chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose within 26 days of first dose/second dose given at day 24; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 26 days of first dose/second dose given at day 24) 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 07-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 26 days of first dose/second dose given at day 24). On 31-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 26 days of first dose/second dose given at day 24) had resolved.            No concomitant medications was provided. No treatment medications was provided.  Patient had taken second dose within 26 days of first dose, second dose given at day 24.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received the booster dose from a vial that expired because it was kept in the refrigerator too long; received the booster dose from a vial that expired because it was kept in the refrigerator too long; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the booster dose from a vial that expired because it was kept in the refrigerator too long) and PRODUCT STORAGE ERROR (received the booster dose from a vial that expired because it was kept in the refrigerator too long) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the booster dose from a vial that expired because it was kept in the refrigerator too long) and PRODUCT STORAGE ERROR (received the booster dose from a vial that expired because it was kept in the refrigerator too long). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received the booster dose from a vial that expired because it was kept in the refrigerator too long) and PRODUCT STORAGE ERROR (received the booster dose from a vial that expired because it was kept in the refrigerator too long) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.  Patient received 3 doses of moderna and was contacted 24 DEC 2021 by the vaccination site where she received her booster dose and was told she received the booster dose from a vial that expired because it was kept in the refrigerator too long. She received the booster dose on 26 OCT 2021. She had not been told if the booster dose was viable or not only that it was expired.
Sex: U
Vaccine: COVID19
Symptoms: Plantar fasciitis
Clinical narrative: giving shot tomorrow for Plantar fasciitis; This spontaneous case was reported by a consumer and describes the occurrence of PLANTAR FASCIITIS (giving shot tomorrow for Plantar fasciitis) 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 Arthritis.    On 18-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 PLANTAR FASCIITIS (giving shot tomorrow for Plantar fasciitis). At the time of the report, PLANTAR FASCIITIS (giving shot tomorrow for Plantar fasciitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that the next dose was not scheduled yet but they said within 3 weeks. Patient had an appointment with foot doctor because patient had arthritis. Doctor would be giving shot tomorrow for Plantar fasciitis and would be giving pain medicine. Patient wanted to know that If patient take shot, would that interfere.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: horrible cough; sore throat; sore arm; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (horrible cough), OROPHARYNGEAL PAIN (sore throat), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 24-Dec-2021, the patient experienced COUGH (horrible cough) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, COUGH (horrible cough) and OROPHARYNGEAL PAIN (sore throat) had not resolved and PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) was resolving.        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 medications were reported.   This case was linked to MOD-2021-428510 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects symptoms of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects symptoms of the moderna 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects symptoms of the moderna vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (side effects symptoms of the moderna vaccine) outcome was unknown.            No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened) 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 EXPIRED PRODUCT ADMINISTERED (A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was given a dose of Moderna vaccine over 12 hours after the vial was opened) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Tendonitis, Vaccination complication
Clinical narrative: PTT; I got pain in my right leg from my ankle almost to my knee now/Started in my ankle and is almost up to my knee; I have an adverse reaction to my booster shot; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (PTT), PAIN IN EXTREMITY (I got pain in my right leg from my ankle almost to my knee now/Started in my ankle and is almost up to my knee) and VACCINATION COMPLICATION (I have an adverse reaction to my booster shot) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced TENDONITIS (PTT), PAIN IN EXTREMITY (I got pain in my right leg from my ankle almost to my knee now/Started in my ankle and is almost up to my knee) and VACCINATION COMPLICATION (I have an adverse reaction to my booster shot). At the time of the report, TENDONITIS (PTT) and PAIN IN EXTREMITY (I got pain in my right leg from my ankle almost to my knee now/Started in my ankle and is almost up to my knee) had not resolved and VACCINATION COMPLICATION (I have an adverse reaction to my booster shot) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lung disorder, Migraine
Clinical narrative: Feeling crappy; Lungs are pretty bad; Migraine for 3-4 days/migraine was off the charts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling crappy), LUNG DISORDER (Lungs are pretty bad) and MIGRAINE (Migraine for 3-4 days/migraine was off the charts) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management.    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 FEELING ABNORMAL (Feeling crappy), LUNG DISORDER (Lungs are pretty bad) and MIGRAINE (Migraine for 3-4 days/migraine was off the charts). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling crappy) and LUNG DISORDER (Lungs are pretty bad) outcome was unknown and MIGRAINE (Migraine for 3-4 days/migraine was off the charts) had resolved.            Concomitant Medications were blood pressure medication.  No Treatment Medications were provided.  Consumer called to report they received their first dose of the Moderna COVID-19 vaccine 2-3 months ago. Patient did not know if he was feeling this way from the vaccine, or if it was COVID.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: after I had the shots I had some chest discomfort; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (after I had the shots I had some chest discomfort) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 CHEST DISCOMFORT (after I had the shots I had some chest discomfort). At the time of the report, CHEST DISCOMFORT (after I had the shots I had some chest discomfort) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the patient received the first Moderna shot in Dec and the second one in Jan. The patient having the shots had some chest discomfort. The patient didn't receive the booster dose and it has been 11 month span since last shot.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal abscess
Clinical narrative: abdominal abscess after first shot; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL ABSCESS (abdominal abscess after first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL ABSCESS (abdominal abscess after first shot) (seriousness criterion medically significant). The patient was treated with CLINDAMYCIN for Abdominal abscess, at a dose of 150 mg and METHYLPREDNISOLONE for Abdominal abscess, at a dose of UNK (steroids). At the time of the report, ABDOMINAL ABSCESS (abdominal abscess after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. It was reported that patient today should receive the second dose of Moderna covid-19 vaccine, but mentioned he was under two prescription clindamycin 150 mg, methylprednisolone (steroids) to an abdominal abscess. Company comment: This case concerns a male patient, with no medical history reported in this case, who experienced the serious unexpected event of Abdominal abscess. The event occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine.  The event was assessed as serious due to Medically Significant. At the time of the report, the outcome of the event was reported as Unknown.  Further information disclosed states that the patient received Clindamycin and Methylprednisolone as treatment drugs.  The rechallenge is unknown since no further information has been disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. A discrepancy remains whether the event occurred after the administration of the vaccine or if it was a previous medical condition.; Sender's Comments: This case concerns a male patient, with no medical history reported in this case, who experienced the serious unexpected event of Abdominal abscess. The event occurred on an unknown date after the administration of the first dose of the mRNA-1273 vaccine.  The event was assessed as serious due to Medically Significant. At the time of the report, the outcome of the event was reported as Unknown.  Further information disclosed states that the patient received Clindamycin and Methylprednisolone as treatment drugs.  The rechallenge is unknown since no further information has been disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. A discrepancy remains whether the event occurred after the administration of the vaccine or if it was a previous medical condition.
Sex: U
Vaccine: COVID19
Symptoms: Dry throat, Vaccination site erythema, Vaccination site swelling
Clinical narrative: have a dry throat.; arm is still red and swollen; arm is still red and swollen; This spontaneous case was reported by a health care professional and describes the occurrence of DRY THROAT (have a dry throat.), VACCINATION SITE ERYTHEMA (arm is still red and swollen) and VACCINATION SITE SWELLING (arm is still red and swollen) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY THROAT (have a dry throat.), VACCINATION SITE ERYTHEMA (arm is still red and swollen) and VACCINATION SITE SWELLING (arm is still red and swollen). At the time of the report, DRY THROAT (have a dry throat.), VACCINATION SITE ERYTHEMA (arm is still red and swollen) and VACCINATION SITE SWELLING (arm is still red and swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided. No Concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient just got finished with therapy of anti viral for shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Patient just got finished with therapy of anti viral for shingles) 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 HERPES ZOSTER (Patient just got finished with therapy of anti viral for shingles). At the time of the report, HERPES ZOSTER (Patient just got finished with therapy of anti viral for shingles) 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 medications were reported. It was reported that the patient had shingles after first dose of the moderna vaccine and finished with therapy of anti viral for shingles.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A booster dose of the Moderna vaccine was administered to one patient past the 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A booster dose of the Moderna vaccine was administered to one patient past the 30 days in the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A booster dose of the Moderna vaccine was administered to one patient past the 30 days in the refrigerator). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (A booster dose of the Moderna vaccine was administered to one patient past the 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was 22-Nov-2021. The vial did not undergo any temperature excursions.  No concomitant medication was provided. No treatment medication was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Limb discomfort, Malaise, Mobility decreased, Pain
Clinical narrative: Feeling unwell; Bad case of vertigo; Dry heels; Couldn't get up; Pain in her stomach; Hurting all over; Really bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up) and ABDOMINAL PAIN UPPER (Pain in her stomach) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032h21a, 027a21a and 007m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Cancer surgery (breast cancer surgery) on 25-Jul-2019. Concomitant products included EXEMESTANE from 25-Jul-2019 to an unknown date for Breast cancer NOS, VITAMINS NOS, FISH OIL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up), ABDOMINAL PAIN UPPER (Pain in her stomach), PAIN (Hurting all over) and VACCINATION COMPLICATION (Really bad reaction). At the time of the report, MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up), ABDOMINAL PAIN UPPER (Pain in her stomach), PAIN (Hurting all over) and VACCINATION COMPLICATION (Really bad reaction) outcome was unknown.            No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vertigo
Clinical narrative: Feeling unwell; Bad case of vertigo; Dry heels; Couldn't get up; Pain in her stomach; Hurting all over; Really bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up) and ABDOMINAL PAIN UPPER (Pain in her stomach) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032h21a, 027a21a and 007m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Cancer surgery (breast cancer surgery) on 25-Jul-2019. Concomitant products included EXEMESTANE from 25-Jul-2019 to an unknown date for Breast cancer NOS, VITAMINS NOS, FISH OIL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up), ABDOMINAL PAIN UPPER (Pain in her stomach), PAIN (Hurting all over) and VACCINATION COMPLICATION (Really bad reaction). At the time of the report, MALAISE (Feeling unwell), VERTIGO (Bad case of vertigo), LIMB DISCOMFORT (Dry heels), MOBILITY DECREASED (Couldn't get up), ABDOMINAL PAIN UPPER (Pain in her stomach), PAIN (Hurting all over) and VACCINATION COMPLICATION (Really bad reaction) outcome was unknown.            No treatment information was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: has chills; still has a fever,; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (has chills) and PYREXIA (still has a fever,) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CHILLS (has chills) and PYREXIA (still has a fever,). At the time of the report, CHILLS (has chills) and PYREXIA (still has a fever,) outcome was unknown.            Patient has given rapid test and Abbott test result was negative.  Treatment and concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe vomiting; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING (Severe vomiting) 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 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced VOMITING (Severe vomiting). At the time of the report, VOMITING (Severe vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.  The reporter reported case for daughter and asked whether vomiting was normal after vaccination or was vomiting noted in clinical trials.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose given at less than 6 months after initial series; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Fatigue, Nausea, Pyrexia
Clinical narrative: shortness of breath; tightness in my throat; anxious which has made the throat tightness worse.; Felt tired; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired) and NAUSEA (nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson covid-19 vaccine (Intramuscular injection and lot number 1805022) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson covid-19 vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with IBUPROFEN on 24-Dec-2021 at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided  Patient reported that tightness feels like someone's hands are around her throat. She took 2 extra strength ibuprofen on 24DEC2021 for her symptoms, which made her feel better. She notes that this feels worse when she is stressed
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: shortness of breath; tightness in my throat; anxious which has made the throat tightness worse.; Felt tired; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired) and NAUSEA (nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson covid-19 vaccine (Intramuscular injection and lot number 1805022) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson covid-19 vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired), NAUSEA (nausea) and PYREXIA (fever). The patient was treated with IBUPROFEN on 24-Dec-2021 at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), THROAT TIGHTNESS (tightness in my throat), ANXIETY (anxious which has made the throat tightness worse.), FATIGUE (Felt tired), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided  Patient reported that tightness feels like someone's hands are around her throat. She took 2 extra strength ibuprofen on 24DEC2021 for her symptoms, which made her feel better. She notes that this feels worse when she is stressed
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: First dose more than 35 days before second dose; first dose was 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (first dose was 0.25 ml) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 35 days before second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904 and 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (first dose was 0.25 ml). On 27-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 35 days before second dose). On 02-Nov-2021, ACCIDENTAL UNDERDOSE (first dose was 0.25 ml) had resolved. On 27-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose more than 35 days before second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Non Significant follow up included reporter's email address.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms
Clinical narrative: cramps on her upper thigh/leg cramps; hard time to sleep; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps on her upper thigh/leg cramps) and INSOMNIA (hard time to sleep) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060h21b) for COVID-19 vaccination.     The patient's past medical history included Leg cramps.    On 11-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MUSCLE SPASMS (cramps on her upper thigh/leg cramps) and INSOMNIA (hard time to sleep). At the time of the report, MUSCLE SPASMS (cramps on her upper thigh/leg cramps) and INSOMNIA (hard time to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient mentioned that she listened to somebody else saying "they experienced something worst".  Concomitant medications was not reported.  The patient did not receive any treatment medications at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Non significant follow up appended
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test, Chest pain, Dyspnoea, Electrocardiogram, Myocardial necrosis marker
Clinical narrative: Chest pain; Feeling hard to breath; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Feeling hard to breath) and PAIN (Body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She was not hospitalized, but quarantined herself and stayed home and self-treated) on 19-Aug-2021. Concurrent medical conditions included Anxiety.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (Feeling hard to breath) and PAIN (Body aches). At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Feeling hard to breath) and PAIN (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Cardiac function test: not provided Not provided. On 19-Aug-2021, Electrocardiogram: not provided Not provided. On 19-Aug-2021, Myocardial necrosis marker: not provided Not provided. On 19-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced chest pain, which stared a couple days after vaccination. It was reported that it could be patient's anxiety that caused it and patient stated that it had been going away and coming back, but was not resolved. Patient had body aches, and sometimes feeling hard to breath but not all the time. Patient also stated that the breathing may also be due to anxiety as well. It was reported that the patient had not seek medical attention, but will go to urgent care in the morning of 28 Dec 2021. The patient also intended to receive the vaccine on 29 Dec 2021.  Treatment medication reported included self treatment which was not specified.  No concomitant medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Chest pain; Feeling hard to breath; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Feeling hard to breath) and PAIN (Body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She was not hospitalized, but quarantined herself and stayed home and self-treated) on 19-Aug-2021. Concurrent medical conditions included Anxiety.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced CHEST PAIN (Chest pain), DYSPNOEA (Feeling hard to breath) and PAIN (Body aches). At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Feeling hard to breath) and PAIN (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Cardiac function test: not provided Not provided. On 19-Aug-2021, Electrocardiogram: not provided Not provided. On 19-Aug-2021, Myocardial necrosis marker: not provided Not provided. On 19-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced chest pain, which stared a couple days after vaccination. It was reported that it could be patient's anxiety that caused it and patient stated that it had been going away and coming back, but was not resolved. Patient had body aches, and sometimes feeling hard to breath but not all the time. Patient also stated that the breathing may also be due to anxiety as well. It was reported that the patient had not seek medical attention, but will go to urgent care in the morning of 28 Dec 2021. The patient also intended to receive the vaccine on 29 Dec 2021.  Treatment medication reported included self treatment which was not specified.  No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (Shingles) 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 HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient was scheduled for the second dose of the Moderna vaccine in Feb 2021, next week since the reported date, but was diagnosed with shingles after having those symptoms. Patient stated that she was informed by her HCP to wait to get the Moderna vaccine because of the shingles diagnosis.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose given at less than 6 months after initial series; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient did not experience any adverse events.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Peripheral swelling
Clinical narrative: swollen right foot; infection in the toe or foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen right foot) and LOCALISED INFECTION (infection in the toe or foot) 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, 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 PERIPHERAL SWELLING (swollen right foot) and LOCALISED INFECTION (infection in the toe or foot). At the time of the report, PERIPHERAL SWELLING (swollen right foot) and LOCALISED INFECTION (infection in the toe or foot) had not resolved.            No concomitant medications were reported. No treatment medications were reported.  Patient was scheduled to receive a Moderna booster shot on 27-Dec-2021. The patient asked whether the possible infection would have any effect on the booster dose of the vaccine or not.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Aches all over the body after booster; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches all over the body after booster) in a 70-year-old female patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches all over the body after booster). At the time of the report, MYALGIA (Aches all over the body after booster) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: An uncomfortable big circle under his armpit; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (An uncomfortable big circle under his armpit) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k21a, 040a21a and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN DISCOLOURATION (An uncomfortable big circle under his armpit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (An uncomfortable big circle under his armpit) had not resolved.            Treatment medication also included A cream.  Concomitant medication was not reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose given at less than 6 months after initial series; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: very sore left arm; swollen arm; achy; tired; my lymph nodes became swollen/swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore left arm), PERIPHERAL SWELLING (swollen arm), PAIN (achy), FATIGUE (tired) and LYMPHADENOPATHY (my lymph nodes became swollen/swollen glands) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04524A, 003C214 and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (very sore left arm), PERIPHERAL SWELLING (swollen arm), PAIN (achy), FATIGUE (tired) and LYMPHADENOPATHY (my lymph nodes became swollen/swollen glands). At the time of the report, PAIN IN EXTREMITY (very sore left arm), PERIPHERAL SWELLING (swollen arm), PAIN (achy), FATIGUE (tired) and LYMPHADENOPATHY (my lymph nodes became swollen/swollen glands) outcome was unknown.            Reporter reported that she received her pneumonia shot on same day as her COVID-19 booster dose. (01-DEC-2021)   No treatment drug information was provided.   This case was linked to MOD-2021-428245 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick on both of them; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (got sick on both of them) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick on both of them). At the time of the report, ILLNESS (got sick on both of them) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-428257 (Patient Link).   Reporter did not allow further contact