chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This spontaneous case was reported by a pharmacist and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 27-Jun-2022 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient never had a diagnosis of COVID and she had no other brand of COVID-19 vaccine. No concomitant medication was reported. Reporter does not know the cause of the pulmonary embolism. No treatment medications was reported.  Company comment: This spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected serious (hospitalization, medically significant) AESI of Pulmonary embolism, about 14 months and 11 days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine 35 days ago, with no reported adverse events. No further information on risk factors, co morbidities, 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 spontaneous case concerns a 60 year old female patient with no reported medical history, who experienced the unexpected serious (hospitalization, medically significant) AESI of Pulmonary embolism, about 14 months and 11 days after receiving the second dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the first dose with the same vaccine 35 days ago, with no reported adverse events. No further information on risk factors, co morbidities, 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered >12 hours post puncture & after exposure to room temperature >24 hours; Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture & after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2022 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced PRODUCT STORAGE ERROR (Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours). On 27-Jun-2022 at 9:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture & after exposure to room temperature >24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture & after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported The vial had been first punctured on Friday & left out at room temperature over the weekend. It was reported that date the vial was initially stored in the refrigerator was 24Jun2022 and on the same day at 12:10pm vial was first punctured. The vial did not  undergo any temperature excursions. No treatment medication was reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: upset stomach; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J Vaccine (First dose of J&J vaccine). Past adverse reactions to the above products included No adverse event with J&J Vaccine.    On 25-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache). In January 2022, ABDOMINAL DISCOMFORT (upset stomach) and HEADACHE (headache) had resolved.            No concomitant information were reported by the reporter. No treatment information were reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fall
Clinical narrative: progression she had in fall; fall; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (progression she had in fall) and FALL (fall) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Stem cell therapy. Concurrent medical conditions included Immunocompromised.   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 CONDITION AGGRAVATED (progression she had in fall) and FALL (fall). At the time of the report, CONDITION AGGRAVATED (progression she had in fall) and FALL (fall) outcome was unknown.            No concomitant medications were reported. Patient required an additional therapy because of the progression she had in fall.
Age: 26.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2017, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) was resolving.            No concomitant medication information provided. It was unknown if patient was enrolled in clinical trial.  No treatment medication information provided.  Causality for Humira: the reporter's causality for the event of ongoing pain was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Thrombosis
Clinical narrative: Cataract; Clot blood; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataract) and THROMBOSIS (Clot blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No reported medical history.  Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant) and THROMBOSIS (Clot blood) (seriousness criterion medically significant). At the time of the report, CATARACT (Cataract) was resolving and THROMBOSIS (Clot blood) outcome was unknown.            Concomitant medication was not provided. For Humira, reporter causality was not provided, causality as per Mfr. was no reasonable possibility. It was unknown if patient was enrolled in COVID-19 clinical trial. The patient had cataract surgery.  Company comment: This spontaneous case concerns a 68-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected serious (medically significant) events of Cataract and Thrombosis (AESI) which occurred unknown days after receiving booster dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient underwent surgery for the treatment of cataract. History of Crohn's disease and co-suspect drug adalimumab remain risk factors for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected serious (medically significant) events of Cataract and Thrombosis (AESI) which occurred unknown days after receiving booster dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient underwent surgery for the treatment of cataract. History of Crohn's disease and co-suspect drug adalimumab remain risk factors for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blister, Rash, Urticaria, Vitamin D, Vitamin D deficiency
Clinical narrative: Vit D deficient; rashes on both legs; welts on both legs, some spots were chronic; blisters on both legs; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (blisters on both legs), VITAMIN D DEFICIENCY (Vit D deficient), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ROSUVASTATIN for High cholesterol.    The patient did not have any allergies.  Concurrent medical conditions included Rheumatoid arthritis (No meds currently for this since. She stopped the medication for this condition in 2012) since 2009, High cholesterol and Osteoarthritis since 2009.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-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 started ROSUVASTATIN (unknown route) at an unspecified dose. In June 2021, the patient experienced BLISTER (blisters on both legs), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic). In September 2021, the patient experienced VITAMIN D DEFICIENCY (Vit D deficient). The patient was treated with COLECALCIFEROL (VIT D [COLECALCIFEROL]) at a dose of 50,000 cc of Vit D once a week plus Vit D (over the counter and COLECALCIFEROL (VIT D3) at a dose of 3000 international unit once a day. At the time of the report, BLISTER (blisters on both legs), VITAMIN D DEFICIENCY (Vit D deficient), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Vitamin D: deficiency deficiency(after 2 doses of the vaccine).         The patient stated that at the beginning of Jun2021, started getting rashes, blisters and welts on both legs, some spots of which were chronic. Rosuvastatin was taken off before Jun2021 because they were thinking this might be causing the rashes.  Patient did not have positive covid-19 test nor diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant drugs were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Biopsy, Lichen planus, Vitamin D
Clinical narrative: Vit D deficient; rashes on both legs; welts on both legs, some spots were chronic; blisters on both legs; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (blisters on both legs), VITAMIN D DEFICIENCY (Vit D deficient), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ROSUVASTATIN for High cholesterol.    The patient did not have any allergies.  Concurrent medical conditions included Rheumatoid arthritis (No meds currently for this since. She stopped the medication for this condition in 2012) since 2009, High cholesterol and Osteoarthritis since 2009.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-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 started ROSUVASTATIN (unknown route) at an unspecified dose. In June 2021, the patient experienced BLISTER (blisters on both legs), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic). In September 2021, the patient experienced VITAMIN D DEFICIENCY (Vit D deficient). The patient was treated with COLECALCIFEROL (VIT D [COLECALCIFEROL]) at a dose of 50,000 cc of Vit D once a week plus Vit D (over the counter and COLECALCIFEROL (VIT D3) at a dose of 3000 international unit once a day. At the time of the report, BLISTER (blisters on both legs), VITAMIN D DEFICIENCY (Vit D deficient), RASH (rashes on both legs) and URTICARIA (welts on both legs, some spots were chronic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Vitamin D: deficiency deficiency(after 2 doses of the vaccine).         The patient stated that at the beginning of Jun2021, started getting rashes, blisters and welts on both legs, some spots of which were chronic. Rosuvastatin was taken off before Jun2021 because they were thinking this might be causing the rashes.  Patient did not have positive covid-19 test nor diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant drugs were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blister, Rash, Urticaria, Vitamin D, Vitamin D deficiency
Clinical narrative: lichen planus/ rash proceeded to include her entire body including her mouth and vagina; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (lichen planus/ rash proceeded to include her entire body including her mouth and vagina) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 009C21A and 006B21A) for COVID-19 prophylaxis.     It was reported that the patient had never been diagnosed with/tested positive for COVID-19. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. .  Previously administered products included for High cholesterol: Rosuvastatin (taken off before Jun2021 (because they were thinking this might be causing the rashes)) until June 2021. Past adverse reactions to the above products included Rash with Rosuvastatin. Concurrent medical conditions included Rheumatoid arthritis (Patient stopped the medication in 2012 and not on medications currently.) since 2009, Cholesterol high, Osteoarthritis since 2009 and Vitamin D deficiency (after 2 doses of the vaccine) since September 2021.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced LICHEN PLANUS (lichen planus/ rash proceeded to include her entire body including her mouth and vagina). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of pill as needed; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2022 at an unspecified dose and frequency; FLUOCINOLONE ACETONIDE (FLUOCINOLONE) at a dose of 0.5; BETAMETHASONE at a dose of every other day and VITAMIN D [VITAMIN D NOS] in March 2022 for Vitamin D deficiency, at a dose of 500000 international unit twice a day. At the time of the report, LICHEN PLANUS (lichen planus/ rash proceeded to include her entire body including her mouth and vagina) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, Vitamin D: lower vitamin d in mar 2022. lower Vitamin D in Mar 2022.. In May 2022, Biopsy: diagnosed with lichen planus Diagnosed with lichen planus.         Patient had Vitamin D deficient in Sep2021 after 2 doses of the vaccine and on 50,000 cc of Vitamine D was given once a week plus Vit D (over the counter) and also Vit D3 3,000IU daily. After received 1st booster dose, in Dec2021 , the rash proceeded to include patient entire body including mouth and vagina and patient was embarrassed by it. It was found out  that during the annual check patient  Vit D level went lower. Patient did not experience a similar event in the past.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Biopsy, Lichen planus, Vitamin D
Clinical narrative: lichen planus/ rash proceeded to include her entire body including her mouth and vagina; This spontaneous case was reported by a patient and describes the occurrence of LICHEN PLANUS (lichen planus/ rash proceeded to include her entire body including her mouth and vagina) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 009C21A and 006B21A) for COVID-19 prophylaxis.     It was reported that the patient had never been diagnosed with/tested positive for COVID-19. Patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. .  Previously administered products included for High cholesterol: Rosuvastatin (taken off before Jun2021 (because they were thinking this might be causing the rashes)) until June 2021. Past adverse reactions to the above products included Rash with Rosuvastatin. Concurrent medical conditions included Rheumatoid arthritis (Patient stopped the medication in 2012 and not on medications currently.) since 2009, Cholesterol high, Osteoarthritis since 2009 and Vitamin D deficiency (after 2 doses of the vaccine) since September 2021.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced LICHEN PLANUS (lichen planus/ rash proceeded to include her entire body including her mouth and vagina). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of pill as needed; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2022 at an unspecified dose and frequency; FLUOCINOLONE ACETONIDE (FLUOCINOLONE) at a dose of 0.5; BETAMETHASONE at a dose of every other day and VITAMIN D [VITAMIN D NOS] in March 2022 for Vitamin D deficiency, at a dose of 500000 international unit twice a day. At the time of the report, LICHEN PLANUS (lichen planus/ rash proceeded to include her entire body including her mouth and vagina) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2022, Vitamin D: lower vitamin d in mar 2022. lower Vitamin D in Mar 2022.. In May 2022, Biopsy: diagnosed with lichen planus Diagnosed with lichen planus.         Patient had Vitamin D deficient in Sep2021 after 2 doses of the vaccine and on 50,000 cc of Vitamine D was given once a week plus Vit D (over the counter) and also Vit D3 3,000IU daily. After received 1st booster dose, in Dec2021 , the rash proceeded to include patient entire body including mouth and vagina and patient was embarrassed by it. It was found out  that during the annual check patient  Vit D level went lower. Patient did not experience a similar event in the past.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Bone disorder, Hypertension
Clinical narrative: Sickness; Hypertension; Bone disorder / Bone felt like they were disintegrated; Mobility decreased / Could not move; General body pain / Evrything hurt; low energy; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), HYPERTENSION (Hypertension), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move) and PAIN (General body pain / Evrything hurt) in a 69-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.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    No Medical History information was reported.   On 10-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In June 2022, the patient experienced ILLNESS (Sickness), HYPERTENSION (Hypertension), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move), PAIN (General body pain / Evrything hurt), ASTHENIA (low energy) and PYREXIA (Low grade fever). At the time of the report, ILLNESS (Sickness), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move), PAIN (General body pain / Evrything hurt) and ASTHENIA (low energy) outcome was unknown and HYPERTENSION (Hypertension) and PYREXIA (Low grade fever) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: not reported Not reported. On an unknown date, Body temperature: 101 101.         No concomitant medications were reported  No treatment medications were reported
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Mobility decreased, Pain, Pyrexia
Clinical narrative: Sickness; Hypertension; Bone disorder / Bone felt like they were disintegrated; Mobility decreased / Could not move; General body pain / Evrything hurt; low energy; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), HYPERTENSION (Hypertension), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move) and PAIN (General body pain / Evrything hurt) in a 69-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.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia.    No Medical History information was reported.   On 10-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In June 2022, the patient experienced ILLNESS (Sickness), HYPERTENSION (Hypertension), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move), PAIN (General body pain / Evrything hurt), ASTHENIA (low energy) and PYREXIA (Low grade fever). At the time of the report, ILLNESS (Sickness), BONE DISORDER (Bone disorder / Bone felt like they were disintegrated), MOBILITY DECREASED (Mobility decreased / Could not move), PAIN (General body pain / Evrything hurt) and ASTHENIA (low energy) outcome was unknown and HYPERTENSION (Hypertension) and PYREXIA (Low grade fever) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: not reported Not reported. On an unknown date, Body temperature: 101 101.         No concomitant medications were reported  No treatment medications were reported
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: Vertigo; Tingling in legs; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and PARAESTHESIA (Tingling in legs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) injection for an unknown indication.    The patient's past medical history included Vertigo (Resolved.) in 2016.   On 16-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 13-Jan-2022, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2022, the patient experienced VERTIGO (Vertigo). In 2022, the patient experienced PARAESTHESIA (Tingling in legs). At the time of the report, VERTIGO (Vertigo) had not resolved and PARAESTHESIA (Tingling in legs) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pruritus, Myalgia, Vaccination site pain
Clinical narrative: Intense itching left arm injection site after 2nd dose lasted 4-5 days; Joint Pain after 2nd dose lasted 4-5 days; Muscle pain after 2nd dose lasted 4-5 days; Fatigue after 2nd dose lasted 4-5 days; Pain on left arm injection site after 2nd dose lasted 4-5 days; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (Intense itching left arm injection site after 2nd dose lasted 4-5 days), ARTHRALGIA (Joint Pain after 2nd dose lasted 4-5 days), MYALGIA (Muscle pain after 2nd dose lasted 4-5 days), FATIGUE (Fatigue after 2nd dose lasted 4-5 days) and VACCINATION SITE PAIN (Pain on left arm injection site after 2nd dose lasted 4-5 days) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 INJECTION SITE PRURITUS (Intense itching left arm injection site after 2nd dose lasted 4-5 days), ARTHRALGIA (Joint Pain after 2nd dose lasted 4-5 days), MYALGIA (Muscle pain after 2nd dose lasted 4-5 days), FATIGUE (Fatigue after 2nd dose lasted 4-5 days) and VACCINATION SITE PAIN (Pain on left arm injection site after 2nd dose lasted 4-5 days). At the time of the report, INJECTION SITE PRURITUS (Intense itching left arm injection site after 2nd dose lasted 4-5 days), ARTHRALGIA (Joint Pain after 2nd dose lasted 4-5 days), MYALGIA (Muscle pain after 2nd dose lasted 4-5 days), FATIGUE (Fatigue after 2nd dose lasted 4-5 days) and VACCINATION SITE PAIN (Pain on left arm injection site after 2nd dose lasted 4-5 days) had resolved.            Concomitant and treatment medication was not reported.   This case was linked to MOD-2022-595957, MOD-2022-595959 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthritis, Gastric disorder
Clinical narrative: Arthritis flare up / Arthritis had been Acting up; Gastric disorder / Issues with Stomach; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis flare up / Arthritis had been Acting up) and GASTRIC DISORDER (Gastric disorder / Issues with Stomach) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis flare up / Arthritis had been Acting up) and GASTRIC DISORDER (Gastric disorder / Issues with Stomach). At the time of the report, ARTHRITIS (Arthritis flare up / Arthritis had been Acting up) and GASTRIC DISORDER (Gastric disorder / Issues with Stomach) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company comment  This is a spontaneous case reported by a consumer, concerning a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non- serious AESI of arthritis (arthritis flare up / arthritis had been acting up) on an unknown date after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was also receiving Adalimumab (HUMIRA) for Rheumatoid arthritis, which could be considered as a confounding factor. No details on risk factors, comorbidities, triggers, labs, diagnostic tests, and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a male patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non- serious AESI of arthritis (arthritis flare up / arthritis had been acting up) on an unknown date after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was also receiving Adalimumab (HUMIRA) for Rheumatoid arthritis, which could be considered as a confounding factor. No details on risk factors, comorbidities, triggers, labs, diagnostic tests, and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old received a Moderna booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received a Moderna booster dose) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (3 dose, for ages 12 and up) on 14-May-2021, Pfizer (second dose and for ages 12 and up) on 07-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 25-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received a Moderna booster dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old received a Moderna booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Patient received Moderna booster to a 14 year and up.  No treatment medications were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Muscle pain after first dose; Fever 101 F for 2.5 days after first dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever 101 F for 2.5 days after first dose) and MYALGIA (Muscle pain after first dose) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 101 F for 2.5 days after first dose) and MYALGIA (Muscle pain after first dose). At the time of the report, PYREXIA (Fever 101 F for 2.5 days after first dose) had resolved and MYALGIA (Muscle pain after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f (High) Fever 101 F.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  Patient had not visited doctor, she does not have a doctor.  No treatment medication was reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Follow up received contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Inappropriate schedule of product administration
Clinical narrative: Patient had received 1st dose on 21-Jan-2021 and 2nd dose on 21-Apr-2021; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 21-Jan-2021 and 2nd dose on 21-Apr-2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20DA and 032120A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus and Retinopathy diabetic (Diabetes Adult Type-2 Chronic). Concomitant products included LISINOPRIL, AMLODIPINE BESYLATE, METFORMIN HCL, ACETYLSALICYLIC ACID (BAYER LOW DOSE) and DULAGLUTIDE (TRULICITY) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 21-Jan-2021 and 2nd dose on 21-Apr-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 21-Jan-2021 and 2nd dose on 21-Apr-2021) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: from 130 to 141 with a range of 146 to 182 From 130 to 141 with a range of 146 to 182.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies to medications, food and other products. Patient had not tested positive for COVID-19.  Other concomitant medications included Statin 5mg per day.  No treatment information was provided.   This case was linked to MOD-2022-570354 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Influenza like illness, Mobility decreased
Clinical narrative: weakness; flu like symptoms; sick; couldn't move; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick) and MOBILITY DECREASED (couldn't move) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Lupus-like syndrome, Swelling, Constipation, Diarrhea, Confusion, Tiredness, Flu like symptoms, Weakness, Limb discomfort and Speech disorder. Concurrent medical conditions included Drug allergy (Dilantin) and MS.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick) and MOBILITY DECREASED (couldn't move). At the time of the report, ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), ILLNESS (sick) and MOBILITY DECREASED (couldn't move) had resolved. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient concomitant medication included radiation therapy. Treatment details were reported.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperglycaemia, Loss of personal independence in daily activities
Clinical narrative: Hyperglycemia/ they experiences sugar going out of control; This affected their normal activities of daily living, they could not excursive; Were tired; This spontaneous case was reported by a patient and describes the occurrence of HYPERGLYCAEMIA (Hyperglycemia/ they experiences sugar going out of control), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This affected their normal activities of daily living, they could not excursive) and FATIGUE (Were tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057m21A, 012L20A, 016M20A and 012F21A) for COVID-19 vaccination.     It was reported that patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Type 2 diabetes mellitus, Allergy NOS and Hypertension. Concomitant products included LISINOPRIL, APIXABAN (ELIQUIS), ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CHOLECALCIFEROL, DULOXETINE, PANTOPRAZOLE, FAMOTIDINE, BUSPIRONE, CARVEDILOL, DULAGLUTIDE (TRULICITY), GLIMEPIRIDE, OMEGA-3 FATTY ACIDS (KRILL OMEGA RED OIL), UBIDECARENONE (COQ10 [UBIDECARENONE]), MULTIVITAMINS [VITAMINS NOS], ATORVASTATIN and LEVOFLOXACIN (LEXA) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERGLYCAEMIA (Hyperglycemia/ they experiences sugar going out of control), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This affected their normal activities of daily living, they could not excursive) and FATIGUE (Were tired). At the time of the report, HYPERGLYCAEMIA (Hyperglycemia/ they experiences sugar going out of control), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (This affected their normal activities of daily living, they could not excursive) and FATIGUE (Were tired) was resolving.            No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient has never experienced a similar event in the past.  No treatment medications were reported.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation) in a 9-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation). At the time of the report, ACCIDENTAL UNDERDOSE (25mcg formulation was given to the 9 year old instead of 0.5mL dose of a 50 mcg formulation) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in arm, chest, back and stomach; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash in arm, chest, back and stomach) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J Vaccine (Lot number :1805029  and Route Intramuscular.) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J Vaccine. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 17-Jun-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash in arm, chest, back and stomach). The patient was treated with PREDNISONE at a dose of 10 milligram for 5 days; LEVOCETIRIZINE at a dose of 5 milligram for 30 days and AMMONIUM LACTATE at an unspecified dose and frequency. At the time of the report, RASH (Rash in arm, chest, back and stomach) had not resolved.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the patient received her 1st and 2nd dose from the same lot of the Moderna COVID-19 vaccine (Lot : 011F21A) which expired on 19MAR2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the patient received her 1st and 2nd dose from the same lot of the Moderna COVID-19 vaccine (Lot : 011F21A) which expired on 19MAR2022) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 011F21A and 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the patient received her 1st and 2nd dose from the same lot of the Moderna COVID-19 vaccine (Lot : 011F21A) which expired on 19MAR2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the patient received her 1st and 2nd dose from the same lot of the Moderna COVID-19 vaccine (Lot : 011F21A) which expired on 19MAR2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 13-May-2022 (dose 1) and 14-Jun-2022 (dose 2) patient had administered the expired dose. Before administration, the refrigerators temperature was -19.5C. Date the vial was initially stored in the refrigerator: 14-JUN-2022. It was reported that vial was not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2022: Live-non significant follow up. On 28-Jun-2022: Live non-significant follow-up On 28-Jun-2022: Non Significant follow up appended