chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Injection site pain
Clinical narrative: FEELING VERY SICK; FATIGUE/ FEELING REALLY TIRED; FEVER OF 102F; ARM PAIN AT INJECTION SITE; POOR APPETITE/ NOT AT ALL HUNGRY AND STILL CAN'T EAT THIS MORNING; BODY ACHES; FELT COLD AND HAD CHILLS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 135 pounds, and height was 62 inches. The patient's concurrent conditions included: kidney issue, penicillin allergy, and migraines, and other pre-existing medical conditions included: Patient was not pregnant at the time of report. The patient experienced drug allergy when treated with acetylsalicylic acid, ibuprofen, oxycodone hydrochloride/paracetamol, and acetylsalicylic acid/caffeine/homatropine terephthalate/oxycodone hydrochloride/oxycodone terephthalate/phenacetin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-OCT-2021, the patient experienced poor appetite/ not at all hungry and still can't eat this morning. On 19-OCT-2021, the patient experienced body aches. On 19-OCT-2021, the patient experienced felt cold and had chills. On 19-OCT-2021, the patient experienced fatigue/ feeling really tired. On 19-OCT-2021, the patient experienced  fever of 102F. On 19-OCT-2021, the patient experienced arm pain at injection site. Laboratory data included: Body temperature (NR: not provided) 102 F. On 20-OCT-2021, the patient experienced feeling very sick. Treatment medications included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt cold and had chills, and had not recovered from fatigue/ feeling really tired,  fever of 102F, arm pain at injection site, body aches, poor appetite/ not at all hungry and still can't eat this morning, and feeling very sick. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: FEELING VERY SICK; FATIGUE/ FEELING REALLY TIRED; FEVER OF 102F; ARM PAIN AT INJECTION SITE; POOR APPETITE/ NOT AT ALL HUNGRY AND STILL CAN'T EAT THIS MORNING; BODY ACHES; FELT COLD AND HAD CHILLS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 135 pounds, and height was 62 inches. The patient's concurrent conditions included: kidney issue, penicillin allergy, and migraines, and other pre-existing medical conditions included: Patient was not pregnant at the time of report. The patient experienced drug allergy when treated with acetylsalicylic acid, ibuprofen, oxycodone hydrochloride/paracetamol, and acetylsalicylic acid/caffeine/homatropine terephthalate/oxycodone hydrochloride/oxycodone terephthalate/phenacetin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-OCT-2021, the patient experienced poor appetite/ not at all hungry and still can't eat this morning. On 19-OCT-2021, the patient experienced body aches. On 19-OCT-2021, the patient experienced felt cold and had chills. On 19-OCT-2021, the patient experienced fatigue/ feeling really tired. On 19-OCT-2021, the patient experienced  fever of 102F. On 19-OCT-2021, the patient experienced arm pain at injection site. Laboratory data included: Body temperature (NR: not provided) 102 F. On 20-OCT-2021, the patient experienced feeling very sick. Treatment medications included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt cold and had chills, and had not recovered from fatigue/ feeling really tired,  fever of 102F, arm pain at injection site, body aches, poor appetite/ not at all hungry and still can't eat this morning, and feeling very sick. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 19 year old male. 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, intramuscular, batch number: 201A21A, expiry: 21-SEP-2021) .5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211038507, 20211038664, 20211039749, 20211038269, 20211002617, 20211034734, 20211038411, 20211038442, 20211038614 and 20211039732.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Middle insomnia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: WHILE SLEEPING, ROLL OVER ON LEFT SIDE THE PAIN AWAKENS; LEFT ARM REMAINS WARM TO THE TOUCH; LEFT ARM SLIGHTLY SWOLLEN (AREA AFFECTED APPROXIMATELY FIVE INCHES); CONTINUAL ARM PAIN; This spontaneous report received from a patient via a company representative concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had no past medical history documented. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, expiry: 21-OCT-2021) .5 ml, administered on 11-OCT-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin calcium for drug used for unknown indication..  On 11-OCT-2021, the patient experienced while sleeping, roll over on left side the pain awakens. On 11-OCT-2021, the patient experienced left arm remains warm to the touch. On 11-OCT-2021, the patient experienced left arm slightly swollen (area affected approximately five inches). On 11-OCT-2021, the patient experienced continual arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from continual arm pain, left arm remains warm to the touch, and left arm slightly swollen (area affected approximately five inches), and the outcome of while sleeping, roll over on left side the pain awakens was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood pressure increased, Blood pressure measurement, Hepatic enzyme, Hepatic enzyme increased, Musculoskeletal stiffness
Clinical narrative: GENERAL BODY PAIN (SORENESS ALL OVER); STIFFNESS ALL OVER; WEIGHT GAIN; BLOOD PRESSURE GONE UP; LIVER PROBLEMS (RAISES IN LIVER ENZYME COUNT); This spontaneous report received from a patient concerned an adult male. The patient's weight was 60 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced general body pain (soreness all over), stiffness all over, weight gain, blood pressure gone up, and liver problems (raises in liver enzyme count). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Increased, Hepatic enzyme (NR: not provided) Increased, and Weight (NR: not provided) 60 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from liver problems (raises in liver enzyme count), and had not recovered from general body pain (soreness all over), stiffness all over, weight gain, and blood pressure gone up. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Weight, Weight increased
Clinical narrative: GENERAL BODY PAIN (SORENESS ALL OVER); STIFFNESS ALL OVER; WEIGHT GAIN; BLOOD PRESSURE GONE UP; LIVER PROBLEMS (RAISES IN LIVER ENZYME COUNT); This spontaneous report received from a patient concerned an adult male. The patient's weight was 60 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced general body pain (soreness all over), stiffness all over, weight gain, blood pressure gone up, and liver problems (raises in liver enzyme count). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Increased, Hepatic enzyme (NR: not provided) Increased, and Weight (NR: not provided) 60 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from liver problems (raises in liver enzyme count), and had not recovered from general body pain (soreness all over), stiffness all over, weight gain, and blood pressure gone up. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Body temperature, Chills, Feeling abnormal
Clinical narrative: BACK ACHE; BAD HEADACHE; FEELING QUEASY; WANTED TO LIE DOWN; CHILLS; STOMACH UPSET; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: 6 stents in heart, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced stomach upset. On 12-MAR-2021, the patient experienced wanted to lie down. On 12-MAR-2021, the patient experienced chills. Laboratory data included: Body temperature (NR: not provided) NO FEVER. On 13-MAR-2021, the patient experienced back ache. On 13-MAR-2021, the patient experienced bad headache. On 13-MAR-2021, the patient experienced feeling queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset, back ache, wanted to lie down, bad headache, and feeling queasy on 13-MAR-2021, and chills on 12-MAR-2021. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: BACK ACHE; BAD HEADACHE; FEELING QUEASY; WANTED TO LIE DOWN; CHILLS; STOMACH UPSET; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: 6 stents in heart, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the patient experienced stomach upset. On 12-MAR-2021, the patient experienced wanted to lie down. On 12-MAR-2021, the patient experienced chills. Laboratory data included: Body temperature (NR: not provided) NO FEVER. On 13-MAR-2021, the patient experienced back ache. On 13-MAR-2021, the patient experienced bad headache. On 13-MAR-2021, the patient experienced feeling queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach upset, back ache, wanted to lie down, bad headache, and feeling queasy on 13-MAR-2021, and chills on 12-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Serum ferritin, Serum ferritin decreased
Clinical narrative: FERRITIN DROPPED TO ALMOST BARE MINIMUM; TROUBLE WITH STAMINA; This spontaneous report received from a parent concerned a male 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: 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/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced ferritin dropped to almost bare minimum, and trouble with stamina. Laboratory data (dates unspecified) included: Ferritin (NR: not provided) dropped to almost bare minimum. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trouble with stamina and ferritin dropped to almost bare minimum was not reported. This report was non-serious. This case, from the same reporter is linked to 20211044338.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Migraine
Clinical narrative: HORRIBLE MIGRAINE ONE WEEK AFTER RECEIVING THE VACCINE; MENSTRUAL CHANGES ONE WEEK AFTER RECEIVING THE VACCINE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced horrible migraine one week after receiving the vaccine. On APR-2021, the patient experienced menstrual changes one week after receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual changes one week after receiving the vaccine, and horrible migraine one week after receiving the vaccine. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: 2 SEVERE VOMITING; HEADACHE; 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: 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/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced 2 severe vomiting, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 2 severe vomiting and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211043449.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: HEART RUSHING; SENSATION OF BLACKING OUT; This spontaneous report received from a consumer concerned a 60 year old 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: Unknown) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-OCT-2021, the patient experienced heart rushing. On 15-OCT-2021, the patient experienced sensation of blacking out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart rushing, and sensation of blacking out. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 antibody test, Skin discolouration
Clinical narrative: SEVERE HEADACHE; TOES STARTED TO TURN PURPLE; 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 concurrent conditions included: granulomatosis with polyangiitis, and other pre-existing medical conditions included: The patient had not tested positive for Covid and had no Covid symptoms. The patient experienced leukocytoclastic vasculitis and petechia all over lower half of body when treated with influenza vaccine.  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 17-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-OCT-2021, the patient experienced toes started to turn purple. On an unspecified date, the patient experienced severe headache. Laboratory data (dates unspecified) included: SARS-CoV-2 IgG antibody test (NR: not provided) 492.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, and the outcome of toes started to turn purple was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Psychomotor hyperactivity
Clinical narrative: FEELS WIRED; TINGLING ON LEFT ARM/TINGLING FROM ELBOW DOWN TO FINGER TIPS/TINGLING IN FEET/FEELING THE TINGLING AGAIN IN LEFT HAND AND RIGHT HAND (FEELS IT IN THE OUTER SIDE OF HAND); This spontaneous report received from a patient concerned a 30 year old male. 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 drug allergies and no reported medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 20-OCT-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 20-OCT-2021, the patient experienced tingling on left arm/tingling from elbow down to finger tips/tingling in feet/feeling the tingling again in left hand and right hand (feels it in the outer side of hand). On 21-OCT-2021, the patient experienced feels wired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling on left arm/tingling from elbow down to finger tips/tingling in feet/feeling the tingling again in left hand and right hand (feels it in the outer side of hand), and feels wired. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: FEELS WIRED; TINGLING ON LEFT ARM/TINGLING FROM ELBOW DOWN TO FINGER TIPS/TINGLING IN FEET/FEELING THE TINGLING AGAIN IN LEFT HAND AND RIGHT HAND (FEELS IT IN THE OUTER SIDE OF HAND); This spontaneous report received from a patient concerned a 30 year old male. 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 drug allergies and no reported medical condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 20-OCT-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 20-OCT-2021, the patient experienced tingling on left arm/tingling from elbow down to finger tips/tingling in feet/feeling the tingling again in left hand and right hand (feels it in the outer side of hand). On 21-OCT-2021, the patient experienced feels wired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling on left arm/tingling from elbow down to finger tips/tingling in feet/feeling the tingling again in left hand and right hand (feels it in the outer side of hand), and feels wired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstrual disorder
Clinical narrative: MENSTRUAL ABNORMALITIES; DEBILITATING FATIGUE; This spontaneous report received from a patient 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, and batch number were not reported) 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/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual abnormalities, and debilitating fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual abnormalities, and debilitating fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS OF LEGS THAT PERSIST; This spontaneous report received from a consumer concerned a male 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: 1822811 expiry: UNKNOWN) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-OCT-2021, the patient experienced numbness of legs that persist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness of legs that persist. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: POTENTIAL ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a consumer 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: 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 patient experienced potential administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration of an expired vaccine was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Headache, Muscular weakness, Palpitations
Clinical narrative: GENERAL WEAKNESS IN THE LEGS AND ARMS; ODD KIND OF TINGLING THROUGHOUT BODY THAT KIND OF WENT INTO HEAD AS WELL; HEADACHE; HEAVY HEART BEAT; HOT FEELING IN FACE AND SAME HOT FEELING DOWN INTO LEGS/GENERAL WARM KIND OF FEELING; CLAMMY KIND OF FEELING; This spontaneous report received from a patient concerned a 46 year old male. 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, intramuscular, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced heavy heart beat. On 19-OCT-2021, the patient experienced hot feeling in face and same hot feeling down into legs/general warm kind of feeling. On 19-OCT-2021, the patient experienced clammy kind of feeling. On 19-OCT-2021, the patient experienced headache. On 21-OCT-2021, the patient experienced general weakness in the legs and arms. On 21-OCT-2021, the patient experienced odd kind of tingling throughout body that kind of went into head as well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from heavy heart beat, hot feeling in face and same hot feeling down into legs/general warm kind of feeling, odd kind of tingling throughout body that kind of went into head as well, general weakness in the legs and arms, and clammy kind of feeling. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: GENERAL WEAKNESS IN THE LEGS AND ARMS; ODD KIND OF TINGLING THROUGHOUT BODY THAT KIND OF WENT INTO HEAD AS WELL; HEADACHE; HEAVY HEART BEAT; HOT FEELING IN FACE AND SAME HOT FEELING DOWN INTO LEGS/GENERAL WARM KIND OF FEELING; CLAMMY KIND OF FEELING; This spontaneous report received from a patient concerned a 46 year old male. 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, intramuscular, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced heavy heart beat. On 19-OCT-2021, the patient experienced hot feeling in face and same hot feeling down into legs/general warm kind of feeling. On 19-OCT-2021, the patient experienced clammy kind of feeling. On 19-OCT-2021, the patient experienced headache. On 21-OCT-2021, the patient experienced general weakness in the legs and arms. On 21-OCT-2021, the patient experienced odd kind of tingling throughout body that kind of went into head as well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from heavy heart beat, hot feeling in face and same hot feeling down into legs/general warm kind of feeling, odd kind of tingling throughout body that kind of went into head as well, general weakness in the legs and arms, and clammy kind of feeling. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Bedridden, Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS (EXTREME BODY ACHES, EXTREME FATIGUE, LOT OF MUSCLE PAIN, BODY FEELS SO WEAK); UNUSUAL JOINT POPPING ESPECIALLY IN ELBOWS; BED RIDDEN; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 180 pounds, and height was 71 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, 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: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced unusual joint popping especially in elbows. On OCT-2021, the patient experienced bed ridden. On 13-OCT-2021, the patient experienced flu-like symptoms (extreme body aches, extreme fatigue, lot of muscle pain, body feels so weak). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms (nagging, extreme body aches, extreme fatigue, lot of muscle pain, body feels so weak), and unusual joint popping especially in elbows, and the outcome of bed ridden was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Ocular hyperaemia, Pain in extremity
Clinical narrative: ANKLE ALMOST GAVE OUT; LEFT EYE HAD REDNESS LIKE A BROKEN BLOOD VESSELS OF THE 3MM SQUARE SIZE AREA AND RED SPOT IN EYE; HIP PAIN ON RIGHT SIDE; PAIN IN BOTH KNEES WHEN WALKING OR GOING UPSTAIRS; SORE ARM IN LEFT; This spontaneous report received from a patient concerned a 57 year old male. 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: 202A21A and expiry: 21-SEP-2021) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-SEP-2021, the patient experienced sore arm in left. On 20-SEP-2021, the patient experienced pain in both knees when walking or going upstairs. On 01-OCT-2021, the patient experienced ankle almost gave out. On 01-OCT-2021, the patient experienced left eye had redness like a broken blood vessels of the 3mm square size area and red spot in eye. On 01-OCT-2021, the patient experienced hip pain on right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm in left, and the outcome of pain in both knees when walking or going upstairs, ankle almost gave out, hip pain on right side and left eye had redness like a broken blood vessels of the 3mm square size area and red spot in eye was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and did not had any drug abuse or illicit drug use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-OCT-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea. This report was non-serious. This report was associated with product quality complaint: 90000198612 .
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Pain in extremity
Clinical narrative: CHRONIC SHOULDER PAIN; LEFT LEG WAS SORE FOR WEEKS; FELT WEAK; 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 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chronic shoulder pain, left leg was sore for weeks, and felt weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left leg was sore for weeks, and the outcome of felt weak and chronic shoulder pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211042950.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Feeling hot, Joint swelling, Pain
Clinical narrative: rheumatoid arthritis; pain in his shoulders and elbow/pain in his hips and ankles; started to swell/The swelling in his upper body; pain in hand; pain in upper body; joint swelling; joints red; joint hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis) 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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant), ARTHRALGIA (pain in his shoulders and elbow/pain in his hips and ankles), SWELLING (started to swell/The swelling in his upper body), PAIN IN EXTREMITY (pain in hand), PAIN (pain in upper body), JOINT SWELLING (joint swelling), ERYTHEMA (joints red) and FEELING HOT (joint hot to touch). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; MELOXICAM for Adverse event, at an unspecified dose and frequency and GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis), ARTHRALGIA (pain in his shoulders and elbow/pain in his hips and ankles), SWELLING (started to swell/The swelling in his upper body), PAIN IN EXTREMITY (pain in hand), PAIN (pain in upper body), JOINT SWELLING (joint swelling), ERYTHEMA (joints red) and FEELING HOT (joint hot to touch) outcome was unknown.            The another medication that started with an "Imm" for rheumatoid arthritis. Concomitant medications were not reported.  Company Comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis. The event occurred after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the information regarding the dose number is not specified. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis. The event occurred after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the information regarding the dose number is not specified. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis, Swelling
Clinical narrative: rheumatoid arthritis; pain in his shoulders and elbow/pain in his hips and ankles; started to swell/The swelling in his upper body; pain in hand; pain in upper body; joint swelling; joints red; joint hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis) 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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant), ARTHRALGIA (pain in his shoulders and elbow/pain in his hips and ankles), SWELLING (started to swell/The swelling in his upper body), PAIN IN EXTREMITY (pain in hand), PAIN (pain in upper body), JOINT SWELLING (joint swelling), ERYTHEMA (joints red) and FEELING HOT (joint hot to touch). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; MELOXICAM for Adverse event, at an unspecified dose and frequency and GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis), ARTHRALGIA (pain in his shoulders and elbow/pain in his hips and ankles), SWELLING (started to swell/The swelling in his upper body), PAIN IN EXTREMITY (pain in hand), PAIN (pain in upper body), JOINT SWELLING (joint swelling), ERYTHEMA (joints red) and FEELING HOT (joint hot to touch) outcome was unknown.            The another medication that started with an "Imm" for rheumatoid arthritis. Concomitant medications were not reported.  Company Comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis. The event occurred after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the information regarding the dose number is not specified. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the serious unexpected event of Rheumatoid arthritis. The event occurred after unspecified dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the information regarding the dose number is not specified. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  It was reported that patient got two doses of the Moderna vaccine and did not get the third one.  No treatment medications reported.    This case was linked to MOD-2021-352765 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever/Fever as high as 99.5 degrees Fahrenheit; fatigue/Tired like a wet dish rag; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), PYREXIA (fever/Fever as high as 99.5 degrees Fahrenheit) and FATIGUE (fatigue/Tired like a wet dish rag) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     Concomitant products included INSULIN, LISINOPRIL, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and AZELASTINE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (Headache). On 26-Mar-2021, the patient experienced PYREXIA (fever/Fever as high as 99.5 degrees Fahrenheit) and FATIGUE (fatigue/Tired like a wet dish rag). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 27-Mar-2021, HEADACHE (Headache), PYREXIA (fever/Fever as high as 99.5 degrees Fahrenheit) and FATIGUE (fatigue/Tired like a wet dish rag) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 99.5 (High) Fever as high as 99.5 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included Pepcid patient had a roach test for antibodies at 4 months and the result was 626 IgG and on the 6 months on September 20th she took the same test and dropped 400 IgG. That was 6 months after my last shots. she still have antibodies.   This case was linked to MOD-2021-226911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Significant follow-up: Patient test details added in Inarrative
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Epistaxis, Nasal congestion
Clinical narrative: scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there; congestion in my nose; very dizzy; Fever 100F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose), DIZZINESS (very dizzy), PYREXIA (Fever 100F) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Low platelets.   On 20-Jul-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) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced PYREXIA (Fever 100F) and CHILLS (Chills). On an unknown date, the patient experienced EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose) and DIZZINESS (very dizzy). At the time of the report, EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose), DIZZINESS (very dizzy) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever 100F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Body temperature: 100f (High) Fever.         No relevant Concomitant medications were reported.   patient took dayquil 3 times for treatment of fever
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there; congestion in my nose; very dizzy; Fever 100F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose), DIZZINESS (very dizzy), PYREXIA (Fever 100F) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Low platelets.   On 20-Jul-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) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced PYREXIA (Fever 100F) and CHILLS (Chills). On an unknown date, the patient experienced EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose) and DIZZINESS (very dizzy). At the time of the report, EPISTAXIS (scratched himself in the nose and saw little blood from inside but not dripping for more than 30mins and is still there), NASAL CONGESTION (congestion in my nose), DIZZINESS (very dizzy) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever 100F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Body temperature: 100f (High) Fever.         No relevant Concomitant medications were reported.   patient took dayquil 3 times for treatment of fever
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Insomnia, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: he felt his head burning; body itching; his neck tendons are tense, his back tendons are tense; he feels tingling on his left feet, he feels tingling on his left leg; he can't sleep; he stands up and feels dizzy; he can't work; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg) and INSOMNIA (he can't sleep) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg), INSOMNIA (he can't sleep), DIZZINESS (he stands up and feels dizzy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can't work). At the time of the report, BURNING SENSATION (he felt his head burning), PRURITUS (body itching), TENDON DISCOMFORT (his neck tendons are tense, his back tendons are tense), PARAESTHESIA (he feels tingling on his left feet, he feels tingling on his left leg), INSOMNIA (he can't sleep), DIZZINESS (he stands up and feels dizzy) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can't work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. patient was tested, a CT scan and a MRI and nothing was found.