chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: The nurse accidently administered the diluent instead of mixing the diluent with the powder; Case reference number US-BN-2021-000033 is a spontaneous case report initially received from a parmacist via Agency (reference number USBAV21-0030) on 22-Jan-2021 and concerns a patient over 60 years-old.  The patient's medical history and concomitant medications details were not provided.  On 22-Jan-2021, the nurse accidently administered to the patient the diluent instead of mixing the diluent with the powder of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731A) for post exposure (Product administration error).   It was stated that the reporter asked if there was anything they can use as the diluent to mix with the vaccine.  At the time of this report it was not known whether the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: Product administration error is listed by convention. Reportedly, the nurse accidently administered to the patient the diluent instead of mixing the diluent with the powder of RabaVert which is considered to be product administration error. No adverse events were reported. Product administration error is not related to t RabaVert but to human action.; Sender's Comments: Product administration error is listed by convention. Reportedly, the nurse accidently administered to the patient the diluent instead of mixing the diluent with the powder of RabaVert which is considered to be product administration error. No adverse events were reported. Product administration error is not related to t RabaVert but to human action.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: The patient got her first dose on Jan 21 and was to come back for her 2nd dose on Jan28th and missed it; Case reference number US-BN-2021-000047 is a spontaneous case report initially received from a health care professional via Agency (reference number USBAV21-0048) on 04-Feb-2021, and concerns a 19-year-old adult female patient.   The patient's medical history and concomitant medication details were not provided.  On 21-Jan-2021, the patient received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731A) at an unknown dose, administered intramuscularly and for pre-exposure prophylaxis.  On 28-Jan-2021, the patient was scheduled for the second vaccination, but it was not possible to administrate the second vaccine dose since the patient missed it (missed dose).   On 04-Feb-2021, the patient received the second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA571B) at an unknown dose, administered intramuscularly and for pre-exposure prophylaxis.  It was not reported if the patient experienced any adverse events due to RabAvert.  It was stated that the reporter asked regarding administration schedule: was it necessary to restart the vaccination schedule or should the vaccination be resumed. After information provided, reporter informed the patient, and stated that the vaccination schedule was resumed.   No further information was provided.; Reporter's Comments: Product dose omission issue i listed by convention. Reportedly the patient missed the second scheduled dose of Rabies vaccine and received the product within a week later, which is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product but to human action.; Sender's Comments: Product dose omission issue i listed by convention. Reportedly the patient missed the second scheduled dose of Rabies vaccine and received the product within a week later, which is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product but to human action.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient did not receive third dose of rabies vaccine; Case reference number US-BN-2021-000051 is a spontaneous case report initially received from a health care professional via Agency (reference number USBAV21-0050) on 08-Feb-2021, and concerns a 43-year-old male patient.   The patient's medical history included hypertension, autism, alcohol abuse, post-traumatic stress disorder and insomnia.  The patient's concomitant medication details were not provided.  On 25-Jan-2021, the patient received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided)  at a dose of 1cc (cubic centimeter), administrated intramuscularly for post-exposure-bite  On 28-Jan-2021, the patient received the second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731B) at a dose of 1cc (cubic centimeter), administrated intramuscularly and for post-exposure bite.  On 01-Feb-2021, the patient was scheduled the third vaccine dose, but it was not administrated (inappropriate schedule of vaccine administered). The patient received antibiotic shot instead of RabAvert.  On 07-Feb-2021, the patient received the third dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731B) at dose of 1cc (cubic centimeter), administrated intramuscularly and for post-exposure prophylaxis.  It was not reported if the patient experienced any adverse events due to RabAvert.  It was stated by the reporter that the patient was immunized with the first dose of the vaccine, and that the patient realized that he did not received the third dose of RabAvert. The antibiotic shot was administrated. Those two events happened at a health care facility other than the reporter's.   No further information was provided.; Reporter's Comments: Inappropriate schedule of vaccine administered is listed by convention. The patient did not receive the scheduled third rabies vaccine which is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to RabaVert, but to human action.; Sender's Comments: Inappropriate schedule of vaccine administered is listed by convention. The patient did not receive the scheduled third rabies vaccine which is considered inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of vaccine administered is not related to RabaVert, but to human action.
Sex: F
Vaccine: RAB
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; Case reference number US-BN-2021-000068 is a spontaneous case report initially received from a physician via Agency (USBAV21-0058) on 17-Feb-2021, and concerns a female patient.  The patient's concomitant medication details and medical history were not provided  On unknown date, the patient started therapy with intramuscular RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for unknown indication.  On an unknown date, the patient received the second dose of intramuscular RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an unknown dose for an unknown indication.  On an unknown date, the patient received the third dose of RabaVert intramuscular (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an unknown dose for an unknown indication.  On an unknown date, the patient experienced anaphylactic reaction.  At the time of this report it is not known whether the patient recovered from anaphylaxis.  The reporter assessed the events as serious and did not provide causality assessment.  No other information was provided.; Reporter's Comments: Anaphylactic reaction is listed for RabaVert as per local SmPC and Global Prescribing Information Version 6. Reportedly, the patient developed anaphylactic reaction after RabaVert vaccination. The exact timelines were not provided. Information regarding medical history and concomitant medications was also not provided at this point. Due to lack of information the contributory role of the suspect product cannot be excluded and the causality is assessed as possibly related to RabaVert. The case is serious due to medical significance of the event.; Sender's Comments: Anaphylactic reaction is listed for RabaVert as per local SmPC and Global Prescribing Information Version 6. Reportedly, the patient developed anaphylactic reaction after RabaVert vaccination. The exact timelines were not provided. Information regarding medical history and concomitant medications was also not provided at this point. Due to lack of information the contributory role of the suspect product cannot be excluded and the causality is assessed as possibly related to RabaVert. The case is serious due to medical significance of the event.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: The patient missed second dose; Case reference number US-BN-2021-000072 is a spontaneous case report initially received from pharmacist via agency (reference number USBAV21-0062) on 18-Feb-2021, and concerns a 64-year-old male patient.  The patient's medical history was not provided.  The patient's concomitant medication included Iviglob-ex (imunnoglobulin human normal).  On 13-Feb-2021, the patient received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an one vial dose, unknown route of administration and for post-exposure prophylaxis.   It was reported that the patient then missed vaccine dose for day 3 (product dose omission issue ).    It was not reported if the patient experienced any adverse events due to RabAvert.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient missed the second dose of RabAvert vaccine which was scheduled on day 3 after the first received dose, that is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product but to human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient missed the second dose of RabAvert vaccine which was scheduled on day 3 after the first received dose, that is considered to be product dose omission issue. No adverse events were reported. Product dose omission issue is not related to the suspect product but to human action.
Sex: M
Vaccine: RAB
Symptoms: Product temperature excursion issue
Clinical narrative: one dose was given after excursion of 8 hours and 41 minutes at 8.2 degrees.; Case reference number US-BN-2021-000136 is a spontaneous case report initially received from nurse via Agency (case reference number USBAV21-0082) on 02-Mar-2021, and concerns a 57-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified date (one week before the second vaccination, as stated by the reporter), the patient received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen (one injection reported), administrated intramuscularly and for pre-exposure prophylaxis.   On 01-Mar-2021, the patient was administrated the second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, administrated intramuscularly and for pre-exposure prophylaxis.  It was stated by the reporter that the vaccine had a temperature excursion of 8 hours and 41 minutes at 8.2 degrees (unit was not specified), and that regardless of the event (Product temperature excursion issue) patient received second vaccine dose.  At the time of this report outcome of this event remains unknown.  It was not reported did the patient experienced any adverse effect due to RabAvert.  No further information was provided.  Company comment: Product temperature excursion issue is listed by convention. Reportedly, the patient received the second dose of RabAvert after the product had been stored at a temperature excursion at 8.2 degrees, that is considered to be product temperature excursion issue. The event is not related to the suspect product but to human action.; Reporter's Comments: Product temperature excursion issue is listed by convention. Reportedly, the patient received the second dose of RabAvert after the product had been stored at a temperature excursion at 8.2 degrees, that is considered to be product temperature excursion issue. The event is not related to the suspect product but to human action.; Sender's Comments: Product temperature excursion issue is listed by convention. Reportedly, the patient received the second dose of RabAvert after the product had been stored at a temperature excursion at 8.2 degrees, that is considered to be product temperature excursion issue. The event is not related to the suspect product but to human action.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Body chill, body soreness, headache, fatigue, nausea
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Grip strength decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: 2 days after receiving the second shot I woke up with throbbing hands and fingers. My fingers and hands have been swollen and throbbing since the second vaccine. My doctor and myself believe it is rheumatoid arthritis triggered from the vaccine. I will have test done to confirm this in 3 months when I received my healthcare back from my employer... The joints in my fingers feel like they are under attack and I believe this to be the case they were perfectly fine before the vaccine and now I can hardly open a can of pop..
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product storage error
Clinical narrative: RabaVert was administered after temperature excursion; Case reference number US-BN-2021-000243 is a spontaneous case report initially received from a health care professional on 17-Mar-2021, and concerns a 9 years-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 03-Nov-2020, RabAvert vial was affected by temperature excursion (Product storage error).  On 04-Nov-2020, the patient received dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731A) at an unknown dosage regimen for post-exposure prophylaxis, from the vial that was affected by the temperature excursion.  At the time of this report it was not known whether the patient developed any adverse event.  This case is linked whit cases US-BN-2020-019887 and US-BN-2021-000244 (same reporter).  Further information was not provided.; Reporter's Comments: Product storage error is listed by convention. Reportedly, the patient received RabAvert that was affected due to temperature excursion which is considered to be product storage error. No adverse events were reported. Product storage error is not related to the suspect product but to human action.; Sender's Comments: Product storage error is listed by convention. Reportedly, the patient received RabAvert that was affected due to temperature excursion which is considered to be product storage error. No adverse events were reported. Product storage error is not related to the suspect product but to human action.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product storage error
Clinical narrative: RabaVert was administered after temperature excursion; Case reference number US-BN-2021-000244 is a spontaneous case report initially received from a health care professional on 17-Mar-2021, and concerns an 8-year-old female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 03-Nov-2020, RabAvert vial was affected to temperature excursion (Product storage error).   On 12-Nov-2020, the patient received dose of RabaVert ,that was affected due to temperature excursion (Inactivated Rabies Virus Vaccine, Batch no. AD01A13C) at unknown dosage regimen for post-exposure prophylaxis.  At the time of this report it was not known whether the patient developed any adverse event.  This case is linked with cases US-BN-2020-019887 and US-BN-2021-000243 (same reporter).  Further information was not provided.; Reporter's Comments: Product storage error is listed by convention. Reportedly, the patient received RabAvert that was affected to temperature excursion which is considered to be product storage error. No adverse events were reported. Product storage error is not related to the suspect product but to human action.; Sender's Comments: Product storage error is listed by convention. Reportedly, the patient received RabAvert that was affected to temperature excursion which is considered to be product storage error. No adverse events were reported. Product storage error is not related to the suspect product but to human action.
Sex: M
Vaccine: RAB
Symptoms: Labelled drug-drug interaction issue, No adverse event
Clinical narrative: human globulin administered with second vaccination; Case reference number US-BN-2021-000265 is a spontaneous case report initially received from a patient via Agency (case reference number USBAV21-0123) on 18-Mar-2021, and concerns a male patient of an unknown demographic.  The patient's medical history was not provided.  The patient's concomitant medications included Human Globulin (immunoglobulin human normal).  On an unspecified date, also reported as five years ago, the patient received RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an unknown dosage regimen, for an unknown indication.   On 16-Mar-2021, approximately five years after previously being vaccinated against Rabies, the patient was vaccinated for the second time and received the first dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen, for post-exposure treatment. The patient stated that human globulin (immunoglobulin) was administered along with the first dose of in the second course of Rabies vaccination (labelled drug-drug interaction issue), despite previously being immunized.  It was not reported if the patient experienced any adverse effect due to RabAvert.  No further information was provided.; Reporter's Comments: Labelled drug-drug interaction issue is listed per convention. Reportedly, the patient was vaccinated with RabAvert for the second time and human globulin was administrated along with the second vaccination, which is considered labelled drug-drug interaction issue. No adverse events were reported. Labelled drug-drug interaction issue is not related to Rabipur, but to human action. The case is considered non serious.; Sender's Comments: Labelled drug-drug interaction issue is listed per convention. Reportedly, the patient was vaccinated with RabAvert for the second time and human globulin was administrated along with the second vaccination, which is considered labelled drug-drug interaction issue. No adverse events were reported. Labelled drug-drug interaction issue is not related to Rabipur, but to human action. The case is considered non serious.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: First dose was administered into gluteal region; Case reference number US-BN-2021-000280 is a spontaneous case report initially received from consumer on 22-Mar-2021, and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 17-Mar-2021, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered into gluteal region (Product administered at inappropriate site).  On 20-Mar-2021, patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered in deltoid region.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  This case is linked with cases US-BN-2021-000281 and US-BN-2021-000282 (same reporter).; Reporter's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.; Sender's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: First dose was administered into gluteal region; Case reference number US-BN-2021-000281 is a spontaneous case report initially received from consumer on 22-Mar-2021, and concerns a female patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 17--Mar-2021, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered into gluteal region (Product administered at inappropriate site).  On 20--Mar-2021, patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack was administered in thigh region.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  This case is linked with cases US-BN-2021-000280 and US-BN-2021-000281 (same reporter).; Reporter's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert into gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.; Sender's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert into gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product storage error
Clinical narrative: The costumer received the item on Friday, but it was left out; Case reference number US-BN-2021-000707 is a spontaneous case report initially received on 29-Mar-2021 from other health professional and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On 26-Mar-2021, the patient was vaccinated with RabAvert (rabies virus (Inactivated, Strain Flury LEP) (PCEC)) at unknown dose, route of administration or anatomical location for unknown indication.  On an unspecified date in 2021, medication was left out ('Product storage error') and the reporter wanted to know if the item was still good to use.  At the time of initial reporting, it was unknown whether the patient experienced any adverse events after RabAvert vaccination.  No further information was provided.; Reporter's Comments: Product storage error is listed by convention. Reportedly, RabAvert was left out. Product storage error is not related to the RabAvert but to a human action.; Sender's Comments: Product storage error is listed by convention. Reportedly, RabAvert was left out. Product storage error is not related to the RabAvert but to a human action.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product administration error, Product storage error
Clinical narrative: The vaccine was reconstituted 2 hour before the patient arrived; Case reference number US-BN-2021-001642 is a spontaneous case report initially received from consumer on 22-Apr-2021, and concerns a patient of an unknown demographics.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On unknown date, the patient received therapy of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for unknown indication.  The vaccine was reconstituted two hours before the patient arrived (Product storage error).  At the time of this report it was no known whether the patient developed any adverse event.  No further information was provided.; Reporter's Comments: Product storage error is listed by convention. Reportedly, the vaccine was reconstituted two hours before the patient arrived. Since the vaccine is to be used immediately after reconstitution that is considered to be product storage error. No adverse events were reported. Product administration error is not related to RabAvert, but to human action.; Sender's Comments: Product storage error is listed by convention. Reportedly, the vaccine was reconstituted two hours before the patient arrived. Since the vaccine is to be used immediately after reconstitution that is considered to be product storage error. No adverse events were reported. Product administration error is not related to RabAvert, but to human action.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received his doses on Day 1, Day7, and Day 14 instead of Day 21 or Day 28; Case reference number US-BN-2021-001675 is a spontaneous case report initially received on 6-May-2021 from other health professional and concerned a male patient of unspecified age.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with first dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: ARBA801A) at standard dose (as reported), via intramuscular route of administration for 'vet student getting pre-exposure vaccines'.   On an unspecified date, on day 7 after the first vaccination, the patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not reported) at unknown dose or unknown route of administration for 'vet student getting pre-exposure vaccines'.  On an unspecified date, on day 14 after the first vaccination, instead of day 21 (or 28) (explicitly coded as 'Inappropriate schedule of vaccine administered'), the patient received third dose of RabaVert (Inactivated Rabies Virus Vaccine; batch number: not reported) at unknown dose or unknown route of administration for 'vet student getting pre-exposure vaccines'.  At the time of this report, it was confirmed that the patient did not experience any adverse events after vaccination.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the third dose of RabAvert on day 14 after the first dose (instead of day 21 or 28) and that is condidered as inappropriate schedule of vaccine administered. The patient did not experience any adverse events after vaccination. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action.; Sender's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the third dose of RabAvert on day 14 after the first dose (instead of day 21 or 28) and that is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse events after vaccination. Inappropriate schedule of vaccine administered is not related to the suspect product but to a human action.
Sex: U
Vaccine: RAB
Symptoms: Product dose omission issue, Product preparation issue, Syringe issue
Clinical narrative: The patient will come back when the new vaccine comes in; During reconstitution of RabAvert, diluent leaked out of the top, when the cap popped off and the diluent leaked out of the syringe; Case reference number US-BN-2021-001685 is a spontaneous case report initially received from a pharmacist via Agency (case PQC number K21-PQC025, reference number: USBAV21-0149) on 06-May-2021, and concerns a patient of an unknown demographics.  The patient's medical history and concomitant medication details were not provided.  It was stated by the reporter that during reconstitution of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. not provided) diluent leaked out of the top, when the cap popped off and the diluent leaked out of the syringe (Product preparation issue). The vaccine was for pre-exposure and the patient will come back when the new vaccine comes in, as reported (Missed dose).  Information on whether the patient experienced any adverse events due to RabAvert was not provided.  Additional information received from Agency on 11-May-2021 included reporter's identifiers, original verbatim report from the reporter and it is blended in the case narrative above.  No further information was provided.; Reporter's Comments: Product dose omission issue and product preparation issue are listed by convention. Reportedly, during reconstitution of RabAvert diluent leaked out of the syringe (product preparation issue). Therefore, the patient didn't receive the dose of RabAvert which is considered missed dose. No adverse events were reported. Missed dose and product preparation issue are not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue and product preparation issue are listed by convention. Reportedly, during reconstitution of RabAvert diluent leaked out of the syringe (product preparation issue). Therefore, the patient didn't receive the dose of RabAvert which is considered missed dose. No adverse events were reported. Missed dose and product preparation issue are not related to the suspect product but to a human action.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizure; Condition aggravated; This case was received via FDA VAERS (Reference number: 1036286) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included seizure.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, SEIZURE (Seizure) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no known allergies has been reported. the concomitant medications not reported . the patient has the medical history of seizures.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Hyperhidrosis, Syncope, Vital signs measurement
Clinical narrative: Syncope; Fall; Head injury; Hyperhidrosis;   This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), FALL (Fall), HEAD INJURY (Head injury) and HYPERHIDROSIS (Hyperhidrosis). At the time of the report, SYNCOPE (Syncope), FALL (Fall), HEAD INJURY (Head injury) and HYPERHIDROSIS (Hyperhidrosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Vital signs measurement: consistent with fainting episode (abnormal) Vital signs consistent with fainting episode and stabilized within fifteen minutes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was reported.   Treatment information was not reported.   On 17Mar02021, it was noted by the reporter that the patient was observed kneeling by a chair as diaphoretic immediately post vaccine. The reporter asked the patient if he would lie down  to be assessed.  The patient then fainted and fell to the floor, hitting the back of his head on the floor. The code team was called for immediate assistance. The patient's head and neck were supported. The patient's vital signs were consistent  with fainting episode  and stabilized within fifteen minutes.  The patient was transferred by EMS to  the hospital for evaluation of head injury.   It was noted by the reporter that the initial assessment showed no immediate neurological deficits and no  superficial  bleeding at head impact location on the patient. Further clinical course is unknown/not reported at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: U
Vaccine: RAB
Symptoms: Product prescribing error
Clinical narrative: prescription to have 4 doses of post exposure; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported the patient had a prescription to have 4 doses of post exposure treatment with RabAvert instead of 5. The Pharmacist said that he was going to make the doctors change the prescription to 5 doses. The case has been linked with the case US2020139456, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020139456:
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Have missed 2 doses of the rabies series / been about a week since first dose; This case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Rabies NVS (RabAvert) for prophylaxis.  Concurrent medical conditions included animal bite. Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. There were 2- 3 patients who have missed 2 doses of the rabies series. The reporter believed it was up to 3 patients. The patient came into the Emergency Room after being bitten by an animal and received the first dose of the vaccine series.  It has been about a week since the first dose, which led to incomplete course of vaccination. The pharmacist states this was a general question from an emergency room nurse to see what they need to do to complete this series.   On the follow up following internal review it was determined that the initial receipt date (26th August 2020) which is earliar than initially reported.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Intercepted product storage error
Clinical narrative: was taken out to give to a patient and it was / was not put inmediately; was taken out to give to a patient and it was / was not put inmediately; This case was reported by a pharmacist via other manufacturer and described the occurrence of intercepted product storage error in a 20-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included Rabies NVS (RabAvert) for prophylaxis.   Concurrent medical conditions included animal bite. Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 27th July 2020, the patient received the 3rd dose of RabAvert. On an unknown date, the patient received RabAvert. On 24th July 2020, unknown after receiving RabAvert and not applicable after receiving RabAvert, the patient experienced intercepted product storage error. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the intercepted product storage error and drug dose administration interval too long were unknown.  Additional information was provided as follows: The age at vaccination was not reported, however the patient could be of 19 or 20 years old at a time of vaccination. The Rabavert vaccine was taken out to give to a patient and it was not put back immediately. I think it was out for about 24 hours. As per the pharmacist, this was the patient's 3rd dose and they rescheduled for a couple of days later. The patient did not get this dosage that was left out. It was a single use vial and they set it out to get it to room temperature before the patient got to the appointment. The patient did not show up for the appointment, and the medication was left in the return to pharmacy bin for about 24 hours. The missed dosage was on 24th July 2020. The patient came in for his appointment and got his vaccine on 27th July 2020. The reporter consented for follow up.   Follow up information received from pharmacist on 11th August 2020: PharmD stated that the patient did not receive the dose that was left out. The patient did not miss the dose, they had another injection they could use to give the dose. The reporter was not sure that the vaccine was back in the fridge or not. The reporter wanted to know if something in the future happened again like this and a vaccine was out of the fridge can it be use. The reporter also wanted to know If vaccine being left out occurs did it change the expiration of the vaccine. This vaccine was at room temperature for 24 hours so probably maximum of 68 to 72 degrees, but the reporter was not exactly sure what the temperature was.   Following internal review it was determined that initial reciept date was 5th August 2020, which is earlier than initially reported.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the 3rd dose; This case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On an unknown date, the patient received the 3rd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient received 1st RabAvert on 28th July 2020 and 2nd RabAvert on 31st July 2020. The patient missed 3rd dose of RabAvert which supposed to receive on 4th August 2020. which led to incomplete course of vaccination. The reporter declined consent for follow up.   Following internal review it was determined that initial reciept date was 6th August 2020, which is earlier than initially reported.
Sex: U
Vaccine: RAB
Symptoms: Product preparation issue, Wrong technique in product usage process
Clinical narrative: she pulled air into the syringe and injected the air and liquid into the vial/had an issue drawing the vaccine out of the vials/she devised her own way of doing it; This case was reported by a pharmacist via other manufacturer and described the occurrence of wrong technique in product usage process in a patient who received Rabies NVS (RabAvert) (batch number ARBA731A, expiry date September 2023) for prophylaxis.   On 12th August 2020, the patient received RabAvert 1 ml. On an unknown date, unknown after receiving RabAvert, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.  Additional information was received as follows: Age at vaccination was not applicable for this report. The Pharmacist reported having questions regarding the reconstitution of rabies vaccine. The pharmacist further added of giving the vaccine to a family of 4 last night and that the nurse had an issue drawing the vaccine out of the vials leading to wrong technique in product usage process. She had one of the old products and it went fine, but the 3 new ones were difficult with the withdrawal from the vial.  The first vial the nurse could not get all of the vaccine out and just discarded it as she felt she contaminated it. The next one she devised her own way of doing it, and she pulled air into the syringe and injected the air and liquid into the vial which led to wrong technique in product usage process. The pahrmacist also informed that as per PI, we should never leave a needle in the vial when we reconstitute. The pharmacist further stated that nurses think the vial is different, but the she was not sure because she did not have any of the other lot to compare. Pharmacist did not have any of the patient information while on call. Upon follow up with the pharmacist, pharmacist stated that they have since administered the vaccine and followed the directions and it worked just fine. This case was linked to case US2020AMR163372 and US2020AMR163383 by same reporter. This case was for patient 2 of 3.   On the follow up following internal review it was determined that the initial receipt date (26th August 2020) which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163383: US-GLAXOSMITHKLINE-US2020AMR163372:
Sex: U
Vaccine: RAB
Symptoms: Wrong technique in product usage process
Clinical narrative: she pulled air into the syringe and injected the air and liquid into the vial/had an issue drawing the vaccine out of the vials/she devised her own way of doing it; This case was reported by a pharmacist via other manufacturer and described the occurrence of wrong technique in product usage process in a patient who received Rabies NVS (RabAvert) (batch number ARBA731A, expiry date September 2023) for prophylaxis.   On 12th August 2020, the patient received RabAvert 1 ml. On 12th August 2020, unknown after receiving RabAvert, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.  Additional information was received as follows: Age at vaccination was not applicable for this report. The Pharmacist reported having questions regarding the reconstitution of rabies vaccine. The pharmacist further added of giving the vaccine to a family of 4 last night and that the nurse had an issue drawing the vaccine out of the vials leading to wrong technique in product usage process. She had one of the old products and it went fine, but the 3 new ones were difficult with the withdrawal from the vial.  The first vial the nurse could not get all of the vaccine out and just discarded it as she felt she contaminated it. The next one she devised her own way of doing it, and she pulled air into the syringe and injected the air and liquid into the vial which led to wrong technique in product usage process. The pahrmacist also informed that as per PI, we should never leave a needle in the vial when we reconstitute. The pharmacist further stated that nurses think the vial is different, but the she was not sure because she did not have any of the other lot to compare. Pharmacist did not have any of the patient information while on call. Upon follow up with the pharmacist, pharmacist stated that they have since administered the vaccine and followed the directions and it worked just fine. This case was linked to case US2020AMR163372 and US2020AMR163382 by same reporter. This case was for patient 2 of 3.   Following internal review it was determined that initial reciept date was 13th August 2020 for follow up 1 and 17th August 2020 for follow up 2 and 3, which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163372: US-GLAXOSMITHKLINE-US2020AMR163382:
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: We had all 4 of the shots and the immunoglobulin for post exposure; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included Rabavert (received 1st dose on unknown date.), Rabavert (received 2nd  dose on 25th November 2016, batch number 595011A, expiry date May 2019.), Rabavert (received 3rd dose on 29th November 2016, batch number 595011A, expiry date May 2019.) and Rabavert (received 4th dose on 6th December 2016, batch number 626011A, expiry date March 2019.).   On an unknown date, the patient received the 5th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient had all 4 of the shots and the immunoglobulin for post exposure prophylaxis for a bat in the house and doctor proposed we get that done.  The reporter did this was November 2016 and had another bat in the house and were instructed by the doctor and hospital to call Agency. The patient informed that the series contains 5 shots not 4. The reporter might not go any further with this and had the rabies shots and called daughter and asked her what she remembered the hospital told her about how long it would last and had the shots and they said 5 years.  The patient saw the bat, caught the bat and got rid of it and are having this problem with bats.  The reporter caller that she needs to speak with her doctor on how to proceed as she did not have a full series with her first series. The patient did not received 5th dose, which led to incomplete course of vaccination. This case linked with US2020AMR163481 and US2020AMR163493, reported by same reporter.   Following internal review it was determined that initial receipt date was 12th August 2020, which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163493: US-GLAXOSMITHKLINE-US2020AMR163481: