chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Myalgia, Nausea, Nervousness
Clinical narrative: headache; sore eyes; sore arms; nausea; fever; found food disgusting; woke up very nervous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 18-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 HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea), PYREXIA (fever), TASTE DISORDER (found food disgusting) and NERVOUSNESS (woke up very nervous). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea), PYREXIA (fever), TASTE DISORDER (found food disgusting) and NERVOUSNESS (woke up very nervous) outcome was unknown.            Patient reported that, on unknown date, her blood pressure was monitored which came with abnormal results. Patient also reported that she had abnormal heartbeat sometimes.  Concomitant products were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up Appended - Reporter's first name updated and lab data was added
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Taste disorder
Clinical narrative: headache; sore eyes; sore arms; nausea; fever; found food disgusting; woke up very nervous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 18-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 HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea), PYREXIA (fever), TASTE DISORDER (found food disgusting) and NERVOUSNESS (woke up very nervous). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), EYE PAIN (sore eyes), MYALGIA (sore arms), NAUSEA (nausea), PYREXIA (fever), TASTE DISORDER (found food disgusting) and NERVOUSNESS (woke up very nervous) outcome was unknown.            Patient reported that, on unknown date, her blood pressure was monitored which came with abnormal results. Patient also reported that she had abnormal heartbeat sometimes.  Concomitant products were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up Appended - Reporter's first name updated and lab data was added
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: left arm swollen; left arm painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen) and PAIN IN EXTREMITY (left arm painful) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure high.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen) and PAIN IN EXTREMITY (left arm painful). On 16-May-2021, PERIPHERAL SWELLING (left arm swollen) and PAIN IN EXTREMITY (left arm painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-229864 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on my hands that is continuing to spread and worsen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my hands that is continuing to spread and worsen) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash on my hands that is continuing to spread and worsen). At the time of the report, RASH (rash on my hands that is continuing to spread and worsen) outcome was unknown.            No concomitant medication was reported. No treatment was reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: rash; fingers have swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and PERIPHERAL SWELLING (fingers have swollen) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 017T21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced RASH (rash) and PERIPHERAL SWELLING (fingers have swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ALLERGY/COLD) at an unspecified dose and frequency. At the time of the report, RASH (rash) and PERIPHERAL SWELLING (fingers have swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information provided as Benadryl.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patient received vaccine affected by the excursion /Patient received vaccine affected by the temp excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion /Patient received vaccine affected by the temp excursion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion /Patient received vaccine affected by the temp excursion). On 11-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion /Patient received vaccine affected by the temp excursion) 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.   No concomitant medications were reported.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information Received on 27-JUL-2021: Contains no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Extension of interval between the 1st and 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extension of interval between the 1st and 2nd dose) 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 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extension of interval between the 1st and 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Extension of interval between the 1st and 2nd dose) 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.   Patient waited until today 21june2021 to get her second dose which was outside of the 42 day window.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Vitreous floaters
Clinical narrative: teeth was sensitive; the floaters in eye were noticeable and intense /  looked like little worm, much more intensified; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (teeth was sensitive) and VITREOUS FLOATERS (the floaters in eye were noticeable and intense /  looked like little worm, much more intensified) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA TEETH (teeth was sensitive) and VITREOUS FLOATERS (the floaters in eye were noticeable and intense /  looked like little worm, much more intensified). At the time of the report, HYPERAESTHESIA TEETH (teeth was sensitive) and VITREOUS FLOATERS (the floaters in eye were noticeable and intense /  looked like little worm, much more intensified) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-229885 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contain significant information patient date of birth and AE contact information updated
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Illness, Myalgia
Clinical narrative: Sick; headache; muscle pain; joint pain; feeling very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (feeling very fatigued) and ILLNESS (Sick) 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 June 1900, the patient experienced FATIGUE (feeling very fatigued). In June 2021, the patient experienced HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (feeling very fatigued) and ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: some back pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (some back pain) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced BACK PAIN (some back pain). 20-Jun-2021, the patient experienced CHILLS (Chills). At the time of the report, BACK PAIN (some back pain) and CHILLS (Chills) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave 2 Moderna vaccines that were from vial that were punctured on 6-19-2-21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 2 Moderna vaccines that were from vial that were punctured on 6-19-2-21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) 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 EXPIRED PRODUCT ADMINISTERED (Gave 2 Moderna vaccines that were from vial that were punctured on 6-19-2-21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 2 Moderna vaccines that were from vial that were punctured on 6-19-2-21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Inflammation, Peripheral swelling, Pruritus
Clinical narrative: Skin was really red; Itching; Hives like rash; Inflammation; Arm was so swollen; Hot to touch; Vaccination site Warmth to touch; Sore at the site of the injection / arm was sore for a couple of days / soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Skin was really red), PRURITUS (Itching), VACCINATION SITE WARMTH (Vaccination site Warmth to touch), INFLAMMATION (Inflammation) and PERIPHERAL SWELLING (Arm was so swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Arthritis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 11-Jun-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Sore at the site of the injection / arm was sore for a couple of days / soreness). On 15-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site Warmth to touch). On 18-Jun-2021, the patient experienced PRURITUS (Itching), INFLAMMATION (Inflammation), PERIPHERAL SWELLING (Arm was so swollen), FEELING HOT (Hot to touch) and VACCINATION SITE RASH (Hives like rash). On 20-Jun-2021, the patient experienced ERYTHEMA (Skin was really red). The patient was treated with HYDROCORTISONE at a dose of 1 % and PREDNISONE at a dose of 1 dosage form. On 14-Jun-2021, VACCINATION SITE PAIN (Sore at the site of the injection / arm was sore for a couple of days / soreness) had resolved. At the time of the report, ERYTHEMA (Skin was really red), VACCINATION SITE WARMTH (Vaccination site Warmth to touch), INFLAMMATION (Inflammation), FEELING HOT (Hot to touch) and VACCINATION SITE RASH (Hives like rash) outcome was unknown and PRURITUS (Itching) and PERIPHERAL SWELLING (Arm was so swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication administered included medications for blood pressure and a few herbs.   The patient stated that the second dose of Moderna vaccine was scheduled on 09-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up document was received on 21-Jun-2021 and contains no new information. On 24-Jun-2021: Follow up document was received on 24-Jun-2021. Concomitant , treatment medication, additional events, onset date of event and outcome were updated. On 06-Jul-2021: Added Medical history Arthritis, Concomitant medication Prednisone . Added New Events Inflammation and peripheral swelling and changed outcome of the event for itching and peripheral swelling from unknown to recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Skin was really red; Itching; Hives like rash; Inflammation; Arm was so swollen; Hot to touch; Vaccination site Warmth to touch; Sore at the site of the injection / arm was sore for a couple of days / soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Skin was really red), PRURITUS (Itching), VACCINATION SITE WARMTH (Vaccination site Warmth to touch), INFLAMMATION (Inflammation) and PERIPHERAL SWELLING (Arm was so swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroidectomy. Concurrent medical conditions included Arthritis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 11-Jun-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Sore at the site of the injection / arm was sore for a couple of days / soreness). On 15-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site Warmth to touch). On 18-Jun-2021, the patient experienced PRURITUS (Itching), INFLAMMATION (Inflammation), PERIPHERAL SWELLING (Arm was so swollen), FEELING HOT (Hot to touch) and VACCINATION SITE RASH (Hives like rash). On 20-Jun-2021, the patient experienced ERYTHEMA (Skin was really red). The patient was treated with HYDROCORTISONE at a dose of 1 % and PREDNISONE at a dose of 1 dosage form. On 14-Jun-2021, VACCINATION SITE PAIN (Sore at the site of the injection / arm was sore for a couple of days / soreness) had resolved. At the time of the report, ERYTHEMA (Skin was really red), VACCINATION SITE WARMTH (Vaccination site Warmth to touch), INFLAMMATION (Inflammation), FEELING HOT (Hot to touch) and VACCINATION SITE RASH (Hives like rash) outcome was unknown and PRURITUS (Itching) and PERIPHERAL SWELLING (Arm was so swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication administered included medications for blood pressure and a few herbs.   The patient stated that the second dose of Moderna vaccine was scheduled on 09-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up document was received on 21-Jun-2021 and contains no new information. On 24-Jun-2021: Follow up document was received on 24-Jun-2021. Concomitant , treatment medication, additional events, onset date of event and outcome were updated. On 06-Jul-2021: Added Medical history Arthritis, Concomitant medication Prednisone . Added New Events Inflammation and peripheral swelling and changed outcome of the event for itching and peripheral swelling from unknown to recovered.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: have been sick ever since; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (have been sick ever since) 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 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (have been sick ever since). At the time of the report, ILLNESS (have been sick ever since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was included. No treatment drug details was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Erythema, Fatigue, Headache
Clinical narrative: left arm swollen; left arm painful; left arm reddish; diarrhea; stomach pain; heaviness in the body that does not go away; excruciating pain in her legs; nausea; terrible fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful), ERYTHEMA (left arm reddish), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0381321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful) and ERYTHEMA (left arm reddish). In June 2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), LIMB DISCOMFORT (heaviness in the body that does not go away), PAIN IN EXTREMITY (excruciating pain in her legs), NAUSEA (nausea), FATIGUE (terrible fatigue) and HEADACHE (headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful), ERYTHEMA (left arm reddish), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), LIMB DISCOMFORT (heaviness in the body that does not go away), PAIN IN EXTREMITY (excruciating pain in her legs), NAUSEA (nausea), FATIGUE (terrible fatigue) and HEADACHE (headache) had not resolved.            This case was linked to MOD-2021-229837 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: left arm swollen; left arm painful; left arm reddish; diarrhea; stomach pain; heaviness in the body that does not go away; excruciating pain in her legs; nausea; terrible fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful), ERYTHEMA (left arm reddish), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0381321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high.   On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful) and ERYTHEMA (left arm reddish). In June 2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), LIMB DISCOMFORT (heaviness in the body that does not go away), PAIN IN EXTREMITY (excruciating pain in her legs), NAUSEA (nausea), FATIGUE (terrible fatigue) and HEADACHE (headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (left arm swollen), PAIN IN EXTREMITY (left arm painful), ERYTHEMA (left arm reddish), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pain), LIMB DISCOMFORT (heaviness in the body that does not go away), PAIN IN EXTREMITY (excruciating pain in her legs), NAUSEA (nausea), FATIGUE (terrible fatigue) and HEADACHE (headache) had not resolved.            This case was linked to MOD-2021-229837 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypokinesia, Pain, Pain in extremity
Clinical narrative: doesn't have full use of her right hand; pain comes and goes; still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot; numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee), HYPOKINESIA (doesn't have full use of her right hand), PAIN (pain comes and goes) and PAIN IN EXTREMITY (still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA (numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee). On an unknown date, the patient experienced HYPOKINESIA (doesn't have full use of her right hand), PAIN (pain comes and goes) and PAIN IN EXTREMITY (still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot). At the time of the report, HYPOAESTHESIA (numbing sensation in her righ arm, hand and leg, right leg gave out right under her knee), HYPOKINESIA (doesn't have full use of her right hand), PAIN (pain comes and goes) and PAIN IN EXTREMITY (still has all of the pain in her arm and hand/her arm is totally not the same since she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided. Caller confirmed information reported in previous. AE  Contact information confirmed.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow up information received. NewEvents Pain and Pain in extremity was added.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Persistent pain for more than 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Persistent pain for more than 6 weeks) 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 No adverse reaction.    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 (Persistent pain for more than 6 weeks). At the time of the report, PAIN (Persistent pain for more than 6 weeks) outcome was unknown.        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: Pulmonary pain
Clinical narrative: pain around lung on the left side; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (pain around lung on the left side) 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, the patient experienced PULMONARY PAIN (pain around lung on the left side). At the time of the report, PULMONARY PAIN (pain around lung on the left side) outcome was unknown. Not Provided          No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. The patient experienced pain around their lung on the left side after receiving the second dose of the Moderna COVID-19 vaccine. The patient especially noticed the lung pain when they try to lie or sit down with their back pressed against anything.   Very limited information regarding this events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Heart rate, Nocturnal dyspnoea, Rash, Sleep disorder
Clinical narrative: Eruption on the right side of the face; Difficulty breathing at night - trouble breathing; standing up she feels dizzy; waking up at night because she has trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Eruption on the right side of the face), NOCTURNAL DYSPNOEA (Difficulty breathing at night - trouble breathing), DIZZINESS POSTURAL (standing up she feels dizzy) and SLEEP DISORDER (waking up at night because she has trouble breathing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 025C21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-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 RASH (Eruption on the right side of the face), NOCTURNAL DYSPNOEA (Difficulty breathing at night - trouble breathing), DIZZINESS POSTURAL (standing up she feels dizzy) and SLEEP DISORDER (waking up at night because she has trouble breathing). At the time of the report, RASH (Eruption on the right side of the face), NOCTURNAL DYSPNOEA (Difficulty breathing at night - trouble breathing), DIZZINESS POSTURAL (standing up she feels dizzy) and SLEEP DISORDER (waking up at night because she has trouble breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Increased.          Treatment information were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not get the second dose after four months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not get the second dose after four months) 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 12-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 PRODUCT DOSE OMISSION ISSUE (did not get the second dose after four months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not get the second dose after four months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported. No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: stiff neck; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PYREXIA (fever). On 18-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-May-2021, MUSCULOSKELETAL STIFFNESS (stiff neck) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the injection arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM OXIDE, COLECALCIFEROL (VIT D [COLECALCIFEROL]), LEVOTHYROXINE and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the injection arm). On 21-Mar-2021, PAIN IN EXTREMITY (Soreness in the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient didn't take any medications to treat the symptoms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Extended length of time after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extended length of time after the 1st dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended length of time after the 1st dose). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Extended length of time after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, SARS-CoV-2 test: positive (Positive) positive. On 11-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. No treatment medication reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up updated on 21-JUN-2021: contain primary reporter details, patient demographic,  Lab report  updated for COVID-19 test
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Oropharyngeal pain
Clinical narrative: Sore throat; Starting to lose voice; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and DYSPHONIA (Starting to lose voice) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and DYSPHONIA (Starting to lose voice). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and DYSPHONIA (Starting to lose voice) 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 reported
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pyrexia, Thinking abnormal
Clinical narrative: felt like he had the flu; not thinking straight; fever; headache; chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), VACCINATION SITE PAIN (soreness at the injection site), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TESTOSTERONE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 11-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 500 mg. At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), VACCINATION SITE PAIN (soreness at the injection site), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-228293, MOD-2021-228278 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt like he had the flu; not thinking straight; fever; headache; chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), VACCINATION SITE PAIN (soreness at the injection site), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TESTOSTERONE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 11-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 500 mg. At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), VACCINATION SITE PAIN (soreness at the injection site), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-228293, MOD-2021-228278 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Hyperhidrosis, Tremor, Vaccination complication
Clinical narrative: in the evening he was freezing to death; started shaking so hard, almost uncontrollably; Sweating; Had issues after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine) in an 82-year-old male 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 LISINOPRIL for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine). At the time of the report, FEELING COLD (in the evening he was freezing to death), TREMOR (started shaking so hard, almost uncontrollably), HYPERHIDROSIS (Sweating) and VACCINATION COMPLICATION (Had issues after receiving the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) 101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported. Treatment medications was not reported.  Patient stated he Had issues after receiving the vaccine   This case was linked to MOD-2021-229842 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant Follow-up received on 28-Jul-2021, added Date of Birth, contact information and event
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Explosive diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhoea) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM OXIDE, VITAMIN D NOS, LEVOTHYROXINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced DIARRHOEA (Explosive diarrhoea). At the time of the report, DIARRHOEA (Explosive diarrhoea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: fever; stiff neck; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), the first episode of PYREXIA (fever) and the second episode of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Jun-2021, the patient experienced the first episode of PYREXIA (fever). On 15-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck). On 20-Jun-2021, the patient experienced the second episode of PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Stiff neck, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Fever and Stiff neck, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved and last episode of PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-229873 (Patient Link).