chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Peripheral coldness
Clinical narrative: Whole left hand was numb; cannot feel pinky; Hand is cold; could not open the last two fingers, the ring finger and the pinky; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (Whole left hand was numb; cannot feel pinky), PERIPHERAL COLDNESS (Hand is cold) and MUSCULOSKELETAL STIFFNESS (could not open the last two fingers, the ring finger and the pinky) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Supraventricular tachycardia. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), VERAPAMIL and CHLORPROPAMIDE (GLUCAMIDE) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HYPOAESTHESIA (Whole left hand was numb; cannot feel pinky), PERIPHERAL COLDNESS (Hand is cold) and MUSCULOSKELETAL STIFFNESS (could not open the last two fingers, the ring finger and the pinky). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Whole left hand was numb; cannot feel pinky) and PERIPHERAL COLDNESS (Hand is cold) outcome was unknown and MUSCULOSKELETAL STIFFNESS (could not open the last two fingers, the ring finger and the pinky) had resolved. Not Provided      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.   Treatment for the events included warm compresses.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Fatigue, Hypotension
Clinical narrative: almost fainted, room was spinning; Dizzy spells; room was spinning; blood pressure reading low; chills; body aches; feeling really worn out and tired; A spontaneous report was received from a consumer concerning a 70- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches/Myalgia, feeling really worn out and tired/Fatigue, almost fainted/Presyncope and the room was spinning/Vertigo, dizzy spells/Dizziness, and blood pressure reading low/Hypotension.  The patient's medical history included, hypertension.  Concomitant medications included, Amlodipine/Benazepril once daily for blood pressure and Clonidine as needed for extremely high blood pressure.   On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch 016M20A) intramuscularly on upper left arm for prophylaxis of COVID-19 infection.  On 11-Mar-2021, prior to the onset of events,the patient received their second of two planned doses of mRNA-1273 (lot/batch 011A21A) intramuscularly on upper left arm for prophylaxis of COVID-19 infection.  On 12-Mar-2021,the patient experienced chills, body aches, feeling really worn out and tired, almost fainted and the room was spinning.  Her blood pressure after the "dizzy spell" was lower than her normal. It was recorded as 115/67. Per the consumer, her normal systolic blood pressure ranges between 130 to 150.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events  was not applicable.  The outcome of the events presyncope, dizzy spells, myalgia, chills, fatigue, vertigo and blood pressure reading low was considered as resolved on 12 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Presyncope, Vertigo
Clinical narrative: almost fainted, room was spinning; Dizzy spells; room was spinning; blood pressure reading low; chills; body aches; feeling really worn out and tired; A spontaneous report was received from a consumer concerning a 70- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches/Myalgia, feeling really worn out and tired/Fatigue, almost fainted/Presyncope and the room was spinning/Vertigo, dizzy spells/Dizziness, and blood pressure reading low/Hypotension.  The patient's medical history included, hypertension.  Concomitant medications included, Amlodipine/Benazepril once daily for blood pressure and Clonidine as needed for extremely high blood pressure.   On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch 016M20A) intramuscularly on upper left arm for prophylaxis of COVID-19 infection.  On 11-Mar-2021, prior to the onset of events,the patient received their second of two planned doses of mRNA-1273 (lot/batch 011A21A) intramuscularly on upper left arm for prophylaxis of COVID-19 infection.  On 12-Mar-2021,the patient experienced chills, body aches, feeling really worn out and tired, almost fainted and the room was spinning.  Her blood pressure after the "dizzy spell" was lower than her normal. It was recorded as 115/67. Per the consumer, her normal systolic blood pressure ranges between 130 to 150.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events  was not applicable.  The outcome of the events presyncope, dizzy spells, myalgia, chills, fatigue, vertigo and blood pressure reading low was considered as resolved on 12 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: one day of not feeling good; achey arm/ felt nothing horrible just sore; elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (one day of not feeling good), PAIN IN EXTREMITY (achey arm/ felt nothing horrible just sore) and PYREXIA (elevated temperature) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Rheumatoid arthritis. Concomitant products included METHOTREXATE, PRAVASTATIN and WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (one day of not feeling good), PAIN IN EXTREMITY (achey arm/ felt nothing horrible just sore) and PYREXIA (elevated temperature). On 03-Mar-2021, VACCINATION COMPLICATION (one day of not feeling good), PAIN IN EXTREMITY (achey arm/ felt nothing horrible just sore) and PYREXIA (elevated temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 99.8 (High) high.         Patient's additional concomitant drugs included, atrial fibrillation medication.  Treatment information was not provided by the reporter.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Describes underarm pain/soreness upon movement with opening and closing left arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Describes underarm pain/soreness upon movement with opening and closing left arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (Describes underarm pain/soreness upon movement with opening and closing left arm). At the time of the report, AXILLARY PAIN (Describes underarm pain/soreness upon movement with opening and closing left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment medicines were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 08-Mar-2021, the patient experienced FATIGUE (Little tired). At the time of the report, FATIGUE (Little tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.    This case was linked to MOD21-052700 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-052700:Cross Linked no
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Sensory disturbance
Clinical narrative: Spider web feeling around his ears and head; Head feels like a sunburn; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY DISTURBANCE (Spider web feeling around his ears and head) and BURNING SENSATION (Head feels like a sunburn) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SENSORY DISTURBANCE (Spider web feeling around his ears and head) and BURNING SENSATION (Head feels like a sunburn). At the time of the report, SENSORY DISTURBANCE (Spider web feeling around his ears and head) and BURNING SENSATION (Head feels like a sunburn) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-026627 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Reporter contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine mild in intensity; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine mild in intensity) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MIGRAINE (Migraine mild in intensity). The patient was treated with PARACETAMOL (TYLENOL) on 11-Mar-2021 for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine mild in intensity) outcome was unknown.            Concomitant product used was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: hand from arm of vaccination swelled; wrist swelled; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand from arm of vaccination swelled) and JOINT SWELLING (wrist swelled) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (hand from arm of vaccination swelled) and JOINT SWELLING (wrist swelled). The patient was treated with CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hand from arm of vaccination swelled) and JOINT SWELLING (wrist swelled) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment for the events included ice on the swelling.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Balance disorder, Blood pressure increased, Dysstasia, Gait disturbance
Clinical narrative: Feel like he has flu without the fever; Stomach does not feel right; When he stands up it's like his equilibrium is a little off, he is unsteady when he stands; Almost like the upper back of his head is very tight; He had to walk with a cane; His blood pressure is elevated because he is worried about his side effects; Unsteady when he stands; Excruciating headaches; Itchiness few days after he received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight) and GAIT DISTURBANCE (He had to walk with a cane) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache NOS. Concomitant products included IBUPROFEN and FISH OIL for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Itchiness few days after he received vaccine). On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight), GAIT DISTURBANCE (He had to walk with a cane), BLOOD PRESSURE INCREASED (His blood pressure is elevated because he is worried about his side effects), DYSSTASIA (Unsteady when he stands) and HEADACHE (Excruciating headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight), GAIT DISTURBANCE (He had to walk with a cane), BLOOD PRESSURE INCREASED (His blood pressure is elevated because he is worried about his side effects), DYSSTASIA (Unsteady when he stands), PRURITUS (Itchiness few days after he received vaccine) and HEADACHE (Excruciating headaches) was resolving.            Other concomitant medications included cholesterol medications and blood pressure medications. Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pruritus, Tension headache
Clinical narrative: Feel like he has flu without the fever; Stomach does not feel right; When he stands up it's like his equilibrium is a little off, he is unsteady when he stands; Almost like the upper back of his head is very tight; He had to walk with a cane; His blood pressure is elevated because he is worried about his side effects; Unsteady when he stands; Excruciating headaches; Itchiness few days after he received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight) and GAIT DISTURBANCE (He had to walk with a cane) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache NOS. Concomitant products included IBUPROFEN and FISH OIL for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Itchiness few days after he received vaccine). On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight), GAIT DISTURBANCE (He had to walk with a cane), BLOOD PRESSURE INCREASED (His blood pressure is elevated because he is worried about his side effects), DYSSTASIA (Unsteady when he stands) and HEADACHE (Excruciating headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight), GAIT DISTURBANCE (He had to walk with a cane), BLOOD PRESSURE INCREASED (His blood pressure is elevated because he is worried about his side effects), DYSSTASIA (Unsteady when he stands), PRURITUS (Itchiness few days after he received vaccine) and HEADACHE (Excruciating headaches) was resolving.            Other concomitant medications included cholesterol medications and blood pressure medications. Treatment information was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Neck pain, Oropharyngeal pain, Sensation of foreign body
Clinical narrative: neck felt sore on the side of injection; Metallic taste; numbness in back of mouth; lump feeling in throat; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste), HYPOAESTHESIA ORAL (numbness in back of mouth), SENSATION OF FOREIGN BODY (lump feeling in throat), OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (neck felt sore on the side of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine. Concomitant products included LOSARTAN POTASSIUM (COZAAR), ALDOSTERONE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste), HYPOAESTHESIA ORAL (numbness in back of mouth), SENSATION OF FOREIGN BODY (lump feeling in throat) and OROPHARYNGEAL PAIN (sore throat). On 03-Mar-2021, the patient experienced NECK PAIN (neck felt sore on the side of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. On 02-Mar-2021, DYSGEUSIA (Metallic taste), HYPOAESTHESIA ORAL (numbness in back of mouth), SENSATION OF FOREIGN BODY (lump feeling in throat) and OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, NECK PAIN (neck felt sore on the side of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Urinary incontinence
Clinical narrative: Wet her pants; Couldn't get up; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Wet her pants) and DYSSTASIA (Couldn't get up) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 12-Mar-2021, the patient experienced URINARY INCONTINENCE (Wet her pants). 12-Mar-2021, the patient experienced DYSSTASIA (Couldn't get up). At the time of the report, URINARY INCONTINENCE (Wet her pants) and DYSSTASIA (Couldn't get up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Felt like hives), VACCINATION SITE MASS (Lump), VACCINATION SITE PRURITUS (Itching in injection site), VACCINATION SITE PAIN (Arm sore/ little sore arm) and VACCINATION SITE ERYTHEMA (Redness in injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A214) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROBIOTICS NOS, VITAMIN D3, LINUM USITATISSIMUM SEED OIL (FLAX OIL) and LYSINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in injection site). On 11-Mar-2021, the patient experienced URTICARIA (Felt like hives), VACCINATION SITE MASS (Lump) and VACCINATION SITE PRURITUS (Itching in injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore/ little sore arm). On 04-Mar-2021, VACCINATION SITE ERYTHEMA (Redness in injection site) had resolved. At the time of the report, URTICARIA (Felt like hives), VACCINATION SITE MASS (Lump), VACCINATION SITE PRURITUS (Itching in injection site) and VACCINATION SITE PAIN (Arm sore/ little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11-Mar-2021, the patient again had little sore arm.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered from vial which was punctured on Feb 25th and stored in refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered from vial which was punctured on Feb 25th and stored in refrigerator) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 STORAGE ERROR (Vaccine administered from vial which was punctured on Feb 25th and stored in refrigerator). On 11-Mar-2021, PRODUCT STORAGE ERROR (Vaccine administered from vial which was punctured on Feb 25th and stored in refrigerator) 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.   This report refers to a case of Product storage error for mRNA-1273, lot # unknown  with no associated Adverse Events.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # unknown  with no associated Adverse Events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: got the 1st dose and experienced pain; A spontaneous report was received from a consumer concerning a 61-year-old, female patient, experienced injection site pain.  The patient's medical history, was not  provided by the reporter, included allergy was not reported,  Concomitant medications reported were not included.  On 09FEB2021, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch  number: 026A21A) route of administration not provided for prophylaxis of COVID-19 infection.     Patient received the first dose on 09FEB2021 and experienced injection site pain that started 3 hours after the vaccine administration and lasted 2 days and he received the second dose on 11MAR2021 at 8 am and started experiencing pain around 4-5pm and he couldnt sleep all night due to excruciating pain. The pain subseeded up to 2 days after the second dose, lab data were not provided.Treatment for the events included ibuprofen and acetaminophen medication.  Action taken with mRNA-1273 in response to the event was not applicable.  The out come of the event was not recovered or not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided  No treatment medications provided
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Loss of mental clarity/fogginess) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 FEELING ABNORMAL (Loss of mental clarity/fogginess). On 12-Mar-2021, FEELING ABNORMAL (Loss of mental clarity/fogginess) 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 product use was not provided. Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001a21a and 0a5a21a) for COVID-19 vaccination.     The patient's past medical history included Hashimoto's thyroiditis in 1995. Concurrent medical conditions included Sulfonamide allergy and Lupus-like syndrome (stable) since 2001. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROXYCHLOROQUINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 31-Jul-2020 and the estimated date of delivery was 07-May-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Pregnancy Form attached which contains 2nd dose information , patient medical History, concomitant medication
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at injection site, mostly swelling; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site, mostly swelling) and VACCINATION SITE PAIN (Pain at injection site) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunization.     No Medical History information was reported.    On 09-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 VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site, mostly swelling). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site, mostly swelling) and VACCINATION SITE PAIN (Pain at injection site) 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.   The patient's medical history was not provided.   Concomitant product use was not provided by the reporter.   No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via eye contact
Clinical narrative: splashed eye with vaccine contents; This spontaneous case was reported by a nurse and describes the occurrence of EXPOSURE VIA EYE CONTACT (splashed eye with vaccine contents) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     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 EXPOSURE VIA EYE CONTACT (splashed eye with vaccine contents). At the time of the report, EXPOSURE VIA EYE CONTACT (splashed eye with vaccine contents) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment flushing of eye with water for 15 minutes.  No concomitant product was reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient 17 years and 5 months old received her first dose of Moderna covid 19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient 17 years and 5 months old received her first dose of Moderna covid 19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021 at 10:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient 17 years and 5 months old received her first dose of Moderna covid 19 vaccine). On 10-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient 17 years and 5 months old received her first dose of Moderna covid 19 vaccine) 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 medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up received updated the gender of the patient. On 29-Mar-2021: Follow-up received updated patient initials, suspect product batch number, patient demographics.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: couldnt sleep all night because of the pain; Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (couldnt sleep all night because of the pain) and VACCINATION SITE PAIN (Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 8:00 AM, 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 SLEEP DISORDER (couldnt sleep all night because of the pain) and VACCINATION SITE PAIN (Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore). The patient was treated with IBUPROFEN at a dose of UNK dosage form and ACETAMINOPHEN at a dose of UNK dosage form. At the time of the report, SLEEP DISORDER (couldnt sleep all night because of the pain) outcome was unknown and VACCINATION SITE PAIN (Pain/ excrutiating pain/worse then first shot-seems to be going away/arm still sore) was resolving.            No concomitant medications reported.     This case was linked to MOD-2021-042928 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH (Rash on her arm). At the time of the report, RASH (Rash on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: follow up email received on 25-jun-21 with NNI
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Injection site warmth, Lymphadenopathy, Sinusitis
Clinical narrative: Sinusitis; Injection site warmth; Hives; Redness; Swelling; extreme Itching; Swollen lymph nodes; Fatigue; Dysphagia; Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE BRUISING (Vaccination site bruising), URTICARIA (Hives) and DYSPHAGIA (Dysphagia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), DYSPHAGIA (Dysphagia), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (extreme Itching). On 10-Mar-2021, the patient experienced SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), URTICARIA (Hives), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK dosage form and HYDROCORTISONE at a dose of UNK dosage form. On 04-Mar-2021, DYSPHAGIA (Dysphagia) had resolved. At the time of the report, SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE BRUISING (Vaccination site bruising), URTICARIA (Hives), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (extreme Itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Sinusitis; Injection site warmth; Hives; Redness; Swelling; extreme Itching; Swollen lymph nodes; Fatigue; Dysphagia; Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE BRUISING (Vaccination site bruising), URTICARIA (Hives) and DYSPHAGIA (Dysphagia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising), DYSPHAGIA (Dysphagia), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (extreme Itching). On 10-Mar-2021, the patient experienced SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), URTICARIA (Hives), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK dosage form and HYDROCORTISONE at a dose of UNK dosage form. On 04-Mar-2021, DYSPHAGIA (Dysphagia) had resolved. At the time of the report, SINUSITIS (Sinusitis), INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE BRUISING (Vaccination site bruising), URTICARIA (Hives), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Fatigue), VACCINATION SITE PRURITUS (extreme Itching), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: Emgality injection (after first dose); Cortisone shot (after first dose); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRUG INTERACTION (Cortisone shot (after first dose)) and DRUG INTERACTION (Emgality injection (after first dose)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: CORTISONE (Cortisone shot) on 10-Mar-2021. Concurrent medical conditions included Limbic encephalitis, Seizure and Migraine. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine, CORTISONE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DRUG INTERACTION (Cortisone shot (after first dose)). On an unknown date, the patient experienced DRUG INTERACTION (Emgality injection (after first dose)). At the time of the report, DRUG INTERACTION (Cortisone shot (after first dose)) and DRUG INTERACTION (Emgality injection (after first dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional concomitant medication includes unspecified seizure medication.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein, Exposure during pregnancy, Prenatal screening test, Ultrasound foetal
Clinical narrative: Pregnant at time of vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included Embryo transfer (paternal history, so child was conceived using IVF) on 20-Dec-2020. Concurrent medical conditions included Allergic asthma (Asthma (allergy-related)) since 01-Jan-1992, Egg allergy (Very mild egg yolk allergy), Dust allergy, Allergy to animals (cats) and Allergy (trees). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], THERANATAL PLUS from 02-Jan-2021 to an unknown date and BUDESONIDE (PULMICORT FLEXHALER) from 02-Nov-2020 to an unknown date for an unknown indication.   On 12-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Nov-2020 and the estimated date of delivery was 07-Sep-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy. The delivery occurred on an unknown date.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Prenatal screening test: no chromosomal abnormalities detected/normal (normal) No chromosomal abnormalities detected/normal. On 24-Mar-2021, Alpha 1 foetoprotein: normal/not elevated (normal) Normal/not elevated. On 22-Apr-2021, Ultrasound foetal: normal/no abnormalities detected (normal) Normal/no abnormalities detected.         Additional concomitant medications include Homacort.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: initial additional
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Dizziness; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness ) and PALPITATIONS (Heart palpitations) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high and Palpitations.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizziness ) and PALPITATIONS (Heart palpitations). On 19-Feb-2021, DIZZINESS (Dizziness ) and PALPITATIONS (Heart palpitations) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received does not contain any significant information. Patient ethnicity and race added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 13-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid Arm) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Covid Arm). At the time of the report, VACCINATION COMPLICATION (Covid Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  The patient's daughter reported that her mother had Covid Arm following the vaccination, and did not want to provide any further details of the event without patient's consent.  Treatment details were not provided.