chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Near death experience
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (nearly died/nearly took my life) and AUTOIMMUNE DISORDER (several issues with my autoimmune system) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (nearly died/nearly took my life) (seriousness criteria hospitalization and medically significant) and AUTOIMMUNE DISORDER (several issues with my autoimmune system) (seriousness criteria hospitalization and medically significant). At the time of the report, NEAR DEATH EXPERIENCE (nearly died/nearly took my life) and AUTOIMMUNE DISORDER (several issues with my autoimmune system) outcome was unknown. Concomitant medication list was not provided. The patient had several hospitalizations. Patient was also seeking medical compensation. Patient only took two doses and refuses to take more. Patient had not been able to find work because they are requiring vaccinations, but patient was refusing to be re-vaccinated. Treatment information was not provided. Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant and hospitalization) events of Near death experience (reported as nearly died/nearly took my life) and Autoimmune disorder after receiving the mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. It was reported that patient had received only two doses of vaccines. Patient reported that she nearly died and had several hospitalizations. Clinical course and treatment details were not reported. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement. Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant and hospitalization) events of Near death experience (reported as nearly died/nearly took my life) and Autoimmune disorder after receiving the mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. It was reported that patient had received only two doses of vaccines. Patient reported that she nearly died and had several hospitalizations. Clinical course and treatment details were not reported. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Granuloma annulare
Clinical narrative: Granuloma annulare after receiving the second shot; This spontaneous case was reported by a patient and describes the occurrence of GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 033C21A) for COVID-19 vaccination.     Patient did not had any acute and chronic illnesses at the time of vaccination. Patient did not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy (Outdoor allergy) and Shellfish allergy. Concomitant products included ESCITALOPRAM OXALATE and HYDROXYZINE HYDROCHLORIDE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot). At the time of the report, GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) outcome was unknown.            Patient started taking prescribed medication after taking the vaccine. He started Escitalopram Oxalate before the booster due to family death. HCP (Health care professional) and Dermatologist were aware of the side effects.  In Dec-2021 patient went to see a dermatologist. Patient was diagnosed with granuloma annulare after receiving the second shot and before the booster.   No treatment information was reported.   This case was linked to MOD-2022-643706.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacterial infection, Fatigue, Feeling hot, Gait disturbance, Headache
Clinical narrative: Granuloma annulare after receiving the second shot; This spontaneous case was reported by a patient and describes the occurrence of GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 033C21A) for COVID-19 vaccination.     Patient did not had any acute and chronic illnesses at the time of vaccination. Patient did not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy (Outdoor allergy) and Shellfish allergy. Concomitant products included ESCITALOPRAM OXALATE and HYDROXYZINE HYDROCHLORIDE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot). At the time of the report, GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) outcome was unknown.            Patient started taking prescribed medication after taking the vaccine. He started Escitalopram Oxalate before the booster due to family death. HCP (Health care professional) and Dermatologist were aware of the side effects.  In Dec-2021 patient went to see a dermatologist. Patient was diagnosed with granuloma annulare after receiving the second shot and before the booster.   No treatment information was reported.   This case was linked to MOD-2022-643706.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Granuloma annulare after receiving the second shot; This spontaneous case was reported by a patient and describes the occurrence of GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 033C21A) for COVID-19 vaccination.     Patient did not had any acute and chronic illnesses at the time of vaccination. Patient did not received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy (Outdoor allergy) and Shellfish allergy. Concomitant products included ESCITALOPRAM OXALATE and HYDROXYZINE HYDROCHLORIDE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot). At the time of the report, GRANULOMA ANNULARE (Granuloma annulare after receiving the second shot) outcome was unknown.            Patient started taking prescribed medication after taking the vaccine. He started Escitalopram Oxalate before the booster due to family death. HCP (Health care professional) and Dermatologist were aware of the side effects.  In Dec-2021 patient went to see a dermatologist. Patient was diagnosed with granuloma annulare after receiving the second shot and before the booster.   No treatment information was reported.   This case was linked to MOD-2022-643706.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Granuloma annulare
Clinical narrative: bacterial infection because it all started in his right nostril; felt hot/Getting very warm; Fatigue; Headache; Could barely walk; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Could barely walk), BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 042B21A and 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Shellfish allergy. Concomitant products included ESCITALOPRAM OXALATE for Prophylaxis, HYDROXYZINE HYDROCHLORIDE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (Could barely walk). On an unknown date, the patient experienced BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, GAIT DISTURBANCE (Could barely walk) had not resolved and BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) declared a false positive.         The patient received all the vaccine on left shoulder.  The patient had a sinus surgery on 23-Aug-2022. Two weeks after that the patient started feeling unwell, nose was dripping and acting odd. Then the patient went to get the rapid test done at the pharmacy. The next day the patient took a PCR test and it came out negative, so it was declared a false positive. Then the ENT stated it was a bacterial infection because it all started in his right nostril. The patient did not have a fever.  No treatment medication was reported.   This case was linked to MOD-2022-643594 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacterial infection, Fatigue, Feeling hot, Gait disturbance, Headache
Clinical narrative: bacterial infection because it all started in his right nostril; felt hot/Getting very warm; Fatigue; Headache; Could barely walk; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Could barely walk), BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 042B21A and 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Shellfish allergy. Concomitant products included ESCITALOPRAM OXALATE for Prophylaxis, HYDROXYZINE HYDROCHLORIDE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (Could barely walk). On an unknown date, the patient experienced BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, GAIT DISTURBANCE (Could barely walk) had not resolved and BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) declared a false positive.         The patient received all the vaccine on left shoulder.  The patient had a sinus surgery on 23-Aug-2022. Two weeks after that the patient started feeling unwell, nose was dripping and acting odd. Then the patient went to get the rapid test done at the pharmacy. The next day the patient took a PCR test and it came out negative, so it was declared a false positive. Then the ENT stated it was a bacterial infection because it all started in his right nostril. The patient did not have a fever.  No treatment medication was reported.   This case was linked to MOD-2022-643594 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: bacterial infection because it all started in his right nostril; felt hot/Getting very warm; Fatigue; Headache; Could barely walk; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (Could barely walk), BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 042B21A and 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Shellfish allergy. Concomitant products included ESCITALOPRAM OXALATE for Prophylaxis, HYDROXYZINE HYDROCHLORIDE for an unknown indication.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (Could barely walk). On an unknown date, the patient experienced BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, GAIT DISTURBANCE (Could barely walk) had not resolved and BACTERIAL INFECTION (bacterial infection because it all started in his right nostril), FEELING HOT (felt hot/Getting very warm), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) declared a false positive.         The patient received all the vaccine on left shoulder.  The patient had a sinus surgery on 23-Aug-2022. Two weeks after that the patient started feeling unwell, nose was dripping and acting odd. Then the patient went to get the rapid test done at the pharmacy. The next day the patient took a PCR test and it came out negative, so it was declared a false positive. Then the ENT stated it was a bacterial infection because it all started in his right nostril. The patient did not have a fever.  No treatment medication was reported.   This case was linked to MOD-2022-643594 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site urticaria
Clinical narrative: her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter; her arm is sore to lift up, tender to the touch; raised, hard, welt on her right arm where she received the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter), VACCINATION SITE PAIN (her arm is sore to lift up, tender to the touch) and VACCINATION SITE URTICARIA (raised, hard, welt on her right arm where she received the injection) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 019B21A and 012A21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Concomitant products included ATENOLOL for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter), VACCINATION SITE PAIN (her arm is sore to lift up, tender to the touch) and VACCINATION SITE URTICARIA (raised, hard, welt on her right arm where she received the injection). At the time of the report, VACCINATION SITE ERYTHEMA (her arm is a red/symptoms seem to be very localized and the redness is only a little bigger than a quarter), VACCINATION SITE PAIN (her arm is sore to lift up, tender to the touch) and VACCINATION SITE URTICARIA (raised, hard, welt on her right arm where she received the injection) outcome was unknown.            Patient height reported as 6'0".  Patient received booster dose.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-643519 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion; No adverse event; Patient received moderna bivalent vaccine after a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 2.5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received moderna bivalent vaccine after a temperature excursion).    No concomitant medication information was provided.No treatment medication were provided.  It was reported that the patient also received 2 primary monovalent Moderna covid-19 vaccines.Storage condition at the time of the excursion was reported as  refrigerated storage.Vial undergone the temperature excursion for 2 minutes below temperature range at 12:11 PM and 5 minutes at 12:31PM. Maximum or minimum temperatures reached was reported as 35.4°F minimum, 47.4°F Maximum. And no notable visual change was reported .The vial was moved from freezer to refrigerator on 08-Sep-2022 . At the time of reporting the vials were returned to the refrigerator within the recommended temperature range.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced FEELING ABNORMAL (Brain fog). At the time of the report, FEELING ABNORMAL (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient received a vaccine 6 months ago and had some brain fog. Unable to confirm which vaccine was received.  No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: bad side effect of tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (bad side effect of tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, the patient experienced TINNITUS (bad side effect of tinnitus). At the time of the report, TINNITUS (bad side effect of tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Moderna Bivalent vaccine be given as a Primary dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Bivalent vaccine be given as a Primary dose) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1744B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Bivalent vaccine be given as a Primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Bivalent vaccine be given as a Primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. The expiration date of vaccine was 12-MAR-2023. No treatment medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Hypoacusis, Inflammation, Sinusitis
Clinical narrative: Trouble hearing; Inflammation; Sinus issues/sinus infections; Possible vaccination effects/did not wake up for a week; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Possible vaccination effects/did not wake up for a week), HYPOACUSIS (Trouble hearing), INFLAMMATION (Inflammation) and SINUSITIS (Sinus issues/sinus infections) in a 78-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 Rheumatoid arthritis.    There was no reported medical history.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 08-Jan-2021, the patient experienced HYPERSOMNIA (Possible vaccination effects/did not wake up for a week). On an unknown date, the patient experienced HYPOACUSIS (Trouble hearing), INFLAMMATION (Inflammation) and SINUSITIS (Sinus issues/sinus infections). The patient was treated with PREDNISONE at an unspecified dose and frequency. In 2021, HYPERSOMNIA (Possible vaccination effects/did not wake up for a week) had resolved. At the time of the report, HYPOACUSIS (Trouble hearing), INFLAMMATION (Inflammation) and SINUSITIS (Sinus issues/sinus infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company comment: This spontaneous case reported by a consumer concerns a 78-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of Hypersomnia. The event occurred on same day after a dose of mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Lab test: Inflammation was at a 50  Primary reporter contact for lot number information was unsuccessful.  The reporter's causality for the event of possible vaccination effects/ did not wake up for a week with Humira had no reasonable possibility. The reporter's causality for the events of trouble hearing and inflammation with Humira was not provided. The reporter's causality for the event sinus issues/ sinus infection  with Humira had a reasonable possibility.; Sender's Comments: This spontaneous case reported by a consumer concerns a 78-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of Hypersomnia. The event occurred on same day after a dose of mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; 1st dose administered on 06Apr2021; 2nd dose administered on 24May2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021) and NO ADVERSE EVENT (No Adverse Event) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Patient did not have allergies to medications, food and other products. Patient did not have acute illnesses at the time of vaccination and up to one month before vaccine.  No treatment details were provided   This case was linked to MOD-2022-643584, MOD-2022-643751 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: No Adverse Event; 1st dose administered on 06Apr2021; 2nd dose administered on 24May2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021) and NO ADVERSE EVENT (No Adverse Event) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Patient did not have allergies to medications, food and other products. Patient did not have acute illnesses at the time of vaccination and up to one month before vaccine.  No treatment details were provided   This case was linked to MOD-2022-643584, MOD-2022-643751 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Electrocardiogram, Palpitations
Clinical narrative: Heart palpitations; Chest discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and CHEST DISCOMFORT (Chest discomfort) in a 25-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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and CHEST DISCOMFORT (Chest discomfort). At the time of the report, PALPITATIONS (Heart palpitations) and CHEST DISCOMFORT (Chest discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: No abnormal findings. On an unknown date, Electrocardiogram: No abnormal findings.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, patient visited the local emergency department on 07-Sep-2022 due to chest discomfort and heart palpitations. Her ED physician mentioned that it might be related to COVID.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Prenatal screening test, Transposition of the great vessels
Clinical narrative: Transposition of the great vessels; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSPOSITION OF THE GREAT VESSELS (Transposition of the great vessels) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030M20A) for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): The mother's past medical history included Miscarriage (approximately 4-5 weeks pregnant) on 30-Apr-2021 and Maternal exposure before pregnancy. Concurrent medical conditions included Asthma.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2022, the patient experienced TRANSPOSITION OF THE GREAT VESSELS (Transposition of the great vessels) (seriousness criteria hospitalization, medically significant and congenital anomaly). The patient was treated with Surgery for Transposition of the great vessels. At the time of the report, TRANSPOSITION OF THE GREAT VESSELS (Transposition of the great vessels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prenatal screening test: Showed no defect.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that prenatal visits showed no defect. Patient had a surgery on 30-Aug-2022 to correct the defect and patient was still in the hospital.  Company comment: This spontaneous case concerns male patient of unknown age with no medical history reported, who experienced the unexpected, serious (hospitalization, congenital anomaly, and medically significant) event of transposition of the great vessels. The patient was born approximately 1 year and 6 months after his mother was exposed to the first dose of mRNA-1273. Prenatal screening and visits did not show the congenital defect. The patient had surgery 6 days after date of birth. Outcome was unknown but patient was still hospitalized at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.      See case  for details regarding the child case.; Sender's Comments: This spontaneous case concerns male patient of unknown age with no medical history reported, who experienced the unexpected, serious (hospitalization, congenital anomaly, and medically significant) event of transposition of the great vessels. The patient was born approximately 1 year and 6 months after his mother was exposed to the first dose of mRNA-1273. Prenatal screening and visits did not show the congenital defect. The patient had surgery 6 days after date of birth. Outcome was unknown but patient was still hospitalized at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Bivalent Booster dose administered instead of primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products. It was unknown if patient was diagnosed or tested positive for COVID-19. No other vaccines were given 1 month prior to Moderna COVID-19 vaccine. The patient did not have any medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination were reported.     On 11-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 11-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Bivalent Booster dose administered instead of primary series dose).    No concomitant medications were reported.  The HCP administered 0.5ml of the new Booster Bivalent vaccine to the patient who was looking for their very first primary series dose. The patient was not experiencing any symptoms after receiving the vaccine. The patient was not on any regular medication. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2022: Live follow-up received contains reporter details, patient demographics, suspect product dose information and  updated I narrative.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Mild rash on the arm where I had the shot/ Near the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Mild rash on the arm where I had the shot/ Near the injection site) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Mild rash on the arm where I had the shot/ Near the injection site). At the time of the report, VACCINATION SITE RASH (Mild rash on the arm where I had the shot/ Near the injection site) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.  The patient had the new Moderna booster with omicron and developed a mild rash on the arm where patient had the shot. It was not terrible but mild.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Received Moderna Covid 19 Monovalent booster instead of Moderna Covid 19 bivalent booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Moderna Covid 19 Monovalent booster instead of Moderna Covid 19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 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 INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Moderna Covid 19 Monovalent booster instead of Moderna Covid 19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Moderna Covid 19 Monovalent booster instead of Moderna Covid 19 bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Received Moderna Covid 19 Monovalent booster instead of Moderna Covid 19 bivalent booster).    No concomitant products were reported. No treatment drugs were reported.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Headache
Clinical narrative: After the second booster patient had a mild headache which lasted until the next day.; Fatigue/ Patient went to bed early; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (After the second booster patient had a mild headache which lasted until the next day.) and FATIGUE (Fatigue/ Patient went to bed early) in a 67-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Tetanus shot on 10-Aug-2022 and Influenza vaccine (Flu Vaccine). Past adverse reactions to the above products included No adverse event with Influenza vaccine and Tetanus shot. Concurrent medical conditions included Pollen allergy, COPD and Anxiety. Concomitant products included QUETIAPINE FUMARATE and BUPROPION for an unknown indication. On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (After the second booster patient had a mild headache which lasted until the next day.) and FATIGUE (Fatigue/ Patient went to bed early). At the time of the report, HEADACHE (After the second booster patient had a mild headache which lasted until the next day.) had resolved and FATIGUE (Fatigue/ Patient went to bed early) outcome was unknown. On 14-Jan-2021, the patient received first dose of Moderna vaccine with lot number reported as 039K20A. On 11-Feb-2021, the patient received second dose of Moderna vaccine with lot number reported as 029L20A. On 26-Oct-2021, the patient received first booster dose of Moderna vaccine with lot number reported as 019F21A. Anatomical location for all the doses related to suspect product (Moderna vaccine) was reported as Left arm bicep and it was reported that patient was taking other medication.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, No adverse event
Clinical narrative: Needle retracted prematurely; Not being covered/so some of the dose was loss; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Needle retracted prematurely), ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Metastatic carcinoma (metastatic cancer).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Needle retracted prematurely), ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Needle retracted prematurely), ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (Needle retracted prematurely) and ACCIDENTAL UNDERDOSE (Not being covered/so some of the dose was loss).    The concomitant medication was not reported by reporter. Patient administered the Moderna Bivalent vaccine and after administered it the needle retracted prematurely so some of the dose was loss. Patient said the patient was immunocompromised with metastatic cancer and the patient was concerned about not being covered. Patient said the doctor suggested to give another half dose, but patient did not know what to do. The treatment medication was not reported by reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; patient received a booster dose instead of a first dose of a Primary dose.; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received a booster dose instead of a first dose of a Primary dose.) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (patient received a booster dose instead of a first dose of a Primary dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (patient received a booster dose instead of a first dose of a Primary dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. It was reported that a patient was mad and frustrated because she received a booster dose instead of first primary care series dose. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: no adverse event; Vaccine administered is underdose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Vaccine administered is underdose) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .3 milliliter. On 10-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Vaccine administered is underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Vaccine administered is underdose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Vaccine administered is underdose).    No concomitant medications were reported.  Patient received first dose of Moderna vaccine on 05-Mar-2021. Patient received second dose of  Moderna vaccine on 02-Apr-2021. Patient received third dose of Moderna vaccine on 16-Dec-2021.  The patient was administered with first booster underdose of 0.3 ml instead of 0.5 ml dose of Moderna vaccine on 10-Sep-2022.  The reporter called to ask for recommendation regarding the next step to be taken after administering the 0.3 ml underdose of booster dose to the patient.  No treatment information was reported.