chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypersomnia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 54 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: 202A21A, 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 weakness. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced arm soreness. On an unspecified date, the subject experienced excessive sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from weakness, tiredness, and arm soreness, and the outcome of excessive sleeping was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Discomfort, Dizziness, Influenza like illness, Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy, lymphedema, neuropathy, sore muscle joints, afib, bipolar disorder, high blood pressure, hypothyroidism, diabetes type 2, copd, high cholesterol, non smoker, non alcohol user, and epilepsy medications sensitivity, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg swelling, flu-like symptoms, vomiting, dizzy/lightheadedness, off balance, sore, and legs hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, vomiting, dizzy/lightheadedness, and off balance, and had not recovered from sore, leg swelling, and legs hurt. This report was non-serious.g
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy, lymphedema, neuropathy, sore muscle joints, afib, bipolar disorder, high blood pressure, hypothyroidism, diabetes type 2, copd, high cholesterol, non smoker, non alcohol user, and epilepsy medications sensitivity, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg swelling, flu-like symptoms, vomiting, dizzy/lightheadedness, off balance, sore, and legs hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, vomiting, dizzy/lightheadedness, and off balance, and had not recovered from sore, leg swelling, and legs hurt. This report was non-serious.g
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: SEVERE BODY ACHES; METALLIC TASTE IN MOUTH LASTING 5  DAYS; Fever; Fatigue; Headache; This spontaneous report received from a parent concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included has severe allergies to many foods.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced severe body aches. On 08-APR-2021, the subject experienced metallic taste in mouth lasting 5 days. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste in mouth lasting 5 days on 13-APR-2021, fever on 09-APR-2021, and fatigue, and the outcome of severe body aches and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: FEELING DIZZY AND LIGHTHEADNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced feeling dizzy and lightheadness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy and lightheadness. This report was non-serious.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Epistaxis, Headache
Clinical narrative: NOSEBLEED; STOMACH CRAMPING; HEADACHE; This spontaneous report received from a patient concerned a 27 year old of unspecified 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: 207a21a, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced nosebleed. On 12-APR-2021, the subject experienced stomach cramping. On 12-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nosebleed, and stomach cramping, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity
Clinical narrative: MUSCLE TWITCHING OF THE RIGHT ARM; BILATERAL LEG PAIN; 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 concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient not had any drug abuse / illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced muscle twitching of the right arm. On 12-APR-2021, the subject experienced bilateral leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitching of the right arm, and bilateral leg pain on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; 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 admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN THE EARS BILATERALLY; 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 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 ringing in the ears bilaterally. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in the ears bilaterally. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Night sweats, Nightmare, Pyrexia
Clinical narrative: FEVER; NIGHTMARE; DIZZINESS; DROWSINESS; NIGHT SWEATS; FATIGUE; This spontaneous report received from a patient concerned an 86 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 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced nightmare. On 06-MAR-2021, the subject experienced dizziness. On 06-MAR-2021, the subject experienced drowsiness. On 06-MAR-2021, the subject experienced night sweats. On 06-MAR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmare, dizziness, drowsiness, and night sweats on 20-MAR-2021, and fever on APR-2021, and was recovering from fatigue. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: FEVER; NIGHTMARE; DIZZINESS; DROWSINESS; NIGHT SWEATS; FATIGUE; This spontaneous report received from a patient concerned an 86 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 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced nightmare. On 06-MAR-2021, the subject experienced dizziness. On 06-MAR-2021, the subject experienced drowsiness. On 06-MAR-2021, the subject experienced night sweats. On 06-MAR-2021, the subject experienced fatigue. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmare, dizziness, drowsiness, and night sweats on 20-MAR-2021, and fever on APR-2021, and was recovering from fatigue. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Formication, Headache, Limb discomfort
Clinical narrative: LEFT RIB PAIN; GROGGY; LEGS FEEL HEAVY; PULSATING MUSCLE LEFT ARM; FEELS LIKE BUG CRAWLING THROUGH SKIN; BODY ACHES; CHATTERING TEETH; SEVER BILATERAL LOWER LEG PAIN; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild infection of covid 19, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A 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 groggy. On 10-APR-2021, the subject experienced legs feel heavy. On 10-APR-2021, the subject experienced sever bilateral lower leg pain. On 10-APR-2021, the subject experienced pulsating muscle left arm. On 10-APR-2021, the subject experienced feels like bug crawling through skin. On 10-APR-2021, the subject experienced chattering teeth. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced left rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left rib pain, fever, body aches, and headache on 12-APR-2021, was recovering from sever bilateral lower leg pain, had not recovered from pulsating muscle left arm, feels like bug crawling through skin, legs feel heavy, and groggy, and the outcome of chattering teeth was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain, Pain in extremity, Pyrexia, Sensory disturbance
Clinical narrative: LEFT RIB PAIN; GROGGY; LEGS FEEL HEAVY; PULSATING MUSCLE LEFT ARM; FEELS LIKE BUG CRAWLING THROUGH SKIN; BODY ACHES; CHATTERING TEETH; SEVER BILATERAL LOWER LEG PAIN; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild infection of covid 19, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A 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 groggy. On 10-APR-2021, the subject experienced legs feel heavy. On 10-APR-2021, the subject experienced sever bilateral lower leg pain. On 10-APR-2021, the subject experienced pulsating muscle left arm. On 10-APR-2021, the subject experienced feels like bug crawling through skin. On 10-APR-2021, the subject experienced chattering teeth. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced left rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left rib pain, fever, body aches, and headache on 12-APR-2021, was recovering from sever bilateral lower leg pain, had not recovered from pulsating muscle left arm, feels like bug crawling through skin, legs feel heavy, and groggy, and the outcome of chattering teeth was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: LEFT RIB PAIN; GROGGY; LEGS FEEL HEAVY; PULSATING MUSCLE LEFT ARM; FEELS LIKE BUG CRAWLING THROUGH SKIN; BODY ACHES; CHATTERING TEETH; SEVER BILATERAL LOWER LEG PAIN; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild infection of covid 19, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A 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 groggy. On 10-APR-2021, the subject experienced legs feel heavy. On 10-APR-2021, the subject experienced sever bilateral lower leg pain. On 10-APR-2021, the subject experienced pulsating muscle left arm. On 10-APR-2021, the subject experienced feels like bug crawling through skin. On 10-APR-2021, the subject experienced chattering teeth. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021, the subject experienced left rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left rib pain, fever, body aches, and headache on 12-APR-2021, was recovering from sever bilateral lower leg pain, had not recovered from pulsating muscle left arm, feels like bug crawling through skin, legs feel heavy, and groggy, and the outcome of chattering teeth was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This spontaneous report received from a patient 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, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: SWELLING OF THE FACE; This spontaneous report received from a consumer concerned a 68 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced swelling of the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the face. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Vision blurred
Clinical narrative: BLURRED VISION; DOUBLE VISION; This spontaneous report received from a patient concerned a 52 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: 1805029 and expiry: 25/MAY/2021) dose was not reported, administered on 27-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced blurred vision. On 31-MAR-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, and double vision. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Hypoaesthesia, Migraine
Clinical narrative: HEART PALPITATIONS; FOOT SWOLLEN; DIZZY SPELLS; MIGRAINE; PAIN RADIATED TO HEAD AND SIDE OF EAR AND SOMETIMES INTO FINGERS; REDNESS ON FOOT; TINGLING ON FOOT; FOOT NUMBNESS; UNABLE TO LIFT ARM; PAIN IN ARM; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, autoimmune disorder, and neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 02-APR-2021 12:30 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced foot swollen. On 02-APR-2021, the subject experienced dizzy spells. On 02-APR-2021, the subject experienced migraine. On 02-APR-2021, the subject experienced pain radiated to head and side of ear and sometimes into fingers. On 02-APR-2021, the subject experienced redness on foot. On 02-APR-2021, the subject experienced tingling on foot. On 02-APR-2021, the subject experienced foot numbness. On 02-APR-2021, the subject experienced unable to lift arm. On 02-APR-2021, the subject experienced pain in arm. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm, headache, heart palpitations, foot swollen, dizzy spells, fever, migraine, pain radiated to head and side of ear and sometimes into fingers, unable to lift arm, redness on foot, foot numbness, and tingling on foot. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: HEART PALPITATIONS; FOOT SWOLLEN; DIZZY SPELLS; MIGRAINE; PAIN RADIATED TO HEAD AND SIDE OF EAR AND SOMETIMES INTO FINGERS; REDNESS ON FOOT; TINGLING ON FOOT; FOOT NUMBNESS; UNABLE TO LIFT ARM; PAIN IN ARM; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, autoimmune disorder, and neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 02-APR-2021 12:30 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced foot swollen. On 02-APR-2021, the subject experienced dizzy spells. On 02-APR-2021, the subject experienced migraine. On 02-APR-2021, the subject experienced pain radiated to head and side of ear and sometimes into fingers. On 02-APR-2021, the subject experienced redness on foot. On 02-APR-2021, the subject experienced tingling on foot. On 02-APR-2021, the subject experienced foot numbness. On 02-APR-2021, the subject experienced unable to lift arm. On 02-APR-2021, the subject experienced pain in arm. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm, headache, heart palpitations, foot swollen, dizzy spells, fever, migraine, pain radiated to head and side of ear and sometimes into fingers, unable to lift arm, redness on foot, foot numbness, and tingling on foot. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: HEART PALPITATIONS; FOOT SWOLLEN; DIZZY SPELLS; MIGRAINE; PAIN RADIATED TO HEAD AND SIDE OF EAR AND SOMETIMES INTO FINGERS; REDNESS ON FOOT; TINGLING ON FOOT; FOOT NUMBNESS; UNABLE TO LIFT ARM; PAIN IN ARM; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, autoimmune disorder, and neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 02-APR-2021 12:30 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced heart palpitations. On 02-APR-2021, the subject experienced foot swollen. On 02-APR-2021, the subject experienced dizzy spells. On 02-APR-2021, the subject experienced migraine. On 02-APR-2021, the subject experienced pain radiated to head and side of ear and sometimes into fingers. On 02-APR-2021, the subject experienced redness on foot. On 02-APR-2021, the subject experienced tingling on foot. On 02-APR-2021, the subject experienced foot numbness. On 02-APR-2021, the subject experienced unable to lift arm. On 02-APR-2021, the subject experienced pain in arm. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm, headache, heart palpitations, foot swollen, dizzy spells, fever, migraine, pain radiated to head and side of ear and sometimes into fingers, unable to lift arm, redness on foot, foot numbness, and tingling on foot. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: FAINTING SPELLS/ SYNCOPE; DIZZINESS/ LIGHTHEADEDNESS; NAUSEA; This spontaneous report received from a health care professional concerned multiple patients of unspecified age and sex. The patients' heights and weights were not reported. The patients had no known drug allergies. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. The reporter stated that, on 10-APR-2021, the patients experienced side effects which included fainting spells/syncope, dizziness/lightheadedness and nausea within 15 minutes or so after vaccination at a mass vaccination clinic.   The events were reported as serious by the reporter.   The patients visited a healthcare professional office for fainting spells/syncope, dizziness/lightheadedness and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting spells/syncope, dizziness/lightheadedness and nausea were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This spontaneous report from a health care professional concerns multiple adult patients of unspecified age and gender from a mass vaccination site who experienced fainting spells/syncope, dizziness/lightheadedness and nausea within 15 minutes or so after the Janssen COVID-19 Vaccine Ad26.COV2 had been administered. Given the close temporal relationship and the nature of the events, the events are considered possibly related to the vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Photophobia
Clinical narrative: SEVERE HEADACHE PAIN 5/10 ON A PAIN SCALE; FEVER 100.9 F; LIGHT SENSITIVITY; CHILLS; BODY ACHES; INTERMITTENT DULL SHOOTING PAIN TO BOTH LEGS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 162 pounds, and height was 65 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced intermittent dull shooting pain to both legs. On 08-APR-2021, the subject experienced light sensitivity. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fever 100.9 f. On 09-APR-2021, the subject experienced severe headache pain 5/10 on a pain scale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light sensitivity on 09-APR-2021, and chills, body aches, and fever 100.9 f on 08-APR-2021, and had not recovered from severe headache pain 5/10 on a pain scale, and intermittent dull shooting pain to both legs. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SEVERE HEADACHE PAIN 5/10 ON A PAIN SCALE; FEVER 100.9 F; LIGHT SENSITIVITY; CHILLS; BODY ACHES; INTERMITTENT DULL SHOOTING PAIN TO BOTH LEGS; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 162 pounds, and height was 65 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced intermittent dull shooting pain to both legs. On 08-APR-2021, the subject experienced light sensitivity. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fever 100.9 f. On 09-APR-2021, the subject experienced severe headache pain 5/10 on a pain scale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light sensitivity on 09-APR-2021, and chills, body aches, and fever 100.9 f on 08-APR-2021, and had not recovered from severe headache pain 5/10 on a pain scale, and intermittent dull shooting pain to both legs. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Malaise, Pain in extremity
Clinical narrative: SWEATING; FELT VERY SICK; LEG SORENESS; SEVERE HEADACHE; FEELING HOT; TINGLING IN RIGHT ARM/LEGS; This spontaneous report received from a patient concerned a 51 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: 041A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced tingling in right arm/legs. On 12-APR-2021, the subject experienced feeling hot. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced felt very sick. On 12-APR-2021, the subject experienced leg soreness. On 12-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, sweating, felt very sick, leg soreness, and severe headache on 12-APR-2021, and tingling in right arm/legs on 11-APR-2021. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: SWEATING; FELT VERY SICK; LEG SORENESS; SEVERE HEADACHE; FEELING HOT; TINGLING IN RIGHT ARM/LEGS; This spontaneous report received from a patient concerned a 51 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: 041A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced tingling in right arm/legs. On 12-APR-2021, the subject experienced feeling hot. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced felt very sick. On 12-APR-2021, the subject experienced leg soreness. On 12-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, sweating, felt very sick, leg soreness, and severe headache on 12-APR-2021, and tingling in right arm/legs on 11-APR-2021. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Migraine, Nausea, Pain
Clinical narrative: BODY ACHE; NAUSEA; CHILLS; VOMITING; HOT FLASHES; MIGRAINE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other 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: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced migraine. On 12-APR-2021, the subject experienced chills. On 12-APR-2021 18:00, the subject experienced nausea. On 13-APR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of vomiting, hot flashes, body ache, chills and migraine was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BODY ACHE; NAUSEA; CHILLS; VOMITING; HOT FLASHES; MIGRAINE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other 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: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced hot flashes. On 12-APR-2021, the subject experienced migraine. On 12-APR-2021, the subject experienced chills. On 12-APR-2021 18:00, the subject experienced nausea. On 13-APR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and the outcome of vomiting, hot flashes, body ache, chills and migraine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: BODY ACHES; HEADACHE; FATIGUE; 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) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and had not recovered from fatigue, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: DIZZY; CHILLS; TIRED; NAUSEA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included genetic blood clot history, supraventricular tachycardia, and covid-19 infection, and concurrent conditions included penicillin allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the patient experienced dizzy, chills, tired, nausea, injection site pain. Patient took Tylenol for chills and Pepcid for nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-APR-2021, was recovering from tired, dizzy, and nausea, and had not recovered from injection site pain. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site swelling, Lymphadenopathy
Clinical narrative: BILATERAL UNDERARM LYMPH NODE SWELLING; TIREDNESS; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, penicillin allergy, non alcohol user, and non smoker. The patient was not pregnant at the time of reporting. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and levofloxacin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site swelling. On 10-APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced bilateral underarm lymph node swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and injection site swelling, and had not recovered from bilateral underarm lymph node swelling. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort, Muscle spasms, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Throat tightness
Clinical narrative: MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Swelling face
Clinical narrative: SWELLING IN CHIN AREA WHICH MOVED ABOVE THE EYE; ITCHING; FATIGUE; 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 was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 12-APR-2021, the subject experienced swelling in chin area which moved above the eye. On 12-APR-2021, the subject experienced itching. On 12-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, and had not recovered from swelling in chin area which moved above the eye, and fatigue. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: NUMBNESS IN HAND; LEG PAIN; 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 admin not reported, batch number: Unk) 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 numbness in hand, and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in hand and leg pain was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Rash
Clinical narrative: RASH; MUSCLE SORENESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced skin rash. On 02-APR-2021, the subject experienced muscle soreness. On 02-APR-2021, the subject experienced tiredness. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from skin rash, muscle soreness, tiredness, and headache on 03-APR-2021. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: PAIN IN LEGS; CHILLS; This spontaneous report received from a patient via a company representative concerned a 42 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-APR-2021, the subject experienced pain in legs. On 12-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in legs and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: ARM SORE; BODY ACHES; CHILLS; BAD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced arm sore. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad headache, arm sore, body aches and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: MILD BODY PAIN / SORENESS; CHILLS; FEVER; MILD HEADACHE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced mild body pain, soreness, chills, fever, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild headache, mild body pain, fever, chills and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHTHEADED; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced lightheaded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded. This report was non-serious.