chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Transaminases, Transaminases increased
Clinical narrative: TRANSIENT TRANSAMINITIS; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hepatitis c, and other pre-existing medical conditions included: The patient's hepatitis C well controlled on unspecified anti-virals. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced transient transaminitis. Laboratory data (dates unspecified) included: Transaminases (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from transient transaminitis. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pyrexia
Clinical narrative: CHEST TIGHTNESS; FEVER; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None, No known allergies. 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 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced chest tightness. On 02-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, and fever on 03-SEP-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: RAPID HEART BEAT THAT LASTED A WEEK; This spontaneous report received from a consumer 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 rapid heart beat that lasted a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart beat that lasted a week. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, unknown race and ethnicity. 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, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-JUN-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) No antibody. 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). This case, from the same reporter is linked to 20210908154.; Sender's Comments: V0: 20210907883-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
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Injection site pain, Limb discomfort, Musculoskeletal stiffness, Neck pain
Clinical narrative: NECK PAIN; FELT LIKE SOMETHING WAS IN THERE WHERE GOT SHOT IN RIGHT ARM; PAIN IN ARM WHERE GOT SHOT; RIGHT ARM FELT STIFF AND TIGHT; WHEN PUT HAND IN AIR HAS TO GUIDE IT WITH OTHER ARM; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced right arm felt stiff and tight. On 07-APR-2021, the patient experienced when put hand in air has to guide it with other arm. On 07-APR-2021, the patient experienced felt like something was in there where got shot in right arm. On 07-APR-2021, the patient experienced pain in arm where got shot. On an unspecified date, the patient experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from when put hand in air has to guide it with other arm, pain in arm where got shot, felt like something was in there where got shot in right arm, and right arm felt stiff and tight, and the outcome of neck pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHES; CHILLS; FATIGUE; HEADACHE; 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, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, treatment medications included: paracetamol. On 01-SEP-2021, the patient experienced body aches. On 01-SEP-2021, the patient experienced chills. On 01-SEP-2021, the patient experienced fatigue. On 01-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fatigue, and headache on 03-SEP-2021. This report was non-serious.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT; RIGHT LEG TO THE KNEE WAS SWOLLEN, ELEVATING IT AND ICING AND THE SWELLING HAD GONE DOWN BUT HASN'T GONE AWAY; DISCOMFORT; This spontaneous report received from a patient concerned an 81 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient was non-smoker, and alcohol use (drinks occasionally), the patient had no known allergies. 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, 1 total, administered on 06-AUG-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, 7-10 days after vaccination patient's right leg to the knee was swollen noticeably. He has been elevating it and icing and the swelling had gone down but hasn't gone away. On same day, the patient experienced discomfort. On Wednesday, 01-SEP-2021, he attempted to go to urgent care but they could not help him so he went to the emergency room (ER) on 03-SEP-2021, and was diagnosed with blood clot. In the emergency room (ER), they did an ultrasound to confirm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, discomfort and right leg to the knee was swollen, elevating it and icing and the swelling had gone down but hasn't gone away was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908108-COVID-19 VACCINE AD26.COV2.S-blood clot. 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: Antibody test, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of an unspecified age, race, and ethnicity. 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 and expiry: unknown) frequency time 1 total, dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient tested positive for covid-19 virus (COVID-19 virus test was positive) and had minor symptoms (reported as suspected clinical vaccination failure and suspected covid-19 infection). On 25-JUN-2021, laboratory data included: Antibody test showed no antibodies. On unspecified date, antibody test was performed and results were unknown.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210907883. This report was associated with product quality complaint.; Sender's Comments: V0- 20210908154-covid-19 vaccine ad26.cov2.s -Suspected clinical 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: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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 02-SEP-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 03-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Influenza like illness, Pruritus
Clinical narrative: ITCHING TO HEAD AND BACK LIKE BAD ALLERGIES; EYES FELT SWOLLEN; FEELING OF HAVING FLU; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-AUG-2021, the patient experienced itching to head and back like bad allergies. On 28-AUG-2021, the patient experienced eyes felt swollen. On 28-AUG-2021, the patient experienced feeling of having flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching to head and back like bad allergies, eyes felt swollen, and feeling of having flu. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: DIFFICULTY BREATHING; 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: Unk) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 01-SEP-2021, the patient experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of difficulty breathing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer 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: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908685 and 20210908729.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Injection site pain
Clinical narrative: FLU SYMPTOMS WHICH DIDN'T FEEL SO GOOD / BODY PAIN; INJECTION SITE SORE / PAIN ON THE JAB SITE; 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 was not reported, administered on 01-SEP-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 SEP-2021, the patient experienced flu symptoms which didn't feel so good / body pain. On SEP-2021, the patient experienced injection site sore / pain on the jab site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms which didn't feel so good / body pain on 04-SEP-2021, and had not recovered from injection site sore / pain on the jab site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Body temperature, Computerised tomogram, Condition aggravated
Clinical narrative: SHORTNESS OF BREATH; NOT BEEN ABLE TO WORK; DRY COUGH; VOMITING; DIARRHEA; NAUSEA; FATIGUE; ARM SORENESS; REDUCED APPETITE; FEELING WORSE; VACCINATION REACTION; SHOULDER SORENESS; BODY ACHES; MILD FEVER/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, and batch number were not reported) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced body aches. On 14-JUL-2021, the patient experienced vaccination reaction. On 14-JUL-2021, the patient experienced shoulder soreness. On 14-JUL-2021, the patient experienced mild fever/fever. On 16-JUL-2021, the patient experienced reduced appetite. On 16-JUL-2021, the patient experienced feeling worse. On 16-JUL-2021, the patient experienced arm soreness. On 16-JUL-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100.4. On 19-JUL-2021, the patient experienced dry cough. On 19-JUL-2021, the patient experienced vomiting. On 19-JUL-2021, the patient experienced diarrhea. On 19-JUL-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99-100.6, and COVID-19 virus test (NR: not provided) Negative. On 29-JUL-2021, the patient experienced shortness of breath. On 29-JUL-2021, the patient experienced not been able to work. Laboratory data included: Blood test (NR: not provided) Negative, COVID-19 virus test (NR: not provided) Negative, and CT scan (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder soreness, mild fever/fever, body aches, arm soreness, fatigue, reduced appetite, dry cough, nausea, vomiting, diarrhea, shortness of breath, not been able to work, feeling worse, and vaccination reaction. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; NOT BEEN ABLE TO WORK; DRY COUGH; VOMITING; DIARRHEA; NAUSEA; FATIGUE; ARM SORENESS; REDUCED APPETITE; FEELING WORSE; VACCINATION REACTION; SHOULDER SORENESS; BODY ACHES; MILD FEVER/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, and batch number were not reported) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced body aches. On 14-JUL-2021, the patient experienced vaccination reaction. On 14-JUL-2021, the patient experienced shoulder soreness. On 14-JUL-2021, the patient experienced mild fever/fever. On 16-JUL-2021, the patient experienced reduced appetite. On 16-JUL-2021, the patient experienced feeling worse. On 16-JUL-2021, the patient experienced arm soreness. On 16-JUL-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100.4. On 19-JUL-2021, the patient experienced dry cough. On 19-JUL-2021, the patient experienced vomiting. On 19-JUL-2021, the patient experienced diarrhea. On 19-JUL-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99-100.6, and COVID-19 virus test (NR: not provided) Negative. On 29-JUL-2021, the patient experienced shortness of breath. On 29-JUL-2021, the patient experienced not been able to work. Laboratory data included: Blood test (NR: not provided) Negative, COVID-19 virus test (NR: not provided) Negative, and CT scan (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder soreness, mild fever/fever, body aches, arm soreness, fatigue, reduced appetite, dry cough, nausea, vomiting, diarrhea, shortness of breath, not been able to work, feeling worse, and vaccination reaction. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Impaired work ability, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; NOT BEEN ABLE TO WORK; DRY COUGH; VOMITING; DIARRHEA; NAUSEA; FATIGUE; ARM SORENESS; REDUCED APPETITE; FEELING WORSE; VACCINATION REACTION; SHOULDER SORENESS; BODY ACHES; MILD FEVER/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, and batch number were not reported) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced body aches. On 14-JUL-2021, the patient experienced vaccination reaction. On 14-JUL-2021, the patient experienced shoulder soreness. On 14-JUL-2021, the patient experienced mild fever/fever. On 16-JUL-2021, the patient experienced reduced appetite. On 16-JUL-2021, the patient experienced feeling worse. On 16-JUL-2021, the patient experienced arm soreness. On 16-JUL-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100.4. On 19-JUL-2021, the patient experienced dry cough. On 19-JUL-2021, the patient experienced vomiting. On 19-JUL-2021, the patient experienced diarrhea. On 19-JUL-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99-100.6, and COVID-19 virus test (NR: not provided) Negative. On 29-JUL-2021, the patient experienced shortness of breath. On 29-JUL-2021, the patient experienced not been able to work. Laboratory data included: Blood test (NR: not provided) Negative, COVID-19 virus test (NR: not provided) Negative, and CT scan (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder soreness, mild fever/fever, body aches, arm soreness, fatigue, reduced appetite, dry cough, nausea, vomiting, diarrhea, shortness of breath, not been able to work, feeling worse, and vaccination reaction. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication, Vomiting
Clinical narrative: SHORTNESS OF BREATH; NOT BEEN ABLE TO WORK; DRY COUGH; VOMITING; DIARRHEA; NAUSEA; FATIGUE; ARM SORENESS; REDUCED APPETITE; FEELING WORSE; VACCINATION REACTION; SHOULDER SORENESS; BODY ACHES; MILD FEVER/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, and batch number were not reported) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUL-2021, the patient experienced body aches. On 14-JUL-2021, the patient experienced vaccination reaction. On 14-JUL-2021, the patient experienced shoulder soreness. On 14-JUL-2021, the patient experienced mild fever/fever. On 16-JUL-2021, the patient experienced reduced appetite. On 16-JUL-2021, the patient experienced feeling worse. On 16-JUL-2021, the patient experienced arm soreness. On 16-JUL-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99-100.4. On 19-JUL-2021, the patient experienced dry cough. On 19-JUL-2021, the patient experienced vomiting. On 19-JUL-2021, the patient experienced diarrhea. On 19-JUL-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 99-100.6, and COVID-19 virus test (NR: not provided) Negative. On 29-JUL-2021, the patient experienced shortness of breath. On 29-JUL-2021, the patient experienced not been able to work. Laboratory data included: Blood test (NR: not provided) Negative, COVID-19 virus test (NR: not provided) Negative, and CT scan (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder soreness, mild fever/fever, body aches, arm soreness, fatigue, reduced appetite, dry cough, nausea, vomiting, diarrhea, shortness of breath, not been able to work, feeling worse, and vaccination reaction. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Peripheral swelling
Clinical narrative: POTENTIAL DVT; LEG SWELLING; INTERMITTENT LEG PAIN/ PAIN ABOUT 3 AND HALF INCHES DISTAL TO THE KNEE ON THE LATERAL PART OF THE LEFT CALF/ PAIN TOWARDS BACKSIDE; This spontaneous report received from a patient concerned a 51 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, non smoker, Hashimotos disease, and high blood pressure, the patient was on medication for high blood pressure and Hashimoto's and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: UNKNOWN) on left arm, dose was not reported, frequency one total administered on 04-SEP-2021 at 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-SEP-2021, the patient experienced leg swelling and intermittent leg pain/pain about 3 and half inches distal to the knee on the lateral part of the left calf, and sometimes pain just towards the backside, and potential DVT. The patient who is HCP, also shared that the pain is a bit worse if she presses down on the spot. She noted that it was started in morning of 05-SEP-2021 about 11 o clock. She was keeping the leg elevated at the heart but did not confirm if she had any plan to contact her PCP as she was concerned of potential DVT. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent leg pain/ pain about 3 and half inches distal to the knee on the lateral part of the left calf/ pain towards backside, and the outcome of leg swelling and potential dvt was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210908758-COVID-19 VACCINE AD26.COV2.S- Potential DVT. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: THROW UP; NAUSEA; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stage 4 kidney disease, small clot, bipolar depression, rectal prolapse surgery, surgery for broken knee cap, and surgery for leak in spinal fluid, and concurrent conditions included: smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient was previously treated with warfarin sodium for small clot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. Concomitant medications included apixaban for small clot. On an unspecified date, the patient experienced throw up, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fatigue and throw up was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908699.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: FELT LIGHTHEADED OFF AND ON; NAUSEOUS AT TIMES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy and did not have the reported symptoms prior to the shot. 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-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-AUG-2021, the patient experienced felt lightheaded off and on. On 27-AUG-2021, the patient experienced nauseous at times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt lightheaded off and on, and nauseous at times. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: SWELLING IN THE LEFT ARM; SWELLING AT THE SITE THAT THE BLOOD WAS DRAWN FROM (NOT THE SITE THAT SHE GOT HER INJECTION IN); I FEEL LIKE I GOT SOCKED IN MY ARM, IT WAS HARD TO LIFT IT/ ARM PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blood donor, and concurrent conditions included: occasional alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known 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, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-SEP-2021, the patient experienced swelling in the left arm. On 04-SEP-2021, the patient experienced swelling at the site that the blood was drawn from (not the site that she got her injection in). On 04-SEP-2021, the patient experienced i feel like i got socked in my arm, it was hard to lift it/ arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling in the left arm, and swelling at the site that the blood was drawn from (not the site that she got her injection in), and the outcome of i feel like i got socked in my arm, it was hard to lift it/ arm pain was not reported. This report was non-serious.; Sender's Comments: V0 :  Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: RECEIVED PFIZER VACCINE AFTER  BEING FULLY VACCINATED WITH  JANSSEN COVID 19 VACCINE; 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:unknown ) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination.  On an unspecified date, the patient experienced received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905638 and 20210909555.
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: RECEIVED PFIZER VACCINE AFTER BEING FULLY VACCINATED WITH JANSSEN COVID 19 VACCINE; This spontaneous report received from a consumer 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 and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received pfizer vaccine after being fully vaccinated with janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905638 and 20210909424.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: SWEATS; CHILLS FOR TWO WEEKS; FEVER; This spontaneous report received from a patient via a company representative concerned a 68 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient might had a very mild case of COVID-19 last year and reacted to the shot. 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 sweats, chills for two weeks, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sweats and chills for two weeks was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908733.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILLS; FATIGUE; 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: 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 chills, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: RASH ON FRONT OF BOTH ARMS, LEGS,CHEST AND STOMACH; SORE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced sore arm. On 05-SEP-2021, the patient experienced rash on front of both arms, legs, chest and stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and rash on front of both arms, legs, chest and stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: COVID-19 BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative via social media (Facebook) concerned a patient of unspecified age, sex, race and ethnic origin. 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, 1 total, administered on 22-Mar-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 an unspecified date, the patient experienced covid-19 breakthrough infection and had suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 breakthrough infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210910687-covid-19 vaccine ad26.cov2.s-Covid-19 breakthrough infection. 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). 20210910687-covid-19 vaccine ad26.cov2.s-suspected clinical 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: U
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Fatigue, Hypokinesia, Muscle spasms, Pain
Clinical narrative: FEELING WAY MORE ACHE AND SORE; BURNING SENSATION IN ARMS; CRAMPY LEGS; CANT GET MOVING; TIRED; 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, and batch number were not reported) dose was not reported, administered on 05-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-SEP-2021, the patient experienced tired. On 06-SEP-2021, the patient experienced feeling way more ache and sore. On 06-SEP-2021, the patient experienced burning sensation in arms. On 06-SEP-2021, the patient experienced crampy legs. On 06-SEP-2021, the patient experienced cant get moving. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling way more ache and sore, and the outcome of tired, burning sensation in arms, crampy legs and cant get moving was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Burning sensation, Fatigue, Hypokinesia, Muscle spasms
Clinical narrative: FEELING WAY MORE ACHE AND SORE; BURNING SENSATION IN ARMS; CRAMPY LEGS; CANT GET MOVING; TIRED; 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, and batch number were not reported) dose was not reported, administered on 05-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-SEP-2021, the patient experienced tired. On 06-SEP-2021, the patient experienced feeling way more ache and sore. On 06-SEP-2021, the patient experienced burning sensation in arms. On 06-SEP-2021, the patient experienced crampy legs. On 06-SEP-2021, the patient experienced cant get moving. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling way more ache and sore, and the outcome of tired, burning sensation in arms, crampy legs and cant get moving was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEELING WAY MORE ACHE AND SORE; BURNING SENSATION IN ARMS; CRAMPY LEGS; CANT GET MOVING; TIRED; 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, and batch number were not reported) dose was not reported, administered on 05-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-SEP-2021, the patient experienced tired. On 06-SEP-2021, the patient experienced feeling way more ache and sore. On 06-SEP-2021, the patient experienced burning sensation in arms. On 06-SEP-2021, the patient experienced crampy legs. On 06-SEP-2021, the patient experienced cant get moving. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling way more ache and sore, and the outcome of tired, burning sensation in arms, crampy legs and cant get moving was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Fatigue, Hypokinesia, Muscle spasms, Pain
Clinical narrative: TEMPERATURE 100.2; TIRED; CAN'T GET MOVING; Burning sensation in arms; Crampy legs; FEEL ACHE; SORE; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-SEP-2021, the patient experienced can't get moving. On 05-SEP-2021, the patient experienced burning sensation in arms. On 05-SEP-2021, the patient experienced crampy legs. On 05-SEP-2021, the patient experienced feel ache. On 05-SEP-2021, the patient experienced sore. On 05-SEP-2021, the patient experienced tired. On 06-SEP-2021, the patient experienced temperature 100.2. Laboratory data included: Body temperature (NR: not provided) 100.2 (unit unspecified). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from temperature 100.2, feel ache, tired, burning sensation in arms, crampy legs, sore, and can't get moving. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Burning sensation, Fatigue, Hypokinesia, Muscle spasms
Clinical narrative: TEMPERATURE 100.2; TIRED; CAN'T GET MOVING; Burning sensation in arms; Crampy legs; FEEL ACHE; SORE; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-SEP-2021, the patient experienced can't get moving. On 05-SEP-2021, the patient experienced burning sensation in arms. On 05-SEP-2021, the patient experienced crampy legs. On 05-SEP-2021, the patient experienced feel ache. On 05-SEP-2021, the patient experienced sore. On 05-SEP-2021, the patient experienced tired. On 06-SEP-2021, the patient experienced temperature 100.2. Laboratory data included: Body temperature (NR: not provided) 100.2 (unit unspecified). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from temperature 100.2, feel ache, tired, burning sensation in arms, crampy legs, sore, and can't get moving. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: TEMPERATURE 100.2; TIRED; CAN'T GET MOVING; Burning sensation in arms; Crampy legs; FEEL ACHE; SORE; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-SEP-2021, the patient experienced can't get moving. On 05-SEP-2021, the patient experienced burning sensation in arms. On 05-SEP-2021, the patient experienced crampy legs. On 05-SEP-2021, the patient experienced feel ache. On 05-SEP-2021, the patient experienced sore. On 05-SEP-2021, the patient experienced tired. On 06-SEP-2021, the patient experienced temperature 100.2. Laboratory data included: Body temperature (NR: not provided) 100.2 (unit unspecified). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from temperature 100.2, feel ache, tired, burning sensation in arms, crampy legs, sore, and can't get moving. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza
Clinical narrative: FLU SYMPTOMS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no medical history, no known 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 04-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-SEP-2021, the patient experienced flu symptoms. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms on 05-SEP-2021. This report was non-serious.