chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: feeling pain; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feeling pain) and FATIGUE (Tired) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (feeling pain) and FATIGUE (Tired). At the time of the report, PAIN (feeling pain) and FATIGUE (Tired) had resolved.      No Concomitant medications were reported. It was reported that patient received all three doses. Reporter said it was not a side effect and it was normal. No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Pain, Swelling, Urticaria
Clinical narrative: Angioedema; uncontrollable hives\urticaria multiformae; Swelling; Pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema), URTICARIA (uncontrollable hives\urticaria multiformae), SWELLING (Swelling) and PAIN (Pain) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criteria hospitalization and medically significant), URTICARIA (uncontrollable hives\urticaria multiformae) (seriousness criterion hospitalization), SWELLING (Swelling) (seriousness criterion hospitalization) and PAIN (Pain) (seriousness criterion hospitalization). At the time of the report, ANGIOEDEMA (Angioedema), URTICARIA (uncontrollable hives\urticaria multiformae), SWELLING (Swelling) and PAIN (Pain) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.  The patient reported an adverse reaction to the Moderna booster. Multiple doctors confirmed that this was the cause to her reaction. She had Angioedema, uncontrollable hives, and urticaria multiformae. She could not function in the real world due to the swelling and pain. She had been hospitalized twice due to the severity of her reaction. She is a healthy 25 year old female who never experienced allergies nor changed up her routine. The only change recently was this booster.  . Company comment This spontaneous case concerns a 25-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization) events of ANGIOEDEMA (hospitalization and medically significant), URTICARIA, SWELLING and PAIN, which occurred on an unknown date after receiving third (booster) dose of mRNA-1273 vaccine in an unknown vaccination schedule. Since vaccination date and event date was not provided, latency cannot be assessed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 25-year-old female patient, with no reported medical history, who experienced the unexpected serious (hospitalization) events of ANGIOEDEMA (hospitalization and medically significant), URTICARIA, SWELLING and PAIN, which occurred on an unknown date after receiving third (booster) dose of mRNA-1273 vaccine in an unknown vaccination schedule. Since vaccination date and event date was not provided, latency cannot be assessed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 17 patients administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  On 14-SEP-2021, the vial was initially stored in the refrigerator and administered on same day.  Vial didn't undergo any temperature excursions. It was unknown in which arm the patient received the Moderna Covid-19 vaccine. The patient did not report any adverse events.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7th patient administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7th patient administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (7th patient administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7th patient administered expired Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that the vaccine did not undergo temperature excursion. Treatment medications were not reported.  The patient did not report any other adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm hurts after vaccination; Arm is red after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts after vaccination) and ERYTHEMA (Arm is red after vaccination) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts after vaccination) and ERYTHEMA (Arm is red after vaccination). At the time of the report, PAIN IN EXTREMITY (Arm hurts after vaccination) and ERYTHEMA (Arm is red after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received expired Moderna COVID-19 vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030B21A) for COVID-19 immunization. No medical history reported. On Sep 24, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 24, 2021, patient administered expired product (patient received expired Moderna COVID-19 vaccine). At the time of the report, administered expired product (patient received expired Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial was initially stored in the refrigerator on Sep 24, 2021. It did not undergo any temperature excursions. It was not known which arm the patient received the Moderna COVID-19 vaccine. It was not known if these vaccines were primary series or booster doses. The patient did not report any other adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 0.25 mL administered as first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25 mL administered as first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (0.25 mL administered as first dose). At the time of the report, ACCIDENTAL UNDERDOSE (0.25 mL administered as first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  The patient received second dose  of 0.5mL 28 days later of first dose. No symptoms reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was on 14 Sep 2021. No temperature excursions reported. The patient did not report any other adverse events. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13th patient administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13th patient administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13th patient administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13th patient administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No any concomitant medications were reported. No any treatment medications were reported. The patient received the vaccination on which arm was unknown. The patient had no adverse event.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (17 patients administered expired Moderna COVID-19 vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011L20A) for COVID-19 immunization. No medical history reported. On Aug 27, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 27, 2021, patient administered expired product (17 patients administered expired Moderna COVID-19 vaccine). At the time of the report, administered expired product (17 patients administered expired Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Listless, Pain in extremity
Clinical narrative: Listlessness; Sore arm; Headache; One day of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of LISTLESS (Listlessness), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (One day of tiredness) 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 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 LISTLESS (Listlessness), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (One day of tiredness). At the time of the report, LISTLESS (Listlessness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown and FATIGUE (One day of tiredness) had resolved.            No concomitant medication information was provided.  No treatment medications were provided.   This case was linked to MOD-2022-490560, MOD-2022-456385 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Listless, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), listless (listlessness), headache and fatigue (one day of tiredness) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm), listless (listlessness), headache and fatigue (one day of tiredness). At the time of the report, pain in extremity (sore arm), listless (listlessness), headache and fatigue (one day of tiredness) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2022-490553, MOD-2022-456385 (patient link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Discouragement, Pyrexia
Clinical narrative: discouragement; diarrhea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISCOURAGEMENT (discouragement), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 940875) for COVID-19 vaccination.     Concomitant products included AMOXICILLIN SODIUM (AMOXILLIN [AMOXICILLIN SODIUM]) for an unknown indication.    On 27-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced DISCOURAGEMENT (discouragement), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills). On 01-Dec-2021, DISCOURAGEMENT (discouragement), DIARRHOEA (diarrhea), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea; Chills; Fever; Soreness at injection site; Headache; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (Occurred may be once a year), Fever (Occurred maybe once every 5 years, if even), Chills (Occurred maybe once every 5 years, if even) and Nausea (Occurred maybe once every 5 years, if even). Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included Bedridden with Flu shot. Concurrent medical conditions included Allergy to antibiotic (Sulfa Antibiotics) and Ulcerative colitis (Flared up after first vaccination, none since) since 01-Apr-1995. Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 01-Jan-2000 to an unknown date and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) from 01-Jan-2021 to an unknown date for Routine health maintenance, BALSALAZIDE DISODIUM from 01-Jan-2012 to an unknown date and CALCIUM, COLECALCIFEROL (CALCIUM +D3) from 01-Jan-2000 to an unknown date for Ulcerative colitis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Headache) and MYALGIA (Muscle soreness). The patient was treated with BALSALAZIDE DISODIUM at a dose of increased my dosage. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Headache) and MYALGIA (Muscle soreness) had not resolved. Not Provided          Concomitant medication include spore probiotic 6 billion CFU + triphala once daily which was taken for general health from 01 Jan 2021 and route of administration was oral. Route of administration of vaccine: VSC. Patient did not had any similar events in past and no other potential causes. In anticipation for a flare up patient increased the dosage of balzalazide. Later decreased the dosage after about 3 weeks (return to twice/day.   This case was linked to MOD-2022-487474, MOD-2022-490806 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Nausea; Chills; Fever; Soreness at injection site; Headache; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (Occurred may be once a year), Fever (Occurred maybe once every 5 years, if even), Chills (Occurred maybe once every 5 years, if even) and Nausea (Occurred maybe once every 5 years, if even). Previously administered products included for Drug use for unknown indication: Flu shot. Past adverse reactions to the above products included Bedridden with Flu shot. Concurrent medical conditions included Allergy to antibiotic (Sulfa Antibiotics) and Ulcerative colitis (Flared up after first vaccination, none since) since 01-Apr-1995. Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 01-Jan-2000 to an unknown date and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) from 01-Jan-2021 to an unknown date for Routine health maintenance, BALSALAZIDE DISODIUM from 01-Jan-2012 to an unknown date and CALCIUM, COLECALCIFEROL (CALCIUM +D3) from 01-Jan-2000 to an unknown date for Ulcerative colitis.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Headache) and MYALGIA (Muscle soreness). The patient was treated with BALSALAZIDE DISODIUM at a dose of increased my dosage. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Headache) and MYALGIA (Muscle soreness) had not resolved. Not Provided          Concomitant medication include spore probiotic 6 billion CFU + triphala once daily which was taken for general health from 01 Jan 2021 and route of administration was oral. Route of administration of vaccine: VSC. Patient did not had any similar events in past and no other potential causes. In anticipation for a flare up patient increased the dosage of balzalazide. Later decreased the dosage after about 3 weeks (return to twice/day.   This case was linked to MOD-2022-487474, MOD-2022-490806 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: 3rd dose administered as a 0.25 mL dose; 3rd dose administered off schedule; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3rd dose administered as a 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered off schedule) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 027A21A and 025B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu (flu shot) on 06-Sep-2021. Past adverse reactions to the above products included No adverse event with Flu. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Drug allergy and Immunocompromised. Concomitant products included SIMVASTATIN for Cholesterol.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (3rd dose administered as a 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered off schedule). On 25-Oct-2021, ACCIDENTAL UNDERDOSE (3rd dose administered as a 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered off schedule) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Immunocompromised patient received the booster dose instead of the 3rd dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received the booster dose instead of the 3rd dose.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received the booster dose instead of the 3rd dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient received the booster dose instead of the 3rd dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Information of concomitant medication was unknown. No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the vaccine I got has expired, vaccine has expired for 10 days and then it is injected into me; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the vaccine I got has expired, vaccine has expired for 10 days and then it is injected into me) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.  No Medical History information was reported.  On 15-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the vaccine I got has expired, vaccine has expired for 10 days and then it is injected into me). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the vaccine I got has expired, vaccine has expired for 10 days and then it is injected into me) outcome was unknown.  No concomitant medication was provided No treatment medication was provided
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of product administered to patient of inappropriate age (received a Moderna vaccination while under the age of 18) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 001J212A) for COVID-19 immunization. No medical history reported. On Jan 26, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 26, 2022, product administered to patient of inappropriate age (received a Moderna vaccination while under the age of 18). At the time of the report, product administered to patient of inappropriate age (received a Moderna vaccination while under the age of 18) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, patient had no side effect after vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: The patient began experiencing a dermal reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (The patient began experiencing a dermal 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 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN REACTION (The patient began experiencing a dermal reaction). At the time of the report, SKIN REACTION (The patient began experiencing a dermal reaction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  The patient had received the Moderna booster dose.  The patient found out via social media groups that others had also been experiencing the same dermal reaction (assumed as chronic spontaneous urticaria).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: transverse myelitis; This literature-non-study case was reported in a literature article and describes the occurrence of MYELITIS TRANSVERSE (transverse myelitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (transverse myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (transverse myelitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYELITIS TRANSVERSE (transverse myelitis) to be related.    No concomitant and treatment information were provided.  Company comment: This Literature-non-study case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Myelitis Transverse. The event occurred approximately 5 days after an unknown dose of mRNA-1273 (Moderna covid-19 vaccine). Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This Literature-non-study case concerns a 67-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Myelitis Transverse. The event occurred approximately 5 days after an unknown dose of mRNA-1273 (Moderna covid-19 vaccine). Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Did the vial undergo any temperature excursions was given No Expiration date :31-DEC-1969 Date the vial was initially stored in the refrigerator: 13-JAN-2022  No concomitant drug information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal pain/Belly Ache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain/Belly Ache) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gallbladder removal (Gall-bladder was taken 15-20 years ago).    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 ABDOMINAL PAIN (Abdominal pain/Belly Ache) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN (Abdominal pain/Belly Ache) and DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient mentioned that the bellyache was there for approximately 6 months as of now. Patient was scheduled to take the second dose on the next day of the time of report. No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Vaccine breakthrough infection; This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    Concomitant and Treatment Medications were not reported.  Company Comment: This Literature non-study case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected serious event of Vaccine breakthrough infection. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The patient is one of twelve patients that was reported to have vaccine breakthrough infections in the study. Further information is requested.   This case was linked to MOD-2022-491471, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491379, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491481 (Patient Link).; Sender's Comments: This Literature non-study case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) event of Vaccine breakthrough infection. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The patient is one of twelve patients that was reported to have vaccine breakthrough infections in the study. Further information is requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Burning sensation, Erythema, Pruritus, Sensitive skin
Clinical narrative: Skin very sensitive / The skin is very sensitive yet; Burning body; when touching with nails he had red marks on skin; Itching a lot; itchiness in the head; Allergic symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Skin very sensitive / The skin is very sensitive yet), BURNING SENSATION (Burning body), ERYTHEMA (when touching with nails he had red marks on skin), PRURITUS (Itching a lot) and PRURITUS (itchiness in the head) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 SENSITIVE SKIN (Skin very sensitive / The skin is very sensitive yet), BURNING SENSATION (Burning body), ERYTHEMA (when touching with nails he had red marks on skin), PRURITUS (Itching a lot), PRURITUS (itchiness in the head) and ALLERGY TO VACCINE (Allergic symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, SENSITIVE SKIN (Skin very sensitive / The skin is very sensitive yet) had not resolved, BURNING SENSATION (Burning body), ERYTHEMA (when touching with nails he had red marks on skin), PRURITUS (Itching a lot) and ALLERGY TO VACCINE (Allergic symptoms) outcome was unknown and PRURITUS (itchiness in the head) had resolved.            It was reported that reaction started after two weeks and it had been a month since then. Patient saw a doctor five days after the symptoms started.  No concomitant medications were reported. Treatment medications also include another drug for allergic reactions, similar to "quartelli".
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (itching all over the body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 039B21A) for COVID-19 immunization. No medical history reported. On Feb 22, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 22, 2022, patient experienced pruritus (itching all over the body). Patient treated with Benadryl (diphenhydramine hydrochloride) at an unspecified dose and frequency. At the time of the report, pruritus (itching all over the body) outcome: unknown. No concomitant medication reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity, Fatigue, Gait disturbance, Vaccination site bruising, Vaccination site pain
Clinical narrative: left arm still hurts and still feels bruised; experienced an abdominal muscle spasm  once after receiving the vaccine; There was a limpness, and the patient had to hold herself up with the wall on the way to the bathroom  and had to lean against the counter when washing her hands; left arm still hurts and still feels bruised; fatigue was worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (left arm still hurts and still feels bruised), ABDOMINAL RIGIDITY (experienced an abdominal muscle spasm  once after receiving the vaccine), GAIT DISTURBANCE (There was a limpness, and the patient had to hold herself up with the wall on the way to the bathroom  and had to lean against the counter when washing her hands), VACCINATION SITE PAIN (left arm still hurts and still feels bruised) and FATIGUE (fatigue was worse) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy (had abdominal muscle spasms due to the peanut allergy followed by brain fog and feeling of heaviness).    On 29-Dec-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 SITE BRUISING (left arm still hurts and still feels bruised), ABDOMINAL RIGIDITY (experienced an abdominal muscle spasm  once after receiving the vaccine), GAIT DISTURBANCE (There was a limpness, and the patient had to hold herself up with the wall on the way to the bathroom  and had to lean against the counter when washing her hands), VACCINATION SITE PAIN (left arm still hurts and still feels bruised) and FATIGUE (fatigue was worse). At the time of the report, VACCINATION SITE BRUISING (left arm still hurts and still feels bruised) and VACCINATION SITE PAIN (left arm still hurts and still feels bruised) had not resolved and ABDOMINAL RIGIDITY (experienced an abdominal muscle spasm  once after receiving the vaccine), GAIT DISTURBANCE (There was a limpness, and the patient had to hold herself up with the wall on the way to the bathroom  and had to lean against the counter when washing her hands) and FATIGUE (fatigue was worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient did not have a history of COVID. It had been 8 weeks after the dose that the patient was still feeling that the arm hurts. The patient experienced an abdominal muscle spasm once after receiving the vaccine.  The patient had a history of peanut allergy that looks a lot like long COVID disease. The spasm that the patient had after receiving the Moderna Covid-19 vaccine looked similar to what the patient experienced with the peanut allergy, except the fact that the fatigue was worse.  No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: anticipated reaction of malaise; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (anticipated reaction of malaise) and PAIN IN EXTREMITY (Sore arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MALAISE (anticipated reaction of malaise) and PAIN IN EXTREMITY (Sore arm). In February 2021, MALAISE (anticipated reaction of malaise) and PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported. Patient experienced anticipated reaction of malaise, sore arm for 3-4 days.   This case was linked to MOD-2021-375534 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A and 022J21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had twice before receiving the first dose).   On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2022 at 7:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022 at 7:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a second dose of the Moderna Covid 19 vaccine from a vial that had been first punctured 22 hours ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Twice before receiving the first dose.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had not reported any symptom after receiving the vaccine.  The patient did not take concomitant medication. The vial was initially stored in the refrigerator was on 21 Feb 2022 and punctured on 21 Feb 2022  at 9.00 AM. The vial was exposed to room temperature range for 3 minutes.No temperature excursions reported. No treatment medications reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: receiving 0.5ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (receiving 0.5ml booster dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 060h21a) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (diagnosis received on Jun 2nd 2019) and Traumatic brain injury. Concurrent medical conditions included Obesity (severe), Cognitive disorder and Memory loss.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (receiving 0.5ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (receiving 0.5ml booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.