chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received second booster dose of the Moderna Covid-19 vaccine on 05-May-2022 lot number which was expired on 03-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second booster dose of the Moderna Covid-19 vaccine on 05-May-2022 lot number which was expired on 03-May-2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 069H21A, 017C21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second booster dose of the Moderna Covid-19 vaccine on 05-May-2022 lot number which was expired on 03-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received second booster dose of the Moderna Covid-19 vaccine on 05-May-2022 lot number which was expired on 03-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. it was reported that patient had not experienced any side effects or adverse events after all the 4 doses of moderna Covid-19 vaccine. No treatment medications were reported.   This case was linked to MOD-2022-561462, MOD-2022-561458, MOD-2022-560262, MOD-2022-560259 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Dysstasia, Headache, Illness
Clinical narrative: feeling very very ill; bed ridden for entire day; couldn't even stand up; Diarrhea; Fever; unbelievable headache / severe headache; throwing up; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. A47A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient was never tested positive with COVID-19.  Concurrent medical conditions included Allergic to cats, Pollen allergy, Migraine, Anxiety, Depression, Asthma and Sleep problem (melatonin for sleep problems.). Concomitant products included MELATONIN and ALPRAZOLAM (XANAX) for Sleep disorder.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (unbelievable headache / severe headache), VOMITING (throwing up) and PAIN IN EXTREMITY (arm was sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Head pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (unbelievable headache / severe headache), VOMITING (throwing up) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.            Patient was on medications for Migraines, anxiety, depression, asthma and allergy shots.   This case was linked to MOD-2022-561640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Live Follow-up document received includes no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: feeling very very ill; bed ridden for entire day; couldn't even stand up; Diarrhea; Fever; unbelievable headache / severe headache; throwing up; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. A47A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient was never tested positive with COVID-19.  Concurrent medical conditions included Allergic to cats, Pollen allergy, Migraine, Anxiety, Depression, Asthma and Sleep problem (melatonin for sleep problems.). Concomitant products included MELATONIN and ALPRAZOLAM (XANAX) for Sleep disorder.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (unbelievable headache / severe headache), VOMITING (throwing up) and PAIN IN EXTREMITY (arm was sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Head pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (feeling very very ill), BEDRIDDEN (bed ridden for entire day), DYSSTASIA (couldn't even stand up), DIARRHOEA (Diarrhea), PYREXIA (Fever), HEADACHE (unbelievable headache / severe headache), VOMITING (throwing up) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.            Patient was on medications for Migraines, anxiety, depression, asthma and allergy shots.   This case was linked to MOD-2022-561640 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Live Follow-up document received includes no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (still in bed) and HEADACHE (Really bad headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, A47A21A and 023M20A) for COVID-19 vaccination. Patient has never tested positive with COVID 19. Concurrent medical conditions included Migraine, Anxiety, Depression, Asthma, Allergy, Sleep problem, Allergic to cats and Pollen allergy. Concomitant products included ALPRAZOLAM (XANAX) for Sleep disorder, MELATONIN for Sleep problem. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (still in bed) and HEADACHE (Really bad headache). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Headache, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (still in bed) had not resolved and HEADACHE (Really bad headache) outcome was unknown. It was reported that patient probably took Xanax to try to sleep. This case was linked to MOD-2022-561631 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up document received includes no new information.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.). At the time of the report, ACCIDENTAL OVERDOSE (Patient is not Immune compromised however, received a third full Moderna Covid-19 dose for his first booster dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  The patient is not Immune compromised however, the patient received a third full Moderna Covid-19 dose for his first booster dose.  No treatment medication was provided by reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022; Vaccine expired on 05-May-2022 administered to patient on 09-May-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 administered to patient on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 administered to patient on 09-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 administered to patient on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial did not undergo any temperature excursions. Patient was not experiencing any symptoms. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (flu symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 INFLUENZA (flu symptoms). At the time of the report, INFLUENZA (flu symptoms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2022-561892, MOD-2022-561887 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (flu symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu symptoms). At the time of the report, INFLUENZA (flu symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2022-561891, MOD-2022-561887 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses were stored in an appropriately functioning freezer and thawed prior to administration (Vaccine was expired on 27Oct2021); administered dose after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose after the expiration date.) and PRODUCT STORAGE ERROR (doses were stored in an appropriately functioning freezer and thawed prior to administration (Vaccine was expired on 27Oct2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose after the expiration date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses were stored in an appropriately functioning freezer and thawed prior to administration (Vaccine was expired on 27Oct2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered dose after the expiration date.) and PRODUCT STORAGE ERROR (doses were stored in an appropriately functioning freezer and thawed prior to administration (Vaccine was expired on 27Oct2021)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was administered to the patient after the manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to the patient after the manufacturer date of expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084j21a, 047b21a and 046a21a) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to the patient after the manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to the patient after the manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 11-Apr-2022.  It was reported that one vial of the Moderna vaccine was administered to two patients on 09-May-2022 after the manufacturer date of expiry of 05-May-2022.  The vial had not undergone any temperature excursions.  On 20-Oct-2021, the patient received first booster dose of Moderna COVID-19 Vaccine.  On 09-May-2022, the patient received second booster dose of Moderna COVID-19 Vaccine.  The patient received Merck pneumonia vaccine on 09-May-2022 at a dose of 0.5 ml.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-561896 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered the Moderna vaccine after the manufacturer date of expiry, to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine after the manufacturer date of expiry, to a patient) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084j21a, 026d21a and 054c21a) for COVID-19 vaccination.     Patient had no allergies to medicines, food and other products. It was unknown that patient ever had COVID test or diagnosis. Patient had no history related to AE both acute or chronic illnesses at the time of vaccination.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine after the manufacturer date of expiry, to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine after the manufacturer date of expiry, to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications  were reported. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) The patient had not experienced a similar event in the past. Patient had no symptoms after receiving the vaccine. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The date vial was initially stored in the refrigerator 11-Apr-2022.The vial did not undergo any temperature excursions. No treatment details  was reported.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: had flu like symptoms for a week; a fever of 101 degree F to 103 degree F for a week; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032f21a, 012m20a and 027a21a) for COVID-19 vaccination.     Patient had no allergies. Patient has never been diagnosed or tested positive for COVID-19. The patient had no history relating to mentioned adverse event or both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included VITAMINS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week). At the time of the report, INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 degree fahrenheit to 103 degree fahrenheit (High) 101 degree Fahrenheit to 103 degree Fahrenheit.         It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications also included low dose of cholesterol medicine and low dose blood pressure medicine.  The patient received first booster dose on 08-Nov-2021 with lot number 032f21a.  The events did not cause patient to seek medical care.  No treatment drug was reported.   This case was linked to MOD-2022-561898, MOD-2022-561901, MOD-2021-177679 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness
Clinical narrative: had flu like symptoms for a week; a fever of 101 degree F to 103 degree F for a week; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032f21a, 012m20a and 027a21a) for COVID-19 vaccination.     Patient had no allergies. Patient has never been diagnosed or tested positive for COVID-19. The patient had no history relating to mentioned adverse event or both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included VITAMINS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week). At the time of the report, INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 degree fahrenheit to 103 degree fahrenheit (High) 101 degree Fahrenheit to 103 degree Fahrenheit.         It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications also included low dose of cholesterol medicine and low dose blood pressure medicine.  The patient received first booster dose on 08-Nov-2021 with lot number 032f21a.  The events did not cause patient to seek medical care.  No treatment drug was reported.   This case was linked to MOD-2022-561898, MOD-2022-561901, MOD-2021-177679 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Immunisation reaction, Influenza, Pain in extremity
Clinical narrative: had flu like symptoms for a week; a fever of 101 degree F to 103 degree F for a week; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032f21a, 012m20a and 027a21a) for COVID-19 vaccination.     Patient had no allergies. Patient has never been diagnosed or tested positive for COVID-19. The patient had no history relating to mentioned adverse event or both Acute and Chronic illnesses at the time of vaccination.  Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included VITAMINS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week). At the time of the report, INFLUENZA LIKE ILLNESS (had flu like symptoms for a week) and PYREXIA (a fever of 101 degree F to 103 degree F for a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 degree fahrenheit to 103 degree fahrenheit (High) 101 degree Fahrenheit to 103 degree Fahrenheit.         It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant medications also included low dose of cholesterol medicine and low dose blood pressure medicine.  The patient received first booster dose on 08-Nov-2021 with lot number 032f21a.  The events did not cause patient to seek medical care.  No treatment drug was reported.   This case was linked to MOD-2022-561898, MOD-2022-561901, MOD-2021-177679 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: she got sick for a few days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got sick for a few days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 immunisation.     Concurrent medical conditions included Blood cholesterol abnormal and Blood pressure abnormal. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she got sick for a few days). At the time of the report, ILLNESS (she got sick for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient used concomitant medications which include low dose of cholesterol medicine, low dose blood pressure medicine. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine The patient did not seek medical care for event (office visit, Urgent care, ER, hospitalized) No treatment drug details was reported. This case was linked to MOD-2022-561898, MOD-2022-561900, MOD-2021-177679 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness
Clinical narrative: she got sick for a few days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got sick for a few days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 immunisation.     Concurrent medical conditions included Blood cholesterol abnormal and Blood pressure abnormal. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she got sick for a few days). At the time of the report, ILLNESS (she got sick for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient used concomitant medications which include low dose of cholesterol medicine, low dose blood pressure medicine. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine The patient did not seek medical care for event (office visit, Urgent care, ER, hospitalized) No treatment drug details was reported. This case was linked to MOD-2022-561898, MOD-2022-561900, MOD-2021-177679 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Immunisation reaction, Influenza, Pain in extremity
Clinical narrative: she got sick for a few days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got sick for a few days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 immunisation.     Concurrent medical conditions included Blood cholesterol abnormal and Blood pressure abnormal. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she got sick for a few days). At the time of the report, ILLNESS (she got sick for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient used concomitant medications which include low dose of cholesterol medicine, low dose blood pressure medicine. No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine The patient did not seek medical care for event (office visit, Urgent care, ER, hospitalized) No treatment drug details was reported. This case was linked to MOD-2022-561898, MOD-2022-561900, MOD-2021-177679 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Illness, Lymphadenitis, Therapeutic response unexpected
Clinical narrative: Super sick after the 2nd dose; The allergies are no longer like before.; Glands under the throat are bothering them as they were inflamed/lymph nodes are activated; Getting tired more than usual; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Super sick after the 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (The allergies are no longer like before.), LYMPHADENITIS (Glands under the throat are bothering them as they were inflamed/lymph nodes are activated) and FATIGUE (Getting tired more than usual) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Every year, starts around April.).    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Super sick after the 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (The allergies are no longer like before.), LYMPHADENITIS (Glands under the throat are bothering them as they were inflamed/lymph nodes are activated) and FATIGUE (Getting tired more than usual). At the time of the report, ILLNESS (Super sick after the 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (The allergies are no longer like before.), LYMPHADENITIS (Glands under the throat are bothering them as they were inflamed/lymph nodes are activated) and FATIGUE (Getting tired more than usual) outcome was unknown.      The patient had allergies every year and patient went to the doctor to get treatment for their allergies but their symptoms got worse every year. No concomitant medications were provided. The patient went to the doctor or urgent care clinic because they were getting tired more than usual. Patient was prescribed with antibiotics as a treatment.   Reporter did not allow further contact
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: The syringe malfunctioned & most of the dose was lost; The syringe malfunctioned & most of the dose was lost; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (The syringe malfunctioned & most of the dose was lost) and UNDERDOSE (The syringe malfunctioned & most of the dose was lost) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-May-2022, the patient experienced DEVICE CONNECTION ISSUE (The syringe malfunctioned & most of the dose was lost) and UNDERDOSE (The syringe malfunctioned & most of the dose was lost). At the time of the report, DEVICE CONNECTION ISSUE (The syringe malfunctioned & most of the dose was lost) and UNDERDOSE (The syringe malfunctioned & most of the dose was lost) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Allergies with medications, food and other products was reported as unknown.  it was unknown if patient ever had COVID positive test or diagnosis.   Acute and Chronic illnesses at the time of vaccination was unknown.   No concomitant medication were reported.   A pharmacist over the weekend gave booster to a patient. The syringe malfunctioned & most of the dose was lost. Patient did not receive a new dose.  No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2022: Follow up document contain no new information.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Mobility decreased
Clinical narrative: Lower back pain; cannot bent over or get out of the car without feeling pain.; experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain), MOBILITY DECREASED (cannot bent over or get out of the car without feeling pain.) and ARTHRALGIA (experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A221A, 039F21A, 029120A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced BACK PAIN (Lower back pain), MOBILITY DECREASED (cannot bent over or get out of the car without feeling pain.) and ARTHRALGIA (experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Lower back pain) and ARTHRALGIA (experiencing joint pain mainly in his shoulders, hips and lower back. He states the his knees hurt both not as much as the joints) had not resolved and MOBILITY DECREASED (cannot bent over or get out of the car without feeling pain.) outcome was unknown.            The patient stated that he takes concomitant medication, but does not specify what type of concomitant medication. Patient also stated that he has no allergies to food or medication.patient stated that the joint pain has not subsist.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: red-purplish skin discoloration/from elbow to the wrist; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (red-purplish skin discoloration/from elbow to the wrist) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No pre-existing condition nor allergy was reported. On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (red-purplish skin discoloration/from elbow to the wrist). At the time of the report, SKIN DISCOLOURATION (red-purplish skin discoloration/from elbow to the wrist) was resolving.  No concomitant medications were reported. The patient had received booster dose of Moderna vaccine on 02Nov2021. It was reported that patient described reaction as non itchy and she won't notice it if she doesn't look at it. The appearance got smaller over the time but still exists till the date of reporting. Reporter contacted primary care doctor and dermatologist and no further action was taken. Reporter did not have vaccination card to provide vaccine lot number.  No treatment medications were provided.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (two or three days were sick like they had the flu, after the first dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. Patient was not having allergies to medications, food and other products. No any medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient's past medical history included COVID-19 on 03-Feb-2020. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (two or three days were sick like they had the flu, after the first dose). At the time of the report, INFLUENZA LIKE ILLNESS (two or three days were sick like they had the flu, after the first dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications was reported. It was reported that events did not cause patient to seek medical care. It was reported patient had not experienced similar events in past. No treatment information was reported. This case was linked to MOD-2022-561915 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait inability, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (two or three days were sick like they had the flu, after the first dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. Patient was not having allergies to medications, food and other products. No any medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient's past medical history included COVID-19 on 03-Feb-2020. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (two or three days were sick like they had the flu, after the first dose). At the time of the report, INFLUENZA LIKE ILLNESS (two or three days were sick like they had the flu, after the first dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications was reported. It was reported that events did not cause patient to seek medical care. It was reported patient had not experienced similar events in past. No treatment information was reported. This case was linked to MOD-2022-561915 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.; after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last; can not walk in the morning and then it gets a little better.; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (can not walk in the morning and then it gets a little better.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.) and ARTHRALGIA (after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 065k21a and 043B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-Feb-2020.   On 02-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.). In April 2022, the patient experienced GAIT INABILITY (can not walk in the morning and then it gets a little better.) and ARTHRALGIA (after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last). At the time of the report, GAIT INABILITY (can not walk in the morning and then it gets a little better.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.) and ARTHRALGIA (after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2020, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication were reported.  It was reported that patient had no allergies.  It was reported that events did not cause patient to seek medical care.  No treatment medication were reported.  It was reported after the second dose a week or two later patient ankles and knees hurt real bad on the joint, and can not  walk in the morning and then it gets a little better  Patient symptoms was same not improved or worsened.   This case was linked to MOD-2022-561913 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait inability, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.; after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last; can not walk in the morning and then it gets a little better.; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (can not walk in the morning and then it gets a little better.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.) and ARTHRALGIA (after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 065k21a and 043B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-Feb-2020.   On 02-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.). In April 2022, the patient experienced GAIT INABILITY (can not walk in the morning and then it gets a little better.) and ARTHRALGIA (after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last). At the time of the report, GAIT INABILITY (can not walk in the morning and then it gets a little better.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient took first dose on 02 May 2021 and a second dose a year later on the 04 Apr 2022.) and ARTHRALGIA (after the second dose a week or two later their ankles and knees hurt real bad on the joint/pain last) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2020, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication were reported.  It was reported that patient had no allergies.  It was reported that events did not cause patient to seek medical care.  No treatment medication were reported.  It was reported after the second dose a week or two later patient ankles and knees hurt real bad on the joint, and can not  walk in the morning and then it gets a little better  Patient symptoms was same not improved or worsened.   This case was linked to MOD-2022-561913 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose beyond 25-35 days time interval; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose beyond 25-35 days time interval) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 025AUA and 939903) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis (Get bronchitis easily) and Asthma (Have asmah).   On 02-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose beyond 25-35 days time interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose beyond 25-35 days time interval) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-561925 (Patient Link).