chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer (unknown cancer type/unknown cancer start date); This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Cancer (unknown cancer type/unknown cancer start date)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer (unknown cancer type/unknown cancer start date)) (seriousness criterion medically significant). The patient was treated with Radiotherapy (chemotherapy and radiation treatment) for Neoplasm malignant. At the time of the report, NEOPLASM MALIGNANT (Cancer (unknown cancer type/unknown cancer start date)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The pharmacist also reported that, 2 months ago the patient was eating something and it cut her esophagus causing bleeding. The patient required a blood transfusion.  Treatment reported for Cancer included chemotherapy and radiation treatment approximately 2 months ago.  This is a spontaneous case concerning an 80-year-old female patient with no medical history reported, who experienced the unexpected event of neoplasm malignant. The event occurred on an unknown date, while the second dose of mRNA  1273 vaccine was received on 17-Apr-2021. Neoplasm malignant a medically significant event, outcome of which was still unknown at the time of report. Patient was having chemotherapy and radiation treatment for approximately 2 months. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 80-year-old female patient with no medical history reported, who experienced the unexpected event of neoplasm malignant. The event occurred on an unknown date, while the second dose of mRNA  1273 vaccine was received on 17-Apr-2021. Neoplasm malignant a medically significant event, outcome of which was still unknown at the time of report. Patient was having chemotherapy and radiation treatment for approximately 2 months. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, VIth nerve paralysis
Clinical narrative: Sixth Nerve Palsy; This spontaneous case was reported by a consumer and describes the occurrence of VITH NERVE PARALYSIS (Sixth Nerve Palsy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced VITH NERVE PARALYSIS (Sixth Nerve Palsy) (seriousness criterion medically significant). At the time of the report, VITH NERVE PARALYSIS (Sixth Nerve Palsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) Everything is fine.         Feeling abnormal is a consequence of the event Diplopia which is subsumed under the event Sixth nerve paralysis. The demographic detail of the patient was reported as  5' 6.5''.Patient had no allergies or any acute or chronic illness. Also patient had not tested positive for COVID-19 and did not receive any other vaccine within one month prior to Moderna. It was reported that patient received booster dose on 28-Oct-2022.  No treatment medications was reported. The patient was taking some unknown concomitant medications  Company Comment: This spontaneous case concerns a 74 year old female Patient, with no medical history reported, who experienced the unexpected, serious (medically significant) event of VIth nerve paralysis which occurred approximately 11 months after the second dose, 12 months after the first dose and unspecified days after the Booster dose of mRNA vaccine administration. Patient experienced double vision and was unable to drive. She underwent MRI which showed normal results. The outcome of the event was reported to be unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74 year old female Patient, with no medical history reported, who experienced the unexpected, serious (medically significant) event of VIth nerve paralysis which occurred approximately 11 months after the second dose, 12 months after the first dose and unspecified days after the Booster dose of mRNA vaccine administration. Patient experienced double vision and was unable to drive. She underwent MRI which showed normal results. The outcome of the event was reported to be unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID after vaccination) 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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID after vaccination). At the time of the report, COVID-19 (COVID after vaccination) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.  The patient received the first 2 doses of the Moderna vaccine and then developed COVID disease. The patient was being cautious too because the patient has a diabetic son.  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The patient received the first 2 doses of mRNA-1273 vaccine then developed COVID disease. The dates of vaccination and onset of the event were unknown. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-527476 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The patient received the first 2 doses of mRNA-1273 vaccine then developed COVID disease. The dates of vaccination and onset of the event were unknown. Clinical course, diagnostic tests and treatment details were not provided in the case. At the time of reporting, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials were initialy stored in refrigerator on 29-March-2022, which was expired on 17-March-2022, and administered on 30-March-2022; Expired dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Vials were initialy stored in refrigerator on 29-March-2022, which was expired on 17-March-2022, and administered on 30-March-2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initialy stored in refrigerator on 29-March-2022, which was expired on 17-March-2022, and administered on 30-March-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) and PRODUCT STORAGE ERROR (Vials were initialy stored in refrigerator on 29-March-2022, which was expired on 17-March-2022, and administered on 30-March-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   The vials were stored in refrigerator on 29-Mar-2022.  It was reported that the vails, were shipped out to vaccine facility were expired. The vails did not undergo temperature excursion.  At the time of reporting no adverse reaction was reported by the patient.  No treatment medication information was given.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose administered to 3 patients; Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022). On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to 3 patients) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The pharmacist stated that, they shipped out 5 vials of the Moderna vaccine to one of their nursing home facilities on 29-Mar-2022 evening. On 30-Mar-2022 morning, 3 doses of the Moderna vaccine were administered to 3 staff members at the facility. After administration, it was found out that the doses given had expired on 17-Mar-2022. At this time, no adverse reactions have been reported by any patients.  Vial did not undergo any temperature excursions.  Treatment medications were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast mass, Breast pain, Confusional state, Fall, Feeling hot
Clinical narrative: she said she did not seem to have much of a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (3 spinal surgeries). Previously administered products included for Migraine: Botox. Past adverse reactions to the above products included No adverse event with Botox. Concurrent medical conditions included Overweight (Patient reported she was a heavy women), Fibromyalgia, Hashimoto's thyroiditis and Non-smoker (Patient reported that she does not smoke). Concomitant products included DIAZEPAM (VALIUM) and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Fibromyalgia.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she said she did not seem to have much of a reaction). At the time of the report, VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she inherited her father's genetics and he didn't had cancer. Her mother had cancer twice. Patient had 2 younger sisters and both have early breast cancer who have inherited her mom's genetics. Patient reported that she had been horrible.  No treatment details were reported.   This case was linked to MOD-2022-527787 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: she said she did not seem to have much of a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (3 spinal surgeries). Previously administered products included for Migraine: Botox. Past adverse reactions to the above products included No adverse event with Botox. Concurrent medical conditions included Overweight (Patient reported she was a heavy women), Fibromyalgia, Hashimoto's thyroiditis and Non-smoker (Patient reported that she does not smoke). Concomitant products included DIAZEPAM (VALIUM) and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Fibromyalgia.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she said she did not seem to have much of a reaction). At the time of the report, VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she inherited her father's genetics and he didn't had cancer. Her mother had cancer twice. Patient had 2 younger sisters and both have early breast cancer who have inherited her mom's genetics. Patient reported that she had been horrible.  No treatment details were reported.   This case was linked to MOD-2022-527787 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered at inappropriate site, Skin mass, Walking aid user
Clinical narrative: she said she did not seem to have much of a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (3 spinal surgeries). Previously administered products included for Migraine: Botox. Past adverse reactions to the above products included No adverse event with Botox. Concurrent medical conditions included Overweight (Patient reported she was a heavy women), Fibromyalgia, Hashimoto's thyroiditis and Non-smoker (Patient reported that she does not smoke). Concomitant products included DIAZEPAM (VALIUM) and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Fibromyalgia.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she said she did not seem to have much of a reaction). At the time of the report, VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she inherited her father's genetics and he didn't had cancer. Her mother had cancer twice. Patient had 2 younger sisters and both have early breast cancer who have inherited her mom's genetics. Patient reported that she had been horrible.  No treatment details were reported.   This case was linked to MOD-2022-527787 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: she said she did not seem to have much of a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (3 spinal surgeries). Previously administered products included for Migraine: Botox. Past adverse reactions to the above products included No adverse event with Botox. Concurrent medical conditions included Overweight (Patient reported she was a heavy women), Fibromyalgia, Hashimoto's thyroiditis and Non-smoker (Patient reported that she does not smoke). Concomitant products included DIAZEPAM (VALIUM) and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Fibromyalgia.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she said she did not seem to have much of a reaction). At the time of the report, VACCINATION COMPLICATION (she said she did not seem to have much of a reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she inherited her father's genetics and he didn't had cancer. Her mother had cancer twice. Patient had 2 younger sisters and both have early breast cancer who have inherited her mom's genetics. Patient reported that she had been horrible.  No treatment details were reported.   This case was linked to MOD-2022-527787 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: flu symptoms 5 or 6 hours after the first injection.; soreness in his injection site left shoulde; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu symptoms 5 or 6 hours after the first injection.) and VACCINATION SITE PAIN (soreness in his injection site left shoulde) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu symptoms 5 or 6 hours after the first injection.) and VACCINATION SITE PAIN (soreness in his injection site left shoulde). At the time of the report, INFLUENZA LIKE ILLNESS (flu symptoms 5 or 6 hours after the first injection.) and VACCINATION SITE PAIN (soreness in his injection site left shoulde) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by the reporter.  Patient experienced flu symptoms 5 or 6 hours after the first injection.  No treatment medication was reported by the reporter.   This case was linked to MOD-2022-528199, MOD-2022-528209 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient had COVID last December very mild and did not harm her; Patient had COVID last December very mild and did not harm her; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had COVID last December very mild and did not harm her) and DRUG INEFFECTIVE (Patient had COVID last December very mild and did not harm her) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In December 2021, the patient experienced COVID-19 (Patient had COVID last December very mild and did not harm her) and DRUG INEFFECTIVE (Patient had COVID last December very mild and did not harm her). At the time of the report, COVID-19 (Patient had COVID last December very mild and did not harm her) and DRUG INEFFECTIVE (Patient had COVID last December very mild and did not harm her) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 91-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 9 months after the second dose of mRNA-1273 vaccine, which was administered in an appropriate schedule of vaccination. Hence, drug ineffective was also captured. COVID-19 was very mild. SARS-CoV-2 test was performed, with a positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 91-year-old female patient, with no medical history reported, who experienced the unexpected, non-serious, and AESI of COVID-19. The event occurred approximately 9 months after the second dose of mRNA-1273 vaccine, which was administered in an appropriate schedule of vaccination. Hence, drug ineffective was also captured. COVID-19 was very mild. SARS-CoV-2 test was performed, with a positive result. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited after booster; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (Vomited after booster) 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 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 VOMITING (Vomited after booster). At the time of the report, VOMITING (Vomited after booster) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-529319, MOD-2022-529320 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Malaise, Papule, Pruritus
Clinical narrative: still itches a little and she develops tiny bumps when she scratches her arm; Nothing really bad but patient wasn't well; It still itches a little/Itchy upper right arm for a week or so; Very tired; Slight fever; Patient received a 3rd full dose for the booster; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (still itches a little and she develops tiny bumps when she scratches her arm), MALAISE (Nothing really bad but patient wasn't well), PRURITUS (It still itches a little/Itchy upper right arm for a week or so), FATIGUE (Very tired) and PYREXIA (Slight fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient confirmed that she had Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. However, details were not provided.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAPULE (still itches a little and she develops tiny bumps when she scratches her arm), MALAISE (Nothing really bad but patient wasn't well), PRURITUS (It still itches a little/Itchy upper right arm for a week or so), FATIGUE (Very tired), PYREXIA (Slight fever) and ACCIDENTAL OVERDOSE (Patient received a 3rd full dose for the booster). At the time of the report, PAPULE (still itches a little and she develops tiny bumps when she scratches her arm) and PRURITUS (It still itches a little/Itchy upper right arm for a week or so) had not resolved and MALAISE (Nothing really bad but patient wasn't well), FATIGUE (Very tired), PYREXIA (Slight fever) and ACCIDENTAL OVERDOSE (Patient received a 3rd full dose for the booster) outcome was unknown.            The patient received 2 primary series and instead of the booster she received a full dose.   The patient was on unspecified concomitant/regular medication.  No information on treatment medications was reported.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: still itches a little and she develops tiny bumps when she scratches her arm; Nothing really bad but patient wasn't well; It still itches a little/Itchy upper right arm for a week or so; Very tired; Slight fever; Patient received a 3rd full dose for the booster; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (still itches a little and she develops tiny bumps when she scratches her arm), MALAISE (Nothing really bad but patient wasn't well), PRURITUS (It still itches a little/Itchy upper right arm for a week or so), FATIGUE (Very tired) and PYREXIA (Slight fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient confirmed that she had Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. However, details were not provided.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAPULE (still itches a little and she develops tiny bumps when she scratches her arm), MALAISE (Nothing really bad but patient wasn't well), PRURITUS (It still itches a little/Itchy upper right arm for a week or so), FATIGUE (Very tired), PYREXIA (Slight fever) and ACCIDENTAL OVERDOSE (Patient received a 3rd full dose for the booster). At the time of the report, PAPULE (still itches a little and she develops tiny bumps when she scratches her arm) and PRURITUS (It still itches a little/Itchy upper right arm for a week or so) had not resolved and MALAISE (Nothing really bad but patient wasn't well), FATIGUE (Very tired), PYREXIA (Slight fever) and ACCIDENTAL OVERDOSE (Patient received a 3rd full dose for the booster) outcome was unknown.            The patient received 2 primary series and instead of the booster she received a full dose.   The patient was on unspecified concomitant/regular medication.  No information on treatment medications was reported.   Reporter did not allow further contact
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myopericarditis
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (transient myopericarditis) in a 44-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: Transient myopericarditis following vaccination for COVID-19. Med Cases; 13(2): 80. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (transient myopericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (transient myopericarditis) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (transient myopericarditis) to be related. No concomitant and treatment medication were reported. An autoimmune mechanism as the cause of cardiac injury, augmented by the increased vaccine reactogenicity seen in younger patients was suspected. Company comment: This literature non-study case concerns a 44 year old male patient with no reported medical history, who experienced the expected serious (important medical event) AESI of Myocarditis, about 48 hours after receiving the second dose of mRNA-1273 vaccine. An autoimmune mechanism as the cause of cardiac injury, augmented by increased vaccine reactogenicity was suspected. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This literature non-study case concerns a 44 year old male patient with no reported medical history, who experienced the expected serious (important medical event) AESI of Myocarditis, about 48 hours after receiving the second dose of mRNA-1273 vaccine. An autoimmune mechanism as the cause of cardiac injury, augmented by increased vaccine reactogenicity was suspected. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose - 25Jan2021; 2nd dose 04Mar2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25Jan2021; 2nd dose 04Mar2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Influenza vaccine (flu vaccine) in September 2021. Past adverse reactions to the above products included No adverse effect with Influenza vaccine. Concurrent medical conditions included Atrial fibrillation (she takes unspecified medications.).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25Jan2021; 2nd dose 04Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25Jan2021; 2nd dose 04Mar2021) outcome was unknown.      No concomitant medications were reported.  Patient did not had Covid-19 diagnosis prior to or after getting the vaccine.  Patient had no history of allergies.  No treatment medications were reported.   This case was linked to MOD-2022-530257 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunodeficient patient given a "booster" dose for a 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunodeficient patient given a "booster" dose for a 3rd dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency, Leukemia and Blood pressure high. Concomitant products included VALSARTAN, AMLODIPINE and HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HCL) for Blood pressure high, INFLUENZA VACCINE (FLU) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunodeficient patient given a "booster" dose for a 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunodeficient patient given a "booster" dose for a 3rd dose) outcome was unknown.            Patient does not had any allergies and not had any Covid-19 diagnosis prior to or after getting the vaccine. 1st booster dose lot number was reported as 088_21A(cannot decipher the 4th character in the lot number) It was reported that patient had flu vaccine in Sep2021. It was reported that patient took 2rd booster dose on 04Feb2022 with lot number 042J21A , they were told that they was given 1/3 of the regular dose. It was also reported that he will clarify with the pharmacy that the dose was administered to him on 08Aug2021 and 04Feb2022. No treatment medications were provided.   This case was linked to MOD-2022-529251 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (0.5 mL booster dose level administered instead of 0.25mL booster dose) in a patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (0.5 mL booster dose level administered instead of 0.25mL booster dose). At the time of the report, ACCIDENTAL OVERDOSE (0.5 mL booster dose level administered instead of 0.25mL booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment information was reported. Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Slight reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Slight reaction). At the time of the report, VACCINATION COMPLICATION (Slight reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The patient received first dose over an year ago with not serious reaction and did not get the seond dose due to event.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Full shot when got the booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Full shot when got the booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received third 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Full shot when got the booster). At the time of the report, ACCIDENTAL OVERDOSE (Full shot when got the booster) outcome was unknown.            It was reported that patient not immunocompromised. Concomitant product information was not provided. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE ERYTHEMA (Red arm at injection site for 2 inches wide) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sodium sulfate) and Drug allergy (Erythromycin). In October 2021, the patient received third 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 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 VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE PAIN (Tinder arm) and VACCINATION SITE ERYTHEMA (Red arm at injection site for 2 inches wide). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Itching arm), VACCINATION SITE PAIN (Tender arm) and VACCINATION SITE ERYTHEMA (Red arm at injection site for 2 inches wide) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant medications were not reported. Treatment details were not reported. This case was linked to MOD-2021-353880 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.; affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve; affected person experienced ongoing headache at the time and later resolved.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.), MALAISE (affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve) and HEADACHE (affected person experienced ongoing headache at the time and later resolved.) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.), MALAISE (affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve) and HEADACHE (affected person experienced ongoing headache at the time and later resolved.). At the time of the report, COVID-19 (after receiving Moderna Covid-19 booster has exposed to Covid-19 virus and tested positive.) outcome was unknown and MALAISE (affected person felt sick for 3 days and didnt wanna do anything, starting day 3 symptoms started to improve) and HEADACHE (affected person experienced ongoing headache at the time and later resolved.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.         No concomitant medication information provided. No treatment medication information provided.  The reporter reported that starting day 3 symptoms started to improve.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022; We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20 Mar 2022 that we gave a few doses of) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20 Mar 2022 was initially stored in the refrigerator on 31 Mar 2022 and administered on 31 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient date of birth reported as 18 Mar in an unspecified year. No concomitant medications were reported. Patient received booster dose. It was reported that the vial was initially stored in the refrigerator was on 31 Mar 2022. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up information received contains no new information.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included High blood pressure medicine.  No treatment details were reported.    This case was linked to MOD-2022-530147, MOD-2022-530162 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: non immunocompromised got 3rd dose (full dose) of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (non immunocompromised got 3rd dose (full dose) of the Moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Arthritis (long before she got the Moderna Covid-19 vaccines) and Pain NOS. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), IBUPROFEN (ADVIL [IBUPROFEN]) and TRAMADOL for Pain management.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (non immunocompromised got 3rd dose (full dose) of the Moderna vaccine). At the time of the report, ACCIDENTAL OVERDOSE (non immunocompromised got 3rd dose (full dose) of the Moderna vaccine) outcome was unknown.            Patient stated that she already got a 3rd dose (full dose) of the vaccine long before Moderna has been authorized for the 1st booster dose. Lot number reported as (013(?)(?)0Afor 1st dose. No information on treatment medications was reported.   Reporter did not allow further contact