chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NORMAL REACTION; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced normal reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of normal reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20210854866.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: MENSTRUAL BLEEDING; This spontaneous report received from a patient via a company representative concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The reporter stated that the patient was in good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstrual bleeding was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: DIZZINESS; CANNOT EVEN FINISH A FULL SHIFT AT WORK; NUMBNESS IN ARMS, FEET, AND NECK; TINGLING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced numbness in arms, feet, and neck. On AUG-2021, the patient experienced tingling.  On AUG-2021, the patient experienced cannot even finish a full shift at work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, numbness in arms, feet, and neck, tingling, and cannot even finish a full shift at work. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: RUN DOWN FOR A COUPLE DAYS; FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 patient experienced run down for a couple days, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and run down for a couple days was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure no follow up will requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and slight headache was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: DIFFICULTY BREATHING/CANNOT CATCH MY BREATHING/BREATHING IS TOUGH/LABORED BREATHING; HEAVINESS IN CHEST; FELT TERRIBLE/FELT AWFUL; ACHES; TIRED/WAS DOWN FOR THE COUNT YESATERDAY; BLISTERING HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and there was 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported. On 25-AUG-2021, the patient experienced heaviness in chest. On 25-AUG-2021, the patient experienced felt terrible/felt awful.  On 25-AUG-2021, the patient experienced aches. On 25-AUG-2021, the patient experienced tired/was down for the count yesterday. On 25-AUG-2021, the patient experienced blistering headache.  On 27-AUG-2021, the patient experienced difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blistering headache on 27-AUG-2021, was recovering from aches, and tired/was down for the count yesterday, had not recovered from heaviness in chest, and difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing, and the outcome of felt terrible/felt awful was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DIFFICULTY BREATHING/CANNOT CATCH MY BREATHING/BREATHING IS TOUGH/LABORED BREATHING; HEAVINESS IN CHEST; FELT TERRIBLE/FELT AWFUL; ACHES; TIRED/WAS DOWN FOR THE COUNT YESATERDAY; BLISTERING HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and there was 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported. On 25-AUG-2021, the patient experienced heaviness in chest. On 25-AUG-2021, the patient experienced felt terrible/felt awful.  On 25-AUG-2021, the patient experienced aches. On 25-AUG-2021, the patient experienced tired/was down for the count yesterday. On 25-AUG-2021, the patient experienced blistering headache.  On 27-AUG-2021, the patient experienced difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blistering headache on 27-AUG-2021, was recovering from aches, and tired/was down for the count yesterday, had not recovered from heaviness in chest, and difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing, and the outcome of felt terrible/felt awful was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Urine analysis abnormal
Clinical narrative: GREEN MUCOUSY DISCHARGE IN URINE; SWEATING; CHILLS; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-AUG-2021, the patient experienced green mucousy discharge in urine.  On 25-AUG-2021, the patient experienced sweating. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced fever. On 25-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, sweating, green mucousy discharge in urine, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: BAD SIDE EFFECTS; SLEPT ALL DAY; SORE ARM; CHILLS; HEADACHE; FEVER; NAUSEAS; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced bad side effects, slept all day, sore arm, chills, headache, fever, nauseas, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache, fever, chills, nauseas, extreme fatigue, bad side effects and slept all day was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: BAD SIDE EFFECTS; SLEPT ALL DAY; SORE ARM; CHILLS; HEADACHE; FEVER; NAUSEAS; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced bad side effects, slept all day, sore arm, chills, headache, fever, nauseas, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, headache, fever, chills, nauseas, extreme fatigue, bad side effects and slept all day was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vertigo, Vomiting
Clinical narrative: FELT VERY SICK; VOMITING; DIARRHEA; HEADACHE; NAUSEOUS/GOING TO THROW UP; POSSIBLE PNEUMONIA IN RIGHT LOWER LUNG; STRUGGLING TO WORK; SOMETHING LIKE VERTIGO ( IT WAS NOT VERTIGO); COLD; FELT SHAKY; EARS GOT HOT; FELT SO DIZZY; UNABLE TO READ; DEPRESSED; VERY UPSET; CHILLS; This spontaneous report received from a patient concerned a 62-year-old White female ,not Hispanic or Latino. The patient's weight was 186 pounds, and height was 65 inches. The patient's concurrent conditions included: hypertension, alcohol consumption (once in a great moon holidays) and non-smoker, and other pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1820096 and expiry: 21-Oct-2021) dose was not reported,1 total administered on 05-Aug-2021 to left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for hypertension, amlodipine for hypertension, losartan for hypertension, ascorbic acid, and zinc.  After one week of vaccination patient felt very sick. She was struggling to work. She stated that she was experiencing something like vertigo (but stated it was not vertigo), and had to intentionally think about her steps. She was experiencing cold, chills, headache and felt shaky. When she was at the hospital, a Computerized Tomography (CT) scan was negative for blood clots, and she was negative for COVID. She was given a Z-pak (azithromycin) for possible pneumonia in the right lower lung. She was currently on day 4 of the Z-pak and had diarrhea and was nauseous. She was also experiencing vomiting, which she described as happening before starting the Z-pak. She was upset that the only treatment she got was for pneumonia, and not for the other symptoms. Patient stated that she had never been this sick in her entire life and stated it as horrible and bad. The hospital wrote her a note that she is not better. Patient was upset and her ear was getting hot, and she continued to feel so dizzy that she felt like she was going to throw up. Patient stated that the eye movement of reading made her sicker and felt very depressed. She was drinking plenty of water and orange juice (OJ). She also started taking Zinc and Vitamin C when she got her Z-pak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt very sick, struggling to work, something like vertigo (it was not vertigo), cold, chills, headache, felt shaky, possible pneumonia in right lower lung, diarrhea, nauseous/going to throw up, vomiting, ears got hot, felt so dizzy, unable to read, depressed and very upset was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210857125-covid-19 vaccine ad26.cov2.s-Possible pneumonia in the right lower lung. 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).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Palpitations
Clinical narrative: HEART PALPITATIONS; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk and expiry date: 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 patient experienced heart palpitations, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, and weakness. This report was non-serious. This case, from the same reporter is linked to 20210856064.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: BODY ACHES; CHILLS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced body aches, chills, and fatigue. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: LITTLE HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and have been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: BURNING STOMACH; 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: 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 patient experienced burning stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning stomach. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dyspepsia, Pain in extremity, Pyrexia
Clinical narrative: STOMACH PAIN; HEARTBURN; SWELLING; LEG PAIN; ANKLE PAIN; RASH ON FACE, NECK AND ARMS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stomach pain, heartburn, swelling, leg pain, ankle pain, rash on face, neck and arms, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain, heartburn, rash on face, neck and arms, fever, leg pain, ankle pain and swelling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: STOMACH PAIN; HEARTBURN; SWELLING; LEG PAIN; ANKLE PAIN; RASH ON FACE, NECK AND ARMS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stomach pain, heartburn, swelling, leg pain, ankle pain, rash on face, neck and arms, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain, heartburn, rash on face, neck and arms, fever, leg pain, ankle pain and swelling was not reported. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Increased tendency to bruise, Pallor, Vaccination site bruising
Clinical narrative: SEMIPAINFUL HEADACHE THAT CAME IN WAVES; BRUISING AT INJECTION SITE; SHE IS PALE; SHE IS VERY PRONE TO  BRUISING; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced she is very prone to bruising. On 12-AUG-2021, the patient experienced bruising at injection site. On 12-AUG-2021, the patient experienced she is pale. On 23-AUG-2021, the patient experienced semipainful headache that came in waves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruising at injection site, semipainful headache that came in waves, she is pale and she is very prone to bruising was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: REAL BAD MUSCLE ACHES; FATIGUE; FEVER; ACHY; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-AUG-2021 00:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced achy. Treatment medications included: paracetamol. On 25-AUG-2021, the patient experienced fatigue. On 25-AUG-2021, the patient experienced fever. On 26-AUG-2021, the patient experienced real bad muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and real bad muscle aches, and had not recovered from fatigue, and achy. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fungal infection, Gait inability, Hypoaesthesia, Onychomadesis
Clinical narrative: FUNGUS; ALL BODY PAIN/BODY HURTING; NOT ABLE TO WALK; BILATERAL FOOT PAIN/BILATERAL LEG PAIN; FELT TIRED; MISSING TOE NAIL; BILATERAL FOOT NUMBNESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient have unspecified allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: paracetamol. On 16-APR-2021, the patient experienced bilateral foot numbness. On 23-APR-2021, the patient experienced missing toe nail. On 23-APR-2021, the patient experienced felt tired. On 23-AUG-2021, the patient experienced bilateral foot pain/bilateral leg pain. On an unspecified date, the patient experienced fungus, all body pain/body hurting, and not able to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral foot numbness on 23-APR-2021, had not recovered from bilateral foot pain/bilateral leg pain, felt tired, and missing toe nail, and the outcome of all body pain/body hurting, not able to walk and fungus was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: FUNGUS; ALL BODY PAIN/BODY HURTING; NOT ABLE TO WALK; BILATERAL FOOT PAIN/BILATERAL LEG PAIN; FELT TIRED; MISSING TOE NAIL; BILATERAL FOOT NUMBNESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient have unspecified allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: paracetamol. On 16-APR-2021, the patient experienced bilateral foot numbness. On 23-APR-2021, the patient experienced missing toe nail. On 23-APR-2021, the patient experienced felt tired. On 23-AUG-2021, the patient experienced bilateral foot pain/bilateral leg pain. On an unspecified date, the patient experienced fungus, all body pain/body hurting, and not able to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bilateral foot numbness on 23-APR-2021, had not recovered from bilateral foot pain/bilateral leg pain, felt tired, and missing toe nail, and the outcome of all body pain/body hurting, not able to walk and fungus was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain
Clinical narrative: BODY PAINING/BODY ACHE; FEELING VERY COLD; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a 23 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-AUG-2021 11:00 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 26-AUG-2021, the patient experienced feeling very cold. On 26-AUG-2021, the patient experienced body paining/body ache. On 26-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, feeling very cold, and body paining/body ache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Lymph node pain, Pain, Pain in extremity
Clinical narrative: BODY ACHES; SORE GLANDS; SORE ARM; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-AUG-2021 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 AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced sore glands. On AUG-2021, the patient experienced sore arm. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore glands, sore arm, chills, and headache on AUG-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: SWELLING; ITCHING; RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced swelling, itching, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, swelling and itching was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Hyperhidrosis, Influenza like illness, Insomnia
Clinical narrative: LOSS OF APPETITE; FLU LIKE SYMPTOMS; COULD NOT SLEEP; SWEAT IT OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced loss of appetite, flu like symptoms, could not sleep, and sweat it out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, flu like symptoms, could not sleep and sweat it out was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MUCH WORSE OFF; This spontaneous report received from a patient via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced much worse off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of much worse off was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: RIGHT LOWER LEG SWELLING; This spontaneous report received from a patient via a company representative concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204b21a, and  expiry: UNKNOWN) dose was not reported, administered on 19-AUG-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced right lower leg swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of right lower leg swelling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia, Vertigo
Clinical narrative: EXACERBATED VERTIGO A BIT; CHILLS; SORE ARM; LOW GRADE BARELY FEVER.; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: vertigo. 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 patient experienced exacerbated vertigo a bit, chills, sore arm, and low grade barely fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exacerbated vertigo a bit, chills, sore arm, and low grade barely fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILLS; DEAD TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and dead tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and dead tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: RIGHT ARM SWELLING AROUND INJECTION SITE; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient does not have any 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, treatment medications included: paracetamol. On 27-AUG-2021, the patient experienced right arm pain. On 28-AUG-2021, the patient experienced right arm swelling around injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, and right arm swelling around injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: SUPER SLEEPY; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced super sleepy, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super sleepy and fatigued was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SLIGHT SORE ARM; A SLIGHT HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight sore arm, a slight headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, a slight headache and slight sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Pneumonia, Suspected COVID-19
Clinical narrative: PNEUMONIA; UNABLE TO WALK; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, two weeks after vaccination the patient experienced suspected covid-19 infection. The patient then ended up in the hospital two weeks after that with pneumonia and was hospitalized on an unspecified date. The patient reported being out of work on disability, got daily headaches and could not walk a block without being wore out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to walk, and the outcome of suspected covid-19 infection and pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged). This report is associated with product quality complaint.; Sender's Comments: V0:20210858943-covid-19 vaccine ad26.cov2.s-Pneumonia. This event 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.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Constipation, Deep vein thrombosis, Fatigue
Clinical narrative: ABDOMINAL PAIN WHICH WAS REALLY UNCOMFORTABLE/STOMACH CRAMPING THAT WAS BRUTAL; TROUBLE SLEEPING; CONSTIPATED; FATIGUE; DEEP VEIN THROMBOSIS; STOMACH BLOATING; This spontaneous report received from a patient concerned a male of unspecified age.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total 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 15-AUG-2021, the patient experienced stomach bloating. The patient felt "blocked up", and thought it was just fatigue. The patient had stomach cramping that was brutal. The patient had a bowel movement the night before reporting that brought some relief, but then the pain started across his abdomen, which he described as really uncomfortable. It was reported that, he was given one dose on the day of discharge from the hospital, then was taking two XARELTO tablets daily for his deep vein thrombosis. The patient felt like someone took their fist and punched him hard in the stomach. On an unspecified date, the patient was constipated and had trouble sleeping. The patient took covid-19 test and it was negative. The patient was thinking to visit the emergency room, but was not certain if he should go.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach bloating on 19-AUG-2021, had not recovered from constipated, and the outcome of fatigue, abdominal pain which was really uncomfortable/stomach cramping that was brutal, trouble sleeping and deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210843197.; Sender's Comments: V0:20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S - deep vein thrombosis,  stomach bloating ,abdominal pain which was really uncomfortable ,constipated, trouble sleeping - 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). V0: 20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  fatigue-This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: ABDOMINAL PAIN WHICH WAS REALLY UNCOMFORTABLE/STOMACH CRAMPING THAT WAS BRUTAL; TROUBLE SLEEPING; CONSTIPATED; FATIGUE; DEEP VEIN THROMBOSIS; STOMACH BLOATING; This spontaneous report received from a patient concerned a male of unspecified age.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total 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 15-AUG-2021, the patient experienced stomach bloating. The patient felt "blocked up", and thought it was just fatigue. The patient had stomach cramping that was brutal. The patient had a bowel movement the night before reporting that brought some relief, but then the pain started across his abdomen, which he described as really uncomfortable. It was reported that, he was given one dose on the day of discharge from the hospital, then was taking two XARELTO tablets daily for his deep vein thrombosis. The patient felt like someone took their fist and punched him hard in the stomach. On an unspecified date, the patient was constipated and had trouble sleeping. The patient took covid-19 test and it was negative. The patient was thinking to visit the emergency room, but was not certain if he should go.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach bloating on 19-AUG-2021, had not recovered from constipated, and the outcome of fatigue, abdominal pain which was really uncomfortable/stomach cramping that was brutal, trouble sleeping and deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210843197.; Sender's Comments: V0:20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S - deep vein thrombosis,  stomach bloating ,abdominal pain which was really uncomfortable ,constipated, trouble sleeping - 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). V0: 20210859224-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  fatigue-This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Electrocardiogram, Headache, Malaise, Pericarditis
Clinical narrative: PERICARDITIS; HEADACHE; UNWELL FEELING; This spontaneous report received from a patient concerned a 70 year (69 year at the time of vaccination) old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure but under control, diabetes but under control, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient had no heart problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient was not feeling well for 3 weeks after vaccination. The patient indicated he was experiencing headaches and was not feeling well about 1 week prior hospitalization. The patient had thought that he had Covid and went to urgent care. Then patient had underwent an electrocardiogram test and everyone thought patient was had heart attack. After that patient underwent catheterization procedure which had indicated everything fine with patient's heart but diagnosed with pericarditis. On 9-APR-2021, patient was hospitalized for pericarditis, unwell feeling and headaches. On 10-APR-2021, the patient was discharged from hospital (Duration of hospitalization was 1 day). The patient had indicated that he was still taking colchicine twice a day for this condition. The patient had visited the cardiologist after he was released from hospital. He was told by his cardiologist that the pericarditis was a virus which can get anywhere in the body. The patient did not feel that the pericarditis was related to the vaccine and because patient believed it would had happened earlier. The patient had a follow up with his cardiologist in OCT-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pericarditis, and the outcome of unwell feeling and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210860091-Covid-19 vaccine ad26.cov2.s-Pericarditis. 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).  20210860091-Covid-19 vaccine ad26.cov2.s-Unwell feeling, Headache. This event(s) is labeled per RSI and is therefore considered potentially related.