chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: My son got his first dose of the Pfizer Covid-19 Vaccine and five days later he had sharp pains in his side followed by vomiting three times and being in pain all night. I took him to pediatrician in morning and was told to go to the ER where they did an emergency appendectomy on the Tuesday following his vaccine. I am not quite sure if it is a direct result of the vaccine but I did research on the website as well as the University and it states a 1/2500 chance through their testing.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Appendicectomy, Appendicitis, Dysstasia
Clinical narrative: My son got his first dose of the Pfizer Covid-19 Vaccine and five days later he had sharp pains in his side followed by vomiting three times and being in pain all night. I took him to pediatrician in morning and was told to go to the ER where they did an emergency appendectomy on the Tuesday following his vaccine. I am not quite sure if it is a direct result of the vaccine but I did research on the website as well as the University and it states a 1/2500 chance through their testing.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pyrexia
Clinical narrative: Fever, muscular & bone pain
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: Left Arm Numbness, Tingling, and Weakness from shoulder to 5th digit of hand. Onset approximately 72 hours post vaccination. Ibuprofen and cold compress only partially relieves symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Chest pain, Clumsiness, Computerised tomogram
Clinical narrative: Arm pain and numbness, chest pain , heart pain was immediately after the shot Face numbness, legs numb , arms numb, left side of body goes numb then right side intermittently, massive headache next day , spinning extreme vertigo , extreme nausea almost passed out , 12 lb weight loss , can?t eat all this in the first 6 days. Still now have face numbness, arms , legs , hands , feet , brain fog . Drooling with face numbness that comes and goes. Dizziness and clumsy.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Drooling, Electrocardiogram, Feeding disorder, Feeling abnormal
Clinical narrative: Arm pain and numbness, chest pain , heart pain was immediately after the shot Face numbness, legs numb , arms numb, left side of body goes numb then right side intermittently, massive headache next day , spinning extreme vertigo , extreme nausea almost passed out , 12 lb weight loss , can?t eat all this in the first 6 days. Still now have face numbness, arms , legs , hands , feet , brain fog . Drooling with face numbness that comes and goes. Dizziness and clumsy.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Immediate post-injection reaction, Nausea, Pain in extremity
Clinical narrative: Arm pain and numbness, chest pain , heart pain was immediately after the shot Face numbness, legs numb , arms numb, left side of body goes numb then right side intermittently, massive headache next day , spinning extreme vertigo , extreme nausea almost passed out , 12 lb weight loss , can?t eat all this in the first 6 days. Still now have face numbness, arms , legs , hands , feet , brain fog . Drooling with face numbness that comes and goes. Dizziness and clumsy.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vertigo, Weight decreased
Clinical narrative: Arm pain and numbness, chest pain , heart pain was immediately after the shot Face numbness, legs numb , arms numb, left side of body goes numb then right side intermittently, massive headache next day , spinning extreme vertigo , extreme nausea almost passed out , 12 lb weight loss , can?t eat all this in the first 6 days. Still now have face numbness, arms , legs , hands , feet , brain fog . Drooling with face numbness that comes and goes. Dizziness and clumsy.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: Right arm tingling finger numb, right arm swollen, red, hot to touch from shoulder to elbow. Severe pain with movement in elbow. Feels strained unable to lift any heavy items. Ibuprofen 800 MG taken and ice applied at home.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Skin warm
Clinical narrative: Right arm tingling finger numb, right arm swollen, red, hot to touch from shoulder to elbow. Severe pain with movement in elbow. Feels strained unable to lift any heavy items. Ibuprofen 800 MG taken and ice applied at home.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Around an hour after receiving first dose, had hives covering my whole torso. They took several weeks to go away. I didn't seek treatment for them. Benadryl keep the worst of the itching at bay.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Injection site muscle weakness, Injection site pain, Palpitations
Clinical narrative: Dizziness immediately after vaccine- remitted within 5 minutes.  Occasional heart palpitations day of and day after vaccine. But the worst is that over 2 weeks later, my left upper arm has incredible pain and has weakened strength.  Pharmacist possibly hit a bursa sac.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears, frequency somewhere around 6,700 to 7,400 hz
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, Bacterial vaginosis, Chronic obstructive pulmonary disease, Computerised tomogram, Dyspnoea
Clinical narrative: Shortness of breath with progressive onset  Dyspnea with exertion or simple walking Emphysema/COPD (non smoking patient) Atelectasis   Other health issues since the vaccine that I didn?t have before: bacterial vaginosis, uti, random leg swelling
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Emphysema, Peripheral swelling, Urinary tract infection
Clinical narrative: Shortness of breath with progressive onset  Dyspnea with exertion or simple walking Emphysema/COPD (non smoking patient) Atelectasis   Other health issues since the vaccine that I didn?t have before: bacterial vaginosis, uti, random leg swelling
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Headache, body aches, L arm sore
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Respiratory failure
Clinical narrative: patient hospitalized with covid PNA, hypoxic resp failure requiring oxygen after being fully vaccinated
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: My injection site is very swollen and hard to the touch. It is also very itchy, warm, and red. I have just been cleaning it and taking Tylenol and it has not effected the reaction.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pain, tightness. Comes and goes away daily for like 2 weeks.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweats, chills, fever of 102°F, body aches, headache, joint pain, fatigue, nausea. Sweats, chills, and fever lasted 8 hours. Body aches, headaches, joint pain, and fatigue lasted for 4 days. Intermittent nausea which was most severe on first day and less severe for the preceding 3 days
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Sweats, chills, fever of 102°F, body aches, headache, joint pain, fatigue, nausea. Sweats, chills, and fever lasted 8 hours. Body aches, headaches, joint pain, and fatigue lasted for 4 days. Intermittent nausea which was most severe on first day and less severe for the preceding 3 days
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Fatigue, Headache
Clinical narrative: Tachycardia, enlarged atrial arch, decreased kidney function, constant headaches, fatigue,
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Renal impairment, Tachycardia, Takayasu's arteritis
Clinical narrative: Tachycardia, enlarged atrial arch, decreased kidney function, constant headaches, fatigue,
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Biopsy skin, Depression, Dry eye, Eczema
Clinical narrative: February 2021- Menstrual cycle started 18 days early, with much heavier bleeding and quarter-sized clots which have lasted for each cycle since Feb.  April 2021- Body rashes, possible eczema, still working with dermatologist and rheumatologist on definite diagnosis.  April/May 2021- daily generalized headaches started; increased anxiety with bouts of depression began; increased daily fatigue.  June 2021- itchy, red, inflamed lower eyelids bilaterally with extreme eye dryness.  July 2021- muscle stiffness and weakness became more noticeable; scalp rashes begin; increased entire body rash/eczema.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye inflammation, Eye pruritus, Fatigue, Heavy menstrual bleeding, Laboratory test
Clinical narrative: February 2021- Menstrual cycle started 18 days early, with much heavier bleeding and quarter-sized clots which have lasted for each cycle since Feb.  April 2021- Body rashes, possible eczema, still working with dermatologist and rheumatologist on definite diagnosis.  April/May 2021- daily generalized headaches started; increased anxiety with bouts of depression began; increased daily fatigue.  June 2021- itchy, red, inflamed lower eyelids bilaterally with extreme eye dryness.  July 2021- muscle stiffness and weakness became more noticeable; scalp rashes begin; increased entire body rash/eczema.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Muscular weakness, Musculoskeletal stiffness, New daily persistent headache, Ocular hyperaemia
Clinical narrative: February 2021- Menstrual cycle started 18 days early, with much heavier bleeding and quarter-sized clots which have lasted for each cycle since Feb.  April 2021- Body rashes, possible eczema, still working with dermatologist and rheumatologist on definite diagnosis.  April/May 2021- daily generalized headaches started; increased anxiety with bouts of depression began; increased daily fatigue.  June 2021- itchy, red, inflamed lower eyelids bilaterally with extreme eye dryness.  July 2021- muscle stiffness and weakness became more noticeable; scalp rashes begin; increased entire body rash/eczema.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Thrombosis
Clinical narrative: February 2021- Menstrual cycle started 18 days early, with much heavier bleeding and quarter-sized clots which have lasted for each cycle since Feb.  April 2021- Body rashes, possible eczema, still working with dermatologist and rheumatologist on definite diagnosis.  April/May 2021- daily generalized headaches started; increased anxiety with bouts of depression began; increased daily fatigue.  June 2021- itchy, red, inflamed lower eyelids bilaterally with extreme eye dryness.  July 2021- muscle stiffness and weakness became more noticeable; scalp rashes begin; increased entire body rash/eczema.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chest pain, Cold sweat, Decreased appetite
Clinical narrative: Extreme disforia, nausea, joint pain,muscle pain, headache,fever, cold sweats,difficulty breathing,chest pain,sensory overload, loss of appetite, anxiety,depression
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Dysphoria, Dyspnoea, Headache, Myalgia
Clinical narrative: Extreme disforia, nausea, joint pain,muscle pain, headache,fever, cold sweats,difficulty breathing,chest pain,sensory overload, loss of appetite, anxiety,depression
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sensory overload
Clinical narrative: Extreme disforia, nausea, joint pain,muscle pain, headache,fever, cold sweats,difficulty breathing,chest pain,sensory overload, loss of appetite, anxiety,depression
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Migraine
Clinical narrative: Severe migraine that persisted two days. Chills and sweating for two days. Nausea and vomiting for the two days after. Day three sever diarrhea  like straight liquid for most of the day.  Severe fatigue on day 4.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Severe migraine that persisted two days. Chills and sweating for two days. Nausea and vomiting for the two days after. Day three sever diarrhea  like straight liquid for most of the day.  Severe fatigue on day 4.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Premenstrual syndrome
Clinical narrative: Very heavy menstrual cycle, extreme PMS, period went from light 3 to 5 days to very heavy 7+ days
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Extra dose administered, Headache, Malaise
Clinical narrative: I went to the Pharmacy to get the seasonal Flu vaccine required for nursing school. I paid for it and filled the forms required by the pharmacy prior vaccine administration. The pharmacist failed to follow the five rights of medication administration and administered me a third dose of COVID vaccine. Once she realized her mistake, she administered me the Flu vaccine on the other arm, which was the vaccine that I was requesting since the beginning. I was very concern because I had my two dosis of COVID vaccine with Moderna (1st Moderna dose 3/5/2021 ; 2nd Moderna dose 4/6/2021) and the pharmacist said that is ok to have the 3rd dose with a different type of vaccine. Starting at 8:45pm the same day, I started with severe headache, malaise, and shoulder pain.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: I went to the Pharmacy to get the seasonal Flu vaccine required for nursing school. I paid for it and filled the forms required by the pharmacy prior vaccine administration. The pharmacist failed to follow the five rights of medication administration and administered me a third dose of COVID vaccine. Once she realized her mistake, she administered me the Flu vaccine on the other arm, which was the vaccine that I was requesting since the beginning. I was very concern because I had my two dosis of COVID vaccine with Moderna (1st Moderna dose 3/5/2021 ; 2nd Moderna dose 4/6/2021) and the pharmacist said that is ok to have the 3rd dose with a different type of vaccine. Starting at 8:45pm the same day, I started with severe headache, malaise, and shoulder pain.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Extra dose administered, Headache, Malaise
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: Nausea, itchy red at site
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: Death. Heart attack
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Vomiting, nausea, fever, muscle weakness, pain at injection site, back pain
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting, nausea, fever, muscle weakness, pain at injection site, back pain
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthrogram, Axillary nerve injury, Blood creatine normal, Blood test, C-reactive protein normal
Clinical narrative: Immediately when the shot was given, I experienced no pain or other adverse event. That evening my upper left arm and shoulder started to become sore and moving my arm in certain directions resulted in sharp pain. Overnight I took acetaminophen for the pain. The next few days my arm improved, but three or four days later I still had limited range of motion. Lifting my arm out to the side, checking my watch, or reaching forward to use a keyboard all resulted in sharp pain. Moving my left arm with my right arm felt fine.  After a week I slowly improved; I had range of motion mostly back but my shoulder still felt uncomfortable. On 4/30 I relapsed and again experienced the limited range of motion as experienced right after the shot -- again I was unable to do something as simple as lifting my arm to check my watch without pain. My primary care doctor recommended ibuprofen and physical therapy. The ibuprofen had no effect, and physical therapy didn't have immediate effects. I again started to recover but mid-May I had a second relapse; like the prior relapse I had the same limited range of motion.  In mid-May I started a series of appointments with a Physical Medicine and Rehabilitation specialist. After blood work, an MRI arthrogram, and electromyography, I was diagnosed with an injury to the left axillary nerve, potentially consistent with Parsonage-Turner syndrome. The electromyography identified instability in the left teres minor and left deltoid. The specialist prescribed three days of methylprednisolone followed by daily gabapentin which I am still taking.  As of this filing I continue to work with a physical therapist where we have some progress restoring stability in the shoulder. The gabapentin has generally helped with reducing pain. Most day to day activities are done with little or no pain. My most recent visit with the PN&R specialist still identified weakness in some muscles and expects full recovery to take the rest of the year. I was previously advised to get my second dose only after I had a full recovery, but with the recent rise of cases the advice is now to get a second dose but consider avoiding Moderna to reduce the risk of a second injury. I have not yet received a second dose.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Full blood count normal, Injection site pain, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Immediately when the shot was given, I experienced no pain or other adverse event. That evening my upper left arm and shoulder started to become sore and moving my arm in certain directions resulted in sharp pain. Overnight I took acetaminophen for the pain. The next few days my arm improved, but three or four days later I still had limited range of motion. Lifting my arm out to the side, checking my watch, or reaching forward to use a keyboard all resulted in sharp pain. Moving my left arm with my right arm felt fine.  After a week I slowly improved; I had range of motion mostly back but my shoulder still felt uncomfortable. On 4/30 I relapsed and again experienced the limited range of motion as experienced right after the shot -- again I was unable to do something as simple as lifting my arm to check my watch without pain. My primary care doctor recommended ibuprofen and physical therapy. The ibuprofen had no effect, and physical therapy didn't have immediate effects. I again started to recover but mid-May I had a second relapse; like the prior relapse I had the same limited range of motion.  In mid-May I started a series of appointments with a Physical Medicine and Rehabilitation specialist. After blood work, an MRI arthrogram, and electromyography, I was diagnosed with an injury to the left axillary nerve, potentially consistent with Parsonage-Turner syndrome. The electromyography identified instability in the left teres minor and left deltoid. The specialist prescribed three days of methylprednisolone followed by daily gabapentin which I am still taking.  As of this filing I continue to work with a physical therapist where we have some progress restoring stability in the shoulder. The gabapentin has generally helped with reducing pain. Most day to day activities are done with little or no pain. My most recent visit with the PN&R specialist still identified weakness in some muscles and expects full recovery to take the rest of the year. I was previously advised to get my second dose only after I had a full recovery, but with the recent rise of cases the advice is now to get a second dose but consider avoiding Moderna to reduce the risk of a second injury. I have not yet received a second dose.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nerve conduction studies normal, Neuralgic amyotrophy, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Immediately when the shot was given, I experienced no pain or other adverse event. That evening my upper left arm and shoulder started to become sore and moving my arm in certain directions resulted in sharp pain. Overnight I took acetaminophen for the pain. The next few days my arm improved, but three or four days later I still had limited range of motion. Lifting my arm out to the side, checking my watch, or reaching forward to use a keyboard all resulted in sharp pain. Moving my left arm with my right arm felt fine.  After a week I slowly improved; I had range of motion mostly back but my shoulder still felt uncomfortable. On 4/30 I relapsed and again experienced the limited range of motion as experienced right after the shot -- again I was unable to do something as simple as lifting my arm to check my watch without pain. My primary care doctor recommended ibuprofen and physical therapy. The ibuprofen had no effect, and physical therapy didn't have immediate effects. I again started to recover but mid-May I had a second relapse; like the prior relapse I had the same limited range of motion.  In mid-May I started a series of appointments with a Physical Medicine and Rehabilitation specialist. After blood work, an MRI arthrogram, and electromyography, I was diagnosed with an injury to the left axillary nerve, potentially consistent with Parsonage-Turner syndrome. The electromyography identified instability in the left teres minor and left deltoid. The specialist prescribed three days of methylprednisolone followed by daily gabapentin which I am still taking.  As of this filing I continue to work with a physical therapist where we have some progress restoring stability in the shoulder. The gabapentin has generally helped with reducing pain. Most day to day activities are done with little or no pain. My most recent visit with the PN&R specialist still identified weakness in some muscles and expects full recovery to take the rest of the year. I was previously advised to get my second dose only after I had a full recovery, but with the recent rise of cases the advice is now to get a second dose but consider avoiding Moderna to reduce the risk of a second injury. I have not yet received a second dose.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram abnormal
Clinical narrative: Tight chest, followed by painful chest pains lasting 1-2 seconds. Happening every 2-3 minutes.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Migraine, Muscle spasms, Neurological symptom
Clinical narrative: Partial stroke like effects. Complex migraines, muscle spasms
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Computerised tomogram head, Feeling abnormal, Full blood count normal, Headache
Clinical narrative: On 08/11/21 at approx 10 pm patient started having a 104.0 temp. Thursday and Friday . Friday night 08/13/21 he started feeling  what he describes as ?brain fog?.   Patient continues to complain of ?brain fog,? and ?I feel like my head is in the clouds,? that has not resolved since receiving his second covid vaccine dose. Was having headaches shortly after for a few days and I took him to the emergency department  on 08/192021. He had a brain CT and had basic labs drawn. We doctor dc?d him home with a diagnosis of headache, and told us to follow up with his  pediatrician. We are waiting to schedule that appointment this week.  The ?brain fog,? has not gone away since 08/13/2021?
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, Laboratory test
Clinical narrative: On 08/11/21 at approx 10 pm patient started having a 104.0 temp. Thursday and Friday . Friday night 08/13/21 he started feeling  what he describes as ?brain fog?.   Patient continues to complain of ?brain fog,? and ?I feel like my head is in the clouds,? that has not resolved since receiving his second covid vaccine dose. Was having headaches shortly after for a few days and I took him to the emergency department  on 08/192021. He had a brain CT and had basic labs drawn. We doctor dc?d him home with a diagnosis of headache, and told us to follow up with his  pediatrician. We are waiting to schedule that appointment this week.  The ?brain fog,? has not gone away since 08/13/2021?
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Chest pain
Clinical narrative: Hours after shot encountered severe severe pain deep in left chest and swelling in left breast  Repeated attack next day but 50% less pain Thought I was going to die the first episode pain was relentless, finally dissipated, did not go to hospital   Having pain mild pain in breast and will see the doctor in the next 2 weeks
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Rhinorrhoea, Thrombosis
Clinical narrative: Woke up to what felt like a runny  nose and i noticed a trickling that wouldn?t  stop.  After running to the bathroom my face had clotted blood and my kept bleeding.  Bleeding stopped after 15/20 minutes
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Irritability
Clinical narrative: Several minutes after having the vaccine I became so dizzy I thought I was going to pass out. I sat for at least 45 minutes before I felt I could walk safely. Since then I have had chills, nausea, a headache and more recent I have been extremely tired and itch terribly.  I feel the symptoms are all connected to the vaccine. I feel unwell and did not before taking the vaccine.  I do not plan on taking the second dose.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pruritus
Clinical narrative: Several minutes after having the vaccine I became so dizzy I thought I was going to pass out. I sat for at least 45 minutes before I felt I could walk safely. Since then I have had chills, nausea, a headache and more recent I have been extremely tired and itch terribly.  I feel the symptoms are all connected to the vaccine. I feel unwell and did not before taking the vaccine.  I do not plan on taking the second dose.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram, Dizziness, Fatigue, Feeling drunk
Clinical narrative: Went to the hospital because my legs swelled up and I was in pain. Things got worse less then 24hrs after the second shoot.  Now I feel tired/ dizzy/ drunk all the time. Almost 24/7. It?s making life really hard for me.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Pain, Peripheral swelling, Quality of life decreased, Ultrasound scan normal
Clinical narrative: Went to the hospital because my legs swelled up and I was in pain. Things got worse less then 24hrs after the second shoot.  Now I feel tired/ dizzy/ drunk all the time. Almost 24/7. It?s making life really hard for me.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest X-ray, Chest pain, Electrocardiogram, Myocardial necrosis marker
Clinical narrative: Chest pain, palpitations
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Chest pain, palpitations
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Full body itchiness
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Arm swelling spread down past my elbow to my forearm. Very hot and tender, dark red nearly bruised looking
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Malaise, Myalgia
Clinical narrative: Fatgued; Joint pain; Fever over 100 °F; Severe body ache/ severe pain; Felt very sick/ feels really bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced MALAISE (Felt very sick/ feels really bad), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain). On 19-Apr-2021, the patient experienced FATIGUE (Fatgued). At the time of the report, MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: over 100 ° (High) over 100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient on 16-Apr-2021 felt a little better and felt better even on 19-Apr-2021. Treatment information was not provided.   This case was linked to MOD-2021-150415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19 may 2021 included  no new information about first dose.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatgued; Joint pain; Fever over 100 °F; Severe body ache/ severe pain; Felt very sick/ feels really bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced MALAISE (Felt very sick/ feels really bad), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain). On 19-Apr-2021, the patient experienced FATIGUE (Fatgued). At the time of the report, MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: over 100 ° (High) over 100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient on 16-Apr-2021 felt a little better and felt better even on 19-Apr-2021. Treatment information was not provided.   This case was linked to MOD-2021-150415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19 may 2021 included  no new information about first dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dehydration, Headache, Hypertension, Influenza virus test
Clinical narrative: respiratory distress; inflammatory systems and response syndrome; High fever; body aches; severe headache; high blood pressure; cough; lab results white blood cells 17,000; dehydration; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Lot Number: SEY0584, expiration date unknown) at age of 69 years old as  a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism due to totalthyroidectomy surgery, high blood pressure, allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID); diltiazem hydrochloride; hydroxychloroquine sulfate (PLAQUENIL). The patient experienced respiratory distress, inflammatory systems and response syndrome, high fever, body aches, severe headache, high blood pressure, cough, lab results white blood cells 17,000, dehydration, all on 11Jul2021 08:00. The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included influenza virus test: negative on 15Jul2021 Blood test, SARS-COV-2 RNA (RT-PCR): negative   on 15Jul2021 Nasal Swab, white blood cell count: 17,000 on 11Jul2021. The outcome of the events was resolving. Therapeutic measures were taken as a result of all events. The treatment included respiratory therapy with albutero,methilpredniloz. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory distress, SARS-CoV-2 test, Systemic inflammatory response syndrome
Clinical narrative: respiratory distress; inflammatory systems and response syndrome; High fever; body aches; severe headache; high blood pressure; cough; lab results white blood cells 17,000; dehydration; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Lot Number: SEY0584, expiration date unknown) at age of 69 years old as  a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism due to totalthyroidectomy surgery, high blood pressure, allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID); diltiazem hydrochloride; hydroxychloroquine sulfate (PLAQUENIL). The patient experienced respiratory distress, inflammatory systems and response syndrome, high fever, body aches, severe headache, high blood pressure, cough, lab results white blood cells 17,000, dehydration, all on 11Jul2021 08:00. The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included influenza virus test: negative on 15Jul2021 Blood test, SARS-COV-2 RNA (RT-PCR): negative   on 15Jul2021 Nasal Swab, white blood cell count: 17,000 on 11Jul2021. The outcome of the events was resolving. Therapeutic measures were taken as a result of all events. The treatment included respiratory therapy with albutero,methilpredniloz. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: respiratory distress; inflammatory systems and response syndrome; High fever; body aches; severe headache; high blood pressure; cough; lab results white blood cells 17,000; dehydration; This is a spontaneous report from a contactable nurse (patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 10Jul2021 16:00 (Lot Number: SEY0584, expiration date unknown) at age of 69 years old as  a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism due to totalthyroidectomy surgery, high blood pressure, allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID); diltiazem hydrochloride; hydroxychloroquine sulfate (PLAQUENIL). The patient experienced respiratory distress, inflammatory systems and response syndrome, high fever, body aches, severe headache, high blood pressure, cough, lab results white blood cells 17,000, dehydration, all on 11Jul2021 08:00. The patient was hospitalized for all events for 4 days. The patient underwent lab tests and procedures which included influenza virus test: negative on 15Jul2021 Blood test, SARS-COV-2 RNA (RT-PCR): negative   on 15Jul2021 Nasal Swab, white blood cell count: 17,000 on 11Jul2021. The outcome of the events was resolving. Therapeutic measures were taken as a result of all events. The treatment included respiratory therapy with albutero,methilpredniloz. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse events result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia
Clinical narrative: Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; Head ache, diarrhea and myalgia all over body still two weeks after 1st dose.; This is a spontaneous report from a contactable consumer or non hcp reported for herself. A 29-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on Apr2021 10:00 hr (at the age of 29-years-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included known allergies to Lobster from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. No other vaccine received in four weeks, no covid prior vaccination and covid was not tested post vaccination. The patient experienced headache, diarrhea and myalgia all over body still two weeks after 1st dose on Apr2021. AE resulted in none of the above (unspecified details). Patient received no treatment. Clinical outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms, Organ failure, Rash
Clinical narrative: organ failure; rash; Dress syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), ORGAN FAILURE (organ failure) and RASH (rash) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 100006) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On 17-Apr-2021, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced ORGAN FAILURE (organ failure) (seriousness criterion hospitalization prolonged) and RASH (rash) (seriousness criterion hospitalization prolonged). At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) had not resolved and ORGAN FAILURE (organ failure) and RASH (rash) outcome was unknown.            Patient taking thyroid medication .Treatment history was not reported .  Patient was hospitalized due to organ failure, rash and multiple other issues.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Malaise, Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; unwell; Miscarriage; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 23-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria hospitalization prolonged, medically significant and congenital anomaly). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 01-Mar-2021, ABORTION SPONTANEOUS (Miscarriage) had not resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and MALAISE (unwell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABORTION SPONTANEOUS (Miscarriage) to be related. No further causality assessments were provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MALAISE (unwell).    It was reported that the patient was pregnant at the time she received the second dose, 1st trimester.  This was her first pregnancy. Right after she was given the vaccine, she started feeling unwell, 2 days later, she miscarried her baby No information on concomitant medication were reported. No treatment details were reported. Company comment: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine.; Sender's Comments: This is a case of vaccine exposure during pregnancy with associated AEs of malaise and serious of event Spontaneous abortion for this 23 year old female after receiving the second dose of the vaccine.
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: No additional adverse effect reported; The vaccine was not fully administered due to the child moving the leg while getting the injection; needle was bent; This spontaneous report was received from a registered nurse, referring to a 3-year-old female patient. The patient's current condition included autism spectrum disorder. Information regarding the patient's pertinent drug reactions/allergies and concomitant medication was not provided.   On 26-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # V005271, was evaluated and changed to the valid lot # U005271, expiration date 21-NOV-2022, 0.5 milliliter, intramuscular in the left thigh) for prophylaxis. During vaccine administration, the patient removed needle from leg due to movement, needle was bent (needle issue). The vaccine was not fully administered due to the child moving the leg while getting the injection (incorrect dose administered). The operator was a trained healthcare professional. There was no treatment for the events. Re-dosing was recommended, and the patient's mother declined at this time. No additional adverse effect reported.  The outcome of the events was also reported as recovered. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: U005271; expirationdate: 21-NOV-2022; deviceage and unit: 0 ; operatorofdevice: Other Health Care Professional; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered an expired dose of MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 23-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S020961, expiration date 07-JUL-2021 (0.5 milliliter, indication was not reported) (expired product administered). The suspect measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had no previous temperature excursions. No additional adverse event was reported.