chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Myalgia, Nasal congestion
Clinical narrative: Shorntess of breath; Stuffy nose; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shorntess of breath), NASAL CONGESTION (Stuffy nose) and MYALGIA (Sore left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced NASAL CONGESTION (Stuffy nose) and MYALGIA (Sore left arm). On 16-Jul-2021, the patient experienced DYSPNOEA (Shorntess of breath). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 16-Jul-2021, NASAL CONGESTION (Stuffy nose) and MYALGIA (Sore left arm) had resolved. At the time of the report, DYSPNOEA (Shorntess of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Heart rate: increased (High) Fast heartbeat..         Concomitant product was not provided.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: achiness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achiness) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MIRTAZAPINE (REMERON) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CALCIUM, COLECALCIFEROL (CALCIUM +VIT D) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (achiness) and HEADACHE (headache). At the time of the report, MYALGIA (achiness) and HEADACHE (headache) had resolved.            No treatment medication was provided  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to MOD-2021-024158 (Patient Link).
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Head discomfort, Overweight, Sneezing, Throat irritation
Clinical narrative: mild respiratory symptoms including  sneezing; head congestion; coughing; scratchy throat; Overweight; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (mild respiratory symptoms including  sneezing), HEAD DISCOMFORT (head congestion), COUGH (coughing), THROAT IRRITATION (scratchy throat) and OVERWEIGHT (Overweight) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SNEEZING (mild respiratory symptoms including  sneezing), HEAD DISCOMFORT (head congestion), COUGH (coughing), THROAT IRRITATION (scratchy throat) and OVERWEIGHT (Overweight). At the time of the report, SNEEZING (mild respiratory symptoms including  sneezing), HEAD DISCOMFORT (head congestion), COUGH (coughing), THROAT IRRITATION (scratchy throat) and OVERWEIGHT (Overweight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose > 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 (First dose > 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose > 35 days ago) 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 provided.  No treatment information mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia
Clinical narrative: Smell loss; Taste loss; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Smell loss), AGEUSIA (Taste loss) and ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021 at 10:38 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Joint pain). On an unknown date, the patient experienced ANOSMIA (Smell loss) and AGEUSIA (Taste loss). At the time of the report, ANOSMIA (Smell loss) and AGEUSIA (Taste loss) had not resolved and ARTHRALGIA (Joint pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after receiving the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: SHINGRIX in October 2018 and SHINGRIX in March 2021.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.). At the time of the report, HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Congestion a side effect of moderna; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jul-2021 and was forwarded to Moderna on 17-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (Congestion a side effect of moderna) 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 NASAL CONGESTION (Congestion a side effect of moderna). At the time of the report, NASAL CONGESTION (Congestion a side effect of moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: she only had a sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she only had a sore arm.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A. and 003A21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-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 MYALGIA (she only had a sore arm.). The patient was treated with ACETAMINOPHEN for COVID-19, at a dose of 1 dosage form and GUAIFENESIN (MUCINEX) for COVID-19, at a dose of 1 dosage form. At the time of the report, MYALGIA (she only had a sore arm.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) on 15Jul2021 she tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant product is given-Allergy meds OTC.   This case was linked to MOD-2021-258894 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: sore throat; Throat swelling; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PHARYNGEAL SWELLING (Throat 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and PHARYNGEAL SWELLING (Throat swelling). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PHARYNGEAL SWELLING (Throat swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. The treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after receiving the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX (received the shingles vaccine in October 2018 and in March 2019, but in spite of that and they experienced shingles after receiving the Moderna COVID-19 vaccine).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.). At the time of the report, HERPES ZOSTER (shingles after receiving the Moderna COVID-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided by reporter. No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Little illness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Little illness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included ANTICOAGULANT CITRATE DEXTROSE and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    In February 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 ILLNESS (Little illness). At the time of the report, ILLNESS (Little illness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-259124 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Suspected COVID-19, Weight
Clinical narrative: COVID-like symptoms; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID-like symptoms) and FATIGUE (Extreme fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 10-Mar-2021, the patient experienced FATIGUE (Extreme fatigue). On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID-like symptoms). At the time of the report, SUSPECTED COVID-19 (COVID-like symptoms) and FATIGUE (Extreme fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Weight: loss of weight (Low) Experienced loss of weight.         Concomitant medications reported included anticoagulant and statin, for unknown indication. No treatment medication were admisnistered by the patient.   This case was linked to MOD-2021-259121 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Headache, Hot flush, Pollakiuria
Clinical narrative: frequent urination over 20 x a day; mild confusion; hot flashes; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination over 20 x a day), CONFUSIONAL STATE (mild confusion), HOT FLUSH (hot flashes) and HEADACHE (Headaches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (frequent urination over 20 x a day), CONFUSIONAL STATE (mild confusion), HOT FLUSH (hot flashes) and HEADACHE (Headaches). At the time of the report, POLLAKIURIA (frequent urination over 20 x a day), CONFUSIONAL STATE (mild confusion), HOT FLUSH (hot flashes) and HEADACHE (Headaches) outcome was unknown.            Concomitant medication were not reported. Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: first dose as covishield and 2nd dose moderna; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (first dose as covishield and 2nd dose moderna) 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) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (first dose as covishield and 2nd dose moderna). At the time of the report, OFF LABEL USE (first dose as covishield and 2nd dose moderna) outcome was unknown.            Reporter did not allow further contact; Sender's Comments: This report refers to a case of interchange of vaccine products for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered expired dose; These vaccines were placed in cooler; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose) and PRODUCT STORAGE ERROR (These vaccines were placed in cooler) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose) and PRODUCT STORAGE ERROR (These vaccines were placed in cooler). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose) and PRODUCT STORAGE ERROR (These vaccines were placed in cooler) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications was reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Bad stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Bad stomach pain) 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 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 ABDOMINAL PAIN UPPER (Bad stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Bad stomach pain) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine dose at 12 Years of age/Dose of the Moderna Covid19 vaccine was administrated to a boy of 12 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine dose at 12 Years of age/Dose of the Moderna Covid19 vaccine was administrated to a boy of 12 years of age) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine dose at 12 Years of age/Dose of the Moderna Covid19 vaccine was administrated to a boy of 12 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine dose at 12 Years of age/Dose of the Moderna Covid19 vaccine was administrated to a boy of 12 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.  Patient after vaccination stayed for 30 minutes and there were no incidents.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Reporter information was updated. On 17-Jul-2021: Non-significant Follow up received - Reporter email address updated
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (Headache) 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 (Dizzy) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizzy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered the Moderna vaccine that was supposed to be discarded; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna vaccine that was supposed to be discarded) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna vaccine that was supposed to be discarded). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna vaccine that was supposed to be discarded) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow Up information received on 28 Jul 2021, contains No New Information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003821A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased, Lactose intolerance, Gluten intolerance, Allergy to metals, Allergy to antibiotic and Allergy to antibiotic. Concomitant products included IRBESARTAN and VERAPAMIL for an unknown indication.   On 23-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced HYPERTENSION (High blood pressure). The patient was treated with CLONIDINE HCL at a dose of 1 mg. On 24-Mar-2021, HYPERTENSION (High blood pressure) had resolved.            This case was linked to MOD-2021-026426, MOD-2021-026426 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Problem with balance; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Problem with balance) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome (during toddler stage).    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 BALANCE DISORDER (Problem with balance). At the time of the report, BALANCE DISORDER (Problem with balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning up a day after my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning up a day after my first vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 BURNING SENSATION (Burning up a day after my first vaccine). At the time of the report, BURNING SENSATION (Burning up a day after my first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: We made an error and gave the Moderna COVID-19 vaccine to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We made an error and gave the Moderna COVID-19 vaccine to a 15 year old) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We made an error and gave the Moderna COVID-19 vaccine to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (We made an error and gave the Moderna COVID-19 vaccine to a 15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unspecific adverse event; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unspecific adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unspecific adverse event). At the time of the report, VACCINATION COMPLICATION (Unspecific adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Non-significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Hypoacusis
Clinical narrative: 5 days after first does ear pain in both ears; Muffled sounds; This spontaneous case was reported by a patient and describes the occurrence of EAR PAIN (5 days after first does ear pain in both ears) and HYPOACUSIS (Muffled sounds) 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, 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 EAR PAIN (5 days after first does ear pain in both ears) and HYPOACUSIS (Muffled sounds). At the time of the report, EAR PAIN (5 days after first does ear pain in both ears) and HYPOACUSIS (Muffled sounds) had not resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-259158 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.            No concomitant medication was given. No treatment medication was given.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pelvic pain
Clinical narrative: Pelvic pain; Pain travelled to her shoulders, outside her shoulders, and her neck; Pain in her neck; Pain in both of her knees Pain travelled to her shoulders, outside her shoulders; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PELVIC PAIN (Pelvic pain), PAIN (Pain travelled to her shoulders, outside her shoulders, and her neck), NECK PAIN (Pain in her neck) and ARTHRALGIA (Pain in both of her knees Pain travelled to her shoulders, outside her shoulders) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis of neck (She has previous diagnoses of arthritis in her neck) and Musculoskeletal stiffness (she was stiff as a board). Concurrent medical conditions included Movements reduced (she could not move) and Joint inflammation (her joints were inflamed).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 PELVIC PAIN (Pelvic pain), PAIN (Pain travelled to her shoulders, outside her shoulders, and her neck), NECK PAIN (Pain in her neck) and ARTHRALGIA (Pain in both of her knees Pain travelled to her shoulders, outside her shoulders). The patient was treated with PREDNISONE on 14-Jun-2021 for Joint pain, at an unspecified dose and frequency. At the time of the report, PELVIC PAIN (Pelvic pain), PAIN (Pain travelled to her shoulders, outside her shoulders, and her neck), NECK PAIN (Pain in her neck) and ARTHRALGIA (Pain in both of her knees Pain travelled to her shoulders, outside her shoulders) was resolving.            No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hypoacusis, Pyrexia
Clinical narrative: Received second dose, ears still muffle; Oddly ear temp much higher than forehead temp / 101.3 degrees; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Received second dose, ears still muffle) and PYREXIA (Oddly ear temp much higher than forehead temp / 101.3 degrees) 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 HYPOACUSIS (Received second dose, ears still muffle) and PYREXIA (Oddly ear temp much higher than forehead temp / 101.3 degrees). At the time of the report, HYPOACUSIS (Received second dose, ears still muffle) and PYREXIA (Oddly ear temp much higher than forehead temp / 101.3 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3.         Relevant concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-259153 (Patient Link).   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Diarrhoea, Illness, Pain
Clinical narrative: severely ill/illest I've ever been; abdominal pain/acute, severe stomach pain; on the floor in pain; diarrhea; uncontrollable vomiting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Surgery (20 plus).    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at a dose of 8 mg and DICYCLOMINE [DICYCLOVERINE] for Vomiting, at an unspecified dose and frequency. At the time of the report, ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Computerised tomogram: abnormal (abnormal) intestines was enlarged and inflamed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that She received the vaccine while taking steroids . Concomitant medications was not reported .Patient also reported that She was on Steroids .   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received contains Treatment history , Medical history
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severely ill/illest I've ever been; abdominal pain/acute, severe stomach pain; on the floor in pain; diarrhea; uncontrollable vomiting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Surgery (20 plus).    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at a dose of 8 mg and DICYCLOMINE [DICYCLOVERINE] for Vomiting, at an unspecified dose and frequency. At the time of the report, ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Computerised tomogram: abnormal (abnormal) intestines was enlarged and inflamed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that She received the vaccine while taking steroids . Concomitant medications was not reported .Patient also reported that She was on Steroids .   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received contains Treatment history , Medical history
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Bone swelling
Clinical narrative: Got lymp on my collar bone; Still aching a little bit; This spontaneous case was reported by a consumer and describes the occurrence of BONE SWELLING (Got lymp on my collar bone) and BONE PAIN (Still aching a little bit) 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 02-Jul-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 BONE SWELLING (Got lymp on my collar bone) and BONE PAIN (Still aching a little bit). At the time of the report, BONE SWELLING (Got lymp on my collar bone) and BONE PAIN (Still aching a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oral herpes
Clinical narrative: sore right arm; cold sore on her lips; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm) and ORAL HERPES (cold sore on her lips) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced MYALGIA (sore right arm) and ORAL HERPES (cold sore on her lips). At the time of the report, MYALGIA (sore right arm) and ORAL HERPES (cold sore on her lips) outcome was unknown.        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.   Treatment Applied Abreva Cream
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nerve injury, Neuralgia, Pain in extremity
Clinical narrative: nerve pain; leg pain; numbness; Nerve damage; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY ( leg pain), HYPOAESTHESIA ( numbness), NERVE INJURY (Nerve damage) and NEURALGIA (nerve pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001421A and 047A21A) for COVID-19 vaccination.     no medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY ( leg pain), HYPOAESTHESIA ( numbness) and NERVE INJURY (Nerve damage). On an unknown date, the patient experienced NEURALGIA (nerve pain). The patient was treated with GABAPENTIN ongoing since an unknown date at a dose of unknown. At the time of the report, PAIN IN EXTREMITY ( leg pain), HYPOAESTHESIA ( numbness) and NEURALGIA (nerve pain) outcome was unknown and NERVE INJURY (Nerve damage) had not resolved.            other medications involve Cholesterol medications.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Use of an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Use of an expired vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Use of an expired vaccine). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Use of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Reporter has stated that patient has received his second dose of expired vaccine after day of its expiry in fridge.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up received on 31-07-2021, contains new information. Updated patient gender as female.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: extreme fatigue; I had 104.5; extreme chest pain; sob; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (extreme chest pain), DYSPNOEA (sob), FATIGUE (extreme fatigue) and PYREXIA (I had 104.5) 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. In May 2021, the patient experienced CHEST PAIN (extreme chest pain) and DYSPNOEA (sob). On an unknown date, the patient experienced FATIGUE (extreme fatigue) and PYREXIA (I had 104.5). At the time of the report, CHEST PAIN (extreme chest pain) and DYSPNOEA (sob) had not resolved and FATIGUE (extreme fatigue) and PYREXIA (I had 104.5) outcome was unknown.            No concomitant medication was provided No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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) (Unknown) was unknown.       No concomitant medication was not reported by the reporter No treatment information was reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle strain, Myalgia, Pain in extremity
Clinical narrative: pain is in the back; feels like muscles are strained; pain in back of legs,The pain is on the top of her legs, from the thighs to her knees. She does not feel the pain in her shins or bottom part of the legs.; pain is on and off,The pain is also in the back not in the front. She says that the pain is still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain is in the back), MUSCLE STRAIN (feels like muscles are strained), PAIN IN EXTREMITY (pain in back of legs,The pain is on the top of her legs, from the thighs to her knees. She does not feel the pain in her shins or bottom part of the legs.) and MYALGIA (pain is on and off,The pain is also in the back not in the front. She says that the pain is still ongoing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 044B21A) for COVID-19 vaccination.     The medical history was provided by the reporter.  Concomitant products included METFORMIN, SPIRONOLACTONE, AMINO ACIDS NOS, MINERALS NOS, VITAMINS NOS (SUPER B [AMINO ACIDS NOS;MINERALS NOS;VITAMINS NOS]), ZINC, FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced BACK PAIN (pain is in the back), MUSCLE STRAIN (feels like muscles are strained), PAIN IN EXTREMITY (pain in back of legs,The pain is on the top of her legs, from the thighs to her knees. She does not feel the pain in her shins or bottom part of the legs.) and MYALGIA (pain is on and off,The pain is also in the back not in the front. She says that the pain is still ongoing). At the time of the report, BACK PAIN (pain is in the back), MUSCLE STRAIN (feels like muscles are strained), PAIN IN EXTREMITY (pain in back of legs,The pain is on the top of her legs, from the thighs to her knees. She does not feel the pain in her shins or bottom part of the legs.) and MYALGIA (pain is on and off,The pain is also in the back not in the front. She says that the pain is still ongoing) had not resolved.            Treatment medication was not provided by the reporter.  After about a week of 2nd dose, patient started experiencing pain in the back of her legs. She says that it feels like her muscles are strained. It feels like she had walked up a big flight of steps. She says that the pain was on and off and she feels better when she was walking. The pain was on the top of her legs, from the thighs to her knees. She does not feel the pain in her shins or bottom part of the legs. The pain was also in the back not in the front. She says that the pain was still ongoing. She does mention that she was not sure if it was because of the vaccine but says that it started after receiving the 2nd dose.