chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch (little bit of a temperature) at both injection sites; First shot missed the muscle; Tight at both injection sites; Red at both injection sites; Puffy at both injection sites; Sore at injection site; Sleepless night for a week; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleepless night for a week), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle) and VACCINATION SITE INDURATION (Tight at both injection sites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On an unknown date, the patient experienced INSOMNIA (Sleepless night for a week), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle), VACCINATION SITE INDURATION (Tight at both injection sites), VACCINATION SITE ERYTHEMA (Red at both injection sites), VACCINATION SITE SWELLING (Puffy at both injection sites) and VACCINATION SITE PAIN (Sore at injection site). On 09-Mar-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, INSOMNIA (Sleepless night for a week), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle), VACCINATION SITE INDURATION (Tight at both injection sites), VACCINATION SITE ERYTHEMA (Red at both injection sites), VACCINATION SITE SWELLING (Puffy at both injection sites) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-259384 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: Red skin scar; This spontaneous case was reported by a physician and describes the occurrence of SCAR (Red skin scar) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M2OA) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (similar reaction to event.). Concurrent medical conditions included Shellfish allergy, Drug allergy (PEG solution), Bigeminy (Heart PVC's), Hypertension and Type II diabetes mellitus. Concomitant products included ATENOLOL, HCTZ, METFORMIN, IBUPROFEN (ADVIL [IBUPROFEN]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced SCAR (Red skin scar). On 06-Mar-2021, SCAR (Red skin scar) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication was reported. Since the patient was hyper-sensitive to PEG Solution which causes violent vomiting in patient, the reporter wants to know whether the PEG solution used in the vaccine could be a root cause of the issue.   This case was linked to MOD-2021-020684 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ERYTHROMYCIN.    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 INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: red at both injection sites; puffy at both injection sites; tight at both injection sites; sore at injection site; sleepless night for a week; hot to the touch (little bit of a temperature) at both injection sites; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE ERYTHEMA (red at both injection sites) and VACCINATION SITE SWELLING (puffy at both injection sites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm hurt). On an unknown date, the patient experienced INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE ERYTHEMA (red at both injection sites), VACCINATION SITE SWELLING (puffy at both injection sites), VACCINATION SITE INDURATION (tight at both injection sites) and VACCINATION SITE PAIN (sore at injection site). On 07-Apr-2021, VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE ERYTHEMA (red at both injection sites), VACCINATION SITE SWELLING (puffy at both injection sites), VACCINATION SITE INDURATION (tight at both injection sites) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown.            No Concomitant medications were provided  No treatment medications were provided.   This case was linked to MOD-2021-259330, MOD-2021-259330 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: red at both injection sites; puffy at both injection sites; tight at both injection sites; sore at injection site; sleepless night for a week; hot to the touch (little bit of a temperature) at both injection sites; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE PAIN (arm hurt), VACCINATION SITE ERYTHEMA (red at both injection sites) and VACCINATION SITE SWELLING (puffy at both injection sites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm hurt). On an unknown date, the patient experienced INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE ERYTHEMA (red at both injection sites), VACCINATION SITE SWELLING (puffy at both injection sites), VACCINATION SITE INDURATION (tight at both injection sites) and VACCINATION SITE PAIN (sore at injection site). On 07-Apr-2021, VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, INSOMNIA (sleepless night for a week), VACCINATION SITE WARMTH (hot to the touch (little bit of a temperature) at both injection sites), VACCINATION SITE ERYTHEMA (red at both injection sites), VACCINATION SITE SWELLING (puffy at both injection sites), VACCINATION SITE INDURATION (tight at both injection sites) and VACCINATION SITE PAIN (sore at injection site) outcome was unknown.            No Concomitant medications were provided  No treatment medications were provided.   This case was linked to MOD-2021-259330, MOD-2021-259330 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: FEEL ABIT UNDER THE WEATHER; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (FEEL ABIT UNDER THE WEATHER) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (FEEL ABIT UNDER THE WEATHER). At the time of the report, ILLNESS (FEEL ABIT UNDER THE WEATHER) outcome was unknown.            No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: armpit sore or hurt; 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 AXILLARY PAIN (armpit sore or hurt) 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 AXILLARY PAIN (armpit sore or hurt). At the time of the report, AXILLARY PAIN (armpit sore or hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pain
Clinical narrative: felt sick; Major body aches like shooting pain; major arm pain,her arm is just a little sore; headache; severe chills; felt nauseated and at the verge of throwing up but never did; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), PAIN (Major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain,her arm is just a little sore), HEADACHE (headache) and CHILLS (severe chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCT) for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   On 26-Jan-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021 at 5:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MALAISE (felt sick), PAIN (Major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain,her arm is just a little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did). At the time of the report, MALAISE (felt sick), PAIN (Major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain,her arm is just a little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did) had resolved.            No treatment  medications were provided by the reporter.   This case was linked to MOD-2021-021726 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt sick; Major body aches like shooting pain; major arm pain,her arm is just a little sore; headache; severe chills; felt nauseated and at the verge of throwing up but never did; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), PAIN (Major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain,her arm is just a little sore), HEADACHE (headache) and CHILLS (severe chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCT) for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   On 26-Jan-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021 at 5:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MALAISE (felt sick), PAIN (Major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain,her arm is just a little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did). At the time of the report, MALAISE (felt sick), PAIN (Major body aches like shooting pain), PAIN IN EXTREMITY (major arm pain,her arm is just a little sore), HEADACHE (headache), CHILLS (severe chills) and NAUSEA (felt nauseated and at the verge of throwing up but never did) had resolved.            No treatment  medications were provided by the reporter.   This case was linked to MOD-2021-021726 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscle weakness). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   This case was linked to MOD-2021-240745 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Hard to the touch; Red area under the site of the injection sensible to the touch; Red area that is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Red area under the site of the injection sensible to the touch) and VACCINATION SITE PAIN (Red area that is sore) 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 VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Red area under the site of the injection sensible to the touch) and VACCINATION SITE PAIN (Red area that is sore). At the time of the report, VACCINATION SITE INDURATION (Hard to the touch), VACCINATION SITE ERYTHEMA (Red area under the site of the injection sensible to the touch) and VACCINATION SITE PAIN (Red area that is sore) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I got vaccinated back in January and February with the moderna but as recently as three days ago I have been feeling symptoms of covid.; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I got vaccinated back in January and February with the moderna but as recently as three days ago I have been feeling symptoms of covid.) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 SUSPECTED COVID-19 (I got vaccinated back in January and February with the moderna but as recently as three days ago I have been feeling symptoms of covid.). At the time of the report, SUSPECTED COVID-19 (I got vaccinated back in January and February with the moderna but as recently as three days ago I have been feeling symptoms of covid.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: never went for my second moderne dose. My first dose was March; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never went for my second moderne dose. My first dose was March) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never went for my second moderne dose. My first dose was March). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never went for my second moderne dose. My first dose was March) had resolved.            No concomitant product information was provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: after firs vaccine black stools now back to normal; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (after firs vaccine black stools now back to normal) 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 FAECES DISCOLOURED (after firs vaccine black stools now back to normal). At the time of the report, FAECES DISCOLOURED (after firs vaccine black stools now back to normal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) 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 COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) 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.   No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Lisinoprill and Statin for an unknown indication.    On 11-Feb-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 MYALGIA (Myalgia). At the time of the report, MYALGIA (Myalgia) 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.   This case was linked to MOD-2021-259911 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 17-Jun-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided          Treatment information was not provided by reporter.   This case was linked to MOD-2021-225634 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Confusional state, Contusion, Rash macular
Clinical narrative: Swelling in ankles; Strange Red Slotching in  lower legs; Bruising a lot more in odd places; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Swelling in ankles), RASH MACULAR (Strange Red Slotching in  lower legs) and CONFUSIONAL STATE (Bruising a lot more in odd places) 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. In 2021, the patient experienced CONTUSION (Swelling in ankles), RASH MACULAR (Strange Red Slotching in  lower legs) and CONFUSIONAL STATE (Bruising a lot more in odd places). At the time of the report, CONTUSION (Swelling in ankles), RASH MACULAR (Strange Red Slotching in  lower legs) and CONFUSIONAL STATE (Bruising a lot more in odd places) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment information was not provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hypoaesthesia, Pain, Scab
Clinical narrative: arm started shaking and wouldn't stop; fingers went completely numb; formed a scab which fell/started scratching on her arm and that formed a scab which fell; felt really dizzy; she had soreness/felt like she was run over by a truck; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arm started shaking and wouldn't stop), HYPOAESTHESIA (fingers went completely numb), SCAB (formed a scab which fell/started scratching on her arm and that formed a scab which fell), DIZZINESS (felt really dizzy) and PAIN (she had soreness/felt like she was run over by a truck) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history and relevant lab data was provided.  Concomitant products included LISINOPRIL and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced TREMOR (arm started shaking and wouldn't stop), HYPOAESTHESIA (fingers went completely numb), SCAB (formed a scab which fell/started scratching on her arm and that formed a scab which fell), DIZZINESS (felt really dizzy), PAIN (she had soreness/felt like she was run over by a truck) and CHILLS (chills). At the time of the report, TREMOR (arm started shaking and wouldn't stop), HYPOAESTHESIA (fingers went completely numb), SCAB (formed a scab which fell/started scratching on her arm and that formed a scab which fell), DIZZINESS (felt really dizzy), PAIN (she had soreness/felt like she was run over by a truck) and CHILLS (chills) outcome was unknown.            She got done an EEG and came up with no signs of seizure, also had a MRI showing no signs of stroke, just little things related to aging. She had blood work too that came up being normal.   This case was linked to MOD-2021-259875 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: arm started shaking and wouldn't stop; fingers went completely numb; formed a scab which fell/started scratching on her arm and that formed a scab which fell; felt really dizzy; she had soreness/felt like she was run over by a truck; chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arm started shaking and wouldn't stop), HYPOAESTHESIA (fingers went completely numb), SCAB (formed a scab which fell/started scratching on her arm and that formed a scab which fell), DIZZINESS (felt really dizzy) and PAIN (she had soreness/felt like she was run over by a truck) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history and relevant lab data was provided.  Concomitant products included LISINOPRIL and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced TREMOR (arm started shaking and wouldn't stop), HYPOAESTHESIA (fingers went completely numb), SCAB (formed a scab which fell/started scratching on her arm and that formed a scab which fell), DIZZINESS (felt really dizzy), PAIN (she had soreness/felt like she was run over by a truck) and CHILLS (chills). At the time of the report, TREMOR (arm started shaking and wouldn't stop), HYPOAESTHESIA (fingers went completely numb), SCAB (formed a scab which fell/started scratching on her arm and that formed a scab which fell), DIZZINESS (felt really dizzy), PAIN (she had soreness/felt like she was run over by a truck) and CHILLS (chills) outcome was unknown.            She got done an EEG and came up with no signs of seizure, also had a MRI showing no signs of stroke, just little things related to aging. She had blood work too that came up being normal.   This case was linked to MOD-2021-259875 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: a patient who missed the second vaccination how does she proceed it's approximately two weeks late now; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a patient who missed the second vaccination how does she proceed it's approximately two weeks late now) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (a patient who missed the second vaccination how does she proceed it's approximately two weeks late now). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a patient who missed the second vaccination how does she proceed it's approximately two weeks late now) 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.   This report refers to a case of Product dose omission issue for mRNA-1273 (lot number unknown) with no associated  reported.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273 (lot number unknown) with no associated reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Insomnia, Lymphadenopathy, Muscular weakness
Clinical narrative: Moderna COVID-19 Vaccine and experienced a side effect.; lymph nodes were swollen and enlarged under arm; pain on left side of the neck; Arm felt weak; Trouble sleeping; had pain at injection site; Had fatigue later that evening; Had joint pain later that evening,; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain on left side of the neck), VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping) and VACCINATION SITE PAIN (had pain at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (pain on left side of the neck), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (had pain at injection site), FATIGUE (Had fatigue later that evening) and ARTHRALGIA (Had joint pain later that evening,). On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.) and LYMPHADENOPATHY (lymph nodes were swollen and enlarged under arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, NECK PAIN (pain on left side of the neck), VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (had pain at injection site), FATIGUE (Had fatigue later that evening) and LYMPHADENOPATHY (lymph nodes were swollen and enlarged under arm) outcome was unknown and ARTHRALGIA (Had joint pain later that evening,) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Birth control tablets was also included in the treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up appended
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination complication, Vaccination site pain
Clinical narrative: Moderna COVID-19 Vaccine and experienced a side effect.; lymph nodes were swollen and enlarged under arm; pain on left side of the neck; Arm felt weak; Trouble sleeping; had pain at injection site; Had fatigue later that evening; Had joint pain later that evening,; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain on left side of the neck), VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping) and VACCINATION SITE PAIN (had pain at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (pain on left side of the neck), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (had pain at injection site), FATIGUE (Had fatigue later that evening) and ARTHRALGIA (Had joint pain later that evening,). On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.) and LYMPHADENOPATHY (lymph nodes were swollen and enlarged under arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, NECK PAIN (pain on left side of the neck), VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.), MUSCULAR WEAKNESS (Arm felt weak), INSOMNIA (Trouble sleeping), VACCINATION SITE PAIN (had pain at injection site), FATIGUE (Had fatigue later that evening) and LYMPHADENOPATHY (lymph nodes were swollen and enlarged under arm) outcome was unknown and ARTHRALGIA (Had joint pain later that evening,) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Birth control tablets was also included in the treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up appended
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Influenza, Peripheral swelling, Rash
Clinical narrative: Flu; Rashes; Arms swelled up; Hairs started to shed off; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Flu), RASH (Rashes), PERIPHERAL SWELLING (Arms swelled up) and ALOPECIA (Hairs started to shed off) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced ALOPECIA (Hairs started to shed off). On an unknown date, the patient experienced INFLUENZA (Flu), RASH (Rashes) and PERIPHERAL SWELLING (Arms swelled up). At the time of the report, INFLUENZA (Flu), RASH (Rashes), PERIPHERAL SWELLING (Arms swelled up) and ALOPECIA (Hairs started to shed off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Nerve injury, Pain, Pain in extremity
Clinical narrative: After 1st dose of vaccine, started to get throbbing pain in her arm; Bursitis; She says she has nerve damage and at night it is pretty rough.; throbbing pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After 1st dose of vaccine, started to get throbbing pain in her arm), BURSITIS (Bursitis), NERVE INJURY (She says she has nerve damage and at night it is pretty rough.) and PAIN (throbbing pain in arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 PAIN IN EXTREMITY (After 1st dose of vaccine, started to get throbbing pain in her arm), BURSITIS (Bursitis), NERVE INJURY (She says she has nerve damage and at night it is pretty rough.) and PAIN (throbbing pain in arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (After 1st dose of vaccine, started to get throbbing pain in her arm), BURSITIS (Bursitis), NERVE INJURY (She says she has nerve damage and at night it is pretty rough.) and PAIN (throbbing pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Pyrexia
Clinical narrative: felt a little bit uncomfortable; temperature of 103 F; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (felt a little bit uncomfortable) and PYREXIA (temperature of 103 F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history is provided by reporter.  Concomitant products included Gabapentin 400 mg 3 times a day, Levothyroxine 50 mcg, Promapar twice a day, Microzide 12.5 mg, MS Contin 30 mg and atorvastatin 10 mg once a day for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced DISCOMFORT (felt a little bit uncomfortable) and PYREXIA (temperature of 103 F). The patient was treated with Diazepam 8 mg once a day ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DISCOMFORT (felt a little bit uncomfortable) and PYREXIA (temperature of 103 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) 101 F.
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia
Clinical narrative: Could the vaccine cause fibromyalgia; 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 FIBROMYALGIA (Could the vaccine cause fibromyalgia) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Could the vaccine cause fibromyalgia). At the time of the report, FIBROMYALGIA (Could the vaccine cause fibromyalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: deviation for dosing schedule; This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (deviation for dosing schedule) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (deviation for dosing schedule). On 29-Mar-2021, PRODUCT DOSE OMISSION ISSUE (deviation for dosing schedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received and contains no new significant information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Tinnitus
Clinical narrative: Tinnitus / Ringing in the ear; Flu Like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms) and TINNITUS (Tinnitus / Ringing in the ear) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms). On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus / Ringing in the ear). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (Flu Like symptoms) had resolved. At the time of the report, TINNITUS (Tinnitus / Ringing in the ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: high fever 103f (High) High Fever 103F.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: don't have my second dose and all ready past 2 month; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (don't have my second dose and all ready past 2 month) 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 PRODUCT DOSE OMISSION ISSUE (don't have my second dose and all ready past 2 month). At the time of the report, PRODUCT DOSE OMISSION ISSUE (don't have my second dose and all ready past 2 month) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: weak all the time due to the pain.; periodical numbness from the shoulder to hand in the injection arm; pain, soreness, achiness; Tired all the time due to pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak all the time due to the pain.), HYPOAESTHESIA (periodical numbness from the shoulder to hand in the injection arm), MYALGIA (pain, soreness, achiness) and FATIGUE (Tired all the time due to pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement in November 2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak all the time due to the pain.), HYPOAESTHESIA (periodical numbness from the shoulder to hand in the injection arm), MYALGIA (pain, soreness, achiness) and FATIGUE (Tired all the time due to pain). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 mg. At the time of the report, ASTHENIA (weak all the time due to the pain.), HYPOAESTHESIA (periodical numbness from the shoulder to hand in the injection arm) and FATIGUE (Tired all the time due to pain) outcome was unknown and MYALGIA (pain, soreness, achiness) had not 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.   Concomitant medications included Lot of unspecified medicines.   This case was linked to MOD-2021-260057 (Patient Link).