chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHES; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and did not had any drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and  expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced headaches. On 31-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and had not recovered from headaches. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Influenza like illness, Nausea
Clinical narrative: NO APPETITE; BAD FLU; JOINT ACHE; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced joint ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, and joint ache on 09-APR-2021, and bad flu, and nausea on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: TERRIBLE FEELING; FEVER; HEADACHE; NAUSEA; 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 administration 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 terrible feeling, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, nausea and terrible feeling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: SEVERE BACK PAIN AT BASE OF SPINE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-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 severe back pain at base of spine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe back pain at base of spine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Ear pain, Feeling hot
Clinical narrative: UNABLE TO WALK; STOMACH CRAMPS; TINGLING; SHOOTING PAIN; THUMPING SHARP PAIN BEHIND EARS; BACK PAIN; FEELING HOT; ARM SORENESS; NAUSEA; HEADACHE; HOT FLASHES; THROWN UP IN HER MOUTH AND SWALLOWED; FELT SUFFOCATING; CHILLS; NUMBNESS IN LEG / NUMBNESS IN ARM FROM WRIST TO SHOULDER; 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: 205A21A ) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced numbness in leg / numbness in arm from wrist to shoulder. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced felt suffocating. On 10-APR-2021, the subject experienced thrown up in her mouth and swallowed. On 12-APR-2021, the subject experienced hot flashes. On an unspecified date, the subject experienced unable to walk, stomach cramps, tingling, shooting pain, thumping sharp pain behind ears, back pain, feeling hot, arm soreness, nausea, and headache. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrown up in her mouth and swallowed, recovered with sequelae from nausea, had not recovered from numbness in leg / numbness in arm from wrist to shoulder, unable to walk, headache, stomach cramps, tingling, shooting pain, chills, hot flashes, arm soreness, and back pain, and the outcome of feeling hot, thumping sharp pain behind ears and felt suffocating was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Hot flush, Hypoaesthesia, Nausea
Clinical narrative: UNABLE TO WALK; STOMACH CRAMPS; TINGLING; SHOOTING PAIN; THUMPING SHARP PAIN BEHIND EARS; BACK PAIN; FEELING HOT; ARM SORENESS; NAUSEA; HEADACHE; HOT FLASHES; THROWN UP IN HER MOUTH AND SWALLOWED; FELT SUFFOCATING; CHILLS; NUMBNESS IN LEG / NUMBNESS IN ARM FROM WRIST TO SHOULDER; 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: 205A21A ) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced numbness in leg / numbness in arm from wrist to shoulder. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced felt suffocating. On 10-APR-2021, the subject experienced thrown up in her mouth and swallowed. On 12-APR-2021, the subject experienced hot flashes. On an unspecified date, the subject experienced unable to walk, stomach cramps, tingling, shooting pain, thumping sharp pain behind ears, back pain, feeling hot, arm soreness, nausea, and headache. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrown up in her mouth and swallowed, recovered with sequelae from nausea, had not recovered from numbness in leg / numbness in arm from wrist to shoulder, unable to walk, headache, stomach cramps, tingling, shooting pain, chills, hot flashes, arm soreness, and back pain, and the outcome of feeling hot, thumping sharp pain behind ears and felt suffocating was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Suffocation feeling, Vomiting
Clinical narrative: UNABLE TO WALK; STOMACH CRAMPS; TINGLING; SHOOTING PAIN; THUMPING SHARP PAIN BEHIND EARS; BACK PAIN; FEELING HOT; ARM SORENESS; NAUSEA; HEADACHE; HOT FLASHES; THROWN UP IN HER MOUTH AND SWALLOWED; FELT SUFFOCATING; CHILLS; NUMBNESS IN LEG / NUMBNESS IN ARM FROM WRIST TO SHOULDER; 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: 205A21A ) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced numbness in leg / numbness in arm from wrist to shoulder. On 09-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced felt suffocating. On 10-APR-2021, the subject experienced thrown up in her mouth and swallowed. On 12-APR-2021, the subject experienced hot flashes. On an unspecified date, the subject experienced unable to walk, stomach cramps, tingling, shooting pain, thumping sharp pain behind ears, back pain, feeling hot, arm soreness, nausea, and headache. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrown up in her mouth and swallowed, recovered with sequelae from nausea, had not recovered from numbness in leg / numbness in arm from wrist to shoulder, unable to walk, headache, stomach cramps, tingling, shooting pain, chills, hot flashes, arm soreness, and back pain, and the outcome of feeling hot, thumping sharp pain behind ears and felt suffocating was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; 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, intramuscular) 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 patient experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pruritus
Clinical narrative: IRRITATED UNDERARM; THREE RED DOTS ON THE SIDE OF THE VACCINE ADMINISTRATION SITE; TENSE SHOULDER; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. 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, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced tense shoulder. On 11-APR-2021, the subject experienced irritated underarm. On 11-APR-2021, the subject experienced three red dots on the side of the vaccine administration site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritated underarm, and tense shoulder, and the outcome of three red dots on the side of the vaccine administration site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nasopharyngitis, Nausea, Pain
Clinical narrative: COLD; PAIN; DIARRHEA; RASH; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 cold, pain, diarrhea, rash, headache, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, pain, headache, fever, nausea, diarrhea and rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: COLD; PAIN; DIARRHEA; RASH; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 cold, pain, diarrhea, rash, headache, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, pain, headache, fever, nausea, diarrhea and rash was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dizziness, Flushing, Injection site nodule, Injection site reaction
Clinical narrative: HARD KNOT AT INJECTION SITE; FLUSHING; DIZZINESS; RED SWELLING AT INJECTION SITE; NAUSEA; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included non smoker, and non alcohol user.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 06-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 hard knot at injection site. On APR-2021, the subject experienced flushing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced red swelling at injection site. On APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, hard knot at injection site, flushing, dizziness, and red swelling at injection site. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: HARD KNOT AT INJECTION SITE; FLUSHING; DIZZINESS; RED SWELLING AT INJECTION SITE; NAUSEA; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included non smoker, and non alcohol user.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 06-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 hard knot at injection site. On APR-2021, the subject experienced flushing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced red swelling at injection site. On APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, hard knot at injection site, flushing, dizziness, and red swelling at injection site. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Dysgeusia, Headache, Pain in extremity
Clinical narrative: METALLIC TASTE; SORE ARM; PAIN IN SHOULDER; HEADACHE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breathing issues, milk allergy, sulfa drug allergy, and hoarseness of voice, and other pre-existing medical conditions included the patient is 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: clarithromycin ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin, and were not reported) 500 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced metallic taste. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste, sore arm, headache, and pain in shoulder. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chest pain, Diarrhoea, Fatigue, Nausea
Clinical narrative: DIARRHEA; VOMITING; BODY ACHES / INTENSE PAIN; HURTS TO BREATHE/BREATHING PROBLEMS; FATIGUE; CHEST PAIN/CHEST PROBLEMS; BED RIDDEN; NAUSEA; This spontaneous report received from a patient concerned a 39 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: 2216279 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain/chest problems. On APR-2021, the subject experienced bed ridden. On APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced body aches / intense pain. On 07-APR-2021, the subject experienced hurts to breathe/breathing problems. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from hurts to breathe/breathing problems, and fatigue, had not recovered from diarrhea, vomiting, and body aches / intense pain, and the outcome of nausea, chest pain/chest problems and bed ridden was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Painful respiration, Vomiting
Clinical narrative: DIARRHEA; VOMITING; BODY ACHES / INTENSE PAIN; HURTS TO BREATHE/BREATHING PROBLEMS; FATIGUE; CHEST PAIN/CHEST PROBLEMS; BED RIDDEN; NAUSEA; This spontaneous report received from a patient concerned a 39 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: 2216279 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain/chest problems. On APR-2021, the subject experienced bed ridden. On APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced body aches / intense pain. On 07-APR-2021, the subject experienced hurts to breathe/breathing problems. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from hurts to breathe/breathing problems, and fatigue, had not recovered from diarrhea, vomiting, and body aches / intense pain, and the outcome of nausea, chest pain/chest problems and bed ridden was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: EXPECTED 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: 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 numbers. No concomitant medications were reported. On an unspecified date, the subject experienced expected side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from expected side effects. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: FATIGUE; SLEEPING MORE THAN USUAL; This spontaneous report received from a consumer concerned an 86 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: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced sleeping more than usual. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleeping more than usual, and fatigue on 11-APR-2021. This report was non-serious.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Tinnitus
Clinical narrative: On 3 rd day after vaccine started to have flash red ears for few days. After 3 weeks of vaccine started to have tinnitus , which I have never had before. Still suffering
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Urticaria
Clinical narrative: Hives and welts not controlled with Benadryl Cream or oral tabs. Went to ER as spread was significant and had IV solumedrol. Hives  led up. Within an hour of discharge they started coming back and were not controlled with Benadryl still. Hives were apprearing in new locations and spreading rapidly again. Went back to ER for further treatment.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Dysstasia, Injection site joint pain, Joint stiffness
Clinical narrative: Joint pains.  1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently 2) Wrist pain will occur when using the joint.  3) Knee joint pain in both knee - stiffness after sitting or from waking up with difficulty standing 4) Lumbar back pain - have had issues with this area prior
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Joint pains.  1) Left should pain with shooting pain down the arm to the wrist. Occurs infrequently 2) Wrist pain will occur when using the joint.  3) Knee joint pain in both knee - stiffness after sitting or from waking up with difficulty standing 4) Lumbar back pain - have had issues with this area prior
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Nausea, Pyrexia
Clinical narrative: Shaking and chills, fever of 101.5, arm soreness, nausea when trying to stand or move, cold sweats
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking and chills, fever of 101.5, arm soreness, nausea when trying to stand or move, cold sweats
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Cough, Fatigue, Hypersomnia
Clinical narrative: Chest pain and swollen lymph nodes for the first week which prevented me from doing my normal activities like exercising. After the first week, I developed knee pain, a cough, and extreme fatigue. I had to miss a day of work on Monday, April 12th due to my symptoms. I slept for 48 hours (Sunday, April 11th 9pm-Tuesday, April 13th 9am) due to my extreme fatigue.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Lymphadenopathy, Mobility decreased
Clinical narrative: Chest pain and swollen lymph nodes for the first week which prevented me from doing my normal activities like exercising. After the first week, I developed knee pain, a cough, and extreme fatigue. I had to miss a day of work on Monday, April 12th due to my symptoms. I slept for 48 hours (Sunday, April 11th 9pm-Tuesday, April 13th 9am) due to my extreme fatigue.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash moving to different parts of the body, itching.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Myalgia
Clinical narrative: Started about 8 hours after shot and lasted 1.5 days. Fever, chills, fatigue, muscle aches, soreness at site, body aches, no appetite, bile function different, couldn't stand up for very long due to fatigue. I am generally a very healthy 60 year old.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Started about 8 hours after shot and lasted 1.5 days. Fever, chills, fatigue, muscle aches, soreness at site, body aches, no appetite, bile function different, couldn't stand up for very long due to fatigue. I am generally a very healthy 60 year old.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Ear congestion, Tinnitus
Clinical narrative: ear fullness-went to ent was given antibiotics but ear fullness remains now tinnitus is starting to happen.  Went to an acupuncturist a few times but issue remains at the same time the ear fullness started, my right hip was sore (previous orthoscopic hip surgery june 2020) made an appointment for the orthopedic and received my second shot while waiting for the appointment.  Woke up after second shot with throbbing pain the the hip.   The intensity has declined but the constant pain persists.  Orthopedic prescribed Meloxicam which has dulled the pain but again it remains
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Insomnia, Pyrexia
Clinical narrative: I had insomnia and a low grade fever. I also had pain and swelling at the injection site and fatigue.  These symptoms began as at about 8:45 PM on 04/15/2021.  I took 325 mg acetaminophen tablet at 09:00 PM and  02:00 AM.  This helped reduce my fever and pain.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Pain, Pyrexia, Sleep disorder
Clinical narrative: Extremely painful body aches and cramping, fatigue, tossing and turning while trying to sleep. 100 degree fever.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: My right arm was sore almost immediately after being vaccinated, but it wasn?t bad. Then later at night when I was trying to get to sleep I was horribly restless, shaking, and feverish. I had to bundle up in blankets because I was so cold. My whole body ached terribly, and I had a headache. It lasted a few hours and I couldn?t get to sleep. At one point I felt extremely nauseous and ran to the bathroom, barely holding back vomit, but then it went away and never came back. The day after that (April 15th) I was extremely fatigued and still had body aches and a headache. I took my temperature at 5 am on April 15th and it was 99.4°. I mostly just slept a lot and didn?t have much of an appetite. My arm was still a little sore during this whole time. As I?m writing this at 5 am on April 16th, I still have a headache.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Restlessness, Tremor
Clinical narrative: My right arm was sore almost immediately after being vaccinated, but it wasn?t bad. Then later at night when I was trying to get to sleep I was horribly restless, shaking, and feverish. I had to bundle up in blankets because I was so cold. My whole body ached terribly, and I had a headache. It lasted a few hours and I couldn?t get to sleep. At one point I felt extremely nauseous and ran to the bathroom, barely holding back vomit, but then it went away and never came back. The day after that (April 15th) I was extremely fatigued and still had body aches and a headache. I took my temperature at 5 am on April 15th and it was 99.4°. I mostly just slept a lot and didn?t have much of an appetite. My arm was still a little sore during this whole time. As I?m writing this at 5 am on April 16th, I still have a headache.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Developed rash and swelling at injection site approximately 6 days after injection. Redness, itching, swelling approximately 3" x 3".  No other effects at this time.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large red, itchy patch appearing 12 days at injection site.  Irregular oval shape. About 2.5 inches in diamdter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Palpitations
Clinical narrative: After I drove up and got my shot, the people had me drive to the next parking lot and park.  We had to park every other space.  By the time I got parked, I started to feel dizzy.  I was afraid to tell anyone because I didn't want to go to the hospital.  At first, I felt extremely dizzy so that I would not have driven if I had been allowed.  Then, My heart then started to race for about 5 minutes before it started to calm down.  The person who gave me my shot wrote on my paper on my dashboard that I had to sit for 20 minutes after my shot.   I sat there for the whole 20 minutes and by the time I left, I felt much better, but it scared me it a bit.  I was told to beep my horn if I had a reaction, but I was afraid too.  I sat in my truck and waited to see if it got better or worse.  It did get better.  I was told by friends that I should report it so I am. I have been fine this week since that happened after the vaccination, without any dizziness or heart racing.  But, I am having pain in my left leg and I'm a little worried about that because people are reporting blood clots.  I think I have a vein that is bad in that leg, although I have never been diagnosed with it.   That area has caused me pain in the past but I am so used to it that I normally just ignore it.  There's just a spot on my left thigh that hurts where I think the veins are bad.  Since the vaccination, I have had more pain in that area.  I don't know if I need to be concerned with that.  I have been trying to wait that out too.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Injection site pain
Clinical narrative: Sore arm, sore muscles along side of injection. Stomach pains and fatigue.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Tinnitus
Clinical narrative: I struggle with persistent debilitating tinnitus- the tinnitus I hear constantly became louder within hours of getting the one Johnson and Johnson vaccine for Covid 19 and to date has not returned to its former baseline. I am concerned because it has been over a week and nothing helps.  I also had mild flu like symptoms for 2 days after the injection which resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Awakened at 1:30am 4-14-21 with intense pain in both of my upper arms and some back and leg discomfort.  Pain at injection site in left arm.  Started having chills and fever ranging from 99.8 to 100.8     Slight nausea later in the day.   Fatigue throughout duration.  Headache.   Loss of appetite.  occasional cough.        Treated symptoms with rest and Tylenol.    416/21 I am having pain in my arms and pains in my armpits but most of my other symptoms have subsided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Limb discomfort, Musculoskeletal discomfort, Nausea
Clinical narrative: Awakened at 1:30am 4-14-21 with intense pain in both of my upper arms and some back and leg discomfort.  Pain at injection site in left arm.  Started having chills and fever ranging from 99.8 to 100.8     Slight nausea later in the day.   Fatigue throughout duration.  Headache.   Loss of appetite.  occasional cough.        Treated symptoms with rest and Tylenol.    416/21 I am having pain in my arms and pains in my armpits but most of my other symptoms have subsided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Awakened at 1:30am 4-14-21 with intense pain in both of my upper arms and some back and leg discomfort.  Pain at injection site in left arm.  Started having chills and fever ranging from 99.8 to 100.8     Slight nausea later in the day.   Fatigue throughout duration.  Headache.   Loss of appetite.  occasional cough.        Treated symptoms with rest and Tylenol.    416/21 I am having pain in my arms and pains in my armpits but most of my other symptoms have subsided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Anticoagulant therapy, Aortic valve disease, Chest X-ray abnormal, Colonoscopy
Clinical narrative: Both my mother and father had their shots on the same day.  Mother (77) had mild fatigue the day after the shot with some arm soreness.  She was fine after about a day.  My father reported  arm soreness and fatigue that lasted about three days after the shot.  He thought he was rebounding from the shot and continued his usual activities.  Though, he started complaining of being "winded" and difficulty breathing.  He slept a lot and continued with fatigue and shallow breathing.  A week after his shot he felt he needed to go to the ER because of difficulty breathing and being exhausted after walking up a flight of stairs (we live in a raised ranch style house).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Endoscopy, Fatigue, Hypopnoea, Pain in extremity
Clinical narrative: Both my mother and father had their shots on the same day.  Mother (77) had mild fatigue the day after the shot with some arm soreness.  She was fine after about a day.  My father reported  arm soreness and fatigue that lasted about three days after the shot.  He thought he was rebounding from the shot and continued his usual activities.  Though, he started complaining of being "winded" and difficulty breathing.  He slept a lot and continued with fatigue and shallow breathing.  A week after his shot he felt he needed to go to the ER because of difficulty breathing and being exhausted after walking up a flight of stairs (we live in a raised ranch style house).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain, Pulmonary thrombosis, Somnolence
Clinical narrative: Both my mother and father had their shots on the same day.  Mother (77) had mild fatigue the day after the shot with some arm soreness.  She was fine after about a day.  My father reported  arm soreness and fatigue that lasted about three days after the shot.  He thought he was rebounding from the shot and continued his usual activities.  Though, he started complaining of being "winded" and difficulty breathing.  He slept a lot and continued with fatigue and shallow breathing.  A week after his shot he felt he needed to go to the ER because of difficulty breathing and being exhausted after walking up a flight of stairs (we live in a raised ranch style house).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Chills, Diarrhoea, Headache
Clinical narrative: Fever, chills, headache, Body ache, diarrhea, muscle ache, backache, joint pain, muscle soreness, stiffness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, Body ache, diarrhea, muscle ache, backache, joint pain, muscle soreness, stiffness
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal bleeding
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pruritus, Pyrexia
Clinical narrative: Fatigue, slight fever, chills same day and next. Itchy arm starting around 5 days after with on and off pain.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Laryngitis, Physical examination
Clinical narrative: On day two after receiving the J&J vaccine, I now have laryngitis (hoarse voice). I visited my ENT doctor, who cannot give an explanation. This is day 33 of my condition. I have never had this condition before.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Migraine, Night sweats
Clinical narrative: Migraine, night sweats, fever, arm pain, sever joint pain, difficult catching breathe, tiredness
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Migraine, night sweats, fever, arm pain, sever joint pain, difficult catching breathe, tiredness
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood urine present, Pain in extremity
Clinical narrative: WEAKNESS - GENERALIZED, LEG PAIN, BLOOD IN URINE
Age: 96.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood urine present, Death, Femur fracture, Pain in extremity
Clinical narrative: WEAKNESS - GENERALIZED, LEG PAIN, BLOOD IN URINE
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Extreme tinnitus.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid replacement, Heart rate increased, Pyrexia
Clinical narrative: Fever of 103.8. ER visit included IV hydration and intramuscular shot of Ibuprofen to reduce fever.  Heart rate noted at 155 upon admittance.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Lymphadenopathy; had fever, Lymphadenopathy; Allergy to Pneumovax; This spontaneous report was received from an unspecified reporter via Pfizer and refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis.  On an unspecified date, she experienced allergy to the vaccine, fever and lymphadenopathy. The treatment was reported as an unspecified antihistamine medication. The outcome of the events was not reported.  The aforementioned events were considered related to the suspect vaccine.; Sender's Comments:  US-PFIZER INC-2021192337:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No PQC or additional AEs reported; PROQUAD administered after temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-MAR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliters (route of administration was not reported), lot # (T028296) rHA and expiration date (16-FEB-2022) administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -10.6 degree celsius (C°) for 3 hours on an unknown date; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No PQC or additional AEs reported.; Caller reported vaccine administered after temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 31-MAR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number S037820, which has been verified to be valid, the expiration date was reported and validated as 24-NOV-2021), at a dose of 0.5 milliliters (ml), as prophylaxis (dose number, route of administration, and anatomical site of vaccination were not provided).         The suspect vaccine was exposed to a temperature of 11.7 degrees Celcius (C) for a time frame of 75 minutes (product storage error), as recorded by digital data logger. No previous temperature excursion or additional adverse events (AEs) were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional adverse events reported; a dose of PROQUAD was given instead of Pentacel; This spontaneous report was received from an office manager, referring to 4-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 05-APR-2021, the patient was given a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, vaccination scheme, anatomical site of injection, route of administration and lot number were not reported; expiration date was reported as 21-DEC-2021) as prophylaxis, instead of hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (strength, lot number and expiration date were not reported) (wrong product administered). No additional adverse events reported. The parents of the patient had not reported adverse side effects from the shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: other severe and personal injuries which are permanent and lasting in nature/other related health complications; Guillain Barre-Syndrome; Information has been received from a lawyer regarding a case in litigation referring to an approximately 61-year-old female patient (pt). Information about concurrent condition, medical history and concomitant medication was not reported. On 24-AUG-2013 (conflicting information, also reported at 63 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2014, the was caused to suffer Guillain barre syndrome, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the pt was caused to suffer serious and dangerous side effects including Guillain barre syndrome, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, the pt required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The pt was informed and believed and further alleged that the pt would in the future be required to obtain further medical and/or hospital care, attention and services. As a foreseeable, direct, and proximate consequence of the pt's actions, omissions and misrepresentations, the pt suffered Guillain barre syndrome and other related health complications (ill-defined disorder). The pt had incurred and would continue to incur medical and related expenses. The pt also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The pt's direct medical losses and costs include physician care, monitoring and treatment. The pt had incurred and would continue to incur mental and physical pain and suffering. The outcome of the events was not recovered.  Upon internal review, Guillain barre syndrome was determined to be medically significant. The events Guillain barre syndrome and ill-defined disorder were considered to be disabling by the lawyer.