chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Made her not feel well; It has been more than 36 days since she got the first dose and has not got the second yet; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Made her not feel well) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since she got the first dose and has not got the second yet) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Made her not feel well) and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since she got the first dose and has not got the second yet). At the time of the report, MALAISE (Made her not feel well) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since she got the first dose and has not got the second yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Product dose omission issue
Clinical narrative: Pneumonia; Patient has not gotten second dose passed 42 day; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten second dose passed 42 day). The patient was hospitalized on 28-Mar-2021 due to PNEUMONIA. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten second dose passed 42 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Other treatment medication included unspecified antibiotics.  Company Comment: This report refers to a case of Product Dose Omission Issue for mRNA-1273 (Lot #: Not Provided)  with the associated adverse event of Pneumonia. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product Dose Omission Issue for mRNA-1273 (Lot #: Not Provided)  with the associated adverse event of Pneumonia. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Cough, Drug ineffective, Headache
Clinical narrative: sore arm; COVID-19; Drug ineffective; coughing; congestion; nasal drainage; sore throat; pressure around her cheek bones; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Drug ineffective), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and NASAL CONGESTION (congestion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CELECOXIB (CELEBREX), ATORVASTATIN, LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced COUGH (coughing), NASAL CONGESTION (congestion), RHINORRHOEA (nasal drainage), OROPHARYNGEAL PAIN (sore throat), BONE PAIN (pressure around her cheek bones) and HEADACHE (headache). On 07-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 07-Aug-2021, DRUG INEFFECTIVE (Drug ineffective) had resolved. At the time of the report, COVID-19 (COVID-19), COUGH (coughing), NASAL CONGESTION (congestion), RHINORRHOEA (nasal drainage), OROPHARYNGEAL PAIN (sore throat), BONE PAIN (pressure around her cheek bones) and HEADACHE (headache) was resolving and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: sore arm; COVID-19; Drug ineffective; coughing; congestion; nasal drainage; sore throat; pressure around her cheek bones; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Drug ineffective), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and NASAL CONGESTION (congestion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included CELECOXIB (CELEBREX), ATORVASTATIN, LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced COUGH (coughing), NASAL CONGESTION (congestion), RHINORRHOEA (nasal drainage), OROPHARYNGEAL PAIN (sore throat), BONE PAIN (pressure around her cheek bones) and HEADACHE (headache). On 07-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 07-Aug-2021, DRUG INEFFECTIVE (Drug ineffective) had resolved. At the time of the report, COVID-19 (COVID-19), COUGH (coughing), NASAL CONGESTION (congestion), RHINORRHOEA (nasal drainage), OROPHARYNGEAL PAIN (sore throat), BONE PAIN (pressure around her cheek bones) and HEADACHE (headache) was resolving and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Off label dosing (second dose received beyond vaccine schedule); This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label dosing (second dose received beyond vaccine schedule)) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Off label dosing (second dose received beyond vaccine schedule)). On 13-Jul-2021, OFF LABEL USE (Off label dosing (second dose received beyond vaccine schedule)) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-283243.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 (A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient did not receive their second dose of the Moderna COVID-19 vaccine, first dose received in February 2021.) 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 medication were provided by the reporter. No treatment medication were provided by the reporter.  The patient was not experiencing any symptoms currently.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Hot flush, Malaise
Clinical narrative: feeling weird in the head down to the chest; hot flashes; feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating; feeling this ill has been debilitating,have to lay down to rest to feel better; nausea; fatigued,really tired; at the site of the injection it got swollen like fluid got in there; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling weird in the head down to the chest), HOT FLUSH (hot flashes), MALAISE (feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating), ASTHENIA (feeling this ill has been debilitating,have to lay down to rest to feel better) and NAUSEA (nausea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced FEELING ABNORMAL (feeling weird in the head down to the chest), HOT FLUSH (hot flashes), MALAISE (feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating), ASTHENIA (feeling this ill has been debilitating,have to lay down to rest to feel better), NAUSEA (nausea), FATIGUE (fatigued,really tired) and VACCINATION SITE SWELLING (at the site of the injection it got swollen like fluid got in there). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Jul-2021, VACCINATION SITE SWELLING (at the site of the injection it got swollen like fluid got in there) had resolved. At the time of the report, FEELING ABNORMAL (feeling weird in the head down to the chest), HOT FLUSH (hot flashes), MALAISE (feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating), ASTHENIA (feeling this ill has been debilitating,have to lay down to rest to feel better), NAUSEA (nausea) and FATIGUE (fatigued,really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications included lot of supplements and most of them help with the patients prostate. The patient explained this feeling of being very sick comes in waves now. Sometimes the patient thinks they maybe feeling better and then it comes back and they have to lay down to rest to feel better. The patient has not gone back to get the second dose because they have been feeling so ill still and they would like to wait until they feel better.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site swelling
Clinical narrative: feeling weird in the head down to the chest; hot flashes; feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating; feeling this ill has been debilitating,have to lay down to rest to feel better; nausea; fatigued,really tired; at the site of the injection it got swollen like fluid got in there; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling weird in the head down to the chest), HOT FLUSH (hot flashes), MALAISE (feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating), ASTHENIA (feeling this ill has been debilitating,have to lay down to rest to feel better) and NAUSEA (nausea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced FEELING ABNORMAL (feeling weird in the head down to the chest), HOT FLUSH (hot flashes), MALAISE (feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating), ASTHENIA (feeling this ill has been debilitating,have to lay down to rest to feel better), NAUSEA (nausea), FATIGUE (fatigued,really tired) and VACCINATION SITE SWELLING (at the site of the injection it got swollen like fluid got in there). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Jul-2021, VACCINATION SITE SWELLING (at the site of the injection it got swollen like fluid got in there) had resolved. At the time of the report, FEELING ABNORMAL (feeling weird in the head down to the chest), HOT FLUSH (hot flashes), MALAISE (feeling of being very sick,feeling of being very sick comes in waves,feeling this ill has been debilitating), ASTHENIA (feeling this ill has been debilitating,have to lay down to rest to feel better), NAUSEA (nausea) and FATIGUE (fatigued,really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications included lot of supplements and most of them help with the patients prostate. The patient explained this feeling of being very sick comes in waves now. Sometimes the patient thinks they maybe feeling better and then it comes back and they have to lay down to rest to feel better. The patient has not gone back to get the second dose because they have been feeling so ill still and they would like to wait until they feel better.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Feeling abnormal, Hypertension, Induration
Clinical narrative: lethargic; Very tired; tightness while stretching; her body and chest feeling like underwater; blood pressure high; a hard painful bump; painful bump; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high) and INDURATION (a hard painful bump) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History information was provided by the reporter.  Concomitant products included IBUPROFEN, VITAMIN D NOS, ESTRADIOL (ESTROGEN), HYDROCHLOROTHIAZIDE and SERTRALINE for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (Very tired). In August 2021, the patient experienced MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump) and NODULE (painful bump). At the time of the report, LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump), NODULE (painful bump) and FATIGUE (Very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Muscle tightness, Nodule
Clinical narrative: lethargic; Very tired; tightness while stretching; her body and chest feeling like underwater; blood pressure high; a hard painful bump; painful bump; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high) and INDURATION (a hard painful bump) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical History information was provided by the reporter.  Concomitant products included IBUPROFEN, VITAMIN D NOS, ESTRADIOL (ESTROGEN), HYDROCHLOROTHIAZIDE and SERTRALINE for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced LETHARGY (lethargic) and FATIGUE (Very tired). In August 2021, the patient experienced MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump) and NODULE (painful bump). At the time of the report, LETHARGY (lethargic), MUSCLE TIGHTNESS (tightness while stretching), FEELING ABNORMAL (her body and chest feeling like underwater), HYPERTENSION (blood pressure high), INDURATION (a hard painful bump), NODULE (painful bump) and FATIGUE (Very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Since taking the vaccine, patient has felt very weak and tired cant do anything during the day; Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day) and FATIGUE (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness   ) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day) and FATIGUE (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness   ). At the time of the report, ASTHENIA (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day) and FATIGUE (Since taking the vaccine, patient has felt very weak and tired cant do anything during the day, Cant shake the tiredness   ) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: arm was sore; J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and INTERCHANGE OF VACCINE PRODUCTS (J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) 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) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021). On 10-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.            It was reported that patient received a dose of J&J vaccine on 09-MAR-2021, lot number: 1305029 for COVID-19 vaccination. No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: a little sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (a little sleepiness) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 88221S) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced SOMNOLENCE (a little sleepiness). At the time of the report, SOMNOLENCE (a little sleepiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-283007 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: He doesn't feel well; Now he feels nauseated; He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (He doesn't feel well), HEADACHE (He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts) and NAUSEA (Now he feels nauseated) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HEADACHE (He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts). On an unknown date, the patient experienced MALAISE (He doesn't feel well) and NAUSEA (Now he feels nauseated). At the time of the report, MALAISE (He doesn't feel well) and NAUSEA (Now he feels nauseated) outcome was unknown and HEADACHE (He started with headache last week(beginning of August)/2 sides of his head and front part of the head hurts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: charlie horse in arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (charlie horse in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (charlie horse in arm). At the time of the report, MUSCLE SPASMS (charlie horse in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-283130 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: sick for a few days; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for a few days) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for a few days) and PYREXIA (low grade fever). At the time of the report, ILLNESS (sick for a few days) and PYREXIA (low grade fever) outcome was unknown.            No Concomitant medication information was reported. No Treatment medications were provided.   This case was linked to MOD-2021-283128 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Influenza, Somnolence
Clinical narrative: feels like he had the flu; does not have appetite; yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am; is very tired; is with lots of pain in the arm where he got the injection; had chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), CHILLS (had chills) and FATIGUE (is very tired) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (had chills). On an unknown date, the patient experienced INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), FATIGUE (is very tired) and VACCINATION SITE PAIN (is with lots of pain in the arm where he got the injection). On 10-Aug-2021, CHILLS (had chills) had resolved. At the time of the report, INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), FATIGUE (is very tired) and VACCINATION SITE PAIN (is with lots of pain in the arm where he got the injection) outcome was unknown.            Treatment information was not reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feels like he had the flu; does not have appetite; yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am; is very tired; is with lots of pain in the arm where he got the injection; had chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), CHILLS (had chills) and FATIGUE (is very tired) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (had chills). On an unknown date, the patient experienced INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), FATIGUE (is very tired) and VACCINATION SITE PAIN (is with lots of pain in the arm where he got the injection). On 10-Aug-2021, CHILLS (had chills) had resolved. At the time of the report, INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), FATIGUE (is very tired) and VACCINATION SITE PAIN (is with lots of pain in the arm where he got the injection) outcome was unknown.            Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: sore arm; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and OROPHARYNGEAL PAIN (sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, PAIN IN EXTREMITY (sore arm) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient passed out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Patient passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Patient passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Pyrexia, Tinnitus
Clinical narrative: her tinnitus is getting worst; the tinnitus has been affecting her hearing; had a fever that was really bad; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (her tinnitus is getting worst), HYPOACUSIS (the tinnitus has been affecting her hearing) and PYREXIA (had a fever that was really bad) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-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 TINNITUS (her tinnitus is getting worst), HYPOACUSIS (the tinnitus has been affecting her hearing) and PYREXIA (had a fever that was really bad). At the time of the report, TINNITUS (her tinnitus is getting worst), HYPOACUSIS (the tinnitus has been affecting her hearing) and PYREXIA (had a fever that was really bad) outcome was unknown.            Other concomitant medication includes estrogen combipatch. No treatment information was reported.   This case was linked to MOD-2021-283150 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Heart rate
Clinical narrative: feeling weak; Fatigue; woke up with fever; woke up with chills; Pulse at 130 up to 136/ rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Pulse at 130 up to 136/ rapid heart rate), ASTHENIA (feeling weak), FATIGUE (Fatigue), PYREXIA (woke up with fever) and CHILLS (woke up with chills) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TEMAZEPAM, ROSUVASTATIN, VALSARTAN, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), FISH OIL, MAGNESIUM and OMEPRAZOLE for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PALPITATIONS (Pulse at 130 up to 136/ rapid heart rate), FATIGUE (Fatigue), PYREXIA (woke up with fever) and CHILLS (woke up with chills). On an unknown date, the patient experienced ASTHENIA (feeling weak). At the time of the report, PALPITATIONS (Pulse at 130 up to 136/ rapid heart rate), ASTHENIA (feeling weak), FATIGUE (Fatigue), PYREXIA (woke up with fever) and CHILLS (woke up with chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, Body temperature: 100 f (High) 100 F. On 06-Aug-2021, Heart rate: 130 up to 136 (High) 130 up to 136.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that at the time of this report, the patient's chief complaint was a rapid heart that fluctuates throughout the day.  No Treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: feeling weak; Fatigue; woke up with fever; woke up with chills; Pulse at 130 up to 136/ rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Pulse at 130 up to 136/ rapid heart rate), ASTHENIA (feeling weak), FATIGUE (Fatigue), PYREXIA (woke up with fever) and CHILLS (woke up with chills) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TEMAZEPAM, ROSUVASTATIN, VALSARTAN, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), FISH OIL, MAGNESIUM and OMEPRAZOLE for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PALPITATIONS (Pulse at 130 up to 136/ rapid heart rate), FATIGUE (Fatigue), PYREXIA (woke up with fever) and CHILLS (woke up with chills). On an unknown date, the patient experienced ASTHENIA (feeling weak). At the time of the report, PALPITATIONS (Pulse at 130 up to 136/ rapid heart rate), ASTHENIA (feeling weak), FATIGUE (Fatigue), PYREXIA (woke up with fever) and CHILLS (woke up with chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, Body temperature: 100 f (High) 100 F. On 06-Aug-2021, Heart rate: 130 up to 136 (High) 130 up to 136.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that at the time of this report, the patient's chief complaint was a rapid heart that fluctuates throughout the day.  No Treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days from fist vaccination/9 weeks out of the recommended window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination/9 weeks out of the recommended window) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination/9 weeks out of the recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days from fist vaccination/9 weeks out of the recommended window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tinnitus
Clinical narrative: her tinnitus is getting worst; felt little bit tired; had a fever that was really bad; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (her tinnitus is getting worst), FATIGUE (felt little bit tired) and PYREXIA (had a fever that was really bad) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (her tinnitus is getting worst), FATIGUE (felt little bit tired) and PYREXIA (had a fever that was really bad). At the time of the report, TINNITUS (her tinnitus is getting worst), FATIGUE (felt little bit tired) and PYREXIA (had a fever that was really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included estrogen combipatch.  Treatment medication was not provided.   This case was linked to MOD-2021-283142 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test positive, SARS-CoV-2 test
Clinical narrative: SARS-CoV-1 test positive.; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-1 TEST POSITIVE ( SARS-CoV-1 test positive.) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced SARS-COV-1 TEST POSITIVE ( SARS-CoV-1 test positive.). At the time of the report, SARS-COV-1 TEST POSITIVE ( SARS-CoV-1 test positive.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  Patient was scheduled for dose 2 on 11-Aug-2021
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Mobility decreased
Clinical narrative: she can't even move; weak; she feels exhausted; shoulder pain; the chill all over; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (she can't even move), ASTHENIA (weak), FATIGUE (she feels exhausted), ARTHRALGIA (shoulder pain) and CHILLS (the chill all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (she can't even move), ASTHENIA (weak), FATIGUE (she feels exhausted), ARTHRALGIA (shoulder pain) and CHILLS (the chill all over). At the time of the report, MOBILITY DECREASED (she can't even move), ASTHENIA (weak), FATIGUE (she feels exhausted), ARTHRALGIA (shoulder pain) and CHILLS (the chill all over) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive the the 2nd dose between 25-35 days of the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive the the 2nd dose between 25-35 days of the 1st dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 PRODUCT DOSE OMISSION ISSUE (Did not receive the the 2nd dose between 25-35 days of the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive the the 2nd dose between 25-35 days of the 1st dose) had resolved.            Concomitant medications were not provided.  Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dyspnoea, Hypersensitivity, Rash, Wheezing
Clinical narrative: Allergic reaction; allergic reaction that progressed over a few days; wheezing; trouble breathing; rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), ALLERGY TO VACCINE (allergic reaction that progressed over a few days), WHEEZING (wheezing), DYSPNOEA (trouble breathing) and RASH (rash all over the body) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included PANTOPRAZOLE and GABAPENTIN for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction), ALLERGY TO VACCINE (allergic reaction that progressed over a few days), WHEEZING (wheezing), DYSPNOEA (trouble breathing) and RASH (rash all over the body). The patient was treated with PREDNISONE for Allergic reaction, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction), ALLERGY TO VACCINE (allergic reaction that progressed over a few days), WHEEZING (wheezing), DYSPNOEA (trouble breathing) and RASH (rash all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Per report, the patient developed an allergic reaction that progressed over the next few day and felt better after treatment. The patient reported that his antibody level  was 70, as informed by his doctor who advised the patient against receiving the second dose of Moderna Covid-19 vaccine.