chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product leakage, Underdose
Clinical narrative: SOME OF THE SERUM CAME OUT AFTER GIVING THE INJECTION (PRODUCT LEAKAGE); SOME OF THE SERUM CAME OUT FROM THE ARM ABOUT 0.3 (POSSIBLE PARTIAL DOSE ADMINISTERED); 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, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced some of the serum came out from the arm about 0.3 (possible partial dose administered). On an unspecified date, the subject experienced some of the serum came out after giving the injection (product leakage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some of the serum came out after giving the injection (product leakage) and some of the serum came out from the arm about 0.3 (possible partial dose administered) was not reported. This report was non-serious. This report was associated with product quality complaint: 90000175305
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: BACK PAIN; LEFT AND RIGHT ARM PAIN; FEELING HOT LIKE A FEVER; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 14:00 at right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Results were not available. On 04-APR-2021, the subject experienced back pain. On 04-APR-2021, the subject experienced left and right arm pain. On 04-APR-2021, the subject experienced feeling hot like a fever. On 05-APR-2021 10:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot like a fever on 04-APR-2021, and had not recovered from left and right arm pain, and back pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: FATIGUE/FEELING REALLY TIRED; FEELING SLIGHTLY WARM; 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 was not reported, administered on 04-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 feeling slightly warm. On 05-APR-2021, the subject experienced fatigue/feeling really tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue/feeling really tired, and the outcome of feeling slightly warm was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: This spontaneous report received from a patient concerned a 19 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: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 on Left arm at 16:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lower back pain and then upper back. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced shaking. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced shivering. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain and then upper back, feeling hot, shaking, chills, and shivering, had not recovered from sweating, and the outcome of really bad headache was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: This spontaneous report received from a patient concerned a 19 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: 1808980, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 on Left arm at 16:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lower back pain and then upper back. On APR-2021, the subject experienced feeling hot. On APR-2021, the subject experienced shaking. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced shivering. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced really bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain and then upper back, feeling hot, shaking, chills, and shivering, had not recovered from sweating, and the outcome of really bad headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: RED WELTS IN ABDOMINAL AREA AND ARMS; 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 (form of admin and route of admin were not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On APR-2021, the subject experienced red welts in abdominal area and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red welts in abdominal area and arms was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysgeusia, Parosmia, Pyrexia
Clinical narrative: BITTER TASTE ON MOUTH (CHEMICAL TASTE); AN INTERMITTENT SENSE OF CHEMICAL SMELL; FEVER; This spontaneous report received from a patient concerned a 31 year old male. 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 on left arm 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 fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 05-APR-2021, the subject experienced bitter taste on mouth (chemical taste). On 05-APR-2021, the subject experienced an intermittent sense of chemical smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from bitter taste on mouth (chemical taste), and an intermittent sense of chemical smell. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: VIOLENTLY ILL; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced violently ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from violently ill. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: IMPROPER STORAGE OF PRODUCT IN USE; This spontaneous report received from a pharmacist 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: 1808978, expiry: UNKNOWN) .5 ml, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the HCP called and stated that, the vaccine which was administrated to the patient was possibly being thawed once as during storage it went back to freezing temperature (26F) as there was an issue with the fridge where it went down to freezing temperature. The exact day of when the incident with the fridge was unknown and 4 vials where involved on the issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administrated after possibly being thawed once and go back to freezing temperature (26f) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210409103-Covid-19 vaccine ad26.cov2.s-Improper storage of product in use. 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: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise, Paranasal sinus hypersecretion, Sinus disorder
Clinical narrative: SINUS DISORDER; NASAL SINUS DISCHARGE; FEELING UNWELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 MAR-2021, the subject experienced sinus disorder. On MAR-2021, the subject experienced nasal sinus discharge. On MAR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling unwell, sinus disorder and nasal sinus discharge was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: BUMP UNDER THE SKIN (KNOT AROUND 1/4 INCH BIG AND A LUMP); RED PATCH (RED SPOT); SWELLING; SORE ARM; This spontaneous report received from a consumer concerned a 70 year old female. The patient's weight was 200 pounds, and height was 63 inches. The patient's concurrent conditions included high blood pressure, type 2 diabetes mellitus, high cholesterol, skin cancer, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no 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 on 02-APR-2021 10:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced sore arm. On 03-APR-2021, the subject experienced bump under the skin (knot around 1/4 inch big and a lump). On 03-APR-2021, the subject experienced red patch (red spot). On 03-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and swelling on 04-APR-2021, and had not recovered from bump under the skin (knot around 1/4 inch big and a lump), and red patch (red spot). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: HIGH STRESS; This spontaneous report received from a patient concerned an elderly of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had underlying conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced high stress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high stress was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: LEAKING NEEDLE ON SYRINGE DURING VACCINATION; 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: not reported) dose was not reported, administered on 02-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced leaking needle on syringe during vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leaking needle on syringe during vaccination was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: BECAME 2 BUMPS/AND NOW HAD MORPHED INTO 1 BIG SWOLLEN MESS AN INCH AND A HALF IN DIAMETER; GOT ARE AND SWOLLEN/BIG SWOLLEN MESS; This spontaneous report received from a patient concerned a 60 year old of unspecified 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced became 2 bumps/and now had morphed into 1 big swollen mess an inch and a half in diameter. On APR-2021, the subject experienced got are and swollen/big swollen mess. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got are and swollen/big swollen mess and became 2 bumps/and now had morphed into 1 big swollen mess an inch and a half in diameter was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: ACHY JOINTS; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 44 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced achy joints, headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy joints, headache and tired was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION; SORE ARM; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seafood allergy, seasonal allergies (pollen), non-alcoholic, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk, Exp: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the patient experienced sore arm. On 01-APR-2021, the patient was hospitalized with Covid-19  after testing positive on 27-MAR-2021. The patient was on high level oxygen (15L @ 91% sat) and had been given remdesivir for 4 days. The patient had not been discharged from the hospital. The patient had been in a hospital for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 infection, and the outcome of sore arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210409401-JANSSEN COVID-19 VACCINE Ad26.COV2.S- COVID-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: DIAGNOSED WITH COVID AFTER VACCINE; 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) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced diagnosed with covid after vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diagnosed with covid after vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: PAIN IN SHOULDER; FATIGUE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced pain in shoulder. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in shoulder on 04-APR-2021, was recovering from fatigue, and the outcome of headache was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Nasopharyngitis, Pain in extremity
Clinical narrative: COLD; FEELING COLD; ARM PAIN; CHILLS; FEVER OF 101.3; This spontaneous report received from a consumer concerned a 20 year old male. The patient's height, and weight were not reported. The patient's past medical history included 3 strokes, and concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced feeling cold. On 03-APR-2021, the subject experienced cold. On 03-APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever of 101.3. Laboratory data included: Body temperature (NR: not provided) 101.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101.3 on 04-APR-2021, was recovering from feeling cold, and had not recovered from cold, chills, and arm pain. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COLD; FEELING COLD; ARM PAIN; CHILLS; FEVER OF 101.3; This spontaneous report received from a consumer concerned a 20 year old male. The patient's height, and weight were not reported. The patient's past medical history included 3 strokes, and concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced feeling cold. On 03-APR-2021, the subject experienced cold. On 03-APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever of 101.3. Laboratory data included: Body temperature (NR: not provided) 101.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101.3 on 04-APR-2021, was recovering from feeling cold, and had not recovered from cold, chills, and arm pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Pyrexia
Clinical narrative: OTHERS / ADVERSE EVENT NOS; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight 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 adverse event nos, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from adverse event nos, chills, and fever. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia, Rash
Clinical narrative: SWOLLEN EYES; RED EYES; RASH AROUND BOTH EYES; This spontaneous report received from a patient concerned a 50 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swollen eyes. On APR-2021, the subject experienced red eyes. On APR-2021, the subject experienced rash around both eyes. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash around both eyes, swollen eyes and red eyes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Bruxism, Decreased appetite, Dyskinesia
Clinical narrative: ITCHING; INVOLUNTARY BODY MOVEMENTS; INVOLUNTARY SPEAKING; STOMACH PAIN; LOSS OF APPETITE; BODY ACHES; LOSS OF TASTE; OVERALL SENSITIVE SKIN-TO TOUCH; EAR PAIN; TEETH CLENCHING; GENERAL FEELING OF MALAISE; RASH; HIGH FEVER; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced involuntary body movements. On MAR-2021, the subject experienced involuntary speaking. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced overall sensitive skin-to touch. On MAR-2021, the subject experienced ear pain. On MAR-2021, the subject experienced teeth clenching. On MAR-2021, the subject experienced general feeling of malaise. On MAR-2021, the subject experienced rash. On MAR-2021, the subject experienced high fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite, extreme fatigue, and general feeling of malaise, and the outcome of rash, itching, high fever, involuntary body movements, involuntary speaking, stomach pain, headache, body aches, loss of taste, overall sensitive skin-to touch, ear pain and teeth clenching was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Malaise, Pain
Clinical narrative: ITCHING; INVOLUNTARY BODY MOVEMENTS; INVOLUNTARY SPEAKING; STOMACH PAIN; LOSS OF APPETITE; BODY ACHES; LOSS OF TASTE; OVERALL SENSITIVE SKIN-TO TOUCH; EAR PAIN; TEETH CLENCHING; GENERAL FEELING OF MALAISE; RASH; HIGH FEVER; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced involuntary body movements. On MAR-2021, the subject experienced involuntary speaking. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced overall sensitive skin-to touch. On MAR-2021, the subject experienced ear pain. On MAR-2021, the subject experienced teeth clenching. On MAR-2021, the subject experienced general feeling of malaise. On MAR-2021, the subject experienced rash. On MAR-2021, the subject experienced high fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite, extreme fatigue, and general feeling of malaise, and the outcome of rash, itching, high fever, involuntary body movements, involuntary speaking, stomach pain, headache, body aches, loss of taste, overall sensitive skin-to touch, ear pain and teeth clenching was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Sensitive skin, Speech disorder
Clinical narrative: ITCHING; INVOLUNTARY BODY MOVEMENTS; INVOLUNTARY SPEAKING; STOMACH PAIN; LOSS OF APPETITE; BODY ACHES; LOSS OF TASTE; OVERALL SENSITIVE SKIN-TO TOUCH; EAR PAIN; TEETH CLENCHING; GENERAL FEELING OF MALAISE; RASH; HIGH FEVER; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced involuntary body movements. On MAR-2021, the subject experienced involuntary speaking. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced overall sensitive skin-to touch. On MAR-2021, the subject experienced ear pain. On MAR-2021, the subject experienced teeth clenching. On MAR-2021, the subject experienced general feeling of malaise. On MAR-2021, the subject experienced rash. On MAR-2021, the subject experienced high fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of appetite, extreme fatigue, and general feeling of malaise, and the outcome of rash, itching, high fever, involuntary body movements, involuntary speaking, stomach pain, headache, body aches, loss of taste, overall sensitive skin-to touch, ear pain and teeth clenching was not reported. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a parent concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies or drug abuse illicit allergy.. The Patient had reported no lingering effect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 on left deltoid at 14:30 hours for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 10-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Photopsia, Pyrexia
Clinical narrative: FLASHING LIGHTS IN LEFT EYE; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced flashing lights in left eye. On 2021, the subject experienced body aches. On 2021, the subject experienced chills. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flashing lights in left eye, and the outcome of chills, fever and body aches was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Fatigue, Myalgia, Nasopharyngitis, Nodule
Clinical narrative: KNOT ON ARM; HEAD COLD SYMPTOMS; CLUSTER LIKE HEADACHE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 175 pounds, and height was 63 inches. The patient's concurrent conditions included neuropathy with surgical intervention, penicillin allergy, abstains from alcohol, and smoker, and other pre-existing medical conditions included no illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, to right arm administered on 02-APR-2021 10:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced muscle aches. On 03-APR-2021, the subject experienced head cold symptoms. On 03-APR-2021, the subject experienced cluster like headache. On 04-APR-2021, the subject experienced knot on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from head cold symptoms, and cluster like headache, and had not recovered from knot on arm, muscle aches, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING ALL OVER THE BODY; 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced itching all over the body. Treatment medications (dates unspecified) included: hydroxyzine, and diphenhydramine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over the body. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Heart rate, Heart rate increased
Clinical narrative: HEART RATE INCREASED; BODY FEELS HOT; CHILLS; HEADACHE; MUSCLE ACHE; This spontaneous report received from a parent concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 12:40 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced heart rate increased. On 05-APR-2021, the subject experienced body feels hot. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced muscle ache. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Increased. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, heart rate increased, headache, body feels hot, and muscle ache. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: HEART RATE INCREASED; BODY FEELS HOT; CHILLS; HEADACHE; MUSCLE ACHE; This spontaneous report received from a parent concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 12:40 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced heart rate increased. On 05-APR-2021, the subject experienced body feels hot. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced muscle ache. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Increased. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, heart rate increased, headache, body feels hot, and muscle ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Injection site pain, Myalgia
Clinical narrative: The patient's height, and weight were not reported. The patient's concurrent conditions included mildly bad asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, The batch number was not reported and has been requested and Expiry: unknown) dose was not reported, administered on 05-APR-2021 12:00 noon on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced generalized muscle aches. On 05-APR-2021, the subject experienced headache.  On 05-APR-2021, the subject experienced nauseous. On 05-APR-2021, the subject experienced injection site pain.  On 05-APR-2021, the subject experienced body temperature increased. Laboratory data included: Body temperature (NR: not provided) 100.6 F (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle aches, headache, nauseous, injection site pain, and body temperature increased. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: The patient's height, and weight were not reported. The patient's concurrent conditions included mildly bad asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, The batch number was not reported and has been requested and Expiry: unknown) dose was not reported, administered on 05-APR-2021 12:00 noon on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced generalized muscle aches. On 05-APR-2021, the subject experienced headache.  On 05-APR-2021, the subject experienced nauseous. On 05-APR-2021, the subject experienced injection site pain.  On 05-APR-2021, the subject experienced body temperature increased. Laboratory data included: Body temperature (NR: not provided) 100.6 F (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle aches, headache, nauseous, injection site pain, and body temperature increased. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SLIGHTLY SORE ARM; FELT TIRED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 02-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 APR-2021, the subject experienced slightly sore arm. On APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slightly sore arm and felt tired was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity, Tinnitus
Clinical narrative: RINGING IN THE EAR; ANXIETY; SORE ARM; This spontaneous report received from a patient concerned a 56 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 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced ringing in the ear. On 01-APR-2021, the subject experienced anxiety. On 01-APR-2021, the subject experienced sore arm. Treatment medications included: ibuprofen. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from ringing in the ear, and anxiety. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: FEELING HORRIBLE; LOSS OF APPETITE; SWEATING; ACHY; CHILLS; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-MAR-2021, the subject experienced tired. On 03-APR-2021, the subject experienced feeling horrible. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced achy. On 03-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, and had not recovered from chills, sweating, achy, loss of appetite, and feeling horrible. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FEELING HORRIBLE; LOSS OF APPETITE; SWEATING; ACHY; CHILLS; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-MAR-2021, the subject experienced tired. On 03-APR-2021, the subject experienced feeling horrible. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced achy. On 03-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 2021, and had not recovered from chills, sweating, achy, loss of appetite, and feeling horrible. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Lethargy, Pain, Pyrexia
Clinical narrative: HAND PAIN (RHEUMATOID ARTHRITIS); LETHARGIC; BODY ACHES; EYE PAIN; CHILLS; FEVER; 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 high blood pressure. 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, frequency once total, administered on 26-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the patient did not feel any symptoms until 01-APR-2021.  On 01-APR-2021, the patient experienced hand pain described as rheumatoid arthritis, lethargy, body aches, eye pain/ocular pressure, chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, body aches, fever, chills, eye pain, and rheumatoid arthritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409942-Covid-19 vaccine ad26.cov2.s-Hand pain (Rheumatoid arthritis). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).