chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pains; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pains) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains). At the time of the report, CHEST PAIN (chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Laboratory investigations were provided. No Treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash at injection site on left arm; itchiness at injection site on left arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (rash at injection site on left arm) and VACCINATION SITE PRURITUS (itchiness at injection site on left arm) in a 47-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) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at injection site on left arm) and VACCINATION SITE PRURITUS (itchiness at injection site on left arm). At the time of the report, VACCINATION SITE RASH (rash at injection site on left arm) and VACCINATION SITE PRURITUS (itchiness at injection site on left arm) had not 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.   Laboratory details was not provided.  The patient was not taking any treatment medication but she was applying topical cream over injection site.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after vaccination) in a 34-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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Gait disturbance, Headache
Clinical narrative: Fever; body aches; headache; fatigue; a lot of pain on joints; pain all over his body; don't like to eat; don't like to walk; feel like I want to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (a lot of pain on joints) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue), ARTHRALGIA (a lot of pain on joints), PAIN (pain all over his body), DECREASED APPETITE (don't like to eat), GAIT DISTURBANCE (don't like to walk) and SOMNOLENCE (feel like I want to sleep). At the time of the report, PYREXIA (Fever), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue), ARTHRALGIA (a lot of pain on joints), PAIN (pain all over his body), DECREASED APPETITE (don't like to eat), GAIT DISTURBANCE (don't like to walk) and SOMNOLENCE (feel like I want to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Fever; body aches; headache; fatigue; a lot of pain on joints; pain all over his body; don't like to eat; don't like to walk; feel like I want to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (a lot of pain on joints) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue), ARTHRALGIA (a lot of pain on joints), PAIN (pain all over his body), DECREASED APPETITE (don't like to eat), GAIT DISTURBANCE (don't like to walk) and SOMNOLENCE (feel like I want to sleep). At the time of the report, PYREXIA (Fever), PAIN (body aches), HEADACHE (headache), FATIGUE (fatigue), ARTHRALGIA (a lot of pain on joints), PAIN (pain all over his body), DECREASED APPETITE (don't like to eat), GAIT DISTURBANCE (don't like to walk) and SOMNOLENCE (feel like I want to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 test came back positive; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 test came back positive) 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 (No Historical condition reported).    On 06-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 SARS-COV-2 TEST POSITIVE (COVID-19 test came back positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 test came back positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; headache frontal lobe; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (headache frontal lobe), MYALGIA (body aches) and CHILLS (chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (headache frontal lobe), MYALGIA (body aches) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (headache frontal lobe), MYALGIA (body aches) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effect is trying to report; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect is trying to report) 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 (no adverse event reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effect is trying to report). At the time of the report, ADVERSE EVENT (Side effect is trying to report) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Myalgia; Arthralgia; Fatigue; Fever; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Lyme disease and COVID-19. Concomitant products included HCTZ, CLONIDINE, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), MONTELUKAST SODIUM (MONOCAST [MONTELUKAST SODIUM]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced ARTHRALGIA (Arthralgia). On 09-Jan-2021, the patient experienced MYALGIA (Myalgia). On 08-Jan-2021, PYREXIA (Fever) had resolved. On 09-Jan-2021, HEADACHE (Headache), ARTHRALGIA (Arthralgia) and MYALGIA (Myalgia) had resolved. At the time of the report, FATIGUE (Fatigue) 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 information was not provided.  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.   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 events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid-19 after receiving Covid 19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for Covid-19 after receiving Covid 19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid-19 after receiving Covid 19 Vaccine). At the time of the report, COVID-19 (Tested positive for Covid-19 after receiving Covid 19 Vaccine) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Erythema, Faeces discoloured, Swelling face
Clinical narrative: real dark black stools; Shortness of breath; face got really red and swollen; face got really red and swollen; Chills; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), SWELLING FACE (face got really red and swollen), ERYTHEMA (face got really red and swollen), FAECES DISCOLOURED (real dark black stools) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced CHILLS (Chills). On 13-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), SWELLING FACE (face got really red and swollen) and ERYTHEMA (face got really red and swollen). On an unknown date, the patient experienced FAECES DISCOLOURED (real dark black stools). At the time of the report, DYSPNOEA (Shortness of breath), SWELLING FACE (face got really red and swollen), ERYTHEMA (face got really red and swollen) and CHILLS (Chills) had resolved and FAECES DISCOLOURED (real dark black stools) 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 was provided.  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.   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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: very hot; hard; itchy; highly inflammation of 4x4in at injection site; Painful quite hard; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site) and VACCINATION SITE PAIN (Painful quiet hard) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-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 WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site), VACCINATION SITE PAIN (Painful quiet hard) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site), VACCINATION SITE PAIN (Painful quiet hard) and VACCINATION SITE ERYTHEMA (red) 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 Zyrtec and Hydrocortisone.  No relevant laboratory details were included.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: very hot; hard; itchy; highly inflammation of 4x4in at injection site; Painful quite hard; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site) and VACCINATION SITE PAIN (Painful quiet hard) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-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 WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site), VACCINATION SITE PAIN (Painful quiet hard) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (very hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (highly inflammation of 4x4in at injection site), VACCINATION SITE PAIN (Painful quiet hard) and VACCINATION SITE ERYTHEMA (red) 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 Zyrtec and Hydrocortisone.  No relevant laboratory details were included.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site joint swelling, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site raised; Injection is reddish; Lymph node under the arm is a little swollen; Injection site got itchy; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT SWELLING (Injection site raised), VACCINATION SITE PRURITUS (Injection site got itchy), VACCINATION SITE PAIN (arm sore), VACCINATION SITE ERYTHEMA (Injection is reddish) and LYMPHADENOPATHY (Lymph node under the arm is a little swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm sore). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site got itchy). On 15-Jan-2021, the patient experienced VACCINATION SITE JOINT SWELLING (Injection site raised), VACCINATION SITE ERYTHEMA (Injection is reddish) and LYMPHADENOPATHY (Lymph node under the arm is a little swollen). At the time of the report, VACCINATION SITE JOINT SWELLING (Injection site raised), VACCINATION SITE PRURITUS (Injection site got itchy), VACCINATION SITE ERYTHEMA (Injection is reddish) and LYMPHADENOPATHY (Lymph node under the arm is a little swollen) had not resolved and VACCINATION SITE PAIN (arm sore) 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.   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 events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Pyrexia, Tremor
Clinical narrative: Shaking; Weakness; affect balance; temperature; Chilly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ASTHENIA (Weakness), BALANCE DISORDER (affect balance), PYREXIA (temperature) and CHILLS (Chilly) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020.    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 TREMOR (Shaking), ASTHENIA (Weakness), BALANCE DISORDER (affect balance), PYREXIA (temperature) and CHILLS (Chilly). At the time of the report, TREMOR (Shaking), ASTHENIA (Weakness), BALANCE DISORDER (affect balance), PYREXIA (temperature) and CHILLS (Chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant details not reported by the reporter. Treatment details not reported by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchy at injection site; Became swollen (raised) injection site; Tender at injection site; Red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE SWELLING (Became swollen (raised) injection site) and VACCINATION SITE PAIN (Tender at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to sulpha drugs).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE RASH (Red rash on the injection site). On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE SWELLING (Became swollen (raised) injection site) and VACCINATION SITE PAIN (Tender at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE SWELLING (Became swollen (raised) injection site) and VACCINATION SITE PAIN (Tender at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took diphenhydramine (5 doses) and cortisone cream on the affected site as treatment.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Stuffy nose; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for Covid), NASAL CONGESTION (Stuffy nose) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nose congestion since 08-Jan-2021.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced NASAL CONGESTION (Stuffy nose). On 12-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). On 07-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, COVID-19 (Tested positive for Covid) and NASAL CONGESTION (Stuffy nose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of  fatigue, COVID-19 and nasal congestion are assessed as unlikely related.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events of  fatigue, COVID-19 and nasal congestion are assessed as unlikely related.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Vomiting
Clinical narrative: Sore arm.; Diarrhea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm.), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm.), DIARRHOEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, PAIN IN EXTREMITY (Sore arm.), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mass excision (Left breast).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches). At the time of the report, LYMPHADENOPATHY (Enlarged lymph nodes between the underarms and breasts 2 lymph nodes about 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Felt very sick; Diarrhea; Couldn't get out of bed; Headache; Severe fatigue; Nausea; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache) and FATIGUE (Severe fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reporter stated patient had COVID-19 on July 28.) on 28-Jul-2020.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache), FATIGUE (Severe fatigue), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 28-Dec-2020, MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache), FATIGUE (Severe fatigue), NAUSEA (Nausea) and PYREXIA (Fever) 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.   No concomitant medications were provided. Additional treatment medications were allergy medications.   Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Felt very sick; Diarrhea; Couldn't get out of bed; Headache; Severe fatigue; Nausea; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache) and FATIGUE (Severe fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reporter stated patient had COVID-19 on July 28.) on 28-Jul-2020.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache), FATIGUE (Severe fatigue), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 28-Dec-2020, MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache), FATIGUE (Severe fatigue), NAUSEA (Nausea) and PYREXIA (Fever) 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.   No concomitant medications were provided. Additional treatment medications were allergy medications.   Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: redness in her arm; feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in her arm) and PYREXIA (feverish) 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 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in her arm) and PYREXIA (feverish). At the time of the report, VACCINATION SITE ERYTHEMA (redness in her arm) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Extreme headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extreme headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Fall and Rib fracture. Concurrent medical conditions included Rib pain (He took a fall and had broken rib recently, and has been taking Tylenol Excedrin and Tylenol #3 for his pain for his rib and his back) and Back pain (He took a fall and had broken rib recently, and has been taking Tylenol Excedrin and Tylenol #3 for his pain for his rib and his back).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (Extreme headache). At the time of the report, HEADACHE (Extreme headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication details reported by the reporter. Treatment medication included Tylenol (paracetamol) Excedrin (aspirin/paracetamol/caffeine); 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Vaccination site hypoaesthesia, Vaccination site paraesthesia, Vaccination site rash
Clinical narrative: Numbness; Tingling; Rash on the same arm; Underarm swollen lymph node; A little sick and felt a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Numbness), VACCINATION SITE PARAESTHESIA (Tingling), VACCINATION SITE RASH (Rash on the same arm), LYMPHADENOPATHY (Underarm swollen lymph node) and FATIGUE (A little sick and felt a little fatigue) in a 38-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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced FATIGUE (A little sick and felt a little fatigue). On 08-Jan-2021, the patient experienced LYMPHADENOPATHY (Underarm swollen lymph node). On 14-Jan-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (Numbness), VACCINATION SITE PARAESTHESIA (Tingling) and VACCINATION SITE RASH (Rash on the same arm). On 11-Jan-2021, LYMPHADENOPATHY (Underarm swollen lymph node) had resolved. At the time of the report, VACCINATION SITE HYPOAESTHESIA (Numbness), VACCINATION SITE PARAESTHESIA (Tingling) and VACCINATION SITE RASH (Rash on the same arm) had not resolved and FATIGUE (A little sick and felt a little fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant details not reported by the reporter. Treatment details not reported by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red blotchy red marks on my arm that are itchy; injection site got red and itchy; injection site got red and itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Red blotchy red marks on my arm that are itchy), VACCINATION SITE PRURITUS (injection site got red and itchy) and VACCINATION SITE ERYTHEMA (injection site got red and itchy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), ATORVASTATIN, METOPROLOL, AMLODIPINE and VITAMINS NOS for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site got red and itchy) and VACCINATION SITE ERYTHEMA (injection site got red and itchy). On 14-Jan-2021, the patient experienced RASH PRURITIC (Red blotchy red marks on my arm that are itchy). At the time of the report, RASH PRURITIC (Red blotchy red marks on my arm that are itchy), VACCINATION SITE PRURITUS (injection site got red and itchy) and VACCINATION SITE ERYTHEMA (injection site got red and 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 included Benadryl and ice.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood urine present, Chills, Diarrhoea
Clinical narrative: Passed blood; Weak; Bad stomach cramps; Chills; Very tired; Vaccination site really sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BLOOD URINE PRESENT (Passed blood), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-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 DIARRHOEA (Diarrhea), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps), CHILLS (Chills), FATIGUE (Very tired) and VACCINATION SITE PAIN (Vaccination site really sore). On 15-Jan-2021, the patient experienced BLOOD URINE PRESENT (Passed blood). At the time of the report, DIARRHOEA (Diarrhea), BLOOD URINE PRESENT (Passed blood), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps), CHILLS (Chills), FATIGUE (Very tired) and VACCINATION SITE PAIN (Vaccination site really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details not reported by the reporter. Treatment details not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Passed blood; Weak; Bad stomach cramps; Chills; Very tired; Vaccination site really sore; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BLOOD URINE PRESENT (Passed blood), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 13-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 DIARRHOEA (Diarrhea), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps), CHILLS (Chills), FATIGUE (Very tired) and VACCINATION SITE PAIN (Vaccination site really sore). On 15-Jan-2021, the patient experienced BLOOD URINE PRESENT (Passed blood). At the time of the report, DIARRHOEA (Diarrhea), BLOOD URINE PRESENT (Passed blood), ASTHENIA (Weak), ABDOMINAL PAIN UPPER (Bad stomach cramps), CHILLS (Chills), FATIGUE (Very tired) and VACCINATION SITE PAIN (Vaccination site really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details not reported by the reporter. Treatment details not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: cold; Fever 101.00 - 101.7 range; She feels wiped out; Body feels achy; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), PYREXIA (Fever 101.00 - 101.7 range), FATIGUE (She feels wiped out) and PAIN (Body feels achy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20M) 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 13-Jan-2021, the patient experienced NASOPHARYNGITIS (cold), PYREXIA (Fever 101.00 - 101.7 range), FATIGUE (She feels wiped out) and PAIN (Body feels achy). At the time of the report, NASOPHARYNGITIS (cold) was resolving and PYREXIA (Fever 101.00 - 101.7 range), FATIGUE (She feels wiped out) and PAIN (Body feels achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.  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.   This case was linked to US-MODERNATX, INC.   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 events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Hypoaesthesia, Palpitations, Paraesthesia
Clinical narrative: Chest pain; Palpitations; Left arm numbness; Tingling in left arm; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Palpitations), HYPOAESTHESIA (Left arm numbness), PARAESTHESIA (Tingling in left arm) and CHILLS (Severe chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (Severe chills). On 08-Jan-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Palpitations), HYPOAESTHESIA (Left arm numbness) and PARAESTHESIA (Tingling in left arm). On 07-Jan-2021, CHILLS (Severe chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Palpitations), HYPOAESTHESIA (Left arm numbness) and PARAESTHESIA (Tingling in left arm) had not resolved.        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.   No treatment was provided. Patients wants to confirm that these are common side effects of vaccine and gives her consent to contact her HCP for her side effects.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Spasm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Spasm at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCLE SPASMS (Spasm at injection site). On 13-Jan-2021, MUSCLE SPASMS (Spasm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported. Treatment details were not reported by the reporter.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Lab details were not provided by the reporter.  Treatment for the events were not provided by the reporter.  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.   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 events, a causal relationship cannot be excluded.