chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hurt in her arm after the second shot of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt in her arm after the second shot of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PAIN IN EXTREMITY (Hurt in her arm after the second shot of vaccine). At the time of the report, PAIN IN EXTREMITY (Hurt in her arm after the second shot of vaccine) outcome was unknown.            Concomitant medications were not reported. No treatment details were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling
Clinical narrative: Swollen arm; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Severe headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 003CB1A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Severe headache). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Severe headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history reported No concomitant medication provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered first dose from vial punctured over 24 hours before; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered first dose from vial punctured over 24 hours before) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered first dose from vial punctured over 24 hours before). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered first dose from vial punctured over 24 hours before) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Treatment information was not reported.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myalgia, Peripheral swelling
Clinical narrative: A pain in the center of their chest/ The pain appears to only occur with certain movements; Swollen arm; Full body soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (A pain in the center of their chest/ The pain appears to only occur with certain movements), PERIPHERAL SWELLING (Swollen arm) and MYALGIA (Full body soreness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced CHEST PAIN (A pain in the center of their chest/ The pain appears to only occur with certain movements), PERIPHERAL SWELLING (Swollen arm) and MYALGIA (Full body soreness). At the time of the report, CHEST PAIN (A pain in the center of their chest/ The pain appears to only occur with certain movements), PERIPHERAL SWELLING (Swollen arm) and MYALGIA (Full body soreness) had not resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.  The patient was not sure if the chest pain is muscle related or possible inflammation of the heart.   This case was linked to MOD-2021-225765 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Pain after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain after first shot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain after first shot). At the time of the report, PAIN IN EXTREMITY (Arm Pain after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: Right Shoulder Bursitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Right Shoulder Bursitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURSITIS (Right Shoulder Bursitis). At the time of the report, BURSITIS (Right Shoulder Bursitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: very bad sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (very bad sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (very bad sore throat). At the time of the report, OROPHARYNGEAL PAIN (very bad sore throat) outcome was unknown.            Patient had a very bad sore throat 24 hours after my 2nd vaccine. No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second Dose (Beyond Day42); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second Dose (Beyond Day42)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second Dose (Beyond Day42)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second Dose (Beyond Day42)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No Treatment information was provided.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Pfizer vaccine second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine second dose) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine second dose). On 03-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer vaccine second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter  No Treatment was provided by the reporter.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late getting 2nd Moderna vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late getting 2nd Moderna vaccine) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 15-May-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 15-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late getting 2nd Moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late getting 2nd Moderna vaccine) outcome was unknown.            No treatment medication were provided. no concomitant was provided
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: 2 rashes like pimples at the exact site of first and second vaccine shot; redness at site of vaccine shot; Hurting at the site of vaccine shot; fever after second shot; magnets gets stock on only one of her arms and at the site of the vaccine.; Arm Pain after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (magnets gets stock on only one of her arms and at the site of the vaccine.), PAIN IN EXTREMITY (Arm Pain after second shot), VACCINATION SITE RASH (2 rashes like pimples at the exact site of first and second vaccine shot), VACCINATION SITE ERYTHEMA (redness at site of vaccine shot) and VACCINATION SITE PAIN (Hurting at the site of vaccine shot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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 PAIN IN EXTREMITY (Arm Pain after second shot). On an unknown date, the patient experienced VACCINATION SITE REACTION (magnets gets stock on only one of her arms and at the site of the vaccine.), VACCINATION SITE RASH (2 rashes like pimples at the exact site of first and second vaccine shot), VACCINATION SITE ERYTHEMA (redness at site of vaccine shot), VACCINATION SITE PAIN (Hurting at the site of vaccine shot) and PYREXIA (fever after second shot). At the time of the report, VACCINATION SITE REACTION (magnets gets stock on only one of her arms and at the site of the vaccine.), PAIN IN EXTREMITY (Arm Pain after second shot), VACCINATION SITE RASH (2 rashes like pimples at the exact site of first and second vaccine shot), VACCINATION SITE ERYTHEMA (redness at site of vaccine shot), VACCINATION SITE PAIN (Hurting at the site of vaccine shot) and PYREXIA (fever after second shot) had resolved.            Concomitant medication and treatment information were not reported.  The patient stated that she was ok after the reaction. However had some reactions which looked like pimples mosquitoes bites, which hurts for a week or so and then was gone. But there were not either a pimple or a mosquitoes bite.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-236783 (E2B Linked Report). This case was linked to MOD-2021-225807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant Follow up added: Updated Outcome and Narrative.; Sender's Comments:  MODERNATX, INC.-MOD-2021-236783:Same reporter
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: 2 rashes like pimples at the exact site of first and second vaccine shot; redness at site of vaccine shot; Hurting at the site of vaccine shot; fever after second shot; magnets gets stock on only one of her arms and at the site of the vaccine.; Arm Pain after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (magnets gets stock on only one of her arms and at the site of the vaccine.), PAIN IN EXTREMITY (Arm Pain after second shot), VACCINATION SITE RASH (2 rashes like pimples at the exact site of first and second vaccine shot), VACCINATION SITE ERYTHEMA (redness at site of vaccine shot) and VACCINATION SITE PAIN (Hurting at the site of vaccine shot) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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 PAIN IN EXTREMITY (Arm Pain after second shot). On an unknown date, the patient experienced VACCINATION SITE REACTION (magnets gets stock on only one of her arms and at the site of the vaccine.), VACCINATION SITE RASH (2 rashes like pimples at the exact site of first and second vaccine shot), VACCINATION SITE ERYTHEMA (redness at site of vaccine shot), VACCINATION SITE PAIN (Hurting at the site of vaccine shot) and PYREXIA (fever after second shot). At the time of the report, VACCINATION SITE REACTION (magnets gets stock on only one of her arms and at the site of the vaccine.), PAIN IN EXTREMITY (Arm Pain after second shot), VACCINATION SITE RASH (2 rashes like pimples at the exact site of first and second vaccine shot), VACCINATION SITE ERYTHEMA (redness at site of vaccine shot), VACCINATION SITE PAIN (Hurting at the site of vaccine shot) and PYREXIA (fever after second shot) had resolved.            Concomitant medication and treatment information were not reported.  The patient stated that she was ok after the reaction. However had some reactions which looked like pimples mosquitoes bites, which hurts for a week or so and then was gone. But there were not either a pimple or a mosquitoes bite.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-236783 (E2B Linked Report). This case was linked to MOD-2021-225807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant Follow up added: Updated Outcome and Narrative.; Sender's Comments:  MODERNATX, INC.-MOD-2021-236783:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received first dose in 20Jan2021/not received the second dose yet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose in 20Jan2021/not received the second dose yet) 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 20-Jan-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 (received first dose in 20Jan2021/not received the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose in 20Jan2021/not received the second dose yet) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: I've experienced PHN from shingles for two years and have been dealing with it. Now,after myvaccine it seems to have gotten a lot worse; After my second dose of Covid vaccine, the pain seemed to get worse.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (I've experienced PHN from shingles for two years and have been dealing with it. Now,after myvaccine it seems to have gotten a lot worse) and PAIN (After my second dose of Covid vaccine, the pain seemed to get worse.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0468B1A and 007821A) for COVID-19 vaccination.     Concurrent medical conditions included Herpes zoster infection neurological (Nerve pain seems to have increased after 2nd Covid vaccine  Patient experienced Post herpatic neuralgia from shingles for two years and have been dealing with it.) since March 2019, Hypertension, Kidney dysfunction, Coronary artery disorder and Carotid artery stenosis (Bilateral). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, METOPROLOL TARTRATE (LOPRESSOR), AMLODIPINE BESILATE (NORVASC), CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ECOTRIN), VITAMIN D3, VACCINIUM MACROCARPON (CRANBERRY EXTRACT [VACCINIUM MACROCARPON]) and FISH OIL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (I've experienced PHN from shingles for two years and have been dealing with it. Now,after myvaccine it seems to have gotten a lot worse) and PAIN (After my second dose of Covid vaccine, the pain seemed to get worse.). At the time of the report, HERPES ZOSTER (I've experienced PHN from shingles for two years and have been dealing with it. Now,after myvaccine it seems to have gotten a lot worse) and PAIN (After my second dose of Covid vaccine, the pain seemed to get worse.) had not resolved.            No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Medical history updated; Concomitant medications added; Events outcome updated and new event added.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ganglion cyst (about 3/4 of an inch in size, on her wrist, for over a year).   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (it's really strange this cyst mysteriously goes away AFTER getting the second vaccine.) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient additionally reported that as expected, Friday (6/4) was a rough day.  Concomitant medications were not provided.  No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Product dose omission issue
Clinical narrative: Did not receive second dose of Moderna COVID-19 vaccine; Slight mini headache; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine) and HEADACHE (Slight mini headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced HEADACHE (Slight mini headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine) and HEADACHE (Slight mini headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other relevant concomitant medications included, multivitamins were reported.   Treatment information was not provided.    Reporter did not allow further contact
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). On 09-Jun-2021, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up information received on 02-Aug-2021 and included patient details (Initial, age, gender, weight, height, race, ethnicity), medical history and first dose details was added. On 14-Aug-2021: Source document contains NNI.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Magnet gets stock at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Magnet gets stock at the vaccination site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LIMB DISCOMFORT (Magnet gets stock at the vaccination site). At the time of the report, LIMB DISCOMFORT (Magnet gets stock at the vaccination site) had resolved.            No treatment medication were provided. No concomitant medication information was provided.   This case was linked to MOD-2021-236783 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains non-significant information On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains non-significant information
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: i am having all kinds of pain in my body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (i am having all kinds of pain in my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (i am having all kinds of pain in my body). At the time of the report, PAIN (i am having all kinds of pain in my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Feels like there is something in it; Arm getting sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like there is something in it) and PAIN IN EXTREMITY (Arm getting sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feels like there is something in it) and PAIN IN EXTREMITY (Arm getting sore). At the time of the report, FEELING ABNORMAL (Feels like there is something in it) and PAIN IN EXTREMITY (Arm getting sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Was sick for 2 days and then it disappeared; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick for 2 days and then it disappeared) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B211A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EZETIMIBE (ZETIA) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick for 2 days and then it disappeared). At the time of the report, ILLNESS (Was sick for 2 days and then it disappeared) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-225993.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient said yes when asked if he had side effects but did not provide further information.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient said yes when asked if he had side effects but did not provide further information.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient said yes when asked if he had side effects but did not provide further information.). At the time of the report, VACCINATION COMPLICATION (Patient said yes when asked if he had side effects but did not provide further information.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications and treatment details reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Cough, Feeling abnormal, Illness
Clinical narrative: having all kinds of bone aches in his calf, elbow, back, neck,; when he coughs, his butt hurts; was sick for 2 days and then it disappeared; does not feel right; losing strength/he lifts the same weight for the past 10 years, but now he cannot; concerned he is not getting any better; butt hurts; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), ILLNESS (was sick for 2 days and then it disappeared), FEELING ABNORMAL (does not feel right) and ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041CZ1A and 048B211A) 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 EZETIMIBE (ZETIA) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), ILLNESS (was sick for 2 days and then it disappeared), FEELING ABNORMAL (does not feel right), ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot), MALAISE (concerned he is not getting any better) and MUSCULOSKELETAL PAIN (butt hurts). At the time of the report, ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), FEELING ABNORMAL (does not feel right), ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot), MALAISE (concerned he is not getting any better) and MUSCULOSKELETAL PAIN (butt hurts) outcome was unknown and ILLNESS (was sick for 2 days and then it disappeared) had resolved.            Patient stated that he does not had any health conditions and he doesn't smoke, drink, or do drugs.  No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal pain
Clinical narrative: having all kinds of bone aches in his calf, elbow, back, neck,; when he coughs, his butt hurts; was sick for 2 days and then it disappeared; does not feel right; losing strength/he lifts the same weight for the past 10 years, but now he cannot; concerned he is not getting any better; butt hurts; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), ILLNESS (was sick for 2 days and then it disappeared), FEELING ABNORMAL (does not feel right) and ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041CZ1A and 048B211A) 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 EZETIMIBE (ZETIA) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), ILLNESS (was sick for 2 days and then it disappeared), FEELING ABNORMAL (does not feel right), ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot), MALAISE (concerned he is not getting any better) and MUSCULOSKELETAL PAIN (butt hurts). At the time of the report, ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), FEELING ABNORMAL (does not feel right), ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot), MALAISE (concerned he is not getting any better) and MUSCULOSKELETAL PAIN (butt hurts) outcome was unknown and ILLNESS (was sick for 2 days and then it disappeared) had resolved.            Patient stated that he does not had any health conditions and he doesn't smoke, drink, or do drugs.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever of 101; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101) and HEADACHE (really bad 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 101) and HEADACHE (really bad headache). At the time of the report, PYREXIA (fever of 101) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: Hives; Itching; Rash; Soreness in arm after first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm after first dose), URTICARIA (Hives), PRURITUS (Itching) and RASH (Rash) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Leg pain and Blood pressure high. Concomitant products included BENAZEPRIL for Blood pressure high, GLICLAZIDE and INSULIN for Diabetes, GABAPENTIN for Leg pain, ALLOPURINOL for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm after first dose). On 15-Apr-2021, the patient experienced URTICARIA (Hives), PRURITUS (Itching) and RASH (Rash). The patient was treated with HYDROXYZINE ongoing since an unknown date for Rash and Itching, at an unspecified dose and frequency. On 17-Apr-2021, PAIN IN EXTREMITY (Soreness in arm after first dose) had resolved. At the time of the report, URTICARIA (Hives), PRURITUS (Itching) and RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications included taking steroid tablets for the rash and itching.   This case was linked to MOD-2021-226049 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Muscle spasms, Pain, Paraesthesia
Clinical narrative: Very sick for a month; Thumb, index and middle finger on right hand are numb and tingling; Regularly in the morning, right hand cramps; tingling in fingers; Excruciating Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating Pain), ILLNESS (Very sick for a month), HYPOAESTHESIA (Thumb, index and middle finger on right hand are numb and tingling), MUSCLE SPASMS (Regularly in the morning, right hand cramps) and PARAESTHESIA (tingling in fingers) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PAIN (Excruciating Pain). On an unknown date, the patient experienced ILLNESS (Very sick for a month), HYPOAESTHESIA (Thumb, index and middle finger on right hand are numb and tingling), MUSCLE SPASMS (Regularly in the morning, right hand cramps) and PARAESTHESIA (tingling in fingers). At the time of the report, PAIN (Excruciating Pain), ILLNESS (Very sick for a month), HYPOAESTHESIA (Thumb, index and middle finger on right hand are numb and tingling), MUSCLE SPASMS (Regularly in the morning, right hand cramps) and PARAESTHESIA (tingling in fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Pain killers and other unspecified medications. Patient has visited emergency room thrice, and he was kept there for hours. No concomitant drugs were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen; Arm hurts; Face red; Fever; Body aches; Tired after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever) and MYALGIA (Body aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Tired after the first dose). At the time of the report, PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Tired after the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was not provided.     This case was linked to MOD-2021-226244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document was received on 17 JUN 2021 and had significant information. Added patient demographics, concomitant medication, Batch number , event body ache.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm swollen; Arm hurts; Face red; Fever; Body aches; Tired after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever) and MYALGIA (Body aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Tired after the first dose). At the time of the report, PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm hurts), ERYTHEMA (Face red), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Tired after the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was not provided.     This case was linked to MOD-2021-226244 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document was received on 17 JUN 2021 and had significant information. Added patient demographics, concomitant medication, Batch number , event body ache.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Pain in extremity, Urticaria
Clinical narrative: It looked like bug bite, look like warts, allergic to vaccine; Welts comes and goes / welts turn into sores; Soreness in arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm after second dose), ALLERGY TO VACCINE (It looked like bug bite, look like warts, allergic to vaccine) and URTICARIA (Welts comes and goes / welts turn into sores) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Leukemia and Kidney absent (1 kidney). Concomitant products included BENAZEPRIL for Blood pressure high, GLICLAZIDE and INSULIN for Diabetes, GABAPENTIN for Pains in legs, ALLOPURINOL for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm after second dose). On an unknown date, the patient experienced ALLERGY TO VACCINE (It looked like bug bite, look like warts, allergic to vaccine) and URTICARIA (Welts comes and goes / welts turn into sores). On 15-May-2021, PAIN IN EXTREMITY (Soreness in arm after second dose) had resolved. At the time of the report, ALLERGY TO VACCINE (It looked like bug bite, look like warts, allergic to vaccine) and URTICARIA (Welts comes and goes / welts turn into sores) outcome was unknown.            Treatment information included steroid tablets.   This case was linked to MOD-2021-226027 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received and added Reporter details (mail address), medical history and added additional events (It looked like bug bite, look like warts, allergic to vaccine and Welts comes and goes/ welts turn into sores) were provided.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced TINNITUS (Ringing in the ears). At the time of the report, TINNITUS (Ringing in the ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heavy menstrual bleeding, Herpes zoster, Palpitations
Clinical narrative: shingles came back; non-stop heavy bleeding since 13 days; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (non-stop heavy bleeding since 13 days), HERPES ZOSTER (shingles came back) and PALPITATIONS (Palpitations) 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 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PALPITATIONS (Palpitations). On 05-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (non-stop heavy bleeding since 13 days). On 13-Jun-2021, the patient experienced HERPES ZOSTER (shingles came back). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 1 dosage form. At the time of the report, HEAVY MENSTRUAL BLEEDING (non-stop heavy bleeding since 13 days), HERPES ZOSTER (shingles came back) and PALPITATIONS (Palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Heart rate increased: abnormal (abnormal) Fast Heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.