chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness in the injected arm; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the injected arm) and FATIGUE (Very tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE) for Blood pressure high, EZETIMIBE for Cholesterol high, LEVOTHYROXINE, PANTOPRAZOLE, VITAMIN D NOS and VITAMIN B COMPLEX (VITAMIN B-COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the injected arm) and FATIGUE (Very tired). On 21-Feb-2021, PAIN IN EXTREMITY (Soreness in the injected arm) and FATIGUE (Very tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was unknown.   This case was linked to MOD-2021-250515 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-250488 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck pain, Pain in extremity, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), VISION BLURRED (Blurred vision in my left eye lasted 15 minutes), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and MYALGIA (muscles in the back of my thighs and neck started to ache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation since 2014 and Thyroid disorder since 1997. Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ) from an unknown date to 06-Jun-2021 and WARFARIN from an unknown date to 06-Jun-2021 for Atrial fibrillation, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, RIVAROXABAN (XARELTO) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain), VISION BLURRED (Blurred vision in my left eye lasted 15 minutes), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and MYALGIA (muscles in the back of my thighs and neck  started to ache). The patient was treated with PREDNISONE at a dose of 40 mg once a day; GABAPENTIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Leg pain), VISION BLURRED (Blurred vision in my left eye lasted 15 minutes), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and MYALGIA (muscles in the back of my thighs and neck started to ache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Blurred vision worse everyday. Prednisone stopped the pain but came back at once. The patient did not have anything like those before. Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Follow-up information included no new information. On 04-Aug-2021: As reported events term and details of concomitant medications and treatment medication were updated. Current condition, vaccine facility information, additional concomitant medication, second dose information and lab tests were added. Event description was updated.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Shortness of breath; is very weak; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and ASTHENIA (is very weak) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced DYSPNOEA (Shortness of breath) and ASTHENIA (is very weak). At the time of the report, DYSPNOEA (Shortness of breath) and ASTHENIA (is very weak) outcome was unknown.            No concomitant medication was reported. No treatment was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: First dose of vaccine administered after excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant medications were not reported.   It was reported that the vaccine temperature was never checked throughout the day. The reporter stated that the vaccines were above 46 degrees F (Fahrenheit) after transport, and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times.   No treatment information was provided by the reporter.     This case was linked to MOD-2021-250531 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast pain, Burning sensation, Muscle spasms
Clinical narrative: burning feeling on both inner thighs; burning feeling on left side of breast; cramping sometimes in the toes, legs, ribs, and neck; cramping in stomach; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning feeling on both inner thighs), BREAST PAIN (burning feeling on left side of breast), MUSCLE SPASMS (cramping sometimes in the toes, legs, ribs, and neck) and ABDOMINAL PAIN (cramping in stomach) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE) for Blood pressure high, EZETIMIBE for Cholesterol high, LEVOTHYROXINE, PANTOPRAZOLE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced BURNING SENSATION (burning feeling on both inner thighs), BREAST PAIN (burning feeling on left side of breast), MUSCLE SPASMS (cramping sometimes in the toes, legs, ribs, and neck) and ABDOMINAL PAIN (cramping in stomach). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Breast pain, Abdominal pain and Muscle spasms, at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (burning feeling on both inner thighs), BREAST PAIN (burning feeling on left side of breast), MUSCLE SPASMS (cramping sometimes in the toes, legs, ribs, and neck) and ABDOMINAL PAIN (cramping in stomach) outcome was unknown.            This case was linked to MOD-2021-250501 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: body aches/ soar arm; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches/ soar arm), NAUSEA (nausea) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy to antibiotic, Drug allergy and Allergy to antibiotic. Concomitant products included MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (D3), LUTEIN [XANTOFYL], ALOE VERA (ALOEVERA EXTRA), CALCIUM and MAGNESIUM for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (body aches/ soar arm), NAUSEA (nausea) and PYREXIA (fever). On 12-Mar-2021, MYALGIA (body aches/ soar arm), NAUSEA (nausea) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 11-Mar-2021, Body temperature: 99.2 (High) at 2:30 am body temperature increased and 100.8 (High) at 07:50 am  body temperature increased.         This case was linked to MOD-2021-033197 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: arm hurts badly; first dose on 17May2021. Patient received second dose on 25Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm hurts badly) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17May2021. Patient received second dose on 25Jun2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17May2021. Patient received second dose on 25Jun2021). On an unknown date, the patient experienced MYALGIA (arm hurts badly). At the time of the report, MYALGIA (arm hurts badly) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 17May2021. Patient received second dose on 25Jun2021) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received vaccine after allowed expiry time; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On 07-Jul-2021, PRODUCT STORAGE ERROR (Patient received vaccine after allowed expiry time) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: Second dose at the age of 12 years old; Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second dose at the age of 12 years old) and INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and ER8736) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.). On 07-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second dose at the age of 12 years old). On 01-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination series - first dose Pfizer vaccine and second dose at the age of 12 years old.) had resolved. On 07-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Second dose at the age of 12 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Patient received vaccine on 1-JUN-2021 from the Pfizer.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Non Significant Follow up includes no new information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times") in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times"). On 11-Mar-2021, PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times") to be not applicable.    No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-250545 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: First dose of vaccine administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) had resolved.        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.   Reporter reported that  the vaccines were kept in hot weather during transport and  the vaccine could have been exposed to temperatures around 90 degrees Fahrenheit in the car.   This case was linked to MOD-2021-250540 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema on skin; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema on skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema on skin). At the time of the report, ECZEMA (Eczema on skin) outcome was unknown.            The concomitant medication were not reported. No treatment medication were reported.    Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: Second dose of vaccine administered after excursion; First dose administered 11Mar2021,Second dose administered 16Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021). On 16-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vaccines were never checked for temperature throughout the day. It was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times. She reported that the average temperature was 82 to 88 degrees F in April.  No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-250537 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose) had resolved.        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.   Concomitant medication use was unknown
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: first dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) outcome was unknown.        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 relevant concomitant medications were provided. No treatment information was provided.  The nurses never checked temperature throughout the day and did not keep track. Reporter reported that the temperature was  definitely above 46 degrees F and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times. She stated the vaccines were kept in hot weather during transport, and believed the vaccine could have been exposed to temperatures around 90 degrees F in the car.    This case was linked to MOD-2021-250547 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021; first dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna COVID-19 vaccine on 11Mar2021 and the second dose of the vaccine on 16 Apr 2021) outcome was unknown.        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 were reported No treatment medication were reported   This case was linked to MOD-2021-250536 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: First dose administered 11Mar2021,Second dose administered 16Apr2021; second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 11Mar2021,Second dose administered 16Apr2021) outcome was unknown.        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 was reported. No treatment medication was reported.   This case was linked to MOD-2021-250544 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: first dose of vaccine administered after excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant medications were not reported.   It was reported that the temperature for vaccines was never checked throughout the day. The reporter stated that the vaccines were above 46 degrees F (fahrenheit) after transport, and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-250558 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: Inappropriate schedule of vaccine administered; Vaccine exposure during pregnancy; First dose of vaccine administered after excursion; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The treatment information was not given.   This case was linked to MOD-2021-250576 (Patient Link).   Reporter did not allow further contact
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: second dose of vaccine administered after excursion; This spontaneous case was reported by an other health professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-250554 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for weeks after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced ILLNESS (Sick for weeks after the second shot). At the time of the report, ILLNESS (Sick for weeks after the second shot) outcome was unknown. Event was stated for group of people and Start Date of event Sick for weeks after the second shot stated 2021. No concomitant medications were mentioned. No treatment details were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes virus infection, Neck pain, Pain in jaw, Pyrexia
Clinical narrative: Herpes infection; Jaw pain; Neck pain; Spike in fever that reached 102°F; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (Herpes infection), PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F) and VACCINATION SITE PAIN (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). On 29-Apr-2021, the patient experienced HERPES VIRUS INFECTION (Herpes infection). The patient was treated with FAMCICLOVIR (FAMCLOVIR) at a dose of 250 mg twice a day. On 24-Apr-2021, PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, HERPES VIRUS INFECTION (Herpes infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-102902 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Herpes infection; Jaw pain; Neck pain; Spike in fever that reached 102°F; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (Herpes infection), PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F) and VACCINATION SITE PAIN (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache). On 29-Apr-2021, the patient experienced HERPES VIRUS INFECTION (Herpes infection). The patient was treated with FAMCICLOVIR (FAMCLOVIR) at a dose of 250 mg twice a day. On 24-Apr-2021, PAIN IN JAW (Jaw pain), NECK PAIN (Neck pain), PYREXIA (Spike in fever that reached 102°F), VACCINATION SITE PAIN (Sore arm) and HEADACHE (Headache) had resolved. At the time of the report, HERPES VIRUS INFECTION (Herpes infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-102902 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from a vial that was out longer than 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that was out longer than 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that was out longer than 12 hours). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from a vial that was out longer than 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vial punctured on 05-Jul-2021 at 12:30 P.M and vaccine administered on 06-Jul-2021 between 9 A.M and 1:30 P.M  Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: received vaccine in left upper arm for both doses. In early stages of pregnancy; second dose of vaccine administered after excursion; first dose of vaccine administered after excursion; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (received vaccine in left upper arm for both doses. In early stages of pregnancy), PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine administered after excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine administered after excursion). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (received vaccine in left upper arm for both doses. In early stages of pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (received vaccine in left upper arm for both doses. In early stages of pregnancy) outcome was unknown and PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine administered after excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not provided.  No treatment medications were not provided.  Date of LMP not provided.   This case was linked to MOD-2021-250555 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received  contains no new significant information.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Vaccination complication
Clinical narrative: Very bad side effect; Red spots on her skin (all over her body, mostly on her arms); Feeling blisters on her back\ back blisters are "tiny grape" size; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Very bad side effect), ERYTHEMA (Red spots on her skin (all over her body, mostly on her arms)) and BLISTER (Feeling blisters on her back\ back blisters are "tiny grape" size) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     Concomitant products included EMPAGLIFLOZIN (JARDIANCE) and ROSUVASTATIN.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Very bad side effect), ERYTHEMA (Red spots on her skin (all over her body, mostly on her arms)) and BLISTER (Feeling blisters on her back\ back blisters are "tiny grape" size). At the time of the report, VACCINATION COMPLICATION (Very bad side effect), ERYTHEMA (Red spots on her skin (all over her body, mostly on her arms)) and BLISTER (Feeling blisters on her back\ back blisters are "tiny grape" size) outcome was unknown.        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.   This case was linked to MOD-2021-250591.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is beyond 6 weeks for his second dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is beyond 6 weeks for his second dose of the vaccine) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is beyond 6 weeks for his second dose of the vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is beyond 6 weeks for his second dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that consumer got his 1st dose of the Moderna COVID-19 vaccine over six weeks ago from reporting date 07-JUL-2021.   Concomitant medication not provided.  Treatment information not provided.