chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Lymphadenopathy, Nausea, Pain, Pain in extremity
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. 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: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Poor quality sleep, Skin laceration, Somnolence, Syncope
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. 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: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. 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: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Electrocardiogram, Flushing, Head injury
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. 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: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Insomnia, Muscle tightness, Paraesthesia, Syncope
Clinical narrative: TIGHT MUSCLES; RIGHT HIP JOINT PAIN; FAINTED; NUMB LEG; TINGLY FOOT; FLUSHED; HIT HIS HEAD; INSOMNIA; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 185 pounds, and height was 69 inches. 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: 1808982) dose was not reported, administered 1 total on 08-APR-2021 13:00 at Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient experienced insomnia and chills at night. On 09-APR-2021, patient was doing physical activity (walking around the store). Patient experienced really sharp and stabbing right hip joint pain, right leg numbness and his right foot felt tingly like it had fallen asleep. That got worse over 5 minutes. Patient experienced very hot and flushed and proceeded to go outside where he fainted (his vision was blurry and in a confused state of mind and experienced hot and nausea) and hit his head. He tried to get up again. He fainted again and eventually came to. He was given stiches. On 11-APR-2021, he was having pain in right joint hip and tight muscles. He visited hospital where an EKG (electrocardiogram) was performed and results was normal. Laboratory data included: EKG: electrocardiogram (NR: not provided) as Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted (nausea/hot/blurry vision/confused state of mind), insomnia, flushed, and chills on APR-2021, was recovering from right hip joint pain, and the outcome of numb leg, tingly foot, hit his head and tight muscles was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422158-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: RIGHT UPPER QUADRANT ABDOMINAL PAIN; HEADACHE; NAUSEA; 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 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: 205A21A, 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 headache. On 08-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced right upper quadrant abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on 10-APR-2021, and had not recovered from right upper quadrant abdominal pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: RIGHT UPPER QUADRANT ABDOMINAL PAIN; HEADACHE; NAUSEA; 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 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: 205A21A, 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 headache. On 08-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced right upper quadrant abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on 10-APR-2021, and had not recovered from right upper quadrant abdominal pain. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, C-reactive protein increased, Cardiac arrest, Computerised tomogram abnormal, Cough
Clinical narrative: One day after the vaccine patient was hospitalized and passed away. It was noted that prior to patient coding then passing he had high anxiety, required oxygen use, and when into asytole.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Hypoxia, Lung infiltration, Pneumonia, Pneumonia bacterial
Clinical narrative: One day after the vaccine patient was hospitalized and passed away. It was noted that prior to patient coding then passing he had high anxiety, required oxygen use, and when into asytole.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Resuscitation, SARS-CoV-2 test negative, Viral test negative, White blood cell count increased
Clinical narrative: One day after the vaccine patient was hospitalized and passed away. It was noted that prior to patient coding then passing he had high anxiety, required oxygen use, and when into asytole.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Cardiac arrest, Cardio-respiratory arrest, Death
Clinical narrative: One day after the vaccine patient was hospitalized and passed away. It was noted that prior to patient coding then passing he had high anxiety, required oxygen use, and when into asytole.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Menstruation irregular, Nausea, Pain in extremity
Clinical narrative: DIZZINESS; OUT OF REALITY; EARLY MENSTRUAL CYCLE WITH HEAVY FLOW; ARM PAIN; FATIGUE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 43 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced out of reality. On APR-2021, the subject experienced early menstrual cycle with heavy flow. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and overall weakness, and the outcome of dizziness, arm pain, nausea, out of reality and early menstrual cycle with heavy flow was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Derealisation, Dizziness, Fatigue, Heavy menstrual bleeding
Clinical narrative: DIZZINESS; OUT OF REALITY; EARLY MENSTRUAL CYCLE WITH HEAVY FLOW; ARM PAIN; FATIGUE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 43 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced out of reality. On APR-2021, the subject experienced early menstrual cycle with heavy flow. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and overall weakness, and the outcome of dizziness, arm pain, nausea, out of reality and early menstrual cycle with heavy flow was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: DIZZINESS; OUT OF REALITY; EARLY MENSTRUAL CYCLE WITH HEAVY FLOW; ARM PAIN; FATIGUE; NAUSEA; OVERALL WEAKNESS; This spontaneous report received from a patient concerned a 43 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced out of reality. On APR-2021, the subject experienced early menstrual cycle with heavy flow. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced overall weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and overall weakness, and the outcome of dizziness, arm pain, nausea, out of reality and early menstrual cycle with heavy flow was not reported. This report was non-serious.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Balance disorder, Cough, Dizziness, Fatigue
Clinical narrative: JOINT SWELLING; FLUID IN JOINTS; FLUID IN NAIL BEDS; COUGH; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, and other pre-existing medical conditions included the patient has history of cardiac diagnosis.  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 27-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication. On an unspecified date, the subject experienced joint swelling, fluid in joints, fluid in nail beds, cough, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and had not recovered from joint swelling, fatigue, headache, fluid in nail beds, and fluid in joints. 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: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Joint swelling, Peripheral swelling
Clinical narrative: JOINT SWELLING; FLUID IN JOINTS; FLUID IN NAIL BEDS; COUGH; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, and other pre-existing medical conditions included the patient has history of cardiac diagnosis.  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 27-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication. On an unspecified date, the subject experienced joint swelling, fluid in joints, fluid in nail beds, cough, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and had not recovered from joint swelling, fatigue, headache, fluid in nail beds, and fluid in joints. 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: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Headache, Joint effusion, Joint swelling
Clinical narrative: JOINT SWELLING; FLUID IN JOINTS; FLUID IN NAIL BEDS; COUGH; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, and other pre-existing medical conditions included the patient has history of cardiac diagnosis.  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 27-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication. On an unspecified date, the subject experienced joint swelling, fluid in joints, fluid in nail beds, cough, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and had not recovered from joint swelling, fatigue, headache, fluid in nail beds, and fluid in joints. 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: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nail bed disorder
Clinical narrative: JOINT SWELLING; FLUID IN JOINTS; FLUID IN NAIL BEDS; COUGH; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, and other pre-existing medical conditions included the patient has history of cardiac diagnosis.  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 27-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication. On an unspecified date, the subject experienced joint swelling, fluid in joints, fluid in nail beds, cough, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, and had not recovered from joint swelling, fatigue, headache, fluid in nail beds, and fluid in joints. 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: 18.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Unevaluable event
Clinical narrative: FELLING TOO HOT OR TOO COLD; STOMACH PAIN; BODY SORENESS; CHILLS; HEADACHE; 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 past medical history included birth control, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient have allergies. but no allergies detail provided.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025,expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced body soreness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced severe headache. On 02-APR-2021, the subject experienced stomach pain. On an unspecified date, the subject experienced felling too hot or too cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness, stomach pain, and severe headache on 13-APR-2021, felling too hot or too cold, and chills on 02-APR-2021. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Abdominal pain upper, Chills, Feeling of body temperature change, Headache, Pain
Clinical narrative: FELLING TOO HOT OR TOO COLD; STOMACH PAIN; BODY SORENESS; CHILLS; HEADACHE; 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 past medical history included birth control, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient have allergies. but no allergies detail provided.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025,expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced body soreness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced severe headache. On 02-APR-2021, the subject experienced stomach pain. On an unspecified date, the subject experienced felling too hot or too cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness, stomach pain, and severe headache on 13-APR-2021, felling too hot or too cold, and chills on 02-APR-2021. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: SEVERE HEADACHE; INABILITY TO SLEEP; This spontaneous report received from a patient concerned a 27 year old. 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: 1808978, expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced inability to sleep. On 02-APR-2021, the subject experienced severe headache.  Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of inability to sleep was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment is not required for nonserious case as per standard protocol.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia
Clinical narrative: SEVERE HEADACHE; INABILITY TO SLEEP; This spontaneous report received from a patient concerned a 27 year old. 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: 1808978, expiry: UNKNWON) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced inability to sleep. On 02-APR-2021, the subject experienced severe headache.  Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and the outcome of inability to sleep was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment is not required for nonserious case as per standard protocol.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Arthralgia, Dizziness, Dysmenorrhoea
Clinical narrative: HAD PERIOD; PAIN; SWEATING; SLIGHT HEADACHE CONTINUES ON AND OFF; FEVERISH; JOINT PAIN; PERIOD CRAMPS THAT PROGRESSED AND GOT WORSE; LOWER INTESTINES DISCOMFORT; CRAMPING; ON AND OFF ALL NIGHT; HEAD, NECK, AND EARS WERE LITTLE ITCHY; DIZZY ON AND OFF; 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 multiple allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergy multiple.  On 07-APR-2021, the subject experienced head, neck, and ears were little itchy. On 07-APR-2021, the subject experienced dizzy on and off. On 07-APR-2021, the subject experienced period cramps that progressed and got worse. On 07-APR-2021, the subject experienced lower intestines discomfort. On 07-APR-2021, the subject experienced cramping. On 07-APR-2021, the subject experienced on and off all night. On 07-APR-2021 20:45, the subject experienced sweating. On 07-APR-2021 20:45, the subject experienced slight headache continues on and off. On 07-APR-2021 20:45, the subject experienced feverish. On 07-APR-2021 20:45, the subject experienced joint pain. On 08-APR-2021, the subject experienced had period. On 08-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head, neck, and ears were little itchy, and dizzy on and off on 07-APR-2021, had not recovered from slight headache continues on and off, and the outcome of joint pain, feverish, sweating, had period, lower intestines discomfort, period cramps that progressed and got worse, pain, cramping and on and off all night was not reported. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heavy menstrual bleeding, Hyperhidrosis, Menstruation irregular, Pelvic pain
Clinical narrative: HAD PERIOD; PAIN; SWEATING; SLIGHT HEADACHE CONTINUES ON AND OFF; FEVERISH; JOINT PAIN; PERIOD CRAMPS THAT PROGRESSED AND GOT WORSE; LOWER INTESTINES DISCOMFORT; CRAMPING; ON AND OFF ALL NIGHT; HEAD, NECK, AND EARS WERE LITTLE ITCHY; DIZZY ON AND OFF; 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 multiple allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergy multiple.  On 07-APR-2021, the subject experienced head, neck, and ears were little itchy. On 07-APR-2021, the subject experienced dizzy on and off. On 07-APR-2021, the subject experienced period cramps that progressed and got worse. On 07-APR-2021, the subject experienced lower intestines discomfort. On 07-APR-2021, the subject experienced cramping. On 07-APR-2021, the subject experienced on and off all night. On 07-APR-2021 20:45, the subject experienced sweating. On 07-APR-2021 20:45, the subject experienced slight headache continues on and off. On 07-APR-2021 20:45, the subject experienced feverish. On 07-APR-2021 20:45, the subject experienced joint pain. On 08-APR-2021, the subject experienced had period. On 08-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head, neck, and ears were little itchy, and dizzy on and off on 07-APR-2021, had not recovered from slight headache continues on and off, and the outcome of joint pain, feverish, sweating, had period, lower intestines discomfort, period cramps that progressed and got worse, pain, cramping and on and off all night was not reported. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Sleep disorder
Clinical narrative: HAD PERIOD; PAIN; SWEATING; SLIGHT HEADACHE CONTINUES ON AND OFF; FEVERISH; JOINT PAIN; PERIOD CRAMPS THAT PROGRESSED AND GOT WORSE; LOWER INTESTINES DISCOMFORT; CRAMPING; ON AND OFF ALL NIGHT; HEAD, NECK, AND EARS WERE LITTLE ITCHY; DIZZY ON AND OFF; 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 multiple allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergy multiple.  On 07-APR-2021, the subject experienced head, neck, and ears were little itchy. On 07-APR-2021, the subject experienced dizzy on and off. On 07-APR-2021, the subject experienced period cramps that progressed and got worse. On 07-APR-2021, the subject experienced lower intestines discomfort. On 07-APR-2021, the subject experienced cramping. On 07-APR-2021, the subject experienced on and off all night. On 07-APR-2021 20:45, the subject experienced sweating. On 07-APR-2021 20:45, the subject experienced slight headache continues on and off. On 07-APR-2021 20:45, the subject experienced feverish. On 07-APR-2021 20:45, the subject experienced joint pain. On 08-APR-2021, the subject experienced had period. On 08-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head, neck, and ears were little itchy, and dizzy on and off on 07-APR-2021, had not recovered from slight headache continues on and off, and the outcome of joint pain, feverish, sweating, had period, lower intestines discomfort, period cramps that progressed and got worse, pain, cramping and on and off all night was not reported. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dizziness, Dysmenorrhoea, Headache
Clinical narrative: HAD PERIOD; PAIN; SWEATING; SLIGHT HEADACHE CONTINUES ON AND OFF; FEVERISH; JOINT PAIN; PERIOD CRAMPS THAT PROGRESSED AND GOT WORSE; LOWER INTESTINES DISCOMFORT; CRAMPING; ON AND OFF ALL NIGHT; HEAD, NECK, AND EARS WERE LITTLE ITCHY; DIZZY ON AND OFF; 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 multiple allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergy multiple.  On 07-APR-2021, the subject experienced head, neck, and ears were little itchy. On 07-APR-2021, the subject experienced dizzy on and off. On 07-APR-2021, the subject experienced period cramps that progressed and got worse. On 07-APR-2021, the subject experienced lower intestines discomfort. On 07-APR-2021, the subject experienced cramping. On 07-APR-2021, the subject experienced on and off all night. On 07-APR-2021 20:45, the subject experienced sweating. On 07-APR-2021 20:45, the subject experienced slight headache continues on and off. On 07-APR-2021 20:45, the subject experienced feverish. On 07-APR-2021 20:45, the subject experienced joint pain. On 08-APR-2021, the subject experienced had period. On 08-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head, neck, and ears were little itchy, and dizzy on and off on 07-APR-2021, had not recovered from slight headache continues on and off, and the outcome of joint pain, feverish, sweating, had period, lower intestines discomfort, period cramps that progressed and got worse, pain, cramping and on and off all night was not reported. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Menstruation irregular, Muscle spasms, Pain, Pruritus
Clinical narrative: HAD PERIOD; PAIN; SWEATING; SLIGHT HEADACHE CONTINUES ON AND OFF; FEVERISH; JOINT PAIN; PERIOD CRAMPS THAT PROGRESSED AND GOT WORSE; LOWER INTESTINES DISCOMFORT; CRAMPING; ON AND OFF ALL NIGHT; HEAD, NECK, AND EARS WERE LITTLE ITCHY; DIZZY ON AND OFF; 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 multiple allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergy multiple.  On 07-APR-2021, the subject experienced head, neck, and ears were little itchy. On 07-APR-2021, the subject experienced dizzy on and off. On 07-APR-2021, the subject experienced period cramps that progressed and got worse. On 07-APR-2021, the subject experienced lower intestines discomfort. On 07-APR-2021, the subject experienced cramping. On 07-APR-2021, the subject experienced on and off all night. On 07-APR-2021 20:45, the subject experienced sweating. On 07-APR-2021 20:45, the subject experienced slight headache continues on and off. On 07-APR-2021 20:45, the subject experienced feverish. On 07-APR-2021 20:45, the subject experienced joint pain. On 08-APR-2021, the subject experienced had period. On 08-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head, neck, and ears were little itchy, and dizzy on and off on 07-APR-2021, had not recovered from slight headache continues on and off, and the outcome of joint pain, feverish, sweating, had period, lower intestines discomfort, period cramps that progressed and got worse, pain, cramping and on and off all night was not reported. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Restlessness
Clinical narrative: HAD PERIOD; PAIN; SWEATING; SLIGHT HEADACHE CONTINUES ON AND OFF; FEVERISH; JOINT PAIN; PERIOD CRAMPS THAT PROGRESSED AND GOT WORSE; LOWER INTESTINES DISCOMFORT; CRAMPING; ON AND OFF ALL NIGHT; HEAD, NECK, AND EARS WERE LITTLE ITCHY; DIZZY ON AND OFF; 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 multiple allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergy multiple.  On 07-APR-2021, the subject experienced head, neck, and ears were little itchy. On 07-APR-2021, the subject experienced dizzy on and off. On 07-APR-2021, the subject experienced period cramps that progressed and got worse. On 07-APR-2021, the subject experienced lower intestines discomfort. On 07-APR-2021, the subject experienced cramping. On 07-APR-2021, the subject experienced on and off all night. On 07-APR-2021 20:45, the subject experienced sweating. On 07-APR-2021 20:45, the subject experienced slight headache continues on and off. On 07-APR-2021 20:45, the subject experienced feverish. On 07-APR-2021 20:45, the subject experienced joint pain. On 08-APR-2021, the subject experienced had period. On 08-APR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head, neck, and ears were little itchy, and dizzy on and off on 07-APR-2021, had not recovered from slight headache continues on and off, and the outcome of joint pain, feverish, sweating, had period, lower intestines discomfort, period cramps that progressed and got worse, pain, cramping and on and off all night was not reported. 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Injection site pain
Clinical narrative: This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain injury, and concurrent conditions included endometrial cancer, fibromyalgia, superventricular tachycardia, focal seizure, penicillin allergy, and shellfish allergy, and other pre-existing medical conditions included the patient was allergic to floxin based drug and zicor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left leg swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg swelling. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Platelet count, Ultrasound Doppler
Clinical narrative: This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included brain injury, and concurrent conditions included endometrial cancer, fibromyalgia, superventricular tachycardia, focal seizure, penicillin allergy, and shellfish allergy, and other pre-existing medical conditions included the patient was allergic to floxin based drug and zicor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left leg swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg swelling. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Headache
Clinical narrative: BLOOD PRESSURE INCREASED; DEBILITATING HEADACHES; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included post-menopause hormone replacement therapy (HRT). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced blood pressure increased. On 29-MAR-2021, the subject experienced debilitating headaches. On 14-APR-2021 09:00, Laboratory data included: Blood pressure (NR: not provided) 150/85 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood pressure increased and headaches was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: BLOOD PRESSURE INCREASED; DEBILITATING HEADACHES; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included post-menopause hormone replacement therapy (HRT). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced blood pressure increased. On 29-MAR-2021, the subject experienced debilitating headaches. On 14-APR-2021 09:00, Laboratory data included: Blood pressure (NR: not provided) 150/85 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood pressure increased and headaches was not reported. This report was non-serious.