chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to the patient after the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after the beyond use date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-218565, MOD-2021-218569.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nausea
Clinical narrative: Cough; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough) and NAUSEA (Nausea). At the time of the report, COUGH (Cough) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Urticaria
Clinical narrative: Coughing; Hives; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and URTICARIA (Hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing) and URTICARIA (Hives). At the time of the report, COUGH (Coughing) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Moderna vaccine administered <25 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered <25 days) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered <25 days). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine administered <25 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue
Clinical narrative: Lack of appetite; Mild chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), CHILLS (Mild chills) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Lack of appetite), CHILLS (Mild chills) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Lack of appetite), CHILLS (Mild chills) and FATIGUE (Fatigue) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-027237 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to Crosslinked cases-MOD21-110132,MOD21-110133,MOD21-110134,MOD21-110135,MOD21-110137,MOD21-110141 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. No concomitant medication was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received a Johnson and Johnson vaccine and then received a dose of the Moderna vaccine) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Induration
Clinical narrative: Arm itchy; Swollen arm; Hard arm; Hot to touch; COVID arm; other pain; fatigue; chills; headache; muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm), FEELING HOT (Hot to touch) and VACCINATION SITE REACTION (COVID arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm) and FEELING HOT (Hot to touch). In June 2021, the patient experienced VACCINATION SITE REACTION (COVID arm), PAIN (other pain), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches and pains). At the time of the report, PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm), FEELING HOT (Hot to touch), VACCINATION SITE REACTION (COVID arm), PAIN (other pain), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches and pains) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications were reported.  Patient was not taking any treatment medications for events- itchy, swollen, hard and hot to touch.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Peripheral swelling, Pruritus, Vaccination site reaction
Clinical narrative: Arm itchy; Swollen arm; Hard arm; Hot to touch; COVID arm; other pain; fatigue; chills; headache; muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm), FEELING HOT (Hot to touch) and VACCINATION SITE REACTION (COVID arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm) and FEELING HOT (Hot to touch). In June 2021, the patient experienced VACCINATION SITE REACTION (COVID arm), PAIN (other pain), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches and pains). At the time of the report, PRURITUS (Arm itchy), PERIPHERAL SWELLING (Swollen arm), INDURATION (Hard arm), FEELING HOT (Hot to touch), VACCINATION SITE REACTION (COVID arm), PAIN (other pain), FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches and pains) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications were reported.  Patient was not taking any treatment medications for events- itchy, swollen, hard and hot to touch.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Migraine, Pain, Pyrexia, Vomiting
Clinical narrative: Migraine; Body ache; Cough; Threw Up; On 3rd daytemperature 99 F; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PAIN (Body ache), COUGH (Cough), VOMITING (Threw Up) and PYREXIA (On 3rd daytemperature 99 F) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), COUGH (Cough), VOMITING (Threw Up) and PYREXIA (On 3rd daytemperature 99 F). an unknown date, the patient experienced PAIN (Body ache). At the time of the report, MIGRAINE (Migraine), VOMITING (Threw Up) and PYREXIA (On 3rd daytemperature 99 F) outcome was unknown and PAIN (Body ache) and COUGH (Cough) had resolved.       Date: Unk, Body temperature: 99F  No information regarding treatment medications was provided by the reporter.   This case was linked to MOD-2021-019704 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pain in my brain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pain in my brain) 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) (Intramuscular) Unknown. On an unknown date, the patient experienced HEADACHE (Pain in my brain). At the time of the report, HEADACHE (Pain in my brain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  No treatment information provided.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Confusional state, Fall, Feeling abnormal
Clinical narrative: Loss of long term memory; Feeling weakness.; Fell down twice on floor from standing position; Looks confused; Out of mind/feels likes somebody has raised hard disk; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Loss of long term memory), ASTHENIA (Feeling weakness.), FALL (Fell down twice on floor from standing position), CONFUSIONAL STATE (Looks confused) and FEELING ABNORMAL (Out of mind/feels likes somebody has raised hard disk) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced AMNESIA (Loss of long term memory), ASTHENIA (Feeling weakness.), FALL (Fell down twice on floor from standing position), CONFUSIONAL STATE (Looks confused) and FEELING ABNORMAL (Out of mind/feels likes somebody has raised hard disk). At the time of the report, AMNESIA (Loss of long term memory) had not resolved and ASTHENIA (Feeling weakness.), FALL (Fell down twice on floor from standing position), CONFUSIONAL STATE (Looks confused) and FEELING ABNORMAL (Out of mind/feels likes somebody has raised hard disk) outcome was unknown.      The patient stated that she is not on concomitant medication. No treatment information was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced headache. At the time of the report, headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Exposure to SARS-CoV-2, Headache, Myalgia
Clinical narrative: COVID like respiratory, hard to breath; Headache; achiness symptoms; got exposed to a person who got COVID positive; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (got exposed to a person who got COVID positive), DYSPNOEA (COVID like respiratory, hard to breath), HEADACHE (Headache) and MYALGIA (achiness symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPOSURE TO SARS-COV-2 (got exposed to a person who got COVID positive). On an unknown date, the patient experienced DYSPNOEA (COVID like respiratory, hard to breath), HEADACHE (Headache) and MYALGIA (achiness symptoms). At the time of the report, EXPOSURE TO SARS-COV-2 (got exposed to a person who got COVID positive), DYSPNOEA (COVID like respiratory, hard to breath), HEADACHE (Headache) and MYALGIA (achiness symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had an appointment for second dose Moderna COVID-19 Vaccine on 21-May-2021. She got exposed to a person who got COVID positive on 11-May-2021. She was planning to go for COVID test.  Concomitant medications were not provided. Treatment information was not reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainted). At the time of the report, SYNCOPE (fainted) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported. The patient received both doses and one was on 26 May 2021. The patient stated that between 7-10 days post vaccine he fainted 3 times in one day. He was concerned that this might happen to him again, but he doesn't know for sure when and this was causing him lot of frustrations. As a healthy man he doesn't think he should faint from getting a vaccine. He also stated that the pharmacist told him there was no reason for him to get side effects from the moderna vaccine since he was a health man.  Very limited information regarding this event has been provided at this time. Further information has been requested. Patient medical condition may be of relevance regrading the event occurrence.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Patient medical condition may be of relevance regrading the event occurrence.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: Arm is swollen; Arm is itchy; Stomach pain; Diarrhea; Nausea; Shaking; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Arm is itchy), ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced PYREXIA (Fever). On 08-Jun-2021, the patient experienced TREMOR (Shaking), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Arm is itchy), ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 08-Jun-2021, PYREXIA (Fever) outcome was unknown. At the time of the report, TREMOR (Shaking), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Arm is itchy), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Body temperature: 103 f (High) Fever with 103 F.         No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pruritus, Pyrexia, Tremor
Clinical narrative: Arm is swollen; Arm is itchy; Stomach pain; Diarrhea; Nausea; Shaking; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Arm is itchy), ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced PYREXIA (Fever). On 08-Jun-2021, the patient experienced TREMOR (Shaking), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Arm is itchy), ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 08-Jun-2021, PYREXIA (Fever) outcome was unknown. At the time of the report, TREMOR (Shaking), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Arm is itchy), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach pain), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Body temperature: 103 f (High) Fever with 103 F.         No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: My first shot was March 26; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My first shot was March 26) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (My first shot was March 26). At the time of the report, PRODUCT DOSE OMISSION ISSUE (My first shot was March 26) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: vaccine leakage (not administered a full dose); vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (vaccine leakage (not administered a full dose)) and UNDERDOSE (vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002DA1C) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced DEVICE CONNECTION ISSUE (vaccine leakage (not administered a full dose)) and UNDERDOSE (vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose). On 10-Jun-2021, DEVICE CONNECTION ISSUE (vaccine leakage (not administered a full dose)) and UNDERDOSE (vaccine leakage (not administered a full dose)\syringe was not tightened and there was a leak. Pharmacist is not sure that the patient received the full dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided. The first dose of the Moderna Covid-19 vaccine to a patient on 10Jun2021 but that the syringe was not tightened and there was a leak.  Pharmacist is not sure that the patient received the full dose and asks for guidance in management
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: running temperature of 100.4 then it went to 101.2; hurting at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (running temperature of 100.4 then it went to 101.2) and VACCINATION SITE PAIN (hurting at the injection site) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (running temperature of 100.4 then it went to 101.2) and VACCINATION SITE PAIN (hurting at the injection site). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PYREXIA (running temperature of 100.4 then it went to 101.2) and VACCINATION SITE PAIN (hurting at the injection site) outcome was unknown. Not Provided          Patient is taking two doses of acetaminophen.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Fatigue, Feeling abnormal, Headache
Clinical narrative: I have now been diagnosed with an autoimmune disease; Numbness in extremities; Tingling in extremities; Fogginess; Swelling in extremities; joint pain; Headache; Bad Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (I have now been diagnosed with an autoimmune disease), HYPOAESTHESIA (Numbness in extremities), PARAESTHESIA (Tingling in extremities), FEELING ABNORMAL (Fogginess) and PERIPHERAL SWELLING (Swelling in extremities) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (I have now been diagnosed with an autoimmune disease), HYPOAESTHESIA (Numbness in extremities), PARAESTHESIA (Tingling in extremities), FEELING ABNORMAL (Fogginess), PERIPHERAL SWELLING (Swelling in extremities), ARTHRALGIA (joint pain), HEADACHE (Headache) and FATIGUE (Bad Fatigue). At the time of the report, AUTOIMMUNE DISORDER (I have now been diagnosed with an autoimmune disease), HYPOAESTHESIA (Numbness in extremities), PARAESTHESIA (Tingling in extremities), FEELING ABNORMAL (Fogginess), PERIPHERAL SWELLING (Swelling in extremities), ARTHRALGIA (joint pain), HEADACHE (Headache) and FATIGUE (Bad Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding these events has been provided at this time. Further information has been  requested. Patient previously undiagnosed medical condition may provide an alterative justification for the vents occurrence.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been  requested. Patient previously undiagnosed medical condition may provide an alterative justification for the vents occurrence.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: I have now been diagnosed with an autoimmune disease; Numbness in extremities; Tingling in extremities; Fogginess; Swelling in extremities; joint pain; Headache; Bad Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (I have now been diagnosed with an autoimmune disease), HYPOAESTHESIA (Numbness in extremities), PARAESTHESIA (Tingling in extremities), FEELING ABNORMAL (Fogginess) and PERIPHERAL SWELLING (Swelling in extremities) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (I have now been diagnosed with an autoimmune disease), HYPOAESTHESIA (Numbness in extremities), PARAESTHESIA (Tingling in extremities), FEELING ABNORMAL (Fogginess), PERIPHERAL SWELLING (Swelling in extremities), ARTHRALGIA (joint pain), HEADACHE (Headache) and FATIGUE (Bad Fatigue). At the time of the report, AUTOIMMUNE DISORDER (I have now been diagnosed with an autoimmune disease), HYPOAESTHESIA (Numbness in extremities), PARAESTHESIA (Tingling in extremities), FEELING ABNORMAL (Fogginess), PERIPHERAL SWELLING (Swelling in extremities), ARTHRALGIA (joint pain), HEADACHE (Headache) and FATIGUE (Bad Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding these events has been provided at this time. Further information has been  requested. Patient previously undiagnosed medical condition may provide an alterative justification for the vents occurrence.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been  requested. Patient previously undiagnosed medical condition may provide an alterative justification for the vents occurrence.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received expired Moderna COVID-19 vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A) for COVID-19 immunization. No medical history reported. On Jun 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 10, 2021, patient administered expired product (patient received expired Moderna COVID-19 vaccine). At the time of the report, administered expired product (patient received expired Moderna COVID-19 vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: i had side effects with my 1st; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i had side effects with my 1st) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (i had side effects with my 1st). At the time of the report, VACCINATION COMPLICATION (i had side effects with my 1st) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: She is also currently pregnant; Sore L arm at site of injection; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (She is also currently pregnant) and INJECTION SITE PAIN (Sore L arm at site of injection) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Vitamin D deficiency. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ASPIRIN [ACETYLSALICYLIC ACID] from 06-Jan-2021 to an unknown date for Prevention, VITAMIN C [ASCORBIC ACID] for Symptomatic treatment, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.    On 15-May-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 15-Nov-2021. On 15-May-2021 at 3:15 PM, the patient experienced INJECTION SITE PAIN (Sore L arm at site of injection). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (She is also currently pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 18-May-2021, INJECTION SITE PAIN (Sore L arm at site of injection) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (She is also currently pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Additional info appended
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numb; Tingly; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb) and PARAESTHESIA (Tingly) 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 HYPOAESTHESIA (Numb) and PARAESTHESIA (Tingly). At the time of the report, HYPOAESTHESIA (Numb) and PARAESTHESIA (Tingly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. No concomitant medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; 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 ADVERSE EVENT (Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had an adverse event  No concomitant medication was reported  No treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Hypotension
Clinical narrative: low blood pressure; high pulse; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (low blood pressure) and HEART RATE INCREASED (high pulse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced HYPOTENSION (low blood pressure) and HEART RATE INCREASED (high pulse). At the time of the report, HYPOTENSION (low blood pressure) and HEART RATE INCREASED (high pulse) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: lymph node pain in my armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (lymph node pain in my armpit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (lymph node pain in my armpit). At the time of the report, LYMPH NODE PAIN (lymph node pain in my armpit) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-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 MYALGIA (Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues). The patient was treated with THERAWORX RELIEF for Myalgia, at an unspecified dose and frequency and HISTAMINE HYDROCHLORIDE (PAIN RELIEVING ARTHRITIS) (topical) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues) had not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: feel tingles on your hands; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feel tingles on your hands) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (feel tingles on your hands). At the time of the report, PARAESTHESIA (feel tingles on your hands) outcome was unknown.            No concomitant medication information provided. No treatment information given. Reporter gave consent for safety follow up.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: crying from the pain in his head; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (crying from the pain in his head) 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 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (crying from the pain in his head). At the time of the report, HEADACHE (crying from the pain in his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No new information
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is so sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is so sore). At the time of the report, PAIN IN EXTREMITY (Arm is so sore) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: head aches; feeling nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head aches) and NAUSEA (feeling nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (head aches) and NAUSEA (feeling nausea). At the time of the report, HEADACHE (head aches) and NAUSEA (feeling nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: Severe back pain; severe pain in the side; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe back pain) and PAIN (severe pain in the side) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Severe back pain) and PAIN (severe pain in the side). At the time of the report, BACK PAIN (Severe back pain) and PAIN (severe pain in the side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were  not provided by the reporter.  Treatment information was not provided.