chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Vaccination complication
Clinical narrative: vaccine side effect I've experienced; monthly cycle twice per month since recieving the vaccination , heavy menstruation; this is the first time I've had irregularies in menstruation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccine side effect I've experienced), HEAVY MENSTRUAL BLEEDING (monthly cycle twice per month since recieving the vaccination , heavy menstruation) and MENSTRUATION IRREGULAR (this is the first time I've had irregularies in menstruation) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (monthly cycle twice per month since recieving the vaccination , heavy menstruation) and MENSTRUATION IRREGULAR (this is the first time I've had irregularies in menstruation). On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccine side effect I've experienced). At the time of the report, VACCINATION COMPLICATION (vaccine side effect I've experienced) outcome was unknown and HEAVY MENSTRUAL BLEEDING (monthly cycle twice per month since recieving the vaccination , heavy menstruation) and MENSTRUATION IRREGULAR (this is the first time I've had irregularies in menstruation) had not resolved.            Concomitant medications information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant Follow-up added to include phone number, height, weight,race,Adverse events
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant drugs are provided   This case was linked to MOD-2021-325771 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Vaginal haemorrhage
Clinical narrative: knot on their collar bone on the left side,almost like a blood clot near their neck; vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MASS (knot on their collar bone on the left side,almost like a blood clot near their neck) and VAGINAL HAEMORRHAGE (vaginal bleeding) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). On an unknown date, the patient experienced MASS (knot on their collar bone on the left side,almost like a blood clot near their neck). At the time of the report, MASS (knot on their collar bone on the left side,almost like a blood clot near their neck) outcome was unknown and VAGINAL HAEMORRHAGE (vaginal bleeding) had not resolved.            No concomitant medications was provided.  Treatment- Assured all day pain relieve
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 16-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: died from COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (died from COVID) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced COVID-19 (died from COVID) (seriousness criterion death). The patient died in September 2021. The reported cause of death was died from covid. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Company comment: This case concerns a 48-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date of September. No autopsy report was provided. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 48-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date of September. No autopsy report was provided. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: died from COVID
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: same pain after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (same pain after receiving the vaccine) 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 PAIN (same pain after receiving the vaccine). At the time of the report, PAIN (same pain after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Ageusia
Clinical narrative: lost sense of taste; adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost sense of taste) and ADVERSE REACTION (adverse reaction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) and FLUOXETINE HYDROCHLORIDE (FLUOXETINE [FLUOXETINE HYDROCHLORIDE]) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced AGEUSIA (lost sense of taste) and ADVERSE REACTION (adverse reaction). At the time of the report, AGEUSIA (lost sense of taste) and ADVERSE REACTION (adverse reaction) had not resolved.            Treatment was not specified.  Patient declares no history of Covid-19 infection; Sender's Comments: This case concerns a 59 year-old, female patient with concomitant use of levothyroxine and fluoxetine, who experienced the non serious unexpected adverse event of special interest of ageusia. The event occurred after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing would be given. The concomitant use of levothyroxine and fluoxetine, remain as confounders. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache, Hot flush, Hypoaesthesia
Clinical narrative: did not get her second dose; Lots of headache/I wake up with headaches; I have spasms in my back; Tightness in my chest/Lots of tightness; Numbness in my fingers; Pain in my arms and chest; Pain in my arms and chest; My body felt flushy and hot that lasted 2- 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest) and CHEST PAIN (Pain in my arms and chest) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her second dose ). The patient was treated with METOPROLOL for Adverse reaction, at a dose of 1 DF twice a day. At the time of the report, MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get her second dose ) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything seemed fine.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication of the patient was not reported.  The patient did not know if she had fever. The patient had different issues every day and was still experiencing all side effects.  The patient did not get her second dose because she was referred to her cardiologist who gave her medicine that did not work. Mother of the patient died with COVID in December and all of her family members tested positive for COVID, only her had not.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Product dose omission issue
Clinical narrative: did not get her second dose; Lots of headache/I wake up with headaches; I have spasms in my back; Tightness in my chest/Lots of tightness; Numbness in my fingers; Pain in my arms and chest; Pain in my arms and chest; My body felt flushy and hot that lasted 2- 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest) and CHEST PAIN (Pain in my arms and chest) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get her second dose ). The patient was treated with METOPROLOL for Adverse reaction, at a dose of 1 DF twice a day. At the time of the report, MUSCLE SPASMS (I have spasms in my back), CHEST DISCOMFORT (Tightness in my chest/Lots of tightness), HYPOAESTHESIA (Numbness in my fingers), PAIN IN EXTREMITY (Pain in my arms and chest), CHEST PAIN (Pain in my arms and chest), HOT FLUSH (My body felt flushy and hot that lasted 2- 3 days) and HEADACHE (Lots of headache/I wake up with headaches) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not get her second dose ) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) everything seemed fine.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication of the patient was not reported.  The patient did not know if she had fever. The patient had different issues every day and was still experiencing all side effects.  The patient did not get her second dose because she was referred to her cardiologist who gave her medicine that did not work. Mother of the patient died with COVID in December and all of her family members tested positive for COVID, only her had not.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising, Vaccination site haemorrhage, Wrong technique in product usage process
Clinical narrative: A bruise at the injection site; she thinks of vaccine being administered in the blood stream and not in to the muscle; While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein; Gusting blood from the injection site after the administration of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Gusting blood from the injection site after the administration of the vaccine), VACCINATION SITE BRUISING (A bruise at the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she thinks of vaccine being administered in the blood stream and not in to the muscle) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Gusting blood from the injection site after the administration of the vaccine), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she thinks of vaccine being administered in the blood stream and not in to the muscle) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein). On 21-Sep-2021, the patient experienced VACCINATION SITE BRUISING (A bruise at the injection site). On 20-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (she thinks of vaccine being administered in the blood stream and not in to the muscle) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (While injecting, the vaccine provider did not make sure if the needle went in to her muscle or vein) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (Gusting blood from the injection site after the administration of the vaccine) and VACCINATION SITE BRUISING (A bruise at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not on any blood thinners, including Aspirin and Ibuprofen.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051E21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with Surgery (Patient had appendicitis and had surgery to get it removed) for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.            No concomitant medication details were reported. No treatment medication details was reported. Patient said she was in good health and did not have any underlying medical condition nor takes any medication. However, two days after receiving her second dose patient had appendicitis and had surgery to get it removed.  Company comment - This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Appendicitis.  The event occurred approximately 30 days after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.; Sender's Comments: This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected serious event of Appendicitis.  The event occurred approximately 30 days after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Illness, Influenza
Clinical narrative: extremely ill/sick; aches/pains; flu symptoms; high fever/102 F fever; extreme fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever) and FATIGUE (extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer of lung stage IV (terminal cancer patient).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-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 ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever), FATIGUE (extreme fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever), FATIGUE (extreme fatigue) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         The patient was on several medications but did not mention them.   The patient received vaccine in unknown arm.   This case was linked to MOD-2021-326237 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: extremely ill/sick; aches/pains; flu symptoms; high fever/102 F fever; extreme fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever) and FATIGUE (extreme fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer of lung stage IV (terminal cancer patient).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-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 ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever), FATIGUE (extreme fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (extremely ill/sick), PAIN (aches/pains), INFLUENZA (flu symptoms), PYREXIA (high fever/102 F fever), FATIGUE (extreme fatigue) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.         The patient was on several medications but did not mention them.   The patient received vaccine in unknown arm.   This case was linked to MOD-2021-326237 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021); Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)). On 20-Sep-2021, PRODUCT STORAGE ERROR (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) and EXPIRED PRODUCT ADMINISTERED (Facility administered by error a dose from a vial that spent more than 30 days on the fridge (since 19Aug2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains significant information. Race and Ethnicity information were updated. Vaccination facility information and both dose details were updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Fall, Product dose omission issue
Clinical narrative: Fell; Broke ankle; Received 1st dose about 30 days ago; unsure when will receive her 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of FALL (Fell), ANKLE FRACTURE (Broke ankle) and PRODUCT DOSE OMISSION ISSUE (Received 1st dose about 30 days ago; unsure when will receive her 2nd dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (Fell), ANKLE FRACTURE (Broke ankle) and PRODUCT DOSE OMISSION ISSUE (Received 1st dose about 30 days ago; unsure when will receive her 2nd dose). At the time of the report, FALL (Fell) and ANKLE FRACTURE (Broke ankle) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received 1st dose about 30 days ago; unsure when will receive her 2nd dose) 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.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, 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 (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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.   No concomitant medications were provided.  No treatment medications were provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered from a vial that was more than 30 days on the fridge; vial that spent more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) and PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge). On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-326421, MOD-2021-326307, MOD-2021-326468, MOD-2021-326218, MOD-2021-326383, MOD-2021-326432, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant Follow up received. Patient initials was updated . Race and ethnicity was added. Dose 2 vaccine administration date, batch number, anatomical location  was added.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2th dose received after 12 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2th dose received after 12 days) 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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2th dose received after 12 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2th dose received after 12 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No tTreatment medications were reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disturbance in attention, Dizziness, Dysarthria, Fatigue
Clinical narrative: It feels like "long COVID"- still having side effects for weeks to months; difficulty concentrating/issues focusing; dizziness; memory issues/wooziness; balancing issues; Numbness in face; burning sensation in the tongue; difficulty articulating; fogginess; fatigue; have not got the 2nd shot; the whole left side was numb/got some numbness on the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness) and BALANCE DISORDER (balancing issues) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm). On an unknown date, the patient experienced MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess), FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot). At the time of the report, MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess) and FATIGUE (fatigue) had not resolved, HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm) was resolving and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) The MRI is normal. On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) has no antibodies, has not contracted COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter was reported that he was experienced side effects are all intermittent and been suffering for about 2 months Reporter reported as  side effects at variant degrees of severity Concomitant medications includes Vitamins and Minerals.  On 09-Aug-2021, the whole left side was numb.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Magnetic resonance imaging, Malaise, Memory impairment
Clinical narrative: It feels like "long COVID"- still having side effects for weeks to months; difficulty concentrating/issues focusing; dizziness; memory issues/wooziness; balancing issues; Numbness in face; burning sensation in the tongue; difficulty articulating; fogginess; fatigue; have not got the 2nd shot; the whole left side was numb/got some numbness on the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness) and BALANCE DISORDER (balancing issues) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm). On an unknown date, the patient experienced MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess), FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot). At the time of the report, MALAISE (It feels like "long COVID"- still having side effects for weeks to months), DISTURBANCE IN ATTENTION (difficulty concentrating/issues focusing), DIZZINESS (dizziness), MEMORY IMPAIRMENT (memory issues/wooziness), BALANCE DISORDER (balancing issues), HYPOAESTHESIA (Numbness in face), TONGUE DISCOMFORT (burning sensation in the tongue), DYSARTHRIA (difficulty articulating), FEELING ABNORMAL (fogginess) and FATIGUE (fatigue) had not resolved, HYPOAESTHESIA (the whole left side was numb/got some numbness on the whole arm) was resolving and PRODUCT DOSE OMISSION ISSUE (have not got the 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) The MRI is normal. On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) has no antibodies, has not contracted COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter was reported that he was experienced side effects are all intermittent and been suffering for about 2 months Reporter reported as  side effects at variant degrees of severity Concomitant medications includes Vitamins and Minerals.  On 09-Aug-2021, the whole left side was numb.