chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Thinking abnormal, Vaccination complication
Clinical narrative: a very big reaction to second shot; loss of balance; brain not operating correctly, the patient couldn't think straight; had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up; really extreme fatigue; headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up) and FATIGUE (really extreme fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Overweight and Blood pressure high.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up), FATIGUE (really extreme fatigue), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up), FATIGUE (really extreme fatigue), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.  The patient had all the symptoms to the extreme for about 30 hours.   This case was linked to MOD-2021-374058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Significant Followup received contains updated reporter's Information, updated patient's demographics and new events are added
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information were not provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was given after the expiration date.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Sore left arm; Shaking; Very tired; 99F without high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Body temperature: 99 (normal) no high fever just 99F.         No treatment details provided. No concomitant medications reported.   This case was linked to MOD-2021-374891, MOD-2021-374892 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sore left arm; Shaking; Very tired; 99F without high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore left arm), TREMOR (Shaking), FATIGUE (Very tired), PYREXIA (99F without high fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Body temperature: 99 (normal) no high fever just 99F.         No treatment details provided. No concomitant medications reported.   This case was linked to MOD-2021-374891, MOD-2021-374892 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 11 patients Moderna Covid-19 Vaccine doses (lot # 046C21A) on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 11 patients Moderna Covid-19 Vaccine doses (lot # 046C21A) on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave 11 patients Moderna Covid-19 Vaccine doses (lot # 046C21A) on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication was provided.  Medical Assistant was reporting that they gave 11 patients Moderna Covid-19 Vaccine doses  on 6-Oct-2021 from a vial (lot: 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30-Aug-2021.  It was the 2nd dose for this patient.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Shaking; Chills, Shivering; Tired; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shaking), CHILLS (Chills,Shivering) and FATIGUE (Tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced TREMOR (Shaking), CHILLS (Chills,Shivering) and FATIGUE (Tired). At the time of the report, TREMOR (Shaking), CHILLS (Chills,Shivering) and FATIGUE (Tired) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-374769 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses were administered to 12 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses were administered to 12 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses were administered to 12 patients). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses were administered to 12 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: felt a little tired; abdominal pain which started in the middle and went to the left; sore arm; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain which started in the middle and went to the left), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (felt a little tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced ABDOMINAL PAIN (abdominal pain which started in the middle and went to the left), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever). 16-Feb-2021, the patient experienced CHILLS (chills). On 17-Feb-2021, the patient experienced FATIGUE (felt a little tired). On 16-Feb-2021, ABDOMINAL PAIN (abdominal pain which started in the middle and went to the left), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (felt a little tired) outcome was unknown.            No Concomitant medications were provided by he reporter. No Treatment information was reported.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (sick) and headaches in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (sick) and headaches. At the time of the report, illness (sick) and headaches outcome: unknown. No concomitant medication or treatment information provided. Patient stated the organization giving the doses told him everybody has been sick and has side effects after the second injection (headaches, etc.).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Incontinence
Clinical narrative: Eyesight was affected,When she was reading, one line superimposed the next line; Felt weak as a kitten; Incontinent; Shivering; Tired; Nauseated; Very achy; Freezing cold; Shaking; Couldn't hold anything in her hand; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line) and ASTHENIA (Felt weak as a kitten) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), INCONTINENCE (Incontinent), CHILLS (Shivering), FATIGUE (Tired), NAUSEA (Nauseated) and MYALGIA (Very achy). On 03-Nov-2021, the patient experienced VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line) and ASTHENIA (Felt weak as a kitten). At the time of the report, FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line), ASTHENIA (Felt weak as a kitten), INCONTINENCE (Incontinent), CHILLS (Shivering), FATIGUE (Tired), NAUSEA (Nauseated) and MYALGIA (Very achy) outcome was unknown.            No Treatment medications were provided No  Concomitant medications were provided patient wants to know why do people with different statures receive the same dosages   This case was linked to MOD-2021-374747 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Nausea, Tremor, Visual impairment
Clinical narrative: Eyesight was affected,When she was reading, one line superimposed the next line; Felt weak as a kitten; Incontinent; Shivering; Tired; Nauseated; Very achy; Freezing cold; Shaking; Couldn't hold anything in her hand; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line) and ASTHENIA (Felt weak as a kitten) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), INCONTINENCE (Incontinent), CHILLS (Shivering), FATIGUE (Tired), NAUSEA (Nauseated) and MYALGIA (Very achy). On 03-Nov-2021, the patient experienced VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line) and ASTHENIA (Felt weak as a kitten). At the time of the report, FEELING COLD (Freezing cold), TREMOR (Shaking), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't hold anything in her hand), VISUAL IMPAIRMENT (Eyesight was affected,When she was reading, one line superimposed the next line), ASTHENIA (Felt weak as a kitten), INCONTINENCE (Incontinent), CHILLS (Shivering), FATIGUE (Tired), NAUSEA (Nauseated) and MYALGIA (Very achy) outcome was unknown.            No Treatment medications were provided No  Concomitant medications were provided patient wants to know why do people with different statures receive the same dosages   This case was linked to MOD-2021-374747 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine may have been administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered) 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 (Expired vaccine may have been administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given. refrigerated Moderna that is 1 day past the 30 days of being refrigerated from frozen.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitants were reported. no treatment medications was provided
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: [after second dose] a little sore arm; [after second dose] tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ([after second dose] a little sore arm) and FATIGUE ([after second dose] tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-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 PAIN IN EXTREMITY ([after second dose] a little sore arm) and FATIGUE ([after second dose] tired). At the time of the report, PAIN IN EXTREMITY ([after second dose] a little sore arm) and FATIGUE ([after second dose] tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-374290 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination site discharge
Clinical narrative: Arm at injection site and band-aid was wet; She felt she didn't get all of the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (Arm at injection site and band-aid was wet) and ACCIDENTAL UNDERDOSE (She felt she didn't get all of the dose) 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 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE DISCHARGE (Arm at injection site and band-aid was wet) and ACCIDENTAL UNDERDOSE (She felt she didn't get all of the dose). On 02-Nov-2021, ACCIDENTAL UNDERDOSE (She felt she didn't get all of the dose) had resolved. At the time of the report, VACCINATION SITE DISCHARGE (Arm at injection site and band-aid was wet) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: With the second dose she also got the lump in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (With the second dose she also got the lump in the injection arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 008B21) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE MASS (With the second dose she also got the lump in the injection arm). At the time of the report, VACCINATION SITE MASS (With the second dose she also got the lump in the injection arm) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported.   This case was linked to MOD-2021-374515 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Illness, Nasopharyngitis
Clinical narrative: Felt terrible almost two weeks later; Moderna arm; Rash blistered; Nauseous; Tired; Feverish; Woke up with cold symptoms; Coughing; Sick; Swelling on my arm/Arm swelled to the size of a golf ball; Rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), FEELING ABNORMAL (Felt terrible almost two weeks later), NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick) and VACCINATION SITE REACTION (Moderna arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-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 PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm). On 30-Oct-2021, the patient experienced ILLNESS (Sick). On 02-Nov-2021, the patient experienced COUGH (Coughing), NASOPHARYNGITIS (Woke up with cold symptoms) and PYREXIA (Feverish). On an unknown date, the patient experienced FEELING ABNORMAL (Felt terrible almost two weeks later), VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), NAUSEA (Nauseous) and FATIGUE (Tired). The patient was treated with Manual therapy (Ice on her arm after blister popped) for Vaccination site reaction; Manual therapy (Ice on her arm after blister popped) for Rash vesicular; Manual therapy (Ice on her arm after blister popped) for Peripheral swelling and Manual therapy (Ice on her arm after blister popped) for Rash. At the time of the report, COUGH (Coughing) and FEELING ABNORMAL (Felt terrible almost two weeks later) had not resolved, NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick), NAUSEA (Nauseous), PYREXIA (Feverish) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  On 03-NOV-2021 patient stated sickness got worse.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pyrexia, Rash, Rash vesicular
Clinical narrative: Felt terrible almost two weeks later; Moderna arm; Rash blistered; Nauseous; Tired; Feverish; Woke up with cold symptoms; Coughing; Sick; Swelling on my arm/Arm swelled to the size of a golf ball; Rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), FEELING ABNORMAL (Felt terrible almost two weeks later), NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick) and VACCINATION SITE REACTION (Moderna arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-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 PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm). On 30-Oct-2021, the patient experienced ILLNESS (Sick). On 02-Nov-2021, the patient experienced COUGH (Coughing), NASOPHARYNGITIS (Woke up with cold symptoms) and PYREXIA (Feverish). On an unknown date, the patient experienced FEELING ABNORMAL (Felt terrible almost two weeks later), VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), NAUSEA (Nauseous) and FATIGUE (Tired). The patient was treated with Manual therapy (Ice on her arm after blister popped) for Vaccination site reaction; Manual therapy (Ice on her arm after blister popped) for Rash vesicular; Manual therapy (Ice on her arm after blister popped) for Peripheral swelling and Manual therapy (Ice on her arm after blister popped) for Rash. At the time of the report, COUGH (Coughing) and FEELING ABNORMAL (Felt terrible almost two weeks later) had not resolved, NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick), NAUSEA (Nauseous), PYREXIA (Feverish) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  On 03-NOV-2021 patient stated sickness got worse.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Felt terrible almost two weeks later; Moderna arm; Rash blistered; Nauseous; Tired; Feverish; Woke up with cold symptoms; Coughing; Sick; Swelling on my arm/Arm swelled to the size of a golf ball; Rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), FEELING ABNORMAL (Felt terrible almost two weeks later), NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick) and VACCINATION SITE REACTION (Moderna arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-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 PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm). On 30-Oct-2021, the patient experienced ILLNESS (Sick). On 02-Nov-2021, the patient experienced COUGH (Coughing), NASOPHARYNGITIS (Woke up with cold symptoms) and PYREXIA (Feverish). On an unknown date, the patient experienced FEELING ABNORMAL (Felt terrible almost two weeks later), VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), NAUSEA (Nauseous) and FATIGUE (Tired). The patient was treated with Manual therapy (Ice on her arm after blister popped) for Vaccination site reaction; Manual therapy (Ice on her arm after blister popped) for Rash vesicular; Manual therapy (Ice on her arm after blister popped) for Peripheral swelling and Manual therapy (Ice on her arm after blister popped) for Rash. At the time of the report, COUGH (Coughing) and FEELING ABNORMAL (Felt terrible almost two weeks later) had not resolved, NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick), NAUSEA (Nauseous), PYREXIA (Feverish) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  On 03-NOV-2021 patient stated sickness got worse.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: they withdrew and administered 30 booster doses out of a Moderna Covid-19 Vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) 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 PRODUCT ADMINISTRATION ERROR (they withdrew and administered 30 booster doses out of a Moderna Covid-19 Vaccine vial). At the time of the report, PRODUCT ADMINISTRATION ERROR (they withdrew and administered 30 booster doses out of a Moderna Covid-19 Vaccine vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment received by the patient.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-019 vaccine  was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ( Moderna Covid-019 vaccine  was given after the expiration date.) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED ( Moderna Covid-019 vaccine  was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED ( Moderna Covid-019 vaccine  was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Number of doses/vials: 4 vials (15 dose). 44 doses Date the vial was initially stored in the refrigerator: 24Sept2021 Date(s) of administration of vaccine: 24Oct2021 - 27Oct2021 Consent given for Safety follow up/contact with caller.  No concomitant medications were administered. No treatment medications were reported.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) 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-24Sept2021 No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; 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 VACCINATION SITE PAIN (pain at the injection site) 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 VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment was provided. No treatment medication was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: knocked out for 24-hours; did a lot of sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (knocked out for 24-hours) and SOMNOLENCE (did a lot of sleeping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (knocked out for 24-hours) and SOMNOLENCE (did a lot of sleeping). At the time of the report, FEELING ABNORMAL (knocked out for 24-hours) and SOMNOLENCE (did a lot of sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.    This case was linked to MOD-2021-374831, MOD-2021-374841 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Lethargy, Somnolence
Clinical narrative: Lethargic; Cannot eat; I've been laying down all day; Extremely tired/tired/worn out/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), DECREASED APPETITE (Cannot eat), SOMNOLENCE (I've been laying down all day) and FATIGUE (Extremely tired/tired/worn out/fatigued) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 023M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced LETHARGY (Lethargic), DECREASED APPETITE (Cannot eat), SOMNOLENCE (I've been laying down all day) and FATIGUE (Extremely tired/tired/worn out/fatigued). At the time of the report, LETHARGY (Lethargic), DECREASED APPETITE (Cannot eat), SOMNOLENCE (I've been laying down all day) and FATIGUE (Extremely tired/tired/worn out/fatigued) outcome 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
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Extremely ill; sweating; vaccination site pain; fever; chills; headache; body ache; extremely fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cystitis interstitial since 1993, Hypertension since 2019, Arthritis since 2007, Chronic back pain since May 2003 and Chronic fatigue syndrome since 1985. Concomitant products included HYDROXYZINE from 2004 to an unknown date for Cystitis interstitial, PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (extremely fatigue). At the time of the report, ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (extremely fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97 (High) Typically about 97 degree celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. It was reported that patient had many RX sensitivities, but not allergies that are life threatening. Patient race is white.   This case was linked to MOD-2021-374847, MOD-2021-368330.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Extremely ill; sweating; vaccination site pain; fever; chills; headache; body ache; extremely fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cystitis interstitial since 1993, Hypertension since 2019, Arthritis since 2007, Chronic back pain since May 2003 and Chronic fatigue syndrome since 1985. Concomitant products included HYDROXYZINE from 2004 to an unknown date for Cystitis interstitial, PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (extremely fatigue). At the time of the report, ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (extremely fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97 (High) Typically about 97 degree celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. It was reported that patient had many RX sensitivities, but not allergies that are life threatening. Patient race is white.   This case was linked to MOD-2021-374847, MOD-2021-368330.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 150 patients received expired vaccines; 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 (150 patients received expired vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A  e and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (150 patients received expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (150 patients received expired vaccines) 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.