chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dehydration, Diarrhoea, Dizziness, Illness
Clinical narrative: Dehydration; Problems with her tummy; sick for two days; getting the flu; Dizzy; Diarrhea from hell; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DIARRHOEA (Diarrhea from hell), DEHYDRATION (Dehydration), ABDOMINAL DISCOMFORT (Problems with her tummy) and ILLNESS (sick for two days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea from hell). On an unknown date, the patient experienced DIZZINESS (Dizzy), DEHYDRATION (Dehydration), ABDOMINAL DISCOMFORT (Problems with her tummy), ILLNESS (sick for two days) and INFLUENZA (getting the flu). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), DIARRHOEA (Diarrhea from hell), DEHYDRATION (Dehydration), ABDOMINAL DISCOMFORT (Problems with her tummy), ILLNESS (sick for two days) and INFLUENZA (getting the flu) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment details included Patient reports taking two tablets of Imodium after the first episode, then two tablets of Imodium after the second episode, and then just drank water after that. She states that the Imodium did not help.   This case was linked to MOD-2021-071038 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Dehydration; Problems with her tummy; sick for two days; getting the flu; Dizzy; Diarrhea from hell; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DIARRHOEA (Diarrhea from hell), DEHYDRATION (Dehydration), ABDOMINAL DISCOMFORT (Problems with her tummy) and ILLNESS (sick for two days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea from hell). On an unknown date, the patient experienced DIZZINESS (Dizzy), DEHYDRATION (Dehydration), ABDOMINAL DISCOMFORT (Problems with her tummy), ILLNESS (sick for two days) and INFLUENZA (getting the flu). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), DIARRHOEA (Diarrhea from hell), DEHYDRATION (Dehydration), ABDOMINAL DISCOMFORT (Problems with her tummy), ILLNESS (sick for two days) and INFLUENZA (getting the flu) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment details included Patient reports taking two tablets of Imodium after the first episode, then two tablets of Imodium after the second episode, and then just drank water after that. She states that the Imodium did not help.   This case was linked to MOD-2021-071038 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Paraesthesia
Clinical narrative: My extremities tingling; My face gets red; A warm feeling; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (My extremities tingling), ERYTHEMA (My face gets red), FEELING HOT (A warm feeling) and FATIGUE (Fatigued) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Atrial fibrillation. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Migraine, CARVEDILOL, RIVAROXABAN (XARELTO), LOSARTAN and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (My extremities tingling), ERYTHEMA (My face gets red), FEELING HOT (A warm feeling) and FATIGUE (Fatigued). At the time of the report, PARAESTHESIA (My extremities tingling), ERYTHEMA (My face gets red), FEELING HOT (A warm feeling) and FATIGUE (Fatigued) had not resolved.            No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: Couldn't move her hands or legs stopped after 10 minutes; This spontaneous case was reported by an other caregiver and describes the occurrence of HYPOKINESIA (Couldn't move her hands or legs stopped after 10 minutes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Lung nodule and WBC increased (Past medical history reported white blood cells are elevated). Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic. Concomitant products included ARIPIPRAZOLE (ABILIFY) and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPOKINESIA (Couldn't move her hands or legs stopped after 10 minutes). On 17-Mar-2021, HYPOKINESIA (Couldn't move her hands or legs stopped after 10 minutes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was okay with Amoxicillin . Treatment information was not provided. Symptoms resolved after 10 minutes
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: Pain in right arm pit (same arm of injection); Little lump in right arm pit (same arm of injection); This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Pain in right arm pit (same arm of injection)) and AXILLARY MASS (Little lump in right arm pit (same arm of injection)) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced AXILLARY PAIN (Pain in right arm pit (same arm of injection)) and AXILLARY MASS (Little lump in right arm pit (same arm of injection)). At the time of the report, AXILLARY PAIN (Pain in right arm pit (same arm of injection)) and AXILLARY MASS (Little lump in right arm pit (same arm of injection)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of ocular hyperemia (red eye) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On Apr 8, 2021, patient experienced ocular hyperemia (red eye). At the time of the report, ocular hyperemia (red  eye): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant product use or treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm really hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm really hurts) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm really hurts). At the time of the report, PAIN IN EXTREMITY (Arm really hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Urticaria
Clinical narrative: Dizzy; Hives; Numbness in face and jaw; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), URTICARIA (Hives) and HYPOAESTHESIA (Numbness in face and jaw) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizzy), URTICARIA (Hives) and HYPOAESTHESIA (Numbness in face and jaw). At the time of the report, DIZZINESS (Dizzy), URTICARIA (Hives) and HYPOAESTHESIA (Numbness in face and jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.  She reported that HPC told to her she had a severe allergic reaction and should not get second dose. However, she was concerned that if she does not have proof of both doses, she will not be able to work or travel.  Treatment information not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Illness, SARS-CoV-2 antibody test
Clinical narrative: Lingering cough; Felt sick; Tested positive for COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (Lingering cough), ILLNESS (Felt sick) and COVID-19 (Tested positive for COVID-19) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (Lingering cough), ILLNESS (Felt sick) and COVID-19 (Tested positive for COVID-19). On 30-Mar-2021, ILLNESS (Felt sick) and COVID-19 (Tested positive for COVID-19) had resolved. At the time of the report, COUGH (Lingering cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 antibody test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information mentioned and Medical history was not provided
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chills, Fatigue, Lethargy, Pain
Clinical narrative: lethargic; body aches; his arthritis has really been bothering him; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PAIN (body aches), ARTHRITIS (his arthritis has really been bothering him), FATIGUE (fatigue) and CHILLS (chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 23-Mar-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. On 24-Mar-2021, the patient experienced LETHARGY (lethargic), PAIN (body aches), ARTHRITIS (his arthritis has really been bothering him), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, LETHARGY (lethargic), PAIN (body aches), ARTHRITIS (his arthritis has really been bothering him), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            Concomitant drugs not provided . No medical history and Treatment drugs not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Discomfort, Fatigue, Malaise, Nasal congestion
Clinical narrative: Violently ill; Congestion; Coughing; vomiting; Little discomfort on arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Little discomfort on arm), MALAISE (Violently ill), NASAL CONGESTION (Congestion), COUGH (Coughing) and FATIGUE (Felt tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DISCOMFORT (Little discomfort on arm) and FATIGUE (Felt tired). On an unknown date, the patient experienced MALAISE (Violently ill), NASAL CONGESTION (Congestion), COUGH (Coughing) and VOMITING (vomiting). At the time of the report, DISCOMFORT (Little discomfort on arm), MALAISE (Violently ill), NASAL CONGESTION (Congestion), COUGH (Coughing), FATIGUE (Felt tired) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications information were provided . No medical history
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Violently ill; Congestion; Coughing; vomiting; Little discomfort on arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Little discomfort on arm), MALAISE (Violently ill), NASAL CONGESTION (Congestion), COUGH (Coughing) and FATIGUE (Felt tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DISCOMFORT (Little discomfort on arm) and FATIGUE (Felt tired). On an unknown date, the patient experienced MALAISE (Violently ill), NASAL CONGESTION (Congestion), COUGH (Coughing) and VOMITING (vomiting). At the time of the report, DISCOMFORT (Little discomfort on arm), MALAISE (Violently ill), NASAL CONGESTION (Congestion), COUGH (Coughing), FATIGUE (Felt tired) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications information were provided . No medical history
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Cough, Feeling hot
Clinical narrative: Weak; Cough; Tired of being hot; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), COUGH (Cough), FEELING HOT (Tired of being hot), PYREXIA (Fever) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (Chills). On 03-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced ASTHENIA (Weak), COUGH (Cough) and FEELING HOT (Tired of being hot). At the time of the report, ASTHENIA (Weak), COUGH (Cough), FEELING HOT (Tired of being hot) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Body temperature: 39 (Inconclusive) 39 °C. On 05-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided by the reporter. The next day on 31 Mar 2021, in the afternoon the patient had felt a little bit of chills so he took a Tylenol and fell asleep and the other day it was like nothing happened. On 01 Apr 2021 (Thursday) and on 02 Apr 2021 (Friday) he was perfect again like if nothing. Then on 03 Apr 2021 (Saturday) the symptoms came back just like on the Wednesday afternoon. The patient started with 39°C fever. The patient said he couldn't go to the doctor so he got a PCR for COVID on 05 Apr 2021, which came back negative. At the time of the report, the patient stated that the fever is still persisting which he had taken Tylenol (paracetamol), and Advil (ibuprofen) for and it goes away. The chills and fever comes back. Also he dah a cough. He was weak and tired of being hot. The patient had returned to Mexico and had planned on seeking medical assistance there. Treatment for event included paracetomol and ibuprofen. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Weak; Cough; Tired of being hot; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), COUGH (Cough), FEELING HOT (Tired of being hot), PYREXIA (Fever) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (Chills). On 03-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced ASTHENIA (Weak), COUGH (Cough) and FEELING HOT (Tired of being hot). At the time of the report, ASTHENIA (Weak), COUGH (Cough), FEELING HOT (Tired of being hot) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Body temperature: 39 (Inconclusive) 39 °C. On 05-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided by the reporter. The next day on 31 Mar 2021, in the afternoon the patient had felt a little bit of chills so he took a Tylenol and fell asleep and the other day it was like nothing happened. On 01 Apr 2021 (Thursday) and on 02 Apr 2021 (Friday) he was perfect again like if nothing. Then on 03 Apr 2021 (Saturday) the symptoms came back just like on the Wednesday afternoon. The patient started with 39°C fever. The patient said he couldn't go to the doctor so he got a PCR for COVID on 05 Apr 2021, which came back negative. At the time of the report, the patient stated that the fever is still persisting which he had taken Tylenol (paracetamol), and Advil (ibuprofen) for and it goes away. The chills and fever comes back. Also he dah a cough. He was weak and tired of being hot. The patient had returned to Mexico and had planned on seeking medical assistance there. Treatment for event included paracetomol and ibuprofen. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, COVID-19, Chills, Feeling abnormal, Headache
Clinical narrative: thought had covid again; Reaction to the shot; Felt bad; Body aches; High fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction to the shot), FEELING ABNORMAL (Felt bad), PAIN (Body aches), COVID-19 (thought had covid again) and PYREXIA (High fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction to the shot), FEELING ABNORMAL (Felt bad), PAIN (Body aches), COVID-19 (thought had covid again), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Reaction to the shot) and COVID-19 (thought had covid again) outcome was unknown and FEELING ABNORMAL (Felt bad), PAIN (Body aches), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. But Patient is under medicines.  The patient thought he had COVID-19 again.  Treatment information provide included paracetamol.   This case was linked to US-MODERNATX, INC.-MOD-2021-071401 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071401:Crossed linked
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: thought had covid again; Reaction to the shot; Felt bad; Body aches; High fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction to the shot), FEELING ABNORMAL (Felt bad), PAIN (Body aches), COVID-19 (thought had covid again) and PYREXIA (High fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction to the shot), FEELING ABNORMAL (Felt bad), PAIN (Body aches), COVID-19 (thought had covid again), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Reaction to the shot) and COVID-19 (thought had covid again) outcome was unknown and FEELING ABNORMAL (Felt bad), PAIN (Body aches), PYREXIA (High fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. But Patient is under medicines.  The patient thought he had COVID-19 again.  Treatment information provide included paracetamol.   This case was linked to US-MODERNATX, INC.-MOD-2021-071401 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071401:Crossed linked
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness is hot on bicep after second dose/Redness at the injection site after second dose; Redness at the injection site after second dose; Soreness at the injection site after second dose; Body Pain after second dose; Joint Pain after second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness is hot on bicep after second dose/Redness at the injection site after second dose), MYALGIA (Body Pain after second dose), ARTHRALGIA (Joint Pain after second dose), VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) and VACCINATION SITE PAIN (Soreness at the injection site after second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 03-Apr-2021, the patient experienced MYALGIA (Body Pain after second dose) and ARTHRALGIA (Joint Pain after second dose). On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) and VACCINATION SITE PAIN (Soreness at the injection site after second dose). On 06-Apr-2021, the patient experienced ERYTHEMA (Redness is hot on bicep after second dose/Redness at the injection site after second dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 05-Apr-2021, MYALGIA (Body Pain after second dose) and ARTHRALGIA (Joint Pain after second dose) had resolved. In April 2021, VACCINATION SITE ERYTHEMA (Redness at the injection site after second dose) and VACCINATION SITE PAIN (Soreness at the injection site after second dose) had resolved. At the time of the report, ERYTHEMA (Redness is hot on bicep after second dose/Redness at the injection site after second dose) had not resolved.            The  concomitant medications on use were not provided. No laboratory data was provided. Treatment included cold compress and paracetamol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Product dose omission issue, Pyrexia
Clinical narrative: he had fever when he was scheduled for 2nd dose; He couldn't get 2nd dose because his throat was messed up; Patient hasn't received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (he had fever when he was scheduled for 2nd dose), OROPHARYNGEAL PAIN (He couldn't get 2nd dose because his throat was messed up) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose). On an unknown date, the patient experienced PYREXIA (he had fever when he was scheduled for 2nd dose) and OROPHARYNGEAL PAIN (He couldn't get 2nd dose because his throat was messed up). At the time of the report, PYREXIA (he had fever when he was scheduled for 2nd dose), OROPHARYNGEAL PAIN (He couldn't get 2nd dose because his throat was messed up) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not provided , treatment drugs not provided and no medical history   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Light headed; Feels itchy around shot site; Left arm red around injection shot; Left arm is hot and warm; Soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm), FEELING HOT (Left arm is hot and warm), DIZZINESS (Light headed), VACCINATION SITE PRURITUS (Feels itchy around shot site) and VACCINATION SITE ERYTHEMA (Left arm red around injection shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Depression. Concomitant products included ESTRADIOL for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm). On 06-Apr-2021, the patient experienced FEELING HOT (Left arm is hot and warm), VACCINATION SITE PRURITUS (Feels itchy around shot site) and VACCINATION SITE ERYTHEMA (Left arm red around injection shot). On 07-Apr-2021, the patient experienced DIZZINESS (Light headed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of left arm), FEELING HOT (Left arm is hot and warm), DIZZINESS (Light headed), VACCINATION SITE PRURITUS (Feels itchy around shot site) and VACCINATION SITE ERYTHEMA (Left arm red around injection shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes Tylenol
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Mtallic taste in mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSGEUSIA (Mtallic taste in mouth) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DYSGEUSIA (Mtallic taste in mouth). At the time of the report, DYSGEUSIA (Mtallic taste in mouth) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not provided. The treatment information was not provided.  The action taken with mRNA1273 for the events were considered as not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Peripheral swelling, Urticaria
Clinical narrative: swelling on her arm; Welts on her arms; Pain in areas she has injured in the past; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her arm), URTICARIA (Welts on her arms), PAIN (Pain in areas she has injured in the past), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included AMLODIPINE BESILATE (NORVASC) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling on her arm), URTICARIA (Welts on her arms), PAIN (Pain in areas she has injured in the past), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, PERIPHERAL SWELLING (swelling on her arm), URTICARIA (Welts on her arms), PAIN (Pain in areas she has injured in the past), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            the action taken with response to the drug is not applicable
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Neck pain, Pollakiuria
Clinical narrative: has to pee every 5-10 minutes; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (has to pee every 5-10 minutes) and NECK PAIN (neck ache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced POLLAKIURIA (has to pee every 5-10 minutes) and NECK PAIN (neck ache). At the time of the report, POLLAKIURIA (has to pee every 5-10 minutes) and NECK PAIN (neck ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take medication to treat symptoms.  Patient reports taking cholesterol medication, drug name was provided.   Second dose is scheduled on 09Apr2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: full body itchy rash 11 days after receiving second dose and it is now developing in his private area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (full body itchy rash 11 days after receiving second dose and it is now developing in his private area) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included ADALIMUMAB (HUMIRA), ATORVASTATIN CALCIUM, ALLOPURINOL, ACETYLSALICYLIC ACID (ASPIRIN 81), TAMSULOSIN HCL, TRAMADOL HCL, SAW PALMETTO [SERENOA REPENS], VITAMIN D3, VITAMIN C [ASCORBIC ACID] and ZINC SULFATE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced RASH PRURITIC (full body itchy rash 11 days after receiving second dose and it is now developing in his private area). At the time of the report, RASH PRURITIC (full body itchy rash 11 days after receiving second dose and it is now developing in his private area) outcome was unknown.            The patient's pharmacist told him to use Calamine lotion on his rash which was not effective. On 05-Apr-2021, the patient's physician prescribed him with treatment medications including Diphenhydramine cream, Cortisone 10 cream, and Prednisone oral tablet. The treatment medications were effective at the reporting time.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm was sore at the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (my arm was sore at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No treatment information provided.).    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 VACCINATION SITE PAIN (my arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (my arm was sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2021-071082 (Linked Report).; Sender's Comments:  MOD-2021-071082:Second dose of vaccine case
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: "gastro-type effects"; Diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT ("gastro-type effects"), DIARRHOEA (Diarrhea) and NAUSEA (nausea) 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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT ("gastro-type effects"), DIARRHOEA (Diarrhea) and NAUSEA (nausea). At the time of the report, ABDOMINAL DISCOMFORT ("gastro-type effects"), DIARRHOEA (Diarrhea) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Dizzy like she's going to pass out; Achy; Tired; Feverish; Nausea; Pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm), DIZZINESS (Dizzy like she's going to pass out), PAIN (Achy), FATIGUE (Tired) and PYREXIA (Feverish) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No prior medical history was reported). Concomitant products included VITAMINS NOS for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm). On 08-Apr-2021, the patient experienced DIZZINESS (Dizzy like she's going to pass out), PAIN (Achy), FATIGUE (Tired), PYREXIA (Feverish) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the left arm), DIZZINESS (Dizzy like she's going to pass out), PAIN (Achy), FATIGUE (Tired), PYREXIA (Feverish) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported included vitamins.  Treatment details included the use of acetaminophen.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizzy like she's going to pass out; Achy; Tired; Feverish; Nausea; Pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm), DIZZINESS (Dizzy like she's going to pass out), PAIN (Achy), FATIGUE (Tired) and PYREXIA (Feverish) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No prior medical history was reported). Concomitant products included VITAMINS NOS for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm). On 08-Apr-2021, the patient experienced DIZZINESS (Dizzy like she's going to pass out), PAIN (Achy), FATIGUE (Tired), PYREXIA (Feverish) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the left arm), DIZZINESS (Dizzy like she's going to pass out), PAIN (Achy), FATIGUE (Tired), PYREXIA (Feverish) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported included vitamins.  Treatment details included the use of acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient that has missed her 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient that has missed her 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 07-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 PRODUCT DOSE OMISSION ISSUE (Patient that has missed her 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient that has missed her 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Fatigue
Clinical narrative: Extreme fatigue; Loss smell/Reduction of smell by 50%; Fatigue after his second shot; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss smell/Reduction of smell by 50%), FATIGUE (Extreme fatigue) and FATIGUE (Fatigue after his second shot) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 011M204) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included FLUOXETINE, TESTOSTERONE, ROSUVASTATIN, FLUTICASONE and METFORMIN for an unknown indication.   On 11-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (Fatigue after his second shot). On 13-Mar-2021, the patient experienced ANOSMIA (Loss smell/Reduction of smell by 50%). On 13-Apr-2021 at 9:00 AM, the patient experienced FATIGUE (Extreme fatigue). The patient was treated with METHYLPREDNISOLONE for Fatigue and Loss of smell, at a dose of 4 milligram (Dospak 21s). On 30-Apr-2021, FATIGUE (Extreme fatigue) had resolved with sequelae. At the time of the report, ANOSMIA (Loss smell/Reduction of smell by 50%) had not resolved and FATIGUE (Fatigue after his second shot) outcome was unknown.            Patient had fatigue after his second shot which was gradually increasing.  On 07-Apr-2021, the event was reported as worst (severe fatigue).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Reporter contact details updated, patient demographic details updated, allergy, suspect product's administration time, concomitant drug information, treatment medication, batch/lot no, additional event  extreme fatigue and loss of smell was added.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little arm pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (a little arm pain). At the time of the report, PAIN IN EXTREMITY (a little arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were blood pressure and cholesterol. No treatment medications were reported.