chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 7 May 2021 and second dose on 14 Jun 2021) outcome was unknown.            Patient did not experienced any symptoms with the previous two doses of the Moderna COVID-19 Vaccine. Patient had a Cholesterol condition for which she was taking Cholesterol medication. No treatment medications were reported for primary doses.   This case was linked to MOD-2022-525811 (Patient Link).   Reporter did not allow further contact
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients; Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) and PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to 16 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Vial did not undergo temperature excursions.  It was reported that date the vial was initially stored in the refrigerator was on 31-Jan-2022.  Treatment information was not provided.   This case was linked to MOD-2022-525860 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a 3rd full dose of Moderna after getting Sputnik V primary series; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a 3rd full dose of Moderna after getting Sputnik V primary series) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Sputnik V (Dose 1, Batch number-1012977) on 27-May-2021, Sputnik V (Dose 2 and Batch number-006H21A) on 15-Oct-2021. Past adverse reactions to the above products included No adverse event with Sputnik V and Sputnik V.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Received a 3rd full dose of Moderna after getting Sputnik V primary series). At the time of the report, ACCIDENTAL OVERDOSE (Received a 3rd full dose of Moderna after getting Sputnik V primary series) outcome was unknown.            No concomitant medication information was provided.  It was reported that patient was not immunocompromised.  No treatment medication were provided.   This case was linked to MOD-2022-525755, MOD-2022-525740 (Patient Link).
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Date the vial was initially stored in the refrigerator: 31Jan2022. The vial did not undergo any temperature excursions. No treatment information provided.   This case was linked to MOD-2022-525860 (Patient Link).
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported tat the patient took half dose booster. Vial was initially stored in the refrigerator on 31-Jan-2022. It was reported that the vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to MOD-2022-525860 (Patient Link).
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-2022) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-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.  On 31-Jan-2022 the vial was initially stored in the refrigerator. The vials did not undergo any temperature excursions.   This case was linked to MOD-2022-525860, MOD-2022-525834, MOD-2022-525851, MOD-2022-525860, MOD-2022-525866, MOD-2022-525870, MOD-2022-525874, MOD-2022-525880, MOD-2022-525890, MOD-2022-525893, MOD-2022-525896, MOD-2022-525903, MOD-2022-525906, MOD-2022-525912, MOD-2022-525915, MOD-2022-525918 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) 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 PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided. Reporter did not allow further contact.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination. No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31 Jan 2022 and administered on 09 Mar 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 by the reporter.  No treatment medication was reported by the reporter.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022; Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that date the vial was initially stored in the refrigerator on 31-Jan-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-525860 (Patient Link).
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-525860 (Patient Link).
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the vial was initially stored in the refrigerator on 31-Jan-2022 and the vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Injection site injury, Keloid scar, Sensitive skin
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Patient experienced a bit of sensitivity in his arm), KELOID SCAR (Unusual keloid scar in the site of needle puncturing to get the blood), INJECTION SITE INJURY (Unusual wound in the arm, in the site of needle puncturing to get the blood) and FATIGUE (Patient felt tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Sulfa Allergy), Sinusitis (whole life), Pre-diabetes (A couple of years ago) and Glaucoma (Eye drops for glaucoma). Concomitant products included HYDROCHLOROTHIAZIDE for Diuretic therapy, BRIMONIDINE TARTRATE for Glaucoma, AMLODIPINE, ATORVASTATIN, LATANOPROST, VITAMINS NOS and CLOTRIMAZOLE for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SENSITIVE SKIN (Patient experienced a bit of sensitivity in his arm), KELOID SCAR (Unusual keloid scar in the site of needle puncturing to get the blood), INJECTION SITE INJURY (Unusual wound in the arm, in the site of needle puncturing to get the blood) and FATIGUE (Patient felt tired). The patient was treated with SULFADIAZINE for Wound, at an unspecified dose and frequency. At the time of the report, SENSITIVE SKIN (Patient experienced a bit of sensitivity in his arm), KELOID SCAR (Unusual keloid scar in the site of needle puncturing to get the blood), INJECTION SITE INJURY (Unusual wound in the arm, in the site of needle puncturing to get the blood) and FATIGUE (Patient felt tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood test: results not reported Results not reported. The patient had received Moderna COVID-19 Vaccine 1st dose on 20Jan2021, 2nd dose on 19Feb2021. 1-2 days after blood test patient developed an unusual keloid scar or wound in the arm, in the site of needle puncturing to get the blood. This case was linked to MOD-2022-525961, MOD-2021-018091 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Exercise induced asthma (Had for most of her life and have needed to use albuterol throughout her life to deal with asthma) since 01-Jan-1989 and Seasonal allergy.  Concomitant products included ALBUTEROL [SALBUTAMOL] from 01-Jan-1989 to an unknown date for Asthma exercise induced, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2019 to an unknown date for Seasonal allergy, EMERGEN C from 01-Jan-2019 to an unknown date for Vitamin supplementation.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021 at 7:00 AM, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). On 28-Jan-2021, MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) had resolved.      It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. The patient had never been diagnosed with/ tested positive for COVID-19.  Patient did not seek medical care for the event.  There were no other potential causes for the event.  The patient did not experience similar event in the past.  No treatment information was provided.   This case was linked to MOD-2022-515889 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: swelling at the injection site (1st dose); slight temperature (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not report patient date of birth. No concomitant medication information was provided. No treatment medication were provided.    This case was linked to MOD-2022-526015 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage). At the time of the report, ACCIDENTAL OVERDOSE (Got another full shot and Moderna  was giving half a shot/ Got a double dosage and not a half a dosage) outcome was unknown.            No concomitant medications information was reported.  Reporter informed that doctors recommended to get the booster that was not approved at that time and patient and her husband both got the booster and had no reactions at all and that they got another full shot but Moderna was giving half a shot.  No treatment medications were provided.   This case was linked to MOD-2022-526032 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (The patient took first booster shots which was not approved as per two doctor advise and then took another full shots (fourth dose).) 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. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (The patient took first booster shots which was not approved as per two doctor advise and then took another full shots (fourth dose).). At the time of the report, EXTRA DOSE ADMINISTERED (The patient took first booster shots which was not approved as per two doctor advise and then took another full shots (fourth dose).) outcome was unknown. No concomitant medications information was reported. It was reported that patient was going to have surgery in Aug-2021. Reporter informed that doctors recommended to get the booster that was not approved at that time and the patient got the booster and had no reactions at all and that patient got another full shot but Moderna was giving half a shot. No treatment medications were provided. This case was linked to MOD-2022-526020 (Patient Link). Reporter did not allow further contact.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: TDAP (Route IM and Lot E55XZ) on 05-May-2021. Past adverse reactions to the above products included No adverse event with TDAP. Concurrent medical conditions included Drug allergy (Propofol). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) from 16-Oct-2020 to an unknown date for Allergy, CELECOXIB (CELEXA [CELECOXIB]) for Insomnia, VITAMIN C [ASCORBIC ACID] from 01-Feb-2022 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 29-Dec-2020 to an unknown date and CENTRUM SILVER +50 from 14-Oct-2020 to an unknown date for Supplementation therapy.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On 21-Jan-2022, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.  Company comment: This is case of drug ineffective for this 53-year-old male patient with no relevant medical history, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 8 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-503784 (Patient Link).; Sender's Comments: This is case of drug ineffective for this 53-year-old male patient with no relevant medical history, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 8 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with/ tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Diagnosed with/ tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.  Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Hypothyroidism since 30-Jul-2021, Obesity since 17-Jul-2020 and Bladder neoplasm (bladder tumor) since 25-Nov-2019. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) from 30-Aug-2013 to an unknown date for Hypothyroidism.  On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jan-2022, the patient experienced COVID-19 (Diagnosed with/ tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Diagnosed with/ tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive; Type of test at home.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient received third dose of mRNA-1273 (Spikevax vaccine) of 0.5mL on 03-Mar-2022 at 09.45am, via intramuscular route on right deltoid (RD). No treatment information was reported.  Company comment: This is case of drug ineffective for this 69-year-old female patient with medical history of bladder tumor, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 9 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-503778 (Patient Link).; Sender's Comments: This is case of drug ineffective for this 69-year-old female patient with medical historyof bladder tumor, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 9 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Essential hypertension
Clinical narrative: ESSENTIAL HYPERTENSION; This spontaneous case was reported by a nurse and describes the occurrence of ESSENTIAL HYPERTENSION (ESSENTIAL HYPERTENSION) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Nov-2021, the patient experienced ESSENTIAL HYPERTENSION (ESSENTIAL HYPERTENSION). The patient was treated with VALSARTAN (oral) on 20-Dec-2021 for Hypertension, at a dose of 40 milligram once a day and NIFEDIPINE (NIFEDIPINE XL) on 26-Nov-2021 for Hypertension, at an unspecified dose and frequency. At the time of the report, ESSENTIAL HYPERTENSION (ESSENTIAL HYPERTENSION) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.     This case was linked to MOD-2022-502124 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore in arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Asthma (Chronic asthma) and Bladder disorder (Bladder problems).   On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore in arm). At the time of the report, PAIN IN EXTREMITY (sore in arm) outcome was unknown.            Concomitant medications were not reported.  The patient declined to provide additional information regarding side effect.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2022: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: How was the vial stored post puncture? RT/fridge? RT the whole time.; Booster dose administered 27 hours and 8 minutes post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered 27 hours and 8 minutes post puncture) and PRODUCT STORAGE ERROR (How was the vial stored post puncture? RT/fridge? RT the whole time.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022 at 2:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022 at 2:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered 27 hours and 8 minutes post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (How was the vial stored post puncture? RT/fridge? RT the whole time.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered 27 hours and 8 minutes post puncture) and PRODUCT STORAGE ERROR (How was the vial stored post puncture? RT/fridge? RT the whole time.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Number of doses/vials: 1 booster dose. On 28-Mar-2022 at 11:24 AM, the vial was initially stored in the refrigerator The vial was first punctured minutes after taking it out of the refrigerator. The vial was stored at room temperature (RT)  (8° to 25°C= 46° to 77°F) the whole time post puncture. Dose was administered >12hours post puncture. The vial did not undergo any temperature excursions.  No treatment medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use; We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had given Moderna COVID-19 vaccine that was beyond the 30 days use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30-day use) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had given Moderna COVID-19 vaccine that was beyond the 30 days use by date, The vial was initially stored in the refrigerator on 02-Feb-2022 and dose administered on 07-Mar-2022 beyond 30 day use. It was reported that the vial had not undergone any temperature excursions. The patient had no event experienced and there was no product complaint associated. No treatment medications were reported.   This case was linked to MOD-2022-519582, MOD-2022-519593, MOD-2022-519602 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised individual got 0.25 mL for 3rd dose, instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised individual got 0.25 mL for 3rd dose, instead of 0.5 mL) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised individual got 0.25 mL for 3rd dose, instead of 0.5 mL). On 05-Nov-2021, ACCIDENTAL UNDERDOSE (Immunocompromised individual got 0.25 mL for 3rd dose, instead of 0.5 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  HCP stated a immunocompromised patient was given 0.25 mL dose for 3rd dose, instead of 0.5 mL.  Treatment information was not provided.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received Vaxelis after it experienced a temperature excursion 8.5 degree for 30 minutes; This non-serious spontaneous safety report was received by regulatory agency reference# 02080012 on 22-DEC-2021 and forwarded on 23-DEC-2021 from a Health Care Professional.  Due to the nature of the event, the causality between Vaxelis and the reported event of 'Temperature excursion' was not applicable.  For reference purposes this case is linked to MCM-002954, MCM-002956, MCM-002957 due to same reporter.  Further information is expected.  FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded on 31-Jan-2022. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min" and Vaxelis remains not applicable.  No further information is expected.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received Vaxelis after it received temperature excursion of 8.5 degrees for 30 mins; This non-serious spontaneous safety report with Agency reference# 02080037 was received by a partner on 22-Dec-2021 from a Health Care Professional, and forwarded to Agency on 23-Dec-2021.  Due to the nature of the event, the causality between Vaxelis and the reported event of 'Temperature excursion' was not applicable.  For reference purposes this case is linked to MCM-002953, MCM-002956, MCM-002957 due to same reporter.  Further information is expected.  FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded to Agency on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between Vaxelis and the reported event of 'Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min' remained not applicable.  No further information is expected.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received V AXELIS after it experienced a temperature excursion of 8.5°C for 30 min.; This non-serious spontaneous safety report with Agency reference# 02080038 was received by a partner on 22-Dec-2021 from a Health Care Professional, and forwarded to Agency on 23-Dec-2021.  Due to the nature of the event, the causality between Vaxelis and the reported event of Temperature excursion' was not applicable.  For reference purposes this case is linked to MCM-002954, MCM-002953, MCM-002957 due to same reporter.  Further information is expected.  FOLLOW-UP INFORMATION was received by Fax from a HCP on 27-Jan-2022. On 28-Jan-2022 additional information was received by the partner from the same HCP and forwarded to Agency on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between Vaxelis and the reported event of 'Patient received Vaxelis after temperature excursion of 8.5 degrees for 30 min' remained not applicable.  No further information is expected.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, DTPPVHBHPB
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received dose of Pediarix at 2 months and Vaxelis at 4 months; This non-serious spontaneous safety report case #02087821 and Interaction #02087770 was received from a Medical Assistant by the partner on 10-Jan-2022 and forwarded on 11-Jan-2022.  Due to the nature of the event, the causality between Vaxelis and the reported event: "the patient received a dose of Pediarix at 2 months followed by a dose of Vaxelis at 4 months" was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION case #02087821 was received from a Medical Assistant by the partner on 28-Jan-2022 and forwarded on 31-Jan-2022. The case is maintained as non-serious. The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient and that the Department of Health recommended Vaxelis at the 6 month visit.  Due to the nature of the event, the causality between Vaxelis and the reported event: "the patient received a dose of Pediarix at 2 months followed by a dose of Vaxelis at 4 months" remains not applicable.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Overdose; Two doses of Hepatitis B given; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1741237-1. The original narrative from the sender is the following:  Two doses of Hepatitis B given at today's office visit. No signs or symptoms noted. Notified of mistake. No further action taken.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Two doses of Hepatitis B given".  No further information is expected.