chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Immediately when I got the shot it burned like really bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Immediately when I got the shot it burned like really bad) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Spasms (bad back spasms and for spinal). Concomitant products included DIAZEPAM, TIZANIDINE and TRAZODONE for Spasm muscle, MELATONIN for an unknown indication.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Immediately when I got the shot it burned like really bad). The patient was treated with METRONIDAZOLE BENZOATE (METROZOLE [METRONIDAZOLE BENZOATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Immediately when I got the shot it burned like really bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included Ice, armband, shoulder rolls.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Constant cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Constant cough) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (She has a autoimmune disorder and when she gets sick, her chest and lungs are very sensitive and flair up easily.).   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced COUGH (Constant cough). At the time of the report, COUGH (Constant cough) outcome was unknown.            No concomitant was provided. Patient treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Limb discomfort, Malaise, Nausea
Clinical narrative: Wobbly legs; Weak legs; feeling a little under the weather in terms of the mood; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Wobbly legs), ASTHENIA (Weak legs), MALAISE (feeling a little under the weather in terms of the mood) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Wobbly legs), ASTHENIA (Weak legs), MALAISE (feeling a little under the weather in terms of the mood) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of prior to taking 2nd shot. At the time of the report, LIMB DISCOMFORT (Wobbly legs), ASTHENIA (Weak legs), MALAISE (feeling a little under the weather in terms of the mood) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-027030 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: The patient stated she did not receive the AE form.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: lost their appetite; Tested positive for COVID-19 after the second dose; fever blister on their face, herpes simplex; Felt like getting the flu, did not feel well at all, very achy; very tired; headache; A spontaneous case report was received from a consumer concerning a 68 -year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever blister on their face/oral herpes, very tired/fatigue, headache, lost their appetite/decreased appetite, tested positive for COVID-19 after the second dose/COVID-19 and felt like getting the flu/influenza like illness.  The patient's medical history was not provided.  Concomitant products known to have been used by the patient, within two weeks prior to the event included Atorvastatin 20mg.  On 18-JAN-2021, the patient received their first of the two planned doses of mRNA-1273(Lot number:013L20A) and on 20-FEB-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 21-FEB-2021,  the patient felt very tired, did not feel well at all, had a headache, was achy, like getting the flu. The patient felt better on the 22-FEB-2021 but still not well. On 22-FEB-2021 they also had fever blister on their face, herpes simplex, still ongoing, but healing. On the 23-FEB-2021 their doctor suggested a test for Covid-19 which was positive, although a mild case. On 25-FEB-2021 the patient lost their appetite too, and felt tired and still had headaches.  Treatment of these events included acetaminophen and famciclovir 500mg, twice a day.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, fever blister on their face/oral herpes, very tired/fatigue, headache, lost their appetite/decreased appetite, tested positive for COVID-19 after the second dose/COVID-19 and felt like getting the flu/influenza like illness were considered unknown.; Reporter's Comments: Covid 19 is unlikely to be related to Moderna Covid 19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: lost their appetite; Tested positive for COVID-19 after the second dose; fever blister on their face, herpes simplex; Felt like getting the flu, did not feel well at all, very achy; very tired; headache; A spontaneous case report was received from a consumer concerning a 68 -year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever blister on their face/oral herpes, very tired/fatigue, headache, lost their appetite/decreased appetite, tested positive for COVID-19 after the second dose/COVID-19 and felt like getting the flu/influenza like illness.  The patient's medical history was not provided.  Concomitant products known to have been used by the patient, within two weeks prior to the event included Atorvastatin 20mg.  On 18-JAN-2021, the patient received their first of the two planned doses of mRNA-1273(Lot number:013L20A) and on 20-FEB-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 21-FEB-2021,  the patient felt very tired, did not feel well at all, had a headache, was achy, like getting the flu. The patient felt better on the 22-FEB-2021 but still not well. On 22-FEB-2021 they also had fever blister on their face, herpes simplex, still ongoing, but healing. On the 23-FEB-2021 their doctor suggested a test for Covid-19 which was positive, although a mild case. On 25-FEB-2021 the patient lost their appetite too, and felt tired and still had headaches.  Treatment of these events included acetaminophen and famciclovir 500mg, twice a day.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, fever blister on their face/oral herpes, very tired/fatigue, headache, lost their appetite/decreased appetite, tested positive for COVID-19 after the second dose/COVID-19 and felt like getting the flu/influenza like illness were considered unknown.; Reporter's Comments: Covid 19 is unlikely to be related to Moderna Covid 19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Influenza like illness, Pyrexia, Vaccination site pain
Clinical narrative: injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), VACCINATION SITE PAIN (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), PYREXIA (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills) and FATIGUE (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchial infection.   On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), DYSPNOEA (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), VACCINATION SITE PAIN (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), PYREXIA (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills) and FATIGUE (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), DYSPNOEA (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), VACCINATION SITE PAIN (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills), PYREXIA (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills) and FATIGUE (soreness of the injection site, shortness of breath, fever, fatigue, and other flu-like symptoms but no chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20 Jul 2021. reporter contact details added, events outcome updated as recovered for all the events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Generalized malaise; warmth at the injection site; chills; Muscle Pain; Headache; joint Pain; Tenderness at the injection site; swelling at the injection site; large red spot at the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Generalized malaise), VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 2018 to an unknown date for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (fatigue). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain), HEADACHE (Headache), ARTHRALGIA (joint Pain), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red spot at the injection site). On an unknown date, the patient experienced MALAISE (Generalized malaise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 28-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, MALAISE (Generalized malaise), VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain), HEADACHE (Headache), ARTHRALGIA (joint Pain), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red spot at the injection site) outcome was unknown.            The action taken with mRNA with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021 .Reporters e-mail address updated On 15-Jul-2021: Follow-up received on 15-JULY2021  and concomitant medications and events were added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Generalized malaise; warmth at the injection site; chills; Muscle Pain; Headache; joint Pain; Tenderness at the injection site; swelling at the injection site; large red spot at the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Generalized malaise), VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 2018 to an unknown date for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (fatigue). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain), HEADACHE (Headache), ARTHRALGIA (joint Pain), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red spot at the injection site). On an unknown date, the patient experienced MALAISE (Generalized malaise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 28-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, MALAISE (Generalized malaise), VACCINATION SITE WARMTH (warmth at the injection site), CHILLS (chills), MYALGIA (Muscle Pain), HEADACHE (Headache), ARTHRALGIA (joint Pain), VACCINATION SITE PAIN (Tenderness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red spot at the injection site) outcome was unknown.            The action taken with mRNA with the events was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up received on 29-APR-2021 .Reporters e-mail address updated On 15-Jul-2021: Follow-up received on 15-JULY2021  and concomitant medications and events were added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Diarrhoea, Headache, Injection site pain
Clinical narrative: Diarrhea; Loss of appetite; Back pain; Vomitting; Pain in the arm at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), BACK PAIN (Back pain), INJECTION SITE PAIN (Pain in the arm at the injection site) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in the arm at the injection site) and HEADACHE (Headache). On 27-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), BACK PAIN (Back pain) and VOMITING (Vomitting). On 28-Feb-2021, VOMITING (Vomitting) had resolved. At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), BACK PAIN (Back pain), INJECTION SITE PAIN (Pain in the arm at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Loss of appetite; Back pain; Vomitting; Pain in the arm at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), BACK PAIN (Back pain), INJECTION SITE PAIN (Pain in the arm at the injection site) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in the arm at the injection site) and HEADACHE (Headache). On 27-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), BACK PAIN (Back pain) and VOMITING (Vomitting). On 28-Feb-2021, VOMITING (Vomitting) had resolved. At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), BACK PAIN (Back pain), INJECTION SITE PAIN (Pain in the arm at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Headache; Chills; Achy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Achy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: achy; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), HEADACHE (headache) and MYALGIA (muscle pain) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), HEADACHE (headache) and MYALGIA (muscle pain). At the time of the report, PAIN (achy), HEADACHE (headache) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR: not interested in follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea
Clinical narrative: Generally weak; feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Generally weak) and NAUSEA (feeling nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Generally weak) and NAUSEA (feeling nauseous). At the time of the report, ASTHENIA (Generally weak) and NAUSEA (feeling nauseous) outcome was unknown.            Patient had taken Advil prior to taking 2nd shot.   This case was linked to MOD-2021-027018 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Cough, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: once it kicked in it was hard to stay out of the bed; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; went to urgent care where had a COVID run and an influenza run both negative; constipated for all the Tylenol; cough.; a fever of 99-101 every day; exhaustion, sweating, body aches, and brain fogged; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged) and SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: other (Negative) other. On an unknown date, SARS-CoV-2 test: other (Negative) OTHER.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also includes: IV Fluids on Urgent Care Concomitant medications were not reported   This case was linked to MOD21-039023.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non-significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Malaise, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: once it kicked in it was hard to stay out of the bed; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; went to urgent care where had a COVID run and an influenza run both negative; constipated for all the Tylenol; cough.; a fever of 99-101 every day; exhaustion, sweating, body aches, and brain fogged; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged) and SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: other (Negative) other. On an unknown date, SARS-CoV-2 test: other (Negative) OTHER.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also includes: IV Fluids on Urgent Care Concomitant medications were not reported   This case was linked to MOD21-039023.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non-significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: once it kicked in it was hard to stay out of the bed; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; exhaustion, sweating, body aches, and brain fogged; went to urgent care where had a COVID run and an influenza run both negative; constipated for all the Tylenol; cough.; a fever of 99-101 every day; exhaustion, sweating, body aches, and brain fogged; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged) and SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (once it kicked in it was hard to stay out of the bed), HYPERHIDROSIS (exhaustion, sweating, body aches, and brain fogged), PAIN (exhaustion, sweating, body aches, and brain fogged), FEELING ABNORMAL (exhaustion, sweating, body aches, and brain fogged), SARS-COV-2 TEST NEGATIVE (went to urgent care where had a COVID run and an influenza run both negative), CONSTIPATION (constipated for all the Tylenol), COUGH (cough.), PYREXIA (a fever of 99-101 every day) and FATIGUE (exhaustion, sweating, body aches, and brain fogged) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: other (Negative) other. On an unknown date, SARS-CoV-2 test: other (Negative) OTHER.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information also includes: IV Fluids on Urgent Care Concomitant medications were not reported   This case was linked to MOD21-039023.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non-significant follow up appended
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: lack of appetite; Temperature was 101.9 F; chills; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). On 24-Feb-2021, DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101.9 (Inconclusive) 101.9.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lack of appetite; Temperature was 101.9 F; chills; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). On 24-Feb-2021, DECREASED APPETITE (lack of appetite), PYREXIA (Temperature was 101.9 F), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101.9 (Inconclusive) 101.9.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Chills, Decreased appetite
Clinical narrative: shortness of breath; chest pains; bad rash on upper body; light headed; diarrhea; tightening of chest; numbness in half of her head/numbness in thigh; loss of brain sharpness, brain fog; chills; Headache; lost of appetite; tired; couldn't sleep; nauseous; achy; weak; arm pain; A spontaneous report was received from a consumer concerning a 61 year old, female patient who developed chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea, achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort .   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number:032L20A on 25 Jan 2021.  On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:004M20A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021,patient received first dose of vaccine and on 22 Feb 2021 received  second dose of vaccine .patient experienced events chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness, dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort.  Treatment for the event included Allegra, farbivent inhaler, Tylenol and Qvar.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: shortness of breath; chest pains; bad rash on upper body; light headed; diarrhea; tightening of chest; numbness in half of her head/numbness in thigh; loss of brain sharpness, brain fog; chills; Headache; lost of appetite; tired; couldn't sleep; nauseous; achy; weak; arm pain; A spontaneous report was received from a consumer concerning a 61 year old, female patient who developed chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea, achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort .   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number:032L20A on 25 Jan 2021.  On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:004M20A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021,patient received first dose of vaccine and on 22 Feb 2021 received  second dose of vaccine .patient experienced events chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness, dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort.  Treatment for the event included Allegra, farbivent inhaler, Tylenol and Qvar.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Insomnia, Myalgia, Nausea
Clinical narrative: shortness of breath; chest pains; bad rash on upper body; light headed; diarrhea; tightening of chest; numbness in half of her head/numbness in thigh; loss of brain sharpness, brain fog; chills; Headache; lost of appetite; tired; couldn't sleep; nauseous; achy; weak; arm pain; A spontaneous report was received from a consumer concerning a 61 year old, female patient who developed chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea, achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort .   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number:032L20A on 25 Jan 2021.  On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:004M20A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021,patient received first dose of vaccine and on 22 Feb 2021 received  second dose of vaccine .patient experienced events chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness, dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort.  Treatment for the event included Allegra, farbivent inhaler, Tylenol and Qvar.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: shortness of breath; chest pains; bad rash on upper body; light headed; diarrhea; tightening of chest; numbness in half of her head/numbness in thigh; loss of brain sharpness, brain fog; chills; Headache; lost of appetite; tired; couldn't sleep; nauseous; achy; weak; arm pain; A spontaneous report was received from a consumer concerning a 61 year old, female patient who developed chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea, achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort .   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number:032L20A on 25 Jan 2021.  On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:004M20A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021,patient received first dose of vaccine and on 22 Feb 2021 received  second dose of vaccine .patient experienced events chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness, dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort.  Treatment for the event included Allegra, farbivent inhaler, Tylenol and Qvar.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bad ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Bad ringing in both ears) 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 TINNITUS (Bad ringing in both ears). At the time of the report, TINNITUS (Bad ringing in both ears) outcome was unknown. Not Provided          No concomitant medication was reported.No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Butterfly rash, Vaccination site rash
Clinical narrative: Rash at the injection site (Covid arm); Butterfly rash in face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site (Covid arm)) and BUTTERFLY RASH (Butterfly rash in face) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Blood pressure high.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site (Covid arm)) and BUTTERFLY RASH (Butterfly rash in face). At the time of the report, VACCINATION SITE RASH (Rash at the injection site (Covid arm)) and BUTTERFLY RASH (Butterfly rash in face) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure and high cholesterol medications.  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.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: "Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body; Rash-All Over Body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS ("Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body) and RASH (Rash-All Over Body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PRURITUS ("Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body) and RASH (Rash-All Over Body). At the time of the report, PRURITUS ("Serious Pruritus" - All Over Body/Itchy Sensation - All Over Body) and RASH (Rash-All Over Body) 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.   The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided