chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neoplasm malignant, Supraventricular tachycardia
Clinical narrative: Since the vaccine patient had come down with cancer and SVT; Since the vaccine patient had come down with cancer and SVT; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (Since the vaccine patient had come down with cancer and SVT) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 NEOPLASM MALIGNANT (Since the vaccine patient had come down with cancer and SVT) (seriousness criterion medically significant) and SUPRAVENTRICULAR TACHYCARDIA (Since the vaccine patient had come down with cancer and SVT). At the time of the report, NEOPLASM MALIGNANT (Since the vaccine patient had come down with cancer and SVT) and SUPRAVENTRICULAR TACHYCARDIA (Since the vaccine patient had come down with cancer and SVT) outcome was unknown.        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.   No concomitant medications were reported.  No treatment information was provided.  Company comment-This spontaneous case concerns an elderly female patient aged 84 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Neoplasm malignant and unexpected non-serious AESI event of Supraventricular tachycardia that occurred in the context of mRNA-1273.222 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events and date of vaccination was not disclosed. It was reported that since the vaccine patient had come down with cancer and SVT. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events, outcome of the events and details pertaining to the previous doses was available in the report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 9-JAN-2021 and second dose on 1-FEB-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 9-JAN-2021 and second dose on 1-FEB-2021) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 9-JAN-2021 and second dose on 1-FEB-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 9-JAN-2021 and second dose on 1-FEB-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient administered the vaccine at a clinic.  It was unknown if  patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine administration.  Patient administered 3rd dose of Moderna COVID-19 vaccine on 05-Nov-2021, Batch/Lot no. 032F21A.  Patient administered 4th dose of Pfizer Bivalent vaccine on 30-Sep-2022, Batch no. GJ6742 via Intramuscular route.  No concomitant medication reported. No treatment medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Experiencing a side effect in his skin; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Experiencing a side effect in his skin) in a male 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Experiencing a side effect in his skin). At the time of the report, IMMUNISATION REACTION (Experiencing a side effect in his skin) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant drug information was provided.  Patient was not a clinical trial participant from Moderna. It was reported that during the pandemic patient received the Moderna vaccine and experienced side effects in the skin.   Treatment medication information was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged) in a 41-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.     Concurrent medical conditions included Wolff-Parkinson-White syndrome (Heart condition called WPS) and Anxiety (Patient takes Valium for anxiety to help him sleep.). Concomitant products included DIAZEPAM (VALIUM) for Anxiety.    On 07-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged). At the time of the report, COVID-19 (Had Covid disease/On 30JAN2023 patient got COVID-19 with severe symptoms and this disease was prolonged) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2023, SARS-CoV-2 test: Positive.     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.   No concomitant medications was reported. It was reported that 1st booster she did not remember the dates. For the 1st booster and with bivalent booster he experienced no symptoms. On 30-Jan-2023 patient got COVID-19 with severe symptoms and this disease was prolonged. Case previously reported in case number AE-00017459, C-INT-0003300 No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-714780 (E2B Linked Report). This case was linked to MOD-2023-715098 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2023: Live Significant follow-up received includes medical history and concomitant medication added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714780:Wife's case
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: For 2nd dose her husband got really tired and not feeling well during 1 day; For 2nd dose her husband got really tired and not feeling well during 1 day; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (For 2nd dose her husband got really tired and not feeling well during 1 day) and FATIGUE (For 2nd dose her husband got really tired and not feeling well during 1 day) in a 41-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Wolff-Parkinson-White syndrome (Heart condition called WPS) and Anxiety. Concomitant products included DIAZEPAM (VALIUM) for Anxiety.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (For 2nd dose her husband got really tired and not feeling well during 1 day) and FATIGUE (For 2nd dose her husband got really tired and not feeling well during 1 day). At the time of the report, MALAISE (For 2nd dose her husband got really tired and not feeling well during 1 day) and FATIGUE (For 2nd dose her husband got really tired and not feeling well during 1 day) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient received the first dose of Moderna vaccine on 09-Mar-2021, and the first booster dose on an unknown date. After first and first booster dose patient did not experience any symptoms. No treatment medications were given.   This case was linked to MOD-2023-714734 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Gait disturbance, Migraine, Parkinson's disease
Clinical narrative: neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's; wobbly when walking; aphasia; she had a headache which came on immediately and lasted for 2 weeks like a migraine.; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's) and GAIT DISTURBANCE (wobbly when walking) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced MIGRAINE (she had a headache which came on immediately and lasted for 2 weeks like a migraine.). On an unknown date, the patient experienced PARKINSON'S DISEASE (neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's) (seriousness criterion medically significant), GAIT DISTURBANCE (wobbly when walking) (seriousness criterion medically significant) and APHASIA (aphasia). The patient was treated with DOPAMINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARKINSON'S DISEASE (neurological symptoms/ She went to her doctor and a neurologist who thought she had Parkinson's), GAIT DISTURBANCE (wobbly when walking) and APHASIA (aphasia) was resolving and MIGRAINE (she had a headache which came on immediately and lasted for 2 weeks like a migraine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had Migraine for 2 weeks after the first dose. Following her symptoms after second dose, she consulted a neurologist who thought she had Parkinson's. Her doctor recommended she not receive an additional dose of the COVID-19 vaccines. She regularly takes dopamine. Her symptoms following the second dose have started to improve, but are not resolved.  Company comment: This spontaneous case concerns a 79-year-old female patient with no medical history reported who experienced the serious (medically significant) unexpected event of Parkinson's disease and Gait disturbance which occurred about unknown days after receiving second dose of mRNA-1273 vaccine. She received dopamine for treatment. Events were resolving at the time of the report. The events had resolved with sequelae at time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Illness, Myalgia, Pyrexia
Clinical narrative: really sick/ she felt sick; fever; metallic taste; felt not good; her whole body hurts / muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick/ she felt sick), PYREXIA (fever), MYALGIA (her whole body hurts / muscle pain), DYSGEUSIA (metallic taste) and FEELING ABNORMAL (felt not good) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Migraine, seasonal allergies. Medication: Zoloft for anxiety, Ajovy for migraine. Caller got COVID-19 on 01FEB2023 with mild to moderate symptoms and it was prolonged.  Concurrent medical conditions included Migraine, Seasonal allergy and Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for Migraine.   On 09-Mar-2021, the patient 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 received second 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. On 01-Feb-2023, the patient experienced MYALGIA (her whole body hurts / muscle pain). On an unknown date, the patient experienced ILLNESS (really sick/ she felt sick), PYREXIA (fever), DYSGEUSIA (metallic taste) and FEELING ABNORMAL (felt not good). At the time of the report, ILLNESS (really sick/ she felt sick), PYREXIA (fever), DYSGEUSIA (metallic taste) and FEELING ABNORMAL (felt not good) outcome was unknown and MYALGIA (her whole body hurts / muscle pain) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got fist vaccine and did not experienced any symptoms.  For 2nd dose, the patient got really sick, whole body hurts, fever and felt not good for like 5 days.  The concomitant medication was not reported.  No treatment was given.   This case was linked to MOD-2023-714780 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.) 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 (Determine course of action when covid vaccine given past expiration date/6 doses administered on 07May2022 with a published expiration date of 25Mar2022.).    No concomitant products were reported.  It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. There was no information about previous COVID-19 vaccination doses. It was reported that determine course of action when COVID vaccine given past expiration date. 6 doses administered on 07 May 2022 from lot number 033H21A with a published expiration date of 25 Mar 2022. Health care professional stated that they were the 1st boosters.   No treatment products were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2023: Follow up received wherein the reporter information, product start date, dose information, event information and narrative updated.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient did get covid-19 right after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient did get covid-19 right after 2nd dose) in an 83-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Patient did get covid-19 right after 2nd dose). At the time of the report, COVID-19 (Patient did get covid-19 right after 2nd dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715020 (E2B Linked Report). This case was linked to MOD-2023-715001 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715020:Wife case
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent vaccine was administered to a child after date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine was administered to a child after date of expiry) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine was administered to a child after date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine was administered to a child after date of expiry) 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 (Monovalent vaccine was administered to a child after date of expiry).    No concomitant medications were provided. No treatment medication was provided.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023; No adverse event; Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date 04-Feb-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 05-Jan-2023 and administered on 27-FEB-2023).    No concomitant medications were reported. It was unknown if patient received any other vaccine 4 weeks prior to COVID-19 vaccine. Health nurse stating that she was inquiring on a medication error with the Moderna Bivalent 6 months to 5 yrs. Dose was administered after 30-day Use by Date of 04-Feb-2023. Moderna Bivalent 6 months to 5 years vaccine dose was administered after 30-day Use by date or after manufacturer date of expiry It was reported that individual vials were used. The vial was initially stored in the refrigerator on 05-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Wife had Covid-19, too.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Wife had Covid-19, too.) in an elderly 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 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 an unknown date, the patient experienced COVID-19 (Wife had Covid-19, too.). At the time of the report, COVID-19 (Wife had Covid-19, too.) 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.   No concomitant medications were reported. On unknown date, patient had received 2 doses of COVID-19 vaccine. Patient got COVID-19 within a month of husband. Patient COVID-19 was like a bad cold. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-715001 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715001:Husband case
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     It was reported that patient received other vaccine in the 4 weeks prior to COVID-19 vaccine and also had received Synergist injection on 07-Mar-2023.  Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE. Past adverse reactions to the above products included No adverse event with PNEUMOCOCCAL VACCINE.    On 09-Mar-2023 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2023 at 11:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023) 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 (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023).    Concomitant drugs were not reported.  It was reported that 1 dose monovalent vial for 6 months to 5 year of unsure size 10 dose of 0.25 5 was initially stored in refrigerator on 23-Feb-2023 at 02:30 pm, was first punctured on 08-Mar-2023 at 11:30 am and was administered on 09-Mar-2023 at 11:30 am. The vial was stored at room temperature post puncture for 24 hours. The vial was not exposed to temperature excursion.   Treatment medications were not provided.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose; 1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 10-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Administered a bivalent vaccine and realized after the fact that a patient should have received a second primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 02-Feb-2023 and 2nd dose administered on 10-Mar-2023).    No concomitant medications were reported.  The patient received 1st dose on 02-Feb-2023 lot number 057A22A.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient did not reported symptoms.   No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient states that he found that people were not getting the second dose within 6 weeks after the first dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient states that he found that people were not getting the second dose within 6 weeks after the first dose) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient states that he found that people were not getting the second dose within 6 weeks after the first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient states that he found that people were not getting the second dose within 6 weeks after the first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), 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 states that he found that people were not getting the second dose within 6 weeks after the first dose).    No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information; Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information), POOR QUALITY PRODUCT ADMINISTERED (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information), POOR QUALITY PRODUCT ADMINISTERED (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information), POOR QUALITY PRODUCT ADMINISTERED (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines were administered in the period following a temperature excursion but prior to the stability assessment information).    No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines were store the wrong way; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccines were store the wrong way) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were store the wrong way) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (vaccines were store the wrong way) 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 PRODUCT STORAGE ERROR (vaccines were store the wrong way).    No concomitant medications was provided. No treatment medications was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her first vaccine on 23-Jul-2021/ 2nd dose on 09-Mar-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient was traveling in May-2023.  The patient did not have any reactions.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The vaccine expired on 12FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12FEB2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     The patient medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 24-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 12FEB2023) 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 (The vaccine expired on 12FEB2023).    The patient was around 20 years old. No concomitant medications were reported.    It was unknown if patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP did not knew if patient experienced any adverse events (AEs).   No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023; No adverse event; I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023) 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 (I work for an organization and a patient was administered a Moderna vaccine that was expired by a few days) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 14Dec2022 but dose was given on 17Jan2023).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  Reporter work for an organization and a patient was administered a Moderna vaccine that was expired by a few days. The HCP explained that the vial expiration date was still good, but it was beyond the storage guidelines. The vial should have been pulled out on 12-Jan-2023, but a dose was given on 17-Jan-2023. The patient did not report any adverse reaction. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 14-Dec-2022. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received the Moderna bivalent booster as their first dose prior to primary series vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent booster as their first dose prior to primary series vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first 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 WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent booster as their first dose prior to primary series vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent booster as their first dose prior to primary series 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 WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent booster as their first dose prior to primary series vaccine).    No concomitant medications were provided. No treatment medication was provided.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthma, COVID-19, Cough, Dyspnoea, Fatigue
Clinical narrative: I had my vaccination on 09/07/2023. I started to experience 03/05/2023 unusual fatigue and cough. On 03/06/2023 I had congestion runny nose headache fatigue and cough. I tested COVID-19 Positive on 03/06/2023. I contacted my physicians office on 03/06/2023 and I was sent to the emergency room as I had trouble breathing. I was diagnosed with asthma. I was prescribed steroids and sent home for rest. I still feel lingering symptoms on 03/14/2023.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 09/07/2023. I started to experience 03/05/2023 unusual fatigue and cough. On 03/06/2023 I had congestion runny nose headache fatigue and cough. I tested COVID-19 Positive on 03/06/2023. I contacted my physicians office on 03/06/2023 and I was sent to the emergency room as I had trouble breathing. I was diagnosed with asthma. I was prescribed steroids and sent home for rest. I still feel lingering symptoms on 03/14/2023.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Headache, Respiratory tract congestion
Clinical narrative: I had a running nose, cough, congestion, and a headache. I tested positive for COVID-19. I talked to a nurse, and she prescribed me Paxlovid on the same day. Within 12 hours, I could tell I was getting better. I still have another 12 doses to take. I occasionally have a cough and fatigue.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a running nose, cough, congestion, and a headache. I tested positive for COVID-19. I talked to a nurse, and she prescribed me Paxlovid on the same day. Within 12 hours, I could tell I was getting better. I still have another 12 doses to take. I occasionally have a cough and fatigue.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Gait inability, Impaired driving ability, Muscle spasms, Pain
Clinical narrative: On February 7, 2023, I noticed that I was having pain in back around 4:00PM sitting in my office chair. I tried a massage chair, but it didn't help. I also was unable to walk without assistance. The pain was so severe I had someone drive me home, and it progressed throughout the day to the point I couldn't move without pain. Two days later I saw a doctor who diagnosed it as muscle spasms. He gave me Ketorolac for quick relief, and Methocarbamol and Nabumetone to take.  Around Saturday night, I was good with the medicine and came off of it on that next Tuesday.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Dyspnoea, Fatigue, Head discomfort, Oropharyngeal pain
Clinical narrative: On January 28, 2023, my symptoms started with a sore throat and developed into fuzzy feeling in my head, not clear minded. I tested positive on January 30th and began Paxlovid. It felt like I had a sinus infection without the sinus issues. I then had chest congestion and once was short of breath. I was very fatigued. After 3 days it was better and then after a few more days I had a rebound. The rebound case began February 7, 2023, and I had the same symptoms but less severe. They lasted another 4 days.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Sinus disorder, Sinusitis
Clinical narrative: On January 28, 2023, my symptoms started with a sore throat and developed into fuzzy feeling in my head, not clear minded. I tested positive on January 30th and began Paxlovid. It felt like I had a sinus infection without the sinus issues. I then had chest congestion and once was short of breath. I was very fatigued. After 3 days it was better and then after a few more days I had a rebound. The rebound case began February 7, 2023, and I had the same symptoms but less severe. They lasted another 4 days.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient waited for 15 minutes following vaccine. Patient stated he felt fine.