chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient received Moderna and still contracted COVID-19; Lack of effect / Adverse effect; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Patient received Moderna and still contracted COVID-19) and DRUG INEFFECTIVE (Lack of effect / Adverse effect) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received Moderna and still contracted COVID-19) and DRUG INEFFECTIVE (Lack of effect / Adverse effect). At the time of the report, COVID-19 (Patient received Moderna and still contracted COVID-19) and DRUG INEFFECTIVE (Lack of effect / Adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug information was provided. Patient's year of birth was 1938 It was reported by the reporter that the patient was not the only one included who got sick. No treatment drug information was provided.  Company comment: This spontaneous case concerns a male patient of about 8 decades old, with no reported medical history, who experienced the non-serious unexpected AESI of COVID 19 which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Drug ineffective was also reported as an event. Further details are not mentioned in the report. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of about 8 decades old, with no reported medical history, who experienced the non-serious unexpected AESI of COVID 19 which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Drug ineffective was also reported as an event. Further details are not mentioned in the report. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) in a 78-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. LITERATURE REFERENCE: Immune thrombocytopenia following COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia) to be related. No concomitant and treatment medication were reported. Company Comment: This literature non-study case concerns a 78-year-old, female patient with no reported medical history, who experienced an unexpected, medically significant AESI Immune thrombocytopenia following a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the event immune thrombocytopenia relative to vaccination cannot be determined with unknown event's start date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported in this case version. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement. Sender's Comments: This literature non-study case concerns a 78-year-old, female patient with no reported medical history, who experienced an unexpected, medically significant AESI Immune thrombocytopenia following a 2nd dose of mRNA-1273 vaccine. Exact onset latency of the event immune thrombocytopenia relative to vaccination cannot be determined with unknown event's start date and vaccine administration date. Further details on the medical history, clinical course, diagnostics, and treatments were not reported in this case version. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; as the second dose they received the Bivalent; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 28-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.     No Medical History information was reported.    On 12-Sep-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (as the second dose they received the Bivalent) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered).    Concomitant product use was not provided by the reporter.   The patient got Moderna monovalent as first dose on 06-Aug-2022 and on 12-Sep-2022, a floater pharmacist confused the patient's Moderna dose with a Moderna Bivalent dose in error.   The patient thus received the Bivalent as second dose.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Slight headache; slight soreness at IJ; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) and VACCINATION SITE PAIN (slight soreness at IJ) in a 56-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.     The patient's past medical history included COVID-19.    On 21-Sep-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 an unknown date, the patient experienced HEADACHE (Slight headache) and VACCINATION SITE PAIN (slight soreness at IJ). At the time of the report, HEADACHE (Slight headache) and VACCINATION SITE PAIN (slight soreness at IJ) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient took Johnson and Johnson vaccine.  Treatment information was not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Extra dose administered, No adverse event
Clinical narrative: No adverse event; receiving two doses at the same day instead of one; Accidental overdose/administration error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (receiving two doses at the same day instead of one), ACCIDENTAL OVERDOSE (Accidental overdose/administration error) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2 dosage form. On 22-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (receiving two doses at the same day instead of one) and ACCIDENTAL OVERDOSE (Accidental overdose/administration error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (receiving two doses at the same day instead of one), ACCIDENTAL OVERDOSE (Accidental overdose/administration error) 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 EXTRA DOSE ADMINISTERED (receiving two doses at the same day instead of one) and ACCIDENTAL OVERDOSE (Accidental overdose/administration error).    No concomitant medication was reported. A patient was administered 2 doses of the bivalent booster Moderna COVID19 vaccine because of an administration error on the same day. No treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Malaise, Mobility decreased, Pain
Clinical narrative: Her temperature is a little over 100/fever; had a fever since 2:30 PM; hives; ache; not feeling well; could not move her arm; a bit draggy; sore arm; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (could not move her arm), FEELING ABNORMAL (a bit draggy), PAIN (ache), MALAISE (not feeling well) and PYREXIA (Her temperature is a little over 100/fever) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 20-Sep-2022, the patient experienced PAIN IN EXTREMITY (sore arm). On 21-Sep-2022, the patient experienced MOBILITY DECREASED (could not move her arm) and FEELING ABNORMAL (a bit draggy). On 22-Sep-2022, the patient experienced PAIN (ache), PYREXIA (had a fever since 2:30 PM) and URTICARIA (hives). 22-Sep-2022, the patient experienced MALAISE (not feeling well). On 22-Sep-2022 at 2:30 PM, the patient experienced PYREXIA (Her temperature is a little over 100/fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (could not move her arm), FEELING ABNORMAL (a bit draggy), PAIN (ache), MALAISE (not feeling well), PYREXIA (Her temperature is a little over 100/fever), PAIN IN EXTREMITY (sore arm), PYREXIA (had a fever since 2:30 PM) and URTICARIA (hives) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2022, Body temperature: temperature is a little over 100.         No concomitant medication information was provided. It was reported that patient previously received 3 monovalent doses. On 15-Feb-2021, the patient received first dose of Moderna covid-19 intramuscular vaccine with lot number 013L20A.  On 15-Mar-2021, the patient received second dose of Moderna covid-19 with lot number 002A21A. On 18-Nov2021, the patient received third dose of Moderna covid-19 with lot number 065F21A. It was reported that patient had high temperature around 100.   This case was linked to MOD-2022-649157 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Her temperature is a little over 100/fever; had a fever since 2:30 PM; hives; ache; not feeling well; could not move her arm; a bit draggy; sore arm; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (could not move her arm), FEELING ABNORMAL (a bit draggy), PAIN (ache), MALAISE (not feeling well) and PYREXIA (Her temperature is a little over 100/fever) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 20-Sep-2022, the patient experienced PAIN IN EXTREMITY (sore arm). On 21-Sep-2022, the patient experienced MOBILITY DECREASED (could not move her arm) and FEELING ABNORMAL (a bit draggy). On 22-Sep-2022, the patient experienced PAIN (ache), PYREXIA (had a fever since 2:30 PM) and URTICARIA (hives). 22-Sep-2022, the patient experienced MALAISE (not feeling well). On 22-Sep-2022 at 2:30 PM, the patient experienced PYREXIA (Her temperature is a little over 100/fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (could not move her arm), FEELING ABNORMAL (a bit draggy), PAIN (ache), MALAISE (not feeling well), PYREXIA (Her temperature is a little over 100/fever), PAIN IN EXTREMITY (sore arm), PYREXIA (had a fever since 2:30 PM) and URTICARIA (hives) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2022, Body temperature: temperature is a little over 100.         No concomitant medication information was provided. It was reported that patient previously received 3 monovalent doses. On 15-Feb-2021, the patient received first dose of Moderna covid-19 intramuscular vaccine with lot number 013L20A.  On 15-Mar-2021, the patient received second dose of Moderna covid-19 with lot number 002A21A. On 18-Nov2021, the patient received third dose of Moderna covid-19 with lot number 065F21A. It was reported that patient had high temperature around 100.   This case was linked to MOD-2022-649157 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Head discomfort, Headache, Illness
Clinical narrative: head felt like a ocean; got sick; diarrhea; very very dizzy; arm hurt; nauseous; headache; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy) and PAIN IN EXTREMITY (arm hurt) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064L21A, 0466210, 038A21A and 024M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack and Stroke. Concurrent medical conditions included Asthma and COPD. Concomitant products included ATORVASTATIN, DABIGATRAN ETEXILATE MESILATE (PRADAXA), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), LURASIDONE HYDROCHLORIDE (LATUDA), ASPIRIN [ACETYLSALICYLIC ACID], SENNA ALEXANDRINA LEAF (SENNA [SENNA ALEXANDRINA LEAF]), DOCUSATE SODIUM (COLACE), CLONAZEPAM (KLONOPIN) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, 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 HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy), PAIN IN EXTREMITY (arm hurt), NAUSEA (nauseous) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy), PAIN IN EXTREMITY (arm hurt), NAUSEA (nauseous) and HEADACHE (headache) outcome was unknown.            Patient was taking two blood pressure medication as Concomitant Product.  The last one patient got was the Pfizer because patient was hoping she would not get sick but did get really sick.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: head felt like a ocean; got sick; diarrhea; very very dizzy; arm hurt; nauseous; headache; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy) and PAIN IN EXTREMITY (arm hurt) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064L21A, 0466210, 038A21A and 024M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack and Stroke. Concurrent medical conditions included Asthma and COPD. Concomitant products included ATORVASTATIN, DABIGATRAN ETEXILATE MESILATE (PRADAXA), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), LURASIDONE HYDROCHLORIDE (LATUDA), ASPIRIN [ACETYLSALICYLIC ACID], SENNA ALEXANDRINA LEAF (SENNA [SENNA ALEXANDRINA LEAF]), DOCUSATE SODIUM (COLACE), CLONAZEPAM (KLONOPIN) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, 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 HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy), PAIN IN EXTREMITY (arm hurt), NAUSEA (nauseous) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (head felt like a ocean), ILLNESS (got sick), DIARRHOEA (diarrhea), DIZZINESS (very very dizzy), PAIN IN EXTREMITY (arm hurt), NAUSEA (nauseous) and HEADACHE (headache) outcome was unknown.            Patient was taking two blood pressure medication as Concomitant Product.  The last one patient got was the Pfizer because patient was hoping she would not get sick but did get really sick.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product label confusion, Product packaging confusion, Wrong product administered
Clinical narrative: No Adverse Event; Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar).    No concomitant medications were reported. Reporter was complaining that the vial caps and labels look too similar, and reporter was requesting that Moderna to do something about the vial similarities. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow-up contains non-significant follow up -QE ID added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain
Clinical narrative: Achiness; Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achiness) and DIARRHOEA (Diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 032M20A, 032F21A and 057M21A) for COVID-19 vaccination. Concurrent medical conditions included Irritable bowel syndrome (Diagnosed many years ago). Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Irritable bowel syndrome.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, 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 PAIN (Achiness) and DIARRHOEA (Diarrhea). At the time of the report, PAIN (Achiness) and DIARRHOEA (Diarrhea) outcome was unknown. The patient called and reported that she received 5 doses of Moderna COVID-19 vaccine, 4 Monovalent and 1 Bivalent. the patient always had the same reaction after all Moderna COVID19, Diarrhea and Achiness. No treatment medications were reported.   This case was linked to MOD-2022-649195 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient received 0.25 mL of Bivalent dose instead of 0.5 mL; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) and (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis .No Medical History information was reported. On 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) and (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL) 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 (Patient received 0.25 mL of Bivalent dose instead of 0.5 mL).  No concomitant medications were reported. It was reported that, the nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, that was they were administering 0.25 mL instead of 0.5 mL to uncompromised adults. No adverse events were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Product label confusion, Product packaging confusion
Clinical narrative: No Adverse Event; Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.  No Medical History information was reported. On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow up received contains Quality complaint number was added.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster) 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 INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent vaccine given as booster).    No Concomitant medications were provided.  It was reported that reporter found out that they could not give the Moderna as a booster starting 31 Aug 2022, but administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. and told that booster that patients received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered monovalent dose as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered monovalent dose as booster) 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 (Administered monovalent dose as booster).    Concomitant product use was not provided by the reporter.  Reporter found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters.  Reporter called public health, who said there was no harm in it.   Reporter was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was administered 0.25 ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml) 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 UNDERDOSE (Patient was administered 0.25 ml instead of 0.5ml).    patient wanted to know patient need to administer the second half if it was within a period of time. Pharmacist stated he had no information on the patient.   No concomitant drug were reported.   No treatment drug were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) 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 (monovalent vaccine given as booster).    No concomitant medication was reported.  It was reported that the caller was the office manager, who had a situation and found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters.  She called public health, who said there's no harm in it. She was also told to call VAERS. She was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  No treatment medication was reported.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.; No adverse event; 1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and  (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 dose of Moderna Covid-19 vaccine (Monovalent) was given after the temperature excursion.).    No concomitant product reported by reporter. Two temperature excursions were occurred with Moderna COVID-19 vaccine (Monovalent) in the freezer. Storage condition at the time of excursion was frozen.  Vials were returned to freezer. No changes were observed upon visual inspection of the vials. No treatment medication reported by reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: lack of energy; chills; fever; sore muscles; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 prior to getting the 1st dose and stayed at home, mild symptoms). Concurrent medical conditions included Coronary artery disease and Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Cholesterol, AMLODIPINE for Coronary artery disease, ACETYLSALICYLIC ACID (BABY ASPIRIN), MAGNESIUM, ZINC, COLECALCIFEROL (VIT D [COLECALCIFEROL]) and MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles). In April 2022, ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles) had resolved.            It was reported patient could not read information on the vaccination card. There was a mention of Pfizer being given as a 1st booster dose but could not tell definitely.  It was reported that patient had same reaction with all doses after dose one on 20-Feb-2021 patient experienced chills, fever, sore muscles and lack of energy which recovered on 23-Feb-2021. After second dose patient experienced chills, fever, sore muscles and lack of energy from 20-Mar-2021 to 23-Mar-2021. After first booster patient experienced chills, fever, sore muscles and lack of energy from 02-Sep-2021 to 05-Sep-2021. Patient felt that these side effects are worse than having COVID-19. The patient did not experience a similar event in the past.  No treatment medications were reported.   This case was linked to MOD-2022-649286 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient administered monovalent dose as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered monovalent dose as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered monovalent dose as booster) 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 administered monovalent dose as booster).    No concomitant medications were provided. The HCP stated that they could not give the Moderna as a booster starting 31-Aug-2022, but they administered 15 monovalent doses as boosters. The HCP also stated some patients already had 3 boosters. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster 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 (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster) 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 (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ patient received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No adverse events were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.   This case was linked to MOD-2022-646512 (Patient Link).