chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: pt says about 2 days after getting vax she had a very sore throat and swollen lymph nodes.  She had trouble swallowing, no appetite, and had severe chills w/ no fever.  She had trouble sleeping and eating.  She could only drink water.  She said she could only get a couple of hours of sleep a night.  Pt developed thrush.  She went to her PCP on 3/18/21.  She was prescribed meds to take.  Pt went to Dr. on 4/2/21 since she was not feeling any better.  She was prescribed more medicine.   She went to PCP on 4/19/2021 he gave her valium so she could some sleep.  He ordered a sleep study.  Pt says she is just starting to get her appetite back but is still having trouble sleeping.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Candida infection, Chills, Decreased appetite, Dysphagia, Insomnia
Clinical narrative: pt says about 2 days after getting vax she had a very sore throat and swollen lymph nodes.  She had trouble swallowing, no appetite, and had severe chills w/ no fever.  She had trouble sleeping and eating.  She could only drink water.  She said she could only get a couple of hours of sleep a night.  Pt developed thrush.  She went to her PCP on 3/18/21.  She was prescribed meds to take.  Pt went to Dr. on 4/2/21 since she was not feeling any better.  She was prescribed more medicine.   She went to PCP on 4/19/2021 he gave her valium so she could some sleep.  He ordered a sleep study.  Pt says she is just starting to get her appetite back but is still having trouble sleeping.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise, Oropharyngeal pain, Sleep study
Clinical narrative: pt says about 2 days after getting vax she had a very sore throat and swollen lymph nodes.  She had trouble swallowing, no appetite, and had severe chills w/ no fever.  She had trouble sleeping and eating.  She could only drink water.  She said she could only get a couple of hours of sleep a night.  Pt developed thrush.  She went to her PCP on 3/18/21.  She was prescribed meds to take.  Pt went to Dr. on 4/2/21 since she was not feeling any better.  She was prescribed more medicine.   She went to PCP on 4/19/2021 he gave her valium so she could some sleep.  He ordered a sleep study.  Pt says she is just starting to get her appetite back but is still having trouble sleeping.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Ear disorder, Feeling abnormal, Headache, Heart rate
Clinical narrative: HEART BEATS STRONGLY; MINOR MUSCLE ACHE; FOGGY FEELING; SHAKING WITH CHILLS; NAGGING HEADACHE; EAR PROBLEM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included she had a reaction to her first flu shot years ago. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced ear problem. On 07-APR-2021, the subject experienced foggy feeling. On 07-APR-2021, the subject experienced shaking with chills. On 07-APR-2021, the subject experienced nagging headache. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced heart beats strongly. On 08-APR-2021, the subject experienced minor muscle ache. Laboratory data included: Heart rate (NR: not provided) 125-130 bpm, 152 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beats strongly, foggy feeling, and shaking with chills on APR-2021, and had not recovered from ear problem, nagging headache, and minor muscle ache. This report was non-serious. This case, from the same reporter is linked to 20210416449.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Myalgia
Clinical narrative: HEART BEATS STRONGLY; MINOR MUSCLE ACHE; FOGGY FEELING; SHAKING WITH CHILLS; NAGGING HEADACHE; EAR PROBLEM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included she had a reaction to her first flu shot years ago. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced ear problem. On 07-APR-2021, the subject experienced foggy feeling. On 07-APR-2021, the subject experienced shaking with chills. On 07-APR-2021, the subject experienced nagging headache. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced heart beats strongly. On 08-APR-2021, the subject experienced minor muscle ache. Laboratory data included: Heart rate (NR: not provided) 125-130 bpm, 152 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beats strongly, foggy feeling, and shaking with chills on APR-2021, and had not recovered from ear problem, nagging headache, and minor muscle ache. This report was non-serious. This case, from the same reporter is linked to 20210416449.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Patient developed L sided facial paralysis 2 weeks after covid #2 moderna vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Patient developed L sided facial paralysis 2 weeks after covid #2 moderna vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: The first shot was Moderna, but the second was Pfizer.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold
Clinical narrative: FELT TIRED AND A COLD DEVELOPING/ WENT AWAY AROUND 7PM THE SAME DAY. TOOK ADVIL AND FELT IMMEDIATE RELIEF.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: FELT TIRED AND A COLD DEVELOPING/ WENT AWAY AROUND 7PM THE SAME DAY. TOOK ADVIL AND FELT IMMEDIATE RELIEF.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Two weeks post-vaccine this patient developed bilateral hand/foot paresthesias.  2.5 weeks post-vaccine he developed bilateral facial weakness/palsy, dysarthria and headaches.  All of the listed symptoms are currently present and have remained constant.  We have treated him with a 2-day course of IV Immunoglobulin (4/19-20) and there has not been any change in his neurologic exam at this point.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Mastication disorder, Neurological symptom, Paraesthesia
Clinical narrative: Two weeks post-vaccine this patient developed bilateral hand/foot paresthesias.  2.5 weeks post-vaccine he developed bilateral facial weakness/palsy, dysarthria and headaches.  All of the listed symptoms are currently present and have remained constant.  We have treated him with a 2-day course of IV Immunoglobulin (4/19-20) and there has not been any change in his neurologic exam at this point.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Eyelid ptosis, Facial paralysis, Facial paresis, Guillain-Barre syndrome
Clinical narrative: Two weeks post-vaccine this patient developed bilateral hand/foot paresthesias.  2.5 weeks post-vaccine he developed bilateral facial weakness/palsy, dysarthria and headaches.  All of the listed symptoms are currently present and have remained constant.  We have treated him with a 2-day course of IV Immunoglobulin (4/19-20) and there has not been any change in his neurologic exam at this point.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal, Mastication disorder, Neuralgia
Clinical narrative: Two weeks post-vaccine this patient developed bilateral hand/foot paresthesias.  2.5 weeks post-vaccine he developed bilateral facial weakness/palsy, dysarthria and headaches.  All of the listed symptoms are currently present and have remained constant.  We have treated him with a 2-day course of IV Immunoglobulin (4/19-20) and there has not been any change in his neurologic exam at this point.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Two weeks post-vaccine this patient developed bilateral hand/foot paresthesias.  2.5 weeks post-vaccine he developed bilateral facial weakness/palsy, dysarthria and headaches.  All of the listed symptoms are currently present and have remained constant.  We have treated him with a 2-day course of IV Immunoglobulin (4/19-20) and there has not been any change in his neurologic exam at this point.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF red blood cell count positive, Dysarthria, Facial paralysis, Facial paresis
Clinical narrative: Two weeks post-vaccine this patient developed bilateral hand/foot paresthesias.  2.5 weeks post-vaccine he developed bilateral facial weakness/palsy, dysarthria and headaches.  All of the listed symptoms are currently present and have remained constant.  We have treated him with a 2-day course of IV Immunoglobulin (4/19-20) and there has not been any change in his neurologic exam at this point.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Immunoglobulin therapy, Magnetic resonance imaging head abnormal, Paraesthesia
Clinical narrative: Two weeks post-vaccine this patient developed bilateral hand/foot paresthesias.  2.5 weeks post-vaccine he developed bilateral facial weakness/palsy, dysarthria and headaches.  All of the listed symptoms are currently present and have remained constant.  We have treated him with a 2-day course of IV Immunoglobulin (4/19-20) and there has not been any change in his neurologic exam at this point.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Ear pain, Headache, Hypoaesthesia
Clinical narrative: Cerebral venous sinus thrombosis
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Jugular vein thrombosis, Migraine, Thrombosis, Transverse sinus thrombosis, Vision blurred
Clinical narrative: Cerebral venous sinus thrombosis
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal
Clinical narrative: Cerebral venous sinus thrombosis
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness from left pinky finger to wrist/numbness on the bottom of right site of right foot and moved up to the ankle; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness from left pinky finger to wrist/numbness on the bottom of right site of right foot and moved up to the ankle) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Shoulder soreness (right). Concomitant products included MELOXICAM for Shoulder soreness, SPIRONOLACTONE and VITAMINS NOS for an unknown indication.    On 28-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 10:45 AM, the patient experienced HYPOAESTHESIA (numbness from left pinky finger to wrist/numbness on the bottom of right site of right foot and moved up to the ankle) (seriousness criterion disability). At the time of the report, HYPOAESTHESIA (numbness from left pinky finger to wrist/numbness on the bottom of right site of right foot and moved up to the ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 28 Jan 2021, the patient did not take her concomitant medications because she was about to receive the vaccine.   The patient did not take any medicine to treat the event. At the time of the report, the numbness was still there but no pain.  This case concerns a 52-year-old female with a serious unexpected event of hypoaesthesia. Event onset 15 minutes after first dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 52-year-old female with a serious unexpected event of hypoaesthesia. Event onset 15 minutes after first dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Oxygen consumption
Clinical narrative: COVID-19 pneumonia; Weakness; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) and ASTHENIA (Weakness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Artificial cardiac pacemaker user and COVID-19 on 01-Feb-2021. Concurrent medical conditions included Chronic kidney disease (20 years).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization prolonged and medically significant) and ASTHENIA (Weakness) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 05-Feb-2021 to 15-Feb-2021 due to ASTHENIA and COVID-19 PNEUMONIA. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia) and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, COVID-19: positive (Positive) positive. On 01-Feb-2021, Oxygen consumption: low (Low) low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information provided mentioned that patient was prescribed vitamin C, vitamin D zinc and steroid. 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.  Healthcare professional was consulted on 05 Feb 2021.   Patient was admitted on 05 Feb 2021 and discharged on 15 Feb2021.  Patient received Nursing House rehab which included oxygen, steps and walking.  Based on the current available information and temporal association between the use of the product and the start date of these event (asthenia), a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. Further information has been requested.   This case was linked to MOD-2021-037770 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event (asthenia), a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19 pneumonia) is assessed as unlikely related to mRNA-1273. Further information has been requested. MOD-2021-037770:Same patient 2nd dose for the case MOD-2021-037770
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Erythema, Heart rate increased, Lip swelling, Periorbital haemorrhage
Clinical narrative: a fib was worse (more erratic heartbeat); eyelid and under the eye looked bruised like a shiner; red markings along side the folds of the nose; face is still red and swollen; slightly elevated blood pressure; lips were swollen; rash running along same side of body as injection; soreness at injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026120A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in February 2000. Concurrent medical conditions included Allergy and Chronic atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS) and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced RASH (rash running along same side of body as injection), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 10-Mar-2021, the patient experienced HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) (seriousness criterion medically significant), PERIORBITAL HAEMORRHAGE (eyelid and under the eye looked bruised like a shiner), ERYTHEMA (red markings along side the folds of the nose), SWELLING FACE (face is still red and swollen), BLOOD PRESSURE INCREASED (slightly elevated blood pressure) and LIP SWELLING (lips were swollen). On 06-Mar-2021, RASH (rash running along same side of body as injection) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. On 17-Mar-2021, PERIORBITAL HAEMORRHAGE (eyelid and under the eye looked bruised like a shiner), ERYTHEMA (red markings along side the folds of the nose) and LIP SWELLING (lips were swollen) had resolved. At the time of the report, HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) and BLOOD PRESSURE INCREASED (slightly elevated blood pressure) outcome was unknown, SWELLING FACE (face is still red and swollen) had not resolved and VACCINATION SITE PAIN (soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Hydrocortisone cream to face.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Vaccination site erythema, Vaccination site pain
Clinical narrative: a fib was worse (more erratic heartbeat); eyelid and under the eye looked bruised like a shiner; red markings along side the folds of the nose; face is still red and swollen; slightly elevated blood pressure; lips were swollen; rash running along same side of body as injection; soreness at injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026120A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in February 2000. Concurrent medical conditions included Allergy and Chronic atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS) and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced RASH (rash running along same side of body as injection), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 10-Mar-2021, the patient experienced HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) (seriousness criterion medically significant), PERIORBITAL HAEMORRHAGE (eyelid and under the eye looked bruised like a shiner), ERYTHEMA (red markings along side the folds of the nose), SWELLING FACE (face is still red and swollen), BLOOD PRESSURE INCREASED (slightly elevated blood pressure) and LIP SWELLING (lips were swollen). On 06-Mar-2021, RASH (rash running along same side of body as injection) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. On 17-Mar-2021, PERIORBITAL HAEMORRHAGE (eyelid and under the eye looked bruised like a shiner), ERYTHEMA (red markings along side the folds of the nose) and LIP SWELLING (lips were swollen) had resolved. At the time of the report, HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) and BLOOD PRESSURE INCREASED (slightly elevated blood pressure) outcome was unknown, SWELLING FACE (face is still red and swollen) had not resolved and VACCINATION SITE PAIN (soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Hydrocortisone cream to face.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Electrocardiogram, Paraesthesia, Vaccination site erythema
Clinical narrative: chest tightness; tingling; stomach pain; big red lump at injection site; vacination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Polyethylene glycol.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling). On 19-Mar-2021, CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Electrocardiogram: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: chest tightness; tingling; stomach pain; big red lump at injection site; vacination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Polyethylene glycol.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (chest tightness), PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling). On 19-Mar-2021, CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PARAESTHESIA (tingling), ABDOMINAL PAIN UPPER (stomach pain), VACCINATION SITE ERYTHEMA (big red lump at injection site) and VACCINATION SITE SWELLING (vacination site swelling) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Electrocardiogram: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood phosphorus, Chills, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: extreme dizziness; fainted; unable to get a reading because the pressure was so low; diarrhea; felt like I was hallucinating; sweating; shivering; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HYPOTENSION (unable to get a reading because the pressure was so low), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering), VOMITING (vomiting) and NAUSEA (nausea). On 27-Mar-2021 at 1:30 AM, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and DIZZINESS (extreme dizziness). 27-Mar-2021 at 1:30 AM, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted), DIZZINESS (extreme dizziness), DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved and HYPOTENSION (unable to get a reading because the pressure was so low), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood phosphorus: 0.6 mg/dl and 4.7 mg/dl. On 27-Mar-2021, Electrocardiogram: abnormal (abnormal) elongated heart rhythm (Arrhythmias) and normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included IV fluids and oral phosphorus.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Hypotension, Nausea, Syncope
Clinical narrative: extreme dizziness; fainted; unable to get a reading because the pressure was so low; diarrhea; felt like I was hallucinating; sweating; shivering; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HYPOTENSION (unable to get a reading because the pressure was so low), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering), VOMITING (vomiting) and NAUSEA (nausea). On 27-Mar-2021 at 1:30 AM, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and DIZZINESS (extreme dizziness). 27-Mar-2021 at 1:30 AM, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted), DIZZINESS (extreme dizziness), DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved and HYPOTENSION (unable to get a reading because the pressure was so low), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood phosphorus: 0.6 mg/dl and 4.7 mg/dl. On 27-Mar-2021, Electrocardiogram: abnormal (abnormal) elongated heart rhythm (Arrhythmias) and normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included IV fluids and oral phosphorus.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: extreme dizziness; fainted; unable to get a reading because the pressure was so low; diarrhea; felt like I was hallucinating; sweating; shivering; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HYPOTENSION (unable to get a reading because the pressure was so low), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering), VOMITING (vomiting) and NAUSEA (nausea). On 27-Mar-2021 at 1:30 AM, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and DIZZINESS (extreme dizziness). 27-Mar-2021 at 1:30 AM, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted), DIZZINESS (extreme dizziness), DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved and HYPOTENSION (unable to get a reading because the pressure was so low), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood phosphorus: 0.6 mg/dl and 4.7 mg/dl. On 27-Mar-2021, Electrocardiogram: abnormal (abnormal) elongated heart rhythm (Arrhythmias) and normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included IV fluids and oral phosphorus.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: patient's both legs and ankles started to become swollen; patient's both legs and ankles started to become swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Relevant medical history not reported).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen). At the time of the report, PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) outcome was unknown. Not Provided          Patient reported concomitant medications which include diabetic medication and goat (gout?) medications.   No further detail was provided. No treatment information was provided for the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Computerised tomogram, Nausea, Pain in extremity, Vomiting
Clinical narrative: dull pain in stomach; presented nausea and vomiting; presented nausea and vomiting; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of APPENDICITIS (dull pain in stomach) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 18-Mar-2021 at 3:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced APPENDICITIS (dull pain in stomach) (seriousness criterion hospitalization). 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Mar-2021, the patient experienced NAUSEA (presented nausea and vomiting) and VOMITING (presented nausea and vomiting). On 19-Mar-2021, APPENDICITIS (dull pain in stomach) had resolved. At the time of the report, NAUSEA (presented nausea and vomiting) and VOMITING (presented nausea and vomiting) had resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Computerised tomogram: abnormal (abnormal) CT abdomen showed Inflamed appendix. Appendicitis was diagnosed..     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.   From the ER, the CAT scan was performed, diagnosed with appendicitis and emergency appendectomy was done on 19-MAR-2021.  Patient was discharged on docusate sodium, Ibuprofen, hydrocodone for surgical pain.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-062603 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-062603:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Chills, Dizziness, Erythema
Clinical narrative: Heart feels fluttery; Extremely Weak; Sore throat; dizziness; my body turned red like I had a sun burn; rash on my body, rash under both breasts; Heart Rate increased; Chills; Red Feet; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart feels fluttery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart feels fluttery) (seriousness criterion medically significant), ASTHENIA (Extremely Weak), RASH (rash on my body, rash under both breasts), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (dizziness), SUNBURN (my body turned red like I had a sun burn), CHILLS (Chills), HEART RATE INCREASED (Heart Rate increased) and ERYTHEMA (Red Feet). At the time of the report, CARDIAC FLUTTER (Heart feels fluttery), ASTHENIA (Extremely Weak), RASH (rash on my body, rash under both breasts), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (dizziness), SUNBURN (my body turned red like I had a sun burn), CHILLS (Chills), HEART RATE INCREASED (Heart Rate increased) and ERYTHEMA (Red Feet) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: This case concerns a 80-year-old female with a serious unexpected event of cardiac flutter, along with nonserious unexpected heart rate increased, dizziness, asthenia, oropharyngeal pain, sunburn and expected rash, erythema, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Oropharyngeal pain, Rash, Sunburn
Clinical narrative: Heart feels fluttery; Extremely Weak; Sore throat; dizziness; my body turned red like I had a sun burn; rash on my body, rash under both breasts; Heart Rate increased; Chills; Red Feet; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart feels fluttery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart feels fluttery) (seriousness criterion medically significant), ASTHENIA (Extremely Weak), RASH (rash on my body, rash under both breasts), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (dizziness), SUNBURN (my body turned red like I had a sun burn), CHILLS (Chills), HEART RATE INCREASED (Heart Rate increased) and ERYTHEMA (Red Feet). At the time of the report, CARDIAC FLUTTER (Heart feels fluttery), ASTHENIA (Extremely Weak), RASH (rash on my body, rash under both breasts), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (dizziness), SUNBURN (my body turned red like I had a sun burn), CHILLS (Chills), HEART RATE INCREASED (Heart Rate increased) and ERYTHEMA (Red Feet) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: This case concerns a 80-year-old female with a serious unexpected event of cardiac flutter, along with nonserious unexpected heart rate increased, dizziness, asthenia, oropharyngeal pain, sunburn and expected rash, erythema, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Computerised tomogram, Myocardial infarction
Clinical narrative: Mild cardiac infarction; 19 mm nodule in left breast; This case was received via an unknown source  on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Mild cardiac infarction) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in August 2020. Concomitant products included CARVEDILOL, OLMESARTAN, ACETYLSALICYLIC ACID (ASPIRIN 81), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and TICAGRELOR (BRILINTA) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced MYOCARDIAL INFARCTION (Mild cardiac infarction) (seriousness criteria hospitalization, medically significant and life threatening) and BREAST MASS (nodule in left breast). On 06-Jan-2021, MYOCARDIAL INFARCTION (Mild cardiac infarction) outcome was unknown. On 12-Feb-2021, BREAST MASS (nodule in left breast) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Computerised tomogram: abnormal CT Scan detected 19mm nodule in left breast.   Mammogram and ultrasound after 6 weeks, and nodule had disappeared.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis in left foot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis in left foot) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (on left foot).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. In March 2021, the patient experienced CELLULITIS (Cellulitis in left foot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in March 2021 to 29-Mar-2021 due to CELLULITIS. At the time of the report, CELLULITIS (Cellulitis in left foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications included unspecified antibiotics.  Daughter did not believe that the cellulitis was related to the vaccine because her mother also had surgery on the same foot.  Company comment:Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: her lymphedema on her right arm became a cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (her lymphedema on her right arm became a cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 029L20A) for an unknown indication.     Concurrent medical conditions included Lymphedema (lymphedema on her right arm for several years). Concomitant products included ALENDRONATE SODIUM (ALENDRONATE), ATENOLOL, FLUOXETINE, ISOSORBIDE MONONITRATE, NIACIN, RANOLAZINE, METFORMIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN and TRAZODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced CELLULITIS (her lymphedema on her right arm became a cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (her lymphedema on her right arm became a cellulitis) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.   As treatment patient took antibiotics (Doxycycline Monohydrate) 100 mg and also a Ceftriaxone injection) for 10 days.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.