chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Hypertension, Hypotension, SARS-CoV-2 test
Clinical narrative: Blood pressure went sky-high/Still had occasional high blood pressure; Blood pressure went low; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood pressure went sky-high/Still had occasional high blood pressure), HYPOTENSION (Blood pressure went low) and COVID-19 (COVID-19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 061E21A, 038A21A and 007M20A) for COVID-19 vaccination.     The patient had no allergies.  Concurrent medical conditions included Low blood pressure.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced HYPERTENSION (Blood pressure went sky-high/Still had occasional high blood pressure) and HYPOTENSION (Blood pressure went low). In 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIFEDIPINE at a dose of 10 milligram. At the time of the report, HYPERTENSION (Blood pressure went sky-high/Still had occasional high blood pressure) had not resolved and HYPOTENSION (Blood pressure went low) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170 and 140. On an unknown date, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  This event caused patient to visit the emergency room , they monitored her and said her blood pressure was 170 . They monitored her until it was on 140 and then she got released.  Company Comment: This is a spontaneous case, concerning a 49-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected of COVID-19, in an unknown date, in the context of the administration of the second booster dose of the mRNA-1273 vaccine (of a correct primary dose administered). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-646305 (Patient Link). Sender's Comments: This is a spontaneous case, concerning a 49-year-old female patient, with no relevant medical history reported, who experienced the non-serious unexpected of COVID-19, in an unknown date, in the context of the administration of the second booster dose of the mRNA-1273 vaccine (of a correct primary dose administered). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse
Clinical narrative: Multiple sclerosis relapse; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Secondary progressive multiple sclerosis.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis relapse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's past medical history was not reported. No concomitant product was reported. No treatment information was reported. Company Comment This spontaneous case concerns a 47-years-old female patient, with medical history of Secondary progressive multiple sclerosis who experienced the unexpected seriousness criterion medically significant AESI of Multiple sclerosis relapse approximately 3 months after a dose of  mRNA-1273 vaccine.  The medical history of Secondary progressive multiple sclerosis is a contributor for the event. At the time of the report, the events outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 47-years-old female patient, with medical history of Secondary progressive multiple sclerosis who experienced the unexpected seriousness criterion medically significant AESI of Multiple sclerosis relapse approximately 3 months after a dose of  mRNA-1273 vaccine.  The medical history of Secondary progressive multiple sclerosis is a contributor for the event. At the time of the report, the events outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Fatigue, Feeling abnormal
Clinical narrative: diagnosed with COVID; felt worse than normal / body felt strange; Did not had any energy; a bit more tired than usual; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (diagnosed with COVID), FEELING ABNORMAL (felt worse than normal / body felt strange), ASTHENIA (Did not had any energy) and FATIGUE (a bit more tired than usual) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 037C21A, 007B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2022, the patient experienced COVID-19 (diagnosed with COVID), FEELING ABNORMAL (felt worse than normal / body felt strange), ASTHENIA (Did not had any energy) and FATIGUE (a bit more tired than usual). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. On 30-Jul-2022, COVID-19 (diagnosed with COVID), FEELING ABNORMAL (felt worse than normal / body felt strange), ASTHENIA (Did not had any energy) and FATIGUE (a bit more tired than usual) had resolved.            No concomitant medications were provided by the reporter.  It was reported that symptoms lasted for about 5 days and took Paxlovid to treat COVID.  Company Comment: This spontaneous case concerns a 78-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of feeling abnormal, asthenia and other expected event approximately 3 months after 4th. dose of  mRNA-1273 vaccine. The patient was treated with PAXLOVID for 5 days. At the time of the report, the events had resolved. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.   Reporter did not allow further contact; Sender's Comments: Company Comment: This spontaneous case concerns a 78-years-old female patient, with no medical history reported who experienced the unexpected AESI of Covid-19, the unexpected events of feeling abnormal, asthenia and other expected event approximately 3 months after 4th. dose of  mRNA-1273 vaccine. The patient was treated with PAXLOVID for 5 days. At the time of the report, the events had resolved. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  Concurrent medical conditions included Heart disorder (Congested heart disease).  On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) was resolving.  No concomitant medications were reported. On 29-Apr-2022, the patient received second booster dose of Moderna COVID-19 vaccine. The patient developed pneumonia with very severe symptoms just after receiving the second booster dose of Moderna vaccine. Currently, the patient started getting the patient's strength back. The patient was very concerned and was hesitant on receiving another Omicron variant vaccine booster dose after suffering like the previous time. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 73-years-old patient, with medical history of Congested heart disease who experienced the unexpected seriousness criterion medically significant event of pneumonia unknown days after a dose of mRNA-1273 vaccine.  At the time of the report, the events was resolving. The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 73-years-old patient, with  medical history of Congested heart disease who experienced the unexpected seriousness criterion medically significant event of pneumonia unknown days after a dose of  mRNA-1273 vaccine.  At the time of the report, the events was resolving.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml 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 INCORRECT DOSE ADMINISTERED (A patient who received a 0.25ml dose of the Moderna Covid-19 vaccine bivalent booster instead of 0.5ml dose).    No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ADVERSE EVENT (patient was in the hospital due to an unrelated reason, but after the 1st dose of Moderna) to be not related.    No concomitant medication details were provided. No treatment medication details were provided.   Patient was waiting to be discharged to a nursing home but no nursing home was willing to take her, if she does not receive her 2nd dose of the Moderna COVID-19 vaccine prior to discharge from the hospital. Patient had already received her 1st dose of Moderna and HCP was looking to see if the patient can receive her 2nd dose prior to the recommended period of 28 days.   HCP had some guidance from early 2021 and wants to know if the guidance remains the same or was there new, updated information for flexibility in vaccine scheduling.  Company Comment This spontaneous case concerns an unknown-years-old female patient, with  no medical history reported who experienced the unexpected seriousness criterion hospitalization event of adverse event unknown days after 1st. dose of  mRNA-1273 vaccine.  At the time of the report, the event outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old female patient, with  no medical history reported who experienced the unexpected seriousness criterion hospitalization event of adverse event unknown days after 1st. dose of  mRNA-1273 vaccine.  At the time of the report, the event outcome was unknown.   The benefit-risk relationship of mrna-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Vomiting
Clinical narrative: chills; nausea; vomiting; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches) in a male patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches). At the time of the report, CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was provided by reporter.  Patient reported that 1 day in bed and muscle aches. He said this symptoms lasted 3 days.  No treatment medication was provided by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 11:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Sep-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Punctured initially at 6:15 PM last night and then was administered at 11:00 AM this morning).    No concomitant medications were reported. On 06-Mar-2021 (lot number 048A21A, expiration date unknown), patient received first dose intramuscularly. On 03-Apr-2021 (lot number 006B21A, expiration date unknown) patient received second dose intramuscularly.  On 23-Oct-2021 (lot number 017F21A, expiration date unknown) patient received third dose intramuscularly.  On 06-Apr-2022 (lot number 002M21A, expiration date unknown), patient received fourth dose intramuscularly. On 18-Sep-2022, a dose of vaccine was taken out at 5:00 PM, punctured initially at 6:15 PM and then was administered at 11:00 AM next morning. Vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriosclerosis, Chest pain, Hyperlipidaemia
Clinical narrative: high cholesterol; plaque in her arteries; chest pain; This spontaneous case was reported by a patient and describes the occurrence of HYPERLIPIDAEMIA (high cholesterol), ARTERIOSCLEROSIS (plaque in her arteries) and CHEST PAIN (chest pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 prophylaxis.     It was reported that patient had never diagnosed with COVID.  Concurrent medical conditions included Drug allergy (Salicylates aspirin.), Sulfonamide allergy (Sulfa drugs) and Incontinence. Concomitant products included OXYBUTYNIN for Incontinence.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced HYPERLIPIDAEMIA (high cholesterol), ARTERIOSCLEROSIS (plaque in her arteries) and CHEST PAIN (chest pain). The patient was treated with ATORVASTATIN ongoing since an unknown date for Cholesterol, at a dose of Atorvastatin (Lipitor). At the time of the report, HYPERLIPIDAEMIA (high cholesterol), ARTERIOSCLEROSIS (plaque in her arteries) and CHEST PAIN (chest pain) outcome was unknown.            It was reported that patient had never had COVID positive test. Patient had never had any acute and Chronic illnesses at the time of vaccination. No other vaccines given within one month prior to Moderna COVID-19 vaccine. It was reported that the patient had not experienced a similar event in the past.  The doctor said that this could be developing chest pain since she was young because of her dietary habits.  It was reported that the medicine for high cholesterol gave her feet pain and swelling in the feet.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; 5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose; 2nd primary dose was administered prior to the recommended interval of 4 weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks) 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 DOSE ADMINISTERED (5 year old received the 6 years to 11 years of age Moderna COVID-19 vaccine as their 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was administered prior to the recommended interval of 4 weeks).    No concomitant products were reported.  it was reported 2 different incidents with administration errors. No treatment drugs were reported
Sex: U
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary dose) 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 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 an unknown date, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary 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 INCORRECT PRODUCT FORMULATION ADMINISTERED (Bivalent dose administered instead of the monovalent as 2nd primary dose). No concomitant medications were reported. No treatment information was provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; Bivalent booster vaccine administered instead of Monovalent booster; Bivalent booster vaccine administered to 17 year old patient instead of Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent) and NO ADVERSE EVENT (No adverse event) in a 17-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 vaccination.     No Medical History information was reported.    In September 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. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent) 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 (Bivalent booster vaccine administered instead of Monovalent booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 17 year old patient instead of Monovalent).    No concomitant medication was reported.   Pharmacist reported that 17 year old patient received a Bivalent Moderna COVID-19 vaccine about 1 week ago from the day of reporting instead of the Monovalent booster and stated that all previous doses of COVID-19 vaccine for this patient were Moderna.  Reporter did not remember if it was the patients first booster or 2nd booster.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The reporter saw a doctor who posted that he experienced tinnitus himself. He said that it would take about a year for it to go away. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin; Stomach upset,GI discomfort,queasy stomach; Move her bowels and her stools, patient noted are looser that normal; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset,GI discomfort,queasy stomach), DIARRHOEA (Move her bowels and her stools, patient noted are looser that normal) and NAUSEA (Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin) in a 76-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 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Previously administered products included for Flu vaccination: Flu vaccine (last year 2021) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Childhood asthma, Bronchitis (Continuing bouts of bronchitis but the last time she got sick was fall of 2-19 before the pandemic.), General anesthesia (nausea and vomiting), Drug allergy (cortisone shot), Drug allergy (Allergic to doxycycline (severe diarrhea),), Drug allergy (Allergic to vibramycin (difficult of breathing)), Drug allergy (Allergic to markain (difficult of breathing)) and Adhesive tape allergy (surgical tape).   On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Sep-2022, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced NAUSEA (Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin). In September 2022, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset,GI discomfort,queasy stomach) and DIARRHOEA (Move her bowels and her stools, patient noted are looser that normal). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset,GI discomfort,queasy stomach) and NAUSEA (Unsettling nausea which is mild to moderate nauseated.ersistent nausea which is discomfortin) had not resolved and DIARRHOEA (Move her bowels and her stools, patient noted are looser that normal) was resolving.            Concomitant medication details were not reported by the reporter.  On 18-MAR-2021, Patient received 1st dose of Moderna COVID-19 Vaccine with lot number 029A21A. On 21-APR-2021, Patient received 2nd dose of Moderna COVID-19 Vaccine with lot number 046A21A. On 10-Nov-2021, Patient received 1st booster dose of Moderna COVID-19 Vaccine with lot number  058F21A. On 09-MAY-2022, Patient received 2nd booster dose of Moderna COVID-19 Vaccine with lot number  004M21A. Treatment received antacids for unknown indication.   This case was linked to MOD-2022-647566, MOD-2022-647558 (Patient Link).
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Mother thinks kids received Bivalent booster instead of Monovalent; Database shows received vaccine meant for 5M-11-year-old for booster dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) in a 12-year-old male 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 vaccination.     No Medical History information was reported.    On 17-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 17-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Database shows received vaccine meant for 5M-11-year-old for booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  The age of patient was reported as 12.5 year old. The patient's mother requested the Bivalent Booster for the patient. The patient's mother observed the HCP drawing the liquid out of the Moderna COVID-19 vaccine vial meant for 5M to 11 year old and administering it to the patient. Later the patient's mother found out that the Bivalent vaccine was not even approved to be used in patients younger than 18.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-647610, US-MODERNATX, INC.-MOD-2022-647605 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647605:Girl Child case US-MODERNATX, INC.-MOD-2022-647610:Mother case
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Product label issue
Clinical narrative: Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine; No adverse event; Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine; This spontaneous case was reported by a physician assistant and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine), PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-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) .25 milliliter. On 19-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine), PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25ml instead of 0,5ml for a booster dose of the Moderna Bivalent Vaccine) and PRODUCT LABEL ISSUE (Health Care Provider becoming confused by the labeling on the Moderna Covid-19 vaccine).    No concomitant medication was reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2022: Live follow up information received: Event (product quality issue) and QE ID no. added.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: couldn't get her 2nd booster, because she had shingles; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (couldn't get her 2nd booster, because she had shingles) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (couldn't get her 2nd booster, because she had shingles). At the time of the report, HERPES ZOSTER (couldn't get her 2nd booster, because she had shingles) had resolved.            No concomitant medications were reported.  Patient received the first and second dose of Moderna vaccine on an unknown date.  Patient daughter reported that the patient couldn't get her 2nd booster, because she had shingles. They wouldn't give it to her, because of that.  No treatment details were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Therapeutic response unexpected
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Started getting tingling below my knees, started around my knee caps, then makes it's way down to my ankles and toes, sometimes goes away but comes back) and THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 939902) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milligram. On an unknown date, the patient experienced PARAESTHESIA (Started getting tingling below my knees, started around my knee caps, then makes it's way down to my ankles and toes, sometimes goes away but comes back) and THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy). At the time of the report, PARAESTHESIA (Started getting tingling below my knees, started around my knee caps, then makes it's way down to my ankles and toes, sometimes goes away but comes back) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) outcome was unknown. The patient had no allergies to medications, food and other products. The patient had no acute and chronic illnesses at the time of vaccination. The patient had never been tested or diagnosed with COVID +. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient did not had any concomitant medications for any condition. It was reported that about one to two months after receiving the 2nd dose, patient started experiencing tingling just below her knees. The tingling sensation started in her knee caps, and traveled down to her legs, ankles, and toes. Three days later, the tinging went away but it came right back. Patient said that this sensation comes and goes and had never completely gone away since it first started. Patient had been experiencing this in both her legs. At first patient thought it could be neuropathy related, but after reading online she did not thought it was neuropathy as it did not felt like it. Patient believed more in herbal remedies than medications. Additionally, patient stated that she had a lot of energy for 2-3 days after receiving each dose and she got a lot of house cleaning done at that time. No treatment medications were reported. This case was linked to MOD-2022-647616 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: I had a lot of energy after my 2 shots, I was cleaning my house like crazy; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. Patient had no allergies. Patient never had COVID positive test or diagnosis. Patient did not receive other vaccines given within 1 month Prior to Moderna COVID-19 vaccine.  On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Patient was not on any concomitant medications for any condition.  It was reported that, the patient had a lot of energy for 2-3 days after the dose and got a lot of house cleaning done at that time.  Patient believes more in herbal remedies than medications. No treatment medications were provided.   This case was linked to MOD-2022-647612 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; given a half dose of the bivalent Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a half dose of the bivalent Moderna booster) and NO ADVERSE EVENT (No adverse event) in a 36-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 11-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) .25 milliliter. On 11-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a half dose of the bivalent Moderna booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given a half dose of the bivalent Moderna 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 (given a half dose of the bivalent Moderna booster).    No concomitant medication were reported.             No treatment information was provided by the reporter.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No Adverse event; 12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster; 12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster), WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in a 12-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.     No Medical History information was reported.    On 17-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 17-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster), WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's 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 assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster) and WRONG PRODUCT ADMINISTERED (12 year old received the Moderna's Bivalent booster instead of the Pfizer's Bivalent booster).    No concomitant medication were reported.             No treatment information was provided by the reporter.