chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: ROOF OF MOUTH ITCHED; FEELS LIKE FACE (JAW) HURTS; DIZZINESS WHEN GOT UP AT NIGHT; CHILLS; THROBBING  HEADACHE; NAUSEA; FEVER; SHAKING FROM INSIDE; KEPT GETTING UP EVERY HOUR AT NIGHT; BURNED AT INJECTION SITE; HAVING DIFFICULTY FALLING BACK TO SLEEP WHEN WOKE UP AT NIGHT; This spontaneous report received from a patient. The patient's concurrent conditions included non hodgkin's lymphoma, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced shaking from inside. On 19-MAR-2021, the subject experienced kept getting up every hour at night. On 19-MAR-2021, the subject experienced burned at injection site. On 19-MAR-2021, the subject experienced having difficulty falling back to sleep when woke up at night. On 19-MAR-2021, the subject experienced dizziness when got up at night. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced throbbing headache. On 19-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:30, Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 20-MAR-2021, the subject experienced feels like face (jaw) hurts. On 20-MAR-2021, the subject experienced roof of mouth itched. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking from inside on 21-MAR-2021, kept getting up every hour at night, having difficulty falling back to sleep when woke up at night, feels like face (jaw) hurts, dizziness when got up at night, roof of mouth itched, throbbing headache, nausea, and fever on 21-MAR-2021 09:00, and chills on 20-MAR-2021, and the outcome of burned at injection site was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pruritus, Sensory disturbance
Clinical narrative: ITCHING ALL OVER THE BODY/ ITCHY HANDS AND FEET; THROAT FELT WEIRD; CHILLS; TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 159.8 pounds, and height was 162.56 centimeters. The patient's concurrent conditions included alcoholic, grass and trees allergy, dust allergy, and non smoker, and other pre-existing medical conditions included patient is allergic to outdoor grass, trees and dust since childhood. drinks alcohol sometimes or once a week. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: 25/MAY/2021) dose was not reported, administered on 15-MAR-2021 14:40 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced itching all over the body/ itchy hands and feet. On 21-MAR-2021, the subject experienced throat felt weird. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching all over the body/ itchy hands and feet, and throat felt weird on 22-MAR-2021, and chills, and tired on 17-MAR-2021. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Haematuria
Clinical narrative: BLOOD IN URINE; TEMPERATURE WENT DOWN; This spontaneous report received from a patient concerned a 71 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: 841A21A, 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 temperature went down. Laboratory data included: Body temperature (NR: not provided) 97.7 F, 96.4 F. On 03-APR-2021, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in urine, and the outcome of temperature went down was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Sneezing
Clinical narrative: RASH ON ARMS AND LEGS (ITCHING AND HOT AND SPLOTCHY DEPENDING IN THE PART OF THE  BODY); SWELLING; REDNESS; BURNING; ITCHING; SNEEZING; 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 the 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced burning. On 05-APR-2021, the subject experienced itching. On 05-APR-2021, the subject experienced sneezing. On 05-APR-2021, the subject experienced swelling. On 05-APR-2021, the subject experienced redness. On 05-APR-2021 08:15, treatment medications included: hydrocortisone. On an unspecified date, the subject experienced rash on arms and legs (itching and hot and splotchy depending in the part of the body). Additional treatment medications (dates unspecified) included: loratadine, and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning, itching, and sneezing on 05-APR-2021, was recovering from redness, had not recovered from swelling, and the outcome of rash on arms and legs (itching and hot and splotchy depending in the part of the body) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: RASH ON ARMS AND LEGS (ITCHING AND HOT AND SPLOTCHY DEPENDING IN THE PART OF THE  BODY); SWELLING; REDNESS; BURNING; ITCHING; SNEEZING; 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 the 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced burning. On 05-APR-2021, the subject experienced itching. On 05-APR-2021, the subject experienced sneezing. On 05-APR-2021, the subject experienced swelling. On 05-APR-2021, the subject experienced redness. On 05-APR-2021 08:15, treatment medications included: hydrocortisone. On an unspecified date, the subject experienced rash on arms and legs (itching and hot and splotchy depending in the part of the body). Additional treatment medications (dates unspecified) included: loratadine, and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning, itching, and sneezing on 05-APR-2021, was recovering from redness, had not recovered from swelling, and the outcome of rash on arms and legs (itching and hot and splotchy depending in the part of the body) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Hyperhidrosis
Clinical narrative: SWEATS; FEELING VERY SICK; WEAK AND MOVING VERY SLOWLY; LOW GRADE FEVER (100.7 DEGREES F); BODY ACHES; HEADACHE; NAUSEA; CHILLS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to plants, dust mite allergy, tree and grass allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient has medical history. the patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced low grade fever (100.7 degrees f). On an unspecified date, the subject experienced sweats, feeling very sick, and weak and moving very slowly. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F, 96 F, 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever (100.7 degrees f), had not recovered from headache, nausea, body aches, chills, and sweats, and the outcome of feeling very sick and weak and moving very slowly was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia
Clinical narrative: SWEATS; FEELING VERY SICK; WEAK AND MOVING VERY SLOWLY; LOW GRADE FEVER (100.7 DEGREES F); BODY ACHES; HEADACHE; NAUSEA; CHILLS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to plants, dust mite allergy, tree and grass allergy, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient has medical history. the patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced low grade fever (100.7 degrees f). On an unspecified date, the subject experienced sweats, feeling very sick, and weak and moving very slowly. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 F, 96 F, 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever (100.7 degrees f), had not recovered from headache, nausea, body aches, chills, and sweats, and the outcome of feeling very sick and weak and moving very slowly was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Needle issue, Pain
Clinical narrative: HEADACHES; MUSCLE ACHES/PAINS; VACCINE EXPELLED ON THE BODY INSTEAD OF GOING INTO THE ARM; NEEDLE WAS NOT SCREWED TO SYRINGE; LETHARGIC; SORENESS AND INSIDE PAIN; ARM PAIN; ARM SWELLING; 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 factor 5 leiden, environmental allergy, food allergy, and pain killers allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm swelling. On APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced vaccine expelled on the body instead of going into the arm. On 03-APR-2021, the subject experienced needle was not screwed to syringe. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced soreness and inside pain. On 03-APR-2021, the subject experienced muscle aches/pains. On 04-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, soreness and inside pain, and muscle aches/pains on 04-APR-2021, had not recovered from headaches, arm pain, and arm swelling, and the outcome of vaccine expelled on the body instead of going into the arm and needle was not screwed to syringe was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard operating procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Product administration error
Clinical narrative: HEADACHES; MUSCLE ACHES/PAINS; VACCINE EXPELLED ON THE BODY INSTEAD OF GOING INTO THE ARM; NEEDLE WAS NOT SCREWED TO SYRINGE; LETHARGIC; SORENESS AND INSIDE PAIN; ARM PAIN; ARM SWELLING; 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 factor 5 leiden, environmental allergy, food allergy, and pain killers allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm swelling. On APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced vaccine expelled on the body instead of going into the arm. On 03-APR-2021, the subject experienced needle was not screwed to syringe. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced soreness and inside pain. On 03-APR-2021, the subject experienced muscle aches/pains. On 04-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, soreness and inside pain, and muscle aches/pains on 04-APR-2021, had not recovered from headaches, arm pain, and arm swelling, and the outcome of vaccine expelled on the body instead of going into the arm and needle was not screwed to syringe was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard operating procedure as the case assessed as non-serious
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure measurement, Body temperature, Bone pain, Fatigue
Clinical narrative: BONE PAIN; PAIN IN UPPER BODY; SIGNIFICANT FATIGUE; FEVER; FIRE WITH NEUROPATHY; VASOVAGAL RESPONSE/ BLOOD PRESSURE DROPPED; This spontaneous report received from a patient concerned a 49 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 3B colon cancer, and chemo induced neuropathy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, total 1 dose, administered on 05-APR-2021; at 13:30 for prophylactic vaccination. Concomitant medications included gabapentin for neuropathy, and pegfilgrastim (Neulasta).  The patient's strength was not fully back because of physical limitations caused by neuropathy. Prior to the vaccination, the patient was well hydrated and took 900 mg gabapentin. On 05-APR-2021, almost immediately after the vaccination, the patient had a vasovagal response and the patient's hand were on fire with neuropathy. The patient's blood pressure (BP) was dropped to 80/40, blood sugar and hydration were fine. The patient recovered in about 20 minutes and felt fine for about 5 hours. The patient went to bed early and woke up with a fever of 100.4 and developed bone pain, pain in upper body that rivals the Neulasta shot with chemotherapy. The patient took paracetamol (extra strength tynenol), was able to reduce the pain and went back to sleep. The same thing happened 5 hours later with the same response with Tylenol. 22 hours post injection, the patient was not on tylenol, and did not feel pain, but the patient did felt significant fatigue. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal response/ blood pressure dropped, bone pain, and pain in upper body, had not recovered from fire with neuropathy and significant fatigue, and the outcome of fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-vasovagal response/ blood pressure dropped. 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.  covid-19 vaccine ad26.cov2. s-fire with neuropathy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Presyncope, Pyrexia
Clinical narrative: BONE PAIN; PAIN IN UPPER BODY; SIGNIFICANT FATIGUE; FEVER; FIRE WITH NEUROPATHY; VASOVAGAL RESPONSE/ BLOOD PRESSURE DROPPED; This spontaneous report received from a patient concerned a 49 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 3B colon cancer, and chemo induced neuropathy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, total 1 dose, administered on 05-APR-2021; at 13:30 for prophylactic vaccination. Concomitant medications included gabapentin for neuropathy, and pegfilgrastim (Neulasta).  The patient's strength was not fully back because of physical limitations caused by neuropathy. Prior to the vaccination, the patient was well hydrated and took 900 mg gabapentin. On 05-APR-2021, almost immediately after the vaccination, the patient had a vasovagal response and the patient's hand were on fire with neuropathy. The patient's blood pressure (BP) was dropped to 80/40, blood sugar and hydration were fine. The patient recovered in about 20 minutes and felt fine for about 5 hours. The patient went to bed early and woke up with a fever of 100.4 and developed bone pain, pain in upper body that rivals the Neulasta shot with chemotherapy. The patient took paracetamol (extra strength tynenol), was able to reduce the pain and went back to sleep. The same thing happened 5 hours later with the same response with Tylenol. 22 hours post injection, the patient was not on tylenol, and did not feel pain, but the patient did felt significant fatigue. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal response/ blood pressure dropped, bone pain, and pain in upper body, had not recovered from fire with neuropathy and significant fatigue, and the outcome of fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-vasovagal response/ blood pressure dropped. 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.  covid-19 vaccine ad26.cov2. s-fire with neuropathy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: INCREASE HEART RATE; FEELING ANXIOUS; UNWELL; CHILLS; HEADACHE; FEVER; 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 past medical history included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced increase heart rate. On 06-APR-2021, the subject experienced feeling anxious. On 06-APR-2021, the subject experienced unwell. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 120 and 158 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, increase heart rate, and fever, and the outcome of unwell and feeling anxious was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: INCREASE HEART RATE; FEELING ANXIOUS; UNWELL; CHILLS; HEADACHE; FEVER; 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 past medical history included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced increase heart rate. On 06-APR-2021, the subject experienced feeling anxious. On 06-APR-2021, the subject experienced unwell. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) 120 and 158 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, increase heart rate, and fever, and the outcome of unwell and feeling anxious was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Limb discomfort, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODES (LYMPH NODES BLEW UP LIKE GRAPEFRUITS ); UNABLE TO PUT ARMS  DOWN; PAIN UNDER HER ARMS ( PAIN UNDER HER ARMPITS); 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: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced pain under her arms (pain under her armpits). On 31-MAR-2021, the subject experienced swollen lymph nodes (lymph nodes blew up like grapefruits ). On 31-MAR-2021, the subject experienced unable to put arms down. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph nodes (lymph nodes blew up like grapefruits), unable to put arms down, and pain under her arms (pain under her armpits). This report was non-serious. Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: SWOLLEN ARMPIT; SORE ARM; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced swollen armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen armpit, and sore arm. 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: Chest discomfort, Chills, Lumbar puncture, Neuropathy peripheral, Scan
Clinical narrative: VERTIGO; VACCINE INDUCED NEUROPATHY; CHILLS; CHEST HEAVINESS; TACHYCARDIA; 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 was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-Mar-2021, the patient started experiencing tingling in various areas of the body at various times of the day. As the days progressed, she had chest heaviness, heart palpitation, and tachycardia. She went to the emergency room three times and was told her symptoms should resolve over time. She was diagnosed with vaccine induced neuropathy on 15-MAR-2021. On 26-MAR-2021, she experienced vertigo. She did not have any of these symptoms prior to using the Janssen COVID-19 vaccine. The tachycardia was not consistent, but happened again a few days ago, and caused concern. Currently she has to see a physical therapist for the vertigo and balance issues that she is experiencing. Laboratory data (dates unspecified) included: Lumbar puncture (NR: not provided) Normal, and Scan (NR: not provided) Normal. Treatment medications (dates unspecified) included: Tylenol (paracetamol) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and had not recovered from vertigo, vaccine induced neuropathy, chest heaviness, and tachycardia. The reporter considered causality between vaccine induced neuropathy, and tachycardia as not related This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210413724 - covid-19 vaccine ad26.cov2.s - vaccine induced neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vertigo
Clinical narrative: VERTIGO; VACCINE INDUCED NEUROPATHY; CHILLS; CHEST HEAVINESS; TACHYCARDIA; 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 was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-Mar-2021, the patient started experiencing tingling in various areas of the body at various times of the day. As the days progressed, she had chest heaviness, heart palpitation, and tachycardia. She went to the emergency room three times and was told her symptoms should resolve over time. She was diagnosed with vaccine induced neuropathy on 15-MAR-2021. On 26-MAR-2021, she experienced vertigo. She did not have any of these symptoms prior to using the Janssen COVID-19 vaccine. The tachycardia was not consistent, but happened again a few days ago, and caused concern. Currently she has to see a physical therapist for the vertigo and balance issues that she is experiencing. Laboratory data (dates unspecified) included: Lumbar puncture (NR: not provided) Normal, and Scan (NR: not provided) Normal. Treatment medications (dates unspecified) included: Tylenol (paracetamol) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and had not recovered from vertigo, vaccine induced neuropathy, chest heaviness, and tachycardia. The reporter considered causality between vaccine induced neuropathy, and tachycardia as not related This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210413724 - covid-19 vaccine ad26.cov2.s - vaccine induced neuropathy. 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: U
Vaccine: COVID19
Symptoms: Off label use, Product administration error, Underdose
Clinical narrative: ENTIRE VACCINE VIAL ADMINISTERED; OFF LABEL USE; 1 VIAL WAS USED TO VACCINATE 9 CONSUMERS; This spontaneous report received from a health care professional concerned multiple patients. 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. No concomitant medications were reported. On 07-APR-2021, the subject experienced entire vaccine vial administered. On 07-APR-2021, the subject experienced off label use. On 07-APR-2021, the subject experienced 1 vial was used to vaccinate 9 consumers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from entire vaccine vial administered, and the outcome of off label use and 1 vial was used to vaccinate 9 consumers was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Chest pain, Chills, Ear pain, Fatigue
Clinical narrative: HEART RATE CONTINUING HOURS AFTER EXERCISE STOPPAGE; SINUS HEADACHE; EAR PAIN; INCREASED TINNITUS; PAIN; SENSITIVE SKIN; OCCASIONAL PINCHES AND PAINS IN MY CHEST/ INCREASED INCIDENTS OF TIGHTNESS IN UPPER CHEST DURING AND AFTER EXERCISE; SINUS PRESSURE ESPECIALLY DURING OR RIGHT AFTER EXERCISE; CHILLS; FATIGUE; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Antibody test (NR: not provided) A very weak positive of the IgG antibodies.  On 28-MAR-2021, the subject experienced heart rate continuing hours after exercise stoppage. On 28-MAR-2021, the subject experienced sinus headache. On 28-MAR-2021, the subject experienced ear pain. On 28-MAR-2021, the subject experienced increased tinnitus. On 28-MAR-2021, the subject experienced pain. On 28-MAR-2021, the subject experienced sensitive skin. On 28-MAR-2021, the subject experienced occasional pinches and pains in my chest/ increased incidents of tightness in upper chest during and after exercise. On 28-MAR-2021, the subject experienced sinus pressure especially during or right after exercise. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus headache, ear pain, increased tinnitus, chills, muscle aches, pain, fever, sensitive skin, fatigue, heart rate continuing hours after exercise stoppage, occasional pinches and pains in my chest/ increased incidents of tightness in upper chest during and after exercise, and sinus pressure especially during or right after exercise. 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: U
Vaccine: COVID19
Symptoms: Heart rate abnormal, Myalgia, Pain, Paranasal sinus discomfort, Pyrexia
Clinical narrative: HEART RATE CONTINUING HOURS AFTER EXERCISE STOPPAGE; SINUS HEADACHE; EAR PAIN; INCREASED TINNITUS; PAIN; SENSITIVE SKIN; OCCASIONAL PINCHES AND PAINS IN MY CHEST/ INCREASED INCIDENTS OF TIGHTNESS IN UPPER CHEST DURING AND AFTER EXERCISE; SINUS PRESSURE ESPECIALLY DURING OR RIGHT AFTER EXERCISE; CHILLS; FATIGUE; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Antibody test (NR: not provided) A very weak positive of the IgG antibodies.  On 28-MAR-2021, the subject experienced heart rate continuing hours after exercise stoppage. On 28-MAR-2021, the subject experienced sinus headache. On 28-MAR-2021, the subject experienced ear pain. On 28-MAR-2021, the subject experienced increased tinnitus. On 28-MAR-2021, the subject experienced pain. On 28-MAR-2021, the subject experienced sensitive skin. On 28-MAR-2021, the subject experienced occasional pinches and pains in my chest/ increased incidents of tightness in upper chest during and after exercise. On 28-MAR-2021, the subject experienced sinus pressure especially during or right after exercise. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus headache, ear pain, increased tinnitus, chills, muscle aches, pain, fever, sensitive skin, fatigue, heart rate continuing hours after exercise stoppage, occasional pinches and pains in my chest/ increased incidents of tightness in upper chest during and after exercise, and sinus pressure especially during or right after exercise. 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: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sensitive skin, Sinus headache, Tinnitus
Clinical narrative: HEART RATE CONTINUING HOURS AFTER EXERCISE STOPPAGE; SINUS HEADACHE; EAR PAIN; INCREASED TINNITUS; PAIN; SENSITIVE SKIN; OCCASIONAL PINCHES AND PAINS IN MY CHEST/ INCREASED INCIDENTS OF TIGHTNESS IN UPPER CHEST DURING AND AFTER EXERCISE; SINUS PRESSURE ESPECIALLY DURING OR RIGHT AFTER EXERCISE; CHILLS; FATIGUE; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. 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 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-MAR-2021, Laboratory data included: Antibody test (NR: not provided) A very weak positive of the IgG antibodies.  On 28-MAR-2021, the subject experienced heart rate continuing hours after exercise stoppage. On 28-MAR-2021, the subject experienced sinus headache. On 28-MAR-2021, the subject experienced ear pain. On 28-MAR-2021, the subject experienced increased tinnitus. On 28-MAR-2021, the subject experienced pain. On 28-MAR-2021, the subject experienced sensitive skin. On 28-MAR-2021, the subject experienced occasional pinches and pains in my chest/ increased incidents of tightness in upper chest during and after exercise. On 28-MAR-2021, the subject experienced sinus pressure especially during or right after exercise. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced fever. On 28-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus headache, ear pain, increased tinnitus, chills, muscle aches, pain, fever, sensitive skin, fatigue, heart rate continuing hours after exercise stoppage, occasional pinches and pains in my chest/ increased incidents of tightness in upper chest during and after exercise, and sinus pressure especially during or right after exercise. 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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Pyrexia
Clinical narrative: RIGHT SIDED CHEST PAIN, NOT EXCRUCIATING, BUT LASTING 90-120 MINUTES; TENSION IN CHEST; CHILLS; FEVER; This spontaneous report received from a patient concerned a 21 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced right sided chest pain, not excruciating, but lasting 90-120 minutes. On 07-APR-2021, the subject experienced tension in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right sided chest pain, not excruciating, but lasting 90-120 minutes, fever, tension in chest, and chills. 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Seizure
Clinical narrative: SEIZURE; HIT HIS HEAD ON THE CONCRETE; This spontaneous report received from a consumer concerned a 55-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) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the patient was sitting with his wife after receiving the JANSSEN COVID-19 vaccine, when he had started to slump over. Patient experienced seizing (passed out and slipped out of his chair and started). It was reported that the patient hit his head on the concrete.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure (pass out and slumped over) and hit his head on the concrete was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210414732 and 20210414751.; Sender's Comments: V0 20210415021-Covid-19 vaccine ad26.cov2.s-Seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: SWEATS; FATIGUE; INCREASED HEART RATE UP TO 108 AT  NIGHT UP TO 95 DURING THE DAY; CHILLS; This spontaneous report received from a patient concerned a 37 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced increased heart rate up to 108 at night up to 95 during the day. On 06-APR-2021, the subject experienced chills. Laboratory data included: Heart rate (NR: not provided) 108, 95. On 07-APR-2021, the subject experienced sweats. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased heart rate up to 108 at night up to 95 during the day, fatigue, sweats, and chills. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; 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 administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event 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: COVID-19, Viral test positive
Clinical narrative: CONFIRMED COVID-19 INFECTION; 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 concurrent conditions included diabetes type 2 (non-insulin dependent).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: Unknown) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced confirmed covid-19 infection. On 05-APR-2021, Laboratory data included: Pharyngeal culture positive viral (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Ear disorder, Feeling abnormal, Headache, Heart rate
Clinical narrative: HEART BEATS STRONGLY; MINOR MUSCLE ACHE; SHAKING WITH CHILLS; NAGGING HEADACHE; FOGGY FEELING; EAR PROBLEM; 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 was previously treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number :unknown) dose was not reported, administered on 07-APR-2021 12:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced ear problem. On 07-APR-2021, treatment medications included: paracetamol. On 07-APR-2021 17:30, the subject experienced foggy feeling. On 07-APR-2021 17:30, the subject experienced nagging headache. On 07-APR-2021 20:15, the subject experienced shaking with chills. On 08-APR-2021, the subject experienced minor muscle ache. Laboratory data included: Heart rate (NR: not provided) 125-130 bpm. On 08-APR-2021 00:15, the subject experienced heart beats strongly. Laboratory data included: Heart rate (NR: not provided) 152 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beats strongly, foggy feeling, and shaking with chills on APR-2021, and had not recovered from nagging headache, minor muscle ache, and ear problem. This report was non-serious. This case, from the same reporter is linked to 20210420580 and 20210420637.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.