chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling hot, Product administered to patient of inappropriate age
Clinical narrative: Updated AE: 17 year old received Second Shot; Dizzy after Second Dose; Body felt warm  (Fever not measured) after Second Dose; Chills after Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Updated AE: 17 year old received Second Shot), DIZZINESS (Dizzy after Second Dose), FEELING HOT (Body felt warm  (Fever not measured) after Second Dose) and CHILLS (Chills after Second Dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], ALBUTEROL SULFATE and VENLAFAXINE for an unknown indication.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Updated AE: 17 year old received Second Shot), DIZZINESS (Dizzy after Second Dose), FEELING HOT (Body felt warm  (Fever not measured) after Second Dose) and CHILLS (Chills after Second Dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Updated AE: 17 year old received Second Shot) had resolved. At the time of the report, DIZZINESS (Dizzy after Second Dose), FEELING HOT (Body felt warm  (Fever not measured) after Second Dose) and CHILLS (Chills after Second Dose) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-250209 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got Results yesterday "Positive"; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Results yesterday "Positive") 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.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced COVID-19 (Got Results yesterday "Positive"). At the time of the report, COVID-19 (Got Results yesterday "Positive") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported No treatment information was provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) 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.   Concomitant information use was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-265450 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever after second shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PYREXIA (Low grade fever after second shot). In March 2021, PYREXIA (Low grade fever after second shot) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Paraesthesia, Throat tightness, Vaccination site pain
Clinical narrative: Today, she noticed that she has dizzy head.; Even right now when she is sitting down, her hip feels funny.; She also has nausea.; Her vocal cord was tight; Within 1st 24 hours, she had a sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Her vocal cord was tight), DIZZINESS (Today, she noticed that she has dizzy head.), PARAESTHESIA (Even right now when she is sitting down, her hip feels funny.), VACCINATION SITE PAIN (Within 1st 24 hours, she had a sore left arm) and NAUSEA (She also has nausea.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced THROAT TIGHTNESS (Her vocal cord was tight) and VACCINATION SITE PAIN (Within 1st 24 hours, she had a sore left arm). On 23-Jul-2021, the patient experienced DIZZINESS (Today, she noticed that she has dizzy head.), PARAESTHESIA (Even right now when she is sitting down, her hip feels funny.) and NAUSEA (She also has nausea.). At the time of the report, THROAT TIGHTNESS (Her vocal cord was tight), DIZZINESS (Today, she noticed that she has dizzy head.), PARAESTHESIA (Even right now when she is sitting down, her hip feels funny.), VACCINATION SITE PAIN (Within 1st 24 hours, she had a sore left arm) and NAUSEA (She also has nausea.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Eye drops for glaucoma.  Treatment information was not provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Swelling, Vaccination site pain
Clinical narrative: malaise; swelling on the left side of the head (near to ear); Pain in arm; Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling on the left side of the head (near to ear)), MALAISE (malaise), VACCINATION SITE PAIN (Pain in arm), FATIGUE (Fatigue) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concomitant products included THIAMAZOLE (METHIMAZOLE), METOPROLOL and IBUPROFEN for an unknown indication.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced HEADACHE (headache). On 02-Jul-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm) and FATIGUE (Fatigue). On 16-Jul-2021, the patient experienced SWELLING (swelling on the left side of the head (near to ear)). On an unknown date, the patient experienced MALAISE (malaise). On 01-Jul-2021, HEADACHE (headache) had resolved. At the time of the report, SWELLING (swelling on the left side of the head (near to ear)), MALAISE (malaise), VACCINATION SITE PAIN (Pain in arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant Follow-up :- Events added. Gender and age were not confirmed and route of administration unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dyspepsia, Headache, Hypoaesthesia, Myalgia
Clinical narrative: face burning sensation; left hand partially numb; burning feeling in stomach; headache 24/7; muscle soreness on the back of legs especially; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (face burning sensation), HYPOAESTHESIA (left hand partially numb), DYSPEPSIA (burning feeling in stomach), HEADACHE (headache 24/7) and MYALGIA (muscle soreness on the back of legs especially) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (face burning sensation), HYPOAESTHESIA (left hand partially numb), DYSPEPSIA (burning feeling in stomach), HEADACHE (headache 24/7) and MYALGIA (muscle soreness on the back of legs especially). At the time of the report, BURNING SENSATION (face burning sensation), HYPOAESTHESIA (left hand partially numb), DYSPEPSIA (burning feeling in stomach), HEADACHE (headache 24/7) and MYALGIA (muscle soreness on the back of legs especially) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Polymenorrhoea
Clinical narrative: 3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days; started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days) and POLYMENORRHOEA (started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later) 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, the patient experienced PALPITATIONS (3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days) and POLYMENORRHOEA (started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later). At the time of the report, PALPITATIONS (3 days after my 1st vaccine I started to have heart palpitations that have yet to resolve after 7 days) had not resolved and POLYMENORRHOEA (started my period the same day as my 1st moderne vaccine was administered  It stopped completely 8 hours later) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: feels weak; left-sided headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (left-sided headache), FATIGUE (Extreme fatigue) and ASTHENIA (feels weak) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced HEADACHE (left-sided headache), FATIGUE (Extreme fatigue) and ASTHENIA (feels weak). At the time of the report, HEADACHE (left-sided headache) had not resolved and FATIGUE (Extreme fatigue) and ASTHENIA (feels weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was not taking any regular prescribed medications and had no known allergies. Patient had taken a pain reliever but still had the headache. Caller stated that they would see HCP next day.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: 1st dose on 29mar21 and 2nd dose on 04may2021; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29mar21 and 2nd dose on 04may2021) and VACCINATION SITE PAIN (Soreness at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tecfidera), Multiple sclerosis (No new lesions or growth in brain between last year's MRI and this year's MRI.), Depression, Anxiety and Post-traumatic stress disorder. Concomitant products included HYDROXYZINE for Anxiety, BUPROPION for Depression, FINGOLIMOD HYDROCHLORIDE (GILENYA) for Multiple sclerosis, GABAPENTIN for Pain, PRAZOSIN for Post-traumatic stress disorder.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29mar21 and 2nd dose on 04may2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 29mar21 and 2nd dose on 04may2021) had resolved and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            The following day of first dose of vaccine, 30-Mar-2021, patient experienced weakness in limbs and stiff, painful joints.  Pushed through and did stretches throughout day to try and keep from locking up.  On March 31, 2021, woke to my right side feeling normal but my left side unwilling to function. Left hand would not enclose and right arm would not raise when desired. Left leg would not tolerate weight and foot had to be watched for footing placement when trying to move. Forced self to move and do things even though exhaustion came quicker. On April 1, 2021, regained function of Left side ligaments but still heavily fatigued. On April 2, 2021, symptoms weren't present and those that were, did not effect daily functions.   This case was linked to MOD-2021-091272 (Patient Link).   Reporter did not allow further contact
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Just a little bit of tiredness but minor; Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) and FATIGUE (Just a little bit of tiredness but minor) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced DIZZINESS (Dizzy spells). On an unknown date, the patient experienced FATIGUE (Just a little bit of tiredness but minor). At the time of the report, DIZZINESS (Dizzy spells) and FATIGUE (Just a little bit of tiredness but minor) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minor soreness at the injection site of her left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor soreness at the injection site of her left arm.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (minor soreness at the injection site of her left arm.). At the time of the report, VACCINATION SITE PAIN (minor soreness at the injection site of her left arm.) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: feeling abnormal; Arm started to hurt at injection site; injection site is hard; injection site is swollen; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEELING ABNORMAL (feeling abnormal), VACCINATION SITE PAIN (Arm started to hurt at injection site), VACCINATION SITE INDURATION (injection site is hard) and VACCINATION SITE SWELLING (injection site is swollen) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.      Medical history was not provided.     On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced DIZZINESS (dizzy). On 21-Jul-2021, the patient experienced VACCINATION SITE PAIN (Arm started to hurt at injection site), VACCINATION SITE INDURATION (injection site is hard) and VACCINATION SITE SWELLING (injection site is swollen). On an unknown date, the patient experienced FEELING ABNORMAL (feeling abnormal). At the time of the report, DIZZINESS (dizzy), FEELING ABNORMAL (feeling abnormal), VACCINATION SITE PAIN (Arm started to hurt at injection site), VACCINATION SITE INDURATION (injection site is hard) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine was given to a 16 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was given to a 16 year old patient) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No specified medical history has been reported.     On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was given to a 16 year old patient). On 23-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine was given to a 16 year old patient) 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 information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contained no new information On 23-Jul-2021: Non-Significant follow up appended
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered with the vaccine which has been stored in the refrigerator for more than 30 days; Administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-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 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided   This case was linked to MOD-2021-265357, MOD-2021-265404, MOD-2021-265450, MOD-2021-265462, MOD-2021-265506, MOD-2021-265612, MOD-2021-265657, MOD-2021-265725, MOD-2021-265759, MOD-2021-265768, MOD-2021-265788, MOD-2021-265803, MOD-2021-265950, MOD-2021-265955, MOD-2021-265450 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash) 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 PRURITUS (itchy) and RASH (rash). At the time of the report, PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown  Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never went back from my second/I only received the first dose of the Moderna vaccine 3 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added Reporter's Email address, Updated PT term of the event.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: low platelet count; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (low platelet count) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (low platelet count). At the time of the report, PLATELET COUNT DECREASED (low platelet count) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low (Low) Low.         No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) 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 MYALGIA (Muscle soreness). At the time of the report, MYALGIA (Muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient asked that Would a ice pack or heat pack  help with muscle soreness or not.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment information was provided   This case was linked to MOD-2021-265450 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Diarrhoea, Dyspepsia, Fatigue, Hypoaesthesia
Clinical narrative: muscle weakness; twitching in legs, arms and feet; diarrhea; stomach acid burning; tingling numbness feeling; tingling numbness feeling; general feeling of unwellness; insomnia; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning) and PARAESTHESIA (tingling numbness feeling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-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 MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature abnormal: (abnormal) unable to regulate body temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle twitching, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: muscle weakness; twitching in legs, arms and feet; diarrhea; stomach acid burning; tingling numbness feeling; tingling numbness feeling; general feeling of unwellness; insomnia; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning) and PARAESTHESIA (tingling numbness feeling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-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 MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature abnormal: (abnormal) unable to regulate body temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: muscle weakness; twitching in legs, arms and feet; diarrhea; stomach acid burning; tingling numbness feeling; tingling numbness feeling; general feeling of unwellness; insomnia; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning) and PARAESTHESIA (tingling numbness feeling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-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 MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), MUSCLE TWITCHING (twitching in legs, arms and feet), DIARRHOEA (diarrhea), DYSPEPSIA (stomach acid burning), PARAESTHESIA (tingling numbness feeling), HYPOAESTHESIA (tingling numbness feeling), VACCINATION COMPLICATION (general feeling of unwellness), INSOMNIA (insomnia), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature abnormal: (abnormal) unable to regulate body temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient who received the 1st dose of the Moderna vaccine "4 months ago"; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine "4 months ago") 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine "4 months ago"). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient who received the 1st dose of the Moderna vaccine "4 months ago") 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 medications details were not reported by the reporter. Treatment details was not reported by the reporter. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(unknown), was unknown
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Dizziness; Heart palpitations; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jul-2021 and was forwarded to Moderna on 24-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PALPITATIONS (Heart palpitations) 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 DIZZINESS (Dizziness) and PALPITATIONS (Heart palpitations). At the time of the report, DIZZINESS (Dizziness) and PALPITATIONS (Heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment details not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea  ) and VOMITING (Vomiting  ) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-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) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced NAUSEA (Nausea  ) and VOMITING (Vomiting  ). At the time of the report, NAUSEA (Nausea  ) and VOMITING (Vomiting  ) outcome was unknown.            Treatment information and concomitant information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had the same side effect from the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had the same side effect from the Moderna COVID19 vaccine) 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, the patient experienced VACCINATION COMPLICATION (Had the same side effect from the Moderna COVID19 vaccine). At the time of the report, VACCINATION COMPLICATION (Had the same side effect from the Moderna COVID19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-265628 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Can I take the second dose now; Pretty sick for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Pretty sick for 4 days) and PRODUCT DOSE OMISSION ISSUE (Can I take the second dose now) 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I take the second dose now). On an unknown date, the patient experienced ILLNESS (Pretty sick for 4 days). On 23-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Can I take the second dose now) had resolved. At the time of the report, ILLNESS (Pretty sick for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fluid retention, Weight
Clinical narrative: Retaining water weight/wont come off; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (Retaining water weight/wont come off) 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 FLUID RETENTION (Retaining water weight/wont come off). At the time of the report, FLUID RETENTION (Retaining water weight/wont come off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: arm still hurts; still a bit painful to try to reach behind my back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm still hurts) and BACK PAIN (still a bit painful to try to reach behind my back) 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 VACCINATION SITE PAIN (arm still hurts) and BACK PAIN (still a bit painful to try to reach behind my back). At the time of the report, VACCINATION SITE PAIN (arm still hurts) and BACK PAIN (still a bit painful to try to reach behind my back) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicine, treatment and medical history were not provided by the reporter. Patient had difficulty in sleeping on his right side.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Sore injection site arm; Headache; Very tired; Patient received his second Moderna Covid-19 vaccine 24 days later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his second Moderna Covid-19 vaccine 24 days later), VACCINATION SITE PAIN (Sore injection site arm), HEADACHE (Headache) and FATIGUE (Very tired) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history were reported.  The patient's past medical history included Cancer.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his second Moderna Covid-19 vaccine 24 days later). On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm) and FATIGUE (Very tired). 28-Feb-2021, the patient experienced HEADACHE (Headache). On 02-Mar-2021, HEADACHE (Headache) and FATIGUE (Very tired) had resolved. On 06-Mar-2021, VACCINATION SITE PAIN (Sore injection site arm) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his second Moderna Covid-19 vaccine 24 days later) had resolved.            No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-265483, MOD-2021-309134 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Significant follow-up appended - Dose 2 date and batch no. updated and medical history update received.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizzy; Nauseous; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), NAUSEA (Nauseous) and VOMITING (Vomiting) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was hanged 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 23-Jul-2021, the patient experienced DIZZINESS (Dizzy), NAUSEA (Nauseous) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizzy), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown.  NO Concomitant information was reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: I had a fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I had a fever) and CHILLS (chills) 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) (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 PYREXIA (I had a fever) and CHILLS (chills). At the time of the report, PYREXIA (I had a fever) and CHILLS (chills) outcome was unknown.            No concomitant medications and no treatment medications were reported.     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vomiting
Clinical narrative: Vomiting; Chills; body pain; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (body pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (body pain). At the time of the report, VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.