chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymphadenopathy
Clinical narrative: CHEST PAIN; SWOLLEN LYMPH NODES; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (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 an unspecified date, the patient experienced chest pain, and swollen lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain and swollen lymph nodes was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Chills, Contusion, Dizziness
Clinical narrative: BRUISING ARMS AND LEGS; SHE COULD NOT GO TO WORK OR DRIVE HER CAR; CHILLS; RASH ON RIGHT ARM; NAUSEATED; HEADACHE; FEVER; BALANCE DISTURBANCES ("FELT  OFF BALANCE, KIND OF LIKE BEING DRUNK"); DIZZY; HEART RATE WAS GOING UP; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, pollen seasonal allergies, non alcoholic, and non-smoker, and other pre-existing medical conditions included: The patient not had any drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. Concomitant medications included thyroid for thyroid.  On 18-AUG-2021, the patient experienced dizzy. On 18-AUG-2021, the patient experienced heart rate was going up. On 18-AUG-2021, the patient experienced balance disturbances ("felt off balance, kind of like being drunk"). On 18-AUG-2021, the patient experienced chills. On 18-AUG-2021, the patient experienced rash on right arm. On 18-AUG-2021, the patient experienced nauseated. On 18-AUG-2021, the patient experienced headache. On 18-AUG-2021, the patient experienced fever. Laboratory data included: Blood pressure (NR: not provided) 120/80 mmHg, and Heart rate (NR: not provided) 108-111 bpm. Treatment medications included: paracetamol. On 19-AUG-2021, the patient experienced bruising arms and legs. On 19-AUG-2021, the patient experienced she could not go to work or drive her car. On 24-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. On 25-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizzy, she could not go to work or drive her car, chills, nauseated, and fever on 2021, heart rate was going up, bruising arms and legs on 29-AUG-2021, balance disturbances ("felt off balance, kind of like being drunk") on 21-AUG-2021, rash on right arm on 22-AUG-2021, and headache on 25-AUG-2021. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Impaired driving ability, Nausea
Clinical narrative: BRUISING ARMS AND LEGS; SHE COULD NOT GO TO WORK OR DRIVE HER CAR; CHILLS; RASH ON RIGHT ARM; NAUSEATED; HEADACHE; FEVER; BALANCE DISTURBANCES ("FELT  OFF BALANCE, KIND OF LIKE BEING DRUNK"); DIZZY; HEART RATE WAS GOING UP; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, pollen seasonal allergies, non alcoholic, and non-smoker, and other pre-existing medical conditions included: The patient not had any drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. Concomitant medications included thyroid for thyroid.  On 18-AUG-2021, the patient experienced dizzy. On 18-AUG-2021, the patient experienced heart rate was going up. On 18-AUG-2021, the patient experienced balance disturbances ("felt off balance, kind of like being drunk"). On 18-AUG-2021, the patient experienced chills. On 18-AUG-2021, the patient experienced rash on right arm. On 18-AUG-2021, the patient experienced nauseated. On 18-AUG-2021, the patient experienced headache. On 18-AUG-2021, the patient experienced fever. Laboratory data included: Blood pressure (NR: not provided) 120/80 mmHg, and Heart rate (NR: not provided) 108-111 bpm. Treatment medications included: paracetamol. On 19-AUG-2021, the patient experienced bruising arms and legs. On 19-AUG-2021, the patient experienced she could not go to work or drive her car. On 24-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. On 25-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizzy, she could not go to work or drive her car, chills, nauseated, and fever on 2021, heart rate was going up, bruising arms and legs on 29-AUG-2021, balance disturbances ("felt off balance, kind of like being drunk") on 21-AUG-2021, rash on right arm on 22-AUG-2021, and headache on 25-AUG-2021. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: BRUISING ARMS AND LEGS; SHE COULD NOT GO TO WORK OR DRIVE HER CAR; CHILLS; RASH ON RIGHT ARM; NAUSEATED; HEADACHE; FEVER; BALANCE DISTURBANCES ("FELT  OFF BALANCE, KIND OF LIKE BEING DRUNK"); DIZZY; HEART RATE WAS GOING UP; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid, pollen seasonal allergies, non alcoholic, and non-smoker, and other pre-existing medical conditions included: The patient not had any drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. Concomitant medications included thyroid for thyroid.  On 18-AUG-2021, the patient experienced dizzy. On 18-AUG-2021, the patient experienced heart rate was going up. On 18-AUG-2021, the patient experienced balance disturbances ("felt off balance, kind of like being drunk"). On 18-AUG-2021, the patient experienced chills. On 18-AUG-2021, the patient experienced rash on right arm. On 18-AUG-2021, the patient experienced nauseated. On 18-AUG-2021, the patient experienced headache. On 18-AUG-2021, the patient experienced fever. Laboratory data included: Blood pressure (NR: not provided) 120/80 mmHg, and Heart rate (NR: not provided) 108-111 bpm. Treatment medications included: paracetamol. On 19-AUG-2021, the patient experienced bruising arms and legs. On 19-AUG-2021, the patient experienced she could not go to work or drive her car. On 24-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. On 25-AUG-2021, Laboratory data included: Heart rate (NR: not provided) 97-111bpm. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizzy, she could not go to work or drive her car, chills, nauseated, and fever on 2021, heart rate was going up, bruising arms and legs on 29-AUG-2021, balance disturbances ("felt off balance, kind of like being drunk") on 21-AUG-2021, rash on right arm on 22-AUG-2021, and headache on 25-AUG-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dizziness, Influenza like illness
Clinical narrative: DIZZY, ESPECIALLY UPON STANDING/CANNOT STAND WITHOUT ASSISTANCE; BAD FLU; TEMPERATURE WAS "OVER 99 DEGREES AND RISING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetic. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced dizzy, especially upon standing/cannot stand without assistance. On 02-SEP-2021, the patient experienced bad flu. On 02-SEP-2021, the patient experienced temperature was "over 99 degrees and rising. Laboratory data included: Body temperature (NR: not provided) 99 degrees and rising. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from temperature was "over 99 degrees and rising, dizzy, especially upon standing/cannot stand without assistance, and bad flu. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Paraesthesia, Presyncope
Clinical narrative: SENSATION OF INTERMITTENT PINS AND NEEDLES IN FINGERTIPS; EXTREME LIGHT HEADEDNESS INTERMITTENTLY; BRAIN FOG/NOT FEELING LIKE MYSELF; UNABLE TO CONCENTRATE; IT FEELS  ALMOST LIKE GOING TO FAINT, BUT DON'T, IT'S NOT DIZZINESS, IT'S WORSE WHEN STAND UP FROM SITTING; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 155 pounds, and height was 64 inches. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient has no significant medical history, no known allergies and patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced extreme light headedness intermittently. On 24-AUG-2021, the patient experienced brain fog/not feeling like myself. On 24-AUG-2021, the patient experienced unable to concentrate. On 24-AUG-2021, the patient experienced it feels almost like going to faint, but don't, it's not dizziness, it's worse when stand up from sitting. On 01-SEP-2021, the patient experienced sensation of intermittent pins and needles in fingertips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from extreme light headedness intermittently, brain fog/not feeling like myself, sensation of intermittent pins and needles in fingertips, and unable to concentrate, and the outcome of it feels almost like going to faint, but don't, it's not dizziness, it's worse when stand up from sitting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: FELT LIKE SHIT; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 an unspecified date, the patient experienced felt like shit, headache, and fatigue. The action taken with covid-19 vaccine was not applicable. The patient was recovering from felt like crap, headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Paraesthesia, Pruritus
Clinical narrative: ENTIRE BACK IS ITCHING BUT NO RASH OR HIVES; ACHINESS ALL OVER THE BODY; TINGLING TO LEFT HAND; CHILLS; EXTREME FATIGUE; 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 pre-existing medical conditions included: The patient had not provided medical history and had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number:1808980,expiry:18-SEP-2021) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, treatment medications included: paracetamol. On 03-SEP-2021, the patient experienced entire back is itching but no rash or hives. On 03-SEP-2021, the patient experienced achiness all over the body. On 03-SEP-2021, the patient experienced tingling to left hand. On 03-SEP-2021, the patient experienced chills. On 03-SEP-2021, the patient experienced extreme fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from entire back is itching but no rash or hives on 04-SEP-2021, was recovering from extreme fatigue, chills, and achiness all over the body, and had not recovered from tingling to left hand. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Paraesthesia
Clinical narrative: INTERMITTENT NUMBNESS IN THE FINGER TIPS OF THE LEFT HAND; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included: sprained neck, and other pre-existing medical conditions included: The patient had no lifestyle changes. The patient had no other issues. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced chills. On 02-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced intermittent numbness in the finger tips of the left hand. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills on 02-SEP-2021, and headache on 03-SEP-2021, and had not recovered from intermittent numbness in the finger tips of the left hand. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram, Facial pain, Headache, Heart rate
Clinical narrative: PAIN IN NECK; PAIN IN FACE; PAIN IN LUNGS WITH SHORTNESS OF BREATH; PAIN IN SHOULDER; TINGLING; NUMBNESS; PAIN IN FEET/ARM; PAIN IN HEAD; SUPRAVENTRICULAR TACHYCARDIA IN HEART; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient is in excellent health. The patient had no history of pre-existing medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the patient experienced supraventricular tachycardia in heart. Laboratory data included: Heart rate (NR: not provided) 167 bpm.  On an unspecified date, the patient experienced pain in neck, pain in face, pain in lungs with shortness of breath, pain in shoulder, tingling, numbness, pain in feet/arm, and pain in head. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normalcy, Lab test (NR: not provided) Normal, and X-ray (NR: not provided) normalcy. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, numbness, pain in feet/arm, pain in head, pain in neck, pain in shoulder, pain in face, supraventricular tachycardia in heart and pain in lungs with shortness of breath was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: PAIN IN NECK; PAIN IN FACE; PAIN IN LUNGS WITH SHORTNESS OF BREATH; PAIN IN SHOULDER; TINGLING; NUMBNESS; PAIN IN FEET/ARM; PAIN IN HEAD; SUPRAVENTRICULAR TACHYCARDIA IN HEART; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient is in excellent health. The patient had no history of pre-existing medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the patient experienced supraventricular tachycardia in heart. Laboratory data included: Heart rate (NR: not provided) 167 bpm.  On an unspecified date, the patient experienced pain in neck, pain in face, pain in lungs with shortness of breath, pain in shoulder, tingling, numbness, pain in feet/arm, and pain in head. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normalcy, Lab test (NR: not provided) Normal, and X-ray (NR: not provided) normalcy. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, numbness, pain in feet/arm, pain in head, pain in neck, pain in shoulder, pain in face, supraventricular tachycardia in heart and pain in lungs with shortness of breath was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain, Supraventricular tachycardia, X-ray
Clinical narrative: PAIN IN NECK; PAIN IN FACE; PAIN IN LUNGS WITH SHORTNESS OF BREATH; PAIN IN SHOULDER; TINGLING; NUMBNESS; PAIN IN FEET/ARM; PAIN IN HEAD; SUPRAVENTRICULAR TACHYCARDIA IN HEART; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient is in excellent health. The patient had no history of pre-existing medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the patient experienced supraventricular tachycardia in heart. Laboratory data included: Heart rate (NR: not provided) 167 bpm.  On an unspecified date, the patient experienced pain in neck, pain in face, pain in lungs with shortness of breath, pain in shoulder, tingling, numbness, pain in feet/arm, and pain in head. Laboratory data (dates unspecified) included: CT scan (NR: not provided) normalcy, Lab test (NR: not provided) Normal, and X-ray (NR: not provided) normalcy. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling, numbness, pain in feet/arm, pain in head, pain in neck, pain in shoulder, pain in face, supraventricular tachycardia in heart and pain in lungs with shortness of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue
Clinical narrative: BRUISES ON LOWER LEFT ARM OR TINY BLOOD SPOTS UNDER SKIN  AND EASY BRUISING; EXTREMELY TIRED (COMPARED THIS LEVEL OF TIREDNESS TO BEING PREGNANT); This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 160 pounds, and height was 61 inches. The patient's past medical history included: stents, and concurrent conditions included: non smoker, and alcohol use, and other pre-existing medical conditions included: patient felt tired prior to receiving the vaccine, The patient had no known drug allergies and and no history of drug abuse or illicit dug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. Concomitant medications included cyanocobalamin for tiredness.  On an unspecified date, the patient experienced bruises on lower left arm or tiny blood spots under skin and easy bruising, and extremely tired (compared this level of tiredness to being pregnant). The action taken with covid-19 vaccine was not applicable. The outcome of the extremely tired (compared this level of tiredness to being pregnant) and bruises on lower left arm or tiny blood spots under skin and easy bruising was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908782.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 11-SEP-2021) dose was not reported, 1 total, administered on left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-AUG-2021, the patient tested positive for Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure) and was quarantined. Patient lost taste and was fatigued. On 05-SEP-2021, at about midnight and at 15:00, patient went to the bathroom. The patient reported no muscle pain and no bunion pain. The patient had lost taste and smell again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210908708-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hangover
Clinical narrative: WORST HANGOVER HAVE EVER HAD (DON'T KNOW IF DRINK) TIMES IT BY 10; MESSED UP; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the patient experienced worst hangover have ever had (don't know if drink) times it by 10, messed up, and chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from messed up, and the outcome of worst hangover have ever had (don't know if drink) times it by 10 and chills was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: VERY SORE ARM AND ACHINESS IN LEGS WITH SHARP PAINS; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's pre-existing medical conditions included: The patient had no known allergies and no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced very sore arm and achiness in legs with sharp pains. The action taken with covid-19 vaccine was not applicable. The patient recovered from very sore arm and achiness in legs with sharp pains on SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20210909059.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Condition aggravated, Diplopia, Eye movement disorder
Clinical narrative: DIFFICULTY IN MOVING EYES; DOUBLE VISION; BEEN INCREASING THE LAST OF 24 HOURS; NORMAL SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced normal symptoms. On 01-SEP-2021, the patient experienced difficulty in moving eyes. On 01-SEP-2021, the patient experienced double vision. On 01-SEP-2021, the patient experienced been increasing the last of 24 hours. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from normal symptoms, difficulty in moving eyes, double vision, and been increasing the last of 24 hours. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-SEP-2021, the patients experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908676 and 20210908685.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: SWEATS; CHILLS FOR TWO WEEKS; FEVER; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient reported that she might had a very mild case of COVID19 last year and reacted to the shot. The patient received covid-19 vaccine (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 patient experienced sweats, chills for two weeks, and fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from sweats, chills for two weeks, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site reaction, Muscular weakness, Vaccination site pain
Clinical narrative: UNTIL NOW ITS SO TIGHT; EVERY TIME PUT HANDS UP DON'T HAVE STRENGTH, VERY WEAK; AFTER I HAVE VACCINE IN THAT SPOT THE PAIN IS THERE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 07-APR-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.  On 2021, the patient experienced until now its so tight. On 2021, the patient experienced every time put hands up don't have strength, very weak. On 2021, the patient experienced after i have vaccine in that spot the pain is there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from until now its so tight, and every time put hands up don't have strength, very weak, and the outcome of after i have vaccine in that spot the pain is there was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Limb discomfort, Movement disorder, Peripheral swelling
Clinical narrative: RIGHT KNEE SWOLLEN AND ACTING WEIRD; BOTH LEGS SWOLLEN BUT IT MORE ON THE RIGHT ONE; HAS TO WAIT A LITTLE  WHEN TRYING TO GET UP FROM SITTING POSITION BECAUSE LEG LIKE FREEZING; UNCOMFORTABLE GETTING IN OR OUT OF THE CAR/THE LEG BOTHERS WHEN TRYING TO EXTEND IT; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, occasional alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, and patient was very healthy. The patient was not on heavy medication except regular over the counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-SEP-2021, the patient experienced right knee swollen and acting weird. On 04-SEP-2021, the patient experienced both legs swollen but it more on the right one. On 04-SEP-2021, the patient experienced has to wait a little when trying to get up from sitting position because leg like freezing. On 04-SEP-2021, the patient experienced uncomfortable getting in or out of the car/the leg bothers when trying to extend it. The action taken with covid-19 vaccine was not applicable. The outcome of the uncomfortable getting in or out of the car/the leg bothers when trying to extend it, right knee swollen and acting weird, both legs swollen but it more on the right one and has to wait a little when trying to get up from sitting position because leg like freezing was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Muscle tightness, Pain, Sensory disturbance
Clinical narrative: ANXIETY; MILD ACHES; FELT LIKE PINCHING IN THE ARMPIT  (FURTHER MENTIONED NOT IN THE ARMPIT AND MORE TOWARDS THE TOP PART OF THE SHOULDER ON THE LEFT SIDE); PULSATING FEELING (FELT BLOOD PUMPING FROM PALM UP TO ELBOW AND HIS SHOULDER AND THE CHEST) BUT ONLY ON THE LEFT SIDE; TIGHT MUSCLE FEELING IN THE CHEST, SHOULDER AND THE ARM ON THE LEFT SIDE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, penicillin allergy, seasonal allergies, alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had 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: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 04-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-SEP-2021, the patient experienced pulsating feeling (felt blood pumping from palm up to elbow and his shoulder and the chest) but only on the left side. On 04-SEP-2021, the patient experienced tight muscle feeling in the chest, shoulder and the arm on the left side. On 04-SEP-2021, the patient experienced mild aches. On 04-SEP-2021, the patient experienced felt like pinching in the armpit (further mentioned not in the armpit and more towards the top part of the shoulder on the left side). On 05-SEP-2021, the patient experienced anxiety. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulsating feeling (felt blood pumping from palm up to elbow and his shoulder and the chest) but only on the left side on 04-SEP-2021, was recovering from mild aches, and had not recovered from tight muscle feeling in the chest, shoulder and the arm on the left side, anxiety, and felt like pinching in the armpit (further mentioned not in the armpit and more towards the top part of the shoulder on the left side). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: GENERAL ACHE; MISERABLE; SORE ARM; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced general ache. On SEP-2021, the patient experienced miserable. On SEP-2021, the patient experienced sore arm. On SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, sore arm, general ache and miserable was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908676, 20210908685 and 20210908729.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dysacusis, Hypoacusis, Pain in jaw, Tinnitus
Clinical narrative: LEFT JAW AREA HURTS; CAN'T HEAR WELL; MAKES AN ECHO NOISE; HIGH RINGING IN LEFT EAR; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: congestive heart failure, grand mal seizures, chronic obstructive pulmonary disease, back problem, leg problem, on oxygen, abstains from alcohol, and cigarette smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with phenobarbital. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. Concomitant medications included oxygen.  On SEP-2021, the patient experienced left jaw area hurts. On SEP-2021, the patient experienced can't hear well. On SEP-2021, the patient experienced makes an echo noise. On SEP-2021, the patient experienced high ringing in left ear. The action taken with covid-19 vaccine was not applicable. The outcome of the high ringing in left ear, left jaw area hurts, can't hear well and makes an echo noise was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; body aches; A spontaneous report was received from a type concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, body aches.  The patient's medical history was not provided. Concomitant medications reported were Acetaminophen for drug use for unknown indication.  No relevant lab data was reported by the reporter.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient experienced chills, body aches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, body aches was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Red rash on left arm; Nausea; Fatigue; Headache; Fever; Chills; Normal red rash; Usual discomfort at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (NORVASC), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 15-Feb-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (Usual discomfort at injection site). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Normal red rash). On 16-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021 at 9:00 PM, the patient experienced FATIGUE (Fatigue). On 17-Mar-2021, the patient experienced NAUSEA (Nausea). On 15-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on left arm). The patient was treated with MULTIVITAMINS [VITAMINS NOS] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Supplements and vitamins were given as concomitant medications.  Patient reported that no medication was taken to relieve the symptoms of 48 hour duration. Patient woke up next morning at 1230am with headache, fever, chills, and nausea beginning at 430am and normal red rash   This case was linked to MOD-2021-064379 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: significant follow up contains updated narrative (no treatment taken)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site discomfort
Clinical narrative: Red rash on left arm; Nausea; Fatigue; Headache; Fever; Chills; Normal red rash; Usual discomfort at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (NORVASC), HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID) and LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 15-Feb-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 1:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOMFORT (Usual discomfort at injection site). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Normal red rash). On 16-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021 at 9:00 PM, the patient experienced FATIGUE (Fatigue). On 17-Mar-2021, the patient experienced NAUSEA (Nausea). On 15-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on left arm). The patient was treated with MULTIVITAMINS [VITAMINS NOS] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash on left arm), VACCINATION SITE DISCOMFORT (Usual discomfort at injection site), RASH ERYTHEMATOUS (Normal red rash), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Supplements and vitamins were given as concomitant medications.  Patient reported that no medication was taken to relieve the symptoms of 48 hour duration. Patient woke up next morning at 1230am with headache, fever, chills, and nausea beginning at 430am and normal red rash   This case was linked to MOD-2021-064379 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: significant follow up contains updated narrative (no treatment taken)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pyrexia
Clinical narrative: Breast pain on same side as the shot; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain on same side as the shot) and PYREXIA (Low grade fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included METFORMIN and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced BREAST PAIN (Breast pain on same side as the shot) and PYREXIA (Low grade fever). At the time of the report, BREAST PAIN (Breast pain on same side as the shot) had not resolved and PYREXIA (Low grade fever) outcome was unknown.            No treatment medication was provided. The patient was waiting to get an appointment with the physician and would follow back when possible.   This case was linked to MOD-2021-246443 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: follow up : Breast pain event outcome was updated to not recovered
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash erythematous
Clinical narrative: red rash all over body, it was on her arms, legs, back and groin were all red; Red rash all over face/her face was all bright red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Red rash all over face/her face was all bright red) and RASH ERYTHEMATOUS (red rash all over body, it was on her arms, legs, back and groin were all red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy since 1950. Concomitant products included VITAMINS NOS, GLUCOSAMINE, CHONDROITIN and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3) 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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced ERYTHEMA (Red rash all over face/her face was all bright red). On 25-Jun-2021, the patient experienced RASH ERYTHEMATOUS (red rash all over body, it was on her arms, legs, back and groin were all red). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) from 22-Jun-2021 to 30-Jun-2021 for Adverse event, at a dose of 20 milligram once a day. On 24-Jun-2021, ERYTHEMA (Red rash all over face/her face was all bright red) had resolved. On 15-Jul-2021, RASH ERYTHEMATOUS (red rash all over body, it was on her arms, legs, back and groin were all red) had resolved.            No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-250539 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Significant follow up received on 20-Aug-2021 which includes event outcome, Medical history, concomitant medication, treatment medication date updated.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication were provided.  No treatment information was provided.   This case was linked to MOD-2021-027888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received contains non significant information.Patient date of vaccination changed from 02-FEB-2021 to 01FEB-2021 (initial version).