chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Ventricular extrasystoles
Clinical narrative: recently diagnosed with paroxysmal ventricular bigeminy; This spontaneous case was reported by a nurse and describes the occurrence of VENTRICULAR EXTRASYSTOLES (recently diagnosed with paroxysmal ventricular bigeminy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Surgical procedure in November 2020.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (recently diagnosed with paroxysmal ventricular bigeminy). At the time of the report, VENTRICULAR EXTRASYSTOLES (recently diagnosed with paroxysmal ventricular bigeminy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Company comment- This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of ventricular extrasystoles. The date of onset of the event was not reported. The patient received two doses of mRNA-1273 Moderna vaccine. The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow-up received contains updated reporter, patient details, medical history, laboratory test details event verbatim and drug information.; Sender's Comments: This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of ventricular extrasystoles. The date of onset of the event was not reported. The patient received two doses of mRNA-1273 Moderna vaccine. The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: a lot of itching all over the body/a week later I got the same reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS. The patient was treated with BENADRYL in 2021 for Itching all over, at a dose of A tablet this day and another one the next day and took 2 tablets, last night and today. At the time of the report, PRURITUS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant medications were not provided by reporter.  The patient received vaccine on 26-Nov-2021 (probably 26-Oct-2021). The patient said that 4 days after the vaccine she experienced a lot of itching all over the body and, she took a tablet of Benadryl on the same day, and another one the next day and, it went away. However a week later patient got the same reaction and also took 2 tablets of Benadryl, previous night and one the day of the report.  The patient does not take regular medication.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had covid after the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19. At the time of the report, COVID-19 outcome was unknown.            No concomitants and treatment were provided.   This case was linked to MOD-2021-377147, MOD-2021-377137 (Patient Link). This is a spontaneous case concerning a male patient of an unknown age with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 vaccine.   No information about the first dose was disclosed. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lymphadenopathy, Vaccination complication
Clinical narrative: had a terrible reaction; had COVID in november; had lymph node pop up under the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, COVID-19, and LYMPHADENOPATHY 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION, COVID-19 and LYMPHADENOPATHY. At the time of the report, VACCINATION COMPLICATION, COVID-19, and LYMPHADENOPATHY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications was provided by the reporter.  Patient experienced Lymph node under the arm, while patient had COVID in November and had a terrible reaction, patient received the COVID -19 vaccine 3 months before.  No treatment medications was provided by the reporter.  This case concerns a patient with unknown age and gender, with no reported medical history, who experienced Non-serious, Unexpected AESI event of Covid 19 which occurred on an unknown date, with an unknown dose of mRNA-1273 Vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine) is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Malaise, Myalgia
Clinical narrative: felt sick; Irritable; with second dose had aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), IRRITABILITY (Irritable) and MYALGIA (with second dose had aches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included GABAPENTIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (felt sick), IRRITABILITY (Irritable) and MYALGIA (with second dose had aches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (felt sick), IRRITABILITY (Irritable) and MYALGIA (with second dose had aches) had not resolved.            This case was linked to MOD-2021-377149, MOD-2021-377159 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Pain behind her right eye that won't go away; developing a throbbing headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN and HEADACHE in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 023M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MYRBETRIQ, ESTRADIOL ACETATE, and LORATADINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE PAIN and HEADACHE. The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency; TYLENOL for Adverse event, at an unspecified dose and frequency, and ALEVE for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE PAIN and HEADACHE had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had undergone MRI and CT scans but with no resolution. The symptoms were ongoing.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling hot, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, FEELING HOT, ERYTHEMA, and HEADACHE in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 028A21A, and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy to Tetracycline, causes yeast infections, Blood pressure, Cholesterol, and Inflammation. Concomitant products included OMEPRAZOLE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced FEELING ABNORMAL, HEADACHE, PYREXIA. On 05-Nov-2021, the patient experienced FEELING ABNORMAL. On an unknown date, the patient experienced FEELING HOT and ERYTHEMA. On 05-Nov-2021, PYREXIA had resolved. At the time of the report, FEELING ABNORMAL and HEADACHE had not resolved and FEELING HOT and ERYTHEMA outcome was unknown. Patient was taking a medication for blood pressure, cholesterol and an anti-inflammatory medication. No treatment medications were provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Neck sore; Had a horrible pain in the head/ Headaches/ Horrible pain shouting through head/ Pain in the head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck sore) and HEADACHE (Had a horrible pain in the head/ Headaches/ Horrible pain shouting through head/ Pain in the head) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Had a horrible pain in the head/ Headaches/ Horrible pain shouting through head/ Pain in the head). On 04-Nov-2021, the patient experienced NECK PAIN (Neck sore). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Headache, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck sore) and HEADACHE (Had a horrible pain in the head/ Headaches/ Horrible pain shouting through head/ Pain in the head) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got first dose around the 12-FEB-2021 and the second dose also in February, two weeks apart. Concomitant product included blood thinners, heart medications, blood pressure medication, cholesterol medication, diabetes medication and pain medications.  On 03-Nov-2021, patient had a horrible pain in the head, headaches.  On 04-Nov-2021, patient also had a neck sore, horrible pain shouting through head, and pain in the head for which patient took Norco.   This case was linked to MOD-2021-377175 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: 2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose; The patients subsequently received a full 0.5ml (100mcg) dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose) and ACCIDENTAL OVERDOSE (The patients subsequently received a full 0.5ml (100mcg) dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD26 (JNJ 78436735).    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose) and ACCIDENTAL OVERDOSE (The patients subsequently received a full 0.5ml (100mcg) dose). On 05-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 patients received full dose Moderna COVID-19 vaccine when they should have received the booster dose) and ACCIDENTAL OVERDOSE (The patients subsequently received a full 0.5ml (100mcg) dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. The patient had received Johnson and Johnson vaccines in March 2021. The patient had subsequently received a full 0.5ml (100mcg) dose as they were receiving the first dose in their Moderna COVID-19 series.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No relevant medical history information was reported.  Concomitant products included CHLORMEZANONE (RESTORIL [CHLORMEZANONE]) for Sleeplessness, PARACETAMOL (TYLENOL 8 HOUR), BIMATOPROST (LUMIGAN), ATORVASTATIN CALCIUM (LIPITOR), MELATONIN and VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-377283, MOD-2021-338725 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Patient had swelling that began to injection areas under the eyes; This spontaneous case was reported by a physician and describes the occurrence of EYE SWELLING (Patient had swelling that began to injection areas under the eyes) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: RESTYLANE L (experienced swollen face under eyes/ cheek area when injected with Restylane lyft.) in February 2021.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (Patient had swelling that began to injection areas under the eyes). At the time of the report, EYE SWELLING (Patient had swelling that began to injection areas under the eyes) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EYE SWELLING (Patient had swelling that began to injection areas under the eyes) to be possibly related.    No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.  This case concerns a 41-year-old, female patient with relevant history of eye and cheek swelling after administration of Restylane Lyft (injectable hyaluronic acid gel) in Feb2021, who experienced the unexpected, non-serious event of eye swelling. The event occurred 5 months and 3 weeks after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The medical history of Restylane Lyft injection, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 41-year-old, female patient with relevant history of eye and cheek swelling after administration of Restylane Lyft (injectable hyaluronic acid gel) in Feb2021, who experienced the unexpected, non-serious event of eye swelling. The event occurred 5 months and 3 weeks after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The medical history of Restylane Lyft injection, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 4 patients were administered vaccines from a vial that has been punctured for greater than 12hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 045A21A, and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced PRODUCT STORAGE ERROR. On 03-Nov-2021, PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   These doses were administered from the same vial which was initially punctured on 26OCT2021 and administered up until 3NOV2021. Concomitant medications were not provided. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Scratch, Swelling
Clinical narrative: Scraped their left sheen; Left sheen swelled a little/swelled a little around the ankle; Was bruised; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scraped their left sheen), SWELLING (Left sheen swelled a little/swelled a little around the ankle) and CONTUSION (Was bruised) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A, 030L20 and 034F21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced SCRATCH (Scraped their left sheen), SWELLING (Left sheen swelled a little/swelled a little around the ankle) and CONTUSION (Was bruised). At the time of the report, SCRATCH (Scraped their left sheen), SWELLING (Left sheen swelled a little/swelled a little around the ankle) and CONTUSION (Was bruised) outcome was unknown.            Concomitant medication also included one a day vitamin over 50.  Treatment medication included antibiotic .  Patient states that they had took the antibiotic since 29-Oct-2021, for a week.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients were administered vaccines from a vial that has been punctured for greater than 12hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs are not provided. Treatment medications are not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Booster dose of 0.5ml instead of 0.25ml administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Booster dose of 0.5ml instead of 0.25ml administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) 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) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Booster dose of 0.5ml instead of 0.25ml administered). At the time of the report, ACCIDENTAL OVERDOSE (Booster dose of 0.5ml instead of 0.25ml administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of accidental overdose (pharmacist inadvertently gave two patients booster shots at 2.5mL instead of 0.25mL) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 002C21A) for COVID-19 immunization. No medical history reported. On Nov 5, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 2.5 milliliter. On Nov 5, 2021, patient experienced accidental overdose (pharmacist inadvertently gave two patients booster shots at 2.5mL instead of 0.25mL). On Nov 5, 2021, accidental overdose (pharmacist inadvertently gave two patients booster shots at 2.5mL instead of 0.25mL) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. She was recently diagnosed that she has no space in her vertebrae; may have problems with walking in the future.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: Sore were they put the needle; Provider gave him a full dose of the Moderna vaccine instead of a half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Provider gave him a full dose of the Moderna vaccine instead of a half dose) and VACCINATION SITE PAIN (Sore were they put the needle) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 037K20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Provider gave him a full dose of the Moderna vaccine instead of a half dose). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore were they put the needle). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Provider gave him a full dose of the Moderna vaccine instead of a half dose) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore were they put the needle) had resolved.            Patient takes several regular medications but, not not want to mention them. Treatment information was not reported. Patient is not immunocompromised
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine removed from freezer 8am on 10/11/2021. No concomitant medications were reported. No treatment details provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was removed from the freezer at 8AM on 11Oct2021.  Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-364617 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-364617:cross-linked to MOD21-157109 (MOD-2021-364617)
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. A vial was punctured 30 times at the clinic. 10 patients who were administered the vaccine were affected. No treatment medication details was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not provided. Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) 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 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medications were provided.  The Nurse is providing information for 35 patients. A vial at their clinic was punctured 30 times. 10 patients were affected. Given the process in place at the vaccination clinic it is not possible to identify the 10 patients who received the compromised vaccine.  It was reported that all doses given are booster doses.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  no concomitant drugs were reported no treatment drugs were reported. Patient date of birth was reported as
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided A vial at their clinic was punctured 30 times. 10 patients were affected.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.; Sender's Comments: This is a case of Expired Product administered for this female patient of an unknown age, with no relevant medical history provided. Reportedly, the patient received the dose of Moderna COVID.19 Vaccine which past the published expiry date. This dose was reported as the third dose of the vaccine for this patient. No adverse events were reported. The company causality for the event of Expired Product administered is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported. Patient date of birth was 1968.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. Patient age year 1956 is mentioned in source document.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's year of birth was given as 1951. No concomitant and medication information provided.  No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided. Patient DOB was reported was 1945.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Haemorrhage, Headache
Clinical narrative: bleeding; stomach pain; felt light-headed; legs start shaking; her legs were shaking so much she couldn't even feel them; goosebumps; headaches; body aches; vomiting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 004M20A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR), PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]) and HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach pain), DIZZINESS (felt light-headed), TREMOR (legs start shaking), PILOERECTION (goosebumps), HEADACHE (headaches), MYALGIA (body aches), VOMITING (vomiting) and FATIGUE (fatigue). 05-Nov-2021, the patient experienced HYPOAESTHESIA (her legs were shaking so much she couldn't even feel them). At the time of the report, HAEMORRHAGE (bleeding), HEADACHE (headaches) and MYALGIA (body aches) had not resolved and ABDOMINAL PAIN UPPER (stomach pain), DIZZINESS (felt light-headed), TREMOR (legs start shaking), HYPOAESTHESIA (her legs were shaking so much she couldn't even feel them), PILOERECTION (goosebumps), VOMITING (vomiting) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not provided.  Company comment- This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred the same day after receiving the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-378037, MOD-2021-378042 (Patient Link).; Sender's Comments: This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred the same day after receiving the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.