chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year old was administered Kinrix vaccines; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The registered nurse reported that a 10 year old patient was administered Kinrix vaccines.  At the time of call, the nurse did not had the patient details, date of administration, or the information of what vaccines were given.  The reporter did not had the lot number/expiration date information of the doses. The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The registered nurse reported that a 10 year old patient was administered Kinrix vaccine, which led to inappropriate age at vaccine administration. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022136451:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter
Age: 10.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year old was administered Kinrix vaccines; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The registered nurse reported that a 10 year old patient was administered Kinrix vaccines.  At the time of call, the nurse did not had the patient details, date of administration, or the information of what vaccines were given.  The reporter did not had the lot number/expiration date information of the doses. The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The registered nurse reported that a 10 year old patient was administered Kinrix vaccine, which led to inappropriate age at vaccine administration. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022136453:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: 4 YO was administered Boostrix; 4 YO was administered Boostrix; Boostrix administration instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 4-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced accidental underdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the accidental underdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The reporter was a nurse. The registered nurse reports a 4 year old patient was administered Boostrix instead of Infanrix. The reporter stated that at the time of call he did not have the patient details, date of administration, lot number, expiration date, or the information of what vaccines were given previously. The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive information: The reporter reported that, they were intending to administer Infanrix and inadvertently administered Boostrix instead of Infanrix, which led to wrong vaccine administered. The patient received Boostrix who was younger than the indicated age which led to inappropriate age at vaccine administration and accidental underdose. This case was 1 of 11 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022136455:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136465:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only diluent portion administered; Only the diluent portion administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA729A, expiry date 30th September 2023) for prophylaxis.   On 19th September 2022, the patient received the 1st dose of Menveo. On 19th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The reporter was a assistant quality care coordinator. The reporter reported that the patient received only diluent portion of Menveo vaccine. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The reporter gave by error Menveo diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave Boostrix instead of the Kinrix; gave a patient Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9zk5t, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse stated that patient was administered with Boostrix dose when he was intended to receive a Kinrix dose. The reporter consented to follow up. No HCP for follow up. Additional Supportive Information: The patient was given Boostrix instead of Kinrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The case US2022136487 was identified as duplicate of US2022136489. The case US2022136489 would be voided and all the future correspondence would be added in this case US2022136487 which stands as a case of record for this patient.
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose on 20Sep2022, expiration date of 18Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 20th September 2022, the patient received Havrix. On 20th September 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.      Additional Information: GSK receipt date: 22-SEP-2022 Reporter's comment: Pharmacist reported that a colleague had administered a dose of Havrix to a patient on 20th September 2022, which had an expiration date of 18th June 2022. At the time of reporting, the dose had not been repeated.  The reporter had consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Thrombosis
Clinical narrative: Blood clot in leg; This case was reported by a pharmacist via call center representative and described the occurrence of thrombosis leg in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced thrombosis leg (serious criteria GSK medically significant). On an unknown date, the outcome of the thrombosis leg was not recovered/not resolved.   It was unknown if the reporter considered the thrombosis leg to be related to Shingrix.     Additional Information: GSK receipt date: 23-SEP-2022 Reporters comment: The patient was not immunocompromised.  The pharmacist called to see if it was safe to administer Shingrix second dose if a patient had a blood clot on her leg.  At the moment of the reporting, Shingrix second dose had not been administered. The reporter did not consent to follow-up as consent was not possible to obtain during the call.
Sex: M
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: ALMOST LOST; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and 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, batch number and expiry date were not reported) dose was not reported, 1 total administered on SEP-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 23-SEP-2022, an year after vaccination, the patient experienced almost lost. It was reported that "We almost lost my brother in law today bc of their vax he took an year ago. They're covering it up with saying that it's genetic". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost lost was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220948253-covid-19 vaccine ad26.cov2.s-almost lost. The event(s) has a compatible/suggestive 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: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Thrombosis
Clinical narrative: BLOOD CLOT ON INSIDE RIGHT ANKLE; COVID-19 SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (diclofenac), and other pre-existing medical conditions included: The patient had no illness at the time of vaccination. The patient had no past history of similar events. The patient had no Adverse event after any previous vaccination(s). The patient had no Pre-existing acute illness 30 days prior to vaccination. The patient had no History of hospitalization in last 30 days. The patient had no Family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination and was not currently breast-feeding. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number was not reported) 1 in total, dose, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 77 years old. Concomitant medication included Listerine mouthwash. On an unspecified date, the patient experienced covid-19 symptoms for 24 hours after the vaccine. On an unspecified date, the patient experienced blood clot on inside right ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 symptoms, and the outcome of blood clot on inside right ankle was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220915331.; Sender's Comments: V0: 20220954311- covid-19 vaccine ad26.cov2.s- blood clot on inside right ankle. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via company representative through social media concerned a patient of unspecified age, sex, race and 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, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre syndrome and it was reported as "Yea don't tell the truth. I got GIALLIA BARREA SYDROM FROM YOUR SHOT. TELL THE TRUTH." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220957375-covid-19 vaccine ad26.cov2.s-Gullian-Barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Rash
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; RASH; This spontaneous report received from a patient via other manufacturer (pfizer) concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. The patient previously received Moderna covid-19 vaccine (elasomeran) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced rash following administration of Moderna covid-19 vaccine (elasomeran) (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  The Patient was revaccinated with different covid-19 vaccine. On an unspecified date, the patient experienced rash for each 10 to 12 days after the shot (dose number in series 2) (dose number in series 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose, start therapy date were not reported for covid-19 prophylaxis.  On an unspecified date, the patient experienced rash following administration of Moderna covid-19 vaccine (elasomeran) (dose number in series 3). The patient got a minor, then a moderate, and a severe rash for each dose and was given a cortisone injection that lasted 5-6 weeks. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from rash, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: SEVERE INJURY; 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 covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe injury was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media, via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, it was reported that, "the Johnson and Johnson vaccine killed my neighbor plus, it was a one dose vaccine how did you have 2 injections", "the Johnson and Johnson vaccine killed my neighbor", "you got lucky...it killed my neighbor".  On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220960539.; Sender's Comments: V0-20220960476-covid-19 vaccine ad26.cov2.s-Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Somnolence
Clinical narrative: sleepy; Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (sleepy) and COVID-19 (Covid) in a male 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. In January 2022, the patient experienced COVID-19 (Covid). On an unknown date, the patient experienced SOMNOLENCE (sleepy). At the time of the report, SOMNOLENCE (sleepy) and COVID-19 (Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medications were provided. It was reported that patient felt very sleepy after receiving the vaccine. No treatment medications were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: A tiny bruise at the injection site after her first 2 shots; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (A tiny bruise at the injection site after her first 2 shots) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer (Patient is recovering from cancer.).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (A tiny bruise at the injection site after her first 2 shots). At the time of the report, VACCINATION SITE BRUISING (A tiny bruise at the injection site after her first 2 shots) outcome was unknown.            No concomitant medication was reported.  Patient did not take any medications to help with the adverse event.   This case was linked to MOD-2022-651643 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Headache, Vaccination site pain
Clinical narrative: Lower back pain; Anxiety because of the error in his wife's vaccine; Headache; Hurts at the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BACK PAIN (Lower back pain), ANXIETY (Anxiety because of the error in his wife's vaccine), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurts at the injection site) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced BACK PAIN (Lower back pain), ANXIETY (Anxiety because of the error in his wife's vaccine), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurts at the injection site). At the time of the report, BACK PAIN (Lower back pain), ANXIETY (Anxiety because of the error in his wife's vaccine), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurts at the injection site) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer stage II, Illness
Clinical narrative: stage 2 breast cancer; I got so sick from the shot; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER STAGE II (stage 2 breast cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER STAGE II (stage 2 breast cancer) (seriousness criterion medically significant) and ILLNESS (I got so sick from the shot). At the time of the report, BREAST CANCER STAGE II (stage 2 breast cancer) had not resolved and ILLNESS (I got so sick from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Patient was prescribed steroids to help.  Company comment. This spontaneous case concerns a female patient, unknown age, with no medical history reported, who received a dose of mRNA  1273 vaccine (reported as first dose of mRNA - 1273) and experienced the unexpected, serious (medically significant) event of breast cancer stage II. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient got so sick from the vaccine that she "could not function for a month" and in an unspecified date she went to urgent care where she was prescribed steroids (unspecified dose and frequency). Laboratory blood tests were performed, and it was mentioned that the oncologist said, "the cancer was environmental". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, unknown age, with no medical history reported, who received a dose of mRNA  1273 vaccine (reported as first dose of mRNA - 1273) and experienced the unexpected, serious (medically significant) event of breast cancer stage II. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient got so sick from the vaccine that she "could not function for a month" and in an unspecified date she went to urgent care where she was prescribed steroids (unspecified dose and frequency). Laboratory blood tests were performed, and it was mentioned that the oncologist said, "the cancer was environmental". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-651849 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651849:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose).    No concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-651842 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651842:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose; 2nd primary dose was given 6 months after the first primary dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose).    No concomitant medications were reported. On 22-FEB-2022, the Patient received first primary dose of Moderna monovalent vaccine of Batch no 033K21-2A, Expiry date was unknown. Patient had not reported any adverse reactions. No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; adults received 0.5 ml of Moderna vial intended for ages 6-11; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (adults received 0.5 ml of Moderna vial intended for ages 6-11).    Concomitant medications were not reported. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Bite
Clinical narrative: got bit by something; This spontaneous case was reported by a patient and describes the occurrence of BITE (got bit by something) in a female patient of an unknown age 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, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BITE (got bit by something). The patient was treated with DOXYCYCLINE for Bite, at an unspecified dose and frequency. At the time of the report, BITE (got bit by something) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had received 4 shots of the COVID-19 vaccinations. It was now 6 months after the last one.  She got bit by something and called the doctor. She was on doxycycline for the bite. HCP said she can still get it the Bivalent vaccination, but she wanted to know from Moderna if she can take it still.
Sex: U
Vaccine: COVID19-2
Symptoms: Vaccination site bruising, Vaccination site discolouration, Vaccination site discomfort
Clinical narrative: bruise at the injection site; black and blue at injection site; some muscles were hit during the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE DISCOMFORT (some muscles were hit during the injection) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE DISCOMFORT (some muscles were hit during the injection). At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site), VACCINATION SITE DISCOLOURATION (black and blue at injection site) and VACCINATION SITE DISCOMFORT (some muscles were hit during the injection) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; called us back and said they had made a mistake and gave him the monovalent, instead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (called us back and said they had made a mistake and gave him the monovalent, instead) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A, 045L21A, 035C21A, 036A21A and 013M20A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (called us back and said they had made a mistake and gave him the monovalent, instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (called us back and said they had made a mistake and gave him the monovalent, instead) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient received first and second dose as full doses.  On 22-Oct-2021, the patient received first booster dose.  On 01-Apr-2022, the patient received second booster dose.  On 14-Sep-2022, the patient received third monovalent booster dose.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little achy  with a sore arm/ sore and achy arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (little achy  with a sore arm/ sore and achy arm) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030C22B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced PAIN IN EXTREMITY (little achy  with a sore arm/ sore and achy arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 27-Sep-2022 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little achy  with a sore arm/ sore and achy arm) outcome was unknown.            No concomitant medication was reported. Patient states that she had two primary doses and two booster doses of vaccine. It was reported that the patient felt like someone sucker punched her. The patient not had any other side effects from it, just a sore and achy arm.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022); No adverse event; The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)), PRODUCT STORAGE ERROR (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 051C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)), PRODUCT STORAGE ERROR (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)) and PRODUCT STORAGE ERROR (The vaccine had been punctured and at room temperature for 5 days before it was administered (from 9/23/2022 until it was administered on 9/28/2022)).    No concomitant medications were provided.  A patient was administered one dose of Spikevax, expiration date 1/13/20123.  The vaccine had been punctured at 23-Sep-2022 and it was administered after 5days at room temperature.  No treatment medications were reported.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 2nd dose given 3 weeks after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1416B and AS1416B) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose).    Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.