chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash the size of a silver dollar at the injection site; It itches sometimes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash the size of a silver dollar at the injection site) and VACCINATION SITE PRURITUS (It itches sometimes) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash the size of a silver dollar at the injection site) and VACCINATION SITE PRURITUS (It itches sometimes). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 3 milligram. At the time of the report, VACCINATION SITE RASH (Rash the size of a silver dollar at the injection site) and VACCINATION SITE PRURITUS (It itches sometimes) 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Influenza, Pain, Pyrexia
Clinical narrative: flu symptoms; body aches; fever/low grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), PAIN (body aches), PYREXIA (fever/low grade fever) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020. Concomitant products included ACETAMINOPHEN and IBUPROFEN for an unknown indication.  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 INFLUENZA (flu symptoms), PAIN (body aches), PYREXIA (fever/low grade fever) and CHILLS (Chills). At the time of the report, INFLUENZA (flu symptoms), PAIN (body aches), PYREXIA (fever/low grade fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, COVID-19: positive (Positive) Patient had COVID-19 back in June..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient is taking unspecified High Blood Pressure Medication and Supplements currently. No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Congestion surgery) in November 2020.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided.  The patient did not receive any treatment because by 22-Jan-2021 he started feeling better.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: received her 1st dose of Moderna covid vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received her 1st dose of Moderna covid vaccine) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 06-Oct-2020 to an unknown date and CYANOCOBALAMIN (VIT B12) from 06-Jun-2016 to an unknown date for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Sep-2020 and the estimated date of delivery was 20-Jun-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received her 1st dose of Moderna covid vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (received her 1st dose of Moderna covid vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided. Estimated date of conception was reported as 04-Oct-2020. Previous pregnancy included live full-term birth without complications on 2018.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Headache, Myalgia, Ultrasound abdomen
Clinical narrative: vaccine exposure during pregnancy; sore arm; headache; fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), MYALGIA (sore arm), HEADACHE (headache) and FATIGUE (fatigue) in a 32-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Previously). Concurrent medical conditions included Drug allergy (Allergic to Morphine and Dicloxacillin).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-May-2021. On 12-Feb-2020, the patient experienced FATIGUE (fatigue). On 12-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), MYALGIA (sore arm) and HEADACHE (headache). On 12-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, MYALGIA (sore arm), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Ultrasound abdomen: normal (normal) good.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is pregnant and is also taking prenatal medication. Treatment information was not provided. patient was tested positive for pregnancy in September.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Vaccination site pain
Clinical narrative: pain and soreness in arm; very hard to raise arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain and soreness in arm) and HYPOKINESIA (very hard to raise arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain and soreness in arm) and HYPOKINESIA (very hard to raise arm). On 17-Jan-2021, VACCINATION SITE PAIN (pain and soreness in arm) outcome was unknown and HYPOKINESIA (very hard to raise arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes ibuprofen and arm exercises. No concomitant medications were provided by reporter.   This case was linked to MOD-2021-013686 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Sick feeling; fever of 101.4 ºF; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick feeling), PYREXIA (fever of 101.4 ºF) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced MALAISE (Sick feeling), PYREXIA (fever of 101.4 ºF) and NAUSEA (Nausea). At the time of the report, MALAISE (Sick feeling), PYREXIA (fever of 101.4 ºF) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol. No concomitant medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Red rash around injection site; Injection site warm to touch; Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading) and VACCINATION SITE RASH (Red rash around injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppressant drug therapy (The patient has been on Immunosuppressant medication therapy for 2 years.).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch) and VACCINATION SITE ERYTHEMA (Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading). On an unknown date, the patient experienced VACCINATION SITE RASH (Red rash around injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE ERYTHEMA (Red raised, firm spot like a giant mosquito bite at injection site/redness is spreading) and VACCINATION SITE RASH (Red rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site pain
Clinical narrative: Tingle of pain; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingle of pain) and VACCINATION SITE PAIN (pain at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PARAESTHESIA (Tingle of pain) and VACCINATION SITE PAIN (pain at injection site). On 19-Jan-2021, PARAESTHESIA (Tingle of pain) had resolved. On 20-Jan-2021, VACCINATION SITE PAIN (pain at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Arm pain; Body aches; Fatigue; Injection site bruising; Pruritis at the site; Swelling at the site; Erythema at the site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PAIN (Body aches), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site) and INJECTION SITE SWELLING (Swelling at the site) in a male patient of an unknown age 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.     The patient's past medical history included COVID-19 in March 2020.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE ERYTHEMA (Erythema at the site). On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain), PAIN (Body aches) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE ERYTHEMA (Erythema at the site) had resolved.        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 unknown.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow-up information processed with initial report. Updated reported events, start date for vaccine, batch/lot number, and medical history. On 15-Apr-2021: Follow-up received on 15-Apr-2021 included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain; Body aches; Fatigue; Injection site bruising; Pruritis at the site; Swelling at the site; Erythema at the site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PAIN (Body aches), INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site) and INJECTION SITE SWELLING (Swelling at the site) in a male patient of an unknown age 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.     The patient's past medical history included COVID-19 in March 2020.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE ERYTHEMA (Erythema at the site). On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PAIN (Body aches) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm pain), PAIN (Body aches) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE BRUISING (Injection site bruising), INJECTION SITE PRURITUS (Pruritis at the site), INJECTION SITE SWELLING (Swelling at the site) and INJECTION SITE ERYTHEMA (Erythema at the site) had resolved.        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 unknown.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow-up information processed with initial report. Updated reported events, start date for vaccine, batch/lot number, and medical history. On 15-Apr-2021: Follow-up received on 15-Apr-2021 included no new information.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Tremor
Clinical narrative: No energy; Hand started shaking; Facial flushing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), TREMOR (Hand started shaking) and FLUSHING (Facial flushing) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE for Shoulder injury and Hip injury, CLOPIDOGREL BISULFATE (PLAVIX), PRAVASTATIN, METOPROLOL and OMEPRAZOLE for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ASTHENIA (No energy), TREMOR (Hand started shaking) and FLUSHING (Facial flushing). The patient was treated with PARACETAMOL (TYLENOL) on 25-Jan-2021 at an unspecified dose and frequency. At the time of the report, ASTHENIA (No energy), TREMOR (Hand started shaking) and FLUSHING (Facial flushing) had resolved.        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 start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Patient email reply received, confirming events resolved but did not provide an end date(s). significant follow up-event outcome appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm itching; arm swelling up; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE SWELLING (arm swelling up) and VACCINATION SITE ERYTHEMA (arm is red) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE SWELLING (arm swelling up) and VACCINATION SITE ERYTHEMA (arm is red). On 28-Jan-2021, VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE SWELLING (arm swelling up) and VACCINATION SITE ERYTHEMA (arm is red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported they did not have any concomitant medications.  Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: it's warm at injection site; site of injection, warm; rash at injection site extending 4-5 inches; red mark like rash that may have cropped up at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (it's warm at injection site), VACCINATION SITE WARMTH (site of injection, warm), VACCINATION SITE RASH (rash at injection site extending 4-5 inches) and VACCINATION SITE ERYTHEMA (red mark like rash that may have cropped up at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 FEELING HOT (it's warm at injection site), VACCINATION SITE WARMTH (site of injection, warm), VACCINATION SITE RASH (rash at injection site extending 4-5 inches) and VACCINATION SITE ERYTHEMA (red mark like rash that may have cropped up at injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of 1 dosage form and CORTISONE ACETATE (CORTISON) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING HOT (it's warm at injection site), VACCINATION SITE WARMTH (site of injection, warm), VACCINATION SITE RASH (rash at injection site extending 4-5 inches) and VACCINATION SITE ERYTHEMA (red mark like rash that may have cropped up at injection site) had resolved. the patient had appointment with nephrologist who diagnosed the events as looked like allergic reaction.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used ice packs as a treatment.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: significant follow up : event outcome updated for all events
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Concomitant products included VITAMINS NOS for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 21-Jan-2021, the patient experienced LYMPHADENOPATHY (lymph nodes swollen at her neck 1 first and now 3). At the time of the report, LYMPHADENOPATHY (lymph nodes swollen at her neck 1 first and now 3), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included high blood pressure medication (an ACE inhibitor)  Treatment medication included alcohol used to treat lymph nodes.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: very bad rash at the injection site/very big round rash; red; Hot; itchy; little hurt arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (little hurt arm), FATIGUE (tired), INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (Hot) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included blood pressure medicines, water pills, VITAMINS NOS, stomach probiotic and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (little hurt arm) and FATIGUE (tired). On an unknown date, the patient experienced INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (Hot) and INJECTION SITE PRURITUS (itchy). At the time of the report, ARTHRALGIA (little hurt arm), FATIGUE (tired), INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (Hot) and INJECTION SITE PRURITUS (itchy) 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.   Treatment medications included Cortisone 10 cream she buy in a store and then the doctor prescribed Betamethasone.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: very bad rash at the injection site/very big round rash; red; Hot; itchy; little hurt arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (little hurt arm), FATIGUE (tired), INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red) and INJECTION SITE WARMTH (Hot) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included blood pressure medicines, water pills, VITAMINS NOS, stomach probiotic and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (little hurt arm) and FATIGUE (tired). On an unknown date, the patient experienced INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (Hot) and INJECTION SITE PRURITUS (itchy). At the time of the report, ARTHRALGIA (little hurt arm), FATIGUE (tired), INJECTION SITE RASH (very bad rash at the injection site/very big round rash), INJECTION SITE ERYTHEMA (red), INJECTION SITE WARMTH (Hot) and INJECTION SITE PRURITUS (itchy) 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.   Treatment medications included Cortisone 10 cream she buy in a store and then the doctor prescribed Betamethasone.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Temperature intolerance
Clinical narrative: Sore; swollen; Heat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (swollen) and TEMPERATURE INTOLERANCE (Heat) 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 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (swollen) and TEMPERATURE INTOLERANCE (Heat). At the time of the report, PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (swollen) and TEMPERATURE INTOLERANCE (Heat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 23-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the event included acetaminophen.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up received on 15-Apr-2021 included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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.    In January 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 PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact; 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: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache
Clinical narrative: weakness; Chills; Headache; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (A little fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced ASTHENIA (weakness), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (A little fatigue). On 25-Jan-2021, CHILLS (Chills), HEADACHE (Headache) and FATIGUE (A little fatigue) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs included for blood pressure and blood thinner.  Treatment drug included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information added.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Skin reaction, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Delayed injection site reaction; Hot to touch injection site; Chills on and off; Injection site puffy,red; Red at injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (Delayed injection site reaction), VACCINATION SITE WARMTH (Hot to touch injection site), CHILLS (Chills on and off), VACCINATION SITE SWELLING (Injection site puffy,red) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 29-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site). On 07-Jan-2021, the patient experienced SKIN REACTION (Delayed injection site reaction), VACCINATION SITE WARMTH (Hot to touch injection site), CHILLS (Chills on and off) and VACCINATION SITE SWELLING (Injection site puffy,red). At the time of the report, SKIN REACTION (Delayed injection site reaction), VACCINATION SITE WARMTH (Hot to touch injection site), CHILLS (Chills on and off), VACCINATION SITE SWELLING (Injection site puffy,red) and VACCINATION SITE ERYTHEMA (Red at injection site) 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.   Treatment information include antihistamines.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) 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 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 URINARY TRACT INFECTION (urinary tract infection). The patient was treated with CIPROFLOXACIN for UTI, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) 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 medications include Cholesterol and high blood pressure medication
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: hot; swelling like an orange; red; tender to the touch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (hot), SWELLING (swelling like an orange), ERYTHEMA (red) and PAIN IN EXTREMITY (tender to the touch) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced SKIN WARM (hot), SWELLING (swelling like an orange), ERYTHEMA (red) and PAIN IN EXTREMITY (tender to the touch). At the time of the report, SKIN WARM (hot), SWELLING (swelling like an orange), ERYTHEMA (red) and PAIN IN EXTREMITY (tender to the touch) 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.   Treatment medication included Benadryl.  No concomitant medications were provided by reporter.   This case was linked to MOD-2021-028011 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Report form received on 14 JUL 2021: No new information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site erythema
Clinical narrative: red spot around the injection site the size of a nickel; Diarrhea on and off; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea on and off) and VACCINATION SITE ERYTHEMA (red spot around the injection site the size of a nickel) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DIARRHOEA (Diarrhea on and off). On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot around the injection site the size of a nickel). At the time of the report, DIARRHOEA (Diarrhea on and off) and VACCINATION SITE ERYTHEMA (red spot around the injection site the size of a nickel) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that they take concomitant medicines for the heart and for blood pressure.   Treatment information was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy Injection Site; Muscle Pain; Severe fatigue lasting about 3 to 4 weeks; Red Injection Site; Painful to touch Injection Site; Tender Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), MYALGIA (Muscle Pain), FATIGUE (Severe fatigue lasting about 3 to 4 weeks), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE PAIN (Painful to touch Injection Site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney failure chronic (3rd stage kidney disease) since 01-Nov-2016 and Hypertension since 1991. Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), AMLODIPINE, ATORVASTATIN, CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +) and ACETAMINOPHEN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), MYALGIA (Muscle Pain), FATIGUE (Severe fatigue lasting about 3 to 4 weeks), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE PAIN (Painful to touch Injection Site) and VACCINATION SITE PAIN (Tender Injection Site). On 22-Feb-2021, VACCINATION SITE PRURITUS (Itchy Injection Site), MYALGIA (Muscle Pain), FATIGUE (Severe fatigue lasting about 3 to 4 weeks), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE PAIN (Painful to touch Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-101970 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Added Patient details (Height, weight, pregnacy status, Race, ). Added product details (two doses). concomitant drugs are added. added Past medication history.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Sore arm; delayed reaction arm itchy; delayed reaction arm red; A spontaneous report was received from a Consumer concerning a  unknown Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like injection site pain, vaccination site pruritus and vaccination site erythema.  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: 027L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On  an unknown date, The patient experienced the events like sore arm, itchiness and redness at the vaccination site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 25-jan-2021, the outcome of the events like sore arm , itchy arm and red arm was unknown. At the time of this report, the outcome of the events like sore arm , itchy arm and red arm was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Rash
Clinical narrative: lip swelling; rash; itchy; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (lip swelling), RASH (rash) and PRURITUS (itchy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for Covid-19 Vaccination.     The patient's past medical history included No adverse reaction (no medical history reported). Concomitant products included ATORVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced LIP SWELLING (lip swelling), RASH (rash) and PRURITUS (itchy). At the time of the report, LIP SWELLING (lip swelling), RASH (rash) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Lump near collar bone on the left side/ Lymph nodes; headache; pain in upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Lump near collar bone on the left side/ Lymph nodes), HEADACHE (headache) and VACCINATION SITE PAIN (pain in upper arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-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 VACCINATION SITE LYMPHADENOPATHY (Lump near collar bone on the left side/ Lymph nodes), HEADACHE (headache) and VACCINATION SITE PAIN (pain in upper arm). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Lump near collar bone on the left side/ Lymph nodes), HEADACHE (headache) and VACCINATION SITE PAIN (pain in upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Peripheral coldness, Pyrexia, Vaccination site swelling
Clinical narrative: fever; headache; injection site is swollen; arm turned icy cold; mouth got very dry; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (arm turned icy cold), DRY MOUTH (mouth got very dry), PYREXIA (fever), HEADACHE (headache) and VACCINATION SITE SWELLING (injection site is swollen) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 23-Jan-2021, the patient experienced PERIPHERAL COLDNESS (arm turned icy cold) and DRY MOUTH (mouth got very dry). On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and VACCINATION SITE SWELLING (injection site is swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL COLDNESS (arm turned icy cold), DRY MOUTH (mouth got very dry), PYREXIA (fever), HEADACHE (headache) and VACCINATION SITE SWELLING (injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medicaions were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: On 20-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20-jan-2021, The patient experienced a bad rash and itching . He states the itching was mostly in his inguinal area, chest, and back. He also clarified that he has hives mostly on his back and red itching in inguinal area and chest.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 20-jan-2021, the outcome of the events like rash, pruritus, urticaria and erythema. was unknown. At the time of this report, the outcome of the events like rash, pruritus, urticaria and erythema  was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Severe Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe Migraines) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MIGRAINE (Severe Migraines). At the time of the report, MIGRAINE (Severe Migraines) 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.  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.; 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.