chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: a lot of headache; tired; wanted to throw up; dizzy; cold; neck pains; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a lot of headache), FATIGUE (tired), NAUSEA (wanted to throw up), DIZZINESS (dizzy) and NASOPHARYNGITIS (cold) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0231A904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (a lot of headache), FATIGUE (tired), NAUSEA (wanted to throw up), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and NECK PAIN (neck pains). On 24-Mar-2021, DIZZINESS (dizzy) had resolved. At the time of the report, HEADACHE (a lot of headache), FATIGUE (tired), NAUSEA (wanted to throw up), NASOPHARYNGITIS (cold) and NECK PAIN (neck pains) 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.   No concomitant products reported  No treatment products reported
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling; itching; feverish around and below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (feverish around and below the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ALBUTEROL SULFATE, ESTRADIOL, GLIPIZIDE, OMEPRAZOLE, DICLOFENAC, CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN AND CODEINE), IBUPROFEN and OTHER VITAMIN PRODUCTS, COMBINATIONS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (feverish around and below the injection site). The patient was treated with ALLERGY MEDICATION (topical) for Swelling, Itching and Vaccination site warmth, at a dose of cream and IBUPROFEN for Swelling, Itching and Vaccination site warmth, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (feverish around and below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Consent for safety to follow-up was received.   Patient wants to know if itching is a side effect of the vaccine and if she should receive the second dose of the vaccine.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (mild rash) in a 78-year-old male patient 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced RASH (mild rash). At the time of the report, RASH (mild rash) outcome was unknown.            No concomitant products reported  No treatment products reported   This case was linked to MOD-2021-058113 (Patient Link).   This case was linked to MOD-2021-058113 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: felt like someone punched me in the arm/ arm pain; sweaty; mild fever feeling; tired-fatigue; soreness in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm), HYPERHIDROSIS (sweaty), PYREXIA (mild fever feeling), FATIGUE (tired-fatigue) and MYALGIA (felt like someone punched me in the arm/ arm pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm) and FATIGUE (tired-fatigue). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (sweaty) and PYREXIA (mild fever feeling). On an unknown date, the patient experienced MYALGIA (felt like someone punched me in the arm/ arm pain). On 27-Mar-2021, PAIN IN EXTREMITY (soreness in her left arm), HYPERHIDROSIS (sweaty) and PYREXIA (mild fever feeling) had resolved. At the time of the report, FATIGUE (tired-fatigue) and MYALGIA (felt like someone punched me in the arm/ arm pain) outcome was unknown. Not Provided      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 reported   This case was linked to MOD-2021-244615 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received and  contains no new information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Eleven days after receiving the vaccine,12mar2021rash on both sides of her body; rash would start out as a red and itchy and then fade to a slight pinkish color; rash would start out as a red and itchy and then fade to a slight pinkish color and would go away; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Eleven days after receiving the vaccine,12mar2021rash on both sides of her body), RASH ERYTHEMATOUS (rash would start out as a red and itchy and then fade to a slight pinkish color) and RASH PRURITIC (rash would start out as a red and itchy and then fade to a slight pinkish color and would go away) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Eleven days after receiving the vaccine,12mar2021rash on both sides of her body), RASH ERYTHEMATOUS (rash would start out as a red and itchy and then fade to a slight pinkish color) and RASH PRURITIC (rash would start out as a red and itchy and then fade to a slight pinkish color and would go away). On 25-Mar-2021, RASH (Eleven days after receiving the vaccine,12mar2021rash on both sides of her body), RASH ERYTHEMATOUS (rash would start out as a red and itchy and then fade to a slight pinkish color) and RASH PRURITIC (rash would start out as a red and itchy and then fade to a slight pinkish color and would go away) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products reported  No treatment products reported
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Very bad rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Very bad rash all over body) in a 78-year-old male patient 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Very bad rash all over body). At the time of the report, RASH (Very bad rash all over body) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-058107 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: NNI. Non significant follow up added
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 04-Mar-2021, the patient received first 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 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling arm). On 06-Mar-2021, PERIPHERAL SWELLING (swelling arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant products reported  No concomitant products reported
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Headache, Injection site erythema, Lymph node pain
Clinical narrative: head hurts; could not raise it; sore to touch; back was hurting; neck and head hurts; still a dark shade of red; was really sore in the lymph nodes on the left side; has a knot at the injection site; legs were weak; it is red; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head hurts), INJECTION SITE ERYTHEMA (it is red), PAIN IN EXTREMITY (arm was sore), MOVEMENT DISORDER (could not raise it) and VACCINATION SITE MASS (has a knot at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoporosis and Spinal disorder. Concomitant products included LISINOPRIL, DESLORATADINE (CLARINEX [DESLORATADINE]), PROBIOTICS NOS, VITAMINS NOS and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 20-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (it is red), VACCINATION SITE MASS (has a knot at the injection site), ASTHENIA (legs were weak) and LYMPH NODE PAIN (was really sore in the lymph nodes on the left side). On 12-Apr-2021, the patient experienced MACULE (still a dark shade of red). On an unknown date, the patient experienced HEADACHE (head hurts), MOVEMENT DISORDER (could not raise it), PAIN (sore to touch), BACK PAIN (back was hurting) and NECK PAIN (neck and head hurts). The patient was treated with AMOXICILLIN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ALCOHOL for Cooling therapy, at an unspecified dose and frequency. At the time of the report, HEADACHE (head hurts), INJECTION SITE ERYTHEMA (it is red), PAIN IN EXTREMITY (arm was sore), MOVEMENT DISORDER (could not raise it), VACCINATION SITE MASS (has a knot at the injection site), ASTHENIA (legs were weak), PAIN (sore to touch), BACK PAIN (back was hurting), NECK PAIN (neck and head hurts), LYMPH NODE PAIN (was really sore in the lymph nodes on the left side) and MACULE (still a dark shade of red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional treatment includes: cold compresses  Patient reports that second dose will be 13-April-2021   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Added events(follow-up note) and event assessment, changed action items for the same.Added dates from the follow-up document for initial events.Added medication in i-narrative supplement.
Sex: F
Vaccine: COVID19
Symptoms: Macule, Movement disorder, Neck pain, Pain, Pain in extremity
Clinical narrative: head hurts; could not raise it; sore to touch; back was hurting; neck and head hurts; still a dark shade of red; was really sore in the lymph nodes on the left side; has a knot at the injection site; legs were weak; it is red; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head hurts), INJECTION SITE ERYTHEMA (it is red), PAIN IN EXTREMITY (arm was sore), MOVEMENT DISORDER (could not raise it) and VACCINATION SITE MASS (has a knot at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoporosis and Spinal disorder. Concomitant products included LISINOPRIL, DESLORATADINE (CLARINEX [DESLORATADINE]), PROBIOTICS NOS, VITAMINS NOS and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 20-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (it is red), VACCINATION SITE MASS (has a knot at the injection site), ASTHENIA (legs were weak) and LYMPH NODE PAIN (was really sore in the lymph nodes on the left side). On 12-Apr-2021, the patient experienced MACULE (still a dark shade of red). On an unknown date, the patient experienced HEADACHE (head hurts), MOVEMENT DISORDER (could not raise it), PAIN (sore to touch), BACK PAIN (back was hurting) and NECK PAIN (neck and head hurts). The patient was treated with AMOXICILLIN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ALCOHOL for Cooling therapy, at an unspecified dose and frequency. At the time of the report, HEADACHE (head hurts), INJECTION SITE ERYTHEMA (it is red), PAIN IN EXTREMITY (arm was sore), MOVEMENT DISORDER (could not raise it), VACCINATION SITE MASS (has a knot at the injection site), ASTHENIA (legs were weak), PAIN (sore to touch), BACK PAIN (back was hurting), NECK PAIN (neck and head hurts), LYMPH NODE PAIN (was really sore in the lymph nodes on the left side) and MACULE (still a dark shade of red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional treatment includes: cold compresses  Patient reports that second dose will be 13-April-2021   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Added events(follow-up note) and event assessment, changed action items for the same.Added dates from the follow-up document for initial events.Added medication in i-narrative supplement.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: head hurts; could not raise it; sore to touch; back was hurting; neck and head hurts; still a dark shade of red; was really sore in the lymph nodes on the left side; has a knot at the injection site; legs were weak; it is red; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head hurts), INJECTION SITE ERYTHEMA (it is red), PAIN IN EXTREMITY (arm was sore), MOVEMENT DISORDER (could not raise it) and VACCINATION SITE MASS (has a knot at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoporosis and Spinal disorder. Concomitant products included LISINOPRIL, DESLORATADINE (CLARINEX [DESLORATADINE]), PROBIOTICS NOS, VITAMINS NOS and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 20-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (it is red), VACCINATION SITE MASS (has a knot at the injection site), ASTHENIA (legs were weak) and LYMPH NODE PAIN (was really sore in the lymph nodes on the left side). On 12-Apr-2021, the patient experienced MACULE (still a dark shade of red). On an unknown date, the patient experienced HEADACHE (head hurts), MOVEMENT DISORDER (could not raise it), PAIN (sore to touch), BACK PAIN (back was hurting) and NECK PAIN (neck and head hurts). The patient was treated with AMOXICILLIN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ALCOHOL for Cooling therapy, at an unspecified dose and frequency. At the time of the report, HEADACHE (head hurts), INJECTION SITE ERYTHEMA (it is red), PAIN IN EXTREMITY (arm was sore), MOVEMENT DISORDER (could not raise it), VACCINATION SITE MASS (has a knot at the injection site), ASTHENIA (legs were weak), PAIN (sore to touch), BACK PAIN (back was hurting), NECK PAIN (neck and head hurts), LYMPH NODE PAIN (was really sore in the lymph nodes on the left side) and MACULE (still a dark shade of red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional treatment includes: cold compresses  Patient reports that second dose will be 13-April-2021   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Added events(follow-up note) and event assessment, changed action items for the same.Added dates from the follow-up document for initial events.Added medication in i-narrative supplement.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Memory impairment
Clinical narrative: chills; fatigue; headache; nausea; memory brain fuzzy; appetite loss; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and MEMORY IMPAIRMENT (memory brain fuzzy) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-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 CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea), MEMORY IMPAIRMENT (memory brain fuzzy) and DECREASED APPETITE (appetite loss). At the time of the report, CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea), MEMORY IMPAIRMENT (memory brain fuzzy) and DECREASED APPETITE (appetite loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product reported, but unknown: t zone twice daily, pill  No treatment products reported
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: chills; fatigue; headache; nausea; memory brain fuzzy; appetite loss; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea) and MEMORY IMPAIRMENT (memory brain fuzzy) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-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 CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea), MEMORY IMPAIRMENT (memory brain fuzzy) and DECREASED APPETITE (appetite loss). At the time of the report, CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), NAUSEA (nausea), MEMORY IMPAIRMENT (memory brain fuzzy) and DECREASED APPETITE (appetite loss) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product reported, but unknown: t zone twice daily, pill  No treatment products reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm at injection site; Itching at injection site; Red at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history information reported.   Concomitant products included CALCIUM, MULTIVITAMIN [VITAMINS NOS] and ANTIDEPRESSANTS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itching at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: mild chills; FEVER; lethargy; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (mild chills), PYREXIA (FEVER) and LETHARGY (lethargy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026A21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (mild chills), PYREXIA (FEVER) and LETHARGY (lethargy). At the time of the report, CHILLS (mild chills), PYREXIA (FEVER) and LETHARGY (lethargy) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A (not clear)) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported. Patient stated he could not take the second dose as he lost his job.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given subcutaneously; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given subcutaneously) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 23-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given subcutaneously). On 23-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       Concomitant medications were not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-JUN-2021 included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: I know a lot of people got symptoms after the second dose.; This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (I know a lot of people got symptoms after the second 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (I know a lot of people got symptoms after the second dose.). At the time of the report, ADVERSE EVENT (I know a lot of people got symptoms after the second dose.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Pyrexia
Clinical narrative: bad headache; fever (100F); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and PYREXIA (fever (100F)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (bad headache) and PYREXIA (fever (100F)). At the time of the report, HEADACHE (bad headache) and PYREXIA (fever (100F)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 99/76 mmHg Low. On 25-Mar-2021, Pyrexia: (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment medication was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and PYREXIA (fever (100F)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (bad headache) and PYREXIA (fever (100F)). At the time of the report, HEADACHE (bad headache) and PYREXIA (fever (100F)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 99/76 mmHg Low. On 25-Mar-2021, Pyrexia: (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment medication was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced RASH (rash on her neck). At the time of the report, RASH (rash on her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient reported that she did not use any medication as treatment.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome since an unknown date.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-030578 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome since an unknown date.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itchiness). At the time of the report, PRURITUS (itchiness) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    This case was linked to MOD-2021-030578 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: Sore throat; Flu-like symptoms; Headache; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, 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), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment details was provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed a skin rash on pubic area, belly, wait, around arm pits and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed a skin rash on pubic area, belly, wait, around arm pits and back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Developed a skin rash on pubic area, belly, wait, around arm pits and back). At the time of the report, RASH (Developed a skin rash on pubic area, belly, wait, around arm pits and back) 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. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed a skin rash on pubic area, belly, wait, around arm pits and back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Developed a skin rash on pubic area, belly, wait, around arm pits and back). At the time of the report, RASH (Developed a skin rash on pubic area, belly, wait, around arm pits and back) 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: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever of 101) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease since an unknown date.   On 23-Mar-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 an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever of 101). At the time of the report, CHILLS (chills) and PYREXIA (fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 High.         No relevant concomitant medications were reported  No treatment information was provided This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever of 101) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease since an unknown date.   On 23-Mar-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 an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever of 101). At the time of the report, CHILLS (chills) and PYREXIA (fever of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101 High.         No relevant concomitant medications were reported  No treatment information was provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: not going to get her second dose; Her mind is not quite the same, she is not as sharp as she was after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not going to get her second dose) and VACCINATION COMPLICATION (Her mind is not quite the same, she is not as sharp as she was after first dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Surgery (Recovering from Back Surgery.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not going to get her second dose) and VACCINATION COMPLICATION (Her mind is not quite the same, she is not as sharp as she was after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not going to get her second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Accident, Inappropriate schedule of product administration
Clinical narrative: second dose scheduled beyond 37 days; accident; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled beyond 37 days) and ACCIDENT (accident) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled beyond 37 days) and ACCIDENT (accident). The patient was treated with TETANUS VACCINE (intramuscular) for Accident, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled beyond 37 days) and ACCIDENT (accident) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator.  Treatment information for accident provided.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with the associated AE of accident.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: Big lump on right side of neck; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 20-Mar-2021, the patient experienced SWELLING (Big lump on right side of neck). The patient was treated with NAPROXEN SODIUM (ALEVE) on 19-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 20-Mar-2021, the patient experienced SWELLING (Big lump on right side of neck). The patient was treated with NAPROXEN SODIUM (ALEVE) on 19-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: very frequent urination; This spontaneous case was reported by a patient and describes the occurrence of POLLAKIURIA (very frequent urination) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (very frequent urination). At the time of the report, POLLAKIURIA (very frequent urination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: Dizziness; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). At the time of the report, DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided by the reporter.  Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea). At the time of the report, DIZZINESS (Dizziness) and DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Paraesthesia
Clinical narrative: Very intense flu like symptoms; Severe Joint Pain; Neurological tingling and buzzing in feet and toes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very intense flu like symptoms), ARTHRALGIA (Severe Joint Pain) and PARAESTHESIA (Neurological tingling and buzzing in feet and toes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AZILSARTAN KAMEDOXOMIL (EDARBI) and CHLORTHALIDONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Very intense flu like symptoms), ARTHRALGIA (Severe Joint Pain) and PARAESTHESIA (Neurological tingling and buzzing in feet and toes). On 14-Mar-2021, INFLUENZA LIKE ILLNESS (Very intense flu like symptoms), ARTHRALGIA (Severe Joint Pain) and PARAESTHESIA (Neurological tingling and buzzing in feet and toes) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD21-053474 (Patient Link).