chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Pain, Tachycardia
Clinical narrative: tachycardia; felt achy; She didn't feel good; injection site started to turn red; headache; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of heart rate increased, tachycardia, PAIN, MALAISE, and VACCINATION SITE ERYTHEMA in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and VITAMINS A & D for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced heart rate increased, PAIN, MALAISE, VACCINATION SITE ERYTHEMA, and headache. On 12-Sep-2021, the patient experienced tachycardia. The patient was treated with TYLENOL at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, heart rate increased, tachycardia, PAIN, MALAISE, VACCINATION SITE ERYTHEMA, and headache outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.  Patient stated that She started noticing increased heartrate next day after receiving 2nd dose. She had been monitoring heart rate on her Fitbit. After 2 days, heart rate started to settle down but it has never gone to baseline. On Sunday (12Sep2021), she went to ER because of increased heart rate. She wants someone to call from safety to follow up because she is concerned about tachycardia. She wants to know about compensation as she went to ER.   This case was linked to MOD-2021-317431 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: tachycardia; felt achy; She didn't feel good; injection site started to turn red; headache; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of heart rate increased, tachycardia, PAIN, MALAISE, and VACCINATION SITE ERYTHEMA in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and VITAMINS A & D for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced heart rate increased, PAIN, MALAISE, VACCINATION SITE ERYTHEMA, and headache. On 12-Sep-2021, the patient experienced tachycardia. The patient was treated with TYLENOL at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, heart rate increased, tachycardia, PAIN, MALAISE, VACCINATION SITE ERYTHEMA, and headache outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.  Patient stated that She started noticing increased heartrate next day after receiving 2nd dose. She had been monitoring heart rate on her Fitbit. After 2 days, heart rate started to settle down but it has never gone to baseline. On Sunday (12Sep2021), she went to ER because of increased heart rate. She wants someone to call from safety to follow up because she is concerned about tachycardia. She wants to know about compensation as she went to ER.   This case was linked to MOD-2021-317431 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: hallucinations; 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 HALLUCINATION (hallucinations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Patient states that the nurse who gives the vaccines at her medical facility told her that 6 people who had the Moderna Covid-19 Vaccine had hallucinations.  company comment This case concerns an unknown age and gender patient with no relevant medical history who experienced serious unexpected event of hallucination on an unknown date after receiving a dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-317637, US-MODERNATX, INC.-MOD-2021-318104 (E2B Linked Report).; Sender's Comments: This case concerns an unknown age and gender patient with no relevant medical history who experienced serious unexpected event of hallucination on an unknown date after receiving a dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2021-317637:Same reporter and Patient but different patient US-MODERNATX, INC.-MOD-2021-318104:Same reporter and Patient but different patient
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain, Pruritus, Pyrexia
Clinical narrative: Hives (painful, itchy, red); Hives (painful, itchy, red); Hives (painful, itchy, red); body aches; hives all over the body; wheezing; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body), WHEEZING (wheezing), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ) and PRURITUS (Hives (painful, itchy, red)) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In September 2021, the patient received third 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 an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced WHEEZING (wheezing). In September 2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced URTICARIA (hives all over the body), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ), PRURITUS (Hives (painful, itchy, red)) and MYALGIA (body aches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency and EPINEPHRINE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over the body), WHEEZING (wheezing), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ), PRURITUS (Hives (painful, itchy, red)), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            No Concomitant medications were reported.   This case was linked to MOD-2021-317635, MOD-2021-317634 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: Hives (painful, itchy, red); Hives (painful, itchy, red); Hives (painful, itchy, red); body aches; hives all over the body; wheezing; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body), WHEEZING (wheezing), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ) and PRURITUS (Hives (painful, itchy, red)) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In September 2021, the patient received third 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 an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced WHEEZING (wheezing). In September 2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced URTICARIA (hives all over the body), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ), PRURITUS (Hives (painful, itchy, red)) and MYALGIA (body aches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency and EPINEPHRINE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives all over the body), WHEEZING (wheezing), PAIN (Hives (painful, itchy, red) ), ERYTHEMA (Hives (painful, itchy, red) ), PRURITUS (Hives (painful, itchy, red)), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            No Concomitant medications were reported.   This case was linked to MOD-2021-317635, MOD-2021-317634 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-317617, MOD-2021-317634.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced FATIGUE (extremely tired). On 23-Jul-2021, FATIGUE (extremely tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.  She saw 2 Dalmatians in her room, it always happened in the dark, and happened 4 times over about a week.   This case was linked to MOD-2021-318104 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-317611:Same reporter and Patient but different patient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination complication, Vaccination site pain
Clinical narrative: an adverse reaction to the COVID Moderna vaccine; m arm was sore/arm was sore; had a little headache/had a little headache; chill; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (an adverse reaction to the COVID Moderna vaccine), PAIN IN EXTREMITY (m arm was sore/arm was sore), HEADACHE (had a little headache/had a little headache) and CHILLS (chill) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 004D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (an adverse reaction to the COVID Moderna vaccine), PAIN IN EXTREMITY (m arm was sore/arm was sore), HEADACHE (had a little headache/had a little headache) and CHILLS (chill). At the time of the report, VACCINATION COMPLICATION (an adverse reaction to the COVID Moderna vaccine), PAIN IN EXTREMITY (m arm was sore/arm was sore), HEADACHE (had a little headache/had a little headache) and CHILLS (chill) outcome was unknown.            Concomitant and treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Added patient identities, vaccine information, event were updated
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose on 28 Jul 2021, no second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose on 28 Jul 2021, no second dose yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose on 28 Jul 2021, no second dose yet). On 13-Sep-2021, PRODUCT DOSE OMISSION ISSUE (First dose on 28 Jul 2021, no second dose yet) had resolved.            No concomitant medications were reported.  Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Influenza like illness, Product dose omission issue
Clinical narrative: Flu-like symptoms; first dose > 35 days ago; Unstable blood pressure; Itching, which lasted up to 9-10 days; Pain at the site of injection was longer than typical for other people; Headache/headaches wouldn't go away; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), HYPERTENSION (Unstable blood pressure), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days) and VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), HYPERTENSION (Unstable blood pressure), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days), VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) and HEADACHE (Headache/headaches wouldn't go away). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days) and VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) had resolved and HYPERTENSION (Unstable blood pressure) and HEADACHE (Headache/headaches wouldn't go away) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160-170 (High) blood pressure was high..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Flu-like symptoms; first dose > 35 days ago; Unstable blood pressure; Itching, which lasted up to 9-10 days; Pain at the site of injection was longer than typical for other people; Headache/headaches wouldn't go away; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), HYPERTENSION (Unstable blood pressure), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days) and VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), HYPERTENSION (Unstable blood pressure), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days), VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) and HEADACHE (Headache/headaches wouldn't go away). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), VACCINATION SITE PRURITUS (Itching, which lasted up to 9-10 days) and VACCINATION SITE PAIN (Pain at the site of injection was longer than typical for other people) had resolved and HYPERTENSION (Unstable blood pressure) and HEADACHE (Headache/headaches wouldn't go away) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160-170 (High) blood pressure was high..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more). The patient was treated with CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) at a dose of once a week. At the time of the report, PAIN IN EXTREMITY (On 16Feb2021, one hour after the shot, he had a little bit of pain in his left arm and then no more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.    This case was linked to MOD-2021-317462 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Urticaria
Clinical narrative: hives uncomfortable specially when it is swollen and appears randomly at random parts of the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives uncomfortable specially when it is swollen and appears randomly at random parts of the body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Kiwi), Allergy to nuts and Bee sting hypersensitivity.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives uncomfortable specially when it is swollen and appears randomly at random parts of the body). The patient was treated with EPINEPHRINE (EPIPEN) for Swollen tongue, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives uncomfortable specially when it is swollen and appears randomly at random parts of the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: positive (Positive) An allergy test will be done once she weans from the antihistamine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Liver support pills and Collagen powder drink Patient tried to stop taking the vaccine 2 days ago but this flared up her side effects.   This case was linked to MOD-2021-317631 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Pain, Pain in extremity
Clinical narrative: pain got worse; pain in thighs; severe long-lasting and bizarre symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain got worse), PAIN IN EXTREMITY (pain in thighs) and ABNORMAL BEHAVIOUR (severe long-lasting and bizarre symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain got worse), PAIN IN EXTREMITY (pain in thighs) and ABNORMAL BEHAVIOUR (severe long-lasting and bizarre symptoms). At the time of the report, PAIN (pain got worse), PAIN IN EXTREMITY (pain in thighs) and ABNORMAL BEHAVIOUR (severe long-lasting and bizarre symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Hypersensitivity, Peripheral swelling, Pruritus
Clinical narrative: Patient believes she had an allergic reaction; Hard chest pain; Difficulty breathing; Swollen arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Hard chest pain), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itching) and HYPERSENSITIVITY (Patient believes she had an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced CHEST PAIN (Hard chest pain), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itching). On 13-Sep-2021, the patient experienced HYPERSENSITIVITY (Patient believes she had an allergic reaction). At the time of the report, CHEST PAIN (Hard chest pain) and HYPERSENSITIVITY (Patient believes she had an allergic reaction) outcome was unknown, DYSPNOEA (Difficulty breathing) was resolving and PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had certain food allergies, but not to medications. No Treatment information was provided. No concomitant information was provided
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Gait disturbance
Clinical narrative: stomach cramps; could barely walk towards the bathroom; Diarrhea; Severe body ache; nausea; headache; fever; body chills; feels too tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache) and NAUSEA (nausea) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills) and FATIGUE (feels too tired). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills) and FATIGUE (feels too tired) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: stomach cramps; could barely walk towards the bathroom; Diarrhea; Severe body ache; nausea; headache; fever; body chills; feels too tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache) and NAUSEA (nausea) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills) and FATIGUE (feels too tired). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), GAIT DISTURBANCE (could barely walk towards the bathroom), DIARRHOEA (Diarrhea), MYALGIA (Severe body ache), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (body chills) and FATIGUE (feels too tired) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Significant tooth pain after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Significant tooth pain after the first vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (Significant tooth pain after the first vaccine). At the time of the report, TOOTHACHE (Significant tooth pain after the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Tongue discomfort
Clinical narrative: congestion in his head; burning cessation on his tongue; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (congestion in his head), TONGUE DISCOMFORT (burning cessation on his tongue) and HEADACHE (headache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified since 2001 and CLL (In remission 4/2021) since 2018. Concomitant products included ATENOLOL from 2001 to an unknown date and DILTIAZEM from 2020 to an unknown date for Arrhythmia, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) from 2010 to an unknown date for Eye disorder NOS, PRAVASTATIN from 2001 to an unknown date for Lipids, VITAMIN D NOS from 2010 to an unknown date for Vitamin deficiency.    On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (congestion in his head), TONGUE DISCOMFORT (burning cessation on his tongue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and PREDNISONE on 14-Jun-2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEAD DISCOMFORT (congestion in his head), TONGUE DISCOMFORT (burning cessation on his tongue) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got the first dose of moderna vaccine ( Batch no: 027A21A)  on 8 Mar 2021.  Treatment included steroid for 5 days. .      Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant follow up received, included Reporter Address added, Patient demographics updated, Patient medical history added, Suspect product details updated. Vaccine facility added. Concomitant medications added
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Arm Pain; Felt fever 98°F; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), PYREXIA (Felt fever), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain), PYREXIA (Felt fever), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm Pain), PYREXIA (Felt fever), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 98 degree F.         No concomitants were provided.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: a lot of people had allergic reactions; 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 ALLERGY TO VACCINE (a lot of people had allergic reactions) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (a lot of people had allergic reactions). At the time of the report, ALLERGY TO VACCINE (a lot of people had allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Balance disorder, COVID-19, Headache
Clinical narrative: balance problem; loss sense of smell; loss sense of taste; severe headache/head hurting really bad; Low grade fever; The patient tested positive for Covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient tested positive for Covid19), BALANCE DISORDER (balance problem), ANOSMIA (loss sense of smell), AGEUSIA (loss sense of taste) and HEADACHE (severe headache/head hurting really bad) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Malaria. Concurrent medical conditions included Blood pressure, Cholesterol and Dementia.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced COVID-19 (The patient tested positive for Covid19). On an unknown date, the patient experienced BALANCE DISORDER (balance problem), ANOSMIA (loss sense of smell), AGEUSIA (loss sense of taste), HEADACHE (severe headache/head hurting really bad) and PYREXIA (Low grade fever). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient tested positive for Covid19), BALANCE DISORDER (balance problem), ANOSMIA (loss sense of smell), AGEUSIA (loss sense of taste), HEADACHE (severe headache/head hurting really bad) and PYREXIA (Low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-1 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was mentioned as patient is taking blood pressure medication, cholesterol medication and dementia medication. Treatment medication was mentioned as patient was treated with an infusion, antibiotic, cough medicine, and a medicine which patient took for malaria which is taken 5 times a day.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-1 test
Clinical narrative: balance problem; loss sense of smell; loss sense of taste; severe headache/head hurting really bad; Low grade fever; The patient tested positive for Covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient tested positive for Covid19), BALANCE DISORDER (balance problem), ANOSMIA (loss sense of smell), AGEUSIA (loss sense of taste) and HEADACHE (severe headache/head hurting really bad) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Malaria. Concurrent medical conditions included Blood pressure, Cholesterol and Dementia.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced COVID-19 (The patient tested positive for Covid19). On an unknown date, the patient experienced BALANCE DISORDER (balance problem), ANOSMIA (loss sense of smell), AGEUSIA (loss sense of taste), HEADACHE (severe headache/head hurting really bad) and PYREXIA (Low grade fever). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient tested positive for Covid19), BALANCE DISORDER (balance problem), ANOSMIA (loss sense of smell), AGEUSIA (loss sense of taste), HEADACHE (severe headache/head hurting really bad) and PYREXIA (Low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-1 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was mentioned as patient is taking blood pressure medication, cholesterol medication and dementia medication. Treatment medication was mentioned as patient was treated with an infusion, antibiotic, cough medicine, and a medicine which patient took for malaria which is taken 5 times a day.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA. At the time of the report, MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications provided.  No treatment medications provided.  The patient asked whether he can take Ibuprofen or Aspirin for pains and aches. He just received the Moderna booster today at 10am.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pulmonary blood clots; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary blood clots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (pulmonary blood clots) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (pulmonary blood clots) outcome was unknown.            Concomitant product was not provided by the reporter.  Company Comment: This case concerns a  female patient, who experienced the unexpected event of Pulmonary blood clots. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-317542 (E2B Linked Report).; Sender's Comments: This case concerns a  female patient, who experienced the unexpected event of Pulmonary blood clots. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2021-317542:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: loss of smell; loss of taste; congestion; fatigue; sore throat; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue) and OROPHARYNGEAL PAIN (sore throat) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the arm). At the time of the report, ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include unspecified antibiotics. No treatment information were provided. Sore throat started on Friday, and congestion started on late Friday / early Saturday. Patient had soreness in the arm (the right arm) over the weekend and loss of smell and taste started on late Sunday / early Monday.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: loss of smell; loss of taste; congestion; fatigue; sore throat; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue) and OROPHARYNGEAL PAIN (sore throat) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the arm). At the time of the report, ANOSMIA (loss of smell), AGEUSIA (loss of taste), THROAT TIGHTNESS (congestion), FATIGUE (fatigue), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include unspecified antibiotics. No treatment information were provided. Sore throat started on Friday, and congestion started on late Friday / early Saturday. Patient had soreness in the arm (the right arm) over the weekend and loss of smell and taste started on late Sunday / early Monday.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Head discomfort, Pruritus, Sneezing
Clinical narrative: Hurting in chest; Head is killing; itching; Sneezing my head off ever since/tired of sneezing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Hurting in chest), HEAD DISCOMFORT (Head is killing), PRURITUS (itching) and SNEEZING (Sneezing my head off ever since/tired of sneezing) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Hurting in chest), HEAD DISCOMFORT (Head is killing), PRURITUS (itching) and SNEEZING (Sneezing my head off ever since/tired of sneezing). At the time of the report, CHEST PAIN (Hurting in chest), HEAD DISCOMFORT (Head is killing), PRURITUS (itching) and SNEEZING (Sneezing my head off ever since/tired of sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: sore throat; congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NASAL CONGESTION (congestion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush
Clinical narrative: Hot flashes; tired; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-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 HOT FLUSH (Hot flashes) and FATIGUE (tired). At the time of the report, HOT FLUSH (Hot flashes) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.