022M, expiry date - 17-Feb-2024)(strength: unknown) via subcutaneous route in the left upper arm for Immunization after post temperature excursion with no adverse event (Poor quality product administered) (latency: same day).  No lab data was reported  Action taken 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: 67.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Limb injury, Neck pain, Pain, Pain in extremity
Clinical narrative: dull ache in his left arm radiating down to his elbow and up to his shoulder and neck; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 67 years old male patient who experienced dull ache in his left arm radiating down to his elbow and up to his shoulder and neck while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT once (formulation, strength and lot number not reported) via intramuscular route in the left deltoid for prophylactic immunization.  On 29-Sep-2022, (latency: 20 minutes) the patient developed a non-serious event of dull ache in his left arm radiating down to his elbow and up to his shoulder and neck (pain) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was reported, "the caller experienced a cut on his leg during storm cleaning and went to his local Emergency Department for a tetanus shot. About 20 minutes after receiving TENIVAC, the patient reports a dull ache in his left arm radiating down to his elbow and up to his shoulder and neck for the last 5 days with little relief until today".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
Sex: U
Vaccine: FLUC3
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) via Regulatory Authority (reference number: SEQW22-03412) and concerned a patient of unspecified age and gender.  The patient's concurrent condition included dementia. The patient's past medical history included a stroke. The patient's concomitant medications included all the medication pertaining to the aftermath of a stroke.  On 20-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and types B. The batch number reported was AS1596C and expiry date 30-Jun-2023. The reporter stated that the vaccination went normal as always.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Flucelvax Quadrivalent, the patient developed nausea and diarrhea. The patient was given 7up and acid as a corrective treatment.   On the same date, the patient recovered from both events. As reported, the patient no longer had these symptoms.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked to the cases 202204734, 202204735, 202204736, 202204737, 202204738, 202204739 and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Flucelvax Quadrivalent due to plausible temporal relationship.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse (reference number: SEQW22-03395) and concerned a 67-years-old, female patient.  The patient's concurrent condition included diabetes. The patient's concomitant medications were not reported.   On 21-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and types B. The batch number reported was 346341 and the expiry date 28-Apr-2023. The reporter stated that the vaccination went normal as always.   On the same day, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient developed nausea and diarrhea. The patient was given 7up and acid as a corrective treatment. Also, a couple of patients did receive anti-diarrhea pills.  On the same date, the patient recovered from both events. The patient no longer had these symptoms.   The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked to the cases 202204733, 202204735, 202204736, 202204737, 202204738, 202204739 and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to a plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to a plausible temporal relationship.
Sex: U
Vaccine: UNK
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22- 03395) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported. It was reported that some of patients were diabetic, however, it was not specified whether this patient was diabetic.   On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza. The batch number reported was 346341 and expiry date was 28-Apr-2023.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient experienced nausea and diarrhea. Nurse Practitioner claimed that as they were nauseated, they gave the patient 7up and an acid. Also, couple of patients did receive anti-diarrhea pills.  On the same day, the patient recovered from both events. The patient no longer had these symptoms.  The reporter did not provide causality assesment.   The case was assessed as non-serious.  This case is linked with the cases 202204733, 202204734, 202204736, 202204737, 202204738, 202204739, and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22-03395) and concerned a 67-years-old female patient.  The patient's concurrent condition included diabetes. The patient's concomitant medications were not reported.  On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. The batch number reported was 346341, and expiration date 28-Apr-2023. The reporter stated that the vaccination went normal as always.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient developed nausea and diarrhoea. It was reported that the patient was given 7up and acid and couple of them received anti-diarrhoea pills as treatment.   On the same date, the patient recovered from the events of nausea and diarrhea. The patient no longer had these symptoms.   The reporter did not provide casualty assessment.   The reporter assessed the case as non-serious.  This case is linked to the cases 202204733, 202204734, 202204735, 202204737, 202204738, 202204739 and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Sex: U
Vaccine: UNK
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22-03395) and concerned a patient of an unspecified age and gender.  The patients' medical history and concomitant medications were not reported. It was reported that some of patients were diabetic, however, it was not specified whether this patient was diabetic.   On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location and indication: not reported). The batch number reported was 346341 and expiration date: 28-Apr-2023.   On 21-Sep-2022, 18h to 24h (during the night) after receiving Fluad Quadrivalent, the patient experienced nausea and diarrhoea. Nurse Practitioner claimed that as they were nauseated, they gave the patient 7up and an acid. Also, couple of patients did receive anti-diarrhea pills.  On the same day, the patient recovered from the events. The patient no longer had these symptoms.  The reporter did not provide cusality assessment.  The case was assessed as non-serious.  This case is linked with the cases 202204733, 202204734, 202204735, 202204736, 202204738, 202204739, and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Sex: U
Vaccine: UNK
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22-03395) and concerned a patient of unspecified age and gender.  The patient's medical history and concomitant medications were not reported. It was reported that some of patients were diabetic, however, it was not specified whether this patient was diabetic.   On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 346341, and expiration date 28-Apr-2023. The reporter stated that the vaccination went normal as always.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient developed nausea and diarrhea. The patient was given 7up and acid as treatment. Also, couple of patients did receive anti-diarrhea pills.  On the same day, the patient recovered from the events. The patient no longer had these symptoms.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  This case is linked with the cases 202204733, 202204734, 202204735, 202204736, 202204737, 202204739, and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pericarditis
Clinical narrative: SHORTNESS OF BREATH; RECURRENT PERICARDITIS; This 60-year-old, female subject (US3262125) was participating in a study (mRNA-1273-P301) and experienced shortness of breath and recurrent pericarditis.    The subject's medical history, as provided by the investigator, included anxiety, restless leg syndrome, seasonal allergies, and postmenopausal. Concomitant medications reported included fluoxetine, ropinirole, and cetirizine hydrochloride.   The subject previously experienced the serious adverse event of shortness of breath (MOD-2022-640460).  Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3, booster) for SARS-CoV-2 vaccination on 27 Oct 2021, approximately 10 months and 21 days before onset of the event.  On 16 Sep 2022, the subject experienced shortness of breath and recurrent pericarditis and was admitted to the hospital. Treatment for the event was not provided.  On 22 Sep 2022, the subject was discharged from the hospital.  On 29 Sep 2022, the subject completed the study.   No action was taken with the study drug in response to the events.   The event, shortness of breath, was reported as resolved on 22 Sep 2022.  The event, recurrent pericarditis, was reported as not resolved.   The investigator assessed the event, shortness of breath and recurrent pericarditis, as not applicable to study drug and not applicable to study procedure.  Follow-up received on 03 Oct 2022 included new event (recurrent pericarditis).   Company Comment: This case concerns a 60-year-old, female subject with a medical history of anxiety, restless leg syndrome, seasonal allergies, and postmenopausal, who experienced the unlisted event shortness of breath and the expected adverse event recurrent pericarditis. The event shortness of breath occurred 2 years 1 month 8 days after the first dose of mRNA-1273 and 10 months 21 days after third (booster) dose. The event recurrent pericarditis occurred 2 years 1 month 8 days after the first dose of mRNA-1273 and 10 months 21 days after third (booster) dose. The event shortness of breath was reported as resolved and the event recurrent pericarditis was reported as not resolved.  The investigator assessed the events as not applicable to IP. The sponsor assessed the events as unrelated to IP in the context of the limited information on subject previous pericarditis history, medical history, other diagnostic reports, reported clinical evaluations included physical exams, lab tests, EKG, Echocardiogram, and cardiologist consultation. Further information will be requested.
Age: 32.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: No adverse event; Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose).    No concomitant medications were reported.  It was reported that  less than half of the liquid vaccine dose leaked out, on the patient's arm and the patient had not receive a full dose of bivalent booster.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2022: Live follow up received contains additional reporter added, patient information, suspect drug information were added. Narrative updated.
Age: 32.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Only 2/3 of the solution was given/ 1/3 of the solution rolled down the arm / patient had not received a full dose).    No concomitant medications were reported.  It was reported that  less than half of the liquid vaccine dose leaked out, on the patient's arm and the patient had not receive a full dose of bivalent booster.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2022: Live follow up received contains additional reporter added, patient information, suspect drug information were added. Narrative updated.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, Medication error
Clinical narrative: No adverse event; patient received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) 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 (patient received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medication information provided.  It was reported that patient had 0.5 ml of a regular Moderna booster.  No treatment information provided.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) 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 (patient received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medication information provided.  It was reported that patient had 0.5 ml of a regular Moderna booster.  No treatment information provided.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, Medication error, Product label confusion, Wrong product administered
Clinical narrative: No adverse event; patient received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) 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 (patient received 0.5 ml the Moderna booster as opposed to the bivalent).    Concomitant medications were not reported.  The patient's Covid 19 vaccination history was unavailable.  No treatment information was provided by the reporter.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) 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 (patient received 0.5 ml the Moderna booster as opposed to the bivalent).    Concomitant medications were not reported.  The patient's Covid 19 vaccination history was unavailable.  No treatment information was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: I run a satellite clinic currently and receive necessary doses of vaccines from the main Clinic. I was sent 1 bottle of monovalent Moderna vaccine. I had 1 pt on the schedule for an initial vaccination. This patient and his wife came in desiring boosters of Covid vaccine. He reports receiving 2 doses of Pfizer last year.  I explained we didn't have the multivalent dose as I was told it was not available yet, and received just the monovalent vaccine. The patient and his wife both elected to receive this vaccine and would wait for the multivalent vaccine when it was available. I was asked by the clinic to submit this variance report.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: I am in a satellite clinic of the local Memorial group and receive the Covid vaccinations every other Wednesday from the local clinic for that day's vaccination clinic. On this day I had 1 pt scheduled for a first time Covid vaccine and received 1 bottle of monovalent Moderna. This patient came in requesting vaccination. We discussed we didn't have the multivalent vaccine and shared the information we received from the local clinic that we didn't know when we would receive it. The pt decided to receive the booster dose of monovalent Moderna and then wait for the multivalent dose when it was available. After the dose was administered we were made aware that the multivalent dose was available but not sent to us.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Rash and hives (itchy) on neck, abdomen, torso, arms, waist and upper legs.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; administration of improperly stored vaccine; This spontaneous report was received from a healthcare business professional referring to a 18-month unknown gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 13-SEP-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dosage form, lot #T026960, expiration date: 17-MAR-2023, administered for prophylaxis (strength and route of administration were not provided) after temperature excursion 32.5 Fahrenheit (F) for 6 hours 12 minutes (product storage error). It was not reported if there was previous temperature excursion. No additional adverse events were reported (no adverse event).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2020, the patient experienced PAIN IN EXTREMITY (Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot). At the time of the report, PAIN IN EXTREMITY (Mild Sore Arm after first primary dose/ Little More Sore Arm than Flu Shot after first primary shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-655011 (E2B Linked Report). This case was linked to MOD-2022-654972, MOD-2022-654973 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-655011:other patient case
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little pain on injection site after first primary shot/Little pain on injection site after 2nd primary shot/Little pain on injection site after first Monovalent Booster/Little pain on injection site after 2nd  Monovalent Booster; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Little pain on injection site after first primary shot/Little pain on injection site after 2nd primary shot/Little pain on injection site after first Monovalent Booster/Little pain on injection site after 2nd  Monovalent Booster) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Little pain on injection site after first primary shot/Little pain on injection site after 2nd primary shot/Little pain on injection site after first Monovalent Booster/Little pain on injection site after 2nd  Monovalent Booster). At the time of the report, VACCINATION SITE PAIN (Little pain on injection site after first primary shot/Little pain on injection site after 2nd primary shot/Little pain on injection site after first Monovalent Booster/Little pain on injection site after 2nd  Monovalent Booster) outcome was unknown.            No concomitant products were reported.  Patient received two primary and two Monovalent boosters and a Bivalent shot. Patient took bivalent booster dose On 04Oct2022 (Lot number AS7162B & Exp. Date 20MAY2023). Patient stated, that the receipt for the Bivalent shot states, Bivalent Booster and has an NDC number on it. Patient stated, that he did not have any side effects after the Bivalent shot. He had a little pain on injection site after the first 4 shots.  No treatment drugs were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Patient potentially received 2 doses per month for 1st and second dose.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient potentially received 2 doses per month for 1st and second dose.).    No concomitant medications were reported. It was reported that vaccine system patient was vaccinated with Moderna monovalent vaccine on 9-Jan2-021, 13-Jan-2021, 06-Feb-2021, 17-Feb2021. Patient informed that she did not received 2 vaccines in the same month, and presented the card which shows 9-Jan-2021, 06-Feb-2021, and 30-Oct-2021. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site after bivalent vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site after bivalent vaccine) 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)) for COVID-19 prophylaxis.  Concurrent medical conditions included Cancer.    On 28-Sep-2022, the patient received fourth 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 VACCINATION SITE PAIN (soreness at the injection site after bivalent vaccine). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site after bivalent vaccine) outcome was unknown. No concomitant medications were reported. It was reported that patient took First dose of Moderna vaccine on 04-Feb-2021, Lot number:011M20A, Dose: 0.5ml. Second dose of Moderna vaccine on 04-Mar-2021, Lot number: 003A21A, Dose: 0.5ml. Third dose of Moderna vaccine (Booster 1) on 17-Nov-2021, Lot number: 004C21A. No treatment medications were reported.   This case was linked to MOD-2022-651191 (Patient Link).