chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Decreased appetite, Diarrhoea, Epistaxis
Clinical narrative: NOSE BLEED; LOSS OF APPETITE; DIARRHEA; LOW GRADE FEVER; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and samter's triad disease, and other pre-existing medical conditions included patient have allergies . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, cetirizine hydrochloride, estradiol, fluticasone propionate, guaifenesin, hydroxyzine, ibuprofen, lansoprazole, levothyroxine sodium, montelukast sodium, omalizumab, and pseudoephedrine.  From 20-MAR-2021 the subject experienced a low grade fever, extreme fatigue, diarrhea, headache, and nose bleed till 29-MAR-2021. On 23-APR-2021, the subject again experienced nose bleed,  loss of appetite, diarrhea and low grade fever ,her fever reduced to a low grade on 27-APR-2021.  On 23-APR-2021, the subject experienced headache, extreme fatigue.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) over 100 degree, and COVID-19 (NR: not provided) Negative (units unspecified). 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 low grade fever, diarrhea, headache, extreme fatigue, nose bleed, and loss of appetite. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: NOSE BLEED; LOSS OF APPETITE; DIARRHEA; LOW GRADE FEVER; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and samter's triad disease, and other pre-existing medical conditions included patient have allergies . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, cetirizine hydrochloride, estradiol, fluticasone propionate, guaifenesin, hydroxyzine, ibuprofen, lansoprazole, levothyroxine sodium, montelukast sodium, omalizumab, and pseudoephedrine.  From 20-MAR-2021 the subject experienced a low grade fever, extreme fatigue, diarrhea, headache, and nose bleed till 29-MAR-2021. On 23-APR-2021, the subject again experienced nose bleed,  loss of appetite, diarrhea and low grade fever ,her fever reduced to a low grade on 27-APR-2021.  On 23-APR-2021, the subject experienced headache, extreme fatigue.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) over 100 degree, and COVID-19 (NR: not provided) Negative (units unspecified). 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 low grade fever, diarrhea, headache, extreme fatigue, nose bleed, and loss of appetite. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Dyspnoea, Hepatic artery thrombosis, Hyperhidrosis
Clinical narrative: CLOT IN SPLENIC ARTERY; CELIAC ARTERY THROMBOSIS; BODY SWEATING; SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a 45 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: 043A21A) dose was not reported, administered to left arm (left deltoid) around 15:00 to 16:00 on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, after 5 days of vaccination, in the morning, while driving patient had very severe abdominal pain, very hard time breathing, had to get out of the car because of that, patient thought he was going to die, after 5-10 minutes he felt chills and body was sweating. His wife took him to the hospital on same day. At the hospital unspecified tests and CAT scans were done, and found clot in splenic and celiac artery. Patient was hospitalized on 14-APR-2021 for 1 day and was discharged around 3pm the next day on 15-APR-2021. Patient had another visit with a hematologist on 28-APR-2021 in morning, he found nothing wrong with the body. Patient now had to take Eliquis for 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body sweating, shortness of breath, on APR-2021, and had not recovered from clot in splenic artery, and celiac artery thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210456348 - Covid-19 vaccine ad26.cov2.s-clot in splenic artery, and celiac artery thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Splenic thrombosis
Clinical narrative: CLOT IN SPLENIC ARTERY; CELIAC ARTERY THROMBOSIS; BODY SWEATING; SHORTNESS OF BREATH; CHILLS; This spontaneous report received from a patient concerned a 45 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: 043A21A) dose was not reported, administered to left arm (left deltoid) around 15:00 to 16:00 on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, after 5 days of vaccination, in the morning, while driving patient had very severe abdominal pain, very hard time breathing, had to get out of the car because of that, patient thought he was going to die, after 5-10 minutes he felt chills and body was sweating. His wife took him to the hospital on same day. At the hospital unspecified tests and CAT scans were done, and found clot in splenic and celiac artery. Patient was hospitalized on 14-APR-2021 for 1 day and was discharged around 3pm the next day on 15-APR-2021. Patient had another visit with a hematologist on 28-APR-2021 in morning, he found nothing wrong with the body. Patient now had to take Eliquis for 6 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, body sweating, shortness of breath, on APR-2021, and had not recovered from clot in splenic artery, and celiac artery thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210456348 - Covid-19 vaccine ad26.cov2.s-clot in splenic artery, and celiac artery thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Pain assessment
Clinical narrative: MUSCLE WEAKNESS; SEVERE HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 120 pounds, and height was 165 centimeters. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug. the patient was not pregnant at the time of report.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced muscle weakness. On 27-APR-2021, the subject experienced severe headache. On 27-APR-2021, the subject experienced extreme fatigue. Laboratory data included: Pain scale (NR: not provided) 7/10 severe headache with a pain level. On 28-APR-2021, Laboratory data included: Pain scale (NR: not provided) 1/10 severe headache with a pain level drops. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, extreme fatigue, and muscle weakness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Tremor
Clinical narrative: COLD; SHAKING; 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, 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 cold, and shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold, and shaking. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site inflammation, Muscle disorder
Clinical narrative: INFLAMMATION AT INJECTION SITE; MUSCLE ACHE; REDNESS AT INJECTION SITE; HEADACHE; LEG PAIN; KNEE PAIN; MUSCLE KNOT; 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: Unk) dose was not reported, administered on 08-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 muscle knot. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced knee pain. On 10-APR-2021, the subject experienced inflammation at injection site. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced redness at injection site. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation at injection site, muscle ache, redness at injection site, and headache, and had not recovered from knee pain, muscle knot, and leg pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: INFLAMMATION AT INJECTION SITE; MUSCLE ACHE; REDNESS AT INJECTION SITE; HEADACHE; LEG PAIN; KNEE PAIN; MUSCLE KNOT; 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: Unk) dose was not reported, administered on 08-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 muscle knot. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced knee pain. On 10-APR-2021, the subject experienced inflammation at injection site. On 10-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced redness at injection site. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammation at injection site, muscle ache, redness at injection site, and headache, and had not recovered from knee pain, muscle knot, and leg pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: HARDLY ABLE TO WALK; LEGS HURT- NUMBNESS TO BOTH LEGS; 'FEELING VERY TIRED' WORSE WITH WALKING; SORE THROAT; HEADACHE -ALL THE TIME; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, 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, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced headache -all the time. On 09-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced hardly able to walk. On 12-APR-2021, the subject experienced legs hurt- numbness to both legs. On 12-APR-2021, the subject experienced 'feeling very tired' worse with walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, and had not recovered from headache -all the time, legs hurt- numbness to both legs, hardly able to walk, and 'feeling very tired' worse with walking. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. On 10-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 body aches, chills, fever, nausea, and headache on 14-APR-2021. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a 23 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: 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 body ache, chills, and low fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, low fever and body ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY PAIN; FEELING TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  Concomitant medications included dienogest/estradiol valerate for contraceptive method.  On an unspecified date, the subject experienced body pain, and feeling tired.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling tired and body pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Myalgia, Pain, Pain in extremity, Vaginal haemorrhage
Clinical narrative: BRUISING ALL OVER BODY; VAGINAL BLEEDING; PAIN; PAIN IN ARM; MUSCLE ACHE; 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On APR-2021, the subject experienced bruising all over body. On APR-2021, the subject experienced vaginal bleeding. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising all over body, vaginal bleeding, muscle ache, pain and pain in arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Fatigue, Myalgia
Clinical narrative: CHEST PAIN; ANXIETY; MUSCLE PAIN; FATIGUE/TIREDNESS; 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: 1808482, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced chest pain, anxiety, muscle pain, and fatigue/tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, fatigue/tiredness, muscle pain and anxiety was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcoholic (The 4 glasses of wine per week (weekends only). and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced swelling of tongue when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 11-MAR-2021 18:44 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021 she had performed antibody test at Doctor's office that was negative. she Had second antibody test on April 15th which was negative as well, which was considered a Confirmed immunological vaccine failure . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210456470-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site mass, Injection site pain, Insomnia
Clinical narrative: FELT HAD NOT SLEPT MUCH; INJECTION SITE TENDER TO TOUCH; 1 INCH LUMP AT INJECTION SITE; PAIN AT INJECTION SITE; TIREDNESS/FATIGUE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and bladder issues. 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 06-APR-2021 for prophylactic vaccination. Concomitant medications included paroxetine for hypertension.  On 06-APR-2021, the subject experienced 1 inch lump at injection site. On 06-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced tiredness/fatigue. On an unspecified date, the subject experienced felt had not slept much, and injection site tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and tiredness/fatigue, had not recovered from 1 inch lump at injection site, and injection site tender to touch, and the outcome of felt had not slept much was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Food allergy, Lip swelling, Lymph node pain, Urticaria
Clinical narrative: LIP SWELLING; HIVES; SEAFOOD ALLERGY; BODY HOT; SORE LYMPH NODES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, treatment medications included: oxycodone/paracetamol. On 07-MAR-2021 17:00, the subject experienced sore lymph nodes. On 10-MAR-2021, the subject experienced body hot. On APR-2021, treatment medications included: epinephrine. On 13-APR-2021, the subject experienced seafood allergy. On 13-APR-2021, the subject experienced hives. On 20-APR-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore lymph nodes on 09-MAR-2021, had not recovered from seafood allergy, and body hot, and the outcome of hives and lip swelling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Non-neutralising antibodies negative
Clinical narrative: NEGATIVE ANTIBODIES; 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: Unknown) dose was not reported, administered on 24-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 24-MAR-2021, the subject experienced negative antibodies. On 28-APR-2021, Laboratory data included: IgG (NR: not provided) Negative, and IgM (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative antibodies was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: A PUNCTURE VACCINE VIAL WAS  ADMINISTER AFTER 18HRS; This spontaneous report received from a pharmacist concerned a 73 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, intramuscular and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced a puncture vaccine vial was administer after 18hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a puncture vaccine vial was administer after 18hrs was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hot flush, Nausea, Rash
Clinical narrative: DIARRHEA; RASH (3 INCHES RED SPOT AND BLUE SPOT ON LEG AND ARM); NAUSEA; HEADACHE(ELECTRIC SHOCK LIKE FEELING); HOT FLASHES; 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 hypertension, and smoker, and other pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced hot flashes. On 09-APR-2021, the subject experienced rash (3 inches red spot and blue spot on leg and arm). On 09-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced headache (electric shock like feeling). On 15-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 22-APR-2021, and had not recovered from rash (3 inches red spot and blue spot on leg and arm), nausea, headache(electric shock like feeling), and hot flashes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; HEADACHE; 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, 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 fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal
Clinical narrative: COUGH; FEELS BAD; 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) dose was not reported, administered on 01-APR-2021 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 cough, and feels bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough and feels bad was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, SARS-CoV-2 test
Clinical narrative: BURNING SENSATION IN THE GROIN AREA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included groin discomfort, and covid 19 infection. The patient was previously treated with steroids for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, and antibiotics for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 12-APR-2021, the subject experienced burning sensation in the groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation in the groin area. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Headache, Heavy menstrual bleeding, Somnolence
Clinical narrative: LONG HEAVY PERIOD WITH CLOTS; LOWER BACK PAIN; SLEEPINESS; WEAK; HEADACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included seasonal allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced long heavy period with clots. On 12-APR-2021, the subject experienced lower back pain. On 12-APR-2021, the subject experienced sleepiness. On 12-APR-2021, the subject experienced weak. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long heavy period with clots, headache, lower back pain, weak, and sleepiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Medication error, Off label use
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; OFF LABEL USE; MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a 62 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: 204A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced expired product administered. On 28-APR-2021, the subject experienced off label use. On 28-APR-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired product administered, off label use and medication error was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Eye irritation, Fatigue
Clinical narrative: FEVER; BURNING IN EYES; COUGH; HEADACHE; CHILLS; INJECTION SITE PAIN; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included seasonal allergies, and non-alcoholic, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included  patient had no drug abuse or illicit drug use. Cigarette smoking: half-a-pack a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1808980) dose was not reported, administered on 07-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced nausea. On 24-APR-2021, the subject experienced headache. On 25-APR-2021, the subject experienced cough. On 26-APR-2021, the subject experienced fever. On 26-APR-2021, the subject experienced burning in eyes. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.0 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, injection site pain, tiredness, and nausea on 08-APR-2021, had not recovered from fever, headache, and cough, and the outcome of burning in eyes was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: FEVER; BURNING IN EYES; COUGH; HEADACHE; CHILLS; INJECTION SITE PAIN; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included seasonal allergies, and non-alcoholic, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included  patient had no drug abuse or illicit drug use. Cigarette smoking: half-a-pack a day. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1808980) dose was not reported, administered on 07-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced injection site pain. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced nausea. On 24-APR-2021, the subject experienced headache. On 25-APR-2021, the subject experienced cough. On 26-APR-2021, the subject experienced fever. On 26-APR-2021, the subject experienced burning in eyes. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.0 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, injection site pain, tiredness, and nausea on 08-APR-2021, had not recovered from fever, headache, and cough, and the outcome of burning in eyes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; 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) 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 chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: ACHES; ILL; FEVER; 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, 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 aches, ill, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from aches, ill, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Fatigue, Malaise, Pyrexia
Clinical narrative: FEVER OF 101; FATIGUE; SEASONAL ALLERGIES; HAD NOT BEEN FEELING GREAT; 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 was not reported, administered on 08-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 seasonal allergies. On APR-2021, the subject experienced had not been feeling great. On APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101 unit not reported. Treatment medications included: naproxen sodium. On 27-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101, had not recovered from fatigue, and the outcome of seasonal allergies and had not been feeling great was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: FEVER OF 101; FATIGUE; SEASONAL ALLERGIES; HAD NOT BEEN FEELING GREAT; 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 was not reported, administered on 08-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 seasonal allergies. On APR-2021, the subject experienced had not been feeling great. On APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced fever of 101. Laboratory data included: Body temperature (NR: not provided) 101 unit not reported. Treatment medications included: naproxen sodium. On 27-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101, had not recovered from fatigue, and the outcome of seasonal allergies and had not been feeling great was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 73 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: 180890, expiry: unknown) dose was not reported,1 total administered in left arm on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient had confirmed immunological vaccine failure. On 27-April-2021, one month and one day after vaccination the serum was drawn, and SARS-COV-2 S1/S2 IgG Assay antibody test was performed and had shown negative antibody result. The patient was not please with the negative antibody result. and believed that the JANSSEN COVID-19 vaccine was not working with no positive antibody response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210456862-COVID-19 VACCINE AD26.COV2.S -confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: SEVERE ANXIETY ABOUT THE POTENTIAL FOR BLOOD CLOTS; This spontaneous report received from a consumer concerned a 23 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, 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 severe anxiety about the potential for blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe anxiety about the potential for blood clots was not reported. This report was non-serious.; Sender's Comments: V0:20210456869  covid-19 vaccine ad26.cov2.s- Medical Assessment comment not required as per standard procedure as case assessed as Non serious
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity, Skin test
Clinical narrative: DIZZINESS/LIGHTHEADEDNESS; SORE ARM; FEELING TIRED; 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 experienced passes out when treated with paracetamol. 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 28-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 tired. On 28-APR-2021, the subject experienced dizziness/lightheadedness. On 28-APR-2021, the subject experienced sore arm. Laboratory data (dates unspecified) included: Skin test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness/lightheadedness, and sore arm, and the outcome of feeling tired was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site mass, Injection site pain
Clinical narrative: CYST LIKE OVAL LUMP AT THE INJECTON SITE ON LEFT ARM; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient concerned a 63-year-old White female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported,1 total, administered in left deltoid on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced injection site pain, fatigue. On 11-APR-2021, the patient experienced cyst like oval lump at the injection site on left arm that was painful to touch. It continued to be there two weeks later. The patient had an appointment with healthcare professional today (as reported,28-APR-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fatigue on 11-APR-2021, had not recovered from cyst like oval lump at the injection site on left arm, and the outcome of drug allergy was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Fatigue, Headache
Clinical narrative: COLD SWEATS; CHILLS; FATIGUE; HEADACHE; 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, 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 cold sweats, chills, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache, chills and cold sweats was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Feeling abnormal
Clinical narrative: ATRIAL FIBRILLATION; DIZZINESS; FELT SHOT WENT STRAIGHT TO BRAIN; 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's concurrent conditions included anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient is currently on anxiety pills and the patient's physician planned to start Lexapro for patient. On an unspecified date, during the vaccination the patient felt that the medicine in the vaccine went straight to her brain. The patient experienced dizziness. After 24 hours of vaccination the patient experienced atrial fibrillation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, feeling abnormal and atrial fibrillation. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210422259.; Sender's Comments: V0: 20210456944-covid-19 vaccine ad26.cov2.s -atrial fibrillation. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nightmare, Pain, Ultrasound scan
Clinical narrative: SICKNESS; PAIN; NIGHTMARES; This spontaneous report received from a patient concerned a 40 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, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced pain. On APR-2021, the subject experienced nightmares. Laboratory data included: Diagnostic ultrasound (NR: not provided) ultrasound of leg showed subject was not sick. On 08-APR-2021, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain, nightmares and sickness was not reported. This report was non-serious.