chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Breast pain, Fatigue, Myalgia
Clinical narrative: Swelling; Breast pain; sugar spike; soreness/ major aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018D21A and 001A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cortisone shot (had a cortisone shot in Jan 2021 but that worn out by Sep 2021.) in January 2021. Past adverse reactions to the above products included No adverse event with Cortisone shot. Concurrent medical conditions included Lactose intolerance, Drug allergy (Metoprolol ER succinate 100 mg), Atrioventricular nodal reentrant tachycardia (SVT/AVNRT, PVC's, APC's), AFib since 2006, Vertigo (before 2006), Blood pressure high (Control High BP), Cholesterol, Osteopenia since 2009, Lyme disease since 2006, Pre-diabetic since 2009, Drug allergy (Macrobid), Drug allergy (Lisinopril), Drug allergy (Nifedical XL) and Drug allergy (Zyrtex).   On 24-Feb-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired). At the time of the report, SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Blood glucose: 15-30 points (High) 15-30 Points.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) to be possibly related.    Patient stated soreness Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-029925, MOD-2021-375494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains  no new information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling; Breast pain; sugar spike; soreness/ major aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018D21A and 001A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cortisone shot (had a cortisone shot in Jan 2021 but that worn out by Sep 2021.) in January 2021. Past adverse reactions to the above products included No adverse event with Cortisone shot. Concurrent medical conditions included Lactose intolerance, Drug allergy (Metoprolol ER succinate 100 mg), Atrioventricular nodal reentrant tachycardia (SVT/AVNRT, PVC's, APC's), AFib since 2006, Vertigo (before 2006), Blood pressure high (Control High BP), Cholesterol, Osteopenia since 2009, Lyme disease since 2006, Pre-diabetic since 2009, Drug allergy (Macrobid), Drug allergy (Lisinopril), Drug allergy (Nifedical XL) and Drug allergy (Zyrtex).   On 24-Feb-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired). At the time of the report, SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Blood glucose: 15-30 points (High) 15-30 Points.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SWELLING (Swelling), BREAST PAIN (Breast pain), BLOOD GLUCOSE INCREASED (sugar spike), MYALGIA (soreness/ major aches) and FATIGUE (tired) to be possibly related.    Patient stated soreness Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-029925, MOD-2021-375494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received contains  no new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Hypertension, Nausea
Clinical narrative: High Blood Pressure; Left arm - soreness; fatigue; nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Blood pressure was fine with pills (metoprolol 25mg p/o q day).) and Allergy (get allergic to a lot of things even). Concomitant products included CICLOSPORIN (RESTASIS) for Eye drop instillation.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HYPERTENSION (High Blood Pressure) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm - soreness), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (Headache). The patient was hospitalized for 4 days due to HYPERTENSION. The patient was treated with METOPROLOL (oral) ongoing since an unknown date for Blood pressure management, at a dose of 25 mg once a day. At the time of the report, HYPERTENSION (High Blood Pressure) was resolving and VACCINATION SITE PAIN (Left arm - soreness), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Blood pressure measurement: increased (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vitamins were provided as concomitant product.  Company Comment: This case concerns a 72 year old female with relevant medical history of hypertension ( controlled with Metroprolol previously ) , who experienced Serious , unexpected event of Hypertension  which occurred 4 months 15  days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the events were unknown. The history of hypertension can be considered as a confounder for this case . The benefit-risk relationship of mRNA-1273 vaccine (Modenra Covid 19 Vaccine ) is not affected by this report.   This case was linked to MOD-2021-380253, MOD-2021-380502 (Patient Link).; Sender's Comments: This case concerns a 72 year old female with relevant medical history of hypertension ( controlled with Metroprolol previously ) , who experienced Serious , unexpected event of Hypertension  which occurred 4 months 15  days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the events were unknown. The history of hypertension can be considered as a confounder for this case . The benefit-risk relationship of mRNA-1273 vaccine (Modenra Covid 19 Vaccine ) is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: High Blood Pressure; Left arm - soreness; fatigue; nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Blood pressure was fine with pills (metoprolol 25mg p/o q day).) and Allergy (get allergic to a lot of things even). Concomitant products included CICLOSPORIN (RESTASIS) for Eye drop instillation.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HYPERTENSION (High Blood Pressure) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm - soreness), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (Headache). The patient was hospitalized for 4 days due to HYPERTENSION. The patient was treated with METOPROLOL (oral) ongoing since an unknown date for Blood pressure management, at a dose of 25 mg once a day. At the time of the report, HYPERTENSION (High Blood Pressure) was resolving and VACCINATION SITE PAIN (Left arm - soreness), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Blood pressure measurement: increased (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vitamins were provided as concomitant product.  Company Comment: This case concerns a 72 year old female with relevant medical history of hypertension ( controlled with Metroprolol previously ) , who experienced Serious , unexpected event of Hypertension  which occurred 4 months 15  days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the events were unknown. The history of hypertension can be considered as a confounder for this case . The benefit-risk relationship of mRNA-1273 vaccine (Modenra Covid 19 Vaccine ) is not affected by this report.   This case was linked to MOD-2021-380253, MOD-2021-380502 (Patient Link).; Sender's Comments: This case concerns a 72 year old female with relevant medical history of hypertension ( controlled with Metroprolol previously ) , who experienced Serious , unexpected event of Hypertension  which occurred 4 months 15  days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the events were unknown. The history of hypertension can be considered as a confounder for this case . The benefit-risk relationship of mRNA-1273 vaccine (Modenra Covid 19 Vaccine ) is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Rash, Rash pruritic
Clinical narrative: Her top lip was swollen.; Then she had some kind of allergic reaction; Some time in October, she got rash again.; She started with an itchy rash on whole body some time in June.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Her top lip was swollen.), RASH PRURITIC (She started with an itchy rash on whole body some time in June.), RASH (Some time in October, she got rash again.) and HYPERSENSITIVITY (Then she had some kind of allergic reaction) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 015M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, OMEPRAZOLE, LEVOTHYROXINE, VENLAFAXINE, GLIMEPIRIDE, LOSARTAN and ATORVASTATIN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced RASH PRURITIC (She started with an itchy rash on whole body some time in June.). In October 2021, the patient experienced RASH (Some time in October, she got rash again.). On an unknown date, the patient experienced LIP SWELLING (Her top lip was swollen.) and HYPERSENSITIVITY (Then she had some kind of allergic reaction). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Her top lip was swollen.), RASH (Some time in October, she got rash again.) and HYPERSENSITIVITY (Then she had some kind of allergic reaction) outcome was unknown and RASH PRURITIC (She started with an itchy rash on whole body some time in June.) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP denies to give her booster.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: congested/snotty; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested/snotty) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced NASAL CONGESTION (congested/snotty). At the time of the report, NASAL CONGESTION (congested/snotty) outcome was unknown.            No concomitant and treatment medications provided.  Patient called to ask if being congested and snotty are side effects of the Moderna Covid-19 booster. Patient reported that she got her booster yesterday, 08Nov2021 around 10:30 am through their health department  This case concerns a 55-year-old female patient with no relevant medical history, who experienced the unexpected event of Nasal Congestion. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 55-year-old female patient with no relevant medical history, who experienced the unexpected event of Nasal Congestion. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone abnormal
Clinical narrative: THS level unbalanced; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD THYROID STIMULATING HORMONE ABNORMAL (THS level unbalanced) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced BLOOD THYROID STIMULATING HORMONE ABNORMAL (THS level unbalanced). At the time of the report, BLOOD THYROID STIMULATING HORMONE ABNORMAL (THS level unbalanced) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood thyroid stimulating hormone: 0.51 or 0.52 (Low) 0.51 or 0.52 WNL. On an unknown date, Blood thyroid stimulating hormone: 1.5-2.2 (High) 1.5-2.2 and 5.72 (High) 5.72 - Latest.         TSH level 5.72 - Latest , Now taking 60mg , 7 days a week TSH level 0.51 or 0.52 , Retained 60mg dose but dropped to 5 days a week WNL Lack of effect No treatment medication details was provided. Cyanne maa Allergan armour thyroid Doctor wrote script for 6 days 60 mg , 1 at 30 mg or 15 mg 1 day nannayaa; Sender's Comments: This case concerns a 66-year-old, female patient, with medical history of hypothyroidism, who experienced the non-serious, unexpected event of blood thyroid stimulating hormone decreased. The event occurred  17 days after second dose of mRNA 1273 vaccine. The patient had her TSH level checked 2 weeks after second dose and revealed that it was lower than her baseline, although still normal. Her medication regimen was changed which led to a higher TSH level, she is still undergoing treatment to make her thyroid hormones balanced. The rechallenge is not applicable as there is no information regarding a third dose. The patient's history of hypothyroidism remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Tremor
Clinical narrative: she felt terrible/felt awful; she was exhausted,/she didn't get out of bed for the entire day.; she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly), FEELING ABNORMAL (she felt terrible/felt awful) and FATIGUE (she was exhausted,/she didn't get out of bed for the entire day.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013B20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly). On 11-Feb-2021, the patient experienced FEELING ABNORMAL (she felt terrible/felt awful) and FATIGUE (she was exhausted,/she didn't get out of bed for the entire day.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 10-Feb-2021 for Tremor, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 11-Feb-2021 for Exhaustion, at an unspecified dose and frequency. At the time of the report, TREMOR (she didn't feel like she had a fever but her whole body was shaky/started to shake but not as badly), FEELING ABNORMAL (she felt terrible/felt awful) and FATIGUE (she was exhausted,/she didn't get out of bed for the entire day.) outcome was unknown.            No  Concomitant medications were provided.  Patient had an ultrasound of the brain but still waiting for the neurologist appointment.   This case was linked to MOD-2021-380725 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Malaise, Somnolence
Clinical narrative: no sense of smell; has been sleeping; has no energy; her body is shaky; no sense of taste; was not feeling good / hasn't been feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was not feeling good / hasn't been feeling good), ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy) and TREMOR (her body is shaky) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced MALAISE (was not feeling good / hasn't been feeling good). On 04-Nov-2021, the patient experienced ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy), TREMOR (her body is shaky) and AGEUSIA (no sense of taste). At the time of the report, MALAISE (was not feeling good / hasn't been feeling good), ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy), TREMOR (her body is shaky) and AGEUSIA (no sense of taste) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.  This is a Spontaneous case concerning a 66-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of ageusia and anosmia. The event occurred approximately 1 day after the first dose of Moderna COVID 19 vaccine. The rechallenge is XXXX. The medical history of not applicable.   The Benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Added patient demography, suspect product details and added events; Sender's Comments: This is a Spontaneous case concerning a 66-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of ageusia and anosmia. The event occurred approximately 1 day after the first dose of Moderna COVID 19 vaccine. The rechallenge is XXXX. The medical history of not applicable.   The Benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: no sense of smell; has been sleeping; has no energy; her body is shaky; no sense of taste; was not feeling good / hasn't been feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was not feeling good / hasn't been feeling good), ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy) and TREMOR (her body is shaky) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced MALAISE (was not feeling good / hasn't been feeling good). On 04-Nov-2021, the patient experienced ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy), TREMOR (her body is shaky) and AGEUSIA (no sense of taste). At the time of the report, MALAISE (was not feeling good / hasn't been feeling good), ANOSMIA (no sense of smell), SOMNOLENCE (has been sleeping), ASTHENIA (has no energy), TREMOR (her body is shaky) and AGEUSIA (no sense of taste) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. List of concomitant medication were not given.  This is a Spontaneous case concerning a 66-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of ageusia and anosmia. The event occurred approximately 1 day after the first dose of Moderna COVID 19 vaccine. The rechallenge is XXXX. The medical history of not applicable.   The Benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Added patient demography, suspect product details and added events; Sender's Comments: This is a Spontaneous case concerning a 66-year-old, female patient with unknown medical history,  who experienced the unexpected non serious (AESI) events of ageusia and anosmia. The event occurred approximately 1 day after the first dose of Moderna COVID 19 vaccine. The rechallenge is XXXX. The medical history of not applicable.   The Benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Report 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 VACCINATION COMPLICATION (Report adverse event). At the time of the report, VACCINATION COMPLICATION (Report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  No treatment medications were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dosage administered, Influenza like illness
Clinical narrative: Flu like symptoms; Half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and INCORRECT DOSAGE ADMINISTERED (Half dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and INCORRECT DOSAGE ADMINISTERED (Half dose). On 02-Nov-2021, INCORRECT DOSAGE ADMINISTERED (Half dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   A immunocompromised patient received a booster dose of the Moderna COVID-19 vaccine (0.25 ml). Patient had flu like symptoms following receipt of the vaccine, but did not take any medications or treatments.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old given vaccine ~ 6 months ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old given vaccine ~ 6 months ago) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. In 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old given vaccine had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Myalgia
Clinical narrative: low-grade flu symptoms; achiness; mainly tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (low-grade flu symptoms), MYALGIA (achiness) and FATIGUE (mainly tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (low-grade flu symptoms), MYALGIA (achiness) and FATIGUE (mainly tired). At the time of the report, INFLUENZA (low-grade flu symptoms), MYALGIA (achiness) and FATIGUE (mainly tired) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Rash erythematous, Swelling
Clinical narrative: red rash. It started breaking out at the top of knees, going to the top of legs.; itchy; redness / red welts; swell; Redness; broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell) and ERYTHEMA (Redness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091DZ1A and 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell), ERYTHEMA (Redness) and RASH (broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of). The patient was treated with LORATADINE for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency; TRIAMCINOLONE (topical) for Adverse event, at a dose of 0.1 percent and CEPHALEXIN [CEFALEXIN] on 08-Nov-2021 for Adverse event, at a dose of 500 milligram every six hours. At the time of the report, RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell), ERYTHEMA (Redness) and RASH (broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of) had not resolved.            Patient didn't had a problem with 1st dose vaccine. Symptoms started with a week and a half later after 2nd dose.  No concomitant medication were given. Patient stated that she would not take a booster
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: red rash. It started breaking out at the top of knees, going to the top of legs.; itchy; redness / red welts; swell; Redness; broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell) and ERYTHEMA (Redness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091DZ1A and 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell), ERYTHEMA (Redness) and RASH (broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of). The patient was treated with LORATADINE for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency; TRIAMCINOLONE (topical) for Adverse event, at a dose of 0.1 percent and CEPHALEXIN [CEFALEXIN] on 08-Nov-2021 for Adverse event, at a dose of 500 milligram every six hours. At the time of the report, RASH ERYTHEMATOUS (red rash. It started breaking out at the top of knees, going to the top of legs.), PRURITUS (itchy), URTICARIA (redness / red welts), SWELLING (swell), ERYTHEMA (Redness) and RASH (broken out all over both arms / tops of hands/ started breaking out at the top of her knees, going to the top of) had not resolved.            Patient didn't had a problem with 1st dose vaccine. Symptoms started with a week and a half later after 2nd dose.  No concomitant medication were given. Patient stated that she would not take a booster
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Half dose as first dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.  No Medical History information was reported. On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Half dose as first dose). On 08-Nov-2021, ACCIDENTAL UNDERDOSE (Half dose as first dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The patient had not received any previous COVID vaccines.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was pulled up in the syringe on 08NOV2021 and stored in room temperature for 23 hours prior to administering; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERERED in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was pulled up in the syringe on 08NOV2021 and stored in room temperature for 23 hours prior to administering). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given. The vial that was first punctured on 08NOV2021 at noon. The vaccine was pulled up in the syringe on 08NOV2021 and stored in room temperature for 23 hours prior to administering a half dose booster to a patient
Sex: U
Vaccine: COVID19
Symptoms: Vulval ulceration, Vulvovaginal pain
Clinical narrative: Severely painful vulvar ulcer; These are very painful - shooting and stabbing pain to the point; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VULVAL ULCERATION and VULVOVAGINAL PAIN 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 VULVAL ULCERATION and VULVOVAGINAL PAIN. The patient was treated with CLOBETASOL for Adverse event, at an unspecified dose and frequency. At the time of the report, VULVAL ULCERATION and VULVOVAGINAL PAIN had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. The reporter stated she has seen 3 cases of severely painful vulvar ulcer in patients who were administered with the COVID-19 vaccine. She was sure that 2 of them received Moderna COVID-19 vaccine. The reporter was observed a few days after the administration of the vaccine. MD states that this was different from the herpetic lesions that she sees these were very painful - shooting and stabbing pain to the point that the patients want to take narcotics. She states that they may not be infectious in origin but may be autoimmune. She prescribed Clobetasol and they resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Headache, Heart rate, Pyrexia
Clinical narrative: Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, PYREXIA, and HEADACHE in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Arrhythmia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS, PYREXIA, and HEADACHE. At the time of the report, CHILLS, PYREXIA, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Blood pressure measurement 173/84 (High). On an unknown date, Heart rate (abnormal), Heart rate irregular.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included Antihypertensive pills. No treatment drugs were reported. Blood Pressure unit showed heartbeat was irregular the day after the Moderna vaccine.   This case was linked to MOD-2021-380721 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Inappropriate schedule of product administration, Pruritus, Skin exfoliation, Swelling face
Clinical narrative: hives which started getting worse/ hives on face and some on arm; face is swollen; its scaly; very bad itching; discomfort; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly), PRURITUS (very bad itching) and DISCOMFORT (discomfort) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE JANSSEN (1st dose and lot # 1805031) on 10-Mar-2021.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 03-Nov-2021, the patient experienced URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly), PRURITUS (very bad itching) and DISCOMFORT (discomfort). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) (topical) in 2021 for Adverse event, at an unspecified dose and frequency. On 28-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly) and PRURITUS (very bad itching) had not resolved and DISCOMFORT (discomfort) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information include applying some water, cream, and possibly milk (agent could not capture for sure, asked consumer again and she said "yes"). Patient states there is no change in her diet and not allergic to anything that she knows of.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow-up received on 11-NOV-2021 include adverse event discomfort added.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives which started getting worse/ hives on face and some on arm; face is swollen; its scaly; very bad itching; discomfort; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly), PRURITUS (very bad itching) and DISCOMFORT (discomfort) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE JANSSEN (1st dose and lot # 1805031) on 10-Mar-2021.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 03-Nov-2021, the patient experienced URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly), PRURITUS (very bad itching) and DISCOMFORT (discomfort). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) (topical) in 2021 for Adverse event, at an unspecified dose and frequency. On 28-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, URTICARIA (hives which started getting worse/ hives on face and some on arm), SWELLING FACE (face is swollen), SKIN EXFOLIATION (its scaly) and PRURITUS (very bad itching) had not resolved and DISCOMFORT (discomfort) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information include applying some water, cream, and possibly milk (agent could not capture for sure, asked consumer again and she said "yes"). Patient states there is no change in her diet and not allergic to anything that she knows of.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow-up received on 11-NOV-2021 include adverse event discomfort added.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Headache, Heart rate, Pyrexia
Clinical narrative: Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Arrhythmia.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 173/84 (High) 173/84 mmHg. On an unknown date, Heart rate: abnormal (abnormal) heartbeat was irregular.         Concomitant medications included Antihypertensive pills were reported.  Treatment information was not provided. The Blood Pressure unit showed heartbeat was irregular the day after both the shots.   This case was linked to MOD-2021-380699 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination complication
Clinical narrative: Wasn't feeling great/felt awful; Had a headache/headaches for the past 2-3 weeks and everyday since/keeps waking up with a headache everyday; Mostly tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, HEADACHE, and FATIGUE in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 029L20A, and 013B20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced VACCINATION COMPLICATION, HEADACHE, and FATIGUE. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency and ADVIL for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION, HEADACHE, and FATIGUE outcome was unknown.            No Concomitant medications were provided by the reporter.    23OCT2021, Patient undergone for ultrasound of brain and waiting for neurologist appointment.   This case was linked to MOD-2021-380630 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose:21Jan2021 and 2nd dose:26Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose:21Jan2021 and 2nd dose:26Feb2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose:21Jan2021 and 2nd dose:26Feb2021). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose:21Jan2021 and 2nd dose:26Feb2021) had resolved.            No concomitant and treatment medications reported.   This case was linked to MOD-2021-379494 (Patient Link).