chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Back pain, Chest discomfort, Chills, Cold sweat
Clinical narrative: URGE TO GO TO THE BATHROOM (BOWEL MOVEMENT); PRESSURE ACROSS THE CHEST; PRESSURE ACROSS THE BACK; THOUGHT I WAS GOING TO PASS OUT; HEART BEATING QUICKLY; URGE TO VOMIT; VOMITED; CHILLS; COLD SWEAT; FEELING SLEEPY; NOSE STUFFY; PAIN UPON INJECTION; DID NOT FEEL LIQUID FROM INJECTION; ANGLE OF THE NEEDLE FROM THE POINT COMING BACKWARDS FROM THE CYLEINDER WAS VERY ANGULAR; This spontaneous report received from a patient concerned a white not hispanic or latino 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, batch number: 1802068) dose and route of administration not reported, administered on 04-MAR-2021 14:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced  feeling sleepy, nose stuffy. The patient also complained that she knows several other people 3 other people who felt pain and she also felt pain when receiving the shot that was more painful than having other shots, also she did not feel the liquid come out of the needle when receiving the injection, the angle of the needle from the point coming backwards from the cylinder was very angular and sharp, noticed 3 other people say 'ooo' from pain when receiving injection.  On 06-MAR-2021, the patient's heart was beating quickly, chills and cold sweat, urge to vomit and also vomited.  On an unspecified date, the patient experienced urge to go to the bathroom (bowel movement), pressure across the chest, pressure across the back, and thought i was going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sleepy, nose stuffy, chills, cold sweat, urge to go to the bathroom (bowel movement), urge to vomit, vomited, pressure across the chest, pressure across the back, and thought i was going to pass out, and the outcome of pain upon injection, did not feel liquid from injection, angle of the needle from the point coming backwards from the cylinder was very angular and heart beating quickly was not reported. This report was non-serious. This case is linked as same reporter to 20210317609, 20210317681, 20210317682.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection, Injection site pain, Nasal congestion, Needle issue
Clinical narrative: URGE TO GO TO THE BATHROOM (BOWEL MOVEMENT); PRESSURE ACROSS THE CHEST; PRESSURE ACROSS THE BACK; THOUGHT I WAS GOING TO PASS OUT; HEART BEATING QUICKLY; URGE TO VOMIT; VOMITED; CHILLS; COLD SWEAT; FEELING SLEEPY; NOSE STUFFY; PAIN UPON INJECTION; DID NOT FEEL LIQUID FROM INJECTION; ANGLE OF THE NEEDLE FROM THE POINT COMING BACKWARDS FROM THE CYLEINDER WAS VERY ANGULAR; This spontaneous report received from a patient concerned a white not hispanic or latino 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, batch number: 1802068) dose and route of administration not reported, administered on 04-MAR-2021 14:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced  feeling sleepy, nose stuffy. The patient also complained that she knows several other people 3 other people who felt pain and she also felt pain when receiving the shot that was more painful than having other shots, also she did not feel the liquid come out of the needle when receiving the injection, the angle of the needle from the point coming backwards from the cylinder was very angular and sharp, noticed 3 other people say 'ooo' from pain when receiving injection.  On 06-MAR-2021, the patient's heart was beating quickly, chills and cold sweat, urge to vomit and also vomited.  On an unspecified date, the patient experienced urge to go to the bathroom (bowel movement), pressure across the chest, pressure across the back, and thought i was going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sleepy, nose stuffy, chills, cold sweat, urge to go to the bathroom (bowel movement), urge to vomit, vomited, pressure across the chest, pressure across the back, and thought i was going to pass out, and the outcome of pain upon injection, did not feel liquid from injection, angle of the needle from the point coming backwards from the cylinder was very angular and heart beating quickly was not reported. This report was non-serious. This case is linked as same reporter to 20210317609, 20210317681, 20210317682.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Somnolence, Vomiting
Clinical narrative: URGE TO GO TO THE BATHROOM (BOWEL MOVEMENT); PRESSURE ACROSS THE CHEST; PRESSURE ACROSS THE BACK; THOUGHT I WAS GOING TO PASS OUT; HEART BEATING QUICKLY; URGE TO VOMIT; VOMITED; CHILLS; COLD SWEAT; FEELING SLEEPY; NOSE STUFFY; PAIN UPON INJECTION; DID NOT FEEL LIQUID FROM INJECTION; ANGLE OF THE NEEDLE FROM THE POINT COMING BACKWARDS FROM THE CYLEINDER WAS VERY ANGULAR; This spontaneous report received from a patient concerned a white not hispanic or latino 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, batch number: 1802068) dose and route of administration not reported, administered on 04-MAR-2021 14:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced  feeling sleepy, nose stuffy. The patient also complained that she knows several other people 3 other people who felt pain and she also felt pain when receiving the shot that was more painful than having other shots, also she did not feel the liquid come out of the needle when receiving the injection, the angle of the needle from the point coming backwards from the cylinder was very angular and sharp, noticed 3 other people say 'ooo' from pain when receiving injection.  On 06-MAR-2021, the patient's heart was beating quickly, chills and cold sweat, urge to vomit and also vomited.  On an unspecified date, the patient experienced urge to go to the bathroom (bowel movement), pressure across the chest, pressure across the back, and thought i was going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sleepy, nose stuffy, chills, cold sweat, urge to go to the bathroom (bowel movement), urge to vomit, vomited, pressure across the chest, pressure across the back, and thought i was going to pass out, and the outcome of pain upon injection, did not feel liquid from injection, angle of the needle from the point coming backwards from the cylinder was very angular and heart beating quickly was not reported. This report was non-serious. This case is linked as same reporter to 20210317609, 20210317681, 20210317682.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chest pain, Dyspnoea, Fatigue
Clinical narrative: TINY BLOOD SPOTS ON THE LEFT THIGH, LEFT SIDE OF FOREHEAD AND NEAR BOTH EYES; CHEST PAIN; SHORTNESS OF BREATH; PERSISTENT ABDOMINAL PAIN; BLURRED VISION; LEG PAIN; MUSCLE ACHE; FEVER; FATIGUE; HEADACHE; SORENESS IN RIGHT ARM; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and allergic to pineapples. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced soreness in right arm. On 16-JUN-2021, the subject experienced tiny blood spots on the left thigh, left side of forehead and near both eyes. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced persistent abdominal pain. On 16-JUN-2021, the subject experienced blurred vision. On 16-JUN-2021, the subject experienced leg pain. On 16-JUN-2021, the subject experienced muscle ache. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced fatigue. On 16-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.8 to 100.2. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in right arm, headache, fatigue, muscle ache, fever, chest pain, shortness of breath, blurred vision, persistent abdominal pain, leg pain, and tiny blood spots on the left thigh, left side of forehead and near both eyes. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia, Skin haemorrhage
Clinical narrative: TINY BLOOD SPOTS ON THE LEFT THIGH, LEFT SIDE OF FOREHEAD AND NEAR BOTH EYES; CHEST PAIN; SHORTNESS OF BREATH; PERSISTENT ABDOMINAL PAIN; BLURRED VISION; LEG PAIN; MUSCLE ACHE; FEVER; FATIGUE; HEADACHE; SORENESS IN RIGHT ARM; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and allergic to pineapples. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced soreness in right arm. On 16-JUN-2021, the subject experienced tiny blood spots on the left thigh, left side of forehead and near both eyes. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced persistent abdominal pain. On 16-JUN-2021, the subject experienced blurred vision. On 16-JUN-2021, the subject experienced leg pain. On 16-JUN-2021, the subject experienced muscle ache. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced fatigue. On 16-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.8 to 100.2. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in right arm, headache, fatigue, muscle ache, fever, chest pain, shortness of breath, blurred vision, persistent abdominal pain, leg pain, and tiny blood spots on the left thigh, left side of forehead and near both eyes. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: TINY BLOOD SPOTS ON THE LEFT THIGH, LEFT SIDE OF FOREHEAD AND NEAR BOTH EYES; CHEST PAIN; SHORTNESS OF BREATH; PERSISTENT ABDOMINAL PAIN; BLURRED VISION; LEG PAIN; MUSCLE ACHE; FEVER; FATIGUE; HEADACHE; SORENESS IN RIGHT ARM; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and allergic to pineapples. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced soreness in right arm. On 16-JUN-2021, the subject experienced tiny blood spots on the left thigh, left side of forehead and near both eyes. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced persistent abdominal pain. On 16-JUN-2021, the subject experienced blurred vision. On 16-JUN-2021, the subject experienced leg pain. On 16-JUN-2021, the subject experienced muscle ache. On 16-JUN-2021, the subject experienced fever. On 16-JUN-2021, the subject experienced fatigue. On 16-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.8 to 100.2. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in right arm, headache, fatigue, muscle ache, fever, chest pain, shortness of breath, blurred vision, persistent abdominal pain, leg pain, and tiny blood spots on the left thigh, left side of forehead and near both eyes. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age, 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) dose was not reported, frequency 1 (total) administered on 08-MAR-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 suspected immunological vaccine failure. On an unspecified date he underwent an Antibody test  which was Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210637986. This report was associated with product quality complaint: 90000183547; Sender's Comments: V0:20210637750-COVID-19 VACCINE AD26.COV2.S-SUSPECTED IMMUNOLOGICAL VACCINE FAILURE. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: MASSIVE STROKE; This spontaneous report received from a consumer. Concerned a 4 decade 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, and expiry: unknown) dose, 1 total 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 after vaccination, the patient experienced massive stroke, and was hospitalized (date unspecified) in a nursing home for two months (60 days). It was reported that the patient was in rehabilitation at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210640075-COVID-19 VACCINE AD26.COV2.S-Massive Stroke. 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: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Dehydration, Influenza, Intermenstrual bleeding
Clinical narrative: SPOTTING BLOOD LOOKED LIKE MENSTRUAL BLEEDING; DEHYDRATION; ABDOMINAL CRAMPING; THINKING ABILITIES COMPROMISED; FEELS LIKE HAVING A HORRIBLE CASE  OF THE FLU; LETHARGIC; NAUSEATED; ENERGY COMPLETELY SUCKED OUT OF WHOLE BODY/NO ENERGY; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and other pre-existing medical conditions included patient had last menstrual cycle in her late 30s and had not been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced energy completely sucked out of whole body/no energy. On 12-JUN-2021, the subject experienced thinking abilities compromised. On 12-JUN-2021, the subject experienced feels like having a horrible case of the flu. On 12-JUN-2021, the subject experienced lethargic. On 12-JUN-2021, the subject experienced nauseated. On 13-JUN-2021, the subject experienced abdominal cramping. On 16-JUN-2021, the subject experienced dehydration. On 17-JUN-2021, the subject experienced spotting blood looked like menstrual bleeding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from energy completely sucked out of whole body/no energy, thinking abilities compromised, feels like having a horrible case of the flu, lethargic, and nauseated, had not recovered from abdominal cramping, and the outcome of dehydration and spotting blood looked like menstrual bleeding was not reported. This report was non-serious.; Sender's Comments: V0;Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Thinking abnormal
Clinical narrative: SPOTTING BLOOD LOOKED LIKE MENSTRUAL BLEEDING; DEHYDRATION; ABDOMINAL CRAMPING; THINKING ABILITIES COMPROMISED; FEELS LIKE HAVING A HORRIBLE CASE  OF THE FLU; LETHARGIC; NAUSEATED; ENERGY COMPLETELY SUCKED OUT OF WHOLE BODY/NO ENERGY; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included tubes tied, and other pre-existing medical conditions included patient had last menstrual cycle in her late 30s and had not been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced energy completely sucked out of whole body/no energy. On 12-JUN-2021, the subject experienced thinking abilities compromised. On 12-JUN-2021, the subject experienced feels like having a horrible case of the flu. On 12-JUN-2021, the subject experienced lethargic. On 12-JUN-2021, the subject experienced nauseated. On 13-JUN-2021, the subject experienced abdominal cramping. On 16-JUN-2021, the subject experienced dehydration. On 17-JUN-2021, the subject experienced spotting blood looked like menstrual bleeding. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from energy completely sucked out of whole body/no energy, thinking abilities compromised, feels like having a horrible case of the flu, lethargic, and nauseated, had not recovered from abdominal cramping, and the outcome of dehydration and spotting blood looked like menstrual bleeding was not reported. This report was non-serious.; Sender's Comments: V0;Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: PATIENT RECEIVED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 50 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: 203A21A expiry: 23-JUN-2021) 0.5 ml, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced subject received expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received expired vaccine was not reported. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: ACHY; FEELING TIRED/FATIGUE; This spontaneous report received from a patient concerned a 75 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: unknown) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced achy. On 15-JUN-2021, the subject experienced feeling tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired/fatigue, and achy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED ADVERSE EVENT; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unspecified adverse event. This report was non-serious. This case, from the same reporter is linked to 20210616652.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Neuralgia
Clinical narrative: NERVE HURT FOR A WEEK; WEAKNESS; 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 subject experienced nerve hurt for a week, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve hurt for a week, and weakness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SAME SYMPTOMS AS WHEN HAD COVID; 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 past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced same symptoms as when had covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same symptoms as when had covid was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Painful respiration
Clinical narrative: COULDN'T WALK WITHOUT PAIN ON THE RIGHT SIDE OF BODY; PAIN WHILE 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: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced couldn't walk without pain on the right side of body. On APR-2021, the subject experienced pain while breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from couldn't walk without pain on the right side of body, and pain while breathing. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhage, Pain
Clinical narrative: This spontaneous report received from a consumer via social media (Facebook) concerned a patient of unspecified age and sex with unknown ethnicity and race.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, 1 total, 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, two weeks later the vaccination, patient was in emergency room with severe pain and bleeding in upper leg. On discharge paper, it was mentioned that patient had probable exposure to COVID-19. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe pain and bleed in upper leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210644813-covid-19 vaccine ad26.cov2.s-Bleeding upper leg. 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: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: GENERALISED ACHING; FEVER; HEADACHE; MUSCLE SORENESS; This spontaneous report received from a patient via a company representative . 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 18-JUN-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 18-JUN-2021, the subject experienced generalised aching. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced headache. On 18-JUN-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-JUN-2021, had not recovered from headache, and the outcome of generalised aching and muscle soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: SWOLLEN LYMPH NODES; SORE THROAT; BODY ACHE; CHILLS; MASSIVE HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a 29 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 MAY-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 JUN-2021, the subject experienced swollen lymph nodes. On JUN-2021, the subject experienced sore throat. On JUN-2021, the subject experienced body ache. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced massive headache. On JUN-2021, the subject experienced fever. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 18-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, massive headache, swollen lymph nodes, sore throat and body ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SWOLLEN LYMPH NODES; SORE THROAT; BODY ACHE; CHILLS; MASSIVE HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a 29 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 MAY-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 JUN-2021, the subject experienced swollen lymph nodes. On JUN-2021, the subject experienced sore throat. On JUN-2021, the subject experienced body ache. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced massive headache. On JUN-2021, the subject experienced fever. On 17-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 102. On 18-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, massive headache, swollen lymph nodes, sore throat and body ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. Patient never had any health issue in past medical record and he claimed a very healthy physic history. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 17-JUN-2021, the patient got COVID-19 test result positive. The patient experienced suspected clinical vaccination failure and suspected covid-19 infection. He stated that he did sports activities very regularly. He was closer to one of his friend with asymptomatic but COVID-19 positive. 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 report was associated with product quality complaint: 90000183485. The suspected product quality complaint has been confirmed to be non-voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210644973-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
Symptoms: Chills, Deafness transitory, Disorientation, Dizziness, Dysgeusia
Clinical narrative: THROWING UP; UNCONTROLLABLE SHAKES FROM HEAD TO TOE FEET WERE EXTREMELY COLD; FELT DISORIENTED; FELT LIKE GOING TO PASS OUT; SEVERE CHILLS; SHORT TERM HEARING LOSS; METALLIC TASTE; This spontaneous report received from a patient concerned a patient of unspecified age and sex and of 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, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 19-JUN-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JUN-2021, within an hour after vaccination the patient had symptoms of short term hearing loss and a metallic taste. After that all was good no signs or symptoms from vaccine, the patient went to bed at 23:00. On 20-JUN-2021, at 1:05 the patient woke up with severe chills and uncontrollable shakes from head to toe feet were extremely cold. The patient was used to stay at -21 temperatures and currently living at place which was rarely ever cold. The patient went outside to warm up roughly for 10 minutes, later felt very disorientated and felt like going to pass out by 1:23 was throwing up two times. Shortly after expelling vomit the patient felt much better. All symptoms seemed to last around an hour or less. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from short term hearing loss, and metallic taste on 19-JUN-2021, and throwing up, uncontrollable shakes from head to toe feet were extremely cold, felt disoriented, felt like going to pass out, and severe chills on 20-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210645469-covid-19 vaccine ad26.cov2.s-Short term hearing loss.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: U
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: THROWING UP; UNCONTROLLABLE SHAKES FROM HEAD TO TOE FEET WERE EXTREMELY COLD; FELT DISORIENTED; FELT LIKE GOING TO PASS OUT; SEVERE CHILLS; SHORT TERM HEARING LOSS; METALLIC TASTE; This spontaneous report received from a patient concerned a patient of unspecified age and sex and of 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, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 19-JUN-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-JUN-2021, within an hour after vaccination the patient had symptoms of short term hearing loss and a metallic taste. After that all was good no signs or symptoms from vaccine, the patient went to bed at 23:00. On 20-JUN-2021, at 1:05 the patient woke up with severe chills and uncontrollable shakes from head to toe feet were extremely cold. The patient was used to stay at -21 temperatures and currently living at place which was rarely ever cold. The patient went outside to warm up roughly for 10 minutes, later felt very disorientated and felt like going to pass out by 1:23 was throwing up two times. Shortly after expelling vomit the patient felt much better. All symptoms seemed to last around an hour or less. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from short term hearing loss, and metallic taste on 19-JUN-2021, and throwing up, uncontrollable shakes from head to toe feet were extremely cold, felt disoriented, felt like going to pass out, and severe chills on 20-JUN-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210645469-covid-19 vaccine ad26.cov2.s-Short term hearing loss.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).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Migraine, Myalgia, Pain
Clinical narrative: ACHY; MIGRAINE HEADACHE; COULD NOT DO ANYTHING; STARTED FEELING TIGHT IN ARMS; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 68 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: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 01-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced migraine headache. On 02-APR-2021, the subject experienced could not do anything. On 02-APR-2021, the subject experienced started feeling tight in arms. On 02-APR-2021, the subject experienced muscle aches. On 02-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, migraine headache, could not do anything, started feeling tight in arms, muscle aches, and fatigue on 03-APR-2021. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ACHY; MIGRAINE HEADACHE; COULD NOT DO ANYTHING; STARTED FEELING TIGHT IN ARMS; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 68 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: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 01-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced migraine headache. On 02-APR-2021, the subject experienced could not do anything. On 02-APR-2021, the subject experienced started feeling tight in arms. On 02-APR-2021, the subject experienced muscle aches. On 02-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, migraine headache, could not do anything, started feeling tight in arms, muscle aches, and fatigue on 03-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose increased, Chest pain, Herpes zoster, Neuralgia
Clinical narrative: SHINGLES ON BACK; NERVE PAIN / LEFT SIDE NERVE PAIN IN CHEST; CHEST PAIN; SPIKING SUGAR FROM 300 TO 400; 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 diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced spiking sugar from 300 to 400. On JUN-2021, the subject experienced chest pain. Laboratory data included: Sugar blood level increased (NR: not provided) Almost 400 than previous 300 (units were not reported). On 16-JUN-2021, the subject experienced shingles on back. On 16-JUN-2021, the subject experienced nerve pain / left side nerve pain in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles on back, nerve pain / left side nerve pain in chest, chest pain, and spiking sugar from 300 to 400. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Headache, Parosmia, Respiratory rate increased
Clinical narrative: This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included ductal carcinoma, and ductal carcinoma surgery, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient had no medical history of drug abuse or illicit drug usage.  The patient was previously treated with lisdexamfetamine mesilate, and vitamins nos. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. Product properly stored from receipt to administration. Concomitant medications included letrozole. On 08-JUN-2021, the subject experienced dry irritated cough. On 08-JUN-2021, the subject experienced sneezy. On 08-JUN-2021, the subject experienced irritated throat. On 08-JUN-2021, the subject experienced dry, raspy and voice changed. On 08-JUN-2021, the subject experienced breathing changed. On 08-JUN-2021, the subject experienced chest irritated and irritation to lungs. On 08-JUN-2021, the subject experienced smell of chemical. On 08-JUN-2021, the subject experienced slight headache.The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry irritated cough, sneezy, slight headache, irritated throat, dry, raspy and voice changed, breathing changed, chest irritated and irritation to lungs, and smell of chemical. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract irritation, Sneezing, Throat irritation
Clinical narrative: This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included ductal carcinoma, and ductal carcinoma surgery, and concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient had no medical history of drug abuse or illicit drug usage.  The patient was previously treated with lisdexamfetamine mesilate, and vitamins nos. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. Product properly stored from receipt to administration. Concomitant medications included letrozole. On 08-JUN-2021, the subject experienced dry irritated cough. On 08-JUN-2021, the subject experienced sneezy. On 08-JUN-2021, the subject experienced irritated throat. On 08-JUN-2021, the subject experienced dry, raspy and voice changed. On 08-JUN-2021, the subject experienced breathing changed. On 08-JUN-2021, the subject experienced chest irritated and irritation to lungs. On 08-JUN-2021, the subject experienced smell of chemical. On 08-JUN-2021, the subject experienced slight headache.The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry irritated cough, sneezy, slight headache, irritated throat, dry, raspy and voice changed, breathing changed, chest irritated and irritation to lungs, and smell of chemical. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: RARE SKIN REACTION; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUN-2021, the subject experienced rare skin reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rare skin reaction. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pruritus, Pyrexia, Rash
Clinical narrative: RED SPOTS ARE ITCHING AND BURNING; RED SPOTS ON LEFT KNEE LEFT ANKLE AND LEFT ARM; SLIGHT FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. 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: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced red spots are itching and burning. On 18-JUN-2021, the subject experienced red spots on left knee left ankle and left arm. On 18-JUN-2021, the subject experienced slight fever. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, red spots on left knee left ankle and left arm, and red spots are itching and burning. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; ARM HURTING FOR ABOUT 2 WEEKS; 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 subject experienced suspected covid-19 infection, and arm hurting for about 2 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm hurting for about 2 weeks and suspected covid-19 infection was not reported. This report was non-serious.