chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral vascular disorder, Post procedural complication
Clinical narrative: knee swelling; pain in knee; total knee replacement; postoperative complication; Circulatory disorder peripheral; numbness; tingling; pain; This spontaneous case was reported by a physician and describes the occurrence of JOINT SWELLING (knee swelling), KNEE ARTHROPLASTY (total knee replacement), ARTHRALGIA (pain in knee), POST PROCEDURAL COMPLICATION (postoperative complication) and PERIPHERAL VASCULAR DISORDER (Circulatory disorder peripheral) in a 77-year-old patient of an unknown gender 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) injection for an unknown indication.    The patient's past medical history included Cigarette smoker (Smoker/ Half of pack of cigarette per day) from 1957 to 1981, Alcohol use (Occasional Alcohol use, might be three times a years) and Knee replacement (Left knee replaced). Concomitant products included GABAPENTIN and IBUPROFEN for an unknown indication.   On 06-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. In 2020, the patient experienced PAIN (pain). On 09-Sep-2020, the patient experienced KNEE ARTHROPLASTY (total knee replacement). In September 2020, the patient experienced POST PROCEDURAL COMPLICATION (postoperative complication), PERIPHERAL VASCULAR DISORDER (Circulatory disorder peripheral), HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling). On an unknown date, the patient experienced JOINT SWELLING (knee swelling) and ARTHRALGIA (pain in knee). At the time of the report, JOINT SWELLING (knee swelling), KNEE ARTHROPLASTY (total knee replacement), ARTHRALGIA (pain in knee), POST PROCEDURAL COMPLICATION (postoperative complication), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling) and PAIN (pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test:.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was unknown.  The action taken with mRNA-1273 in response to the events were not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest X-ray, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Reaction to covid-19 vaccine; Recurred diarrhea; Recurred fever; Recurred fatigue; Teeth chattering/recurred chills; Body aching/muscle pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue) and CHILLS (Teeth chattering/recurred chills) in a 59-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 Crohn's disease.    The patient's past medical history included COVID-19 from 02-Feb-2021 to February 2021, Back pain from January 2021 to February 2021 and Stomach cramps from January 2021 to February 2021. Concurrent medical conditions included Crohn's. Concomitant products included COLESTYRAMINE (CHOLESTYRAMIN) for an unknown indication.   On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 24-Apr-2021, the patient experienced VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue), CHILLS (Teeth chattering/recurred chills), MYALGIA (Body aching/muscle pain) and NAUSEA (Nausea). On 26-Apr-2021, VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue), CHILLS (Teeth chattering/recurred chills), MYALGIA (Body aching/muscle pain) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: Positive. In February 2021, SARS-CoV-2 test: Negative. On 30-Mar-2021, Chest X-ray: (Inconclusive) Waiting on results.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was mentioned.  The reporter's causality for the event(s) of back pain, stomach cramps and COVID-19 with was no reasonable possibility.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Vaccination complication
Clinical narrative: Reaction to covid-19 vaccine; Recurred diarrhea; Recurred fever; Recurred fatigue; Teeth chattering/recurred chills; Body aching/muscle pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue) and CHILLS (Teeth chattering/recurred chills) in a 59-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 Crohn's disease.    The patient's past medical history included COVID-19 from 02-Feb-2021 to February 2021, Back pain from January 2021 to February 2021 and Stomach cramps from January 2021 to February 2021. Concurrent medical conditions included Crohn's. Concomitant products included COLESTYRAMINE (CHOLESTYRAMIN) for an unknown indication.   On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 24-Apr-2021, the patient experienced VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue), CHILLS (Teeth chattering/recurred chills), MYALGIA (Body aching/muscle pain) and NAUSEA (Nausea). On 26-Apr-2021, VACCINATION COMPLICATION (Reaction to covid-19 vaccine), DIARRHEA (Recurred diarrhea), PYREXIA (Recurred fever), FATIGUE (Recurred fatigue), CHILLS (Teeth chattering/recurred chills), MYALGIA (Body aching/muscle pain) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test: Positive. In February 2021, SARS-CoV-2 test: Negative. On 30-Mar-2021, Chest X-ray: (Inconclusive) Waiting on results.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was mentioned.  The reporter's causality for the event(s) of back pain, stomach cramps and COVID-19 with was no reasonable possibility.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021; Muscle soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021) and MYALGIA (Muscle soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple allergies (Patient is allergic to so many things).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021) and MYALGIA (Muscle soreness). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First vaccine dose administered 24-FEB-2021, second dose administered in Apr-2021) had resolved and MYALGIA (Muscle soreness) had not resolved.            No relevant concomitant medications were reported.  Patient visited doctor who recommended acupuncture for treatment.   This case was linked to MOD-2021-041363 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Malaise
Clinical narrative: Felt terrible; Body ache; Headache; Joint ache; Fatigue; 101 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101 degree fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine), Penicillin allergy and Osteoporosis (Condition has improved and have reclast infusions annually.) since 2000. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) from 20-Jan-2021 to 30-Jan-2021 for Back pain.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021 at 8:30 AM, the patient experienced PYREXIA (101 degree fever). On 08-Mar-2021 at 8:00 PM, PYREXIA (101 degree fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 101 (Inconclusive) 101 degree.         No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Felt terrible; Body ache; Headache; Joint ache; Fatigue; 101 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101 degree fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine), Penicillin allergy and Osteoporosis (Condition has improved and have reclast infusions annually.) since 2000. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) from 20-Jan-2021 to 30-Jan-2021 for Back pain.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021 at 8:30 AM, the patient experienced PYREXIA (101 degree fever). On 08-Mar-2021 at 8:00 PM, PYREXIA (101 degree fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 101 (Inconclusive) 101 degree.         No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear swelling, Skin discolouration, Vaccination site induration, Vaccination site lymphadenopathy
Clinical narrative: swelling of the right ear; discoloration of right cheek; Itchy bump on the site of injection; swelling of glands in neck on injection side; Itchy bump on the site of injection; Itchy bump on the site of injection; Sore joints; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first 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 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints). On an unknown date, the patient experienced EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE INDURATION (Itchy bump on the site of injection) and VACCINATION SITE LYMPHADENOPATHY (swelling of glands in neck on injection side). At the time of the report, EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up appendedNNI(NO NEW INFORMATION ) WAS ADDED.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling of the right ear; discoloration of right cheek; Itchy bump on the site of injection; swelling of glands in neck on injection side; Itchy bump on the site of injection; Itchy bump on the site of injection; Sore joints; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first 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 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints). On an unknown date, the patient experienced EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE INDURATION (Itchy bump on the site of injection) and VACCINATION SITE LYMPHADENOPATHY (swelling of glands in neck on injection side). At the time of the report, EAR SWELLING (swelling of the right ear), SKIN DISCOLOURATION (discoloration of right cheek), VACCINATION SITE PRURITUS (Itchy bump on the site of injection), VACCINATION SITE SWELLING (Itchy bump on the site of injection) and ARTHRALGIA (Sore joints) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up appendedNNI(NO NEW INFORMATION ) WAS ADDED.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Sensitisation
Clinical narrative: right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head); slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SENSITISATION (right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head)) and HEADACHE (slight headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced HEADACHE (slight headache). On 06-May-2021, the patient experienced SENSITISATION (right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head)). On 06-May-2021, HEADACHE (slight headache) had resolved. At the time of the report, SENSITISATION (right side of head sensitive to touch, sensitivity of scalp (right side of head), sensitivity above (right) ear, pins and needles feeling (right side of head)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Illness, Malaise, Somnolence
Clinical narrative: felt ill; out of balance; felt sick; sleep whole next day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt ill), BALANCE DISORDER (out of balance), ILLNESS (felt sick) and SOMNOLENCE (sleep whole next day) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MALAISE (felt ill), BALANCE DISORDER (out of balance), ILLNESS (felt sick) and SOMNOLENCE (sleep whole next day). On 25-Feb-2021, MALAISE (felt ill), BALANCE DISORDER (out of balance), ILLNESS (felt sick) and SOMNOLENCE (sleep whole next day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX on 05-May-2021 and VARICELLA VACCINE on 05-May-2021.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported No treatment information was provided
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Lump in his throat), RASH PRURITIC (Rash itches a little bit) and RASH (Rash on his torso(ribs, stomach, and lower spine on his back)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PHARYNGEAL SWELLING (Lump in his throat), RASH PRURITIC (Rash itches a little bit) and RASH (Rash on his torso(ribs, stomach, and lower spine on his back)). At the time of the report, PHARYNGEAL SWELLING (Lump in his throat), RASH PRURITIC (Rash itches a little bit) and RASH (Rash on his torso(ribs, stomach, and lower spine on his back)) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol increased
Clinical narrative: bloodwork showed signs of elevated levels of something to do with your heart; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD CHOLESTEROL INCREASED (bloodwork showed signs of elevated levels of something to do with your heart) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL INCREASED (bloodwork showed signs of elevated levels of something to do with your heart). At the time of the report, BLOOD CHOLESTEROL INCREASED (bloodwork showed signs of elevated levels of something to do with your heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications information were provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Hypopnoea, Illness
Clinical narrative: She cant walk or clothe without pain; skin on torso hurts so bad; really bad foot spams; nausea; sick; dizziness; sore throat; shallow breathing; constant urge to urinate; body pain; horrible headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing) and MICTURITION URGENCY (constant urge to urinate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 THYROID (ARMOUR THYROID) for an unknown indication.   On 28-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) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash). On 28-Apr-2021, the patient experienced ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache). On an unknown date, the patient experienced GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad). On 03-Apr-2021, RASH (rash) had resolved. On 30-Apr-2021, ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache) had resolved. At the time of the report, GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad) outcome was unknown.            No treatment information was available. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Micturition urgency, Muscle spasms, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: She cant walk or clothe without pain; skin on torso hurts so bad; really bad foot spams; nausea; sick; dizziness; sore throat; shallow breathing; constant urge to urinate; body pain; horrible headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing) and MICTURITION URGENCY (constant urge to urinate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 THYROID (ARMOUR THYROID) for an unknown indication.   On 28-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) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash). On 28-Apr-2021, the patient experienced ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache). On an unknown date, the patient experienced GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad). On 03-Apr-2021, RASH (rash) had resolved. On 30-Apr-2021, ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache) had resolved. At the time of the report, GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad) outcome was unknown.            No treatment information was available. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Rash
Clinical narrative: She cant walk or clothe without pain; skin on torso hurts so bad; really bad foot spams; nausea; sick; dizziness; sore throat; shallow breathing; constant urge to urinate; body pain; horrible headache; rash; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing) and MICTURITION URGENCY (constant urge to urinate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 THYROID (ARMOUR THYROID) for an unknown indication.   On 28-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) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash). On 28-Apr-2021, the patient experienced ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache). On an unknown date, the patient experienced GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad). On 03-Apr-2021, RASH (rash) had resolved. On 30-Apr-2021, ILLNESS (sick), DIZZINESS (dizziness), OROPHARYNGEAL PAIN (sore throat), HYPOPNEA (shallow breathing), MICTURITION URGENCY (constant urge to urinate), MUSCLE SPASMS (really bad foot spams), NAUSEA (nausea), MYALGIA (body pain) and HEADACHE (horrible headache) had resolved. At the time of the report, GAIT DISTURBANCE (She cant walk or clothe without pain) and PAIN OF SKIN (skin on torso hurts so bad) outcome was unknown.            No treatment information was available. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite). At the time of the report, DECREASED APPETITE (loss of appetite) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Heart rate increased, Hyperhidrosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and HYPERHIDROSIS (Sweat) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter.  On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 COUGH (Cough) and HYPERHIDROSIS (Sweat). At the time of the report, COUGH (Cough) and HYPERHIDROSIS (Sweat) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: 140 (High) not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications include medicine for Atrial Fibrillation. No treatment information available. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up was received on 07 june 2021 the patient stated that wanted to update safety with his assumption
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: itchy whole body; mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy whole body) and PAIN IN EXTREMITY (mild sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (mild sore arm). On 03-May-2021, the patient experienced PRURITUS (itchy whole body). At the time of the report, PRURITUS (itchy whole body) and PAIN IN EXTREMITY (mild sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment medication include Allegra .
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Illness, Influenza, Musculoskeletal stiffness
Clinical narrative: weight loss; head hurting; stiffness; sick for two days"; sick for two days"; loss of appetite; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for two days"), INFLUENZA (sick for two days"), DECREASED APPETITE (loss of appetite), SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Narcolepsy. Concomitant products included ALLOPURINOL and AMITRIPTYLINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced ILLNESS (sick for two days"), INFLUENZA (sick for two days"), DECREASED APPETITE (loss of appetite) and SWELLING (Swelling). On 28-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and HEADACHE (head hurting). On an unknown date, the patient experienced WEIGHT DECREASED (weight loss). On 27-Apr-2021, ILLNESS (sick for two days"), INFLUENZA (sick for two days") and DECREASED APPETITE (loss of appetite) had resolved. At the time of the report, SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (stiffness), WEIGHT DECREASED (weight loss) and HEADACHE (head hurting) outcome was unknown. Not Provided          Treatment History Includes Anti Inflammatory ,Benadryl IV  and Toradol.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Weight decreased
Clinical narrative: weight loss; head hurting; stiffness; sick for two days"; sick for two days"; loss of appetite; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for two days"), INFLUENZA (sick for two days"), DECREASED APPETITE (loss of appetite), SWELLING (Swelling) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Narcolepsy. Concomitant products included ALLOPURINOL and AMITRIPTYLINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced ILLNESS (sick for two days"), INFLUENZA (sick for two days"), DECREASED APPETITE (loss of appetite) and SWELLING (Swelling). On 28-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and HEADACHE (head hurting). On an unknown date, the patient experienced WEIGHT DECREASED (weight loss). On 27-Apr-2021, ILLNESS (sick for two days"), INFLUENZA (sick for two days") and DECREASED APPETITE (loss of appetite) had resolved. At the time of the report, SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (stiffness), WEIGHT DECREASED (weight loss) and HEADACHE (head hurting) outcome was unknown. Not Provided          Treatment History Includes Anti Inflammatory ,Benadryl IV  and Toradol.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; Fever (99.7 body temperature); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever (99.7 body temperature)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-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 06-May-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever (99.7 body temperature)). At the time of the report, CHILLS (Chills) and PYREXIA (Fever (99.7 body temperature)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 99.7 (Inconclusive) Fever (99.7 body temperature).         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Ligament sprain, Mycobacterium tuberculosis complex test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Wrist sprain; Swollen joint; Vaccination site swelling; Vaccination site pruritus; Vaccination site erythema; Vaccination site warmth; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), LIGAMENT SPRAIN (Wrist sprain), JOINT SWELLING (Swollen joint), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided by the reporter.  Concurrent medical conditions included Alcohol use (One glass of hard liquor every month), Macular degeneration, Rheumatoid arthritis, Blood pressure high and Adhesive tape allergy. Concomitant products included ADALIMUMAB for Rheumatoid arthritis, PERINDOPRIL ERBUMINE and AFLIBERCEPT for an unknown indication, METHOTREXATE.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced LIGAMENT SPRAIN (Wrist sprain) and JOINT SWELLING (Swollen joint). On 03-Mar-2021, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. At the time of the report, LIGAMENT SPRAIN (Wrist sprain) and JOINT SWELLING (Swollen joint) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Mycobacterium tuberculosis complex test: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered JOINT SWELLING (Swollen joint) to be not related. No further causality assessments were provided for VACCINATION SITE WARMTH (Vaccination site warmth), LIGAMENT SPRAIN (Wrist sprain), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema).    No Treatment medications were reported.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Wrist sprain; Swollen joint; Vaccination site swelling; Vaccination site pruritus; Vaccination site erythema; Vaccination site warmth; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), LIGAMENT SPRAIN (Wrist sprain), JOINT SWELLING (Swollen joint), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided by the reporter.  Concurrent medical conditions included Alcohol use (One glass of hard liquor every month), Macular degeneration, Rheumatoid arthritis, Blood pressure high and Adhesive tape allergy. Concomitant products included ADALIMUMAB for Rheumatoid arthritis, PERINDOPRIL ERBUMINE and AFLIBERCEPT for an unknown indication, METHOTREXATE.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). On an unknown date, the patient experienced LIGAMENT SPRAIN (Wrist sprain) and JOINT SWELLING (Swollen joint). On 03-Mar-2021, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved. At the time of the report, LIGAMENT SPRAIN (Wrist sprain) and JOINT SWELLING (Swollen joint) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Mycobacterium tuberculosis complex test: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered JOINT SWELLING (Swollen joint) to be not related. No further causality assessments were provided for VACCINATION SITE WARMTH (Vaccination site warmth), LIGAMENT SPRAIN (Wrist sprain), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE ERYTHEMA (Vaccination site erythema).    No Treatment medications were reported.   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache/Head Hurts; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/Head Hurts) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C214. and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypercholesterolaemia (Cholesterol ). Concomitant products included EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced HEADACHE (Headache/Head Hurts). At the time of the report, HEADACHE (Headache/Head Hurts) outcome was unknown.            Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore left arm). At the time of the report, MYALGIA (Sore left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Headache, Illness, Myalgia
Clinical narrative: Said she had every side effect listed; Sickness; Fatigue; Muscle pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Said she had every side effect listed), ILLNESS (Sickness), FATIGUE (Fatigue), MYALGIA (Muscle pain) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B218) 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 APIXABAN (ELIQUIS) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced ADVERSE EVENT (Said she had every side effect listed), ILLNESS (Sickness), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ADVERSE EVENT (Said she had every side effect listed), ILLNESS (Sickness), FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included High blood pressure pill , medicine for cholesterol and pill for irregular heart beat, all to be taken every day respectively. Treatment medication included Tylenol 1000 mg 3 times a day, as advised by doctor.