chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Derealisation, Fatigue
Clinical narrative: did not feel like herself; right arm itchiness; could not do anything; felt exhausted; sore right arm; had no energy; feel like she had acovid again; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), ASTHENIA (had no energy), MALAISE (could not do anything), DEREALISATION (did not feel like herself) and PRURITUS (right arm itchiness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Thyroid activity decreased. Concomitant products included SERTRALINE and INSULIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm), ASTHENIA (had no energy), FEELING ABNORMAL (feel like she had acovid again), PYREXIA (fever) and CHILLS (chills). On 06-Feb-2021, the patient experienced MALAISE (could not do anything) and FATIGUE (felt exhausted). On an unknown date, the patient experienced DEREALISATION (did not feel like herself) and PRURITUS (right arm itchiness). The patient was treated with PARACETAMOL (TYLENOL) 05-Feb-2021 at an unspecified dose and frequency. On 07-Feb-2021, FEELING ABNORMAL (feel like she had acovid again), CHILLS (chills) and FATIGUE (felt exhausted) had resolved. On 08-Feb-2021, ASTHENIA (had no energy) and MALAISE (could not do anything) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm) and PRURITUS (right arm itchiness) had not resolved, DEREALISATION (did not feel like herself) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: did not feel like herself; right arm itchiness; could not do anything; felt exhausted; sore right arm; had no energy; feel like she had acovid again; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), ASTHENIA (had no energy), MALAISE (could not do anything), DEREALISATION (did not feel like herself) and PRURITUS (right arm itchiness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Thyroid activity decreased. Concomitant products included SERTRALINE and INSULIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm), ASTHENIA (had no energy), FEELING ABNORMAL (feel like she had acovid again), PYREXIA (fever) and CHILLS (chills). On 06-Feb-2021, the patient experienced MALAISE (could not do anything) and FATIGUE (felt exhausted). On an unknown date, the patient experienced DEREALISATION (did not feel like herself) and PRURITUS (right arm itchiness). The patient was treated with PARACETAMOL (TYLENOL) 05-Feb-2021 at an unspecified dose and frequency. On 07-Feb-2021, FEELING ABNORMAL (feel like she had acovid again), CHILLS (chills) and FATIGUE (felt exhausted) had resolved. On 08-Feb-2021, ASTHENIA (had no energy) and MALAISE (could not do anything) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm) and PRURITUS (right arm itchiness) had not resolved, DEREALISATION (did not feel like herself) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, Swelling face, Toothache
Clinical narrative: Tooth ache; Swollen face/swollen nose/swollen cheeks; one eye swolllen; started experiencing allergic side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included KETOROLAC and MELOXICAM for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects). At the time of the report, TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None for swelling, some pain medications and antibiotic.  Concomitant medication also included clomaxin.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever like symptoms). At the time of the report, PYREXIA (Fever like symptoms) had resolved.            No treatment information was provided.  No concomitant medication was provided.    This case was linked to MOD-2021-025847, MOD-2021-025858 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site lymphadenopathy
Clinical narrative: Swollen lymph nodes in her arm; There's also some in her neck and clavicle area; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in her arm) and LYMPHADENOPATHY (There's also some in her neck and clavicle area) in an 80-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 25-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 LYMPHADENOPATHY (Swollen lymph nodes in her arm) and LYMPHADENOPATHY (There's also some in her neck and clavicle area). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in her arm) and LYMPHADENOPATHY (There's also some in her neck and clavicle area) outcome was unknown. 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.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Pain, SARS-CoV-2 test positive
Clinical narrative: stuffy nose; ache; little queasy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), PAIN (ache) and NAUSEA (little queasy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced NASAL CONGESTION (stuffy nose), PAIN (ache) and NAUSEA (little queasy). At the time of the report, NASAL CONGESTION (stuffy nose), PAIN (ache) and NAUSEA (little queasy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site warmth
Clinical narrative: the redness seems to be moving down my arm 4-5 inches from the injection; it's warm to the touch; injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 INJECTION SITE PAIN (injection site was sore). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch). At the time of the report, INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The entire reddened area has moved down about 4-5 inches from the injection site. It's oblong in shape, but about the circumference of an orange and it's warm to the touch. Concomitant medication information not provided. Treatment information not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: nausea; sore arm; fatigue; temperature going up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (temperature going up) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced NAUSEA (nausea), MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (temperature going up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (temperature going up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry mouth, Headache, Vaccination site pain
Clinical narrative: dry mouth; joint pain; headaches; chills; very painful at the shot site; This spontaneous case was reported by an other and describes the occurrence of DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site). At the time of the report, DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Her upper arm was all red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her upper arm was all red) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (Her upper arm was all red). At the time of the report, ERYTHEMA (Her upper arm was all red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. Treatment details included was not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: swollen lump and hardness around the injection; swollen lump and hardness around the injection; flu like symptoms; red around the injection site about the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE ERYTHEMA (red around the injection site about the size of a quarter), VACCINATION SITE INDURATION (swollen lump and hardness around the injection) and VACCINATION SITE SWELLING (swollen lump and hardness around the injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE ERYTHEMA (red around the injection site about the size of a quarter). On 21-Feb-2021, the patient experienced VACCINATION SITE INDURATION (swollen lump and hardness around the injection) and VACCINATION SITE SWELLING (swollen lump and hardness around the injection). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE ERYTHEMA (red around the injection site about the size of a quarter), VACCINATION SITE INDURATION (swollen lump and hardness around the injection) and VACCINATION SITE SWELLING (swollen lump and hardness around the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: detailed below.     The patient's past medical history included Flu vaccination in 2020.    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 PAIN IN EXTREMITY (Arm was sore). On 21-Jan-2021, the patient experienced VACCINATION SITE MASS (felt like it was lumpy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Arm in the area of the injection site became red/redness migrated toward my elbow) and VACCINATION SITE PAIN (painful). On an unknown date, the patient experienced FEELING ABNORMAL (feels slightly uncomfortable). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itching, at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. On 25-Jan-2021, VACCINATION SITE MASS (felt like it was lumpy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Arm in the area of the injection site became red/redness migrated toward my elbow) and VACCINATION SITE PAIN (painful) had resolved. At the time of the report, FEELING ABNORMAL (feels slightly uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: detailed below.     The patient's past medical history included Flu vaccination in 2020.    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 PAIN IN EXTREMITY (Arm was sore). On 21-Jan-2021, the patient experienced VACCINATION SITE MASS (felt like it was lumpy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Arm in the area of the injection site became red/redness migrated toward my elbow) and VACCINATION SITE PAIN (painful). On an unknown date, the patient experienced FEELING ABNORMAL (feels slightly uncomfortable). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itching, at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. On 25-Jan-2021, VACCINATION SITE MASS (felt like it was lumpy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Arm in the area of the injection site became red/redness migrated toward my elbow) and VACCINATION SITE PAIN (painful) had resolved. At the time of the report, FEELING ABNORMAL (feels slightly uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 25-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 EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection). At the time of the report, EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection) 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. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021 updated contact information.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Eye pain, Headache, Malaise
Clinical narrative: Haven't been feeling great; pain in the eyes; feels kind of dizzy; pain in the joints; Headache; A terrible reaction, pain from the hair of their head to the bottom of their feet; fever 103.2 ºF, fever of 100.2 ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and PYREXIA (fever 103.2 ºF, fever of 100.2 ºF) in a 42-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.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet) and PYREXIA (fever 103.2 ºF, fever of 100.2 ºF). On 29-Jan-2021, the patient experienced EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), ARTHRALGIA (pain in the joints) and HEADACHE (Headache). On an unknown date, the patient experienced MALAISE (Haven't been feeling great). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), PYREXIA (fever 103.2 ºF, fever of 100.2 ºF) and ARTHRALGIA (pain in the joints) had resolved and DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and HEADACHE (Headache) had not resolved.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Haven't been feeling great; pain in the eyes; feels kind of dizzy; pain in the joints; Headache; A terrible reaction, pain from the hair of their head to the bottom of their feet; fever 103.2 ºF, fever of 100.2 ºF; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and PYREXIA (fever 103.2 ºF, fever of 100.2 ºF) in a 42-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.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet) and PYREXIA (fever 103.2 ºF, fever of 100.2 ºF). On 29-Jan-2021, the patient experienced EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), ARTHRALGIA (pain in the joints) and HEADACHE (Headache). On an unknown date, the patient experienced MALAISE (Haven't been feeling great). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), PYREXIA (fever 103.2 ºF, fever of 100.2 ºF) and ARTHRALGIA (pain in the joints) had resolved and DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and HEADACHE (Headache) had not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: blood came out when it was punctured, for a few second, enough to stain the cotton ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (blood came out when it was punctured, for a few second, enough to stain the cotton ball) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (blood came out when it was punctured, for a few second, enough to stain the cotton ball). At the time of the report, VACCINATION SITE HAEMORRHAGE (blood came out when it was punctured, for a few second, enough to stain the cotton ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 event, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: He experienced redness and soreness on his arm following vaccination; redness and soreness on his arm following vaccination; redness and soreness on his arm following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (redness and soreness on his arm following vaccination), ERYTHEMA (redness and soreness on his arm following vaccination) and PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (redness and soreness on his arm following vaccination) and ERYTHEMA (redness and soreness on his arm following vaccination). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination). At the time of the report, PAIN (redness and soreness on his arm following vaccination), ERYTHEMA (redness and soreness on his arm following vaccination) and PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR attached NNI case.
Sex: F
Vaccine: COVID19
Symptoms: Bite, Lip swelling
Clinical narrative: lips swelled up; chewing on the inside of her cheeks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks). At the time of the report, LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.  No concomitant medication 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.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever like symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever like symptoms). At the time of the report, PYREXIA (Fever like symptoms) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-025847, MOD-2021-025842 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Rash around the injection site; Warm around the injection site; Injection site itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches). At the time of the report, VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity, Rash, Skin irritation, Vaccination site pain
Clinical narrative: pain in arm; chaffing armpit and feels uncomfortable; chaffing armpit and feels uncomfortable; rash under his armpit; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), SKIN IRRITATION (chaffing armpit and feels uncomfortable), DISCOMFORT (chaffing armpit and feels uncomfortable), RASH (rash under his armpit) and VACCINATION SITE PAIN (pain at injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), SKIN IRRITATION (chaffing armpit and feels uncomfortable), DISCOMFORT (chaffing armpit and feels uncomfortable), RASH (rash under his armpit) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, PAIN IN EXTREMITY (pain in arm), SKIN IRRITATION (chaffing armpit and feels uncomfortable), DISCOMFORT (chaffing armpit and feels uncomfortable), RASH (rash under his armpit) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment medication included a cream.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Dizziness, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: delayed cutaneous hypersensitivity; Woozy feeling; Bit short of breath; Unsteady; Hives; Site of inoculation on left upper arm was very itchy; Red hive at injection site; Rash devolved at injection site; It was raised (at injection site)/2x3 inch raised; Soreness at the injection site; Not feeling great; it was red (at injection site); Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady) and URTICARIA (Hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021 at 4:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy), VACCINATION SITE URTICARIA (Red hive at injection site), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Jan-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy) and VACCINATION SITE URTICARIA (Red hive at injection site) had resolved. At the time of the report, DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: 62-70 (Inconclusive) 62-70.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-235772, MOD-2021-025863.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: received on 24-Jun-2021 contains significant information about  AE details and outcome On 24-Jun-2021: Follow-up 2 received on 24-Jun-2021 contains non-significant information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Nausea, Urticaria, Vaccination site erythema
Clinical narrative: delayed cutaneous hypersensitivity; Woozy feeling; Bit short of breath; Unsteady; Hives; Site of inoculation on left upper arm was very itchy; Red hive at injection site; Rash devolved at injection site; It was raised (at injection site)/2x3 inch raised; Soreness at the injection site; Not feeling great; it was red (at injection site); Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady) and URTICARIA (Hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021 at 4:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy), VACCINATION SITE URTICARIA (Red hive at injection site), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Jan-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy) and VACCINATION SITE URTICARIA (Red hive at injection site) had resolved. At the time of the report, DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: 62-70 (Inconclusive) 62-70.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-235772, MOD-2021-025863.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: received on 24-Jun-2021 contains significant information about  AE details and outcome On 24-Jun-2021: Follow-up 2 received on 24-Jun-2021 contains non-significant information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: delayed cutaneous hypersensitivity; Woozy feeling; Bit short of breath; Unsteady; Hives; Site of inoculation on left upper arm was very itchy; Red hive at injection site; Rash devolved at injection site; It was raised (at injection site)/2x3 inch raised; Soreness at the injection site; Not feeling great; it was red (at injection site); Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady) and URTICARIA (Hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021 at 4:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy), VACCINATION SITE URTICARIA (Red hive at injection site), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Jan-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy) and VACCINATION SITE URTICARIA (Red hive at injection site) had resolved. At the time of the report, DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: 62-70 (Inconclusive) 62-70.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-235772, MOD-2021-025863.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: received on 24-Jun-2021 contains significant information about  AE details and outcome On 24-Jun-2021: Follow-up 2 received on 24-Jun-2021 contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: the arm is very red; swollen; the arm is very red, swollen, and tender; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 16-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 ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender). At the time of the report, ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender) had not resolved. Not Related   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 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. Further information has been requested.
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 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old got the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up document was received on 29-Jun-2021 and contains no new information.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Have been very sick; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced have been very sick.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced have been very sick.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date the outcome of event have been very sick was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.