chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: 12 hrs after vaccine I was awaken by stabbing pain in my right thigh and chest pain.  Pain lasted about 5 min, after which my muscles started rapidly twitching all over body. Muscles are twitching every few seconds, I am having multiple muscle cramps at random times, sharp intermittent pain all over body.  I started having frequent tremors in my hands, muscles feel strained and it is difficult to walk or perform on the piano (my job).  2 days ago I started experiencing constant pins and needles all over my body.  My pulse is in the 80s (normally in the 60s), I feel frequent heart palpitations.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Sneezing
Clinical narrative: Severe headache, moderate-severe upper body muscle pain, nasal congestion and sneezing
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Throat irritation, Throat tightness
Clinical narrative: Shortness of breath, dyspnea, itchy throat, sweaty, throat felt tight. Treatment here in the ER was racemic epinephrine, im epinephrine, famotidine, albuterol nebulizer solution, dexamethasone iv, 1L of NS.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash began approximately 5 days after vaccine. Some improvement with Benadryl.  Patient denies any other associated symptoms.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Seizure, Unresponsive to stimuli
Clinical narrative: Pale/unresponsive approx. 1 min after receiving vaccine. Appeared to have a seizure.   After about 5-7 min appeared to improve.  Reported after event that she had hx of "vasvagals".  Transported to local hospital for further assessment.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: 4cm subcutaneous nodule antecubital fossa left arm, day after 2nd vaccine Plan to monitor over the next month.  If no resolution, get an ultrasound
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: chills, muscle aches, joint pain, headache, nausea
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site swelling, Myalgia
Clinical narrative: 24 hours after vaccine: chills, headache, muscle aches, fatigue, symptoms resolved within 8hrs of onset.  48 hours after vaccine localized swelling at injection site continuing for 3+ days
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Dizziness, Fatigue
Clinical narrative: Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off.   Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak.  I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches.  The fever responded well to Ibuprofen. I hydrated with water and Gatorade.  It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hunger, Hyperhidrosis, Hypersomnia, Influenza
Clinical narrative: Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off.   Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak.  I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches.  The fever responded well to Ibuprofen. I hydrated with water and Gatorade.  It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Woke up at 0700 drenched in sweat with chills. Slight fever of 99.7F . Started my work day from home with a meeting at 0900 and knew by 0920 that I had to take the day off.   Spent the entire rest of the day and night in bed. Fever peaked at 101.1F , nausea, constant headache, shaking chills and then sweats, extreme fatigue and full body severe muscle soreness. Light headed and very weak.  I slept all day until almost 1500. When I woke up my fever was gone. I'm left tonight feeling hungry again along with some residual sore muscles and aches.  The fever responded well to Ibuprofen. I hydrated with water and Gatorade.  It pretty much felt like influenza for just under 48 hours. I feel like I'm past the worst of it now, but I'm not fully recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Immediate post-injection reaction, Oropharyngeal discomfort, Peripheral coldness
Clinical narrative: Began sweating profusely within minutes over while body, hands ice cold but overall not feeling cold or hot, visibly shivering uncontrollably, throat discomfort - all resolved slowly over 4 hours following vaccination
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 5 DAYS OUT I STILL HAVE SWELLING & PAIN AT THE INJECTION SITE, IT IS ALSO WARM/HOT TO TOUCH AND STARTED TO ITCH ON 5/3/21
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Patient reported temporary loss of taste about 8-10 hours after vaccination. It resolved spontaneously overnight
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Behaviour disorder, Blood pressure increased, Chills, Dizziness, Dyspnoea
Clinical narrative: Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fever/chills,headache  My left arm became very painful immediately after injection(the injection didn't hurt,it was after needle removed & she was getting bandage), then I started to feel lightheaded & disoriented and trouble breathing and Blood pressure elevated but it was very low immediately after injection. Didn't start feeling well until  more than 2 wks after shot.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Immediate post-injection reaction, Lip swelling
Clinical narrative: Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fever/chills,headache  My left arm became very painful immediately after injection(the injection didn't hurt,it was after needle removed & she was getting bandage), then I started to feel lightheaded & disoriented and trouble breathing and Blood pressure elevated but it was very low immediately after injection. Didn't start feeling well until  more than 2 wks after shot.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Swelling face
Clinical narrative: Swollen facial/lip,, very painful arm, feeling disoriented, severe trouble breathing, very tired, fever/chills,headache  My left arm became very painful immediately after injection(the injection didn't hurt,it was after needle removed & she was getting bandage), then I started to feel lightheaded & disoriented and trouble breathing and Blood pressure elevated but it was very low immediately after injection. Didn't start feeling well until  more than 2 wks after shot.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; This spontaneous report received from a patient  concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient was previously treated with Tylenol (paracetamol) for loss of mobility in arm which caused by pneumococcal vaccine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine  was not applicable. The outcome of blurred vision was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:  Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 11-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: ARM HURT; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 year old female. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 01-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced arm hurt. On 02-MAY-2021, the subject experienced fever. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, fever, headache and fatigue on 03-MAY-2021. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN CHEEK (ONE SIDE); This spontaneous report received from a pharmacist concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 14:50 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced tingling in cheek (one side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in cheek (one side). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: A FEW DROPS OF VACCINE CAME  OUT OF THE SYRINGE ONTO THE  PATIENT'S ARM; UNDER DOSE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced a few drops of vaccine came out of the syringe onto the subject's arm, and under dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a few drops of vaccine came out of the syringe onto the patient's arm and under dose was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Lymphadenopathy, Mass, Neck pain, Pain in extremity
Clinical narrative: FLANK PAIN (LEFT); SWELLING (FRONT OF CHEST); LUMP ON LEFT CLAVICLE; NECK PAIN; LYMPHADENOPATHY; PAIN IN ARM; This spontaneous report received from a pharmacist concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 22/JUN/2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced flank pain (left). On 03-MAY-2021, the subject experienced swelling (front of chest). On 03-MAY-2021, the subject experienced lump on left clavicle. On 03-MAY-2021, the subject experienced neck pain. On 03-MAY-2021, the subject experienced lymphadenopathy. On 03-MAY-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flank pain (left), swelling (front of chest), lump on left clavicle, pain in arm, neck pain, and lymphadenopathy. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: FLANK PAIN (LEFT); SWELLING (FRONT OF CHEST); LUMP ON LEFT CLAVICLE; NECK PAIN; LYMPHADENOPATHY; PAIN IN ARM; This spontaneous report received from a pharmacist concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 22/JUN/2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced flank pain (left). On 03-MAY-2021, the subject experienced swelling (front of chest). On 03-MAY-2021, the subject experienced lump on left clavicle. On 03-MAY-2021, the subject experienced neck pain. On 03-MAY-2021, the subject experienced lymphadenopathy. On 03-MAY-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flank pain (left), swelling (front of chest), lump on left clavicle, pain in arm, neck pain, and lymphadenopathy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LITTLE TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tired was not reported. This report was non-serious. This case, from the same reporter is linked to.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hot flush, Nausea, Pain
Clinical narrative: HOT FLASHES; BODY ACHES; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient could breath normally again on the upside of his lungs, sinuses weren't as bad, could taste again. The patient received covid-19 vaccine (suspension for injection, route of admin not reported,) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be required for this case. No concomitant medications were reported. On an unspecified date, the subject experienced hot flashes, body aches, chills, and nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the hot flashes, chills, nausea and body aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PUNCTURED VIAL REFRIGERATED AND EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, alcoholism, and cigarette smoker, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 25-MAY-2021) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced punctured vial refrigerated and expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from punctured vial refrigerated and expired vaccine administered. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Decreased appetite, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR  APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypertension, Nausea, Swollen tongue, Vomiting
Clinical narrative: HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR  APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR  APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 02-APR-2021, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects on 03-APR-2021. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: PAIN IN ARM; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 77 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  2021, the subject experienced pain in arm. On 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, and tiredness on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Sensory disturbance
Clinical narrative: ELECTRICAL IMPULSES ON BACK AND LEGS; TAPPING ON HEAD; TINGLING SENSATION ON FACE NEAR MOUTH LIKE ELECTRICAL IMPULSES; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no medical history present the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced tingling sensation on face near mouth like electrical impulses. On 10-MAR-2021, the subject experienced tapping on head. On 21-MAR-2021, the subject experienced electrical impulses on back and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation on face near mouth like electrical impulses on 07-MAR-2021, and tapping on head, and had not recovered from electrical impulses on back and legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: STINGING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced stinging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Head discomfort, Neck pain
Clinical narrative: DIZZINESS; HEAVINESS IN THE HEAD; NECK PAIN; TEMPORARY DISCOMFORT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, heaviness in the head, neck pain, and temporary discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, heaviness in the head, neck pain and temporary discomfort was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: DIZZY; RUN DOWN; TIRED; WEAK; FEVERISH; HEADACHE; TIRED; WEAK; SORE ARM; This spontaneous report received from a consumer concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included leg amputation, and other pre-existing medical conditions included past medication include glybizide. The patient was previously treated with metformin for drug used for unknown indication, simvastatin for drug used for unknown indication, gabapentin for drug used for unknown indication, and insulin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced weak. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced weak. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 09-APR-2021, and tired, and weak on APR-2021, and had not recovered from feverish, headache, dizzy, run down, tired, and weak. This report was non-serious. This case, from the same reporter is linked.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: DIZZY; RUN DOWN; TIRED; WEAK; FEVERISH; HEADACHE; TIRED; WEAK; SORE ARM; This spontaneous report received from a consumer concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included leg amputation, and other pre-existing medical conditions included past medication include glybizide. The patient was previously treated with metformin for drug used for unknown indication, simvastatin for drug used for unknown indication, gabapentin for drug used for unknown indication, and insulin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced weak. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced weak. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 09-APR-2021, and tired, and weak on APR-2021, and had not recovered from feverish, headache, dizzy, run down, tired, and weak. This report was non-serious. This case, from the same reporter is linked.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Lip swelling, Swelling, Swelling face, Vaccination complication
Clinical narrative: 3 partial Anaphylactic reaction; Face was swollen; Nose was swollen; Lips were swollen; bad reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (3 partial Anaphylactic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION COMPLICATION (bad reaction to the vaccine). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (3 partial Anaphylactic reaction) (seriousness criterion medically significant), SWELLING FACE (Face was swollen), SWELLING (Nose was swollen) and LIP SWELLING (Lips were swollen). At the time of the report, ANAPHYLACTIC REACTION (3 partial Anaphylactic reaction), VACCINATION COMPLICATION (bad reaction to the vaccine), SWELLING FACE (Face was swollen), SWELLING (Nose was swollen) and LIP SWELLING (Lips were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided. Treatment information included steroids.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Case upgraded to serious as "3 partial anaphylactic reactions " events added. Patient's contact information updated for further follow-up.; Sender's Comments: Based on the 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Respiratory tract haemorrhage, Vaccination site pain
Clinical narrative: blood clot coming out of the mouth when coughing; Nose bleed; pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. K1OC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in her left arm). On an unknown date, the patient experienced RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) (seriousness criterion medically significant) and EPISTAXIS (Nose bleed). At the time of the report, RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) and EPISTAXIS (Nose bleed) outcome was unknown and VACCINATION SITE PAIN (pain in her left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.  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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: patient's address was updated (changed), adverse events updated; 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: M
Vaccine: COVID19
Symptoms: Tachycardia, Tremor, Vaccination site pain
Clinical narrative: potassium deficiency; shaking; nervousness; rapid heart beat; anxiety; no appetite; felt hot; Sore arm at the injection site; muscle pain; sore muscles; bad fatigue; pulse went down; blood pressure went up; didn't feel well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKALAEMIA (potassium deficiency) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergy to: tetracyclines). Concomitant products included VERAPAMIL, LOSARTAN, CHLOROTHIAZIDE, DIAZEPAM and DOXAZOSIN for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced HEART RATE DECREASED (pulse went down), BLOOD PRESSURE INCREASED (blood pressure went up) and MALAISE (didn't feel well). On an unknown date, the patient experienced HYPOKALAEMIA (potassium deficiency) (seriousness criterion medically significant), TREMOR (shaking), NERVOUSNESS (nervousness), TACHYCARDIA (rapid heart beat), ANXIETY (anxiety), DECREASED APPETITE (no appetite), FEELING HOT (felt hot), VACCINATION SITE PAIN (Sore arm at the injection site), MYALGIA (muscle pain; sore muscles) and FATIGUE (bad fatigue). At the time of the report, HYPOKALAEMIA (potassium deficiency), TACHYCARDIA (rapid heart beat), HEART RATE DECREASED (pulse went down), BLOOD PRESSURE INCREASED (blood pressure went up), MALAISE (didn't feel well), DECREASED APPETITE (no appetite), FEELING HOT (felt hot), VACCINATION SITE PAIN (Sore arm at the injection site), MYALGIA (muscle pain; sore muscles) and FATIGUE (bad fatigue) outcome was unknown and TREMOR (shaking), NERVOUSNESS (nervousness) and ANXIETY (anxiety) had not resolved.            The patient received escitalopram 10mg daily, but stopped taking after 4 days as he was feeling depressed. Reporter stated that the patient went to the emergency room  on 26APR2021 due to changes in blood pressure and pulse. "It wasn't because of the vaccine. He had a potassium deficiency."  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for  the event of hypokalemia which is unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27apr2021: updated event and possible causality. Reporter does not think the blood pressure and pulse issues related to vaccine; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for  the event of hypokalemia which is unlikely.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Erythema, Joint swelling, Peripheral swelling, Tenderness
Clinical narrative: arrhythmia nervosa; Ankles swollen; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia nervosa) in a 77-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.     No Medical History information was reported.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (arrhythmia nervosa) (seriousness criterion medically significant), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender). At the time of the report, ARRHYTHMIA (arrhythmia nervosa), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender) had not resolved.            No concomitant medications provided. Treatment included  doxycycline and prednisone.  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.; 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Vaccination complication
Clinical narrative: neuropathy; having unusual reaction; shooting pain in an abdomen towards ovaries; extreme pain in spinal cord , it hurts badly;hand hurts like hell; numbness in both feet; tingling in both feet; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Neuropathy (Neuropathy 7 years ago) and Myelitis transverse (Patient had scar on spinal cord and caused by transverse myelitis.).    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION COMPLICATION (having unusual reaction), PAIN (shooting pain in an abdomen towards ovaries; extreme pain in spinal cord , it hurts badly;hand hurts like hell), HYPOAESTHESIA (numbness in both feet) and PARAESTHESIA (tingling in both feet). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), VACCINATION COMPLICATION (having unusual reaction), PAIN (shooting pain in an abdomen towards ovaries; extreme pain in spinal cord , it hurts badly;hand hurts like hell), HYPOAESTHESIA (numbness in both feet) and PARAESTHESIA (tingling in both feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.  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.; 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Myocardial infarction
Clinical narrative: myocardial infarction with 100% vessel occlusion; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction with 100% vessel occlusion) and ANGINA PECTORIS (Chest pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VERAPAMIL, LABETALOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ANGINA PECTORIS (Chest pain) (seriousness criterion hospitalization). On 24-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (myocardial infarction with 100% vessel occlusion) (seriousness criterion hospitalization). On 26-Apr-2021, MYOCARDIAL INFARCTION (myocardial infarction with 100% vessel occlusion) had resolved. At the time of the report, ANGINA PECTORIS (Chest pain) outcome was unknown.            The patient had an urgent coronary intervention and was discharged from the ER on 26Apr2021. He was informed about an additional 80% occlusion which will require stenting in a future.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  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.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica, Systemic lupus erythematosus
Clinical narrative: Lupus flare up; Sciatica Pain in the Hip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica and Arthritis. Concurrent medical conditions included Sjogren's syndrome and Lupus erythematosus systemic.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant) and SCIATICA (Sciatica Pain in the Hip). On 27-Apr-2021, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) and SCIATICA (Sciatica Pain in the Hip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. The patient visited the Emergency Room (Does not remember exact date but it happened after vaccination). Treatment medication reported includes Prednisone, Morphine and Phenergan.  Company comment: 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.; 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.