chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Feeling abnormal, Headache, Muscle swelling, Pain
Clinical narrative: FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight, height, and medical history were not reported. As per reporter patient was healthy. 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.  The reported stated that presence of antibodies should be tested before taking the vaccine and taking the vaccine with covid antibodies present can kill. The patient died on an unspecified date with unknown cause of death after vaccination. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210428954 -covid-19 vaccine ad26.cov2.s -Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: RAYNAUD'S PHENOMENON; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included raynaud's phenomenon, and concurrent conditions included high cholesterol, and arthritis in hands. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced raynaud's phenomenon. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raynaud's phenomenon was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: SPENT THREE STRAIGHT DAYS IN EMERGENCY ROOM; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (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 spent three straight days in emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spent three straight days in emergency room was not reported. This report was non-serious.; Sender's Comments: MAC; V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: VOMITING; COUGH; SWEATING; CHILLS; MUSCLE PAIN; NAUSEA; BODY ACHE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, depression, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced muscle pain. On 09-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, and had not recovered from tired, chills, nausea, body ache, muscle pain, vomiting, and cough. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: VOMITING; COUGH; SWEATING; CHILLS; MUSCLE PAIN; NAUSEA; BODY ACHE; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, depression, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced muscle pain. On 09-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced cough. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, and had not recovered from tired, chills, nausea, body ache, muscle pain, vomiting, and cough. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; MILD POST VACCINATION REACTIONS; This spontaneous report received from a patient concerned a 45-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, same day after vaccination the patient experienced mild post vaccination reactions but was fine (got this after probing). On 13-APR-2021, the patient took covid -19 virus test and the result was positive which came on 14-APR-2021. On 14-APR-2021, the patient experienced suspected covid-19 infection and suspected clinical vaccination failure. The patient experienced covid like symptoms of bad cold, runny nose, fever and felt sick. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99-99.5 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild post vaccination reactions, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product quality complaint (PQC): 90000176416.; Sender's Comments: V0: 20210429156- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This events is considered not related. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: BLOODY STOOL; DIARRHEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered on 05-APR-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.  It was reported that the patient received vaccine 9 days ago and had bloody stools and diarrhea. But the patient felt fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bloody stool, and diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210429343-covid-19 vaccine ad26.cov2.s-Bloody stool. 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: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Headache, Hyperhidrosis
Clinical narrative: SWEATS; SWOLLEN EYES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 44 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and hospitalisation, 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: 1808980 expiry: 20/JUN/2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sweats. On 06-APR-2021, the subject experienced swollen eyes. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats on 08-APR-2021, swollen eyes, and fatigue on 07-APR-2021, and headache on 10-APR-2021. This report was non-serious.; Sender's Comments: V0-Medical assessment comment is not required, as per standard operating procedures, as case was assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODE; ACHE ALL OVER; ANXIETY; ARM PAIN; CHILLS; TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced swollen lymph node. On 09-APR-2021, the subject experienced ache all over. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced arm pain. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache all over, and fever on APR-2021, and arm pain, chills, tired, and headache on 10-APR-2021, had not recovered from swollen lymph node, and the outcome of anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: SWOLLEN LYMPH NODE; ACHE ALL OVER; ANXIETY; ARM PAIN; CHILLS; TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced swollen lymph node. On 09-APR-2021, the subject experienced ache all over. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced arm pain. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache all over, and fever on APR-2021, and arm pain, chills, tired, and headache on 10-APR-2021, had not recovered from swollen lymph node, and the outcome of anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy, and other pre-existing medical conditions included 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: 1805029, and expiry: 05-MAY-2021) dose was not reported, 1 total, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced heart attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210429381-covid-19 vaccine ad26.cov2.s-Heart attack. 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: Blood test, Computerised tomogram, Ophthalmological examination, Optic neuritis
Clinical narrative: OPTIC NEURITIS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: F1808980, and expiry: UNKNOWN) with unspecified dose on left arm, on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, patient experienced loss of vision on the right eye that had not gotten better or worse since then. Patient went to ophthalmologist on 12-APR-2021 who diagnosed patient with optic neuritis and referred to neuro-ophthalmologist. On 13-APR-2021, patient went to emergency eye and ear. Patient was having upcoming appointments with primary doctor and neuro-ophthalmologist at the time of reporting.  On 12-APR-2021, Laboratory data included: Dilated pupils (NR: not provided) diagnose with optic neuritis by eye doctor. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) normal findings, and CT scan (NR: not provided) normal findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from optic neuritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210429417-covid-19 vaccine ad26.cov2.s-Optic neuritis. 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: Goitre, Musculoskeletal stiffness, Myalgia, Pain in extremity, Swelling
Clinical narrative: THYROID SWOLLEN AND HARD; RIGHT NECK SWOLLEN/HARD; SORE ARM; NECK BACK MUSCLE PAIN; HARDENED RIGHT NECK MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced hardened right neck muscle. On 2021, the subject experienced right neck swollen/hard. On 2021, the subject experienced sore arm. On 2021, the subject experienced neck back muscle pain. On MAR-2021, the subject experienced thyroid swollen and hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck back muscle pain on 2021, had not recovered from thyroid swollen and hard, and the outcome of right neck swollen/hard, sore arm and hardened right neck muscle was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Aphonia, Chest discomfort, Headache, Nausea
Clinical narrative: LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Decreased appetite
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; LOSS OF APPETITE; CRAMPING ON RIGHT  CALF/SPASMS FOR FEW HOURS; SHOOTING PAIN IN  RIGHT HIP; SHORTNESS OF BREATH; CHILLS; BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced loss of smell, loss of taste, loss of appetite, cramping on right calf/spasms for few hours, and shooting pain in right hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, shortness of breath, shooting pain in right hip, loss of appetite, loss of smell, loss of taste, and cramping on right calf/spasms for few hours, and the outcome of fatigue, chills and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Muscle spasms, Pain
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; LOSS OF APPETITE; CRAMPING ON RIGHT  CALF/SPASMS FOR FEW HOURS; SHOOTING PAIN IN  RIGHT HIP; SHORTNESS OF BREATH; CHILLS; BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced loss of smell, loss of taste, loss of appetite, cramping on right calf/spasms for few hours, and shooting pain in right hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, shortness of breath, shooting pain in right hip, loss of appetite, loss of smell, loss of taste, and cramping on right calf/spasms for few hours, and the outcome of fatigue, chills and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intermenstrual bleeding, Muscle spasms, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included intrauterine device (iud), and other pre-existing medical conditions included the patient did not have any medical history. 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, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced cramps. Treatment medications included: ibuprofen. On 12-APR-2021 16:00, the subject experienced fever. On 14-APR-2021 09:00, the subject experienced vaginal bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 13-APR-2021, and fever on 12-APR-2021, had not recovered from vaginal bleeding, and the outcome of cramps was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Retching, Vomiting
Clinical narrative: SEVERE DIARRHEA 3 TIMES; STOMACH ACHES; VOMITING; FEELING OF GAGGING; This spontaneous report received from a consumer concerned an 86 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included bedridden. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced severe diarrhea 3 times. On 01-APR-2021, the subject experienced stomach aches. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feeling of gagging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea 3 times, stomach aches, vomiting, and feeling of gagging on 02-APR-2021. This report was non-serious.; Sender's Comments: V0: As per standard protocol ,MAC comment is not required for non-serious case
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; CHEST PAIN; This spontaneous report received from a patient via a company representative via the local news, concerned a 60 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) at an unspecified dose on 06-MAR-2021 for prophylactic vaccination. The anatomical vaccination site was not reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 01-APR-2021, 26 days after vaccination, the patient went to hospital due to chest pain. On 08-APR-2021, 33 days after vaccination, the patient was diagnosed with pulmonary embolism, and was hospitalized. The patient reported he suffered a blood clot after receiving the vaccine and was diagnosed with a pulmonary emboli. On 11-APR-2021, the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism and chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: A 60-year-old man experienced chest pain 26 days after vaccine and was hospitalized with pulmonary emboli 33 days after vaccine. Medical history and concomitant medications were not reported. The latency of greater than 3 weeks makes this unlikely related to vaccine. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including contacting the news station that reported the event.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood test, Chest discomfort, Condition aggravated
Clinical narrative: LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Lethargy, Myalgia
Clinical narrative: LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Poor quality sleep, Pyrexia
Clinical narrative: LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 350 pounds, and height was 75 inches. The patient's concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Headache, Paralysis, Pyrexia
Clinical narrative: PARALYSIS; UNABLE TO WALK/ WALKING DIFFICULTY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1total, for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was paralyzed after receiving vaccine, the patient was hospitalized for 7 days. The patient did not had blood clot, but had difficulty walking, fever, chills, headache and was unable to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralysis, fever, chills, headache, and unable to walk/ walking difficulty. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210430056-Covid-19 vaccine ad26.cov2.s-Paralysis. This events is considered unassessable. The events 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 events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Contusion, Dizziness, Feeling abnormal
Clinical narrative: SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HER BODY; UNSTEADY; ITCHING RASH; STABBING HEADACHE; DIZZINESS; FOGGINESS; BRUISING; FLUSHED FACE; EXTREME RIGHT KNEE SWELLING; LEG PAIN; DISTENDED VEINS; BALANCE IS OFF; PULSATING SENSATION; HIVES TO ARMS; 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 sulfa allergy, and other pre-existing medical conditions included the patient had family history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A214 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced balance is off. On APR-2021, the subject experienced pulsating sensation. On APR-2021, the subject experienced hives to arms. On 07-APR-2021, the subject experienced extreme right knee swelling. On 07-APR-2021, the subject experienced distended veins. On 07-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced bruising. On 08-APR-2021, the subject experienced flushed face. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced fogginess. On 10-APR-2021, the subject experienced stabbing headache. On 11-APR-2021, the subject experienced unsteady. On 11-APR-2021, the subject experienced sensitivity at the top of the head. On 11-APR-2021, the subject experienced pressure in the head. On 11-APR-2021, the subject experienced overwhelming amount of heat coming from her body. On 11-APR-2021, the subject experienced itching rash.  On 12-APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and Diagnostic ultrasound (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching rash, distended veins, dizziness, stabbing headache, fogginess, flushed face, and overwhelming amount of heat coming from her body, had not recovered from extreme right knee swelling, leg pain, unsteady, bruising, sensitivity at the top of the head, and pressure in the head, and the outcome of hives to arms, balance is off and pulsating sensation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Head discomfort, Headache, Hyperaesthesia
Clinical narrative: SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HER BODY; UNSTEADY; ITCHING RASH; STABBING HEADACHE; DIZZINESS; FOGGINESS; BRUISING; FLUSHED FACE; EXTREME RIGHT KNEE SWELLING; LEG PAIN; DISTENDED VEINS; BALANCE IS OFF; PULSATING SENSATION; HIVES TO ARMS; 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 sulfa allergy, and other pre-existing medical conditions included the patient had family history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A214 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced balance is off. On APR-2021, the subject experienced pulsating sensation. On APR-2021, the subject experienced hives to arms. On 07-APR-2021, the subject experienced extreme right knee swelling. On 07-APR-2021, the subject experienced distended veins. On 07-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced bruising. On 08-APR-2021, the subject experienced flushed face. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced fogginess. On 10-APR-2021, the subject experienced stabbing headache. On 11-APR-2021, the subject experienced unsteady. On 11-APR-2021, the subject experienced sensitivity at the top of the head. On 11-APR-2021, the subject experienced pressure in the head. On 11-APR-2021, the subject experienced overwhelming amount of heat coming from her body. On 11-APR-2021, the subject experienced itching rash.  On 12-APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and Diagnostic ultrasound (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching rash, distended veins, dizziness, stabbing headache, fogginess, flushed face, and overwhelming amount of heat coming from her body, had not recovered from extreme right knee swelling, leg pain, unsteady, bruising, sensitivity at the top of the head, and pressure in the head, and the outcome of hives to arms, balance is off and pulsating sensation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.