chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Diagnosed with cancer; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (Diagnosed with cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 NEOPLASM MALIGNANT (Diagnosed with cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (Diagnosed with cancer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEOPLASM MALIGNANT (Diagnosed with cancer) to be not related.    No concomitant medication was reported.  Reporter stated that the patient previously received 1st, 2nd and 1st booster dose of Moderna COVID-19 Vaccine, and he was recently diagnosed with cancer. Patient needs to start chemotherapy next week from date of report.  Company comment:This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious (important medical event) event of Neoplasm malignant, unspecified days after receiving the booster dose of COVID -19 vaccination with mRNA-1273 vaccine. The patient reported that he previously received first and second doses and then the first booster dose of mRNA-1273. He was recently diagnosed with cancer and had to start chemotherapy. His HCP mentioned that cancer was not caused by vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious (important medical event) event of Neoplasm malignant, unspecified days after receiving the booster dose of COVID -19 vaccination with mRNA-1273 vaccine. The patient reported that he previously received first and second doses and then the first booster dose of mRNA-1273. He was recently diagnosed with cancer and had to start chemotherapy. His HCP mentioned that cancer was not caused by vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injected arm after first primary shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injected arm after first primary shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injected arm after first primary shot). On 21-Feb-2021, VACCINATION SITE PAIN (Sore injected arm after first primary shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-557549, MOD-2022-557681, MOD-2022-557682 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Immunisation reaction, Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Having a reaction to the vaccine; Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch; Second shot was giving to lowbetween her shoulder and elbowand got reddish; Arm got very sore; Patient went to get the second booster and got .05ml instead of .25ml; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Having a reaction to the vaccine), VACCINATION SITE WARMTH (Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch), PAIN IN EXTREMITY (Arm got very sore), VACCINATION SITE ERYTHEMA (Second shot was giving to lowbetween her shoulder and elbowand got reddish) and ACCIDENTAL UNDERDOSE (Patient went to get the second booster and got .05ml instead of .25ml) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .05 milliliter. On 14-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient went to get the second booster and got .05ml instead of .25ml). On 15-Apr-2022, the patient experienced PAIN IN EXTREMITY (Arm got very sore). On an unknown date, the patient experienced IMMUNISATION REACTION (Having a reaction to the vaccine), VACCINATION SITE WARMTH (Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch) and VACCINATION SITE ERYTHEMA (Second shot was giving to lowbetween her shoulder and elbowand got reddish). At the time of the report, IMMUNISATION REACTION (Having a reaction to the vaccine), VACCINATION SITE WARMTH (Second shot was giving to lowbetween her shoulder and elbowand got reddish and was hot to the touch), PAIN IN EXTREMITY (Arm got very sore), VACCINATION SITE ERYTHEMA (Second shot was giving to lowbetween her shoulder and elbowand got reddish) and ACCIDENTAL UNDERDOSE (Patient went to get the second booster and got .05ml instead of .25ml) outcome was unknown.            No concomitant medications were reported. It was reported that the patient went to get the second booster, and got 0.05ml instead of 0.25ml, because there were negligence when they were processing the syringes. And 45 minutes later the patient was asked to go back to the clinic and get a 2ml doses to complete dosages of a booster. After the second booster the patient noticed the second shot was giving to low between shoulder and elbow and got reddish, had to go to the emergency room, because patient's friend thought it was infected, and was hot to the touch. Doctor said patient was having a reaction to the vaccine, and that the immune system was working.  Patient stated that with all the Moderna covid19 vaccines her arm got really sore. No treatment information was reported.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Threw-up after 2nd primary shot/Vomiting after 2nd primary shot; Headache after 2nd primary shot; Muscle Ache after 2nd primary shot; Chills after 2nd primary shot; Nausea after 2nd primary shot; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Threw-up after 2nd primary shot/Vomiting after 2nd primary shot), HEADACHE (Headache after 2nd primary shot), MYALGIA (Muscle Ache after 2nd primary shot), CHILLS (Chills after 2nd primary shot) and NAUSEA (Nausea after 2nd primary shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VOMITING (Threw-up after 2nd primary shot/Vomiting after 2nd primary shot), HEADACHE (Headache after 2nd primary shot), MYALGIA (Muscle Ache after 2nd primary shot), CHILLS (Chills after 2nd primary shot) and NAUSEA (Nausea after 2nd primary shot). In March 2021, VOMITING (Threw-up after 2nd primary shot/Vomiting after 2nd primary shot), HEADACHE (Headache after 2nd primary shot), MYALGIA (Muscle Ache after 2nd primary shot), CHILLS (Chills after 2nd primary shot) and NAUSEA (Nausea after 2nd primary shot) had resolved.            Concomitant medications was not provided by the reporter. The patient had events for 10 hours. Treatment information was not provided.   This case was linked to MOD-2022-557682, MOD-2022-557486, MOD-2022-557681 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored at room temperature greater than 24 hours after first puncture and then administered; Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture) and PRODUCT STORAGE ERROR (Vaccine stored at room temperature greater than 24 hours after first puncture and then administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022 at 6:20 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-May-2022 at 6:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored at room temperature greater than 24 hours after first puncture and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given at greater than 24 hours (Room Temperature)/Vaccine given past 12 hours of first puncture) and PRODUCT STORAGE ERROR (Vaccine stored at room temperature greater than 24 hours after first puncture and then administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was taken out of the freezer on 22-Apr-2022. Vial was taken out of refrigerator on 01-May-2022. The vial was stored at room temperature after it was first punctured on 01-May-2022, at 1:55 PM. Total time of vial at room temperature was around 28 Hours, 25 Minutes.  No treatment information was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm hurts; Arm feels numb; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) and HYPOAESTHESIA (Arm feels numb) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson (1st Dose). Past adverse reactions to the above products included No adverse event with Johnson & Johnson.    On 02-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced PAIN IN EXTREMITY (Arm hurts) and HYPOAESTHESIA (Arm feels numb). The patient was treated with IBUPROFEN for Pain in arm and Numbness of upper arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown and HYPOAESTHESIA (Arm feels numb) had not resolved.            No concomitant medication was provided.  Patient received the first booster of the Moderna COVID 19 vaccine on 02-May-2022.   Patient took Ibuprofen as treatment, but patient arm was still feeling numb.   This case was linked to MOD-2022-557662 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling hand; Sored left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling hand) and PAIN IN EXTREMITY (Sored left arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (first dose). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 02-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced PARAESTHESIA (Tingling hand) and PAIN IN EXTREMITY (Sored left arm). At the time of the report, PARAESTHESIA (Tingling hand) and PAIN IN EXTREMITY (Sored left arm) outcome was unknown.            It was reported that the patient does not take any concomitant medication.  Patient had not taken medication to fight the symptoms.   This case was linked to MOD-2022-557642 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fall, Fatigue, Inappropriate schedule of product administration
Clinical narrative: fell; Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021; chills; exhaustion; flu like reactions; weakness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), FALL (fell), CHILLS (chills) and FATIGUE (exhaustion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and RA.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021). In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion). On an unknown date, the patient experienced FALL (fell). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in November 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), FALL (fell), CHILLS (chills), FATIGUE (exhaustion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021) outcome was unknown.            No concomitant medications were reported. Reporter stated that events usually started later the same day as or the next day after receiving the third dose.   This case was linked to MOD-2022-557659, MOD-2022-557548 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: fell; Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021; chills; exhaustion; flu like reactions; weakness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), FALL (fell), CHILLS (chills) and FATIGUE (exhaustion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and RA.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021). In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), CHILLS (chills) and FATIGUE (exhaustion). On an unknown date, the patient experienced FALL (fell). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in November 2021 for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like reactions), ASTHENIA (weakness), FALL (fell), CHILLS (chills), FATIGUE (exhaustion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Being immunocompromised received 3rd dose on 01Nov2021 while 2nd dose on 08Mar2021) outcome was unknown.            No concomitant medications were reported. Reporter stated that events usually started later the same day as or the next day after receiving the third dose.   This case was linked to MOD-2022-557659, MOD-2022-557548 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Mild muscle ache; Mild chills; A little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild muscle ache), CHILLS (Mild chills) and HEADACHE (A little headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 041L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced MYALGIA (Mild muscle ache), CHILLS (Mild chills) and HEADACHE (A little headache). On 10-Dec-2021, MYALGIA (Mild muscle ache), CHILLS (Mild chills) and HEADACHE (A little headache) had resolved.            Concomitant medications were not reported.  On 10-Dec-2021, the patient received the first booster dose of Moderna vaccine.  The patient experienced the adverse events for 5 hours and it did not felt as bad as after the previous Moderna vaccine dose.  The patient had informed the physician about the reactions and had not taken any medicine.   This case was linked to MOD-2022-557486, MOD-2022-557682, MOD-2022-557549 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Headache, Insomnia, Myalgia
Clinical narrative: Could not sleep; Very bad headache/Massive headache; body ache; Throwing up violently; Spent all day in bed; Did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good), BEDRIDDEN (Spent all day in bed), INSOMNIA (Could not sleep), HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 058H21A, 041L20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022 at 11:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022 at 11:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Did not feel good). On 01-May-2022, the patient experienced BEDRIDDEN (Spent all day in bed), HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache). 01-May-2022, the patient experienced VOMITING (Throwing up violently). On 01-May-2022 at 2:00 AM, the patient experienced INSOMNIA (Could not sleep). On 01-May-2022, VOMITING (Throwing up violently) had resolved. On 02-May-2022, BEDRIDDEN (Spent all day in bed) and INSOMNIA (Could not sleep) had resolved. On 03-May-2022, HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache) had resolved. At the time of the report, FEELING ABNORMAL (Did not feel good) outcome was unknown.            No concomitant medication information was provided by the reporter.  On 01-May-2022, by midnight, the patient had very bad headache and body ache and by 02.00 A.M., the patient was throwing up violently, had a massive headache and could not sleep.  The patient had informed the physician about the reactions and had not taken any medicine.  No treatment medication was reported.   This case was linked to MOD-2022-557681, MOD-2022-557486, MOD-2022-557549 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Could not sleep; Very bad headache/Massive headache; body ache; Throwing up violently; Spent all day in bed; Did not feel good; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good), BEDRIDDEN (Spent all day in bed), INSOMNIA (Could not sleep), HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 058H21A, 041L20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022 at 11:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022 at 11:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (Did not feel good). On 01-May-2022, the patient experienced BEDRIDDEN (Spent all day in bed), HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache). 01-May-2022, the patient experienced VOMITING (Throwing up violently). On 01-May-2022 at 2:00 AM, the patient experienced INSOMNIA (Could not sleep). On 01-May-2022, VOMITING (Throwing up violently) had resolved. On 02-May-2022, BEDRIDDEN (Spent all day in bed) and INSOMNIA (Could not sleep) had resolved. On 03-May-2022, HEADACHE (Very bad headache/Massive headache) and MYALGIA (body ache) had resolved. At the time of the report, FEELING ABNORMAL (Did not feel good) outcome was unknown.            No concomitant medication information was provided by the reporter.  On 01-May-2022, by midnight, the patient had very bad headache and body ache and by 02.00 A.M., the patient was throwing up violently, had a massive headache and could not sleep.  The patient had informed the physician about the reactions and had not taken any medicine.  No treatment medication was reported.   This case was linked to MOD-2022-557681, MOD-2022-557486, MOD-2022-557549 (Patient Link).
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose of expired Moderna Covid-19 vaccine was given to a patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of expired Moderna Covid-19 vaccine was given to a patient.) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Patient had no allergies to medications, food, and other product.     On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of expired Moderna Covid-19 vaccine was given to a patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of expired Moderna Covid-19 vaccine was given to a patient.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 22-Apr-2022 the vial was initially stored in the refrigerator. The vial did not undergo any previous temperature excursions. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Follow up received: Date the vial was initially stored in the refrigerator was updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-MAY-2022; expiration date of 01-May-2022 but doses were given today 04-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given today 04-May-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-MAY-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given today 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given today 04-May-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 01-APR-2022 and administered on 04-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 by reporter. The vial was initially stored in the refrigerator on 01-APR-2022. The vial did not undergo any temperature excursions. It was reported that patient have not called to report any adverse events No treatment medications were reported by reporter.   This case was linked to MOD-2022-558253 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Source document contains no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022; expiration date of 01-May-2022 but doses were given 04-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given 04-May-2022) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given 04-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date of 01-May-2022 but doses were given 04-May-2022) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered on 04-May-2022 was initially stored in the refrigerator on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Date the vial was initially stored in the refrigerator: 01-Apr-2022.  Vial did not undergo any temperature excursions.  It was started that the patient has not called to report any adverse events.  Treatment medications were not provided.   This case was linked to MOD-2022-558234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: The follow up information received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rosacea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rosacea (purplish spots on face) and fatigue (extreme fatigue) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. It was reported the patient declined providing information on pre-existing condition and allergy. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced rosacea (purplish spots on face) and fatigue (extreme fatigue). At the time of the report, rosacea (purplish spots on face) and fatigue (extreme fatigue) outcome: unknown. No concomitant medication or treatment information provided. The patient received a booster dose.  The caller declined to provide contact information when agent tried to clarify few times. She said she was angry with her current side effects. No further contact allowed.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received the 2nd booster from a vial that had been open for more than 12 hours.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received the 2nd booster from a vial that had been open for more than 12 hours.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received the 2nd booster from a vial that had been open for more than 12 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received the 2nd booster from a vial that had been open for more than 12 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. The vial was initially stored in the refrigerator 2May 2022, the vial was first punctured 3 may 2022 at 11:00 am and at time of administration of vaccine was 4 may 2022, around 9 am. The vial stored post puncture was in Room temperature. Vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8 to 25 degree Celsius 46° to 77°F) was for 22 hours. No Adverse event were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2022: Follow-up received contain no significant information
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Vomiting
Clinical narrative: Cramps & stuff; She's throwing up and having violent vomiting; chills; Body aches; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCLE SPASMS (Cramps & stuff), VOMITING (She's throwing up and having violent vomiting), CHILLS (chills), MYALGIA (Body aches) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 014F21A, 016M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Gluten sensitivity, Lactose intolerant, Egg allergy and Seasonal allergy.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced MUSCLE SPASMS (Cramps & stuff), VOMITING (She's throwing up and having violent vomiting), CHILLS (chills), MYALGIA (Body aches) and HEADACHE (headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-May-2022 at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) on 04-May-2022 at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramps & stuff), VOMITING (She's throwing up and having violent vomiting), CHILLS (chills), MYALGIA (Body aches) and HEADACHE (headache) had not resolved.            Concomitant medication information was not provided by the reporter.  It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had any acute and chronic illnesses at the time of vaccination. It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.   Patient began vomiting about 45 min ago the call. It was reported that none of the events caused the patient to seek medical care. It was unknown if the patient had experienced similar events in the past. It was said that the patient symptoms had worsened. Patient never had any of the events with the other shots. Patient had took Aleve 1.5 hours before the call and patient had asked for Benadryl after the shot and got it.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: Minor bottom lip swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Minor bottom lip swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had never tested positive or diagnosed with COVID-19.  The patient's past medical history included Scar (old injury has resolved) and Dermal filler injection.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Nov-2021, the patient experienced LIP SWELLING (Minor bottom lip swelling). At the time of the report, LIP SWELLING (Minor bottom lip swelling) had resolved.            No concomitant medication information was provided.  The patient had the similar event Minor bottom lip swelling with first dose as well.  No treatment medication information was given.   This case was linked to MOD-2022-558775, MOD-2021-079367 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash
Clinical narrative: Minor bottom lip swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Minor bottom lip swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had never tested positive or diagnosed with COVID-19.  The patient's past medical history included Scar (old injury has resolved) and Dermal filler injection.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Nov-2021, the patient experienced LIP SWELLING (Minor bottom lip swelling). At the time of the report, LIP SWELLING (Minor bottom lip swelling) had resolved.            No concomitant medication information was provided.  The patient had the similar event Minor bottom lip swelling with first dose as well.  No treatment medication information was given.   This case was linked to MOD-2022-558775, MOD-2021-079367 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not have any allergies in past.  No information was reported about positive Covid-19 test nor about its diagnosis.  Patient had not received any other vaccines 1 month prior to receiving  moderna Covid-19  vaccine.  Concurrent medical conditions included Scar (Old scar tissue from an old injury ,No change old injury has resolved).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).). At the time of the report, VACCINATION SITE RASH (Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).) outcome was unknown.     Patient stated she had never received any dermal face fillers in the past.  Concomitant drugs were not reported. It was reported that patient experienced a similar events in the past from another Moderna dose. She also mentioned  after receiving the second Moderna primary series dose, she did not experience any adverse events. Treatment details were not given.   This case was linked to MOD-2022-558751, MOD-2021-079367 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site rash
Clinical narrative: Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not have any allergies in past.  No information was reported about positive Covid-19 test nor about its diagnosis.  Patient had not received any other vaccines 1 month prior to receiving  moderna Covid-19  vaccine.  Concurrent medical conditions included Scar (Old scar tissue from an old injury ,No change old injury has resolved).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).). At the time of the report, VACCINATION SITE RASH (Patient experienced the Moderna Rash below the vaccination site (IM left deltoid).) outcome was unknown.     Patient stated she had never received any dermal face fillers in the past.  Concomitant drugs were not reported. It was reported that patient experienced a similar events in the past from another Moderna dose. She also mentioned  after receiving the second Moderna primary series dose, she did not experience any adverse events. Treatment details were not given.   This case was linked to MOD-2022-558751, MOD-2021-079367 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after First Dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after First Dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus (No medications).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (Diarrhea after First Dose). At the time of the report, DIARRHOEA (Diarrhea after First Dose) had not resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.  No concomitant medication information was provided.  MD did refer him to a gastroenterologist but he did not make a follow up appointment with gastroenterologist. No treatment medication information was given.   This case was linked to MOD-2022-558762, MOD-2022-558763 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea kind of continued but it did not get worst; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea kind of continued but it did not get worst) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus (No Medications).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIARRHOEA (Diarrhea kind of continued but it did not get worst). At the time of the report, DIARRHOEA (Diarrhea kind of continued but it did not get worst) had not resolved.            No concomitant medication information was provided.  MD did refer him to a gastroenterologist, but he did not make a follow up appointment with gastroenterologist. No treatment medication information was provided.   This case was linked to MOD-2022-558756, MOD-2022-558763 (Patient Link).   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022; patient was administered with an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     Patient has no acute illness at the time of vaccination and up to one month before. It was unknown that patient ever tested positive or diagnosed with COVID-19. It was also unknown that if patient had any chronic conditions.  Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2022 at 1:40 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Apr-2022 at 1:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 25-Apr-2022 and administered to patient on 25-Apr-22, after manufacturer date of expiry 24-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (patient was administered with an expired dose) to be related.    The race of the patient was reported.  Concomitant medication information was unknown.  The vials were initially stored in refrigerator on 25-Apr-2022. The vials has not undergone temperature excursion. It was reported Moderna booster was given on 25-Apr-2022, thinking that expiration date was 27-Apr-2022. Later noticed that vaccine expiration date was 24-Apr-2022.  No treatment medication information was given.