chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer forget about her second shot. She wants to make sure that whether she did get her second dose or not) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant details were provided No treatment details were provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysuria, Groin pain, Vaccination site swelling, Vulvovaginal pain
Clinical narrative: Felt light headed after she got the vaccine but she is not sure if she was light headed; Painful urination; Left groin going up to her stomach was painful when she urinate; Left side of her vagina was painful when she urinate; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed after she got the vaccine but she is not sure if she was light headed), DYSURIA (Painful urination), GROIN PAIN (Left groin going up to her stomach was painful when she urinate), VULVOVAGINAL PAIN (Left side of her vagina was painful when she urinate) and VACCINATION SITE SWELLING (swollen arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination.     The patient's past medical history included UTI. Concurrent medical conditions included COPD.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Felt light headed after she got the vaccine but she is not sure if she was light headed), DYSURIA (Painful urination), GROIN PAIN (Left groin going up to her stomach was painful when she urinate), VULVOVAGINAL PAIN (Left side of her vagina was painful when she urinate) and VACCINATION SITE SWELLING (swollen arm). At the time of the report, DIZZINESS (Felt light headed after she got the vaccine but she is not sure if she was light headed), DYSURIA (Painful urination), GROIN PAIN (Left groin going up to her stomach was painful when she urinate), VULVOVAGINAL PAIN (Left side of her vagina was painful when she urinate) and VACCINATION SITE SWELLING (swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disorientation, Dysstasia, Fatigue, Musculoskeletal stiffness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dysstasia (he couldn't stand), musculoskeletal stiffness (he couldn't bend his head), somnolence (spent all time sleeping), disorientation and pyrexia (fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 047A21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 13, 2021, patient experienced dysstasia (he couldn't stand), musculoskeletal stiffness (he couldn't bend his head), somnolence (spent all time sleeping), disorientation, pyrexia (fever), fatigue, chills and vaccination site pain (site of injection is sore). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; and water. At the time of the report, dysstasia (he couldn't stand), musculoskeletal stiffness (he couldn't bend his head), somnolence (spent all time sleeping), disorientation, pyrexia (fever), fatigue, chills and vaccination site pain (site of injection is sore) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dysstasia (he couldn't stand), musculoskeletal stiffness (he couldn't bend his head), somnolence (spent all time sleeping), disorientation and pyrexia (fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 047A21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 13, 2021, patient experienced dysstasia (he couldn't stand), musculoskeletal stiffness (he couldn't bend his head), somnolence (spent all time sleeping), disorientation, pyrexia (fever), fatigue, chills and vaccination site pain (site of injection is sore). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; and water. At the time of the report, dysstasia (he couldn't stand), musculoskeletal stiffness (he couldn't bend his head), somnolence (spent all time sleeping), disorientation, pyrexia (fever), fatigue, chills and vaccination site pain (site of injection is sore) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Oropharyngeal pain
Clinical narrative: Dry cough; Full blown flue like symptoms.; Sore throat; This spontaneous case was reported by a non-health professional and describes the occurrence of COUGH (Dry cough), INFLUENZA LIKE ILLNESS (Full blown flue like symptoms.) and OROPHARYNGEAL PAIN (Sore throat) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medically reported history).    On 25-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 COUGH (Dry cough), INFLUENZA LIKE ILLNESS (Full blown flue like symptoms.) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, COUGH (Dry cough), INFLUENZA LIKE ILLNESS (Full blown flue like symptoms.) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant list provided.  No treatment information was provided. A little soon after the vaccination she had dry cough and full blown flu like symptoms. She had sore throat and felt as if she had pneumonia. 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.; Sender'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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, Muscle spasms, Musculoskeletal discomfort
Clinical narrative: Cramping she had is similar to the one she has on day one of her period; Back hurts; Period two weeks after completing previous; Brownish spotting; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping she had is similar to the one she has on day one of her period), MUSCULOSKELETAL DISCOMFORT (Back hurts), MENSTRUAL DISORDER (Period two weeks after completing previous) and INTERMENSTRUAL BLEEDING (Brownish spotting) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE SPASMS (Cramping she had is similar to the one she has on day one of her period), MUSCULOSKELETAL DISCOMFORT (Back hurts), MENSTRUAL DISORDER (Period two weeks after completing previous) and INTERMENSTRUAL BLEEDING (Brownish spotting). At the time of the report, MUSCLE SPASMS (Cramping she had is similar to the one she has on day one of her period), MUSCULOSKELETAL DISCOMFORT (Back hurts), MENSTRUAL DISORDER (Period two weeks after completing previous) and INTERMENSTRUAL BLEEDING (Brownish spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: severe abdominal pain, similar to labor; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe abdominal pain, similar to labor) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 20-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ABDOMINAL PAIN (severe abdominal pain, similar to labor). At the time of the report, ABDOMINAL PAIN (severe abdominal pain, similar to labor) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for event include omeprazole.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Vaccination site reaction, Vaccination site warmth
Clinical narrative: itched; Rash about 4 inches long by the time it stopped; red; hot; developed covid arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itched), RASH (Rash about 4 inches long by the time it stopped), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE REACTION (developed covid arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRURITUS (itched), RASH (Rash about 4 inches long by the time it stopped), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE REACTION (developed covid arm). At the time of the report, PRURITUS (itched), RASH (Rash about 4 inches long by the time it stopped), ERYTHEMA (red), VACCINATION SITE WARMTH (hot) and VACCINATION SITE REACTION (developed covid arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site pain
Clinical narrative: Sore Injection Site (After First Vaccine); Arm Hurts and never fully recovered after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site (After First Vaccine)) and AXILLARY PAIN (Arm Hurts and never fully recovered after First Vaccine) in a 51-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).  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   In March 2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site (After First Vaccine)) and AXILLARY PAIN (Arm Hurts and never fully recovered after First Vaccine).   In March 2021, VACCINATION SITE PAIN (Sore Injection Site (After First Vaccine)) had resolved. At the time of the report, AXILLARY PAIN (Arm Hurts and never fully recovered after First Vaccine) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076721 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076721:second dose
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia
Clinical narrative: could not sleep; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination.     No Medical History was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.  On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 17-Mar-2021, the patient experienced INSOMNIA (could not sleep) and CHILLS (chills). On 18-Mar-2021, INSOMNIA (could not sleep) and CHILLS (chills) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-078972 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Nausea
Clinical narrative: flu-like symptoms; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (dizziness) and NAUSEA (nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 31-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 14-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (dizziness) and NAUSEA (nausea) had resolved. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Event onset date updated as 14-APR-2021 and event outcome updated. Patient denied consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Other female patient with these issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Other female patient with these issues) 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.    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 ADVERSE REACTION (Other female patient with these issues). At the time of the report, ADVERSE REACTION (Other female patient with these issues) outcome was unknown. Not Provided      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: soreness in the right arm; flu-like symptoms; low-grade temperature; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (low-grade temperature), CHILLS (chills) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Alpha-gal allergy.  On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in the right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (low-grade temperature), CHILLS (chills) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (low-grade temperature), CHILLS (chills) and MYALGIA (body aches) had resolved. On 06-Mar-2021, VACCINATION SITE PAIN (soreness in the right arm) had resolved.     Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-009093, MOD-2021-076802 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: chills; fatigue; Severe headache; fever after getting the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), HEADACHE (Severe headache) and PYREXIA (fever after getting the shot) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue), HEADACHE (Severe headache) and PYREXIA (fever after getting the shot). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at a dose of 200 milligram four times per day. At the time of the report, CHILLS (chills), FATIGUE (fatigue), HEADACHE (Severe headache) and PYREXIA (fever after getting the shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive Positive.     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 by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to touch bump at injection site; bump at injection site; one inch swollen at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch bump at injection site), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (one inch swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Apr-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 SITE WARMTH (hot to touch bump at injection site), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (one inch swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site).   At the time of the report, VACCINATION SITE WARMTH (hot to touch bump at injection site), VACCINATION SITE MASS (bump at injection site), VACCINATION SITE SWELLING (one inch swollen at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Left eye is blurry; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Left eye is blurry) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    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 VISION BLURRED (Left eye is blurry). At the time of the report, VISION BLURRED (Left eye is blurry) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of constant dizziness and occasional nausea in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history included asthma since an unknown date. Concomitant products included Albuterol (salbutamol sulfate) for asthma. On Apr 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 12, 2021, patient experienced constant dizziness and occasional nausea. At the time of the report, constant dizziness and occasional nausea outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or treatment information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Severe lethargy; Ache; Fever 102degree F; Headache; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 01LJ20A) for COVID-19 vaccination.     Concurrent medical conditions included Constipation chronic (Chronic constipation for past 5 Years) since 2016 and Shellfish allergy. Concomitant products included LINACLOTIDE (LINZESS) and MACROGOL 3350 (MIRALAX) for Constipation, BIFIDOBACTERIUM INFANTIS (ALIGN) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache). On 07-Apr-2021, LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) 102 degree. In April 2021, SARS-CoV-2 test negative: (Negative) In Emergency room Covid-19 test was negative. In April 2021, Viral test negative: (Negative) In Emergency room Viral panel was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided   This case was linked to MOD-2021-009535; Sender'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Viral test negative
Clinical narrative: Severe lethargy; Ache; Fever 102degree F; Headache; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 01LJ20A) for COVID-19 vaccination.     Concurrent medical conditions included Constipation chronic (Chronic constipation for past 5 Years) since 2016 and Shellfish allergy. Concomitant products included LINACLOTIDE (LINZESS) and MACROGOL 3350 (MIRALAX) for Constipation, BIFIDOBACTERIUM INFANTIS (ALIGN) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache). On 07-Apr-2021, LETHARGY (Severe lethargy), PAIN (Ache), PYREXIA (Fever 102degree F) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) 102 degree. In April 2021, SARS-CoV-2 test negative: (Negative) In Emergency room Covid-19 test was negative. In April 2021, Viral test negative: (Negative) In Emergency room Viral panel was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided   This case was linked to MOD-2021-009535; Sender'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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain, Vomiting
Clinical narrative: Diarrhea; Vomiting; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Sore arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) since an unknown date and Open heart surgery since an unknown date. Concurrent medical conditions included Blood pressure high.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Sore arm). The patient was treated with GUAIFENESIN (TUSSIN [GUAIFENESIN]) for Adverse event, at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL (CORICIDIN [CHLORPHENAMINE MALEATE;PARACETAMOL]) for Mucus discharge and Runny nose, at an unspecified dose and frequency. On 16-Mar-2021, DIARRHOEA (Diarrhea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-076710, US-MODERNATX, INC.-MOD-2021-077197, US-MODERNATX, INC.-MOD-2021-076831, US-MODERNATX, INC.-MOD-2021-077211 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076710:Same reporter US-MODERNATX, INC.-MOD-2021-077197:Same reporter US-MODERNATX, INC.-MOD-2021-076831:2nd dose case US-MODERNATX, INC.-MOD-2021-077211:Same reporter
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever that is "on and off"; headache that is "on and off"; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever that is "on and off") and HEADACHE (headache that is "on and off") in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever that is "on and off") and HEADACHE (headache that is "on and off"). At the time of the report, PYREXIA (fever that is "on and off") and HEADACHE (headache that is "on and off") outcome was unknown. Not Provided          Treatment Motrin   This case was linked to US-MODERNATX, INC.-MOD-2021-076161 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076161:first dose
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia, Swelling
Clinical narrative: Chills After the Second Shot; Fever After the Second Shot; Body Aches After the Second Shot; Lymph Node Swelling in Left Armpit and a little in left side of Neck; Neck swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills After the Second Shot), PYREXIA (Fever After the Second Shot), PAIN (Body Aches After the Second Shot), LYMPHADENOPATHY (Lymph Node Swelling in Left Armpit and a little in left side of Neck) and SWELLING (Neck swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Apr-2021, the patient experienced CHILLS (Chills After the Second Shot), PYREXIA (Fever After the Second Shot), PAIN (Body Aches After the Second Shot), LYMPHADENOPATHY (Lymph Node Swelling in Left Armpit and a little in left side of Neck) and SWELLING (Neck swelling).   On 05-Apr-2021, PYREXIA (Fever After the Second Shot) had resolved. On 09-Apr-2021, CHILLS (Chills After the Second Shot) had resolved.   At the time of the report, PAIN (Body Aches After the Second Shot), LYMPHADENOPATHY (Lymph Node Swelling in Left Armpit and a little in left side of Neck) and SWELLING (Neck swelling) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-076671 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Illness, Nasal congestion, SARS-CoV-2 test
Clinical narrative: tested positive result for Covid-19; Felt sick; Loss of Taste; Stuffy Nose; Congested Sinuses; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 03-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose), SINUS CONGESTION (Congested Sinuses) and COVID-19 (tested positive result for Covid-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose) and SINUS CONGESTION (Congested Sinuses). On an unknown date, the patient experienced COVID-19 (tested positive result for Covid-19). At the time of the report, ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose) and SINUS CONGESTION (Congested Sinuses) was resolving and COVID-19 (tested positive result for Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant F/U received : Lab data and additional event and event outcome are updated. 2nd dose information added.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: tested positive result for Covid-19; Felt sick; Loss of Taste; Stuffy Nose; Congested Sinuses; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 03-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose), SINUS CONGESTION (Congested Sinuses) and COVID-19 (tested positive result for Covid-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose) and SINUS CONGESTION (Congested Sinuses). On an unknown date, the patient experienced COVID-19 (tested positive result for Covid-19). At the time of the report, ILLNESS (Felt sick), AGEUSIA (Loss of Taste), NASAL CONGESTION (Stuffy Nose) and SINUS CONGESTION (Congested Sinuses) was resolving and COVID-19 (tested positive result for Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant F/U received : Lab data and additional event and event outcome are updated. 2nd dose information added.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Insomnia, Productive cough, Rhinorrhoea, Secretion discharge
Clinical narrative: mucus; runny nose; phlegm and mucus; dry cough; awake all night; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), INSOMNIA (awake all night), SECRETION DISCHARGE (mucus), RHINORRHOEA (runny nose) and PRODUCTIVE COUGH (phlegm and mucus) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Apr-2021, the patient experienced COUGH (dry cough) and INSOMNIA (awake all night). On 13-Apr-2021, the patient experienced SECRETION DISCHARGE (mucus), RHINORRHOEA (runny nose) and PRODUCTIVE COUGH (phlegm and mucus). The patient was treated with GUAIFENESIN (TUSSIN [GUAIFENESIN]) for Adverse event, at an unspecified dose and frequency and ASCORBIC ACID, CAFFEINE, CHLORPHENAMINE MALEATE, SALICYLAMIDE (CORICIDIN [ASCORBIC ACID;CAFFEINE;CHLORPHENAMINE MALEATE;SALICYLAMIDE]) for Mucus discharge and Runny nose, at an unspecified dose and frequency. On 13-Apr-2021, INSOMNIA (awake all night) had resolved.   At the time of the report, COUGH (dry cough), SECRETION DISCHARGE (mucus) and PRODUCTIVE COUGH (phlegm and mucus) had resolved and RHINORRHOEA (runny nose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   It is reported that patient has been given unknown prescription by HCP for Diarrhea. Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-076718, MOD-2021-076812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient's e-mail address updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness of the arm; heavy arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of the arm) and VACCINATION SITE SWELLING (heavy arm after the injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   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 VACCINATION SITE PAIN (soreness of the arm) and VACCINATION SITE SWELLING (heavy arm after the injection). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE PAIN (soreness of the arm) and VACCINATION SITE SWELLING (heavy arm after the injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients; 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 TEMPERATURE EXCURSION ISSUE (after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients) 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 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (after unknown time of thawing, no less that 15 minutes at room temperature, this vaccine was administered to patients) outcome was unknown. Not Provided      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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong technique in device usage process
Clinical narrative: he said that there was no vaccine in syringe; 1ml dose for first injection; This spontaneous case was reported by a physician and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (he said that there was no vaccine in syringe) and INCORRECT DOSE ADMINISTERED (1ml dose for first injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (he said that there was no vaccine in syringe) and INCORRECT DOSE ADMINISTERED (1ml dose for first injection). On 14-Apr-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (he said that there was no vaccine in syringe) and INCORRECT DOSE ADMINISTERED (1ml dose for first injection) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Event added
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea, a lower GI problem; got really worse after second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea, a lower GI problem; got really worse after second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), LEVOTHYROXINE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Severe diarrhea, a lower GI problem; got really worse after second dose). At the time of the report, DIARRHOEA (Severe diarrhea, a lower GI problem; got really worse after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-040930 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-040930:Same reporter/different patient (husband)
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Bump under his skin resembling marble at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump under his skin resembling marble at the injection site) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE MASS (Bump under his skin resembling marble at the injection site).   At the time of the report, VACCINATION SITE MASS (Bump under his skin resembling marble at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-076842 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Expired product administered, Pain, Pyrexia
Clinical narrative: Achy; Expired product administered; 101 degree temp; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Achy), EXPIRED PRODUCT ADMINISTERED (Expired product administered) and PYREXIA (101 degree temp) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (Achy) and PYREXIA (101 degree temp). 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved. At the time of the report, PAIN (Achy) and PYREXIA (101 degree temp) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 101 (High) 101 degree temp.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that three doses were left out at ambient room temperature past there beyond use date. There is a possibility that this individual as well as two others may have received one of these doses. There have been no physical adverse effects reported due to the possible excursion  Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-076450, MOD-2021-076469, MOD-2021-076488, MOD-2021-076520, MOD-2021-076552, MOD-2021-076610, MOD-2021-076389 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Reporter and patient details updated. Event and first dose and second dose details updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nauseous) 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 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (nauseous). At the time of the report, HEADACHE (headache) and NAUSEA (nauseous) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter. No treatment information was provided.