chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: DIFFICULTY SLEEPING; SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficulty sleeping. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fatigue and difficulty sleeping was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Decreased appetite, Dizziness, Feeling of body temperature change
Clinical narrative: DIZZINESS; FEELING COLD THEN WARMTH; FELT LIKE STAGGERING; COULD NOT SLEEP; COULD NOT EAT; BAD CHILLS/FREEZING; HEADACHE/HEAD HURT; LOST SENSE OF SMELL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost sense of smell. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced feeling cold then warmth. On 06-APR-2021, the subject experienced felt like staggering. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced could not eat. On 06-APR-2021, the subject experienced bad chills/freezing. On 06-APR-2021, the subject experienced headache/head hurt. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache/head hurt on 07-APR-2021, had not recovered from dizziness, bad chills/freezing, feeling cold then warmth, could not sleep, and could not eat, and the outcome of lost sense of smell and felt like staggering was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Insomnia, SARS-CoV-2 test
Clinical narrative: DIZZINESS; FEELING COLD THEN WARMTH; FELT LIKE STAGGERING; COULD NOT SLEEP; COULD NOT EAT; BAD CHILLS/FREEZING; HEADACHE/HEAD HURT; LOST SENSE OF SMELL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lost sense of smell. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced feeling cold then warmth. On 06-APR-2021, the subject experienced felt like staggering. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced could not eat. On 06-APR-2021, the subject experienced bad chills/freezing. On 06-APR-2021, the subject experienced headache/head hurt. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache/head hurt on 07-APR-2021, had not recovered from dizziness, bad chills/freezing, feeling cold then warmth, could not sleep, and could not eat, and the outcome of lost sense of smell and felt like staggering was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 08:45 to right arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Pain
Clinical narrative: FEELING ACHY; FEELING WEAK; HEAD HURTING; FEELING 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 concurrent conditions included hyperkalemia, congestive heart failure, diabetes ii, neuropathy, osteoarthritis, and chronic obstructive pulmonary disease.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included magnesium chloride for drug used for unknown indication. On APR-2021, the subject experienced feeling weak. On APR-2021, the subject experienced head hurting. On APR-2021, the subject experienced feeling sick. On 06-APR-2021, the subject experienced feeling achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, and feeling weak, and the outcome of head hurting and feeling achy was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: DIARRHEA; HEADACHES; TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 93 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, route of admin not reported, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered in Left Arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, diarrhea, and tiredness. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dyspnoea, Headache, Injection site pain
Clinical narrative: BODY ACHES; SHORTNESS OF BREATH; LOSS OF APPETITE; SORE ARM; HEADACHE; FEVER; NAUSEA; FEELS VACCINE WAS ADMINISTERED A  LITTLE HIGH ON THE SHOULDER; MORE PAINFUL SHOT THAN EXPECTED; This spontaneous report received from a patient concerned a 31 year old female. 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, intra muscular and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:45 on left arm  for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feels vaccine was administered a little high on the shoulder. On 05-APR-2021, the subject experienced more painful shot than expected. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 05-APR-2021 20:00, the subject experienced body aches. On 05-APR-2021 20:00, the subject experienced shortness of breath. On 05-APR-2021 20:00, the subject experienced loss of appetite. On 05-APR-2021 20:00, the subject experienced sore arm. On 05-APR-2021 20:00, the subject experienced headache. On 05-APR-2021 20:00, the subject experienced fever. On 05-APR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shortness of breath, loss of appetite, headache, fever, and nausea on 07-APR-2021 18:10, and more painful shot than expected on 05-APR-2021, was recovering from sore arm, and the outcome of feels vaccine was administered a little high on the shoulder was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Product administered at inappropriate site, Pyrexia
Clinical narrative: BODY ACHES; SHORTNESS OF BREATH; LOSS OF APPETITE; SORE ARM; HEADACHE; FEVER; NAUSEA; FEELS VACCINE WAS ADMINISTERED A  LITTLE HIGH ON THE SHOULDER; MORE PAINFUL SHOT THAN EXPECTED; This spontaneous report received from a patient concerned a 31 year old female. 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, intra muscular and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:45 on left arm  for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feels vaccine was administered a little high on the shoulder. On 05-APR-2021, the subject experienced more painful shot than expected. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 05-APR-2021 20:00, the subject experienced body aches. On 05-APR-2021 20:00, the subject experienced shortness of breath. On 05-APR-2021 20:00, the subject experienced loss of appetite. On 05-APR-2021 20:00, the subject experienced sore arm. On 05-APR-2021 20:00, the subject experienced headache. On 05-APR-2021 20:00, the subject experienced fever. On 05-APR-2021 20:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shortness of breath, loss of appetite, headache, fever, and nausea on 07-APR-2021 18:10, and more painful shot than expected on 05-APR-2021, was recovering from sore arm, and the outcome of feels vaccine was administered a little high on the shoulder was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling
Clinical narrative: SMALL BUMP ON ARM; ARM SWELLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 subject experienced small bump on arm, and arm swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small bump on arm and arm swelling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye disorder, Sinus headache, Visual impairment
Clinical narrative: This spontaneous report received from a patient concerned a 70 year old female. The patient's weight was 250 pounds, and height was not reported. The patient's concurrent conditions included sinus problem: seem to have a lot since covid discovered and need to stay in, sulfa, and levaquin, and other pre-existing medical conditions included the patient had allergies to things outside (different trees, shrubs, and plants.).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 17:15 on Right arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced worse sinus headache. On 05-APR-2021 01:00, the subject experienced dizziness. On 06-APR-2021, the subject experienced something black spot left eye. On 06-APR-2021, the subject experienced white spot corner of left eye. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from something black spot left eye on 06-APR-2021, was recovering from dizziness, and the outcome of worse sinus headache and white spot corner of left eye was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: PAIN IN LEFT ARM; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered to left arm on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced pain in left arm. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in left arm, and nausea on 04-APR-2021. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included high cholesterol, and spinal cord surgery. 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 03-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Influenza, Injection site pain, Pain
Clinical narrative: FELT AWFUL AND  NOT GREAT; FELT LIKE FLU; SORE, ACHES ALL OVER; HIGH FEVER; INJECTION SITE PAIN; DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin bees.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1848422, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced dizzy. On 18-MAR-2021, the subject experienced injection site pain. On 19-MAR-2021, the subject experienced felt awful and not great. On 19-MAR-2021, the subject experienced felt like flu. On 19-MAR-2021, the subject experienced sore, aches all over. On 19-MAR-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 18-MAR-2021, and felt like flu, sore aches all over, and high fever on 21-MAR-2021, and had not recovered from injection site pain, and felt awful and not great. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FELT AWFUL AND  NOT GREAT; FELT LIKE FLU; SORE, ACHES ALL OVER; HIGH FEVER; INJECTION SITE PAIN; DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin bees.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1848422, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced dizzy. On 18-MAR-2021, the subject experienced injection site pain. On 19-MAR-2021, the subject experienced felt awful and not great. On 19-MAR-2021, the subject experienced felt like flu. On 19-MAR-2021, the subject experienced sore, aches all over. On 19-MAR-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 18-MAR-2021, and felt like flu, sore aches all over, and high fever on 21-MAR-2021, and had not recovered from injection site pain, and felt awful and not great. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: LITTLE ACHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced little achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; EXHAUSTED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced headache, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and exhausted. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Myalgia
Clinical narrative: LOWER BACK PAIN; MUSCLE PAIN IN LEGS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced lower back pain. On 07-APR-2021, the patient experienced muscle pain in legs. On 07-APR-2021, the patient experienced fatigue. On 07-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain in legs, lower back pain, fatigue, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE DISCOMFORT; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no previous medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 03-APR-2021 to left arm 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 07-APR-2021, the subject experienced injection site discomfort. On 07-APR-2021, the subject experienced swelling at injection site. On 07-APR-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling at injection site, and redness at injection site, and the outcome of injection site discomfort was not reported. This report was non-serious.    I
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysgeusia, Feeling drunk, Nausea
Clinical narrative: DIZZINESS; CHEST TIGHTNESS; DRUNK FEELING; CHEMICAL TASTE IN THE BACK OF THROAT; NAUSEA; This spontaneous report received from a consumer concerned a 38 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced chest tightness. On 07-APR-2021, the subject experienced drunk feeling. On 07-APR-2021, the subject experienced chemical taste in the back of throat. On 07-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness on 07-APR-2021, and had not recovered from dizziness, nausea, drunk feeling, and chemical taste in the back of throat. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: INJECTION SITE BLEEDING; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site bleeding. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN THE FINGERS; This spontaneous report received from a pharmacist concerned a 53 year old male. 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced tingling in the fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in the fingers. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: BODY ACHE; HEADACHE; HEAD SLIGHTLY WARM TO TOUCH; 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 concurrent conditions included common allergies in the spring, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 19:30 on left arm for prophylactic vaccination. No concomitant medications were reported. . On 07-APR-2021, the subject experienced head slightly warm to touch. On 07-APR-2021 07:30, the subject experienced body ache. On 07-APR-2021 07:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, and head slightly warm to touch. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: BILATERAL LYMPH NODE SWELLING BEHIND THE EARS/ LYMPH NODE SWELLING ON THE COLLARBONE TO THE RIGHT SIDE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced bilateral lymph node swelling behind the ears/ lymph node swelling on the collarbone to the right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, and had not recovered from bilateral lymph node swelling behind the ears/ lymph node swelling on the collarbone to the right side. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Tremor
Clinical narrative: SHAKY; SHIVERS/ COLD; FATIGUE; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 09:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced shaky. On 07-APR-2021, the subject experienced shivers/ cold. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, shivers/ cold, and shaky, and had not recovered from muscle aches, and headache. This report was non-serious.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Off label use, Product administered to patient of inappropriate age
Clinical narrative: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; FLU-LIKE SYMPTOMS; This spontaneous report received from a physician concerned a 15 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 03-APR-2021, the subject experienced flu-like symptoms. On an unspecified date, the subject experienced drug administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 04-APR-2021, and the outcome of drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: INJECTION SITE PAIN; HURTS; This spontaneous report received from a patient. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced hurts. On 17-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, and the outcome of hurts was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site mass, Product administration error
Clinical narrative: INJECTION SITE BUMP; ADMINISTRATION ERROR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 07-APR-2021 to deltoid for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site bump. On 07-APR-2021, the subject experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and injection site bump was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Nausea, Pain
Clinical narrative: A LITTLE BIT OF PAIN IN THE CHEST; HURTING ALL OVER; FEELING SICK TO STOMACH; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced a little bit of pain in the chest. On 07-APR-2021, the subject experienced hurting all over. On 07-APR-2021, the subject experienced feeling sick to stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a little bit of pain in the chest, hurting all over, and feeling sick to stomach. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard  procedure as the case was assessed as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: PAIN AT RIGHT KNEE REPLACEMENT AND LEFT KNEE; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced pain at right knee replacement and left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at right knee replacement and left knee. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: INTESTINAL COMPLICATIONS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced intestinal complications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of intestinal complications was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Presyncope
Clinical narrative: FELT LIGHTHEADED AND DIZZY; BODY TINGLES; FELT LIKE HE WAS GOING TO PASS OUT; This spontaneous report received from a consumer concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 12:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced felt lightheaded and dizzy. On 06-APR-2021, the subject experienced body tingles. On 06-APR-2021, the subject experienced felt like he was going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt lightheaded and dizzy, body tingles and felt like he was going to pass out was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: PAIN; SKIN BURNING SENSATION; BURNING SENSATION IN JOINTS; CHILLS; FATIGUE; MUSCLE SORENESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, diabetes neuropathy, and lupus flare-up. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021;10:00 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced muscle soreness. On 07-APR-2021 22:00, the subject experienced pain. On 07-APR-2021 22:00, the subject experienced skin burning sensation. On 07-APR-2021 22:00, the subject experienced burning sensation in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, muscle soreness, chills, skin burning sensation, burning sensation in joints and pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: PAIN; SKIN BURNING SENSATION; BURNING SENSATION IN JOINTS; CHILLS; FATIGUE; MUSCLE SORENESS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, diabetes neuropathy, and lupus flare-up. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021;10:00 for prophylactic vaccination. The batch number was not reported and has been requested.   No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced muscle soreness. On 07-APR-2021 22:00, the subject experienced pain. On 07-APR-2021 22:00, the subject experienced skin burning sensation. On 07-APR-2021 22:00, the subject experienced burning sensation in joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, muscle soreness, chills, skin burning sensation, burning sensation in joints and pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES, BODY SORENESS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches, body soreness. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, body aches, body soreness and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced off label use, and product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.     .
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: LEG PAIN; MUSCLE ACHE; 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 concurrent conditions included arthritis. The patient was previously treated with prednisone for arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included mycophenolate mofetil for arthritis. On an unspecified date, the subject experienced leg pain, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and muscle ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: NOSE DRIP; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 subject experienced nose drip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210411567 and 20210414424.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain in extremity
Clinical narrative: FEELING WARM; SORE ARM; CHILLS / FREEZING; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 vaccinated on the left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced chills / freezing. On 07-APR-2021, the patient experienced headache. On 07-APR-2021, the patient experienced sore arm. On 07-APR-2021, the patient experienced feeling warm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, chills / freezing, and headache, and the outcome of feeling warm was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Malaise
Clinical narrative: DIZZINESS; FEELING UNWELL; FATIGUE; WEAKNESS; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no history of medical conditions and no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose was not reported, administered on 06-APR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, dizziness, weakness, and feeling unwell. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: HIVES; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included occasional alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041a21a, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 at left deltoid for prophylactic vaccination.  No concomitant medications were reported.  On 03-APR-2021, the subject experienced headaches. On 07-APR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, and hives. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Joint swelling, Nausea, Pain in extremity, Pyrexia
Clinical narrative: FOOT PAIN; SWELLING OF RIGHT ANKLE; FEVER; NAUSEA; PAIN ON THE ARM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered in left arm on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced pain on the arm. On 04-APR-2021, the subject experienced swelling of right ankle. On an unspecified date, the subject experienced foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, nausea, and pain on the arm on 04-APR-2021, and the outcome of swelling of right ankle and foot pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cough
Clinical narrative: This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not given and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced cough. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cough was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: FLU LIKE SYMPTOMS; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the patient experienced flu like symptoms. On 08-APR-2021, the patient experienced body aches. On 08-APR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, chills and body aches was not reported. This report was non-serious.