chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Rash on abdomen; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) and RASH (Rash on abdomen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 PAIN IN EXTREMITY (soreness in arm). On 03-Feb-2021, the patient experienced RASH (Rash on abdomen). On 05-Feb-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. At the time of the report, RASH (Rash on abdomen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy injection site; injection site got swollen (the size of a quarter) throughout the night the swelling extended; injection site got hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended), VACCINATION SITE MASS (injection site got hard) and VACCINATION SITE PRURITUS (itchy injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended) and VACCINATION SITE MASS (injection site got hard). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy injection site). At the time of the report, VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended), VACCINATION SITE MASS (injection site got hard) and VACCINATION SITE PRURITUS (itchy injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included birth control.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: feels very tired after vaccination.; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal, normal (normal) normal and normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site red; Vaccination site sore; Vaccination site itchy; Vaccination site red; Vaccination site pain; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (Vaccination site swelling), the second episode of VACCINATION SITE ERYTHEMA (Vaccination site red) and VACCINATION SITE PAIN (Vaccination site sore) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SERTRALINE and OMEPRAZOLE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced the first episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling). On 06-Feb-2021, the patient experienced the second episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site sore) and VACCINATION SITE PRURITUS (Vaccination site itchy). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved and last episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site sore) and VACCINATION SITE PRURITUS (Vaccination site itchy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pain at the injection site; 99.5° - 100.6° fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site) and PYREXIA (99.5° - 100.6° fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PAIN (Pain at the injection site) and PYREXIA (99.5° - 100.6° fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Pain at the injection site) and PYREXIA (99.5° - 100.6° fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills, shakes; Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills, shakes), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (Chills, shakes), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). On 29-Jan-2021, CHILLS (Chills, shakes), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 30-Jan-2021, FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. The patient went through an eight hour period where he had those symptoms. He continued to be fatigued for another 24 hours.; 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.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Intentional product use issue
Clinical narrative: scheduled to get my second Moderna dose on 23-Jan-2021, but i cancelled that; mild to moderate symptoms of COVID; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (mild to moderate symptoms of COVID) and INTENTIONAL PRODUCT USE ISSUE (scheduled to get my second Moderna dose on 23-Jan-2021, but i cancelled that) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertensive (high risk disease criteria).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Jan-2021, the patient experienced COVID-19 (mild to moderate symptoms of COVID). On 23-Jan-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (scheduled to get my second Moderna dose on 23-Jan-2021, but i cancelled that). The patient was treated with BAMLANIVIMAB at an unspecified dose and frequency. On 23-Jan-2021, INTENTIONAL PRODUCT USE ISSUE (scheduled to get my second Moderna dose on 23-Jan-2021, but i cancelled that) had resolved. At the time of the report, COVID-19 (mild to moderate symptoms of COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: sore arm,arm is also sore again; Injection site has redness, knot (hardness) and tenderness; Injection site has redness; Injection site has redness, knot (hardness) and tenderness; injection site has developed a rash and is spreading as the day progresses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site has redness, knot (hardness) and tenderness), VACCINATION SITE RASH (injection site has developed a rash and is spreading as the day progresses), PAIN IN EXTREMITY (sore arm,arm is also sore again), VACCINATION SITE PAIN (Injection site has redness, knot (hardness) and tenderness) and VACCINATION SITE ERYTHEMA (Injection site has redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and EZETIMIBE (ZETIA) for Cholesterol, TELMISARTAN for Hypertension, VITAMINS NOS for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Injection site has redness, knot (hardness) and tenderness), VACCINATION SITE RASH (injection site has developed a rash and is spreading as the day progresses), VACCINATION SITE PAIN (Injection site has redness, knot (hardness) and tenderness) and VACCINATION SITE ERYTHEMA (Injection site has redness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm,arm is also sore again). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Injection site has redness, knot (hardness) and tenderness), VACCINATION SITE RASH (injection site has developed a rash and is spreading as the day progresses), PAIN IN EXTREMITY (sore arm,arm is also sore again), VACCINATION SITE PAIN (Injection site has redness, knot (hardness) and tenderness) and VACCINATION SITE ERYTHEMA (Injection site has redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: new events are updated.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: sore arm; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (sore arm) and PAIN IN EXTREMITY (arm pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 an unknown date, the patient experienced LIMB DISCOMFORT (sore arm) and PAIN IN EXTREMITY (arm pain). At the time of the report, LIMB DISCOMFORT (sore arm) and PAIN IN EXTREMITY (arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Swelling at injection site; Redness at injection site; Soreness at injection site; Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one; Stiffness at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PAIN (Soreness at injection site), ARTHRALGIA (Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one) and MUSCULOSKELETAL STIFFNESS (Stiffness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported). Concomitant products included LISINOPRIL, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CALCIUM and VITAMINS NOS for an unknown indication.    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 INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PAIN (Soreness at injection site), ARTHRALGIA (Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one) and MUSCULOSKELETAL STIFFNESS (Stiffness at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PAIN (Soreness at injection site) and MUSCULOSKELETAL STIFFNESS (Stiffness at injection site) was resolving and ARTHRALGIA (Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Influenza like illness, Lip pain, Oropharyngeal pain
Clinical narrative: Flue like symptoms; Sore arm; Sore throat; Very sore and crack lips; Fever; Joint hurt; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips) and PYREXIA (Fever) in a female patient of an unknown age 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips), PYREXIA (Fever) and ARTHRALGIA (Joint hurt). At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips), PYREXIA (Fever) and ARTHRALGIA (Joint hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     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.   This case was linked to MOD21-023612, MOD-2021-025872, MOD-2021-025828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporter contact details was updated.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Flue like symptoms; Sore arm; Sore throat; Very sore and crack lips; Fever; Joint hurt; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips) and PYREXIA (Fever) in a female patient of an unknown age 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips), PYREXIA (Fever) and ARTHRALGIA (Joint hurt). At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms), PAIN IN EXTREMITY (Sore arm), OROPHARYNGEAL PAIN (Sore throat), LIP PAIN (Very sore and crack lips), PYREXIA (Fever) and ARTHRALGIA (Joint hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     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.   This case was linked to MOD21-023612, MOD-2021-025872, MOD-2021-025828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporter contact details was updated.
Age: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Dyspnoea, Inappropriate schedule of product administration, Wheezing
Clinical narrative: First vaccine administered on 14-Jan-2021 and second on 17-Jan-2021; cough; Shortness of breath; wheezing; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine administered on 14-Jan-2021 and second on 17-Jan-2021), COUGH (cough), DYSPNOEA (Shortness of breath) and WHEEZING (wheezing) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced COUGH (cough), DYSPNOEA (Shortness of breath) and WHEEZING (wheezing). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine administered on 14-Jan-2021 and second on 17-Jan-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine administered on 14-Jan-2021 and second on 17-Jan-2021) had resolved and COUGH (cough), DYSPNOEA (Shortness of breath) and WHEEZING (wheezing) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dry mouth, Dysgeusia, Fatigue, Pruritus
Clinical narrative: Tiny little blisters moved to the Left Hand and Injection Site; Fatigue; Wakes up from hand itching; Blister on right hand; Dry mouth; Metallic Taste in the mouth; Itching; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blister on right hand), DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic Taste in the mouth), PRURITUS (Itching) and BLISTER (Tiny little blisters moved to the Left Hand and Injection Site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer and Surgery (left wrist was fractured/surgery). Concomitant products included ANASTROZOLE (ARIMIDEX) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced BLISTER (Blister on right hand), DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic Taste in the mouth) and PRURITUS (Itching). On 23-Feb-2021, the patient experienced BLISTER (Tiny little blisters moved to the Left Hand and Injection Site), FATIGUE (Fatigue) and PRURITUS (Wakes up from hand itching). On 24-Feb-2021, BLISTER (Blister on right hand), DRY MOUTH (Dry mouth) and DYSGEUSIA (Metallic Taste in the mouth) had resolved. At the time of the report, PRURITUS (Itching), BLISTER (Tiny little blisters moved to the Left Hand and Injection Site), FATIGUE (Fatigue) and PRURITUS (Wakes up from hand itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Chest pain
Clinical narrative: Chest pain; Chest tightness on her left side.; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest tightness on her left side.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest tightness on her left side.). The patient was treated with NAPROXEN at a dose of 220 milligram. At the time of the report, CHEST PAIN (Chest pain) and CHEST DISCOMFORT (Chest tightness on her left side.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site vesicles
Clinical narrative: blister bump; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (blister bump) and VACCINATION SITE ERYTHEMA (redness) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 VACCINATION SITE ERYTHEMA (redness). On 05-Feb-2021, the patient experienced VACCINATION SITE VESICLES (blister bump). At the time of the report, VACCINATION SITE VESICLES (blister bump) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. no treatment details reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot; Swelling at injection site and bellow right elbow (egg sized lump); Painful to the touch; A spontaneous report was received from a consumer concerning a 64-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling at injection site and bellow right elbow (egg sized lump), hot, painful to the touch, now was down to his forearm as twice as big.  The patient's medical history fell and hit his elbow really bad, he had bruise and really hurt. Concomitant medications reported were levothyroxine and celecoxib, both were used for an unknown indication.  On 25-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 057G20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient experienced the events swelling at injection site and below right elbow (egg sized lump), hot, painful to the touch. On an unknown date, the physician recommended ice plus ibuprofen and to keep the arm elevated. They drew a circle around the swelling to see if it got bigger and it did. Now was down to his forearm - twice as big.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, swelling at injection site and bellow right elbow (egg sized lump), hot, painful to the touch, now was down to his forearm as twice as big was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Severe vertigo; Anxiety; Heart felt fast; Sweating; Drowsy; Nauseous; Sore arm; Threw up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating) and SOMNOLENCE (Drowsy) in a female patient of an unknown age 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 26-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 VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating), SOMNOLENCE (Drowsy), NAUSEA (Nauseous), PAIN IN EXTREMITY (Sore arm), VOMITING (Threw up) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating), SOMNOLENCE (Drowsy), NAUSEA (Nauseous), PAIN IN EXTREMITY (Sore arm), VOMITING (Threw up) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Somnolence, Vertigo, Vomiting
Clinical narrative: Severe vertigo; Anxiety; Heart felt fast; Sweating; Drowsy; Nauseous; Sore arm; Threw up; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating) and SOMNOLENCE (Drowsy) in a female patient of an unknown age 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 26-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 VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating), SOMNOLENCE (Drowsy), NAUSEA (Nauseous), PAIN IN EXTREMITY (Sore arm), VOMITING (Threw up) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VERTIGO (Severe vertigo), ANXIETY (Anxiety), PALPITATIONS (Heart felt fast), HYPERHIDROSIS (Sweating), SOMNOLENCE (Drowsy), NAUSEA (Nauseous), PAIN IN EXTREMITY (Sore arm), VOMITING (Threw up) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Tenderness
Clinical narrative: Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx); lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues; Tenderness of the Mouth; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)), TENDERNESS (Tenderness of the Mouth) and SWELLING FACE (lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included UBIDECARENONE (COQ10 [UBIDECARENONE]) for Heart alternation.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced TENDERNESS (Tenderness of the Mouth). On 26-Jan-2021, the patient experienced LIP SWELLING (Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)) and SWELLING FACE (lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 28-Jan-2021, LIP SWELLING (Swollen Bottom Lip/lower lip was very swollen/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)) and SWELLING FACE (lip was very swollen as were cheeks on both sides/Swelling of upper airway (lips, tongue, throat, uvula, or larynx)/oral issues) had resolved. At the time of the report, TENDERNESS (Tenderness of the Mouth) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication includes Anti-Histamines   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received and it contains No New Information. Second dose information picked from Follow up 1 source document and action taken with suspect drug updated accordingly. Concomitant product indication added as medical history.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema
Clinical narrative: Right arm swollen; Right arm red; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Right arm swollen) and VACCINATION SITE JOINT ERYTHEMA (Right arm red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Breast tumor benign (Breast tumor removed a year ago under the right arm.).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (Right arm swollen) and VACCINATION SITE JOINT ERYTHEMA (Right arm red). On 25-Feb-2021, PERIPHERAL SWELLING (Right arm swollen) and VACCINATION SITE JOINT ERYTHEMA (Right arm red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient have rash all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient have rash all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (Patient have rash all over). At the time of the report, RASH (Patient have rash all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the known safety profile of mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for covid-19.; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive for covid-19.) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Positive for covid-19.). At the time of the report, COVID-19 (Positive for covid-19.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 medications were not provided.  Treatment information was not provided.  HCP called to get guidance on whether a covid-19 positive patient could received the second dose of the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: NNI
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dysphonia, Ear discomfort, Eye swelling
Clinical narrative: Body aches; Facial swelling; Eye swelling; Ear clogged; Tightness in chest; Congestion; Sore throat; Voice is hoarse; Chills; Fever; A spontaneous report was received from a 49 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed fever, body aches, chills, facial swelling, eye swelling, ear clogged, tightness in chest, congestion, sore throat, and voice is hoarse.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient received her first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 04-FEB-2021, the patient received her second of two planned doses of mRNA-1273 (lot number: 0297207) intramuscularly for the prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient developed fever, body aches and chills for 48 hours. The patient also developed facial swelling, eye swelling, clogged ear, tightness in chest, congestion, sore throat, and a hoarse voice. The patient stated that she had substantial reactions but just wanted to report this. The patient was aware that these symptoms can occur. The patient may contact her physician if she needed any additional help with the symptoms.  Action taken with mRNA-1273 in relation to the events was not applicable.  The outcomes of the events, fever, body aches, and chills, were resolved and the outcomes for events, facial swelling, eye swelling, ear clogged, tightness in chest, congestion, sore throat, and voice is hoarse, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lower respiratory tract congestion, Oropharyngeal pain, Pain, Pyrexia, Swelling face
Clinical narrative: Body aches; Facial swelling; Eye swelling; Ear clogged; Tightness in chest; Congestion; Sore throat; Voice is hoarse; Chills; Fever; A spontaneous report was received from a 49 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed fever, body aches, chills, facial swelling, eye swelling, ear clogged, tightness in chest, congestion, sore throat, and voice is hoarse.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient received her first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 04-FEB-2021, the patient received her second of two planned doses of mRNA-1273 (lot number: 0297207) intramuscularly for the prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient developed fever, body aches and chills for 48 hours. The patient also developed facial swelling, eye swelling, clogged ear, tightness in chest, congestion, sore throat, and a hoarse voice. The patient stated that she had substantial reactions but just wanted to report this. The patient was aware that these symptoms can occur. The patient may contact her physician if she needed any additional help with the symptoms.  Action taken with mRNA-1273 in relation to the events was not applicable.  The outcomes of the events, fever, body aches, and chills, were resolved and the outcomes for events, facial swelling, eye swelling, ear clogged, tightness in chest, congestion, sore throat, and voice is hoarse, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm was sore; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (Arm was red) in a 75-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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (Arm was red). At the time of the report, VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (Arm was red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The treatment information was not provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Myalgia, vaccination site erythema and vaccination site pain are consistent with the product known safety.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: stiffness in injection arm; throbbing in injection arm; injection arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in injection arm), PAIN (throbbing in injection arm) and VACCINATION SITE PAIN (injection arm is sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in injection arm), PAIN (throbbing in injection arm) and VACCINATION SITE PAIN (injection arm is sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in injection arm), PAIN (throbbing in injection arm) and VACCINATION SITE PAIN (injection arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Vaccination site pain is consistent with the product known safety
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: She still has swelling and a red area on her arm about the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (She still has swelling and a red area on her arm about the size of a silver dollar) in a female 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.    On 20-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 VACCINATION SITE SWELLING (She still has swelling and a red area on her arm about the size of a silver dollar). At the time of the report, VACCINATION SITE SWELLING (She still has swelling and a red area on her arm about the size of a silver dollar) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported 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 onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching; Redness; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching and redness around the site of injection.  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 their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced itching and redness around the site of injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, itching and redness around the site of injection was unknown.; Reporter'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.