chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Sinusitis
Clinical narrative: sinus problems; headache; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), SINUSITIS (sinus problems) and HEADACHE (headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 10-May-2021, the patient experienced SINUSITIS (sinus problems) and HEADACHE (headache). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at a dose of 1 dosage form. On 23-Apr-2021, PAIN IN EXTREMITY (sore right arm) had resolved. On 13-May-2021, SINUSITIS (sinus problems) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter.   This case was linked to MOD21-105978, MOD-2021-200945 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: stomach has been in knots.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach has been in knots.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach has been in knots.). At the time of the report, ABDOMINAL DISCOMFORT (stomach has been in knots.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: Staff Patient stomach has been in knots since he got his 1st shot.  Treatment medicines were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Rhinorrhoea
Clinical narrative: runny nose; was not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and MALAISE (was not feeling well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced MALAISE (was not feeling well). On an unknown date, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) and MALAISE (was not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No Treatment medications were provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Rhinorrhoea
Clinical narrative: Every afternoon I get a runny nose; Every afternoon I feel weak; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Every afternoon I get a runny nose) and ASTHENIA (Every afternoon I feel weak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Every afternoon I get a runny nose) and ASTHENIA (Every afternoon I feel weak). At the time of the report, RHINORRHOEA (Every afternoon I get a runny nose) and ASTHENIA (Every afternoon I feel weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration, Skin warm
Clinical narrative: a brown circle that looked like a blood clot inside; warm to touch and spreading all over her body; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), SKIN DISCOLOURATION (a brown circle that looked like a blood clot inside) and SKIN WARM (warm to touch and spreading all over her body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 002B21A) for COVID-19 vaccination.     No medical information provided.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soreness in arm). On 10-Apr-2021, the patient experienced SKIN DISCOLOURATION (a brown circle that looked like a blood clot inside) and SKIN WARM (warm to touch and spreading all over her body). On 08-Apr-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. At the time of the report, SKIN DISCOLOURATION (a brown circle that looked like a blood clot inside) and SKIN WARM (warm to touch and spreading all over her body) outcome was unknown. Not Provided          No concomitant medication provided. No treatment medication provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-202126, MOD-2021-202126 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got the first dose of the Moderna vaccine on 01Apr2021 and has not got the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 01Apr2021 and has not got the second dose yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-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 PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 01Apr2021 and has not got the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 01Apr2021 and has not got the second dose yet) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  treatment medications was not given.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Screaming
Clinical narrative: she just woke up screaming; She couldn't move either; she had pain all over; This spontaneous case was reported by a consumer and describes the occurrence of SCREAMING (she just woke up screaming), HYPOKINESIA (She couldn't move either) and MYALGIA (she had pain all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced SCREAMING (she just woke up screaming), HYPOKINESIA (She couldn't move either) and MYALGIA (she had pain all over). At the time of the report, SCREAMING (she just woke up screaming), HYPOKINESIA (She couldn't move either) and MYALGIA (she had pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN (Body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced HEADACHE (Headache) and PAIN (Body aches). At the time of the report, HEADACHE (Headache) and PAIN (Body aches) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 02-Jun-2021, the patient experienced NECK PAIN (Neck soreness). At the time of the report, NECK PAIN (Neck soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient did not received any treatment. Patient allergies and medical history was not provided. After one day of receiving vaccine patient felt sore in the base neck and left side of the neck.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: What are the side effects from this vaccine ? / YES; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are the side effects from this vaccine ? / YES) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are the side effects from this vaccine ? / YES). At the time of the report, VACCINATION COMPLICATION (What are the side effects from this vaccine ? / YES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT AND TREATMENT DRUGS WERE USED
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Diarrhea; Cramping; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy to antibiotic (Allergy to Keflex.) and Allergy to antibiotic (Allergy to Micins.). Concomitant products included THYROID (ARMOUR THYROID) for Thyroiditis NOS, NAPROXEN SODIUM (ALEVE), PROBIOTICS NOS, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramping). The patient was treated with SIMETICONE (GAS X) at an unspecified dose and frequency. On 10-Jun-2021, DIARRHOEA (Diarrhea) and MUSCLE SPASMS (Cramping) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received on 30-JUN-2021 contains significant information. Updated patient demographics, updated medical history, updated first dose information, updated stop date of the events and changed event outcome from unknown to recovered/resolved
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: She then had to return to a different location missing out on her second dose of the Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She then had to return to different location missing out on her second dose of the Moderna vaccination) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A214) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRODUCT DOSE OMISSION ISSUE (She then had to return to a different location  missing out on her second dose of the Moderna vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She then had to return to a different location missing out on her second dose of the Moderna vaccination) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No new information.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: felt like million dollar; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (felt like million dollar) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (felt like million dollar). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (felt like million dollar) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-207524.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Myalgia, Pyrexia
Clinical narrative: Cough; Fever; Chills; Headache; Bodyache; This spontaneous case was reported by a pharmacist and describes the occurrence of COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) 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 29-Jan-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 COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache). At the time of the report, COUGH (Cough), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Bodyache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.     This case was linked to MOD-2021-208905.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Malaise, Myalgia
Clinical narrative: hasn't been feeling well; A patient received second dose and experienced extreme tiredness; A patient received second dose and experienced Body aches; A patient received second dose and experienced soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (hasn't been feeling well), FATIGUE (A patient received second dose and experienced extreme tiredness), MYALGIA (A patient received second dose and experienced Body aches) and INJECTION SITE PAIN (A patient received second dose and experienced soreness of arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Depression, Anxiety and BPH. Concomitant products included BUSPIRONE for Anxiety, TAMSULOSIN for BPH, BENAZEPRIL and AMLODIPINE for Blood pressure, ATORVASTATIN for Cholesterol, ESCITALOPRAM for Depression.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced MALAISE (hasn't been feeling well), FATIGUE (A patient received second dose and experienced extreme tiredness), MYALGIA (A patient received second dose and experienced Body aches) and INJECTION SITE PAIN (A patient received second dose and experienced soreness of arm). At the time of the report, MALAISE (hasn't been feeling well) had not resolved and FATIGUE (A patient received second dose and experienced extreme tiredness), MYALGIA (A patient received second dose and experienced Body aches) and INJECTION SITE PAIN (A patient received second dose and experienced soreness of arm) outcome was unknown.            No treatment information was provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   This case was linked to MOD-2021-209217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Significant FU. Concomitant medications and events added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: Chills; 101 degree temperature; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (101 degree temperature) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Lisinopril.).    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (101 degree temperature) and NAUSEA (nausea). At the time of the report, CHILLS (Chills), PYREXIA (101 degree temperature) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (101-degree fahrenheit): (Inconclusive) 101degrees Fahrenheit of temperature at around 2-3am today..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications included Epipen (for emergency), Inhaler (not specified) and Hypertensive meds (not specified). No treatment medications provided by the reporter.   This case was linked to MOD-2021-209227 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site erythema
Clinical narrative: a rash; red spot on my forearm; Arm hurt since then/Arm dull pain since then; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt since then/Arm dull pain since then), VACCINATION SITE ERYTHEMA (red spot on my forearm) and RASH (a rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt since then/Arm dull pain since then). On 30-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot on my forearm). On 01-Jun-2021, the patient experienced RASH (a rash). At the time of the report, PAIN IN EXTREMITY (Arm hurt since then/Arm dull pain since then), VACCINATION SITE ERYTHEMA (red spot on my forearm) and RASH (a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO treatment and concomitant medications were reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: The whole room got dimmer after receiving the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VISUAL IMPAIRMENT (The whole room got dimmer after receiving the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 130B21A and 001B21) for COVID-19 vaccination.     The patient's past medical history included Migraine (She has migraine 10 years back.). Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, LOSARTAN, DILTIAZEM, CETIRIZINE HYDROCHLORIDE (ZYRTEC), FLUTICASONE PROPIONATE (FLONASE), SALBUTAMOL SULFATE (ALBUTEROL), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MAGNESIUM, IRON (IRON Supplement) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Apr-2021, the patient experienced VISUAL IMPAIRMENT (The whole room got dimmer after receiving the vaccine). In April 2021, VISUAL IMPAIRMENT (The whole room got dimmer after receiving the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Additional information received on 04 June 2021 in which patient initials updated. On 30-Jun-2021: Significant Follow-up document received on 30 June 2021 with patient's current medical condition reported.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cellulitis
Clinical narrative: pt hospitalized on 8/26/2021 for cellulitis and tested positive on admit (asymptomatic)
Sex: U
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: mental health side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MENTAL DISORDER (mental health side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 MENTAL DISORDER (mental health side effects). At the time of the report, MENTAL DISORDER (mental health side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Depression, Headache, Hyperhidrosis
Clinical narrative: Fever 37.2, depression, nausea, weakness, high blood pressure, headache, absence of appetite, sweating, drowsiness since the next day after the first shot.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Pyrexia, Somnolence
Clinical narrative: Fever 37.2, depression, nausea, weakness, high blood pressure, headache, absence of appetite, sweating, drowsiness since the next day after the first shot.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Pharyngeal swelling, Pruritus, Swelling face
Clinical narrative: On 5 MAR 21, I was driving home from PT, and broke out in itchy welts on my face, particularly the right side, the right side of my throat, and right side of my face swelled up over the next hour.  Over the next month, I noticed I was short of breath and my heart rate was going up very quickly with intense cardio, which I do regularly.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On 5 MAR 21, I was driving home from PT, and broke out in itchy welts on my face, particularly the right side, the right side of my throat, and right side of my face swelled up over the next hour.  Over the next month, I noticed I was short of breath and my heart rate was going up very quickly with intense cardio, which I do regularly.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever Headaches
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Dyspnoea, Pulmonary embolism, Respiratory viral panel
Clinical narrative: Shortness of breath pulmonary embolism weakness
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Shortness of breath pulmonary embolism weakness
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning). At the time of the report, BURNING SENSATION (Burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: very bad joint pain; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (very bad joint pain) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced ARTHRALGIA (very bad joint pain) and CHILLS (chills). At the time of the report, ARTHRALGIA (very bad joint pain) and CHILLS (chills) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Migraine
Clinical narrative: stomach pains; Migraine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pains) and MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pains) and MIGRAINE (Migraine). At the time of the report, ABDOMINAL PAIN UPPER (stomach pains) and MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past due 42 daysfor the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past due 42 daysfor the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past due 42 daysfor the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past due 42 daysfor the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and medical history details are not provided by the Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: slight ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (slight ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (slight ache). At the time of the report, MYALGIA (slight ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Why does my chest hurt; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Why does my chest hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Why does my chest hurt). At the time of the report, CHEST PAIN (Why does my chest hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: extremely sore / achiness; red arm; fever; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (extremely sore / achiness), ERYTHEMA (red arm) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced MYALGIA (extremely sore / achiness), ERYTHEMA (red arm) and PYREXIA (fever). At the time of the report, MYALGIA (extremely sore / achiness), ERYTHEMA (red arm) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2021, SARS-CoV-2 antibody test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant drugs included  no treatment drugs included   This case was linked to MOD-2021-209538 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient came for 2nd dose of the Moderna covid-19 vaccine, 43 day after their first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Decreased appetite, Pyrexia, SARS-CoV-2 test
Clinical narrative: Loss of apetite; Vomit; fever; Weakness/ loss of energy; Sleepy; Bed ridden; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bed ridden), DECREASED APPETITE (Loss of apetite), ASTHENIA (Weakness/ loss of energy), SOMNOLENCE (Sleepy) and VOMITING (Vomit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 032l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included AFib and Blood pressure fluctuation (unspecified). Concomitant products included LOSARTAN, APIXABAN (ELIQUIS), PROPAFENONE HCL and DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE TIMOLOL) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced BEDRIDDEN (Bed ridden), ASTHENIA (Weakness/ loss of energy) and SOMNOLENCE (Sleepy). On an unknown date, the patient experienced DECREASED APPETITE (Loss of apetite), VOMITING (Vomit) and PYREXIA (fever). On 05-Mar-2021, BEDRIDDEN (Bed ridden), ASTHENIA (Weakness/ loss of energy) and SOMNOLENCE (Sleepy) had resolved. At the time of the report, DECREASED APPETITE (Loss of apetite), VOMITING (Vomit) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive.         Treatment medication use was not provided by the reporter.    The action taken with mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-024666 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Loss of apetite; Vomit; fever; Weakness/ loss of energy; Sleepy; Bed ridden; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Bed ridden), DECREASED APPETITE (Loss of apetite), ASTHENIA (Weakness/ loss of energy), SOMNOLENCE (Sleepy) and VOMITING (Vomit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 032l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included AFib and Blood pressure fluctuation (unspecified). Concomitant products included LOSARTAN, APIXABAN (ELIQUIS), PROPAFENONE HCL and DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE TIMOLOL) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced BEDRIDDEN (Bed ridden), ASTHENIA (Weakness/ loss of energy) and SOMNOLENCE (Sleepy). On an unknown date, the patient experienced DECREASED APPETITE (Loss of apetite), VOMITING (Vomit) and PYREXIA (fever). On 05-Mar-2021, BEDRIDDEN (Bed ridden), ASTHENIA (Weakness/ loss of energy) and SOMNOLENCE (Sleepy) had resolved. At the time of the report, DECREASED APPETITE (Loss of apetite), VOMITING (Vomit) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive.         Treatment medication use was not provided by the reporter.    The action taken with mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-024666 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: The neighbor had a lump in her armpit after the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MASS (The neighbor had a lump in her armpit after the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASS (The neighbor had a lump in her armpit after the 1st dose). At the time of the report, MASS (The neighbor had a lump in her armpit after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: past 35 day window for second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past 35 day window for second dose) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past 35 day window for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past 35 day window for second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Prolonged joint pain; Prolonged muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain). At the time of the report, ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-211604, MOD-2021-211592 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug, Hypertension since 01-Jan-2017, Diabetes mellitus since 01-Jan-2017 and Hyperlipidemia since 01-Jan-2017.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Patient demographics, medical history updated.; Sender's Comments:  :MOD-2021-111481
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nauseous; Puke a little; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and VOMITING (Puke a little) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced NAUSEA (Nauseous) and VOMITING (Puke a little). At the time of the report, NAUSEA (Nauseous) and VOMITING (Puke a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Breast enlargement
Clinical narrative: On vaccine side i have breast enlargement; This spontaneous case was reported by a consumer and describes the occurrence of BREAST ENLARGEMENT (On vaccine side i have breast enlargement) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST ENLARGEMENT (On vaccine side i have breast enlargement). At the time of the report, BREAST ENLARGEMENT (On vaccine side i have breast enlargement) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.No treatment information was provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure increased, Cough, Fatigue, Headache
Clinical narrative: chronic headaches; threw up; continues runny nose; blood sugar out of whack; Pain; small cough; terrible fatigue; blood pressure out of whack; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough) and FATIGUE (terrible fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, 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 experienced HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough), FATIGUE (terrible fatigue), BLOOD PRESSURE INCREASED (blood pressure out of whack), BLOOD GLUCOSE INCREASED (blood sugar out of whack) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (chronic headaches), VOMITING (threw up), RHINORRHOEA (continues runny nose), COUGH (small cough), FATIGUE (terrible fatigue), BLOOD PRESSURE INCREASED (blood pressure out of whack) and PAIN (Pain) outcome was unknown. Not Provided          No concomitant medications were reported.   Reporter did not allow further contact