chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (looks like broken blood vessels) and ERYTHEMA (redness on arm between elbow and fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported). Concomitant products included Blood Thinner and blood pressure medication for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FEELING ABNORMAL (looks like broken blood vessels) and ERYTHEMA (redness on arm between elbow and fingers). At the time of the report, FEELING ABNORMAL (looks like broken blood vessels) and ERYTHEMA (redness on arm between elbow and fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Nine days later she had knot on her arm), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy in arm), ERYTHEMA (Red in her arm) and RASH (Circular rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced LIMB DISCOMFORT (Nine days later she had knot on her arm), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy in arm), ERYTHEMA (Red in her arm) and RASH (Circular rash). At the time of the report, LIMB DISCOMFORT (Nine days later she had knot on her arm), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy in arm), ERYTHEMA (Red in her arm) and RASH (Circular rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: lung drained after open heart surgery; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG DISORDER (lung drained after open heart surgery) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Patient had open heart surgery earlier this year.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced LUNG DISORDER (lung drained after open heart surgery). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, LUNG DISORDER (lung drained after open heart surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment included prednisone.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: PAIN IN HER NECK; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (PAIN IN HER NECK) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    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 NECK PAIN (PAIN IN HER NECK). At the time of the report, NECK PAIN (PAIN IN HER NECK) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Pyrexia
Clinical narrative: loss of appetite; elevated temperature; perspiring chills; shivering so bad; aches on the joint; This spontaneous case was reported by a  and describes the occurrence of DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 24-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 DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint). At the time of the report, DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Lymphadenopathy, Pruritus, Rash
Clinical narrative: burning sensation on her body; itchy and burning sensation on her body; swollen gland; rash underneath her elbow; fatigue; Arm swelling (injection site); This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelling (injection site)). On 04-Mar-2021, the patient experienced BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow), FATIGUE (fatigue) and VACCINATION SITE SWELLING (Arm swelling (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: burning sensation on her body; itchy and burning sensation on her body; swollen gland; rash underneath her elbow; fatigue; Arm swelling (injection site); This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelling (injection site)). On 04-Mar-2021, the patient experienced BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (burning sensation on her body), PRURITUS (itchy and burning sensation on her body), LYMPHADENOPATHY (swollen gland), RASH (rash underneath her elbow), FATIGUE (fatigue) and VACCINATION SITE SWELLING (Arm swelling (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: stomach cramps; hot and cold sensation; fatigue; felt "sick" with colds; fever; shivering; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt sick with colds, fever, shivering, fatigue, hot and cold sensation, stomach cramps.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 040A71A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events, felt sick with colds, fever, shivering. On 6 Mar 2021, the patient experienced the events, fatigue. hot and cold sensation, stomach cramps.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), felt sick with colds, fever, shivering, fatigue, hot and cold sensation, stomach cramps was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Reversed hot-cold sensation
Clinical narrative: stomach cramps; hot and cold sensation; fatigue; felt "sick" with colds; fever; shivering; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt sick with colds, fever, shivering, fatigue, hot and cold sensation, stomach cramps.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 040A71A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the events, felt sick with colds, fever, shivering. On 6 Mar 2021, the patient experienced the events, fatigue. hot and cold sensation, stomach cramps.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), felt sick with colds, fever, shivering, fatigue, hot and cold sensation, stomach cramps was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (body aches), RASH PRURITIC (itchy rash), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unkown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included SIMVASTATIN and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and FATIGUE (tiredness). On 06-Mar-2021, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, ASTHENIA (weakness), PAIN (body aches), RASH PRURITIC (itchy rash), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (body aches), RASH PRURITIC (itchy rash), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unkown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included SIMVASTATIN and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and FATIGUE (tiredness). On 06-Mar-2021, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, ASTHENIA (weakness), PAIN (body aches), RASH PRURITIC (itchy rash), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: temperature of 101.2; hurts all over; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 101.2) and MYALGIA (hurts all over) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced PYREXIA (temperature of 101.2) and MYALGIA (hurts all over). At the time of the report, PYREXIA (temperature of 101.2) and MYALGIA (hurts all over) 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.   Upon callback, patient confirmed information provided in voicemail. She got the vaccine in her left arm. LOT# not available as she could not find it on the vaccination card. Patient notes that she already had coronavirus back in September. Questioning if she should have not gotten the vaccine since she did have coronavirus back then. She is also wondering what she should do about the second vaccine as she does not want to experience these side effects again.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Pain in extremity, Swelling
Clinical narrative: Sore arm; Swelling; Redness; Chills; Fatigue; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, swelling, redness, chills and fatigue.  The patient's medical history included chronic back pain. Concomitant medications reported were Synthroid, Vitamin B Complex, Yeast Rice ( for unknown indication).  On 24 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the events- sore arm. swelling, redness, chills and  fatigue. She claimed after receiving the vaccine her back pain has gone away(26 Feb 2021).  No lab data was provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events- sore arm, swelling, redness, chills and  fatigue was considered resolved on 25 Feb 2021.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: No appetite; Diarrhea; Congested cough; Nausea; Tired /  Fatigued /Couldn't get out of bed; Asthma symptoms; A spontaneous report was received from a  67-years-old  female patient  concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events asthma symptoms, tired, fatigued, congested cough, nausea, diarrhea, couldn't get out of bed, no appetite.  The patient's medical history was not provided. Concomitant medications reported were Asthma Medications.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event asthma symptoms . On 2 Mar 2021, the patient experienced the events tired, fatigued, congested cough, nausea, diarrhea.  On 3 Mar 2021, the patient experienced the events couldn't get out of bed. no appetite.  Treatment details included Prednisone, Azithromycin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, asthma symptoms, tired,fatigued,congested cough,nausea,diarrhea,couldn't get out of bed,no appetite was considered as recovering/ resolving.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: No appetite; Diarrhea; Congested cough; Nausea; Tired /  Fatigued /Couldn't get out of bed; Asthma symptoms; A spontaneous report was received from a  67-years-old  female patient  concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events asthma symptoms, tired, fatigued, congested cough, nausea, diarrhea, couldn't get out of bed, no appetite.  The patient's medical history was not provided. Concomitant medications reported were Asthma Medications.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event asthma symptoms . On 2 Mar 2021, the patient experienced the events tired, fatigued, congested cough, nausea, diarrhea.  On 3 Mar 2021, the patient experienced the events couldn't get out of bed. no appetite.  Treatment details included Prednisone, Azithromycin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, asthma symptoms, tired,fatigued,congested cough,nausea,diarrhea,couldn't get out of bed,no appetite was considered as recovering/ resolving.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Running nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RHINORRHOEA (Running nose). At the time of the report, RHINORRHOEA (Running nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Left arm pain at the site of the injection; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Left arm pain at the site of the injection) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE PAIN (Left arm pain at the site of the injection) and HEADACHE (headache). At the time of the report, INJECTION SITE PAIN (Left arm pain at the site of the injection) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of relaxation, Pain in extremity
Clinical narrative: Now I feel good, Feel a little better than I did; Felt a little woozy-like; Arm hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a little woozy-like), PAIN IN EXTREMITY (Arm hurt) and FEELING OF RELAXATION (Now I feel good, Feel a little better than I did) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes, COPD and Allergy (Seasonal in the morning.). Concomitant products included AMLODIPINE for Blood pressure high, HYDROCHLOROTHIAZIDE for Diabetes, METFORMIN HCL and ALBUTEROL SULFATE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Felt a little woozy-like) and PAIN IN EXTREMITY (Arm hurt). On 04-Mar-2021, the patient experienced FEELING OF RELAXATION (Now I feel good, Feel a little better than I did). At the time of the report, DIZZINESS (Felt a little woozy-like), PAIN IN EXTREMITY (Arm hurt) and FEELING OF RELAXATION (Now I feel good, Feel a little better than I did) 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Leg Cram; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MUSCLE SPASMS (Leg Cram) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included WARFARIN, ALLOPURINOL, LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 05-Mar-2021, the patient experienced MUSCLE SPASMS (Leg Cram). On 05-Mar-2021, MUSCLE SPASMS (Leg Cram) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills; severe muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (severe muscle aches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (severe muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Muscle ache, at a dose of 1 dosage form every four hours and IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL FLU & BODY ACHE) for Muscle ache, at a dose of 1 dosage form every four hours. At the time of the report, CHILLS (chills) and MYALGIA (severe muscle aches) outcome was unknown.            Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Pain, Pyrexia, Rash
Clinical narrative: rash on the face; headache; Fever; couldn't move the arm at all; face swelling; body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), RASH (rash on the face) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus erythematosus.    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 MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), HEADACHE (headache) and PYREXIA (Fever). On 04-Mar-2021, the patient experienced RASH (rash on the face). At the time of the report, MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown and RASH (rash on the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: rash on the face; headache; Fever; couldn't move the arm at all; face swelling; body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), RASH (rash on the face) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus erythematosus.    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 MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), HEADACHE (headache) and PYREXIA (Fever). On 04-Mar-2021, the patient experienced RASH (rash on the face). At the time of the report, MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown and RASH (rash on the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint stiffness, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: Arm Hurts; Sore Arm; Stiff Left Arm; Very Sleepy; Fever 100.1 (on forehead); Very Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm Hurts), PAIN IN EXTREMITY (Sore Arm), JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy) and PYREXIA (Fever 100.1 (on forehead)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LIMB DISCOMFORT (Arm Hurts), PAIN IN EXTREMITY (Sore Arm), JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy), PYREXIA (Fever 100.1 (on forehead)) and FATIGUE (Very Tired). On 07-Mar-2021, JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy), PYREXIA (Fever 100.1 (on forehead)) and FATIGUE (Very Tired) had resolved. At the time of the report, LIMB DISCOMFORT (Arm Hurts) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Arm Hurts; Sore Arm; Stiff Left Arm; Very Sleepy; Fever 100.1 (on forehead); Very Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm Hurts), PAIN IN EXTREMITY (Sore Arm), JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy) and PYREXIA (Fever 100.1 (on forehead)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LIMB DISCOMFORT (Arm Hurts), PAIN IN EXTREMITY (Sore Arm), JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy), PYREXIA (Fever 100.1 (on forehead)) and FATIGUE (Very Tired). On 07-Mar-2021, JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy), PYREXIA (Fever 100.1 (on forehead)) and FATIGUE (Very Tired) had resolved. At the time of the report, LIMB DISCOMFORT (Arm Hurts) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Pyrexia
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint). At the time of the report, DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Lethargy
Clinical narrative: heart rate was high - 74; lethargic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic) and HEART RATE INCREASED (heart rate was high - 74) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced LETHARGY (lethargic). On 04-Mar-2021, the patient experienced HEART RATE INCREASED (heart rate was high - 74). At the time of the report, LETHARGY (lethargic) and HEART RATE INCREASED (heart rate was high - 74) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: high 74.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing more; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing more) 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 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced COUGH (coughing more). At the time of the report, COUGH (coughing more) had resolved.            No relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Event outcome updated
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: warmth at the site of the injection; itching at the site of the injection; pain at the site of the injection; swelling at the site of the injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warmth at the site of the injection), INJECTION SITE PRURITUS (itching at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection) and INJECTION SITE SWELLING (swelling at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (warmth at the site of the injection), INJECTION SITE PRURITUS (itching at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection) and INJECTION SITE SWELLING (swelling at the site of the injection). At the time of the report, INJECTION SITE WARMTH (warmth at the site of the injection), INJECTION SITE PRURITUS (itching at the site of the injection), INJECTION SITE PAIN (pain at the site of the injection) and INJECTION SITE SWELLING (swelling at the site of the injection) outcome was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Influenza like illness, Injection site erythema
Clinical narrative: achiness in shoulders; achiness in neck; flu like symptoms; redness at the injection site; it is hot; was "miserable all over"; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (achiness in shoulders), NECK PAIN (achiness in neck), INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE WARMTH (it is hot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Penicillin allergy and Drug allergy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ARTHRALGIA (achiness in shoulders), NECK PAIN (achiness in neck), INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE WARMTH (it is hot), FEELING ABNORMAL (was "miserable all over"), HEADACHE (headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (achiness in shoulders), NECK PAIN (achiness in neck), INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE WARMTH (it is hot), FEELING ABNORMAL (was "miserable all over"), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Neck pain, Pyrexia
Clinical narrative: achiness in shoulders; achiness in neck; flu like symptoms; redness at the injection site; it is hot; was "miserable all over"; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (achiness in shoulders), NECK PAIN (achiness in neck), INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE WARMTH (it is hot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concurrent medical conditions included Penicillin allergy and Drug allergy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ARTHRALGIA (achiness in shoulders), NECK PAIN (achiness in neck), INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE WARMTH (it is hot), FEELING ABNORMAL (was "miserable all over"), HEADACHE (headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (achiness in shoulders), NECK PAIN (achiness in neck), INFLUENZA LIKE ILLNESS (flu like symptoms), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE WARMTH (it is hot), FEELING ABNORMAL (was "miserable all over"), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the trunk of her body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives all over the trunk of her body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced URTICARIA (Hives all over the trunk of her body). At the time of the report, URTICARIA (Hives all over the trunk of her body) 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blister, Chills, Dysgeusia
Clinical narrative: Muscles in buttocks, top part felt like light sunburn on skin; Shingles; Muscles hurt where incision was from surgery; Blisters on waist; Really bad pain on right hip; Redness on waist; Arm was really sore; Chills real bad; Skin felt like it had mild acid on it like sunburn; Felt warmth in body; Back pain - quite intense; Metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt warmth in body), BACK PAIN (Back pain - quite intense), DYSGEUSIA (Metallic taste in mouth), SUNBURN (Muscles in buttocks, top part felt like light sunburn on skin) and SUNBURN (Skin felt like it had mild acid on it like sunburn) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L120A or 032LD0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthrodesis and Back surgery (History of 3 back surgeries).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced FEELING HOT (Felt warmth in body), BACK PAIN (Back pain - quite intense), DYSGEUSIA (Metallic taste in mouth), SUNBURN (Skin felt like it had mild acid on it like sunburn) and CHILLS (Chills real bad). On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was really sore). On 14-Feb-2021, the patient experienced ERYTHEMA (Redness on waist) and ARTHRALGIA (Really bad pain on right hip). On 15-Feb-2021, the patient experienced BLISTER (Blisters on waist). On an unknown date, the patient experienced SUNBURN (Muscles in buttocks, top part felt like light sunburn on skin), HERPES ZOSTER (Shingles) and MYALGIA (Muscles hurt where incision was from surgery). The patient was treated with GABAPENTIN at a dose of 100 milligram one a day at night and HYDROCODONE at a dose of 7.5 milligram 1/2 tablet. At the time of the report, FEELING HOT (Felt warmth in body), BACK PAIN (Back pain - quite intense), DYSGEUSIA (Metallic taste in mouth), SUNBURN (Muscles in buttocks, top part felt like light sunburn on skin), SUNBURN (Skin felt like it had mild acid on it like sunburn), PAIN IN EXTREMITY (Arm was really sore), ERYTHEMA (Redness on waist), BLISTER (Blisters on waist), HERPES ZOSTER (Shingles), CHILLS (Chills real bad), ARTHRALGIA (Really bad pain on right hip) and MYALGIA (Muscles hurt where incision was from surgery) 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.   Concomitant product information was not provided. Patient received treatment of Heating Pad and Physical Therapy. Patient scheduled second dose on 08Mar2021.   This case was linked to MOD21-045740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 and contains non significant information