chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Eye inflammation, Fatigue
Clinical narrative: ACHY FLU-LIKE PAIN; JOINT PAIN; NO ENERGY; KNEE PAIN/ ARTHRITIC TYPE ACHE; WEAKNESS; HEADACHE; EXHAUSTION; NERVE PAIN ON HEAD; RIGHT SIDE EYE INFLAMMATION; SLEEP MORE THAN NORMAL-HAVE A HARD TIME GETTING UP; PAIN IN MY BODY; PAIN IN LOWER BACK; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included torn meniscus of the left knee, minor brain blockage, fibromyalgia, cervical spinal stenosis, degenerative disk disease, disabled, overweight, mild egg allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: not reported) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for minor brain blockage. On 2021, treatment medications included: cannabidiol. On MAR-2021, the subject experienced sleep more than normal-have a hard time getting up. On MAR-2021, the subject experienced pain in my body. On MAR-2021, the subject experienced pain in lower back. On MAR-2021, the subject experienced nerve pain on head. On MAR-2021, the subject experienced right side eye inflammation. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced exhaustion. On 11-MAR-2021, the subject experienced knee pain/ arthritic type ache. On 08-APR-2021, the subject experienced achy flu-like pain. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in lower back on 2021, and right side eye inflammation, had not recovered from knee pain/ arthritic type ache, and the outcome of headache, pain in my body, weakness, sleep more than normal-have a hard time getting up, exhaustion, achy flu-like pain, nerve pain on head, joint pain and no energy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Influenza like illness, Neuralgia, Pain
Clinical narrative: ACHY FLU-LIKE PAIN; JOINT PAIN; NO ENERGY; KNEE PAIN/ ARTHRITIC TYPE ACHE; WEAKNESS; HEADACHE; EXHAUSTION; NERVE PAIN ON HEAD; RIGHT SIDE EYE INFLAMMATION; SLEEP MORE THAN NORMAL-HAVE A HARD TIME GETTING UP; PAIN IN MY BODY; PAIN IN LOWER BACK; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included torn meniscus of the left knee, minor brain blockage, fibromyalgia, cervical spinal stenosis, degenerative disk disease, disabled, overweight, mild egg allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: not reported) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for minor brain blockage. On 2021, treatment medications included: cannabidiol. On MAR-2021, the subject experienced sleep more than normal-have a hard time getting up. On MAR-2021, the subject experienced pain in my body. On MAR-2021, the subject experienced pain in lower back. On MAR-2021, the subject experienced nerve pain on head. On MAR-2021, the subject experienced right side eye inflammation. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced exhaustion. On 11-MAR-2021, the subject experienced knee pain/ arthritic type ache. On 08-APR-2021, the subject experienced achy flu-like pain. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in lower back on 2021, and right side eye inflammation, had not recovered from knee pain/ arthritic type ache, and the outcome of headache, pain in my body, weakness, sleep more than normal-have a hard time getting up, exhaustion, achy flu-like pain, nerve pain on head, joint pain and no energy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: DIZZY; FELT WEIRD; 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 not reported) dose was not reported, administered on 24-MAR-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 24-MAR-2021, the subject experienced dizzy. On 24-MAR-2021, the subject experienced felt weird. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy and felt weird was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: BRUISING AT THE SITE OF INJECTION (SMALL BLACK BLUE MARK); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included neuropathy, restless leg syndrome, allergy to peg in miralax, and root canal infection.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 30-MAR-2021 15:00 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 hydroxychloroquine phosphate for drug used for unknown indication, paracetamol for neuropathy, and root canal infection, and amoxicillin for root canal infection. On an unspecified date, the subject experienced bruising at the site of injection (small black blue mark). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising at the site of injection (small black blue mark) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Injection site pain, Lethargy
Clinical narrative: MENTAL FOGGINESS; LETHARGY; WARM FEELING IN ARM; TINGLING FEELING IN ARM; HEAVY BODY FATIGUE; MILD TO MODERATE ACHES AT INJECTION SITE; 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, 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 mental fogginess, lethargy, warm feeling in arm, tingling feeling in arm, heavy body fatigue, and mild to moderate aches at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heavy body fatigue, lethargy, mental fogginess, mild to moderate aches at injection site, warm feeling in arm and tingling feeling in arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: MENTAL FOGGINESS; LETHARGY; WARM FEELING IN ARM; TINGLING FEELING IN ARM; HEAVY BODY FATIGUE; MILD TO MODERATE ACHES AT INJECTION SITE; 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, 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 mental fogginess, lethargy, warm feeling in arm, tingling feeling in arm, heavy body fatigue, and mild to moderate aches at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heavy body fatigue, lethargy, mental fogginess, mild to moderate aches at injection site, warm feeling in arm and tingling feeling in arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Nausea, Pain
Clinical narrative: LETHARGY; BODY ACHES; DRY IRRITATED THROAT; CHILLS; HEADACHE; FEVER; NAUSEA; ARM PAIN; This spontaneous report received from a patient concerned a 30-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:1808609, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced arm pain. On 31-MAR-2021, the patient experienced nausea. On 01-APR-2021, the patient experienced lethargy. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced dry irritated throat. On 01-APR-2021, the patient experienced chills. On 01-APR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, headache, body aches, fever, dry irritated throat, chills, arm pain, and nausea. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Throat irritation
Clinical narrative: LETHARGY; BODY ACHES; DRY IRRITATED THROAT; CHILLS; HEADACHE; FEVER; NAUSEA; ARM PAIN; This spontaneous report received from a patient concerned a 30-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:1808609, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient experienced arm pain. On 31-MAR-2021, the patient experienced nausea. On 01-APR-2021, the patient experienced lethargy. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced dry irritated throat. On 01-APR-2021, the patient experienced chills. On 01-APR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, headache, body aches, fever, dry irritated throat, chills, arm pain, and nausea. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Otitis externa
Clinical narrative: BELL'S PALSY; OUTER EAR INFECTION/EAR ACHE, PAIN AND REDNESS; This spontaneous report received from a patient concerned a 67 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 expiry: UNKNOWN) dose was not reported, 1 total administered on 14-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient, experienced pain from 19-MAR-2021 to 21-MAR-2021. On 21-MAR-2021, the patient experienced outer ear infection. On the same day, she went to the Urgent Care and the physician gave her ear drops (unspecified) for outer ear infection which was used only for two times. According to her physician, her ear was a little red. She stated that as per her age and family history, she went to the emergency room on 22-March-2021 and found out that she had Bell's Palsy. She went to the ophthalmologist who gave Neo-Poly-Dex 0.1 percent (3.5 grams) ointment. Treatment medications included: dexamethasone/neomycin/polymyxin b.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bell's palsy, and the outcome of outer ear infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407047-COVID-19 VACCINE AD26.COV2.S-bells's palsy. 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.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Central nervous system inflammation, Ear pain, Eye operation, Eyelid function disorder
Clinical narrative: BELL'S PALSY; OUTER EAR INFECTION/EAR ACHE, PAIN AND REDNESS; This spontaneous report received from a patient concerned a 67 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 expiry: UNKNOWN) dose was not reported, 1 total administered on 14-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient, experienced pain from 19-MAR-2021 to 21-MAR-2021. On 21-MAR-2021, the patient experienced outer ear infection. On the same day, she went to the Urgent Care and the physician gave her ear drops (unspecified) for outer ear infection which was used only for two times. According to her physician, her ear was a little red. She stated that as per her age and family history, she went to the emergency room on 22-March-2021 and found out that she had Bell's Palsy. She went to the ophthalmologist who gave Neo-Poly-Dex 0.1 percent (3.5 grams) ointment. Treatment medications included: dexamethasone/neomycin/polymyxin b.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bell's palsy, and the outcome of outer ear infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407047-COVID-19 VACCINE AD26.COV2.S-bells's palsy. 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.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelids protective suture
Clinical narrative: BELL'S PALSY; OUTER EAR INFECTION/EAR ACHE, PAIN AND REDNESS; This spontaneous report received from a patient concerned a 67 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 expiry: UNKNOWN) dose was not reported, 1 total administered on 14-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient, experienced pain from 19-MAR-2021 to 21-MAR-2021. On 21-MAR-2021, the patient experienced outer ear infection. On the same day, she went to the Urgent Care and the physician gave her ear drops (unspecified) for outer ear infection which was used only for two times. According to her physician, her ear was a little red. She stated that as per her age and family history, she went to the emergency room on 22-March-2021 and found out that she had Bell's Palsy. She went to the ophthalmologist who gave Neo-Poly-Dex 0.1 percent (3.5 grams) ointment. Treatment medications included: dexamethasone/neomycin/polymyxin b.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bell's palsy, and the outcome of outer ear infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210407047-COVID-19 VACCINE AD26.COV2.S-bells's palsy. 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.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; This spontaneous report received from a health care professional concerned an 18 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: 1808978, expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid muscle on 03-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021 18:00, the patient experienced body aches, chills and fever. On 03/Apr/2021 at 18:00; the patient had fever of 100.1 (unit not specified) and was treated with 2 extra strength Tylenol. At 22:00 the patient had fever of 101.0 (unit not specified) and patient was treated with 2 Ibuprofen 200 milligram. On 04-Apr-2021, at 14:30, the patient had fever of 102.9 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and body aches. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210407171-covid-19 vaccine ad26.cov2.s-Body ache, Chills. 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). 20210407171-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Injection site pain, Nausea, Pyrexia
Clinical narrative: DIARRHEA; NAUSEA; CONGESTION; FEVER; INJECTION SITE PAIN; This spontaneous report received from a female patient (health care professional) of an unspecified age reporting on herself. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, non-smoker, and no alcohol use.  The patient had no known drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609,expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 99.8 degree. On 25-MAR-2021, the patient experienced fever. On 27-MAR-2021, the patient experienced congestion. On 27-MAR-2021, the patient experienced nausea. On 31-MAR-2021, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, congestion, nausea, and diarrhea, and the outcome of injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: DIARRHEA; NAUSEA; CONGESTION; FEVER; INJECTION SITE PAIN; This spontaneous report received from a female patient (health care professional) of an unspecified age reporting on herself. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, non-smoker, and no alcohol use.  The patient had no known drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609,expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 99.8 degree. On 25-MAR-2021, the patient experienced fever. On 27-MAR-2021, the patient experienced congestion. On 27-MAR-2021, the patient experienced nausea. On 31-MAR-2021, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, congestion, nausea, and diarrhea, and the outcome of injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Injection site pain, Pain
Clinical narrative: BODY ACHES; TROUBLE WALKING; INJECTION SITE PAIN; 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: Unknown and expiry: unknown) dose was not reported, administered on 01-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 body aches. On APR-2021, the subject experienced trouble walking. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, trouble walking, injection site pain, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 04-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 04-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS; TEMP 102.6; HEADACHE; 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 admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 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 chills, temp 102.6, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp 102.6, headache and chills was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: TERRIBLE MUSCLE ACHES IN NECK BACK AND LEGS; HEADACHES; TIRED; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's concurrent conditions included seizure disorder, 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced terrible muscle aches in neck back and legs. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from terrible muscle aches in neck back and legs, and headaches, and the outcome of tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported  and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: UNCONTROLLED VOMITING; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mitral valve prolapse, and cat hair allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered to right arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced uncontrolled vomiting. On 02-APR-2021, the subject experienced headache. On 02-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 uncontrolled vomiting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: HEADACHE; BODY ACHES; CHILLS; This spontaneous report received from a parent concerned a 25 year old male. The patient's weight was 155 pounds, and height was 69 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,  expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 11:00 on left arm  for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced chills. 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 body aches, and chills on 02-APR-2021, and had not recovered from headache. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MINOR FLARE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis vulgaris, 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: not reported) 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 number. Concomitant medications included guselkumab for psoriasis vulgaris. On an unspecified date, the subject experienced minor flare. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minor flare was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Headache, Lip dry, Nausea
Clinical narrative: DIZZY; NAUSEA; HEADACHE; FEELING HOT; COLD FINGERS; DRY LIPS; This spontaneous report received from a patient concerned a 66 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: 043a21a, expiry: not reported) dose was not reported, administered on 04-APR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced feeling hot. On 04-APR-2021, the subject experienced cold fingers. On 04-APR-2021, the subject experienced dry lips. On 04-APR-2021 23:00, the subject experienced dizzy. On 04-APR-2021 23:00, the subject experienced nausea. On 04-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, feeling hot, cold fingers, and dizzy, and the outcome of dry lips was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: DIZZY; NAUSEA; HEADACHE; FEELING HOT; COLD FINGERS; DRY LIPS; This spontaneous report received from a patient concerned a 66 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: 043a21a, expiry: not reported) dose was not reported, administered on 04-APR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced feeling hot. On 04-APR-2021, the subject experienced cold fingers. On 04-APR-2021, the subject experienced dry lips. On 04-APR-2021 23:00, the subject experienced dizzy. On 04-APR-2021 23:00, the subject experienced nausea. On 04-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, feeling hot, cold fingers, and dizzy, and the outcome of dry lips was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension, Rhinorrhoea
Clinical narrative: ELEVATED BLOOD PRESSURE; RUNNY NOSE; HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned a 62 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced elevated blood pressure, and runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the elevated blood pressure, runny nose, headache and tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: SHOULDER FELT LIKE GOT A TETANUS SHOT; This spontaneous report received from a patient via a company representative 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 shoulder felt like got a tetanus shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shoulder felt like got a tetanus shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: ADMINISTERED THE ENTIRE VIAL OF THE JANSSEN COVID-19  VACCINE; This spontaneous report received from a physician 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced administered the entire vial of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered the entire vial of the janssen covid-19 vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: SLEEPY; This spontaneous report received from a consumer concerned an 87 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: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Influenza
Clinical narrative: FLU SYMPTOMS; SIDE EFFECTS; 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. 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 flu symptoms, and side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu symptoms and side effects was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: MILD FEVER; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included familial mediterranean fever. 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 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced mild fever. Laboratory data included: Body temperature (NR: not provided) 99.4-100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fever was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Injection site pain, Speech disorder, Swelling face
Clinical narrative: FACIAL IS SWELLING; SLURRY WORDS; DIZZINESS; SWOLLEN TONGUE; HARD TO TALK; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient had no known drug allergies at the time of reporting. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 about 1 hour and 30 minutes ago (as reported) on for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient experienced facial is swelling. On 05-APR-2021, the patient experienced slurry words. On 05-APR-2021, the patient experienced dizziness. On 05-APR-2021, the patient experienced swollen tongue. On 05-APR-2021, the patient experienced hard to talk. On 05-APR-2021, the patient experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial is swelling, slurry words, dizziness, soreness at injection site, swollen tongue, and hard to talk. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: FACIAL IS SWELLING; SLURRY WORDS; DIZZINESS; SWOLLEN TONGUE; HARD TO TALK; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient had no known drug allergies at the time of reporting. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 about 1 hour and 30 minutes ago (as reported) on for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the patient experienced facial is swelling. On 05-APR-2021, the patient experienced slurry words. On 05-APR-2021, the patient experienced dizziness. On 05-APR-2021, the patient experienced swollen tongue. On 05-APR-2021, the patient experienced hard to talk. On 05-APR-2021, the patient experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial is swelling, slurry words, dizziness, soreness at injection site, swollen tongue, and hard to talk. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site reaction, Lethargy, Pyrexia
Clinical narrative: REDNESS AND SWELLING ON SITE; LETHARGIC; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 53 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 batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination at left arm.. No concomitant medications were reported. On 03-APR-2021, the subject experienced redness and swelling on site. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced low grade fever. On 03-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from redness and swelling on site, low grade fever, and lethargic. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cholecystitis infective
Clinical narrative: GALLBLADDER INFECTION; 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, 1 total, administered on 06-MAR-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 an unspecified date, in morning, patient woke up with a big knot in stomach which turned out to be gallbladder infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gallbladder infection was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and gallbladder infection as not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210408859-covid-19 vaccine ad26.cov2.s-gallbladder infection. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; TIREDNESS; BODY ACHES, ACHES AND PAINS; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotics allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches, aches and pains. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 99.3 deg. On 04-APR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 99.3 deg. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 28-MAR-2021, and had not recovered from fever, body aches, aches and pains, and chills. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: NAUSEA; FEVER; SWEATING; PAIN/INJECTION SITE PAIN; SWELLING/INJECTION SITE SWELLING; HIVES; BODY ACHES; EXHAUSTION; REDNESS/INJECTION SITE REDNESS; This spontaneous report received from a patient 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 15:00 in right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body aches. On 03-APR-2021, the subject experienced pain/injection site pain. On 03-APR-2021, the subject experienced swelling/injection site swelling. On 03-APR-2021, the subject experienced hives. On 03-APR-2021, the subject experienced exhaustion. On 03-APR-2021, the subject experienced redness/injection site redness. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.9, 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and exhaustion on 05-APR-2021, sweating on 04-APR-2021, and hives on 03-APR-2021, was recovering from fever, and pain/injection site pain, and had not recovered from nausea, redness/injection site redness, and swelling/injection site swelling. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia, Urticaria
Clinical narrative: NAUSEA; FEVER; SWEATING; PAIN/INJECTION SITE PAIN; SWELLING/INJECTION SITE SWELLING; HIVES; BODY ACHES; EXHAUSTION; REDNESS/INJECTION SITE REDNESS; This spontaneous report received from a patient 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 15:00 in right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body aches. On 03-APR-2021, the subject experienced pain/injection site pain. On 03-APR-2021, the subject experienced swelling/injection site swelling. On 03-APR-2021, the subject experienced hives. On 03-APR-2021, the subject experienced exhaustion. On 03-APR-2021, the subject experienced redness/injection site redness. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.9, 99.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and exhaustion on 05-APR-2021, sweating on 04-APR-2021, and hives on 03-APR-2021, was recovering from fever, and pain/injection site pain, and had not recovered from nausea, redness/injection site redness, and swelling/injection site swelling. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE GIVEN OUTSIDE TEMPERATURE EXCURSION/ADMINISTERED A 6TH DOSE FROM VIAL; This spontaneous report received from a health care professional concerned a 58 year old female. 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 allergies the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 31-DEC-2069) dose was not reported, administered on 05-APR-2021 08:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced dose given outside temperature excursion/administered a 6th dose froml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given outside temperature excursion/administered a 6th dose froml was not reported. This report was non-serious.