chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Muscle spasms, Rash, Rhinorrhoea
Clinical narrative: LEG CRAMPS; CHEST PAIN; RUNNY NOSE; FOLATE DEFICIENCY; VITAMIN D DEFICIENCY; RASH; FEELING UNWELL; LACK OF ENERGY; CHILLS; HEADACHE; BEING WIPED OUT; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included orthopedic problems, asthma, attention deficit hyperactivity disorder, allergic to house dust, allergic to dog hair, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and also not pregnant at the time of vaccination. The patient received Pfizer vaccine on January 14, 2021 and February 4, 2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced leg cramps. On 2021, the subject experienced chest pain. On 2021, the subject experienced runny nose. On 2021, the subject experienced folate deficiency. On 2021, the subject experienced vitamin d deficiency. On 2021, the subject experienced rash. On 2021, the subject experienced feeling unwell. On 2021, the subject experienced lack of energy. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced being wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, leg cramps, rash, runny nose, feeling unwell, lack of energy, folate deficiency, vitamin d deficiency, and being wiped out, and the outcome of chest pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: LEG CRAMPS; CHEST PAIN; RUNNY NOSE; FOLATE DEFICIENCY; VITAMIN D DEFICIENCY; RASH; FEELING UNWELL; LACK OF ENERGY; CHILLS; HEADACHE; BEING WIPED OUT; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included orthopedic problems, asthma, attention deficit hyperactivity disorder, allergic to house dust, allergic to dog hair, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and also not pregnant at the time of vaccination. The patient received Pfizer vaccine on January 14, 2021 and February 4, 2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced leg cramps. On 2021, the subject experienced chest pain. On 2021, the subject experienced runny nose. On 2021, the subject experienced folate deficiency. On 2021, the subject experienced vitamin d deficiency. On 2021, the subject experienced rash. On 2021, the subject experienced feeling unwell. On 2021, the subject experienced lack of energy. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced being wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, leg cramps, rash, runny nose, feeling unwell, lack of energy, folate deficiency, vitamin d deficiency, and being wiped out, and the outcome of chest pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a consumer concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to .
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Disorientation, Dizziness, Fatigue, Pyrexia
Clinical narrative: EARS RINGING; VOMITING; TIREDNESS; FEVER; DIZZINESS; DISORIENTED; This spontaneous report received from a patient concerned a 42 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: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) Over 100 (unit unspecified). On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced ears ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, and had not recovered from dizziness, disoriented, tiredness, ears ringing, and fever. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vomiting
Clinical narrative: EARS RINGING; VOMITING; TIREDNESS; FEVER; DIZZINESS; DISORIENTED; This spontaneous report received from a patient concerned a 42 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: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) Over 100 (unit unspecified). On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced ears ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, and had not recovered from dizziness, disoriented, tiredness, ears ringing, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported.  On 11-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative, and SARS-CoV-2 rapid POC test (NR: not provided) negative. On 13-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: SARS-CoV-2 PCR test (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.; Sender's Comments: V0  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Anxiety, Arthralgia, Attention deficit hyperactivity disorder, Back pain
Clinical narrative: BAD CHILD MEMORY; ANGER; NOT EATING ALOT; INSOMNIA; RINGING IN EARS; HYPERNESS; ANXIETY; HEADACHE; HEARD A CRACK IN KNEE; LOW BACK PAIN; ENHANCED LEFT KNEE PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heard a crack in knee. On 25-MAR-2021, the subject experienced low back pain. On 25-MAR-2021, the subject experienced enhanced left knee pain. On 26-MAR-2021, the subject experienced bad child memory. On 26-MAR-2021, the subject experienced anger. On 26-MAR-2021, the subject experienced not eating alot. On 26-MAR-2021, the subject experienced insomnia. On 26-MAR-2021, the subject experienced ringing in ears. On 26-MAR-2021, the subject experienced hyperness. On 26-MAR-2021, the subject experienced anxiety. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low back pain, had not recovered from enhanced left knee pain, anxiety, anger, headache, not eating alot, insomnia, hyperness, and bad child memory, and the outcome of ringing in ears and heard a crack in knee was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypophagia, Insomnia, Lower limb fracture, Nightmare
Clinical narrative: BAD CHILD MEMORY; ANGER; NOT EATING ALOT; INSOMNIA; RINGING IN EARS; HYPERNESS; ANXIETY; HEADACHE; HEARD A CRACK IN KNEE; LOW BACK PAIN; ENHANCED LEFT KNEE PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heard a crack in knee. On 25-MAR-2021, the subject experienced low back pain. On 25-MAR-2021, the subject experienced enhanced left knee pain. On 26-MAR-2021, the subject experienced bad child memory. On 26-MAR-2021, the subject experienced anger. On 26-MAR-2021, the subject experienced not eating alot. On 26-MAR-2021, the subject experienced insomnia. On 26-MAR-2021, the subject experienced ringing in ears. On 26-MAR-2021, the subject experienced hyperness. On 26-MAR-2021, the subject experienced anxiety. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low back pain, had not recovered from enhanced left knee pain, anxiety, anger, headache, not eating alot, insomnia, hyperness, and bad child memory, and the outcome of ringing in ears and heard a crack in knee was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: BAD CHILD MEMORY; ANGER; NOT EATING ALOT; INSOMNIA; RINGING IN EARS; HYPERNESS; ANXIETY; HEADACHE; HEARD A CRACK IN KNEE; LOW BACK PAIN; ENHANCED LEFT KNEE PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heard a crack in knee. On 25-MAR-2021, the subject experienced low back pain. On 25-MAR-2021, the subject experienced enhanced left knee pain. On 26-MAR-2021, the subject experienced bad child memory. On 26-MAR-2021, the subject experienced anger. On 26-MAR-2021, the subject experienced not eating alot. On 26-MAR-2021, the subject experienced insomnia. On 26-MAR-2021, the subject experienced ringing in ears. On 26-MAR-2021, the subject experienced hyperness. On 26-MAR-2021, the subject experienced anxiety. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low back pain, had not recovered from enhanced left knee pain, anxiety, anger, headache, not eating alot, insomnia, hyperness, and bad child memory, and the outcome of ringing in ears and heard a crack in knee was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: BREATHING WAS HIGHER THAN NORMAL; BODY FELT LITTLE OUT OF CONTROL; DIZZY; MORE LETHARGIC; MORE TIRED; NAUSEA; HEART RATE WAS ELEVATED; ARM PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 202 pounds, and height was 54 inches. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. 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, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arm pain. On APR-2021, the subject experienced heart rate was elevated. On APR-2021, the subject experienced arm pain. Laboratory data included: Breathing rate increased (NR: not provided) 23 breaths per minute, and Heart rate (NR: not provided) 19 to 54 milliseconds. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced body felt little out of control. On 09-APR-2021, the subject experienced more lethargic. On 09-APR-2021, the subject experienced more tired. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced breathing was higher than normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate was elevated on 13-APR-2021, and breathing was higher than normal on 11-APR-2021, and the outcome of nausea, more lethargic, dizzy, arm pain, body felt little out of control and more tired 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
Symptoms: Lethargy, Nausea, Pain in extremity, Respiratory rate increased
Clinical narrative: BREATHING WAS HIGHER THAN NORMAL; BODY FELT LITTLE OUT OF CONTROL; DIZZY; MORE LETHARGIC; MORE TIRED; NAUSEA; HEART RATE WAS ELEVATED; ARM PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 202 pounds, and height was 54 inches. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. 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, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arm pain. On APR-2021, the subject experienced heart rate was elevated. On APR-2021, the subject experienced arm pain. Laboratory data included: Breathing rate increased (NR: not provided) 23 breaths per minute, and Heart rate (NR: not provided) 19 to 54 milliseconds. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced body felt little out of control. On 09-APR-2021, the subject experienced more lethargic. On 09-APR-2021, the subject experienced more tired. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced breathing was higher than normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate was elevated on 13-APR-2021, and breathing was higher than normal on 11-APR-2021, and the outcome of nausea, more lethargic, dizzy, arm pain, body felt little out of control and more tired 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness, Middle insomnia
Clinical narrative: FLU LIKE SYMPTOMS; SHORTNESS OF BREATH PERIODICALLY DURING THE NIGHT; WAKE FROM SLEEP; This spontaneous report received from a consumer concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, shortness of breath periodically during the night, and wake from sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and shortness of breath periodically during the night on 06-APR-2021, and the outcome of wake from sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: BREATHLESSNESS; DIZZY; MAJOR DIARRHEA; SLEEPING ALMOST LIKE SHE WAS DRUGGED /DEEP SLEEP; SORE ARM; SEVERE NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned a 66 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: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced breathlessness. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced major diarrhea. On APR-2021, the subject experienced sleeping almost like she was drugged /deep sleep. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, headache, dizzy, breathlessness, severe nausea, major diarrhea, sore arm, and sleeping almost like she was drugged /deep sleep. 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: Hypersomnia, Nausea, Pain in extremity
Clinical narrative: BREATHLESSNESS; DIZZY; MAJOR DIARRHEA; SLEEPING ALMOST LIKE SHE WAS DRUGGED /DEEP SLEEP; SORE ARM; SEVERE NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned a 66 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: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced breathlessness. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced major diarrhea. On APR-2021, the subject experienced sleeping almost like she was drugged /deep sleep. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, headache, dizzy, breathlessness, severe nausea, major diarrhea, sore arm, and sleeping almost like she was drugged /deep sleep. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pain
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, 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 body aches. On 06-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 07-APR-2021, and had not recovered from shortness of breath. 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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Cough, Dizziness
Clinical narrative: COUGH; BACK PAIN; CHILLS/SHIVERS; HEADACHE IN RIGHT TEMPLE, MALICIOUS HEADACHE; FEVER; LIGHT HEADEDNESS, DIZZINESS; VOMITING; This spontaneous report received from a patient concerned a 45 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced light headedness, dizziness. On an unspecified date, the subject experienced cough, back pain, chills/shivers, headache in right temple, malicious headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, dizziness on 12-APR-2021, had not recovered from headache in right temple, malicious headache, and back pain, and the outcome of vomiting, cough, chills/shivers and fever was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: COUGH; BACK PAIN; CHILLS/SHIVERS; HEADACHE IN RIGHT TEMPLE, MALICIOUS HEADACHE; FEVER; LIGHT HEADEDNESS, DIZZINESS; VOMITING; This spontaneous report received from a patient concerned a 45 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced light headedness, dizziness. On an unspecified date, the subject experienced cough, back pain, chills/shivers, headache in right temple, malicious headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headedness, dizziness on 12-APR-2021, had not recovered from headache in right temple, malicious headache, and back pain, and the outcome of vomiting, cough, chills/shivers and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Epistaxis, Headache, Pyrexia
Clinical narrative: SORE BACK; HEADACHE; FEVER; NOSE BLEEDS; This spontaneous report received from a consumer 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 administration not reported, batch number: 042A21A, 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 nose bleeds. On 02-APR-2021, the subject experienced sore back. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and the outcome of sore back, fever and nose bleeds was not reported. 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: Injection site bruising, Injection site exfoliation, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: INJECTION SITE BRUISE (2 INCH IN SIZE); SKIN PEELING AT THE INJECTION SITE; RASH ON INJECTION SITE; INJECTION SITE TENDER; FEVER; 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. O n 14-APR-2021, the subject experienced injection site bruise (2 inch in size). On 14-APR-2021, the subject experienced skin peeling at the injection site. On 14-APR-2021, the subject experienced rash on injection site. On 14-APR-2021, the subject experienced injection site tender. On 14-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 14-APR-2021, and had not recovered from rash on injection site, injection site tender, injection site bruise (2 inch in size), and skin peeling at the injection site. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment not required for non -serious cases
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: RASH ON BACK, FACE, AROUND WRISTS ON BOTH SIDES; CHILLS; MILDLY FEVERISH; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to grass, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: unknown) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced mildly feverish. On 13-APR-2021 19:00, the subject experienced rash on back, face, around wrists on both sides. On 13-APR-2021 22:00, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mildly feverish on 13-APR-2021, and had not recovered from rash on back, face, around wrists on both sides. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza virus test negative, Lymphadenopathy, Malaise, Pain
Clinical narrative: LYMPH NODE SWELLED UNDERNEATH ARM; ACHES ALL OVER; NOT FEEL GREAT; SPLITTING HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE, and Influenza antibody test negative (NR: not provided) Negative. On an unspecified date, the subject experienced lymph node swelled underneath arm, aches all over, not feel great, splitting headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of lymph node swelled underneath arm, not feel great, splitting headache and aches all over was not reported. 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: Pyrexia, SARS-CoV-2 test
Clinical narrative: LYMPH NODE SWELLED UNDERNEATH ARM; ACHES ALL OVER; NOT FEEL GREAT; SPLITTING HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) NEGATIVE, and Influenza antibody test negative (NR: not provided) Negative. On an unspecified date, the subject experienced lymph node swelled underneath arm, aches all over, not feel great, splitting headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of lymph node swelled underneath arm, not feel great, splitting headache and aches all over was not reported. 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: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: PASSED OUT; This spontaneous report received from a consumer concerned a male 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) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient passed out immediately upon receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of passed out was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210428755.; Sender's Comments: V0: 20210429067-covid-19 vaccine ad26.cov2.s-passed out. 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
Symptoms: Abdominal pain, Dyspnoea, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: BRAIN FOGGINESS; HEADACHE; SHORTNESS OF BREATH; ABDOMINAL PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa, occasionally drinks, and non-smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: unknown) dose was not reported, 1 total dose, administered on 09-APR-2021 14:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 (Saturday morning), the patient experienced shortness of breath, headache, abdominal pain and leg pain. Later, the symptoms were significantly decrease, however he was still experiencing shortness of breath and sometimes brain fogginess. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, abdominal pain, and leg pain, and had not recovered from brain fogginess, and shortness of breath. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Pain
Clinical narrative: NOSE BLEEDS; BODY ACHES; FATIGUE; 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 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue on 08-APR-2021, and the outcome of nose bleeds was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Hypertension, Presyncope
Clinical narrative: PRE-SYNCOPE; 3 NOSE BLEEDS; HIGH BLOOD PRESSURE; 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 was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pre-syncope. On 2021, the subject experienced 3 nose bleeds. On 2021, the subject experienced high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pre-syncope, and the outcome of 3 nose bleeds and high blood pressure was not reported. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Epistaxis
Clinical narrative: BLOODY NOSE; BELL'S PALSY; This spontaneous report received from a patient concerned a 73 year old female patient. The patient's height, and weight were not reported. The patient's past medical history included carotid surgery on 12-MAR-2021.  The patient received vaccination with JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered to left arm on 02-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for blood thinner. The patient reported no other symptoms or side effects after the vaccine.  Around 07-APR-2021, patient started getting Bell's palsy and went to the Emergency Room (ER) because she thought she was having a stroke. The patient was diagnosed with Bell's palsy. The patient followed up with primary care provided on 12-APR-2021. Patient's Bell's palsy was not recovered completely but was almost gone. The patient had bloody nose on 13-APR-2021 and went to urgent care. The patient was told not to worry about it and 'it will probably never happen again'.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding from nose, and was recovering from bell's palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 73-year-old female patient experienced medically important Bell's palsy 5 days after receiving JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) intramuscularly to left arm for prophylactic vaccination. The patient's had carotid surgery 21 days prior to the vaccination. Concomitant medications included clopidogrel bisulphate. The patient reported no other symptoms after the vaccination. She started to get Bell's palsy symptoms 5 days post vaccination and visited emergency room. She was diagnosed with Bell's palsy. Details of symptoms, diagnosis, treatment were not reported. She followed up with primary care provider 10 days post vaccination and was seen with Bell's palsy "almost gone". She was recovering from Bell's palsy. The patient experienced non-serious bloody nose the next day and had recovered.  Although information is limited, as there is no confirmatory epidemiologic/biologic evidence that vaccinations cause/contribute to the development of Bell's palsy, and the most common causes include viral infection and diabetes, the event is assessed to have an indeterminate causal association to immunization, per WHO causality classification for adverse events following immunization. Company causality for Bell's Palsy is considered not related to JANSSEN COVID-19 VACCINE.  Additional information has been requested for further assessment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Dyspnoea, Epistaxis, Fibrin D dimer increased
Clinical narrative: ELEVATED D-DIMER; SHORTNESS OF BREATH; NOSE BLEED; BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced nose bleed. On 12-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced elevated d-dimer. Laboratory data included: CT scan (NR: not provided) Negative, and Fibrin D dimer high (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, nose bleed, chills, and fever on 12-APR-2021, and had not recovered from headache, shortness of breath, and elevated d-dimer. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: ELEVATED D-DIMER; SHORTNESS OF BREATH; NOSE BLEED; BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced nose bleed. On 12-APR-2021, the subject experienced shortness of breath. On 13-APR-2021, the subject experienced elevated d-dimer. Laboratory data included: CT scan (NR: not provided) Negative, and Fibrin D dimer high (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, nose bleed, chills, and fever on 12-APR-2021, and had not recovered from headache, shortness of breath, and elevated d-dimer. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Headache, Pyrexia
Clinical narrative: DIARRHEA; DIZZINESS; LEFT NOSTRIL PAIN; HEADACHE ON LEFT SIDE/ HEADACHE FELT THROUGH EAR; TEMP 102-103; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced left nostril pain. On 10-APR-2021, the subject experienced headache on left side/ headache felt through ear. On 10-APR-2021, the subject experienced temp 102-103. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache on left side/ headache felt through ear, diarrhea, left nostril pain, temp 102-103 and dizziness was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinalgia
Clinical narrative: DIARRHEA; DIZZINESS; LEFT NOSTRIL PAIN; HEADACHE ON LEFT SIDE/ HEADACHE FELT THROUGH EAR; TEMP 102-103; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201821A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced left nostril pain. On 10-APR-2021, the subject experienced headache on left side/ headache felt through ear. On 10-APR-2021, the subject experienced temp 102-103. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache on left side/ headache felt through ear, diarrhea, left nostril pain, temp 102-103 and dizziness was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Lip swelling, Nausea, Pyrexia
Clinical narrative: RANDOM VAGINAL SPOTTING; SWOLLEN LIP; NAUSEA; VOMITING (THREW UP TWICE); FELT "FUZZY"; CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included nausea, and vomiting, and concurrent conditions included acne, and allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included spironolactone for acne, and cetirizine hydrochloride for allergies. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced felt "fuzzy". On 11-APR-2021, the subject experienced vomiting (threw up twice). On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced swollen lip. On 13-APR-2021, the subject experienced random vaginal spotting. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt "fuzzy", vomiting (threw up twice), and nausea on 11-APR-2021, swollen lip on 12-APR-2021, and chills, and fever on 10-APR-2021, and had not recovered from random vaginal spotting. This report was non-serious.