chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: may have received 3 doses of the SHINGRIX vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st January 2022) and Shingrix (received 2nd dose 4th March 2022).   On 7th June 2022, the patient received the 3rd dose of Shingrix. On 7th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The reporter stated that the patient might have received 3 doses of the Shingrix vaccine. It was not confirmed that the patient had received 3 doses. The reporter gave consent for follow-up health care professional provided limited information. Health care professional stated that it was possible that the dates provided refer to billing dates and not administration dates. Health care professional would confirm with the patient Additional Supportive Information:  The patient received 3rd dose of Shingrix after receiving 2 doses which led to, extra dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS FOR A FEW DAYS AT SITE OF INJECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported..  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness for a few days at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness for a few days at site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20220707759.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: SEVERE HEADACHE; BODY ACHES; NAUSEA; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-JUL-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUL-2022, the patient experienced body aches, nausea, and low grade fever. Laboratory data included: Body temperature 101.5. On 06-JUL-2022, the patient experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, nausea, body aches, and low grade fever. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Tinnitus, Vaccination failure, Wheezing
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; A RINGING IN EAR WITH A HIGH PITCH SOUND; FELT WHEEZY FOR ABOUT 15 SECONDS AFTER RECEIVING THE VACCINE; This spontaneous report received from a patient concerned a 60 year old male with unspecified ethnicity.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 16-FEB-2022) dose was not reported, 1 total administered on 08-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 60 years old. No concomitant medications were reported.  On 08-APR-2021, after receiving the vaccine the patient felt wheezy for 15 seconds when he was about to drive and then it went away and he didn't have any other problems. On 09-APR-2021 morning after he received his vaccine, he heard about it causing blood clots. On 30-JUN-2022, he had a ringing in his ear with a high pitch sound for which he had to wear an ear plug. On 04-JUL-2022, he woke up with headache/sinus headache, he felt sick and had a scratchy/ itchy throat. On an unspecified date, he tested positive with an at home test which indicated suspected covid-19 infection and suspected clinical vaccination failure. Laboratory data (dates unspecified) included: SARS-CoV-2 test (severe acute respiratory syndrome coronavirus-2) Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt wheezy for about 15 seconds after receiving the vaccine on 08-APR-2021, and the outcome of a ringing in ear with a high pitch sound, suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000241331.; Sender's Comments: V0: 20220713404-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Haemorrhage, Impaired healing, Skin atrophy, Skin wound
Clinical narrative: FEET BLEED; WOUNDS ON HANDS; THIN SKIN; BLISTERS EASILY/BLISTERS ON FEET; WOUNDS ON HANDS TOOK VERY LONG TIME TO HEAL; This spontaneous report received from a patient via another pharmaceutical company concerned an elderly male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: exposure to covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total, first dose was administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The age at time of vaccination was 66 years old. The patient received non-company suspect drug adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa, and moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced feet bleed, wounds on hands, thin skin, blisters easily/blisters on feet, and wounds on hands took very long time to heal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from blisters easily/blisters on feet, and the outcome of feet bleed, wounds on hands, thin skin and wounds on hands took very long time to heal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220713416-COVID-19 VACCINE AD26.COV2.S-feet bleed. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a parent concerned a 19 year old male.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 19 years old. No concomitant medications were reported.  On 05-JUL-2022, the patient experienced tested positive for covid. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220712200.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: BAD RINGING IN THE EARS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bad ringing in the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad ringing in the ears was not reported. This report was non-serious. This case, from the same reporter is linked to 20220714792 and 20220715147.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 51 year old female . Initial information was processed along with the additional information received on 08-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre diabetes, asthma, hypertension, hypothyroidism, penicillin allergy, and drug allergy (Advil, Leviquin, Zithromax, Metformin), and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 26-MAR-2021 for prophylactic vaccination. Age at time of vaccination 50 years old. The patient received second dose of non-company suspect vaccine elasomeran (Moderna vaccine) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 059H21A expiry: UNKNOWN) dose was not reported, administered to the left arm on 07-JAN-2022 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide, and levothyroxine sodium. On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2) which led to suspected clinical vaccination failure (Dose number in series 1). The patient was treated with non company suspect drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 09-JUN-2022 to 16-JUN-2022 for the treatment of covid-19. On 24-JUN-2022, 08:00, the patient experienced rebound covid (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000241596; Sender's Comments: V0. 20220715390-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related..
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills, Tired after both injections on both reported dates about 3 hours after administration; Chills, Tired after both injections on both reported dates about 3 hours after administration; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills, Tired after both injections on both reported dates about 3 hours after administration) and FATIGUE (Chills, Tired after both injections on both reported dates about 3 hours after administration) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027h21B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE  (Dose Number 1, Batch/Lot No. was 1802070,  Location of injection site Left arm, Vaccine Administration Time 10:45 AM) on 09-Mar-2021, JANSSEN COVID-19 VACCINE  (Dose Number 1, Batch/Lot No. was 1802070,  Location of injection site Left arm and Vaccine Administration Time 10:45 AM) on 09-Mar-2021; for Drug use for unknown indication: Iodine and sulfamethoxazole / trimethoprim. Past adverse reactions to the above products included Allergy with Iodine and sulfamethoxazole / trimethoprim; Chills with JANSSEN COVID-19 VACCINE; and Tiredness with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Pollen allergy and Dust allergy. Concomitant products included ROSUVASTATIN from 31-May-2021 to 13-Jun-2022 for an unknown indication.    On 28-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced CHILLS (Chills, Tired after both injections on both reported dates about 3 hours after administration) and FATIGUE (Chills, Tired after both injections on both reported dates about 3 hours after administration). At the time of the report, CHILLS (Chills, Tired after both injections on both reported dates about 3 hours after administration) and FATIGUE (Chills, Tired after both injections on both reported dates about 3 hours after administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-Jun-2022 to 17-Jun-2022 for COVID-19 treatment, at an unspecified dose and frequency. Paxlovid batch no. reported GA3594. Device Date reported 23Jun2022 No treatment information was provided for the reported events.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2022: Upon internal Review on 11-Jul-2022, significant correction was performed to update Spikevax from Historical vaccine to Suspect product and previously captured suspect product PAXLOVID updated to treatment for COVID-19. Case become valid and narrative updated accordingly.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Product dose omission issue
Clinical narrative: Was not feeling well and ended up not going back to get the 2nd dose; As she was sick a lot/With other illnesses; Missed dose/2nd dose not yet received by the patient/Patient never got the 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Was not feeling well and ended up not going back to get the 2nd dose), ILLNESS (As she was sick a lot/With other illnesses) and PRODUCT DOSE OMISSION ISSUE (Missed dose/2nd dose not yet received by the patient/Patient never got the 2nd dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No allergy was reported.  Patient had not been diagnosed with/ tested positive for COVID-19.     On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Was not feeling well and ended up not going back to get the 2nd dose), ILLNESS (As she was sick a lot/With other illnesses) and PRODUCT DOSE OMISSION ISSUE (Missed dose/2nd dose not yet received by the patient/Patient never got the 2nd dose). At the time of the report, MALAISE (Was not feeling well and ended up not going back to get the 2nd dose), ILLNESS (As she was sick a lot/With other illnesses) and PRODUCT DOSE OMISSION ISSUE (Missed dose/2nd dose not yet received by the patient/Patient never got the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation reaction, Inappropriate schedule of product administration, Malaise, Pain
Clinical narrative: 1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021; spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days; felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise; felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise; had very, very strong reactions to these vaccines; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), IMMUNISATION REACTION (had very, very strong reactions to these vaccines), PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-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 really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise) and IMMUNISATION REACTION (had very, very strong reactions to these vaccines). On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021). In September 2021, the patient experienced PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days). At the time of the report, MALAISE (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise) and PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days) had resolved and IMMUNISATION REACTION (had very, very strong reactions to these vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 101 101 F.         No Concomitant medication was reported. The patient waited so long between the 1st & 2nd doses to make sure it wasn't an allergic reaction.Patient did not had Covid as far as patient knows.  No Treatment medication was reported   This case was linked to MOD-2022-600694, MOD-2022-600690 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021; spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days; felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise; felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise; had very, very strong reactions to these vaccines; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), IMMUNISATION REACTION (had very, very strong reactions to these vaccines), PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-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 really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise) and IMMUNISATION REACTION (had very, very strong reactions to these vaccines). On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021). In September 2021, the patient experienced PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days). At the time of the report, MALAISE (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise) and PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days) had resolved and IMMUNISATION REACTION (had very, very strong reactions to these vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 101 101 F.         No Concomitant medication was reported. The patient waited so long between the 1st & 2nd doses to make sure it wasn't an allergic reaction.Patient did not had Covid as far as patient knows.  No Treatment medication was reported   This case was linked to MOD-2022-600694, MOD-2022-600690 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was exposed to room temperature for 24 hours and 10 minutes approximately; Booster dose administered after exposure to room temperature for 24 hours and 10 minutes; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 06-Jul-2022 and was forwarded to Moderna on 06-Jul-2022.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered after exposure to room temperature for 24 hours and 10 minutes) and PRODUCT STORAGE ERROR (vial was exposed to room temperature for 24 hours and 10 minutes approximately) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered after exposure to room temperature for 24 hours and 10 minutes). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature for 24 hours and 10 minutes approximately). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered after exposure to room temperature for 24 hours and 10 minutes) and PRODUCT STORAGE ERROR (vial was exposed to room temperature for 24 hours and 10 minutes approximately) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No Treatment medications were reported Date the vial was initially stored in the refrigerator was reported as 27-Jun-2022. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree celcius to 25 degree celcius = 46 degree celcius to 77 degree F) was reported as 24 hours and 10 minutes.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) 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) 2 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml). At the time of the report, ACCIDENTAL OVERDOSE (administered a 2 year 2 ml of the 6 months to 5 years of age Moderna COVID-19 vaccine instead of 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; the vial was initially stored in the refrigerator  26May2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.  On 26 May 2022, the vial was initially stored in the refrigerator. Between 26 Jun 2022 to 04 Jul 2022 vaccines were administered. to 7 patients.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was used beyond its use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was used beyond its use date) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was used beyond its use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was used beyond its use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient received one of the Moderna COVID-19 vaccine vials was used on 7/5/2022 while it has a beyond use date of 7/2/2022 as it was placed at refrigeration temperature (36F-46F) on 6/2/2022. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Somnolence
Clinical narrative: Sleeping for almost eight hours during the day; Splitting headache; I am extremely tired; Chills; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleeping for almost eight hours during the day), HEADACHE (Splitting headache), FATIGUE (I am extremely tired) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced SOMNOLENCE (Sleeping for almost eight hours during the day), HEADACHE (Splitting headache), FATIGUE (I am extremely tired) and CHILLS (Chills). At the time of the report, SOMNOLENCE (Sleeping for almost eight hours during the day), HEADACHE (Splitting headache), FATIGUE (I am extremely tired) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not provided. Patient took a booster shot a week ago. Patient did not have cough at all. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered doses past it's expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered doses past it's expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered doses past it's expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered doses past it's expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The Moderna COVID-19 vial expired on 05Jul2022 and administered in 06Jul2022. Number of doses/vials present was 1. The vial was initially stored in the refrigerator on 06-Jul-2022. It did not undergo any temperature excursions.  No treatment medications were reported.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric patients (6 & 7 years old) received the First Pediatric dose of Moderna COVID-19 Vaccine from a vial that was meant to be used for 6 Months to 5-years-old.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced OFF LABEL USE (6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old). At the time of the report, OFF LABEL USE (6 Month to 5-year-old vial presentation utilized for first dose in patients 6 to 11-year-old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eye disorder, Hypertension, Immunisation reaction
Clinical narrative: real side effects of the second booster; eye problems; high blood pressure; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (real side effects of the second booster), EYE DISORDER (eye problems) and HYPERTENSION (high blood pressure) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    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, the patient experienced IMMUNISATION REACTION (real side effects of the second booster), EYE DISORDER (eye problems) and HYPERTENSION (high blood pressure). At the time of the report, IMMUNISATION REACTION (real side effects of the second booster), EYE DISORDER (eye problems) and HYPERTENSION (high blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  Reporter stated that he listened about some people talking about the real side effects of the second booster. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-602077 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-602077:crosslinked case (same reporter)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient was administered with the vaccine after 30 days use by date; Patient was administered with the vaccine after 30 days use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with the vaccine after 30 days use by date) and PRODUCT STORAGE ERROR (Patient was administered with the vaccine after 30 days use by date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with the vaccine after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered with the vaccine after 30 days use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with the vaccine after 30 days use by date) and PRODUCT STORAGE ERROR (Patient was administered with the vaccine after 30 days use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported the date the vial was initially stored in the refrigerator was on 22 Apr 2022. And the vial had not undergone any temperature excursions.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2022: Follow up received contains non significant information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vestibular neuronitis
Clinical narrative: diagnosed with vestibular neuritis; collapsed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VESTIBULAR NEURONITIS (diagnosed with vestibular neuritis) and SYNCOPE (collapsed) in a 48-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced VESTIBULAR NEURONITIS (diagnosed with vestibular neuritis) (seriousness criteria hospitalization and medically significant) and SYNCOPE (collapsed) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 01-Jul-2022 due to SYNCOPE and VESTIBULAR NEURONITIS. At the time of the report, VESTIBULAR NEURONITIS (diagnosed with vestibular neuritis) had not resolved and SYNCOPE (collapsed) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient was not on concomitant medications. The patient did not have a history of dizziness. On 01-Jul-2022 patient was at work and got super dizzy and collapsed. The patient was taken to Emergency room and several tests were done and they admitted her. Reporter stated the patient was due for her second dose on 05-Jul-2022 but could not receive that since she was currently hospitalized. The patient was hospitalized at the time of the call on 07-Jul-2022. The reporter stated patient would be discharged on an unknown date to go for physical therapy at an inpatient rehabilitation facility since she was still dizzy and cannot hardly walk. Reporter stated that the doctors had not mentioned that was vaccine related at all. The patient was being treated with antibiotics, steroids, and other medications.  Company comment: This spontaneous case concerns a female patient aged 48 years, with no medical history reported who experienced the unexpected seriousness criteria hospitalization and medically significant events of vestibular neuronitis and syncope 25 days after 1st dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 48 years, with no medical history reported who experienced the unexpected seriousness criteria hospitalization and medically significant events of vestibular neuronitis and syncope 25 days after 1st dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days; Moderna COVID booster was given and the vaccine was expired; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID booster was given and the vaccine was expired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID booster was given and the vaccine was expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID booster was given and the vaccine was expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The vaccine was expired, not from the manufactured date. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2022: Follow-up information received contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough for over a month; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough for over a month) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 COUGH (Cough for over a month). At the time of the report, COUGH (Cough for over a month) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: end up with vasculitis after receiving the Moderna vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VASCULITIS (end up with vasculitis after receiving the Moderna vaccines) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis and did not take other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Patient was allergic to certain Opioid Percocet.) and Vasculitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VASCULITIS (end up with vasculitis after receiving the Moderna vaccines). At the time of the report, VASCULITIS (end up with vasculitis after receiving the Moderna vaccines) outcome was unknown.            Patient height was reported as 5.4 F.  Patient was taking other unspecified medication.  Patient had the primary doses and the first booster.  Treatment information was not provided by the reporter.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced OFF LABEL USE (6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial). At the time of the report, OFF LABEL USE (6 month old was given a 0.25 ml (50 mcg) dose out of the red cap vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that no signs of adverse events were noted after administration. No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Intentional product use issue
Clinical narrative: First dose of Moderna in February 2022 and waited to get the second dose; looking at the batch number and says they got the shot but it expired in May; This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (First dose of Moderna in February 2022 and waited to get the second dose) and EXPIRED PRODUCT ADMINISTERED (looking at the batch number and says they got the shot but it expired in May) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2022, the patient experienced INTENTIONAL PRODUCT USE ISSUE (First dose of Moderna in February 2022 and waited to get the second dose) and EXPIRED PRODUCT ADMINISTERED (looking at the batch number and says they got the shot but it expired in May). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (First dose of Moderna in February 2022 and waited to get the second dose) and EXPIRED PRODUCT ADMINISTERED (looking at the batch number and says they got the shot but it expired in May) outcome was unknown.            Concomitant medication of the patient was not reported.   The patient reported that the lot number was put on some website and it was found that the lot number expired 20-May-2022.  The patient had first dose of Moderna in February 2022, but she got seriously sick and ended up in ICU due to her esophagus. For this reason the patient waited to get the second dose.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-602828 (Patient Link).