chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension
Clinical narrative: DIZZY; HYPOTENSIVE; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and other pre-existing medical conditions included the patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 12:45 for prophylactic vaccination. Concomitant medications included venlafaxine for depression. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced hypotensive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy and hypotensive was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; INTENSE PAIN DOWN ARM; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 MAR-2021, the subject experienced neck pain. On MAR-2021, the subject experienced intense pain down arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, and intense pain down arm on 2021. This report was non-serious. This case, from the same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: CHILLS; NAUSEATED; FEVER; HEADACHE; ACHE ALL OVER; 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: 1802068, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced ache all over, chills, nauseated, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache all over, chills, nauseated, fever and headache was not reported. This report was non-serious. This case, from the same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RASHES WITH ITCHINESS SPREADING FROM ARMS TO BACK; 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: Unknown) dose was not reported, administered on 10-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 an unspecified date, the subject experienced rashes with itchiness spreading from arms to back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rashes with itchiness spreading from arms to back was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Hypotension
Clinical narrative: BRADYCARDIA; HYPOTENSION; This spontaneous report received from a health care professional concerned a 56 year old female. This report was received from news/social media. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and iodine allergy. 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, 1 total, administered on 08-APR-2021 for prophylactic vaccination. The vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported.  On 08-APR-2021, at 12:46, the patient experienced lightheadedness, hypotension, bradycardia and nausea and the patient was evaluated by emergency medical services (EMS), the patient was sent to hospital for further observation. The patient was hospitalized for 1 day and discharged in good health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bradycardia, and hypotension on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210415566.; Sender's Comments: 20210441834-covid-19 vaccine ad26.cov2.s-Bradycardia, Hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: SYNCOPE; This spontaneous report received from a other health professional (Nurse) via social media/news concerned a 37 year old white, not Hispanic female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, administered, 1 total, on 08-APR-2021 for prophylactic vaccination. The vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported. On 08-APR-2021, at 12:57, the patient experienced syncope, hypotension and bradycardia. The patient was evaluated by emergency medical services (EMS) and sent to hospital for further observation. The patient was discharged in good health. The patient recovered from syncope on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210415566.; Sender's Comments: V0: 20210441898-COVID-19 VACCINE AD26.COV2.S - Syncope. 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: Nausea
Clinical narrative: NAUSEA; 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, batch number: 202A21A,expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. Treatment medications included: bismuth subsalicylate. 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from a consumer concerned a 48 year old female. This report was received from news/social media. 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, 1 total administered on 08-APR-2021 for prophylactic vaccination. Vaccination site had outdoor temperatures around 78-80 degrees. No concomitant medications were reported.  On an unspecified date in  APR-2021, the patient experienced allergic reaction (rash), after vaccination and was hospitalized (date unspecified). Treatment medications given on an unspecified date in /APR/2021 included: epinephrine, methylprednisolone sodium succinate, diphenhydramine hydrochloride and fluid. The patient was hospitalized overnight and was discharged with good health. The duration of hospitalization was 1 day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction on APR-2021. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to. Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S- ALLERGIC REACTION. This event is labeled and is therefore considered potentially related.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, breast cancer, hypothyroid, atrial fibrillation, morphine allergy, penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, clopidogrel bisulfate, and salbutamol. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHT-HEADED; This spontaneous report received from a consumer concerned a 21 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced light-headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light-headed was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHTHEADED; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheaded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lightheaded was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: TASTE CHANGE; SMELL CHANGE; This spontaneous report received from a patient concerned an elderly 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced taste change. On 27-MAR-2021, the subject experienced smell change. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from taste change, and had not recovered from smell change. This report was non-serious. This report was associated with product quality complaint.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: NECK PAIN; HEADACHE/PAIN RADIATING FROM NECK TO POSTERIOR SKULL; NAUSEA; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and hormonal change, 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, intramuscular, batch number: Unknown) dose was not reported, administered on 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 APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced neck pain. On 08-APR-2021, the subject experienced headache/pain radiating from neck to posterior skull. On 08-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 headache/pain radiating from neck to posterior skull, neck pain, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: SHARP PAIN UPON DEEP INHALATION; This spontaneous report received from a health care professional concerned a 6 decade 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced sharp pain upon deep inhalation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain upon deep inhalation. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included the patient has one kidney, and seafood allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A,) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bumpy rash on back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bumpy rash on back was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: HEART RATE INCREASED; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, hypothyroid, gout, and penicillin allergy. 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 APR-2021, Laboratory data included: Heart rate (NR: not provided) Fluctuates around mid 90s in the afternoon and nights. On 10-APR-2021, the subject experienced heart rate increased. Laboratory data included: Heart rate increased (NR: not provided) 115 beats per minute. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart rate increased. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Pain in extremity
Clinical narrative: CHEST PAIN; CHEST PAIN RADIATING TO STOMACH ON AND OFF; PAIN LIKE SENSITIVE TO TOUCH ON LOWER BACK OF LEGS BELOW KNEE (RIGHT LEG IS MORE SENSITIVE TO THE TOUCH THAN LEFT); This spontaneous report received from a patient concerned a 45 year old male. 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 did not known allergies and 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: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left). On 20-APR-2021, the subject experienced chest pain. On 20-APR-2021, the subject experienced chest pain radiating to stomach on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain like sensitive to touch on lower back of legs below knee (right leg is more sensitive to the touch than left), and chest pain, and the outcome of chest pain radiating to stomach on and off was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: DULL PAIN/BURN AT REST; SHARP PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced dull pain/burn at rest. On 07-APR-2021, the subject experienced sharp pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain in left arm, and dull pain/burn at rest. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: PAIN EXTENDING TO THE NECK; FEELING PAIN FROM SHOULDER TO ARM; This spontaneous report received from a patient concerned a 50 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: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021, the subject experienced pain extending to the neck. On 17-APR-2021, the subject experienced feeling pain from shoulder to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling pain from shoulder to arm, and pain extending to the neck. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient via a company representative concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ciu.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. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included omalizumab. On an unspecified date, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Syncope
Clinical narrative: FAINT; HYPOTENSION; DIAPHORETIC; This spontaneous report received from a health care professional concerned a 53 year old  female. This report was received from news/social media. 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, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient was faint and experienced hypotension and was diaphoretic. The patient was released after observation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the faint, hypotension and diaphoretic was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210415566.; Sender's Comments: V0-20210442589- Covid-19 vaccine ad26.cov2.s-Faint. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: SHAKING; BODY ACHE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned an adult 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: 1802068 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced headache. On 26-Mar-2021, the subject experienced shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body ache, chills, fever, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Illness, Pain
Clinical narrative: ACHES; SWEATS; SICKNESS; CHILLS; FEVER; 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, sweats, sickness, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, sweats, chills, fever, fatigue and sickness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHES; SWEATS; SICKNESS; CHILLS; FEVER; 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, sweats, sickness, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aches, sweats, chills, fever, fatigue and sickness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: SHORT OF BREATH; TIREDNESS; DIZZINESS; NAUSEA; HEADACHE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included on the previous day of report, patient took sleeping pills.  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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-APR-2021, the subject experienced dizziness. On 20-APR-2021, the subject experienced nausea. On 20-APR-2021, the subject experienced headache. On 21-APR-2021, the subject experienced short of breath. On 21-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, headache, and dizziness, and had not recovered from tiredness, and short of breath. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Muscle strain, Pain in extremity
Clinical narrative: CRAMPING SENSATION; BAD LEFT LEG PAIN; HEADACHE DAILY; LEFT LEG MUSCLE PULLED; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left leg muscle pulled. On 10-APR-2021, the subject experienced headache daily. On 21-APR-2021, the subject experienced cramping sensation. On 21-APR-2021, the subject experienced bad left leg pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad left leg pain, headache daily, and cramping sensation, and the outcome of left leg muscle pulled was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; 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: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 15-APR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: COLD LIKE SYMPTOMS; UNWELL FEELING; This spontaneous report received from a female patient of unspecified age via a company representative. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced cold like symptoms, and unwell feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold like symptoms, and unwell feeling. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: BODY ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included thyroid issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and 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 headache. On 13-APR-2021, the subject experienced body aches. 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 headache, nausea, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: ARM DISCOMFORT; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced arm discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm discomfort on 19-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Nausea
Clinical narrative: METALLIC TASTE IN MOUTH; VERY MILD NAUSEA; LITTLE TIRED; 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 hypertension, asthma, and unspecified allergy.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 10-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 metallic taste in mouth. On APR-2021, the subject experienced very mild nausea. On APR-2021, the subject experienced little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little tired, metallic taste in mouth, and very mild nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: ROUGH WITH IMMUNE RESPONSE; This spontaneous report received from a patient via a company representative 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: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 08-APR-2021, the subject experienced rough with immune response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rough with immune response on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: PANIC ATTACK; DIZZINESS; HEADACHE; VERY FATIGUE; LOSS OF BALANCE; CONFUSION; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18052029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: PCR (NR: not provided) Negative. On 12-APR-2021, the subject experienced loss of balance. On 12-APR-2021, the subject experienced confusion. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced very fatigue. On 15-APR-2021, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack on 16-APR-2021, and had not recovered from loss of balance, headache, confusion, very fatigue, and dizziness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Panic attack, Polymerase chain reaction
Clinical narrative: PANIC ATTACK; DIZZINESS; HEADACHE; VERY FATIGUE; LOSS OF BALANCE; CONFUSION; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18052029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: PCR (NR: not provided) Negative. On 12-APR-2021, the subject experienced loss of balance. On 12-APR-2021, the subject experienced confusion. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced very fatigue. On 15-APR-2021, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack on 16-APR-2021, and had not recovered from loss of balance, headache, confusion, very fatigue, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE SORENESS AREAS ON BODY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bone on bone lower back, pain in upper right thigh, fullness in groin, and fullness neck lymph nodes. 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 muscle soreness areas on body. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle soreness areas on body. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: LOSS OF APPETITE/ANOREXIC; FELT HOT; NOT MYSELF; MALAISE; TIRED; DIARRHEA; SHAKES; SWEATING; CHILLS; FEVERISH; SICKNESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, high cholesterol, low thyroid, illness, and hospitalization, and concurrent conditions included penicillin allergy, cbd (cannabidiol), and chronic hives, and other pre-existing medical conditions included patient may have had covid or the flu or some virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced diarrhea. On 16-APR-2021, the subject experienced loss of appetite/anorexic. On 16-APR-2021, the subject experienced felt hot. On 16-APR-2021, the subject experienced not myself. On 16-APR-2021, the subject experienced malaise. On 16-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, diarrhea, sweating, chills, and feverish on 10-APR-2021, and loss of appetite/anorexic, felt hot, not myself, malaise, and tired on 18-APR-2021, and the outcome of sickness was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Illness, Malaise, Pyrexia
Clinical narrative: LOSS OF APPETITE/ANOREXIC; FELT HOT; NOT MYSELF; MALAISE; TIRED; DIARRHEA; SHAKES; SWEATING; CHILLS; FEVERISH; SICKNESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, high cholesterol, low thyroid, illness, and hospitalization, and concurrent conditions included penicillin allergy, cbd (cannabidiol), and chronic hives, and other pre-existing medical conditions included patient may have had covid or the flu or some virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced diarrhea. On 16-APR-2021, the subject experienced loss of appetite/anorexic. On 16-APR-2021, the subject experienced felt hot. On 16-APR-2021, the subject experienced not myself. On 16-APR-2021, the subject experienced malaise. On 16-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, diarrhea, sweating, chills, and feverish on 10-APR-2021, and loss of appetite/anorexic, felt hot, not myself, malaise, and tired on 18-APR-2021, and the outcome of sickness was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: LOSS OF APPETITE/ANOREXIC; FELT HOT; NOT MYSELF; MALAISE; TIRED; DIARRHEA; SHAKES; SWEATING; CHILLS; FEVERISH; SICKNESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included high blood pressure, high cholesterol, low thyroid, illness, and hospitalization, and concurrent conditions included penicillin allergy, cbd (cannabidiol), and chronic hives, and other pre-existing medical conditions included patient may have had covid or the flu or some virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced shakes. On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced diarrhea. On 16-APR-2021, the subject experienced loss of appetite/anorexic. On 16-APR-2021, the subject experienced felt hot. On 16-APR-2021, the subject experienced not myself. On 16-APR-2021, the subject experienced malaise. On 16-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, diarrhea, sweating, chills, and feverish on 10-APR-2021, and loss of appetite/anorexic, felt hot, not myself, malaise, and tired on 18-APR-2021, and the outcome of sickness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: BAD COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bruising, and anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bad cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad cold. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; HEADACHE; EXTREMELY TIRED; 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) 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 body ache, chills, fever, headache, and extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache, headache and extremely tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Illness, Tremor
Clinical narrative: SHAKY; LOSS OF APPETITE; FELT HORRIBLE; SICK; VOMITED; FATIGUE; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, and thyroid issue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 03-APR-2021, the subject experienced fatigue. On 17-APR-2021, the subject experienced sick. On 17-APR-2021, the subject experienced vomited. On 18-APR-2021, the subject experienced felt horrible. On an unspecified date, the subject experienced shaky, and loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited, and fatigue on 04-APR-2021, and the outcome of sick, shaky and loss of appetite was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SHAKY; LOSS OF APPETITE; FELT HORRIBLE; SICK; VOMITED; FATIGUE; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, and thyroid issue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 03-APR-2021, the subject experienced fatigue. On 17-APR-2021, the subject experienced sick. On 17-APR-2021, the subject experienced vomited. On 18-APR-2021, the subject experienced felt horrible. On an unspecified date, the subject experienced shaky, and loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited, and fatigue on 04-APR-2021, and the outcome of sick, shaky and loss of appetite was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: SKIN ALLERGY ON HANDS, ARMS AND FEET; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included do not have any history of food or chemical allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced skin allergy on hands, arms and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin allergy on hands, arms and feet was not reported. This report was non-serious.