chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: Very ill; Only able to sleep for 3 hours; Diarrhea through the night; Nausea; Chills; Headache at the back of her head (the headache was all night); Fever of 103.4; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very ill), INSOMNIA (Only able to sleep for 3 hours), DIARRHOEA (Diarrhea through the night), NAUSEA (Nausea) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ILLNESS (Very ill). 17-Feb-2021, the patient experienced INSOMNIA (Only able to sleep for 3 hours), DIARRHOEA (Diarrhea through the night), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Headache at the back of her head (the headache was all night)) and PYREXIA (Fever of 103.4). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, ILLNESS (Very ill), INSOMNIA (Only able to sleep for 3 hours), DIARRHOEA (Diarrhea through the night), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Headache at the back of her head (the headache was all night)) and PYREXIA (Fever of 103.4) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 103.4 (High) fever of 103.4..         No concomitants medication were reported.  Patient started to felt good on the third day.   This case was linked to MOD-2021-371308 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Illness, Mobility decreased, Muscle discomfort
Clinical narrative: vegetable in all muscles; was in bed/ no strength in body; could not lift; nauseous; sick to stomach; sick all day; arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got sore), ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day), MUSCLE DISCOMFORT (vegetable in all muscles) and ASTHENIA (was in bed/ no strength in body) in a 71-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.     No medical history was provided by the reporter.  The patient's past medical history included Prostate cancer stage IV (prostate cancer 11 years Ago) and Coronary artery bypass graft (heart bypass surgery 11 years ago). Concomitant products included METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) and ATORVASTATIN CALCIUM (AVASTATIN) for an unknown indication.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm got sore). On 29-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day) and NAUSEA (nauseous). On 31-Oct-2021, the patient experienced MUSCLE DISCOMFORT (vegetable in all muscles), ASTHENIA (was in bed/ no strength in body) and MOBILITY DECREASED (could not lift). At the time of the report, PAIN IN EXTREMITY (arm got sore), ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day), MUSCLE DISCOMFORT (vegetable in all muscles), ASTHENIA (was in bed/ no strength in body), MOBILITY DECREASED (could not lift) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not specified   This case was linked to MOD-2021-370242 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: vegetable in all muscles; was in bed/ no strength in body; could not lift; nauseous; sick to stomach; sick all day; arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got sore), ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day), MUSCLE DISCOMFORT (vegetable in all muscles) and ASTHENIA (was in bed/ no strength in body) in a 71-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.     No medical history was provided by the reporter.  The patient's past medical history included Prostate cancer stage IV (prostate cancer 11 years Ago) and Coronary artery bypass graft (heart bypass surgery 11 years ago). Concomitant products included METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) and ATORVASTATIN CALCIUM (AVASTATIN) for an unknown indication.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm got sore). On 29-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day) and NAUSEA (nauseous). On 31-Oct-2021, the patient experienced MUSCLE DISCOMFORT (vegetable in all muscles), ASTHENIA (was in bed/ no strength in body) and MOBILITY DECREASED (could not lift). At the time of the report, PAIN IN EXTREMITY (arm got sore), ABDOMINAL DISCOMFORT (sick to stomach), ILLNESS (sick all day), MUSCLE DISCOMFORT (vegetable in all muscles), ASTHENIA (was in bed/ no strength in body), MOBILITY DECREASED (could not lift) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications was not specified   This case was linked to MOD-2021-370242 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Venous thrombosis limb
Clinical narrative: Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept; This spontaneous case was reported by a consumer and describes the occurrence of VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) (seriousness criterion medically significant). At the time of the report, VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VENOUS THROMBOSIS LIMB (Giant blood clot in the calf of one of his legs/size of a football/bothering me when I slept) to be possibly related.    No concomitant and treatment medications are provided by the reporter.  Three weeks after got his shot, patient had a blood clot in one of his legs. It is the size of a football. The doctors cannot operate on it because he'll bleed out.  Patient's gone to 7 different doctors and confident that it's his vaccination.  The doctor told him that only has 1-2 years left to live.  The patient wants to know if a bunch of people got blood clots from your vaccine. patient went to the emergency room in September 2021.  This spontaneous case report concerns a 63 year-old male whose medical history was not provided, who experienced the serious unexpected event of Venous thrombosis limb. The event occurred approximately 3 weeks after the second dose of a proper schedule of product administration (28 days between doses) of Moderna COVID-19 vaccine. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report; Sender's Comments: This spontaneous case report concerns a 63 year-old male, whose medical history was not provided, who experienced the serious unexpected event of Venous thrombosis limb. The event occurred approximately 3 weeks after the second dose of a proper schedule of product administration (28 days between doses) of Moderna COVID-19 vaccine. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body aches; woke up with a fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (woke up with a fever) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (woke up with a fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in October 2021 for Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches) outcome was unknown and PYREXIA (woke up with a fever) was resolving.            NO Concomitant drug reported.   This case was linked to MOD-2021-370234 (Patient Link).
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm has swollen halfway through the upper arm; Upper part of arm is red; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm has swollen halfway through the upper arm), VACCINATION SITE ERYTHEMA (Upper part of arm is red) and VACCINATION SITE PAIN (Tenderness at injection site) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 002A21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (Tenderness at injection site). On 31-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Arm has swollen halfway through the upper arm) and VACCINATION SITE ERYTHEMA (Upper part of arm is red). At the time of the report, VACCINATION SITE SWELLING (Arm has swollen halfway through the upper arm), VACCINATION SITE ERYTHEMA (Upper part of arm is red) and VACCINATION SITE PAIN (Tenderness at injection site) outcome was unknown.            Relevant concomitant medication was included high blood pressure medication. Patient was advised to keep an eye out on the redness and contact HCP if it starts going down the arm. The redness has not moved towards bottom of the arm.  No medications has been taken for adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Added dosage information and new event.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Lymphoma, Vaccination site rash
Clinical narrative: subcutaneous lymphoma; noticed a rash on the right arm where he got the second shot, near but not the same site as the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (subcutaneous lymphoma) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LATANOPROST, CICLOSPORIN (RESTASIS), MAGNESIUM, VITAMIN C [ASCORBIC ACID] and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced LYMPHOMA (subcutaneous lymphoma) (seriousness criterion medically significant) and VACCINATION SITE RASH (noticed a rash on the right arm where he got the second shot, near but not the same site as the vaccination). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) for Lymphoma, at an unspecified dose and frequency. At the time of the report, LYMPHOMA (subcutaneous lymphoma) and VACCINATION SITE RASH (noticed a rash on the right arm where he got the second shot, near but not the same site as the vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) saw that it was a subcutaneous lymphoma of some sort.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case concerns a 62 year-old male patient with no reported medical history who experienced the unexpected serious event of lymphoma. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 62 year-old male patient with no reported medical history who experienced the unexpected serious event of lymphoma. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Interchange of vaccine products
Clinical narrative: Diarrhea; Sore throat; Nausea; feeling light-headed; adverse event after Moderna booster vaccine with mix and match after Pfizer; Chills; Headache; Muscle ache/Body ache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (feeling light-headed), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine ((lot EN6208)) on 17-Mar-2021 and Pfizer vaccine ((lot EW0150)) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Penicillin allergy, Allergy to allopathic drugs (sulfa, ACE-i), Hypertension since 2013 and Asthma since 1980. Concomitant products included LOSARTAN, AMLODIPINE and HCTZ for Hypertension.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, the patient experienced CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (adverse event after Moderna booster vaccine with mix and match after Pfizer). 31-Oct-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle ache/Body ache). 31-Oct-2021, the patient experienced CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (adverse event after Moderna booster vaccine with mix and match after Pfizer). On 31-Oct-2021 at 3:30 AM, the patient experienced DIZZINESS (feeling light-headed). On 01-Nov-2021, the patient experienced DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat) and NAUSEA (Nausea). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. On 31-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (adverse event after Moderna booster vaccine with mix and match after Pfizer) had resolved. At the time of the report, DIZZINESS (feeling light-headed), DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle ache/Body ache) and NAUSEA (Nausea) had resolved and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Birth control medication was taken orally.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Reporter occupation and type updated, added medical history details, Updated event outcome
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Diarrhea; Sore throat; Nausea; feeling light-headed; adverse event after Moderna booster vaccine with mix and match after Pfizer; Chills; Headache; Muscle ache/Body ache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (feeling light-headed), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine ((lot EN6208)) on 17-Mar-2021 and Pfizer vaccine ((lot EW0150)) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Penicillin allergy, Allergy to allopathic drugs (sulfa, ACE-i), Hypertension since 2013 and Asthma since 1980. Concomitant products included LOSARTAN, AMLODIPINE and HCTZ for Hypertension.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, the patient experienced CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (adverse event after Moderna booster vaccine with mix and match after Pfizer). 31-Oct-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Muscle ache/Body ache). 31-Oct-2021, the patient experienced CHILLS (Chills) and INTERCHANGE OF VACCINE PRODUCTS (adverse event after Moderna booster vaccine with mix and match after Pfizer). On 31-Oct-2021 at 3:30 AM, the patient experienced DIZZINESS (feeling light-headed). On 01-Nov-2021, the patient experienced DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat) and NAUSEA (Nausea). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. On 31-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (adverse event after Moderna booster vaccine with mix and match after Pfizer) had resolved. At the time of the report, DIZZINESS (feeling light-headed), DIARRHOEA (Diarrhea), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle ache/Body ache) and NAUSEA (Nausea) had resolved and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Birth control medication was taken orally.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Reporter occupation and type updated, added medical history details, Updated event outcome
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient was administered with booster dose.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash on the back of her left hand and backway on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed a rash on the back of her left hand and backway on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029K20A) for COVID-19 vaccination.     Previously administered products included for Vaccination: flu vaccine and flu vaccine. Past adverse reactions to the above products included Hives with flu vaccine; and Itching with flu vaccine. Concurrent medical conditions included Drug allergy (many allergies to around 40-50 medications, Benadryl).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (developed a rash on the back of her left hand and backway on the left arm). At the time of the report, RASH (developed a rash on the back of her left hand and backway on the left arm) outcome was unknown.            NO Concomitant medication was reported NO treatment Drug was reported Over the years when patient got the flu shot, patient would break into hives and bad itching. To avoid this, patient was advised to take Prednisone before getting the flu shot which helped.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medication were reported  No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow up received on 05-Nov-2021 contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Epigastric discomfort, Headache, Myalgia, Nausea
Clinical narrative: Gastro-symptoms; Gastric pain; Pain in the arm; Nausea; Headache; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CANDESARTAN CILEXETIL (ATACAND) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever). At the time of the report, EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-370262, MOD-2021-370460 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Gastro-symptoms; Gastric pain; Pain in the arm; Nausea; Headache; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CANDESARTAN CILEXETIL (ATACAND) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever). At the time of the report, EPIGASTRIC DISCOMFORT (Gastro-symptoms), ABDOMINAL PAIN UPPER (Gastric pain), VACCINATION SITE PAIN (Pain in the arm), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.   This case was linked to MOD-2021-370262, MOD-2021-370460 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Quadriplegia, Walking aid user
Clinical narrative: Legs and arms were completely paralyzed; Could not walk; Using the walker to move; This spontaneous case was reported by a consumer and describes the occurrence of QUADRIPLEGIA (Legs and arms were completely paralyzed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 010M20A and 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Pneumonia (mild case.). Concurrent medical conditions included Adrenoleukodystrophy (Defined as long fatty acids attacking myeloid sheath, damaging it similar to what happens in sclerosis).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced QUADRIPLEGIA (Legs and arms were completely paralyzed) (seriousness criterion medically significant), GAIT INABILITY (Could not walk) and WALKING AID USER (Using the walker to move). At the time of the report, QUADRIPLEGIA (Legs and arms were completely paralyzed), GAIT INABILITY (Could not walk) and WALKING AID USER (Using the walker to move) outcome was unknown.            No Concomitants and Treatment medication were reported.  Company comment: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Quadriplegia. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-370528, MOD-2021-370729 (Patient Link).; Sender's Comments: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Quadriplegia. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: legs completely paralyzed/could not move legs; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (legs completely paralyzed/could not move legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and Pneumonia (a mild case). Concurrent medical conditions included Adrenoleukodystrophy (Defined as long fatty acids attacking myeloid sheath, damaging it similar to what happens in sclerosis. It is a long progression disease and patient walks around with a walker.).    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced MONOPLEGIA (legs completely paralyzed/could not move legs) (seriousness criterion medically significant). On 30-Oct-2021, MONOPLEGIA (legs completely paralyzed/could not move legs) had resolved.            No concomitant medication provided.  The day after booster dose patient could not move legs, these were completely paralyzed. Arms were fine. Symptoms lasted until 30-Oct-2021 morning.  Booster dose was given in right dominant arm.  No treatment information provided.  Company Comment: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Monoplegia. The event occurred on the day after the third dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-370698, MOD-2021-370528 (Patient Link).; Sender's Comments: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Monoplegia. The event occurred on the day after the third dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; Bad body aches; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Bad body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026l20a) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised. Concomitant products included RITUXIMAB (RITUXAN) for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Bad body aches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Bad body aches) 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 medications provided.   This case was linked to MOD-2021-371163, MOD-2021-371168 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Genital ulceration, Herpes virus test, Varicella virus test
Clinical narrative: Painful acute genital ulcers; This spontaneous case was reported by a pharmacist and describes the occurrence of GENITAL ULCERATION (Painful acute genital ulcers) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised. Concomitant products included RITUXIMAB (RITUXAN) from 06-Nov-2020 to 10-May-2021 for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE for an unknown indication.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENITAL ULCERATION (Painful acute genital ulcers). The patient was treated with CLOBETASOL for Genital ulceration, at an unspecified dose and frequency and LIDOCAINE for Genital ulceration, at an unspecified dose and frequency. At the time of the report, GENITAL ULCERATION (Painful acute genital ulcers) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Herpes virus test: negative (Negative) negative and negative (Negative) negative. On an unknown date, Varicella virus test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient thought she got herpes and seen by OBGYN (Obstetrician-Gynecologists) right away. Felt very painful. The patient was referred to ID OBGYN and she was sure that the side effect was due to vaccine.   This case was linked to MOD-2021-370939, MOD-2021-371168 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Genital ulceration, Pain
Clinical narrative: acute genital ulcers; Body aches; Fatigue; chills; This spontaneous case was reported by a pharmacist and describes the occurrence of GENITAL ULCERATION (acute genital ulcers), PAIN (Body aches), FATIGUE (Fatigue) and CHILLS (chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071f21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis. Concomitant products included RITUXIMAB (RITUXAN) from 06-Nov-2020 to 10-May-2021 for Rheumatoid arthritis, LEVOTHYROXINE SODIUM (SYNTHROID) and SPIRONOLACTONE for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PAIN (Body aches), FATIGUE (Fatigue) and CHILLS (chills). On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENITAL ULCERATION (acute genital ulcers). The patient was treated with CLOBETASOL for Genital ulceration, at an unspecified dose and frequency. At the time of the report, GENITAL ULCERATION (acute genital ulcers), PAIN (Body aches), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was wondering if she had severe reaction because the rituximab (Rituxan) infusion was not separated with the vaccine. The patient reported she did not produce antibodies, rheumatologist recommended to space out with infusion, rescheduled the infusion so she could get the 3rd dose of vaccine before her infusion.  After developing, the acute genital ulcers after 3rd dose, the patient had not seen a doctor yet. The patient used leftover clobetasol cream from previous treatment.  Treatment information for rest of the events were not reported by the reporter.   This case was linked to MOD-2021-370939, MOD-2021-371163 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Myalgia
Clinical narrative: he was sick for a day; chills; body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over). At the time of the report, ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) had resolved. Not Provided          No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-371343, MOD-2021-369390 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: potentially received dose from expired vial; 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 EXPIRED PRODUCT ADMINISTERED (potentially received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (potentially received dose from expired vial). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (potentially received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral coldness, Pollakiuria
Clinical narrative: fingers are cold; sore left arm; "couldn't hold in my water" had to rush to use bathroom last night/ "I think I did too much yesterday; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (fingers are cold), PAIN IN EXTREMITY (sore left arm), POLLAKIURIA ("couldn't hold in my water" had to rush to use bathroom last night/ "I think I did too much yesterday) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-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) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (fingers are cold), PAIN IN EXTREMITY (sore left arm), POLLAKIURIA ("couldn't hold in my water" had to rush to use bathroom last night/ "I think I did too much yesterday) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, PERIPHERAL COLDNESS (fingers are cold), PAIN IN EXTREMITY (sore left arm), POLLAKIURIA ("couldn't hold in my water" had to rush to use bathroom last night/ "I think I did too much yesterday) and HEADACHE (headache) outcome was unknown.            No concomitant medication was provided by the reporter Green alcohol was used as treatment for injection site,
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021, the patient received third 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-372320 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Feeling abnormal, Gait disturbance
Clinical narrative: Woke up with every bone in the body aching; Felt like she went through the "ringer."; Severe reaction to the vaccine; Could not hardly walk,; Ankles were so tender and painful; Severe headaches/"Worst headache I've ever had"; Body aches; Low grade fever of 99.9 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,) and ARTHRALGIA (Ankles were so tender and painful) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 026620A and 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-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 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,), ARTHRALGIA (Ankles were so tender and painful), HEADACHE (Severe headaches/"Worst headache I've ever had"), MYALGIA (Body aches) and PYREXIA (Low grade fever of 99.9 degrees Fahrenheit). At the time of the report, BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,), ARTHRALGIA (Ankles were so tender and painful), HEADACHE (Severe headaches/"Worst headache I've ever had"), MYALGIA (Body aches) and PYREXIA (Low grade fever of 99.9 degrees Fahrenheit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 degrees fahrenheit (High) low grade fever of 99.9 degrees Fahrenheit.     Treatment medication include Tylenol to Advil. No concomitant medications were provided by the reporter. Patient felt like she went through the "ringer."
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Woke up with every bone in the body aching; Felt like she went through the "ringer."; Severe reaction to the vaccine; Could not hardly walk,; Ankles were so tender and painful; Severe headaches/"Worst headache I've ever had"; Body aches; Low grade fever of 99.9 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,) and ARTHRALGIA (Ankles were so tender and painful) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 026620A and 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-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 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,), ARTHRALGIA (Ankles were so tender and painful), HEADACHE (Severe headaches/"Worst headache I've ever had"), MYALGIA (Body aches) and PYREXIA (Low grade fever of 99.9 degrees Fahrenheit). At the time of the report, BONE PAIN (Woke up with every bone in the body aching), FEELING ABNORMAL (Felt like she went through the "ringer."), VACCINATION COMPLICATION (Severe reaction to the vaccine), GAIT DISTURBANCE (Could not hardly walk,), ARTHRALGIA (Ankles were so tender and painful), HEADACHE (Severe headaches/"Worst headache I've ever had"), MYALGIA (Body aches) and PYREXIA (Low grade fever of 99.9 degrees Fahrenheit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 degrees fahrenheit (High) low grade fever of 99.9 degrees Fahrenheit.     Treatment medication include Tylenol to Advil. No concomitant medications were provided by the reporter. Patient felt like she went through the "ringer."