chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021; Dose administered after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 08 Nov 2021, moved to refrigerator on 11 Nov 2021, Administered on 12 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date moved to refrigeration 11 Nov 2021. No treatment information was reported.   This case was linked to MOD-2022-570637, MOD-2022-570643 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021; Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021) and EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021). At the time of the report, PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021) and EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021   This case was linked to MOD-2022-570635, MOD-2022-570643 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Change in sense of smell; Change in sense of taste; This spontaneous case was reported by a patient and describes the occurrence of PAROSMIA (Change in sense of smell) and TASTE DISORDER (Change in sense of taste) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Change in sense of smell) and TASTE DISORDER (Change in sense of taste). At the time of the report, PAROSMIA (Change in sense of smell) and TASTE DISORDER (Change in sense of taste) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications details were reported.  Patient received Moderna Covid-19 vaccine and since then the sense of smell and taste had changed. Patient did not provide additional information and said she would call Moderna back to providemore information. Patient did  not had vaccination card with herself when asked.   No treatment medications details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass, Immunisation reaction
Clinical narrative: Open heart surgery/Triple vessel bypass graft; Felt a little iffy after Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CORONARY ARTERY BYPASS (Open heart surgery/Triple vessel bypass graft) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CORONARY ARTERY BYPASS (Open heart surgery/Triple vessel bypass graft) (seriousness criterion medically significant) and IMMUNISATION REACTION (Felt a little iffy after Covid vaccine). At the time of the report, CORONARY ARTERY BYPASS (Open heart surgery/Triple vessel bypass graft) and IMMUNISATION REACTION (Felt a little iffy after Covid vaccine) was resolving.            No concomitant medications were reported. It was unknown if the patient was enrolled in a COVID-19 vaccine Trial. Patient was felt iffy after the COVID vaccine and it was about for a day. No treatment medications were reported.  Company Comment: This spontaneous case concerns an adult male patient with unknown age with no reported medical history who experienced the unexpected serious event (important medical event) of Coronary Artery Bypass. The event Coronary Artery Bypass occurred on unknown date after a dose of mRNA-1273. Outcome of the event was resolving.  Adult male and co suspect adalimumab remains a confounder. Non serious event of Immunisation Reaction was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with unknown age with no reported medical history who experienced the unexpected serious event (important medical event) of Coronary Artery Bypass. The event Coronary Artery Bypass occurred on unknown date after a dose of mRNA-1273. Outcome of the event was resolving.  Adult male and co suspect adalimumab remains a confounder. Non serious event of Immunisation Reaction was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 034F21A, 009C21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Asthmatic and Immunocompromised.   On 30-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 08-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, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Patient was on medications and did not want to provide the medications because it was a lot of them. No treatment information was provided.   This case was linked to MOD-2022-570997 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Immunodeficiency
Clinical narrative: immune deficiency problem after booster; bad issue after booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (immune deficiency problem after booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (immune deficiency problem after booster) (seriousness criterion medically significant) and IMMUNISATION REACTION (bad issue after booster). At the time of the report, IMMUNODEFICIENCY (immune deficiency problem after booster) and IMMUNISATION REACTION (bad issue after booster) outcome was unknown.            No concomitant medication reported. No treatment medication details reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore left arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (sore left arm) and FATIGUE (Fatigue) 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.   Patient was not immunocompromised. No treatment medication was reported.   This case was linked to MOD-2022-570982, MOD-2022-570996, MOD-2022-571007, MOD-2022-571008 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial  did not undergo any temperature excursions. All vials were removed from freezer just prior to administration times. No concomitant medications information was reported.   This case was linked to MOD-2022-570980, MOD-2022-570985, MOD-2022-571139 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Significant follow-up appended- Lot number added.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date; Received expired 2nd booster vaccine beyond MFG Expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster vaccine beyond MFG Expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster vaccine beyond MFG Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster vaccine beyond MFG Expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19MAY2022/ Received expired 2nd booster vaccine beyond MFG Expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  On 19-MAY-2022, the vial was initially stored in the refrigerator and on same date the vial were administrated to the patient. The vial did not undergo any temperature excursions. The patient received expired 2nd booster vaccine beyond manufacturing expiry date.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Fatigue, Pain in extremity
Clinical narrative: sore left arm; Fatigue; Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), FATIGUE (Fatigue) and ACCIDENTAL UNDERDOSE (Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Patient was not immunocompromised.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), FATIGUE (Fatigue) and ACCIDENTAL UNDERDOSE (Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021). At the time of the report, PAIN IN EXTREMITY (sore left arm), FATIGUE (Fatigue) and ACCIDENTAL UNDERDOSE (Caller partner received his second Moderna COVID-19 vaccine booster shot on 8FEB2021) outcome was unknown.            No treatment medications were reported by the reporter.   This case was linked to MOD-2022-570966, MOD-2022-570996, MOD-2022-571007, MOD-2022-571008 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45; Administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 8:45 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 24-Mar-2022 and removed from freezer just prior to administration time on 05-Apr-2022 at 08:45) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported from a pharmacist of a hospital that recently found out the patient was administered with an expired vaccine. There was no information on date of the vial that was initially stored in the refrigerator. The vial had not undergone any temperature excursions. The vial was removed from freezer just prior to administration time. No treatment medications were reported.   This case was linked to MOD-2022-570968, MOD-2022-570980, MOD-2022-571139 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow up received includes batch number was added, start time was added for suspect vaccine and product storage error event was added.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: It was a bad 24 hours; Chills; Fever that climbed to above 102 degrees Farenheight; Bad body aches; Fatigue; Injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Injection site arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Injection site arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: climbed to above 102 degrees farenheight (High) climbed to above 102 degrees Farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-571008, MOD-2022-571007 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: It was a bad 24 hours; Chills; Fever that climbed to above 102 degrees Farenheight; Bad body aches; Fatigue; Injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Injection site arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (It was a bad 24 hours), CHILLS (Chills), PYREXIA (Fever that climbed to above 102 degrees Farenheight), MYALGIA (Bad body aches), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Injection site arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: climbed to above 102 degrees farenheight (High) climbed to above 102 degrees Farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-571008, MOD-2022-571007 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation reaction, Product storage error
Clinical narrative: patient received a dose of Moderna from a vial that had been punctured for more than 12 hours; vial stored post puncture in R/T FRIDGE and it was never really left out at room temp; adverse event; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (adverse event), EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (vial stored post puncture in R/T FRIDGE and it was never really left out at room temp) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 013F21A, 014M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022 at 1:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced IMMUNISATION REACTION (adverse event) and PRODUCT STORAGE ERROR (vial stored post puncture in R/T FRIDGE and it was never really left out at room temp). On 18-May-2022 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours). At the time of the report, IMMUNISATION REACTION (adverse event), EXPIRED PRODUCT ADMINISTERED (patient received a dose of Moderna from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (vial stored post puncture in R/T FRIDGE and it was never really left out at room temp) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 12-May-2022, the vial was initially stored in the refrigerator. On 17-May-2022, at 2.16 pm, the vial was first punctured.   The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-571179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Live Significant Follow up information received, Patient information and reporter information was updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Overdose, Vaccination site pain
Clinical narrative: Patient and her husband received the third full dose of 100mcg and are not immunocompromised; had fatigue; left arm was really hurting; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Patient and her husband received the third full dose of 100mcg and are not immunocompromised), FATIGUE (had fatigue) and VACCINATION SITE PAIN (left arm was really hurting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 04-Oct-2021, the patient experienced OVERDOSE (Patient and her husband received the third full dose of 100mcg and are not immunocompromised), FATIGUE (had fatigue) and VACCINATION SITE PAIN (left arm was really hurting). At the time of the report, OVERDOSE (Patient and her husband received the third full dose of 100mcg and are not immunocompromised), FATIGUE (had fatigue) and VACCINATION SITE PAIN (left arm was really hurting) outcome was unknown.            Treatment details was not reported by the reporter.   This case was linked to MOD-2022-570966, MOD-2022-570982, MOD-2022-571007 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised and did not receive full dose/Caller reportsreceived the wrong booster dose and received a half dose instead of the full dose.) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-571010, MOD-2022-570742, MOD-2022-571011 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asplenia and Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (Caller reports her husband received the wrong booster dose and received a half dose instead of the full dose.) outcome was unknown.            No concomitant medication information was provided.  It was reported that the patient received wrong booster dose and received a half dose instead of the full dose.  No treatment medication were provided.   This case was linked to MOD-2022-570971 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney failure (3rd stage), Autistic disorder and Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised and did not receive a third full dose/He received a half dose instead of the full dose.) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided.  The patient received wrong booster dose. He received a half dose instead of the full dose.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid-19) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 COVID-19 (Tested positive for covid-19). At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications was reported. No treatment was reported.  Company Comment: This is a spontaneous case concerning a 78-year-old patient of an unknown gender with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 78-year-old patient of an unknown gender with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I had a mild case of covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had a mild case of covid) 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 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 COVID-19 (I had a mild case of covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 06-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I had a mild case of covid) outcome was unknown.            Concomitant and treatment medication were not reported.  Company comment-This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19(reported as I had a mild case of covid) on an unknown date after third dose of mRNA-1273 vaccine. Patient reported Covid-19 on an unknown date and was treated with PAXLOVID((NIRMATRELVIR, RITONAVIR) for 5 days (from 2nd May to 6th May 2022). No further details on clinical course, lab test results were reported. Patient had received initial two doses of vaccine with Moderna on unknown dates. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19(reported as I had a mild case of covid) on an unknown date after third dose of mRNA-1273 vaccine. Patient reported Covid-19 on an unknown date and was treated with PAXLOVID((NIRMATRELVIR, RITONAVIR) for 5 days (from 2nd May to 6th May 2022). No further details on clinical course, lab test results were reported. Patient had received initial two doses of vaccine with Moderna on unknown dates. Outcome of the event was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Musculoskeletal discomfort, Pain, Paraesthesia
Clinical narrative: Because of the swelling patient went to her doctor's office/Shoulder is swollen; itchy on the inside; Burning on the inside/hands are burning on the inside; Shoulder is not moving; Hands are swollen/Fingers are swollen; patient is in so much pain; Numbness; Tingling; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving) and PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no history of allergies and medical history relating to adverse event and both acute and chronic similar past illnesses was reported as none.     On 06-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving), PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen), PAIN (patient is in so much pain), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling). The patient was treated with PARACETAMOL (TYLENOL) for Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving), PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen), PAIN (patient is in so much pain), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Swelling
Clinical narrative: Because of the swelling patient went to her doctor's office/Shoulder is swollen; itchy on the inside; Burning on the inside/hands are burning on the inside; Shoulder is not moving; Hands are swollen/Fingers are swollen; patient is in so much pain; Numbness; Tingling; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving) and PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no history of allergies and medical history relating to adverse event and both acute and chronic similar past illnesses was reported as none.     On 06-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving), PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen), PAIN (patient is in so much pain), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling). The patient was treated with PARACETAMOL (TYLENOL) for Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (Because of the swelling patient went to her doctor's office/Shoulder is swollen), PRURITUS (itchy on the inside), BURNING SENSATION (Burning on the inside/hands are burning on the inside), MUSCULOSKELETAL DISCOMFORT (Shoulder is not moving), PERIPHERAL SWELLING (Hands are swollen/Fingers are swollen), PAIN (patient is in so much pain), HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: Rebound COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound COVID) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EW0150 Location of injection: Arm Right) on 02-Apr-2021 and Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EW0171 Location of injection: Arm Right) on 23-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech.   On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022, the patient experienced COVID-19 (Rebound COVID). At the time of the report, COVID-19 (Rebound COVID) had not resolved.            No concomitant medication was provided by the reporter.  The patient had allergy of unknown medication. The device date was reported as 18-May-2022.  No treatment medication was provided by the reporter.  Company Comment: This spontaneous case concerns a 63-year-old male patient with no relevant medical history, who experienced unexpected AESI event of covid-19 on 13-May-2022. The event occurred 5 months 12 days after the 3rd dose of the mRNA-1273 (Spikevax) which was administered on 01-Dec-2021. The patient had received 1 dose of Paxlovid 09 days before the event. Patient had received two doses of Pfizer / BioNTech (covid-19 vaccine AstraZeneca) on 02-Apr-2021 and 23-Apr-2021. The event COVID-19 infection was reported to as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old male patient with no relevant medical history, who experienced unexpected AESI event of covid-19 on 13-May-2022. The event occurred 5 months 12 days after the 3rd dose of the mRNA-1273 (Spikevax) which was administered on 01-Dec-2021. The patient had received 1 dose of Paxlovid 09 days before the event. Patient had received two doses of Pfizer / BioNTech (covid-19 vaccine AstraZeneca) on 02-Apr-2021 and 23-Apr-2021. The event COVID-19 infection was reported to as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 27-Jan-2022 and date removed from fridge 28-Jan-2022; Vaccine was expired on 27-Jan-2022 and patient administered on 28-Jan-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27-Jan-2022 and patient administered on 28-Jan-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 27-Jan-2022 and date removed from fridge 28-Jan-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27-Jan-2022 and patient administered on 28-Jan-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 27-Jan-2022 and date removed from fridge 28-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 27-Jan-2022 and patient administered on 28-Jan-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 27-Jan-2022 and date removed from fridge 28-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the vaccine was removed from the fridge and administered to the patient on 28-Jan-2022 after the expiration date i.e on 27-Jan-2022.  The vaccines were stored in the freezer and only removed as needed to thaw and then administered. The vials were taken out at a time and thawed as they did not thaw an entire box.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 24-Mar-2022 and was stored in refrigeration on 29-Mar-2022 and administered on 26-APR-2022; Adminstered vaccine past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adminstered vaccine past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was expired on 24-Mar-2022 and was stored in refrigeration on 29-Mar-2022 and administered on 26-APR-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adminstered vaccine past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 24-Mar-2022 and was stored in refrigeration on 29-Mar-2022 and administered on 26-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adminstered vaccine past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was expired on 24-Mar-2022 and was stored in refrigeration on 29-Mar-2022 and administered on 26-APR-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, by used date was mentioned as 24-Apr-2022. The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  Treatment details were not reported by the reporter.