chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.    This case was linked to MOD-2021-014543 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tiredness; Pain in arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and FATIGUE (tiredness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 013M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Drug allergy. Concomitant products included CLOBETASOL for Psoriasis.   In 2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced FATIGUE (tiredness). On 11-Jan-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 08-Feb-2021, FATIGUE (tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Pain in arm) and FATIGUE (tiredness) to be possibly related.    Treatment information was not provided.    This case was linked to MOD-2021-087452 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, the patient experienced PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications not reported.  No treatment information was provided.   This case was linked to MOD-2021-031118 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Influenza like illness
Clinical narrative: flu like symptoms; Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and ABDOMINAL DISCOMFORT (Upset stomach) 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 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 INFLUENZA LIKE ILLNESS (flu like symptoms) and ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and ABDOMINAL DISCOMFORT (Upset stomach) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain/soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain/soreness at injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No medical history was provided by the reporter.  Concurrent medical conditions included Crohn's disease (moderate to severe adult Crohn's disease).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain/soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Pain/soreness at injection site) outcome was unknown.            Treatment medication was not provided. It was unknown if patient was enrolled in COVID-19 Vaccination Trial.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25-May-2021  does not contain any new information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash
Clinical narrative: Diarrhoea; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhoea) and RASH (Rash) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    Concurrent medical conditions included Drug allergy (Sulfa allergies associated manifestation for the hives). Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (OCELLA) and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhoea) and RASH (Rash). At the time of the report, DIARRHOEA (Diarrhoea) was resolving and RASH (Rash) 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Urinary tract infection, Vaccination site pain
Clinical narrative: lethargy; urinary tract infection; vaccination site pain; tiredness; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (lethargy) and VACCINATION SITE PAIN (vaccination site pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced LETHARGY (lethargy) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, LETHARGY (lethargy) and VACCINATION SITE PAIN (vaccination site pain) was resolving.        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 drugs not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Hyperhidrosis, Lymphadenopathy, Neck pain
Clinical narrative: vaccination site erythema; vaccination site pruritus; sweating; neck pain; weght gain; appetite lost; fatigue; lymphadenopathy cervical; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Chronic lymphocytic leukemia in 2013, Blood pressure high, Diabetes, High cholesterol, Heartburn, Stroke and Alcohol use. Concurrent medical conditions included Drug allergy (Tetracycline,penicillin). Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] for Cardiovascular disorder NOS, METFORMIN for Diabetes, PANTOPRAZOLE SODIUM for Heartburn, ATORVASTATIN for High cholesterol, ALLOPURINOL for Kidney disorder, TETRACYCLINE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Weight increased
Clinical narrative: vaccination site erythema; vaccination site pruritus; sweating; neck pain; weght gain; appetite lost; fatigue; lymphadenopathy cervical; This spontaneous case was reported by a health care professional and describes the occurrence of   in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for CLL.    The patient's past medical history included Chronic lymphocytic leukemia in 2013, Blood pressure high, Diabetes, High cholesterol, Heartburn, Stroke and Alcohol use. Concurrent medical conditions included Drug allergy (Tetracycline,penicillin). Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] for Cardiovascular disorder NOS, METFORMIN for Diabetes, PANTOPRAZOLE SODIUM for Heartburn, ATORVASTATIN for High cholesterol, ALLOPURINOL for Kidney disorder, TETRACYCLINE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Somnolence
Clinical narrative: Sleepy; Tired; Fever; This spontaneous case was reported by a physician and describes the occurrence of SOMNOLENCE (Sleepy), PYREXIA (Fever) and FATIGUE (Tired) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Lymphoma.    Concurrent medical conditions included Allergy to antibiotic (Erythromycin) and Penicillin allergy (Penicillin). Concomitant products included CODEINE, PARACETAMOL, MUPIROCIN, METOPROLOL SUCCINATE, FOLIC ACID, LORATADINE (CLARITIN [LORATADINE]), CALCIUM, BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN LOW), NAPROXEN SODIUM (ALEVE) and VITAMIN D3 for an unknown indication.   On 04-Apr-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In April 2021, 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) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced SOMNOLENCE (Sleepy) and FATIGUE (Tired). In April 2021, PYREXIA (Fever) had resolved. At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-05-2021  contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Macule, Pain in extremity, Purpura
Clinical narrative: Purpura and macules on legs; purpura and macules on legs; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PURPURA (Purpura and macules on legs), MACULE (purpura and macules on legs) and PAIN IN EXTREMITY (Pain in arm) 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 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced PURPURA (Purpura and macules on legs) and MACULE (purpura and macules on legs). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PURPURA (Purpura and macules on legs) and MACULE (purpura and macules on legs) had not resolved and PAIN IN EXTREMITY (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided. It is unknown whether the patient received the second planned dose scheduled for 02MAY2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Pain in extremity, Pyrexia
Clinical narrative: Abscess; Aches and pain in legs; Low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukaemia (5 YEARS REMISSION) on 15-Sep-2015, Perfume sensitivity and Allergy to plants (Hayweed). Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), VALSARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 10-Feb-2021 at 11:00 AM, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever). At the time of the report, ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever) outcome was unknown.            Treatment for the event included antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-033331 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Nodule, Swelling
Clinical narrative: Inflammatory reaction/ inflammation; Nodules/ granulomatous nodules; Swelling and lumpiness; This spontaneous case was reported by a health care professional and describes the occurrence of INFLAMMATION (Inflammatory reaction/ inflammation), NODULE (Nodules/ granulomatous nodules ) and SWELLING (Swelling and lumpiness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient was injected with Restylane Defyne around the jawline in September 2020.  The patient's past medical history included Anxiety, Depression and Dermal filler injection. Concurrent medical conditions included Sulfonamide allergy and Restless legs. Concomitant products included Restylane Defyne for an unknown indication.    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 INFLAMMATION (Inflammatory reaction/ inflammation), NODULE (Nodules/ granulomatous nodules ) and SWELLING (Swelling and lumpiness). At the time of the report, INFLAMMATION (Inflammatory reaction/ inflammation) outcome was unknown and NODULE (Nodules/ granulomatous nodules ) and SWELLING (Swelling and lumpiness) was resolving.        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.   Patient was injected with Restylane Defyne around the jawline in September 2020.  Follow up: Treatment provided was several rounds of injectable treatments to help reduce the inflammation in the area.  The patient had had a COVID-19 vaccine 7 to 8 weeks prior to seeing reporter on April 20 of 2021. A couple of weeks after  patients vaccine  developed swelling and lumpiness consistent with granulomatous nodules in the area where  had facial fillers placed which was below the oral commisure.The patient  has had a dramatic improvement, the reporter expect that this will resolve with further treatment. There should be no long lasting deformity or problems from this.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updated reporter information. Updated patient information i.e age, race, sex  and medical history.Added events swelling and lumpiness,  granulomatous nodules both outcome recovering.Updated all events outcome to recovering.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (102.9); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever (102.9)) 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 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever (102.9)). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever (102.9)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Pyrexia: 100.3 f (High) high.         Concomitant medication not provided. . Action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 24, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-088773 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Feel joint pain all over; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Feel joint pain all over) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (Feel joint pain all over). At the time of the report, ARTHRALGIA (Feel joint pain all over) outcome was unknown.            Treatment medication not provided. Concomitant medication not provided.    This case was linked to MOD-2021-088766 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Dyspnoea, Malaise, Off label use
Clinical narrative: After receiving second COVID shot, world was spinning; Not feeling well emotionally; Not feeling well physically; Prescribed Tyvaso 10-20 breaths inhaled, four times a day; Feeling anxious; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling anxious), DYSPNOEA (Out of breath), VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally) and MALAISE (Not feeling well physically) 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.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM from 03-Mar-2017 to an unknown date for Primary pulmonary hypertension, AMBRISENTAN for an unknown indication, SILDENAFIL CITRATE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ANXIETY (Feeling anxious) and DYSPNOEA (Out of breath). On an unknown date, the patient experienced VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally), MALAISE (Not feeling well physically) and OFF LABEL USE (Prescribed Tyvaso 10-20 breaths inhaled, four times a day). At the time of the report, ANXIETY (Feeling anxious), DYSPNOEA (Out of breath), VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally), MALAISE (Not feeling well physically) and OFF LABEL USE (Prescribed Tyvaso 10-20 breaths inhaled, four times a day) outcome was unknown.            treatment to the events not provided. Treprostinil sodium in regimen 2 the dose strength was 18-54 microgram qid  , in regimen 3 the dose strength was increased to 60-120 microgram qid.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: follow up information received new events , concomitant medications were added.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: After receiving second COVID shot, world was spinning; Not feeling well emotionally; Not feeling well physically; Prescribed Tyvaso 10-20 breaths inhaled, four times a day; Feeling anxious; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling anxious), DYSPNOEA (Out of breath), VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally) and MALAISE (Not feeling well physically) 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.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM from 03-Mar-2017 to an unknown date for Primary pulmonary hypertension, AMBRISENTAN for an unknown indication, SILDENAFIL CITRATE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ANXIETY (Feeling anxious) and DYSPNOEA (Out of breath). On an unknown date, the patient experienced VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally), MALAISE (Not feeling well physically) and OFF LABEL USE (Prescribed Tyvaso 10-20 breaths inhaled, four times a day). At the time of the report, ANXIETY (Feeling anxious), DYSPNOEA (Out of breath), VERTIGO (After receiving second COVID shot, world was spinning), DEPRESSION (Not feeling well emotionally), MALAISE (Not feeling well physically) and OFF LABEL USE (Prescribed Tyvaso 10-20 breaths inhaled, four times a day) outcome was unknown.            treatment to the events not provided. Treprostinil sodium in regimen 2 the dose strength was 18-54 microgram qid  , in regimen 3 the dose strength was increased to 60-120 microgram qid.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: follow up information received new events , concomitant medications were added.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Violently sick after Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Violently sick after Moderna vaccine) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Violently sick after Moderna vaccine). At the time of the report, ILLNESS (Violently sick after Moderna vaccine) outcome was unknown.            No concomitant medication provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Really sore Arm; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Really sore Arm) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On an unknown date, the patient experienced MYALGIA (Really sore Arm). At the time of the report, MYALGIA (Really sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's wife reported that he had a scheduled oncology appointment. No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache dull; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache dull ) 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 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 HEADACHE (Headache dull ). At the time of the report, HEADACHE (Headache dull ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the treatment history was not reported.  the concomitant medications and medical history was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (Fatigue) in a 66-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to event was not applicable.   This case was linked to MOD-2021-088825 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Swelling arm; Vaccination site pruritus; Vaccination site rash; Vaccination site erythema; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Bull's eye maculopathy.   On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm). In March 2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On 06-Mar-2021, PERIPHERAL SWELLING (Swelling arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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 drugs not reported. Treatment information was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling arm; Vaccination site pruritus; Vaccination site rash; Vaccination site erythema; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Bull's eye maculopathy.   On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm). In March 2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). On 06-Mar-2021, PERIPHERAL SWELLING (Swelling arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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 drugs not reported. Treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site swelling
Clinical narrative: Arm Swelling; Mild Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm Swelling) and FATIGUE (Mild Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal, Fruit allergy, Pollen allergy, Hypertension (1995) and Cholesterol high (1995). Concomitant products included SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension.    On 09-Feb-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Arm Swelling) and FATIGUE (Mild Fatigue). At the time of the report, VACCINATION SITE SWELLING (Arm Swelling) and FATIGUE (Mild Fatigue) had resolved.            The patient recovered from the events of arm swelling and mild fatigue within 72 hours of vaccination.    This case was linked to MOD-2021-010929 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  No concomitant medications reported.  No treatment information provided.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort
Clinical narrative: Burning and discomfort; Burning and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and discomfort) and DISCOMFORT (Burning and discomfort) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LOSARTAN from 09-Oct-2016 to an unknown date and OMEPRAZOLE from 07-Aug-2016 to an unknown date.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BURNING SENSATION (Burning and discomfort) and DISCOMFORT (Burning and discomfort). On 12-Feb-2021, BURNING SENSATION (Burning and discomfort) and DISCOMFORT (Burning and discomfort) had resolved.        The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   No treatment of events was reported.   This case was linked to MOD-2021-008973 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness
Clinical narrative: Diarrhea; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) 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 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 DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The events started about several days after vaccination.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (soreness). At the time of the report, INJECTION SITE PAIN (soreness) outcome was unknown.            No treatment information was reported. No relevant concomitant medications were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received Half the Vaccine Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received Half the Vaccine Dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced UNDERDOSE (Received Half the Vaccine Dose). At the time of the report, UNDERDOSE (Received Half the Vaccine Dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: Numbness; Poufy Cheeks; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness) and SWELLING FACE (Poufy Cheeks) 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 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 HYPOAESTHESIA (Numbness) and SWELLING FACE (Poufy Cheeks). At the time of the report, HYPOAESTHESIA (Numbness) and SWELLING FACE (Poufy Cheeks) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Myalgia
Clinical narrative: dizziness/light headedness; feeling unwell; Body aches; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (dizziness/light headedness), MALAISE (feeling unwell) and MYALGIA (Body aches) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Non-tobacco user since an unknown date and Abstains from alcohol since an unknown date.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MYALGIA (Body aches). On 26-Mar-2021, the patient experienced DIZZINESS (dizziness/light headedness) and MALAISE (feeling unwell). At the time of the report, DIZZINESS (dizziness/light headedness) and MALAISE (feeling unwell) was resolving and MYALGIA (Body aches) had resolved.            No known allergies were reported. No concomitant medication was reported No treatment details were provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Rash
Clinical narrative: Rash; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Arthritis.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (Rash) and CHILLS (chills). At the time of the report, RASH (Rash) and CHILLS (chills) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medication reported includes Tylenol.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Dose leaked out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Dose leaked out) 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 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Dose leaked out). On 23-Apr-2021, ACCIDENTAL UNDERDOSE (Dose leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Infectious mononucleosis, Pyrexia
Clinical narrative: sickness; FATIGUE; FEVER; blood work shows mononucleosis; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, FATIGUE, PYREXIA, and INFECTIOUS MONONUCLEOSIS in a 79-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced ILLNESS, FATIGUE, PYREXIA, and INFECTIOUS MONONUCLEOSIS. At the time of the report, ILLNESS, FATIGUE, PYREXIA, and INFECTIOUS MONONUCLEOSIS outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Reporter requests to send VAERS form.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This spontaneous case was reported by an other and describes the occurrence of MIGRAINE (very severe migraine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #046B21A) for COVID-19 vaccination.     Concomitant products included ORAL CONTRACEPTIVE NOS.   On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Apr-2021, the patient experienced MIGRAINE (very severe migraine). At the time of the report, MIGRAINE (very severe migraine) outcome was unknown.            Patient took Tylenol to treat symptoms.