chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pyrexia, Restless legs syndrome, SARS-CoV-2 test, Thirst
Clinical narrative: feels very shaky; has no appetite; is very thirsty; thrown up 8 times; cold sweats; restless leg syndrome; fever of 102.3; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A  no ex) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive three months back).    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), PYREXIA (fever of 102.3), CHILLS (chills) and NAUSEA (nausea). On 09-Aug-2021, the patient experienced VOMITING (thrown up 8 times). On an unknown date, the patient experienced NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty). At the time of the report, COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite), THIRST (is very thirsty), PYREXIA (fever of 102.3), CHILLS (chills), NAUSEA (nausea) and VOMITING (thrown up 8 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive. On 08-Aug-2021, Body temperature: 102.3 f (High) 102.3 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes no concomitant medication. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: feels very shaky; has no appetite; is very thirsty; thrown up 8 times; cold sweats; restless leg syndrome; fever of 102.3; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A  no ex) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive three months back).    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), PYREXIA (fever of 102.3), CHILLS (chills) and NAUSEA (nausea). On 09-Aug-2021, the patient experienced VOMITING (thrown up 8 times). On an unknown date, the patient experienced NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty). At the time of the report, COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite), THIRST (is very thirsty), PYREXIA (fever of 102.3), CHILLS (chills), NAUSEA (nausea) and VOMITING (thrown up 8 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive. On 08-Aug-2021, Body temperature: 102.3 f (High) 102.3 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes no concomitant medication. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Greater than 35 days between Moderna Covid-19 vaccinations; Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19 vaccinations) and VACCINATION COMPLICATION (Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19 vaccinations). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Moderna Covid-19 vaccinations) had resolved and VACCINATION COMPLICATION (Dermatologist diagnosed her adverse reaction from 29MAR2021 as Covid Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have a lot of people had bad reactions to the Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have a lot of people had bad reactions to the Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    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 (I have a lot of people had bad reactions to the Vaccine). At the time of the report, VACCINATION COMPLICATION (I have a lot of people had bad reactions to the Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Extra dose administered, Fatigue, Headache, Vaccination site pain
Clinical narrative: Extreme fatigue; Both injection site arms are sore; Headache; Patient received a third dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), VACCINATION SITE PAIN (Both injection site arms are sore), HEADACHE (Headache) and EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna Covid-19 vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L28 and 002A21A) for COVID-19 vaccination.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) dosage was changed to 50 mcg. On an unknown date, the patient received first dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced FATIGUE (Extreme fatigue), VACCINATION SITE PAIN (Both injection site arms are sore) and HEADACHE (Headache). On 07-Aug-2021, EXTRA DOSE ADMINISTERED (Patient received a third dose of the Moderna Covid-19 vaccine) had resolved. At the time of the report, FATIGUE (Extreme fatigue), VACCINATION SITE PAIN (Both injection site arms are sore) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Swelling
Clinical narrative: slight flu like symptoms; little reaction to the last one with a little swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (slight flu like symptoms) and SWELLING (little reaction to the last one with a little swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (slight flu like symptoms) and SWELLING (little reaction to the last one with a little swelling). At the time of the report, INFLUENZA LIKE ILLNESS (slight flu like symptoms) and SWELLING (little reaction to the last one with a little swelling) outcome was unknown.            No concomitant was provided. No treatment was provided.   This case was linked to MOD-2021-281437 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL and PRAVASTATIN for an unknown indication.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Unknown. On an unknown date, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) had resolved.            Patient also taking centrum silver for her eyes. No treatment details were provided.   This case was linked to MOD-2021-037805 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of depression in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced depression). At the time of the report, depression outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: I got really sick for nearly two days after getting the shot.; had one shot of the Moderna vaccine, but it was eight months ago.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got really sick for nearly two days after getting the shot.) and PRODUCT DOSE OMISSION ISSUE (had one shot of the Moderna vaccine, but it was eight months ago.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got really sick for nearly two days after getting the shot.) and PRODUCT DOSE OMISSION ISSUE (had one shot of the Moderna vaccine, but it was eight months ago.). At the time of the report, ILLNESS (I got really sick for nearly two days after getting the shot.) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had one shot of the Moderna vaccine, but it was eight months ago.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. Reported that patient had COVID-19 3 months prior to receiving vaccine. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: dizziness; weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and ASTHENIA (weakness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and ASTHENIA (weakness). At the time of the report, DIZZINESS (dizziness) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Crying, Discomfort, Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: Body started acting weird; Arm started hurting; could not move without crying; Crying; excruciating pain of whole body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying) and MYALGIA (excruciating pain of whole body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying), MYALGIA (excruciating pain of whole body) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying), MYALGIA (excruciating pain of whole body) and PYREXIA (Fever) had resolved.            Concomitant medications were not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body started acting weird; Arm started hurting; could not move without crying; Crying; excruciating pain of whole body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying) and MYALGIA (excruciating pain of whole body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying), MYALGIA (excruciating pain of whole body) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Body started acting weird), PAIN IN EXTREMITY (Arm started hurting), DISCOMFORT (could not move without crying), CRYING (Crying), MYALGIA (excruciating pain of whole body) and PYREXIA (Fever) had resolved.            Concomitant medications were not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Lymphadenopathy, Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat/Soreness in throat; Congestion; Coughing; Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive; Swelling of the lymph nodes; Fatigued/tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive) and LYMPHADENOPATHY (Swelling of the lymph nodes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL, LORATADINE (CLARITINE), FLUOXETINE, LEVOTHYROXINE, ALOGLIPTIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive), LYMPHADENOPATHY (Swelling of the lymph nodes) and FATIGUE (Fatigued/tired). At the time of the report, OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive), LYMPHADENOPATHY (Swelling of the lymph nodes) and FATIGUE (Fatigued/tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: negative (Negative) tested negative for the rapid test.         It was reported that patient called and stated that she is fully vaccinated and has been exposed to her 2 children who tested positive for covid and are sick with covid. She stated that both kids are wearing a mask in the house and remain upstairs for most of the time. She stated that one of the children was not vaccinated as they are 17 years old. She stated that she has 2 people in the house with the virus.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-Significant follow up appended
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sneezing
Clinical narrative: Sore throat/Soreness in throat; Congestion; Coughing; Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive; Swelling of the lymph nodes; Fatigued/tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive) and LYMPHADENOPATHY (Swelling of the lymph nodes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL, LORATADINE (CLARITINE), FLUOXETINE, LEVOTHYROXINE, ALOGLIPTIN, MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive), LYMPHADENOPATHY (Swelling of the lymph nodes) and FATIGUE (Fatigued/tired). At the time of the report, OROPHARYNGEAL PAIN (Sore throat/Soreness in throat), NASAL CONGESTION (Congestion), COUGH (Coughing), SNEEZING (Sneezing but could be allergies per patient/Reported sneezing 5 times in a row which was expulsive), LYMPHADENOPATHY (Swelling of the lymph nodes) and FATIGUE (Fatigued/tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, SARS-CoV-2 test: negative (Negative) tested negative for the rapid test.         It was reported that patient called and stated that she is fully vaccinated and has been exposed to her 2 children who tested positive for covid and are sick with covid. She stated that both kids are wearing a mask in the house and remain upstairs for most of the time. She stated that one of the children was not vaccinated as they are 17 years old. She stated that she has 2 people in the house with the virus.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-Significant follow up appended
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Infective glossitis, Lip infection, Lip swelling, Oral candidiasis, Pain in extremity
Clinical narrative: thrush infection on his tongue and his lips; thrush infection on his tongue and his lips and tongue are currently swollen; thrush infection on his tongue; thrush infection on his lips; experiencing a thrush infection on his tongue and his lips and tongue are currently swollen; sore arm; second dose not received in allowed time window; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen), INFECTIVE GLOSSITIS (thrush infection on his tongue), LIP INFECTION (thrush infection on his lips) and LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen), INFECTIVE GLOSSITIS (thrush infection on his tongue), LIP INFECTION (thrush infection on his lips), LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen), PAIN IN EXTREMITY (sore arm) and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window). At the time of the report, ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen) and LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen) was resolving, INFECTIVE GLOSSITIS (thrush infection on his tongue) and LIP INFECTION (thrush infection on his lips) had not resolved, PAIN IN EXTREMITY (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported .   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: live follow up : Events added
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Swollen tongue
Clinical narrative: thrush infection on his tongue and his lips; thrush infection on his tongue and his lips and tongue are currently swollen; thrush infection on his tongue; thrush infection on his lips; experiencing a thrush infection on his tongue and his lips and tongue are currently swollen; sore arm; second dose not received in allowed time window; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen), INFECTIVE GLOSSITIS (thrush infection on his tongue), LIP INFECTION (thrush infection on his lips) and LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen), INFECTIVE GLOSSITIS (thrush infection on his tongue), LIP INFECTION (thrush infection on his lips), LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen), PAIN IN EXTREMITY (sore arm) and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window). At the time of the report, ORAL CANDIDIASIS (thrush infection on his tongue and his lips), SWOLLEN TONGUE (thrush infection on his tongue and his lips and tongue are currently swollen) and LIP SWELLING (experiencing a thrush infection on his tongue and his lips and tongue are currently swollen) was resolving, INFECTIVE GLOSSITIS (thrush infection on his tongue) and LIP INFECTION (thrush infection on his lips) had not resolved, PAIN IN EXTREMITY (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose not received in allowed time window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported .   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: live follow up : Events added
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness in spine/my spine is stiff and I am having trouble moving around; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in spine/my spine is stiff and I am having trouble moving around) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Degenerative disc disease, Pericarditis, Asthma, COPD and Bronchitis. Concurrent medical conditions included Drug allergy (yellow dye sulfa), Penicillin allergy, Drug allergy (codeine) and Drug allergy (coconut).    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in spine/my spine is stiff and I am having trouble moving around). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in spine/my spine is stiff and I am having trouble moving around) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Historical condition include TIAs.  No relevant concomitant medications were reported.  No treatment information was provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: random severe muscular and joint pain; random severe muscular and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (random severe muscular and joint pain) and ARTHRALGIA (random severe muscular and joint pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0l0m20A) for Prevention.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (random severe muscular and joint pain) and ARTHRALGIA (random severe muscular and joint pain). On 03-Aug-2021, MYALGIA (random severe muscular and joint pain) and ARTHRALGIA (random severe muscular and joint pain) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: its been more than 42 days; they have not received the second dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (its been more than 42 days; they have not received the second dose.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (its been more than 42 days; they have not received the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (its been more than 42 days; they have not received the second dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product storage error
Clinical narrative: 2 months apart; Room temperature; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to the company on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 months apart) and PRODUCT STORAGE ERROR (Room temperature) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 months apart) and PRODUCT STORAGE ERROR (Room temperature). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 months apart) and PRODUCT STORAGE ERROR (Room temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.; Sender's Comments: This report refers to a case of medication error, Inappropriate schedule of product administration and  Product storage error for 2nd dose of Covid 19/mRNA-1273 vaccine (lot number/batch number unknown) with no associated adverse event reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm is sore) and HEADACHE (I had a headache) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D211A) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (I had a headache). On 10-Aug-2021, the patient experienced VACCINATION SITE PAIN (My arm is sore). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (My arm is sore) and HEADACHE (I had a headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Anxiety, Breast pain, Crying, Restlessness
Clinical narrative: over 4 weeks (period has not appeared yet); I have anxiety; Breast pain; I have restlessness; I wake up in the morning crying; This spontaneous case was reported by a non-health professional and describes the occurrence of AMENORRHOEA (over 4 weeks (period has not appeared yet)), ANXIETY (I have anxiety), BREAST PAIN (Breast pain), RESTLESSNESS (I have restlessness) and CRYING (I wake up in the morning crying) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 018B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LABETALOL, LEVOTHYROXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (over 4 weeks (period has not appeared yet)), ANXIETY (I have anxiety), BREAST PAIN (Breast pain), RESTLESSNESS (I have restlessness) and CRYING (I wake up in the morning crying). At the time of the report, AMENORRHOEA (over 4 weeks (period has not appeared yet)), ANXIETY (I have anxiety), BREAST PAIN (Breast pain), RESTLESSNESS (I have restlessness) and CRYING (I wake up in the morning crying) outcome was unknown.            Patient has no thyroid issues.  Blood work done and everything was normal.  Treatment information was not provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered at ~31 hours post vial puncture and at room temp; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered at ~31 hours post vial puncture and at room temp) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered at ~31 hours post vial puncture and at room temp). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered at ~31 hours post vial puncture and at room temp) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter  No treatment medication were provided by reporter; Sender's Comments: This report refers to a case of medication error, administration of expired Covid 19/mRNA vaccine with lot number/batch number 006D21A with no known adverse event associated reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Induration, Pain, Skin discolouration
Clinical narrative: My upper arm started to get really red/ red/ it almost went down to my elbow; Hard; Swelling; It looked discolored; It still hurts periodically; there is a little nodule below  the injection site now; Covid arm; Allergic reaction; Where  I got the shot, it got red around and also red in the center; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), INDURATION (Hard), SWELLING (Swelling), SKIN DISCOLOURATION (It looked discolored) and PAIN (It still hurts periodically) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), INDURATION (Hard), SWELLING (Swelling), SKIN DISCOLOURATION (It looked discolored), PAIN (It still hurts periodically), VACCINATION SITE NODULE (there is a little nodule below  the injection site now), VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE ERYTHEMA (Where  I got the shot, it got red around and also red in the center). At the time of the report, ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Where  I got the shot, it got red around and also red in the center) had resolved, INDURATION (Hard), SKIN DISCOLOURATION (It looked discolored), VACCINATION SITE NODULE (there is a little nodule below  the injection site now), VACCINATION SITE REACTION (Covid arm) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and PAIN (It still hurts periodically) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site nodule, Vaccination site reaction
Clinical narrative: My upper arm started to get really red/ red/ it almost went down to my elbow; Hard; Swelling; It looked discolored; It still hurts periodically; there is a little nodule below  the injection site now; Covid arm; Allergic reaction; Where  I got the shot, it got red around and also red in the center; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), INDURATION (Hard), SWELLING (Swelling), SKIN DISCOLOURATION (It looked discolored) and PAIN (It still hurts periodically) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), INDURATION (Hard), SWELLING (Swelling), SKIN DISCOLOURATION (It looked discolored), PAIN (It still hurts periodically), VACCINATION SITE NODULE (there is a little nodule below  the injection site now), VACCINATION SITE REACTION (Covid arm), HYPERSENSITIVITY (Allergic reaction) and VACCINATION SITE ERYTHEMA (Where  I got the shot, it got red around and also red in the center). At the time of the report, ERYTHEMA (My upper arm started to get really red/ red/ it almost went down to my elbow), SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Where  I got the shot, it got red around and also red in the center) had resolved, INDURATION (Hard), SKIN DISCOLOURATION (It looked discolored), VACCINATION SITE NODULE (there is a little nodule below  the injection site now), VACCINATION SITE REACTION (Covid arm) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and PAIN (It still hurts periodically) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Intentional dose omission, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL DOSE OMISSION (The 2nd dose is out for me I will not be getting it), TINNITUS (7 days ago patient reports tinnitus or ringing in ears began, and this has been ongoing constantly since then) and FATIGUE (first 3-4 days patient reports experiencing fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005021A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced FATIGUE (first 3-4 days patient reports experiencing fatigue). On 03-Aug-2021, the patient experienced TINNITUS (7 days ago patient reports tinnitus or ringing in ears began, and this has been ongoing constantly since then). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (The 2nd dose is out for me I will not be getting it). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Aug-2021, FATIGUE (first 3-4 days patient reports experiencing fatigue) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (The 2nd dose is out for me I will not be getting it) outcome was unknown and TINNITUS (7 days ago patient reports tinnitus or ringing in ears began, and this has been ongoing constantly since then) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Concomitant product information was not provided. Patient stated that "The 2nd dose is out for me I will not be getting it". Reporter did not allow further contact.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Restlessness, Weight decreased
Clinical narrative: restlessness exacerbated; lost 25 pounds; anxious; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RESTLESSNESS (restlessness exacerbated), WEIGHT DECREASED (lost 25 pounds) and ANXIETY (anxious) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESTLESSNESS (restlessness exacerbated), WEIGHT DECREASED (lost 25 pounds) and ANXIETY (anxious). At the time of the report, RESTLESSNESS (restlessness exacerbated), WEIGHT DECREASED (lost 25 pounds) and ANXIETY (anxious) outcome was unknown.            No Concomitant use were reported No Treatment were reported   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (face went numb) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 040C21A) for COVID-19 immunization. No medical history reported. On Aug 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 7, 2021, patient experienced hypoesthesia (face went numb). On Aug 10, 2021, hypoesthesia (face went numb): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose within 24 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 24 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis of scalp (He's being treated for Scalp psoriasis with prednisone and Clobetasol for 10 days now). Concomitant products included PREDNISONE for Psoriasis, CLOBETASOL PROPIONATE (CLOBETASOL [CLOBETASOL PROPIONATE]) for Psoriasis of scalp.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 24 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 24 days) outcome was unknown.            No treatment medications were reported.