chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over the body; very tired; nausea, she threw-up; body aches; running on fever 103°F; chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (body aches), RASH (rash all over the body), PYREXIA (running on fever 103°F), CHILLS (chills) and NAUSEA (nausea, she threw-up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no relevant medical history provided).    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (body aches), PYREXIA (running on fever 103°F), CHILLS (chills) and NAUSEA (nausea, she threw-up). On 03-Feb-2021, the patient experienced FATIGUE (very tired). On 04-Feb-2021, the patient experienced RASH (rash all over the body). At the time of the report, PAIN (body aches), RASH (rash all over the body), CHILLS (chills), NAUSEA (nausea, she threw-up) and FATIGUE (very tired) outcome was unknown and PYREXIA (running on fever 103°F) had not resolved.            Concomitant medications included unspecified medications for renal insufficiency and epilepsy.  It was reported that after the first dose of the vaccine, the patient was okay.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient stated no improvement after taking paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information received reporter contact details updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hypokinesia, Myalgia
Clinical narrative: She was miserable; Could barely move; Aches and pains; chills; Tired/Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 (tested positive on 27 Dec 2020) from 25-Dec-2020 to 06-Jan-2021. Concomitant products included MULTIVITAMIN FOR WOMEN, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE SULFATE POTASSIUM CHLORIDE, METHYLSULFONYLMETHANE (GLUCOSAMINE & CHONDROITIN & MSM) and EMERGEN C for an unknown indication.   On 28-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Jan-2021, FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, SARS-CoV-2 test: positive (Positive) positive.         Treatment medication included Ibuprofen. Patient also states she drank lots of water and slept almost round the clock.  Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-080655 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient information updated. Concomitant medications updated. Event treatment information updated.; Sender's Comments: based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: She was miserable; Could barely move; Aches and pains; chills; Tired/Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 (tested positive on 27 Dec 2020) from 25-Dec-2020 to 06-Jan-2021. Concomitant products included MULTIVITAMIN FOR WOMEN, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE SULFATE POTASSIUM CHLORIDE, METHYLSULFONYLMETHANE (GLUCOSAMINE & CHONDROITIN & MSM) and EMERGEN C for an unknown indication.   On 28-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Jan-2021, FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, SARS-CoV-2 test: positive (Positive) positive.         Treatment medication included Ibuprofen. Patient also states she drank lots of water and slept almost round the clock.  Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-080655 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient information updated. Concomitant medications updated. Event treatment information updated.; Sender's Comments: based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI before second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (UTI before second dose) 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 04-Feb-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 28-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI before second dose). At the time of the report, URINARY TRACT INFECTION (UTI before second dose) outcome was unknown.            No relevant concomitant medications reported. Treatment information include nitrofurantoin. Action taken with mRNA-123 is not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Hypoaesthesia oral, Lip swelling, Lymphadenopathy
Clinical narrative: Adenopathy supra clavicular on the left side of her neck (same side as the vaccine arm) about; Scratchy Throat; Mild Swelling of Upper Lip; Numbness in the lips,; High Blood Pressure; Pain in the Left Side of the Neck; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Scratchy Throat), LIP SWELLING (Mild Swelling of Upper Lip), HYPOAESTHESIA ORAL (Numbness in the lips,), BLOOD PRESSURE INCREASED (High Blood Pressure) and NECK PAIN (Pain in the Left Side of the Neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced OROPHARYNGEAL DISCOMFORT (Scratchy Throat), LIP SWELLING (Mild Swelling of Upper Lip), HYPOAESTHESIA ORAL (Numbness in the lips,), BLOOD PRESSURE INCREASED (High Blood Pressure) and NECK PAIN (Pain in the Left Side of the Neck). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Adenopathy supra clavicular on the left side of her neck (same side as the vaccine arm) about). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 28-Dec-2020, OROPHARYNGEAL DISCOMFORT (Scratchy Throat), LIP SWELLING (Mild Swelling of Upper Lip), HYPOAESTHESIA ORAL (Numbness in the lips,), BLOOD PRESSURE INCREASED (High Blood Pressure) and NECK PAIN (Pain in the Left Side of the Neck) had resolved. On 10-Jan-2021, LYMPHADENOPATHY (Adenopathy supra clavicular on the left side of her neck (same side as the vaccine arm) about) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Blood pressure measurement: (High) 180/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Benadryl injection. No concomitants were provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal discomfort
Clinical narrative: Adenopathy supra clavicular on the left side of her neck (same side as the vaccine arm) about; Scratchy Throat; Mild Swelling of Upper Lip; Numbness in the lips,; High Blood Pressure; Pain in the Left Side of the Neck; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Scratchy Throat), LIP SWELLING (Mild Swelling of Upper Lip), HYPOAESTHESIA ORAL (Numbness in the lips,), BLOOD PRESSURE INCREASED (High Blood Pressure) and NECK PAIN (Pain in the Left Side of the Neck) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced OROPHARYNGEAL DISCOMFORT (Scratchy Throat), LIP SWELLING (Mild Swelling of Upper Lip), HYPOAESTHESIA ORAL (Numbness in the lips,), BLOOD PRESSURE INCREASED (High Blood Pressure) and NECK PAIN (Pain in the Left Side of the Neck). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Adenopathy supra clavicular on the left side of her neck (same side as the vaccine arm) about). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 28-Dec-2020, OROPHARYNGEAL DISCOMFORT (Scratchy Throat), LIP SWELLING (Mild Swelling of Upper Lip), HYPOAESTHESIA ORAL (Numbness in the lips,), BLOOD PRESSURE INCREASED (High Blood Pressure) and NECK PAIN (Pain in the Left Side of the Neck) had resolved. On 10-Jan-2021, LYMPHADENOPATHY (Adenopathy supra clavicular on the left side of her neck (same side as the vaccine arm) about) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Blood pressure measurement: (High) 180/100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Benadryl injection. No concomitants were provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC ((Rash is) itchy), RASH ERYTHEMATOUS ((Rash is) red) and RASH (Tiny rash on torso) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC ((Rash is) itchy), RASH ERYTHEMATOUS ((Rash is) red) and RASH (Tiny rash on torso). At the time of the report, RASH PRURITIC ((Rash is) itchy), RASH ERYTHEMATOUS ((Rash is) red) and RASH (Tiny rash on torso) 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: Rash at the injection site; Itching at the injection site; Redness at the injection site; Throbbing in her left arm from shoulder to hand; A spontaneous report was received from  a consumer concerning a female patient of 75 years of age,who was administered with Moderna's covid-19 vaccine and experienced Throbbing in her left arm from shoulder to hand, Rash , Itching, Redness, and Broken out at the injection site.  Patient's medical history was not provided.No relevant concomitant medications were mentioned.  On 26-JAN-2021,patient received the first of two planned doses of mRNA-1273  vaccine(Lot number:012120A) for prophylaxis of covid-19 infection.  On 28-JAN-2021,the patient experienced throbbing in her left arm from the shoulder to hand.Symptoms ended on 29-JAN-2021.On 03-FEB-2021 the patient experienced a rash,itching, redness and broken out at the injection site.No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  Outcome for the event Throbbing in the left arm was considered resolved.The events rash, itching, redness and broken out at the injection site were not resolved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy, Dust allergy and Allergy to animal dander. Concomitant products included METOPROLOL SUCCINATE, HYDROCHLOROTHIAZIDE and VALSARTAN for Hypertension, LOSARTAN, NORTRIPTYLINE, FISH OIL, VITAMIN C [ASCORBIC ACID], VITAMIN D3 and UBIQUINOL for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 03-Feb-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. Not Provided          Concomitant product used included metropolol succinate, HCTZ and valsartan for hypertension, losartan, nortriptyline, renew probiotic, fish oil, vitamin c, vitamin d3 and ubiquinol.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Medical history was updated (Medication allergies), Patient details were added, Event causality was updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia oral, Rash erythematous
Clinical narrative: Tingling on mouth and tongue; Red patches on the skin/red rash; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (Tingling on mouth and tongue), RASH ERYTHEMATOUS (Red patches on the skin/red rash) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PARAESTHESIA ORAL (Tingling on mouth and tongue), RASH ERYTHEMATOUS (Red patches on the skin/red rash) and HEADACHE (Headache). At the time of the report, PARAESTHESIA ORAL (Tingling on mouth and tongue), RASH ERYTHEMATOUS (Red patches on the skin/red rash) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment information is unknown(maybe Acetaminophen)   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Added patient demographics and event updated from erythema to red rash.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red, swollen, and itch; soreness in her arm; red, swollen, and itchy; red, swollen, and itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red, swollen, and itch), VACCINATION SITE PAIN (soreness in her arm), VACCINATION SITE ERYTHEMA (red, swollen, and itchy) and VACCINATION SITE SWELLING (red, swollen, and itch) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (red, swollen, and itch), VACCINATION SITE PAIN (soreness in her arm), VACCINATION SITE ERYTHEMA (red, swollen, and itchy) and VACCINATION SITE SWELLING (red, swollen, and itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (red, swollen, and itch), VACCINATION SITE PAIN (soreness in her arm), VACCINATION SITE ERYTHEMA (red, swollen, and itchy) and VACCINATION SITE SWELLING (red, swollen, and itch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included that the patient took Tylenol for pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced SWELLING FACE (Face is swollen). At the time of the report, SWELLING FACE (Face is swollen) outcome was unknown. Not Provided          Treatment include steroids. Concomitant medications were not reported.   Action taken with mRNA-1273 in response to the events was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: feels warm; itching; arm  is red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feels warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (arm  is red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FEELING HOT (feels warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (arm  is red). At the time of the report, FEELING HOT (feels warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (arm  is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash, Vaccination site warmth
Clinical narrative: Red bumpy rash at site of injection on R arm; More tired than usual; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Red bumpy rash at site of injection on R arm) and FATIGUE (More tired than usual) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included GABAPENTIN for Neuropathy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch) and FATIGUE (More tired than usual). On an unknown date, the patient experienced VACCINATION SITE RASH (Red bumpy rash at site of injection on R arm). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE RASH (Red bumpy rash at site of injection on R arm) and FATIGUE (More tired than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site hypersensitivity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (sensitivity at the injection site) and MYALGIA (very mild aching) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported.  Concomitant products included FLOMAX (FLOMAX URINATE) for Urination difficulty. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (sensitivity at the injection site) and MYALGIA (very mild aching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION SITE HYPERSENSITIVITY (sensitivity at the injection site) and MYALGIA (very mild aching) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for COVID-19.     No Medical History information was reported.    On 02-Feb-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 PAIN IN EXTREMITY (pain arm). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included, Advil.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site pain
Clinical narrative: dizziness; like nauseas to my stomach; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness ), NAUSEA (like nauseas to my stomach) and VACCINATION SITE PAIN (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included ATORVASTATIN, VITAMIN B3 and FLUOXETINE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 16-Feb-2021, the patient experienced DIZZINESS (dizziness ), NAUSEA (like nauseas to my stomach) and VACCINATION SITE PAIN (sore arm). On 16-Feb-2021, DIZZINESS (dizziness ) and NAUSEA (like nauseas to my stomach) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itch like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch like a mosquito bite) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse events reported).    On 09-Feb-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 PRURITUS (itch like a mosquito bite). At the time of the report, PRURITUS (itch like a mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm Soreness - Near Injection Site; Arm Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Soreness - Near Injection Site) and VACCINATION SITE ERYTHEMA (Arm Redness - Near Injection Site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm Soreness - Near Injection Site) and VACCINATION SITE ERYTHEMA (Arm Redness - Near Injection Site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PAIN (Arm Soreness - Near Injection Site) and VACCINATION SITE ERYTHEMA (Arm Redness - Near Injection Site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication use information was unknown. Treatment information include ibuprofen and antihistamine.   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Temperature went up and down (a degree or two); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature went up and down (a degree or two)) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature went up and down (a degree or two)). At the time of the report, PYREXIA (Temperature went up and down (a degree or two)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: Cough; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Fever) and HEADACHE (Headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COUGH (Cough), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and event outcomes updated.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: slept off and on all day; Taste was terrible; felt zapped; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept off and on all day), AGEUSIA (Taste was terrible), FEELING ABNORMAL (felt zapped) and FATIGUE (Fatigue) in a 77-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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INSOMNIA (slept off and on all day), AGEUSIA (Taste was terrible), FEELING ABNORMAL (felt zapped) and FATIGUE (Fatigue). On 07-Feb-2021, INSOMNIA (slept off and on all day), AGEUSIA (Taste was terrible), FEELING ABNORMAL (felt zapped) and FATIGUE (Fatigue) had resolved.      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-2021-016705 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; Muscle pain; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  fatigue, muscle pain/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced fatigue, muscle pain.  Treatment details included Unknown.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of  fatigue, muscle pain/myalgia was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sneezing
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of NASAL CONGESTION (Stuffy nose) and SNEEZING (Sneezing) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose) and SNEEZING (Sneezing). At the time of the report, NASAL CONGESTION (Stuffy nose) and SNEEZING (Sneezing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Right where the shot was it´s kind of itchy; Right where the shot was it got really red; A spontaneous report was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right where the shot was it got really red, (right where the shot was) it was kind of itchy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: O16M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) right where the shot was it got really red, (right where the shot was) it was kind of itchy.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), right where the shot was it got really red, (right where the shot was) it was kind of itchy was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  The events are consistent with the known safety profile of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Sore arm; fatigue; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Sore arm) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (Sore arm) and FATIGUE (fatigue). At the time of the report, ARTHRALGIA (Sore arm) and FATIGUE (fatigue) had resolved.            No treatment information and concomitant medication was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was not applicable.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: left arm of injection is hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (left arm of injection is hard to touch) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE INDURATION (left arm of injection is hard to touch). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (left arm of injection is hard to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included, pre-diabetes medication, blood thinner, blood pressure medication, vitamins and a heart medication, not otherwise specified.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Pyrexia
Clinical narrative: Chest pressure or tightness in chest; Fever; Chills; A spontaneous report was received from a consumer concerning a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chest pressure or tightness in chest/ chest discomfort, chills, fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 15 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015N20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events chest pressure or tightness in chest, chills, fever.  Treatment details included Has taken Tylenol and Advil.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   The outcome of events, chest pressure or tightness in chest, chills, fever was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Rash on the forehead / Shooting pain on the head; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shooting pain on the head/ headache, rash on the forehead/ rash, shingles/ herpes zoster.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event shooting pain on the head. On 9 Feb 2021, the patient experienced the event rash on the forehead. On 10 Feb 2021, the patient experienced the event shingles.  Treatment details included Valacyclovir 1000mg three times daily for 7 days.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   The outcome of events, shooting pain on the head, rash on the forehead, shingles was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site rash
Clinical narrative: Red blotches around the injection site; Redness in a circle around the injection site; A spontaneous report was received from a healthcare professional concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red blotches around the injection site/ rash macular, redness in a circle around the injection site/ injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 022M20A) via unknown route for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events red blotches around the injection site, redness in a circle around the injection site.  Treatment details included put an ice pack on the area.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, red blotches around the injection site, redness in a circle around the injection site was unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Achy all over; Really tired; A spontaneous report was received from a consumer concerning a 89-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events really tired/ fatigue, achy all over/ pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events really tired, achy all over.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, really tired, achy all over was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 104 Temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (104 Temperature) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-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) (unknown route) 1. On 18-Feb-2021, the patient experienced PYREXIA (104 Temperature). At the time of the report, PYREXIA (104 Temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever of 103 degrees; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high fever of 103 degrees/ pyrexia.  The patient's medical history was not provided. Concomitant medications reported were Tylenol Two tablets for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events high fever of 103 degrees.  Treatment details included 2 tablets of Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.   The outcome of events, high fever of 103 degrees was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Vaccination site pain
Clinical narrative: Mild soreness at injection site; colorful flashing light in the peripheral vision of my right eye; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  colorful flashing light in the peripheral vision of my right eye/photopsia, mild soreness at injection site/vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced colorful flashing light in the peripheral vision of my right eye/photopsia. On 18 Feb 2021, the patient experienced mild soreness at injection site/vaccination site pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of mild soreness at injection site/vaccination site pain was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache after getting second Moderna vaccine that had gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after getting second Moderna vaccine that had gotten worse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ZINC, VALSARTAN, ROSUVASTATIN CALCIUM (CRESTOR) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 03-Feb-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced HEADACHE (headache after getting second Moderna vaccine that had gotten worse). At the time of the report, HEADACHE (headache after getting second Moderna vaccine that had gotten worse) had not resolved.            Treatment was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.