chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired 2nd primary dose, beyond 12  hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 011B22A and 011B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2022 at 10:50 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2022 at 10:50 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired 2nd primary dose, beyond 12  hours post puncture). No concomitant medications were reported. On 03-Oct-2022, at 03:18 PM the vial was first punctured. Dose was administered post 12 hours of puncture. Vial was stored in room temperature post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was19 hours and 30 Minutes. Vial did not undergo any temperature excursions. No treatment details were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Tongue discomfort
Clinical narrative: lips burning; tongue burning; This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (lips burning) and TONGUE DISCOMFORT (tongue burning) 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)) (batch no. AS7164B) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Flu: Flu vaccine (Last year). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfa allergy), Allergy to nuts (hazel nuts) and Blood pressure high (diagnosed prior to getting the vaccine). Concomitant products included LABETALOL for Blood pressure high.    On 03-Oct-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 03-Oct-2022, the patient experienced ORAL DISCOMFORT (lips burning) and TONGUE DISCOMFORT (tongue burning). At the time of the report, ORAL DISCOMFORT (lips burning) and TONGUE DISCOMFORT (tongue burning) had not resolved.            On 30-Jan-2021 patient received the first dose of vaccine lot number 012M20A. On 27-Feb-2021 patient received the second dose of vaccine lot number 014M20A. On 01-Nov-2021 patient received the first booster dose of vaccine. On 13-Apr-2022 patient received the second booster dose of vaccine lot number 046L21A. It was reported that patient did not experienced similar event in the past. No death was not occurred and autopsy was not done. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Very cold after previous 3 doses; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Very cold after previous 3 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine (had them for the last 5 yrs with no affect.). Past adverse reactions to the above products included No adverse event with Flu vaccine.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Very cold after previous 3 doses). At the time of the report, NASOPHARYNGITIS (Very cold after previous 3 doses) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-654912 (Patient Link).   Reporter did not allow further contact
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse effects; Patient administered with the bivalent vaccine; 12 years old administered with the bivalent booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered with the bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old administered with the bivalent booster dose) and NO ADVERSE EVENT (no adverse effects) 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 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose 1, lot number FL0007) on 30-Dec-2021, Pfizer COVID-19 Vaccine (Dose 2 and lot number FJ6369) on 03-Feb-2022. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On 30-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered with the bivalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old administered with the bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse effects). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered with the bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 years old administered with the bivalent booster dose) and NO ADVERSE EVENT (no adverse effects) outcome was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-654913 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-654913:Same reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.   On 29-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 29-Sep-2022, the patient experienced UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent 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 assessment was provided for UNDERDOSE (patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    No concomitant medications was reported. It was reported that patient did not had any adverse events. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654905, US-MODERNATX, INC.-MOD-2022-654910, US-MODERNATX, INC.-MOD-2022-654894 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654905:Patient No -2 US-MODERNATX, INC.-MOD-2022-654910:Patient No -4 US-MODERNATX, INC.-MOD-2022-654894:Patient No-1
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Administered with 0.25ml of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered with 0.25ml of the 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 vaccination.     No Medical History information was reported.    On 30-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 30-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administered with 0.25ml of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered with 0.25ml of the 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 (Administered with 0.25ml of the bivalent booster).    No relevant concomitant medications were reported.  Patient was inadvertently administered with 0.25ml of the Moderna bivalent booster dose.  Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired vaccine).    No concomitant medications were reported.  HCP reported that a patient received the Monovalent expired vaccine on 04-Oct-2022 and Patient didn't experience any side effects.   It was reported that dose was administered 30 days after date of expiry. Vial size was mentioned as 5.5 ml. The vial was stored in the refrigerator on 07-Sep-2022 and The Vial didn't undergo temperature excursion study.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Hospitalized due to an infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Hospitalized due to an infection) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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 INFECTION (Hospitalized due to an infection) (seriousness criterion hospitalization). At the time of the report, INFECTION (Hospitalized due to an infection) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient clarified that who was hospitalized due to an infection was her husband. When agent asked for information about AE form, caller stated she was running out of time and could not answer to the queries (limited AE). Treatment information was not provided.; Sender's Comments: This is a spontaneous case concerning reported by a consumer regarding a male patient of unknown age with no reported medical history, who experienced the unexpected serious (hospitalization) event of infection. Due to very limited information, it is unclear latency and /or relationship with the administration of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Developed swelling about 4 inches further down in their inner arm; Tenderness about 4 inches further down and in their inner arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (Developed swelling about 4 inches further down in their inner arm) and VACCINATION SITE PAIN (Tenderness about 4 inches further down and in their inner arm) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) for an unknown indication.    Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension.   On 15-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 and dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE HIGH DOSE QUADRIVALENT) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced VACCINATION SITE SWELLING (Developed swelling about 4 inches further down in their inner arm) and VACCINATION SITE PAIN (Tenderness about 4 inches further down and in their inner arm). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Developed swelling about 4 inches further down in their inner arm) and VACCINATION SITE PAIN (Tenderness about 4 inches further down and in their inner arm) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient had a location reaction to one of the vaccines. The patient had received Flu shot: Fluzone Highdose along with Moderna COVID bivalent on 15-Sep-2022 on the upper left arm. Then not right away but later that day she developed swelling and tenderness about 4 inches further down and in their inner arm. Patient mentioned that it did go away. Patient took Aleve after the reaction and it helped.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Vaccination site pain
Clinical narrative: Felt bad, blah, for 12 hours.; malaise, for 12 hours.; Soreness at injection site, 12 hours.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad, blah, for 12 hours.), MALAISE (malaise, for 12 hours.) and VACCINATION SITE PAIN (Soreness at injection site, 12 hours.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A, 002A21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (Felt bad, blah, for 12 hours.), MALAISE (malaise, for 12 hours.) and VACCINATION SITE PAIN (Soreness at injection site, 12 hours.). At the time of the report, FEELING ABNORMAL (Felt bad, blah, for 12 hours.), MALAISE (malaise, for 12 hours.) and VACCINATION SITE PAIN (Soreness at injection site, 12 hours.) had resolved.      No concomitant medication information provided. It was reported that patient was calling because she received a form from safety but didn't want anyone thinking that she had serious problems. She knows that if she had taken some Tylenol, symptoms would had been relived, she just didn't want anything hindering the efficacy of the vaccine. It was reported that patient took first booster dose No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-651643 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651643:same reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced COVID-19 (Patient got COVID-19). At the time of the report, COVID-19 (Patient got COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication information was provided.  It was reported that patient earlier received her primary series and 1st booster dose of the Moderna Vaccine.  Treatment was provided as unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; vomited; headache; achiness; tingling like pins and needles in his thumb; felt dehydrated; Took Ambien to go to sleep; fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achiness), PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep) and FATIGUE (fatigued) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine (2 doses of Pfizer vaccine). Past adverse reactions to the above products included No adverse event with Johnson COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.  On 03-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Oct-2022, the patient experienced PAIN (achiness), PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep) and FATIGUE (fatigued). On 04-Oct-2022, the patient experienced NAUSEA (nausea), VOMITING (vomited) and HEADACHE (headache). The patient was treated with ZOLPIDEM TARTRATE (AMBIEN) at an unspecified dose and frequency. At the time of the report, PAIN (achiness) had not resolved and PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep), FATIGUE (fatigued), NAUSEA (nausea), VOMITING (vomited) and HEADACHE (headache) outcome was unknown. No concomitant medications was reported.  After receiving the bivalent vaccine patient came home at 2:00 and felt fine. Patient ate a late lunch or an early dinner, laid down, and went to bed. Slight achiness when he woke up with light fatigue, and Felt a little tingling like pins and needles in his thumb. Woke up at 10:00 PM. Patient took Ambien to go to sleep. Patient felt dehydrated. Drank dehydrated soda. Around 1-2 AM he went to the bathroom with nausea, and vomited. Went back to sleep. Got up next day morning. Had a small protein cookie for breakfast. The more patient moved around felt achy. Had a headache. Laid down from 11-12:00 to 3:00. Woke up with continued achiness. No sore throat. No additional medications or treatments.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Sleep disorder, Vomiting
Clinical narrative: nausea; vomited; headache; achiness; tingling like pins and needles in his thumb; felt dehydrated; Took Ambien to go to sleep; fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achiness), PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep) and FATIGUE (fatigued) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Johnson COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine (2 doses of Pfizer vaccine). Past adverse reactions to the above products included No adverse event with Johnson COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.  On 03-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Oct-2022, the patient experienced PAIN (achiness), PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep) and FATIGUE (fatigued). On 04-Oct-2022, the patient experienced NAUSEA (nausea), VOMITING (vomited) and HEADACHE (headache). The patient was treated with ZOLPIDEM TARTRATE (AMBIEN) at an unspecified dose and frequency. At the time of the report, PAIN (achiness) had not resolved and PARAESTHESIA (tingling like pins and needles in his thumb), DEHYDRATION (felt dehydrated), SLEEP DISORDER (Took Ambien to go to sleep), FATIGUE (fatigued), NAUSEA (nausea), VOMITING (vomited) and HEADACHE (headache) outcome was unknown. No concomitant medications was reported.  After receiving the bivalent vaccine patient came home at 2:00 and felt fine. Patient ate a late lunch or an early dinner, laid down, and went to bed. Slight achiness when he woke up with light fatigue, and Felt a little tingling like pins and needles in his thumb. Woke up at 10:00 PM. Patient took Ambien to go to sleep. Patient felt dehydrated. Drank dehydrated soda. Around 1-2 AM he went to the bathroom with nausea, and vomited. Went back to sleep. Got up next day morning. Had a small protein cookie for breakfast. The more patient moved around felt achy. Had a headache. Laid down from 11-12:00 to 3:00. Woke up with continued achiness. No sore throat. No additional medications or treatments.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event; Received Monovalent booster instead of Bivalent; he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot); This spontaneous case was reported by a patient and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Monovalent booster instead of Bivalent), EXTRA DOSE ADMINISTERED (he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot)) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Monovalent booster instead of Bivalent) and EXTRA DOSE ADMINISTERED (he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Monovalent booster instead of Bivalent), EXTRA DOSE ADMINISTERED (he already had 2 primary and 2 booster doses of Moderna COVID-19 vaccine so they gave an extra Monovalent booster dose (5th Shot)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  It was reported that patient went to the pharmacy to receive Bivalent Moderna COVID-19 vaccine a couple weeks ago. He does not remember the exact date. But he received the Monovalent booster again by mistake. He states that the pharmacy informed him later that they administered a Monovalent booster by mistake.  No treatment information was provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was first punctured: 03Oct2022 around 1PM administration of vaccine: 04Oct2022 around Noon/ Dose administered more than 12 hours post puncture; No adverse event; Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours), PRODUCT STORAGE ERROR (vial was first punctured: 03Oct2022 around 1PM administration of vaccine: 04Oct2022 around Noon/ Dose administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured: 03Oct2022 around 1PM administration of vaccine: 04Oct2022 around Noon/ Dose administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture/Dose administered after exposure to room temperature more than 24 hours), PRODUCT STORAGE ERROR (vial was first punctured: 03Oct2022 around 1PM administration of vaccine: 04Oct2022 around Noon/ Dose administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      Patient age was 84 years 6 months.  No concomitant medication information provided.  Dose administered more than 12 hours post puncture and Dose administered after exposure to room temperature more than 24 hours.  Individual vials or unbroken cartons 1 vial. Vial size was 2.5 mL and was administered around noon. The vial stored post puncture at room temperature. Date and time the vial was first punctured was 03-Oct-2022 around 1PM. Date, the vial was initially stored in the refrigerator was 21-Sep-2022. The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 23 hours.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; I got my bivalent booster a couple of weeks ago. I was inadvertently given the Moderna monovalent.; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (I got my bivalent booster a couple of weeks ago. I was inadvertently given the Moderna monovalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (I got my bivalent booster a couple of weeks ago. I was inadvertently given the moderna monovalent.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (I got my bivalent booster a couple of weeks ago. I was inadvertently given the moderna monovalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) 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 MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was reported that reporters brother got the vaccine and had a heart attack the next day or 2. It was reported that reporter had a friend who was diagnosed with terminal cancer.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of Myocardial infarction, the next day or two after the mRNA-1273 vaccine, dose number not provided. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of Myocardial infarction, the next day or two after the mRNA-1273 vaccine, dose number not provided. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash in right arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash in right arm) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AF7162B) for COVID-19 vaccination.     The patient had no allergies to medications,food and other products. The patient never had COVID positive test or diagnosis. The patient had no medical history related to mentioned AE and both acute and chronic illnesses at the time of vaccination.     On 04-Oct-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 05-Oct-2022, the patient experienced RASH (rash in right arm). At the time of the report, RASH (rash in right arm) had not resolved.            It was reported that all previous vaccines she received were Moderna. The AE doesn't cause patient to seek medical care office visit, urgent care, ER, hospitalized.  The patient did not experienced a similar event in the past. The symptoms were same. Patient does not take any concomitant medication. No treatment information was provided.   This case was linked to MOD-2022-655104 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first 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 IN EXTREMITY (sore arm) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness) outcome was unknown. Patient had no allergies. Patient never had COVID positive test or diagnosis. Patient did not have any history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. Patient did not take any concomitant medication.  Patient experienced sore arm and tiredness in all four doses of Moderna covid-19 vaccinations. No treatment information was provided by the reporter.   This case was linked to MOD-2022-655103 (Patient Link).
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time; No Adverse event; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old patient of an unknown gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was accidentally administered the second primary dose of the Moderna Covid 19 vaccine 1 week earlier than suggested time).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator and administered past the 30 day use by date; no adverse event; they inadvertently administered a dose from a vial which was past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date) and NO ADVERSE EVENT (no adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered a dose from a vial which was past the 30 day use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator and administered past the 30 day use by date).    No concomitant medications were reported. No treatment medications were reported.  The vial size was of 5.5 ml. The beyond use date written on the vial was 01-Oct-2022. The vial did not undergo any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022; No adverse event; Administered a vaccine after the beyond-use-date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered a vaccine after the beyond-use-date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 03-Oct-2022).    No concomitant medication was reported. No treatment medication was reported.  The reporter asked about the next steps since a patient was administered a vaccine (monovalent, first dose) after the beyond-use-date.  The vial was of 5.5 ml size and was stored in a box. The vial did not undergo any temperature excursions.  No further information was available with the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; administered a Moderna regular vaccine instead of the omicron; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered a Moderna regular vaccine instead of the omicron) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (administered a Moderna regular vaccine instead of the omicron). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered a Moderna regular vaccine instead of the omicron) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (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 a Moderna regular vaccine instead of the omicron).    No concomitant medications were provided by the reporter. The pharmacist enquired whether there were any recommendations when the patient could receive the omicron booster. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site inflammation
Clinical narrative: vaccine went into the subcutaneous layer rather than the muscle layer; arm was not sore, just a little bit of inflammation; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine went into the subcutaneous layer rather than the muscle layer) and VACCINATION SITE INFLAMMATION (arm was not sore, just a little bit of inflammation) 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)) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine went into the subcutaneous layer rather than the muscle layer) and VACCINATION SITE INFLAMMATION (arm was not sore, just a little bit of inflammation). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (vaccine went into the subcutaneous layer rather than the muscle layer) and VACCINATION SITE INFLAMMATION (arm was not sore, just a little bit of inflammation) outcome was unknown.            Concomitant medication was not provided. It was reported that the patient got the bivalent booster dose and the vaccine provider used a 5/8 inch needle to administer the vaccine to them. The vaccine provider grabbed the arm to form a muscle (patient was 120 lbs) but did not use the whole depth of the needle and patient thought that the vaccine went into the subcutaneous layer rather than the muscle layer. The arm was not sore - just a little bit of inflammation and not the usual. There was no fever. As per patient it could be a vaccine failure.  Treatment information was not provided.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; bivalent booster inadvertently administered instead of 1st dose of primary; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary) 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 WRONG PRODUCT ADMINISTERED (bivalent booster inadvertently administered instead of 1st dose of primary).    No concomitant medication was reported. No treatment information was provided.