chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, more than a month after vaccination, it was reported that the patient underwent COV-2 antibody IgG (Immunoglobulin G) test and the results were negative. It was also reported that on an unspecified date, the patient blood work were taken and had detected antibodies against SARS-CoV-2 spike protein including the receptor binding domain (RBD). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210521321- covid-19 vaccine ad26.cov2.s-confirmed immunological 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
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: BILATERAL SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced bilateral swelling in hands and feet. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bilateral swelling in hands and feet. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: BLOOD CLOTS; HEART ATTACK; This spontaneous report received from a social media via a company representative concerned a patient of unspecified age and sex with unknown ethnicity. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry were unknown) 1 total 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 heart attack due to blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522101-Covid-19 vaccine ad26.cov2.s-Blood clots, Heart attack. This event(s) is considered un-assessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vision blurred, Visual impairment
Clinical narrative: LIGHT SENSITIVITY TO EYES; BLURRED VISION; VISION CHANGES; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included connective tissue disease, polyglandular failure (type 2), and raynaud's disease, and concurrent conditions included fibromyalgia, chronic hashimoto's disease, chronic lyme's disease, hypophosphatasia, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with clindamycin, codeine, lansoprazole, and glycopyrronium bromide. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced light sensitivity to eyes. On 10-MAY-2021, the subject experienced blurred vision. On 10-MAY-2021, the subject experienced vision changes. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from light sensitivity to eyes, blurred vision, and vision changes. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: DID NOT GET ALLERGY FROM ANIMAL DANDER AND FAT PUMP DECREASED BY HALF; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included allergy to animal hair, and fiberglass allergy, and concurrent conditions included hypertension, abstains from alcohol, non smoker, and huge fat pump on left arm, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1818609) dose was not reported, administered on 15-MAR-2021 14:00 on left arm for prophylactic vaccination. Concomitant medications included amlodipine for hypertension, hydrochlorothiazide for hypertension, lisinopril for hypertension, and metformin for hypertension. On 2021, the subject experienced did not get allergy from animal dander and fat pump decreased by half. The action taken with covid-19 vaccine  was not applicable. The outcome of did not get allergy from animal dander and fat pump decreased by half was not reported. This report was non-serious..
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Injection site pain, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: HEART ACHE; SORE THROAT; BODY ACHE; SNIFFLES; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned an 81 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, disabled, emphysema, and seasonal allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced injection site soreness. On 08-MAY-2021, the subject experienced sniffles. On 10-MAY-2021, the subject experienced body ache. On 11-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced heart ache. The action taken with covid-19 vaccine was not applicable. The patient was recovering from injection site soreness, and sniffles, and had not recovered from body ache, heart ache, and sore throat. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: PRODUCT STORED AT ROOM TEMPERATURE FOR 3 HOURS; EXPIRED DOSE WAS ADMINISTRATED TO THE PATIENT; This spontaneous report received from a pharmacist concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021, the subject experienced expired dose was administrated to the subject. On an unspecified date, the subject experienced product stored at room temperature for 3 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the expired dose was administrated to the patient and product stored at room temperature for 3 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite
Clinical narrative: LACK OF APPETITE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-MAY-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 10-MAY-2021, the subject experienced lack of appetite. On 10-MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The outcome of the chills and lack of appetite was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Nausea, Nodule, Pain in extremity
Clinical narrative: RED BRUISE TO LEFT ARM; LEFT ARM WARM TO TOUCH; HARD KNOT ON LEFT ARM; PAIN TO LEFT SHOULDER/ARM; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included cyclic vomiting syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 09-MAY-2021, the subject experienced pain to left shoulder/arm. On 09-MAY-2021, the subject experienced headache. On 09-MAY-2021, the subject experienced nausea. On 10-MAY-2021, the subject experienced hard knot on left arm. On 11-MAY-2021, the subject experienced left arm warm to touch. On 12-MAY-2021, the subject experienced red bruise to left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and nausea, and had not recovered from hard knot on left arm, pain to left shoulder/arm, left arm warm to touch, and red bruise to left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: RED BRUISE TO LEFT ARM; LEFT ARM WARM TO TOUCH; HARD KNOT ON LEFT ARM; PAIN TO LEFT SHOULDER/ARM; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included cyclic vomiting syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 09-MAY-2021, the subject experienced pain to left shoulder/arm. On 09-MAY-2021, the subject experienced headache. On 09-MAY-2021, the subject experienced nausea. On 10-MAY-2021, the subject experienced hard knot on left arm. On 11-MAY-2021, the subject experienced left arm warm to touch. On 12-MAY-2021, the subject experienced red bruise to left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and nausea, and had not recovered from hard knot on left arm, pain to left shoulder/arm, left arm warm to touch, and red bruise to left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no previous immunization and no patient medical history. The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sick. The action taken with covid-19 vaccine was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: MILD HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A,expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced mild headache. On 13-MAY-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.3 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from low grade fever, and mild headache. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: BODY PAIN; HEAD IS SWIMMY/LIGHT-HEADED; CHILLS; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included no known allergies no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced body pain. On 13-MAY-2021, the subject experienced head is swimmy/light-headed. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, body pain, head is swimmy/light-headed, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Decreased appetite, Dysgeusia
Clinical narrative: FLU LIKE SYMPTOMS; STOMACH ISSUES; BODY ACHES; LOSS OF APPETITE; FELT AWFUL; CHILLS; LOST OF TASTE BUDS; METALLIC TASTE; INJECTION SITE PAIN; FEVER; ARM STARTED TO HURT; LIPS BURNING; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included steroid allergy, sulfa drugs allergy, allergic to metals, some other seasonal allergies, cancer, lyme disease, and disability in the foot, and other pre-existing medical conditions included patient was allergic to spine injection. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A2A, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included codeine, ibuprofen, and paracetamol. On 29-APR-2021, the subject experienced lips burning. On 29-APR-2021, the subject experienced arm started to hurt. On 29-APR-2021, the subject experienced injection site pain. On 29-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 09-MAY-2021, the subject experienced lost of taste buds. On 09-MAY-2021, the subject experienced metallic taste. On 10-MAY-2021, the subject experienced flu like symptoms. On 10-MAY-2021, the subject experienced stomach issues. On 10-MAY-2021, the subject experienced body aches. On 10-MAY-2021, the subject experienced loss of appetite. On 10-MAY-2021, the subject experienced felt awful. On 10-MAY-2021, the subject experienced chills. On 11-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and Influenza virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from lips burning, and injection site pain on 2021, was recovering from fever, chills, flu like symptoms, stomach issues, body aches, loss of appetite, felt awful, and arm started to hurt, and had not recovered from lost of taste buds, and metallic taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastric disorder, Influenza like illness, Influenza virus test, Injection site pain
Clinical narrative: FLU LIKE SYMPTOMS; STOMACH ISSUES; BODY ACHES; LOSS OF APPETITE; FELT AWFUL; CHILLS; LOST OF TASTE BUDS; METALLIC TASTE; INJECTION SITE PAIN; FEVER; ARM STARTED TO HURT; LIPS BURNING; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included steroid allergy, sulfa drugs allergy, allergic to metals, some other seasonal allergies, cancer, lyme disease, and disability in the foot, and other pre-existing medical conditions included patient was allergic to spine injection. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A2A, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included codeine, ibuprofen, and paracetamol. On 29-APR-2021, the subject experienced lips burning. On 29-APR-2021, the subject experienced arm started to hurt. On 29-APR-2021, the subject experienced injection site pain. On 29-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 09-MAY-2021, the subject experienced lost of taste buds. On 09-MAY-2021, the subject experienced metallic taste. On 10-MAY-2021, the subject experienced flu like symptoms. On 10-MAY-2021, the subject experienced stomach issues. On 10-MAY-2021, the subject experienced body aches. On 10-MAY-2021, the subject experienced loss of appetite. On 10-MAY-2021, the subject experienced felt awful. On 10-MAY-2021, the subject experienced chills. On 11-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and Influenza virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from lips burning, and injection site pain on 2021, was recovering from fever, chills, flu like symptoms, stomach issues, body aches, loss of appetite, felt awful, and arm started to hurt, and had not recovered from lost of taste buds, and metallic taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: FLU LIKE SYMPTOMS; STOMACH ISSUES; BODY ACHES; LOSS OF APPETITE; FELT AWFUL; CHILLS; LOST OF TASTE BUDS; METALLIC TASTE; INJECTION SITE PAIN; FEVER; ARM STARTED TO HURT; LIPS BURNING; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included steroid allergy, sulfa drugs allergy, allergic to metals, some other seasonal allergies, cancer, lyme disease, and disability in the foot, and other pre-existing medical conditions included patient was allergic to spine injection. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A2A, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included codeine, ibuprofen, and paracetamol. On 29-APR-2021, the subject experienced lips burning. On 29-APR-2021, the subject experienced arm started to hurt. On 29-APR-2021, the subject experienced injection site pain. On 29-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 09-MAY-2021, the subject experienced lost of taste buds. On 09-MAY-2021, the subject experienced metallic taste. On 10-MAY-2021, the subject experienced flu like symptoms. On 10-MAY-2021, the subject experienced stomach issues. On 10-MAY-2021, the subject experienced body aches. On 10-MAY-2021, the subject experienced loss of appetite. On 10-MAY-2021, the subject experienced felt awful. On 10-MAY-2021, the subject experienced chills. On 11-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative, and Influenza virus test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The patient recovered from lips burning, and injection site pain on 2021, was recovering from fever, chills, flu like symptoms, stomach issues, body aches, loss of appetite, felt awful, and arm started to hurt, and had not recovered from lost of taste buds, and metallic taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Nausea, Pyrexia
Clinical narrative: NAUSEA; MUSCLE ACHES; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced muscle aches. On 08-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 -100 F. On 13-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from nausea, fever, and muscle aches. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: LIGHT-HEADEDNESS; BODY ACHES; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced light-headedness. On 13-MAY-2021, the subject experienced body aches. The action taken with covid-19 vaccine was not applicable. The patient recovered from light-headedness, and body aches on 13-MAY-2021. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Presyncope
Clinical narrative: FEELS HORRIBLE; SEVERE FLU LIKE SYMPTOMS; ALMOST PASSED OUT; This spontaneous report received from a consumer concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included work out. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced severe flu like symptoms. On 12-MAY-2021, the subject experienced almost passed out. On 13-MAY-2021, the subject experienced feels horrible. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from feels horrible, and the outcome of severe flu like symptoms and almost passed out was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: FELL ASLEEP; FEVER; VERY TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 14-MAY-2021, the subject experienced fever. On 14-MAY-2021, the subject experienced fell asleep. On 14-MAY-2021, the subject experienced very tired.  Laboratory data included: Body temperature (NR: not provided) 100 degree. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, very tired and fell asleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain
Clinical narrative: SORE THROAT; THROBBING HEADACHE; STOMACH PAIN THAT HE DESCRIBED AS MUSCLE PAIN; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, non smoker, and stuffy head, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced sore throat. On 13-MAY-2021, the subject experienced throbbing headache. On 13-MAY-2021, the subject experienced stomach pain that he described as muscle pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from throbbing headache, stomach pain that he described as muscle pain, and sore throat. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the fever, chills and headache was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Nausea, Pain
Clinical narrative: VOMITING; BODY ACHES; CHILLS; FEVER; NAUSEA; PAIN IN ARM; WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced pain in arm. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021 22:00, the subject experienced vomiting. On 12-MAY-2021 22:00, the subject experienced body aches. On 12-MAY-2021 22:00, the subject experienced chills. On 12-MAY-2021 22:00, the subject experienced fever. On 12-MAY-2021 22:00, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) Pretty high. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, and had not recovered from chills, body aches, nausea, vomiting, pain in arm, and weakness. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: VOMITING; BODY ACHES; CHILLS; FEVER; NAUSEA; PAIN IN ARM; WEAKNESS; This spontaneous report received from a patient concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced pain in arm. On 12-MAY-2021, the subject experienced weakness. On 12-MAY-2021 22:00, the subject experienced vomiting. On 12-MAY-2021 22:00, the subject experienced body aches. On 12-MAY-2021 22:00, the subject experienced chills. On 12-MAY-2021 22:00, the subject experienced fever. On 12-MAY-2021 22:00, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) Pretty high. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, and had not recovered from chills, body aches, nausea, vomiting, pain in arm, and weakness. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced severe headache. The action taken with covid-19 vaccine  was not applicable. The outcome of severe headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Vision blurred
Clinical narrative: SEVERE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced severe headache. The action taken with covid-19 vaccine  was not applicable. The outcome of severe headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Gastrooesophageal reflux disease, Head discomfort, Headache
Clinical narrative: PRESSURE IN HER HEAD; SOME ACID REFLUX; FELT SUPER BAD; SOME PAIN ALL OVER THE BODY; A LOT OF CHILLS; HEADACHES; HIGH FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced pressure in her head. On 12-MAY-2021, the subject experienced some acid reflux. On 12-MAY-2021, the subject experienced felt super bad. On 12-MAY-2021, the subject experienced some pain all over the body. On 12-MAY-2021, the subject experienced a lot of chills. On 12-MAY-2021, the subject experienced headaches. On 12-MAY-2021, the subject experienced high fever. On 13-MAY-2021 03:00:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from some pain all over the body, headaches, pressure in her head, a lot of chills, high fever, and some acid reflux, and the outcome of felt super bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: PRESSURE IN HER HEAD; SOME ACID REFLUX; FELT SUPER BAD; SOME PAIN ALL OVER THE BODY; A LOT OF CHILLS; HEADACHES; HIGH FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced pressure in her head. On 12-MAY-2021, the subject experienced some acid reflux. On 12-MAY-2021, the subject experienced felt super bad. On 12-MAY-2021, the subject experienced some pain all over the body. On 12-MAY-2021, the subject experienced a lot of chills. On 12-MAY-2021, the subject experienced headaches. On 12-MAY-2021, the subject experienced high fever. On 13-MAY-2021 03:00:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from some pain all over the body, headaches, pressure in her head, a lot of chills, high fever, and some acid reflux, and the outcome of felt super bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood pressure measurement, Dizziness, Fatigue
Clinical narrative: BLOOD PRESSURE 133/88; DIZZINESS; NECK PAIN; STOMACH UNSETTLED; LEGS ARE WOBBLY; WEAKNESS; TIRED; BACK OF HEAD PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 133/88 mmHg. On an unspecified date, the subject experienced blood pressure 133/88, dizziness, neck pain, stomach unsettled, legs are wobbly, weakness, tired, and back of head pain. The action taken with covid-19 vaccine  was not applicable. The outcome of the blood pressure 133/88, weakness, dizziness, neck pain, stomach unsettled, legs are wobbly, tired and back of head pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Muscular weakness, Neck pain
Clinical narrative: BLOOD PRESSURE 133/88; DIZZINESS; NECK PAIN; STOMACH UNSETTLED; LEGS ARE WOBBLY; WEAKNESS; TIRED; BACK OF HEAD PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 133/88 mmHg. On an unspecified date, the subject experienced blood pressure 133/88, dizziness, neck pain, stomach unsettled, legs are wobbly, weakness, tired, and back of head pain. The action taken with covid-19 vaccine  was not applicable. The outcome of the blood pressure 133/88, weakness, dizziness, neck pain, stomach unsettled, legs are wobbly, tired and back of head pain was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Fatigue, Hypertensive emergency
Clinical narrative: Blood pressure went up to 190/120; High grade fever of 102.7F; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120) (seriousness criterion medically significant), PYREXIA (High grade fever of 102.7F), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Feb-2021, HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120), PYREXIA (High grade fever of 102.7F), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: high (High) 190/120 mmHg.. On 13-Feb-2021, Body temperature: high (High) 102 degree Fahrenheit.. On 13-Feb-2021, Pulse abnormal: high (High) 116..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes Tylenol.  Company Comment: This case concerns a 67-year-old male with a serious unexpected event of hypertensive emergency, and nonserious expected pyrexia, chills, and fatigue. Latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: Additional information included specific side effects/events that the patient experienced.; Sender's Comments: This case concerns a 67-year-old male with a serious unexpected event of hypertensive emergency, and nonserious expected pyrexia, chills, and fatigue. Latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse abnormal, Pyrexia
Clinical narrative: Blood pressure went up to 190/120; High grade fever of 102.7F; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120) (seriousness criterion medically significant), PYREXIA (High grade fever of 102.7F), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Feb-2021, HYPERTENSIVE EMERGENCY (Blood pressure went up to 190/120), PYREXIA (High grade fever of 102.7F), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: high (High) 190/120 mmHg.. On 13-Feb-2021, Body temperature: high (High) 102 degree Fahrenheit.. On 13-Feb-2021, Pulse abnormal: high (High) 116..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes Tylenol.  Company Comment: This case concerns a 67-year-old male with a serious unexpected event of hypertensive emergency, and nonserious expected pyrexia, chills, and fatigue. Latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: Additional information included specific side effects/events that the patient experienced.; Sender's Comments: This case concerns a 67-year-old male with a serious unexpected event of hypertensive emergency, and nonserious expected pyrexia, chills, and fatigue. Latency 9 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Surgery
Clinical narrative: Had Colon surgery, removed 6-8 inch of colon and reattached; He also got an infection and is on antibiotics now; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SURGERY (Had Colon surgery, removed 6-8 inch of colon and reattached) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Years back).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SURGERY (Had Colon surgery, removed 6-8 inch of colon and reattached) (seriousness criterion medically significant) and INFECTION (He also got an infection and is on antibiotics now). At the time of the report, SURGERY (Had Colon surgery, removed 6-8 inch of colon and reattached) and INFECTION (He also got an infection and is on antibiotics now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood thinners. Treatment for the event included antibiotics.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin reaction, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Massive outbreak of urticaria/Hives) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). On 22-Jan-2021, the patient experienced URTICARIA (Massive outbreak of urticaria/Hives) (seriousness criterion medically significant). On 26-Jan-2021, the patient experienced SKIN REACTION (Delayed reaction). At the time of the report, URTICARIA (Massive outbreak of urticaria/Hives), SKIN REACTION (Delayed reaction) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 80-year-old female with a serious unexpected event  of urticaria, and nonserious unexpected skin reaction and expected rash. Latency 8 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 80-year-old female with a serious unexpected event  of urticaria, and nonserious unexpected skin reaction and expected rash. Latency 8 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.