chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vomiting
Clinical narrative: not feeling well for a couple of days; throwing up for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well for a couple of days) and VOMITING (throwing up for a couple of days) 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 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MALAISE (not feeling well for a couple of days) and VOMITING (throwing up for a couple of days). At the time of the report, MALAISE (not feeling well for a couple of days) and VOMITING (throwing up for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided. Patient reported that her daughter was not feeling well and throwing up for a couple of days after getting the first dose of the vaccine on 12Oct2021.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Weight increased
Clinical narrative: gained weight; swollen feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (gained weight) and PERIPHERAL SWELLING (swollen feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not asked) 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) at an unspecified dose. On an unknown date, the patient experienced WEIGHT INCREASED (gained weight) and PERIPHERAL SWELLING (swollen feet). At the time of the report, WEIGHT INCREASED (gained weight) and PERIPHERAL SWELLING (swollen feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Glomerular filtration rate, Glomerular filtration rate decreased
Clinical narrative: GFR of 47; Temperature up to 99 point something for about 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature up to 99 point something for about 2 days.) and GLOMERULAR FILTRATION RATE DECREASED (GFR of 47) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature up to 99 point something for about 2 days.). On 24-Sep-2021, the patient experienced GLOMERULAR FILTRATION RATE DECREASED (GFR of 47). On 17-Sep-2021, BODY TEMPERATURE INCREASED (Temperature up to 99 point something for about 2 days.) had resolved. At the time of the report, GLOMERULAR FILTRATION RATE DECREASED (GFR of 47) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Glomerular filtration rate: 62 (Low) Low. On 15-Sep-2021, Body temperature: 99 (High) High. On 17-Sep-2021, Body temperature: 99 (High) High. On 24-Sep-2021, Glomerular filtration rate: 47 (Low) Low. On 12-Oct-2021, Glomerular filtration rate: 49 (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She did not experience any symptoms after the first 2 doses was noted.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination site pain
Clinical narrative: think that it is they have been infected with actual covid-19; Arm gets so sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (think that it is they have been infected with actual covid-19) and VACCINATION SITE PAIN (Arm gets so sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (Arm gets so sore). On an unknown date, the patient experienced SUSPECTED COVID-19 (think that it is they have been infected with actual covid-19). At the time of the report, SUSPECTED COVID-19 (think that it is they have been infected with actual covid-19) and VACCINATION SITE PAIN (Arm gets so sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that Vaccine is a Spike Protein and Put covid into the vaccine and then injected into their body. Patient scheduled for dose 2 on 02-Nov-2021. No medical query is raised since the reporter did not provide consent for follow-up. Concomitant information was not reported. Treatment information was not reported   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of suspected COVID-19. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the events occurred after the first dose and there is no information about the second. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick) 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. On an unknown date, the patient experienced ILLNESS (got very sick). At the time of the report, ILLNESS (got very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-352611 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported  No treatment medication information was reported   This case was linked to MOD-2021-352611 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Heavy menstrual bleeding, Hot flush, Menstrual disorder
Clinical narrative: Hot flashes; PMDD; Got period first time after 3 years; She got her period. It was heavy; She was out of her mind, crazy/It was really bad, she was not herself.; Racing thoughts; Super anxious; Arm hurt for one day; Ringing in the ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear), HOT FLUSH (Hot flashes), PREMENSTRUAL DYSPHORIC DISORDER (PMDD), MENSTRUAL DISORDER (Got period first time after 3 years) and HEAVY MENSTRUAL BLEEDING (She got her period. It was heavy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included ESTRADIOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in the ear). On an unknown date, the patient experienced HOT FLUSH (Hot flashes), PREMENSTRUAL DYSPHORIC DISORDER (PMDD), MENSTRUAL DISORDER (Got period first time after 3 years), HEAVY MENSTRUAL BLEEDING (She got her period. It was heavy), FEELING ABNORMAL (She was out of her mind, crazy/It was really bad, she was not herself.), TACHYPHRENIA (Racing thoughts), ANXIETY (Super anxious) and PAIN IN EXTREMITY (Arm hurt for one day). The patient was treated with PROPRANOLOL for Anxiety, at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in the ear) and HOT FLUSH (Hot flashes) had not resolved and PREMENSTRUAL DYSPHORIC DISORDER (PMDD), MENSTRUAL DISORDER (Got period first time after 3 years), HEAVY MENSTRUAL BLEEDING (She got her period. It was heavy), FEELING ABNORMAL (She was out of her mind, crazy/It was really bad, she was not herself.), TACHYPHRENIA (Racing thoughts), ANXIETY (Super anxious) and PAIN IN EXTREMITY (Arm hurt for one day) had resolved.            Patient has reported about she got her period to her OBGYN doctor and doctor said it was not a period but even though she says it was a period.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Premenstrual dysphoric disorder, Tachyphrenia, Tinnitus
Clinical narrative: Hot flashes; PMDD; Got period first time after 3 years; She got her period. It was heavy; She was out of her mind, crazy/It was really bad, she was not herself.; Racing thoughts; Super anxious; Arm hurt for one day; Ringing in the ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear), HOT FLUSH (Hot flashes), PREMENSTRUAL DYSPHORIC DISORDER (PMDD), MENSTRUAL DISORDER (Got period first time after 3 years) and HEAVY MENSTRUAL BLEEDING (She got her period. It was heavy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was reported.  Concomitant products included ESTRADIOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in the ear). On an unknown date, the patient experienced HOT FLUSH (Hot flashes), PREMENSTRUAL DYSPHORIC DISORDER (PMDD), MENSTRUAL DISORDER (Got period first time after 3 years), HEAVY MENSTRUAL BLEEDING (She got her period. It was heavy), FEELING ABNORMAL (She was out of her mind, crazy/It was really bad, she was not herself.), TACHYPHRENIA (Racing thoughts), ANXIETY (Super anxious) and PAIN IN EXTREMITY (Arm hurt for one day). The patient was treated with PROPRANOLOL for Anxiety, at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in the ear) and HOT FLUSH (Hot flashes) had not resolved and PREMENSTRUAL DYSPHORIC DISORDER (PMDD), MENSTRUAL DISORDER (Got period first time after 3 years), HEAVY MENSTRUAL BLEEDING (She got her period. It was heavy), FEELING ABNORMAL (She was out of her mind, crazy/It was really bad, she was not herself.), TACHYPHRENIA (Racing thoughts), ANXIETY (Super anxious) and PAIN IN EXTREMITY (Arm hurt for one day) had resolved.            Patient has reported about she got her period to her OBGYN doctor and doctor said it was not a period but even though she says it was a period.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise; can still feel the first shot/ still has pain at the injection site of the first dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise) and VACCINATION SITE PAIN (can still feel the first shot/ still has pain at the injection site of the first dose.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE BRUISING (She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise) and VACCINATION SITE PAIN (can still feel the first shot/ still has pain at the injection site of the first dose.). At the time of the report, VACCINATION SITE BRUISING (She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise) and VACCINATION SITE PAIN (can still feel the first shot/ still has pain at the injection site of the first dose.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-352988 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the injection site of the second dose is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (the injection site of the second dose is painful) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (the injection site of the second dose is painful). At the time of the report, VACCINATION SITE PAIN (the injection site of the second dose is painful) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-352986 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after first dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm after first dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after first dose). At the time of the report, VACCINATION SITE PAIN (Sore arm after first dose) 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 products were reported.  No treatment information was reported by the reporter.  Patient took second dose and third dose on 12 Feb 2021 and 13 Oct 2021 respectively.   This case was linked to MOD-2021-352994, MOD-2021-352996, MOD-2021-352613, MOD-2021-352622, MOD-2021-352623 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after second dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm after second dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after second dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment Information was provided by the reporter.  Patient took third dose on 13 Oct 2021.   This case was linked to MOD-2021-352991, MOD-2021-352996, MOD-2021-352613, MOD-2021-352622, MOD-2021-352623 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: got third dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got third dose from an expired vial) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 025L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got third dose from an expired vial). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (got third dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.  No treatment medication was reported.    This case was linked to MOD-2021-352994, MOD-2021-352991, MOD-2021-352994 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Magnetic resonance imaging, Mobility decreased, Vaccination complication, Vaccination site pain
Clinical narrative: Showing a tiny bit of arthritis in there; She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee; Adverse reaction to the shot; She has some arm pain after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Showing a tiny bit of arthritis in there), MOBILITY DECREASED (She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee), VACCINATION COMPLICATION (Adverse reaction to the shot) and VACCINATION SITE PAIN (She has some arm pain after receiving the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Showing a tiny bit of arthritis in there), MOBILITY DECREASED (She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee), VACCINATION COMPLICATION (Adverse reaction to the shot) and VACCINATION SITE PAIN (She has some arm pain after receiving the vaccine). The patient was treated with METHYLPREDNISOLONE on 24-Sep-2021 for Adverse event, at a dose of 40 mg and LIDOCAINE on 24-Sep-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, ARTHRITIS (Showing a tiny bit of arthritis in there), MOBILITY DECREASED (She feels crippled by the shot/She feels if she takes a step or moves the wrong way like she has ripped out her knee), VACCINATION COMPLICATION (Adverse reaction to the shot) and VACCINATION SITE PAIN (She has some arm pain after receiving the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: abnormal (abnormal) A tiny bit of arthritis in there.         No relevant concomitant medications were reported.  Patient has had 2 x-rays for her knee prior to dose 1 and showed no changes, as well as multiple doctor visits as she felt crippled post the shot at the time.   This case was linked to MOD-2021-352971 (Patient Link).; Sender's Comments: This case concerns a 59-year-old female patient with no relevant medical history, who experienced the unexpected event of Arthritis. The event occurred an unknown date after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). Rechallenge was not applicable since the outcome of events were unknown. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Malaise, Nausea, Off label use
Clinical narrative: dizziness; really not feeling well; nausea; vomiting; 101° F fever; off label use; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (101° F fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (101° F fever) and OFF LABEL USE (off label use). In 2021, OFF LABEL USE (off label use) had resolved. At the time of the report, DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (101° F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) 101° F fever.         No concomitant drugs were reported.  Patient took the 3rd shot two weeks ago from the time of reporting.   Doctor advised the patient to take rest.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: dizziness; really not feeling well; nausea; vomiting; 101° F fever; off label use; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (101° F fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (101° F fever) and OFF LABEL USE (off label use). In 2021, OFF LABEL USE (off label use) had resolved. At the time of the report, DIZZINESS (dizziness), MALAISE (really not feeling well), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (101° F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) 101° F fever.         No concomitant drugs were reported.  Patient took the 3rd shot two weeks ago from the time of reporting.   Doctor advised the patient to take rest.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients,vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-352611 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In regards to the vial of Moderna vial Lot: 048F21A  that was received in the refrigerator on 01SEP2021 and has been used to vaccinate past its expiration date of 01OCT2021. A carton of vials in the fridge which was put in there from the freezer on 01Sep2021. Vials were used on 5-Oct-2021, 7-Oct-2021, 8-Oct-2021, 11-Oct-2021 and 12-Oct-2021. In total, 16 patients were vaccinated in these dates using 5 vials.   No concomitant medication was reported.  No treatment drug was reported.   This case was linked to MOD-2021-352843 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the carton of vials was stored in the freezer on 01-Sep-2021. Expiration date of vial was 01-Oct-2021.  No Concomitant medication reported. No treatment medication reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Influenza like illness, Pain in extremity
Clinical narrative: Flu like symptoms; Sore arm; Did not have a menstrual cycle untill the first week of August; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Did not have a menstrual cycle untill the first week of August), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced AMENORRHOEA (Did not have a menstrual cycle untill the first week of August). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Sore arm). At the time of the report, AMENORRHOEA (Did not have a menstrual cycle untill the first week of August), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that patient was on menstrual cycle while receiving first dose and then patient did not have a menstrual cycle until the first week of August. When the patient finally had menstrual cycle, it was like a blood bath.  Concomitant medication reported included pain medicine used when needed. Treatment details were not provided.   This case was linked to MOD-2021-353350 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose: 65 Days after first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose: 65 Days after first) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose: 65 Days after first). On 12-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose: 65 Days after first) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was reported by the patient that the second dose was given too fast.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Pyrexia, Sneezing
Clinical narrative: coughing; sneezing; weakness/became very weak; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), SNEEZING (sneezing), ASTHENIA (weakness/became very weak) and PYREXIA (fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), SNEEZING (sneezing), ASTHENIA (weakness/became very weak) and PYREXIA (fever). At the time of the report, COUGH (coughing), SNEEZING (sneezing), ASTHENIA (weakness/became very weak) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment details were reported.   This case was linked to MOD21-152710 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-152710:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: pain in the arm; soreness in the arm; is also getting the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), MYALGIA (soreness in the arm) and CHILLS (is also getting the chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), MYALGIA (soreness in the arm) and CHILLS (is also getting the chills). At the time of the report, PAIN IN EXTREMITY (pain in the arm), MYALGIA (soreness in the arm) and CHILLS (is also getting the chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by reporter No treatment medication were provided by reporter
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-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 EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Vaccination site pain
Clinical narrative: Tingling; Soreness; Pain at the left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), MYALGIA (Soreness) and VACCINATION SITE PAIN (Pain at the left arm injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (Tingling), MYALGIA (Soreness) and VACCINATION SITE PAIN (Pain at the left arm injection site). At the time of the report, PARAESTHESIA (Tingling), MYALGIA (Soreness) and VACCINATION SITE PAIN (Pain at the left arm injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided. Patient received second dose and experienced no adverse reactions.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired yesterday, given today; Vaccines were frozen and allowed to thaw for 45 minutes before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired yesterday, given today) and PRODUCT STORAGE ERROR (Vaccines were frozen and allowed to thaw for 45 minutes before) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired yesterday, given today) and PRODUCT STORAGE ERROR (Vaccines were frozen and allowed to thaw for 45 minutes before). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired yesterday, given today) and PRODUCT STORAGE ERROR (Vaccines were frozen and allowed to thaw for 45 minutes before) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow up received contains added reporter details, dose number, batch number and new event .
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the dose of the Moderna COVID 19 vaccine after 30 days use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided. Number of doses/vials- 1 Date the vial was initially stored in the refrigerator was 10 SEPT 2021 Date(s) of administration of vaccine was 14 OCT 2021 The vial did not undergo any temperature excursions.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Taste the vaccine in her mouth; Smell the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Taste the vaccine in her mouth) and PAROSMIA (Smell the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced TASTE DISORDER (Taste the vaccine in her mouth) and PAROSMIA (Smell the vaccine). At the time of the report, TASTE DISORDER (Taste the vaccine in her mouth) and PAROSMIA (Smell the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Feeling abnormal, Pyrexia
Clinical narrative: blisters all around her lips; felt really lousy; chills; really high fever (about 102.5°F); This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blisters all around her lips, inside and out), FEELING ABNORMAL (felt really lousy), CHILLS (chills) and PYREXIA (really high fever (about 102.5°F)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 BLISTER (blisters all around her lips, inside and out), FEELING ABNORMAL (felt really lousy), CHILLS (chills) and PYREXIA (really high fever (about 102.5°F)). At the time of the report, BLISTER (blisters all around her lips, inside and out), FEELING ABNORMAL (felt really lousy), CHILLS (chills) and PYREXIA (really high fever (about 102.5°F)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication information not provided.  Treatment information not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: sweating; was kind of low for a while; flu symptoms; was cold when he went to bed; dizziness; fever/a lot of fever/fever was 101; chills; tiredness/Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING ABNORMAL (was kind of low for a while), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed) and DIZZINESS (dizziness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LA0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.    On 14-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 HYPERHIDROSIS (sweating), FEELING ABNORMAL (was kind of low for a while), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed), DIZZINESS (dizziness), PYREXIA (fever/a lot of fever/fever was 101), CHILLS (chills) and FATIGUE (tiredness/Felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed), DIZZINESS (dizziness), PYREXIA (fever/a lot of fever/fever was 101), CHILLS (chills) and FATIGUE (tiredness/Felt tired) outcome was unknown and FEELING ABNORMAL (was kind of low for a while) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever was 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-353325, MOD-2021-353320 (Patient Link).