chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypersomnia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SLEPT A LOT; This spontaneous report received from a patient via a company representative concerned a 47 year old white, not hispanic or latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported(dose number in series: 1), 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-DEC-2021, the patient experienced symptoms of slept a lot, headache, sore throat, congestion with runny nose, sneezing (dose number in series: 1) and performed rapid home test binax  Laboratory data included: COVID-19 antigen test (NR: not provided) negative. On 30-DEC-2021, the patient experienced confirmed covid-19 infection, and confirmed clinical vaccination failure. Laboratory data included: COVID-19 PCR( polymerase chain reaction) test (NR: not provided) positive, patient performed rapid home test binax , COVID-19 antigen test (NR: not provided) negative. On 31-DEC-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) negative. On 01-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, slept a lot and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint:90000210285.; Sender's Comments: V0: 20220108126-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned an unspecified age male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808978, and expiry: Unknown) dose was not reported, dose number in series was 1, 1 total, administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-DEC-2021, the patient had suspected covid-19 infection. He started experiencing symptoms which included runny nose and cough since 24-DEC-2021, followed by loss of taste and smell since 26-DEC-2021. On 28-DEC-2021, the patient underwent COVID-19 antigen test which was found to be positive which result in suspected clinical vaccination failure (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000210601.; Sender's Comments: V0: 20220109995-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: She began having itching/her scalp was itching so bad she thought it may be lice.; welts; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She began having itching/her scalp was itching so bad she thought it may be lice.), URTICARIA (welts) and RASH (Rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 023M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced PRURITUS (She began having itching/her scalp was itching so bad she thought it may be lice.), URTICARIA (welts) and RASH (Rash). The patient was treated with OATMEAL at a dose of Oatmeal baths. At the time of the report, PRURITUS (She began having itching/her scalp was itching so bad she thought it may be lice.), URTICARIA (welts) and RASH (Rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was antihistamines and anti-itch creams. But the patient reported that nothing was working.   This case was linked to MOD-2022-440551.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: for some of us ,getting the shot , is a sure way to get the flu; Initial information on 01-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient for some of whom, getting the shot , is a sure way to get the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported; formulation: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "for some of us ,getting the shot , is a sure way to get the flu"  (influenza) (unknown latency).  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (for some of us ,getting the shot , is a sure way to get the flu ).  At time of reporting, the outcome was Unknown for the event for some of us ,getting the shot , is a sure way to get the flu .
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Lymphadenopathy, Peripheral swelling, Sluggishness
Clinical narrative: Extreme Sluggishness, swollen lymph nodes under arms, swollen armpits, sporadic pimple style rash across entire body.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Immediate post-injection reaction, Tenderness
Clinical narrative: PATIENR REFER BREATHING PROBLEM, TENDERNESS IN ARM, AND STOMACH UPSET INMEDIATLY AFTER THE DOSE.  BLOOD PRESSURE WAS 170/101 mmHg. PULSE 99  LIQUID DIPHENHYDRAMINE OTC WAS GIVEN TO PATIENT, 15 ML ONCE.  EMERGENCY SYSTEM WAS ACTIVATED AND ARRIVED IN 10 MINUTES. PATIENT WAS TAKEN TO THE NEAREST HOSPITAL. PATIENT WAS FULLY RECOVERED AFTER 48 HOURS OF THE ADVERSE EFFECT
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient received Moderna vaccine for 1st dose.  He did not experience any adverse effects.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, body aches
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Fatigue
Clinical narrative: Was just over 6 weeks pregnant at time of vaccination. Pregnancy confirmed via two home tests. Estimated delivery date was August 31, 2022. About 38 hours after receiving the vaccine booster, I began a spontaneous miscarriage. My physical reactions to the booster prior to miscarriage were mild and mirrored my reactions to the first two doses. I was fatigued and needed to rest several times during the day and limited my activity and productivity greatly. There may or may not be a correlation to the booster, but I wanted to report the event for future data and studies.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Pain
Clinical narrative: Extreme lower back pain. Sharp shooting pain in spine and burning lowe back.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Fever x 3 days, fatigue, body aches, joint pain, pain at injection site, headache
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever x 3 days, fatigue, body aches, joint pain, pain at injection site, headache
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: I?ve been spotting before getting my period for the last eight months. I spotted two days before I got my period in May,  1 day before in June,  two days before in July, two days before in August, one week before in October, and one day before in November. The spotting lasted anywhere from 1 to 3 days. September and December were the only months where I didn?t spot. Nothing has changed in my diet, exercise, or medication routine. I have never spotted before in my life
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I've had a headache in my forehead area since the second shot. It starts strong in the morning, but during the day goes away and comes back. It's been very consistent for 3 months now.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Areflexia, CSF protein increased, Gait disturbance, Gait inability, Guillain-Barre syndrome
Clinical narrative: C/o f increased lower extremity weakness and difficulty ambulating. We recommended the patient come into the office for evaluation, however, his wife was unable to get him here. His wife indicated that symptoms were consistent with prior flares of his multiple sclerosis, and his symptoms were consistent with such. Patient was subsequently treated with 1 g of methylprednisolone IV for 5 days followed by 60 mg prednisone taper for 5 days..        He presented to the ED on 11/9 for worsening of his lower extremity weakness and developed inability to walk or roll over in bed. The provider at the emergency department was in contact with our office. It was recommended that they proceed with MRI scan of the brain, cervical, and thoracic spine with and without contrast to assess for enhancing lesions. They also performed MRI scan of lumbosacral spine. No significant abnormalities were identified. Patient's wife advocated that the patient be admitted to the hospital. Patient was subsequently evaluated by a neurologist who noticed that the patient had lost his reflexes and did not feel his presentation was secondary to his multiple sclerosis or steroid-induced myopathy. Subsequent lumbar puncture positive for elevated proteins which was diagnostic for Guillane-Barre. He was treated with a 5 day course of IVIG which provided some improvement of his symptoms. Patient and his wife endorse all of his new symptoms developed secondary to obtaining his second COVID-19 vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Magnetic resonance imaging spinal normal
Clinical narrative: C/o f increased lower extremity weakness and difficulty ambulating. We recommended the patient come into the office for evaluation, however, his wife was unable to get him here. His wife indicated that symptoms were consistent with prior flares of his multiple sclerosis, and his symptoms were consistent with such. Patient was subsequently treated with 1 g of methylprednisolone IV for 5 days followed by 60 mg prednisone taper for 5 days..        He presented to the ED on 11/9 for worsening of his lower extremity weakness and developed inability to walk or roll over in bed. The provider at the emergency department was in contact with our office. It was recommended that they proceed with MRI scan of the brain, cervical, and thoracic spine with and without contrast to assess for enhancing lesions. They also performed MRI scan of lumbosacral spine. No significant abnormalities were identified. Patient's wife advocated that the patient be admitted to the hospital. Patient was subsequently evaluated by a neurologist who noticed that the patient had lost his reflexes and did not feel his presentation was secondary to his multiple sclerosis or steroid-induced myopathy. Subsequent lumbar puncture positive for elevated proteins which was diagnostic for Guillane-Barre. He was treated with a 5 day course of IVIG which provided some improvement of his symptoms. Patient and his wife endorse all of his new symptoms developed secondary to obtaining his second COVID-19 vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness, Myopathy, Neurological examination abnormal, Scan with contrast normal
Clinical narrative: C/o f increased lower extremity weakness and difficulty ambulating. We recommended the patient come into the office for evaluation, however, his wife was unable to get him here. His wife indicated that symptoms were consistent with prior flares of his multiple sclerosis, and his symptoms were consistent with such. Patient was subsequently treated with 1 g of methylprednisolone IV for 5 days followed by 60 mg prednisone taper for 5 days..        He presented to the ED on 11/9 for worsening of his lower extremity weakness and developed inability to walk or roll over in bed. The provider at the emergency department was in contact with our office. It was recommended that they proceed with MRI scan of the brain, cervical, and thoracic spine with and without contrast to assess for enhancing lesions. They also performed MRI scan of lumbosacral spine. No significant abnormalities were identified. Patient's wife advocated that the patient be admitted to the hospital. Patient was subsequently evaluated by a neurologist who noticed that the patient had lost his reflexes and did not feel his presentation was secondary to his multiple sclerosis or steroid-induced myopathy. Subsequent lumbar puncture positive for elevated proteins which was diagnostic for Guillane-Barre. He was treated with a 5 day course of IVIG which provided some improvement of his symptoms. Patient and his wife endorse all of his new symptoms developed secondary to obtaining his second COVID-19 vaccination.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Spinal pain
Clinical narrative: Debilitating spine pain for the first 5 days and now into the second week debilitating headaches that come and  linger for hours.  Note: this is very concerning, he has never had headaches.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Metabolic function test, Sinus tachycardia, Tremor, Ventricular extrasystoles
Clinical narrative: Vaccine at 1145 Awoke at 0300 ( approx 15.25 hours after first jab) shaking and could not stop. No fever HR is persistently 150s.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea (began on 11/28/2021) and general fatigue for several days. Then an extreme headache developed, especially after waking to the point where my eyes would water. Headaches started approximately 2-3 days after receiving the booster. Headaches were most severe within an hour or so after waking. December 2 was one of the most severe headaches, where functioning in the morning was distorted due to severe pain. Tylenol/ibuprofen did not help. Headaches subsided for the most part after the morning of 12/2/2021.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Pain, Pain in extremity
Clinical narrative: Cold sweats: 6 hrs Arm soreness: 24 hrs Body aches: 24 hrs Severe headache: 48 hrs
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears (tinnitus).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Red, hot, hard at injection site.  Itching worsening
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: I had itchy eyeballs
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Physical examination, Urticaria
Clinical narrative: URTICARIA
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: During a review of the internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood pressure increased, Chills, Cold sweat, Concussion
Clinical narrative: 10 minutes after receiving the vaccine, my blood pressure increased to 164/94. felt like i was going to pass out. face turned red, heart rate was in the 120s.  They had me lie in the recliner for an hour while monitoring my BP. after an hour it was within normal range, so i came back to work.  15 minutes after getting back to work i felt off again, my coworker said my face turned bright red, so i rechecked my BP. It was back up to 160/90s.  I left to go home and after another 10 minutes i felt like id pass out again. my right arm/hand felt clammy, while my left arm felt like i had an ice pack laying on top of my arm. I then had extreme pain in my kidney area that shot around to my abdomen, i then felt extreme urgency to urinate. after about 5 minutes those symptoms faded. i made it home at 3:45pm, still feeling like I could pass out.      i woke in the night around 1:15am. felt chills, severe body ache, severe headache, nausea, and fever of 102.  this lasted for 3 days.  my head has felt like i had a concussion  since getting the shot.  I am having severe headaches ever since and ringing in my ears.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Headache, Micturition urgency, Nausea
Clinical narrative: 10 minutes after receiving the vaccine, my blood pressure increased to 164/94. felt like i was going to pass out. face turned red, heart rate was in the 120s.  They had me lie in the recliner for an hour while monitoring my BP. after an hour it was within normal range, so i came back to work.  15 minutes after getting back to work i felt off again, my coworker said my face turned bright red, so i rechecked my BP. It was back up to 160/90s.  I left to go home and after another 10 minutes i felt like id pass out again. my right arm/hand felt clammy, while my left arm felt like i had an ice pack laying on top of my arm. I then had extreme pain in my kidney area that shot around to my abdomen, i then felt extreme urgency to urinate. after about 5 minutes those symptoms faded. i made it home at 3:45pm, still feeling like I could pass out.      i woke in the night around 1:15am. felt chills, severe body ache, severe headache, nausea, and fever of 102.  this lasted for 3 days.  my head has felt like i had a concussion  since getting the shot.  I am having severe headaches ever since and ringing in my ears.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Renal pain, Sleep disorder, Tinnitus
Clinical narrative: 10 minutes after receiving the vaccine, my blood pressure increased to 164/94. felt like i was going to pass out. face turned red, heart rate was in the 120s.  They had me lie in the recliner for an hour while monitoring my BP. after an hour it was within normal range, so i came back to work.  15 minutes after getting back to work i felt off again, my coworker said my face turned bright red, so i rechecked my BP. It was back up to 160/90s.  I left to go home and after another 10 minutes i felt like id pass out again. my right arm/hand felt clammy, while my left arm felt like i had an ice pack laying on top of my arm. I then had extreme pain in my kidney area that shot around to my abdomen, i then felt extreme urgency to urinate. after about 5 minutes those symptoms faded. i made it home at 3:45pm, still feeling like I could pass out.      i woke in the night around 1:15am. felt chills, severe body ache, severe headache, nausea, and fever of 102.  this lasted for 3 days.  my head has felt like i had a concussion  since getting the shot.  I am having severe headaches ever since and ringing in my ears.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood pressure increased, Chills, Cold sweat, Dizziness
Clinical narrative: 10 minutes after receiving the vaccine, my blood pressure increased to 164/94. felt like i was going to pass out. face turned red, heart rate was in the 120s.  They had me lie in the recliner for an hour while monitoring my BP. after an hour it was within normal range, so i came back to work.  15 minutes after getting back to work i felt off again, my coworker said my face turned bright red, so i rechecked my BP. It was back up to 160/90s.  I left to go home and after another 10 minutes i felt like id pass out again. my right arm/hand felt clammy, while my left arm felt like i had an ice pack laying on top of my arm. I then had extreme pain in my kidney area that shot around to my abdomen, i then felt extreme urgency to urinate. after about 5 minutes those symptoms faded. i made it home at 3:45pm, still feeling like I could pass out.      i woke in the night around 1:15am. felt chills, severe body ache, severe headache, nausea, and fever of 102.  this lasted for 3 days.  my head has felt like i had a concussion  since getting the shot.  I am having severe headaches ever since and ringing in my ears.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling abnormal, Headache, Micturition urgency, Pain
Clinical narrative: 10 minutes after receiving the vaccine, my blood pressure increased to 164/94. felt like i was going to pass out. face turned red, heart rate was in the 120s.  They had me lie in the recliner for an hour while monitoring my BP. after an hour it was within normal range, so i came back to work.  15 minutes after getting back to work i felt off again, my coworker said my face turned bright red, so i rechecked my BP. It was back up to 160/90s.  I left to go home and after another 10 minutes i felt like id pass out again. my right arm/hand felt clammy, while my left arm felt like i had an ice pack laying on top of my arm. I then had extreme pain in my kidney area that shot around to my abdomen, i then felt extreme urgency to urinate. after about 5 minutes those symptoms faded. i made it home at 3:45pm, still feeling like I could pass out.      i woke in the night around 1:15am. felt chills, severe body ache, severe headache, nausea, and fever of 102.  this lasted for 3 days.  my head has felt like i had a concussion  since getting the shot.  I am having severe headaches ever since and ringing in my ears.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Pyrexia, Renal pain, Sleep disorder, Tinnitus
Clinical narrative: 10 minutes after receiving the vaccine, my blood pressure increased to 164/94. felt like i was going to pass out. face turned red, heart rate was in the 120s.  They had me lie in the recliner for an hour while monitoring my BP. after an hour it was within normal range, so i came back to work.  15 minutes after getting back to work i felt off again, my coworker said my face turned bright red, so i rechecked my BP. It was back up to 160/90s.  I left to go home and after another 10 minutes i felt like id pass out again. my right arm/hand felt clammy, while my left arm felt like i had an ice pack laying on top of my arm. I then had extreme pain in my kidney area that shot around to my abdomen, i then felt extreme urgency to urinate. after about 5 minutes those symptoms faded. i made it home at 3:45pm, still feeling like I could pass out.      i woke in the night around 1:15am. felt chills, severe body ache, severe headache, nausea, and fever of 102.  this lasted for 3 days.  my head has felt like i had a concussion  since getting the shot.  I am having severe headaches ever since and ringing in my ears.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Had 3 Moderna shots (january, february, and the booster on 11/3/21).  After the 2nd shot, she had suffered from bilateral frozen shoulder.  She underwent PT for months and had completely recovered.  Immediately after the Booster shot, she suffered from frozen shoulder again, Is now unable to move R shoulder against gravity.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Bone pain/myalgias, fatigue, ipsilateral axillary & supraclavicular lymphadenopathy
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and tender to touch lymph node in right armpit.   Persistent and at times severe headache.   Nausea and dizziness.  Right arm is sore at injection site.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Swollen and tender to touch lymph node in right armpit.   Persistent and at times severe headache.   Nausea and dizziness.  Right arm is sore at injection site.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: I got the shot at 4:00 on friday and had no immediate adverse affects. Saturday I woke up not feeling very good but not terribly bad, had a bad headache and arm pain where shot was administered.  Glands in underarm on shot side were swollen.  By mid afternoon, I was feeling pretty bad.  Stayed in bed.  By Sunday morning, I was running a 101 fever, severe headache, nausea, body aches and pains, and chills.  Stayed in bed all day and took Naproxen for the affects.  Not much eating or beverages.  By Monday I felt a little better, no fever, no headache, still nauseas but manageable.  I had adverse reactions to all 3 shots I have taken.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I got the shot at 4:00 on friday and had no immediate adverse affects. Saturday I woke up not feeling very good but not terribly bad, had a bad headache and arm pain where shot was administered.  Glands in underarm on shot side were swollen.  By mid afternoon, I was feeling pretty bad.  Stayed in bed.  By Sunday morning, I was running a 101 fever, severe headache, nausea, body aches and pains, and chills.  Stayed in bed all day and took Naproxen for the affects.  Not much eating or beverages.  By Monday I felt a little better, no fever, no headache, still nauseas but manageable.  I had adverse reactions to all 3 shots I have taken.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: During a review of the internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe Tinnitus set in 24 hours after second vaccine and has not diminished
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram
Clinical narrative: Developed Bell's Palsy 2 weeks after receiving Covid Booster
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bell's Palsy 2 weeks after receiving Covid Booster
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Biopsy endometrium normal, Blood test abnormal, Contraception, Endometrial thickening
Clinical narrative: I started bleeding 10/5/21;  I am POST menopausal. I had severe bleeding with massive clots. I went to Dr 10/19/21 to stop bleeding. Dr put me on Progestrone to stop it. It stopped for 24 hrs then back heavy again. Oct 26 was put on birth control pills to stop bleeding. Which it did. Preventative cancer screening took place. My uterus had a thickened endometrial lining (16mm) diagnosed via ultrasound. Had to have a VERY painful endometrial biopsy which was cancer negative. I lost so much blood I had blood test and it came back I'm anemic (due to blood loss). I had more labs which came back as I am absolutely diagnosed POST menopausal.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Postmenopausal haemorrhage, Ultrasound uterus abnormal
Clinical narrative: I started bleeding 10/5/21;  I am POST menopausal. I had severe bleeding with massive clots. I went to Dr 10/19/21 to stop bleeding. Dr put me on Progestrone to stop it. It stopped for 24 hrs then back heavy again. Oct 26 was put on birth control pills to stop bleeding. Which it did. Preventative cancer screening took place. My uterus had a thickened endometrial lining (16mm) diagnosed via ultrasound. Had to have a VERY painful endometrial biopsy which was cancer negative. I lost so much blood I had blood test and it came back I'm anemic (due to blood loss). I had more labs which came back as I am absolutely diagnosed POST menopausal.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Ran a fever of 100.4 for 8 hours started at 5pm. Severe body aches and chills
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: covid related death
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, and over all body aches starting approximately 12 hours after injection lasting approximately 24 hours
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported. This form is being submitted due to patient's age being less than 18 years old,  (17 years 11 months) given at time of injection for Moderna Booster vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Had chills and fever and could not stand up without throwing up ( I rarely throw up). Nausea continued when I was lying down this started at 5am and continued straight through, getting a little worse in the middle of the day and started to subside at about 5p. By 7p I was able to go to couch and take tiny sips of pedialite and water. The next day I was completely fine, just fatigued and weak from throwing up all day. I ate normally, did normal exercise, etc.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Had chills and fever and could not stand up without throwing up ( I rarely throw up). Nausea continued when I was lying down this started at 5am and continued straight through, getting a little worse in the middle of the day and started to subside at about 5p. By 7p I was able to go to couch and take tiny sips of pedialite and water. The next day I was completely fine, just fatigued and weak from throwing up all day. I ate normally, did normal exercise, etc.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Decreased appetite, Pyrexia
Clinical narrative: By 6pm the day of the shot I had a fever of 100.4. The highest fever I recorded over the weekend was 101.4. Cold sweats, weakness, loss of appetite.  It is now 1/10/2022, 7:50 AM and my fever is still 100.6
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Interchange of vaccine products, Rash
Clinical narrative: Two weeks after the Covid 19 booster a rash on my torso (front and back) emerged and was diagnosed as a Shingles infection.   I received the Pfizer vaccine for my first 2 Covid 19 shots.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate increased
Clinical narrative: Patient states that heart rate always feels high and he's been having joint pain lately.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood glucose normal, C-reactive protein increased, Carbon dioxide decreased, Differential white blood cell count
Clinical narrative: Hives and angioedema beginning 8 days post-vaccination. Controlled short term with prednisone, hydroxyzine, Claritin, controlled long term with Claritin. Residual symptoms include rash, itching, dermographia. Symptoms have continued for 6+ weeks.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count decreased, Fibrin D dimer increased, Full blood count, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Hives and angioedema beginning 8 days post-vaccination. Controlled short term with prednisone, hydroxyzine, Claritin, controlled long term with Claritin. Residual symptoms include rash, itching, dermographia. Symptoms have continued for 6+ weeks.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count decreased, Mean cell haemoglobin concentration normal, Mechanical urticaria, Metabolic function test, Monocyte count decreased
Clinical narrative: Hives and angioedema beginning 8 days post-vaccination. Controlled short term with prednisone, hydroxyzine, Claritin, controlled long term with Claritin. Residual symptoms include rash, itching, dermographia. Symptoms have continued for 6+ weeks.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count increased, Pruritus, Rash, Red blood cell count decreased, Urticaria
Clinical narrative: Hives and angioedema beginning 8 days post-vaccination. Controlled short term with prednisone, hydroxyzine, Claritin, controlled long term with Claritin. Residual symptoms include rash, itching, dermographia. Symptoms have continued for 6+ weeks.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Hives and angioedema beginning 8 days post-vaccination. Controlled short term with prednisone, hydroxyzine, Claritin, controlled long term with Claritin. Residual symptoms include rash, itching, dermographia. Symptoms have continued for 6+ weeks.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Cold symptoms, fever
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: 1030 - patient complained syncope, the patient was alert and calm. vital signs stable (blood pressure 124/82, heart rate 82, oxygen satuartion 97%). the patient laid down and monitoring for 10 minutes. 1040 - patient was alert and calm. vital signs stable (124/82, heart rate 96). denied any discomfort, patient sent home with her mother.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dyspnoea
Clinical narrative: Heaviness in chest, heart fluttering, shortness of breath with simple tasks
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Patient presented with Tachycardia on 12/04/2022 post Pfizer vaccination. Her caregiver stated her pulse was as high as 182 BPM.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Child with no history of nosebleeds is now having spontaneous nose bleeds post booster vaccine on 6 January 2021.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted 1/2/2022 and tested positive for COVID. Patient was fully vaccinated and expired 1/9/2022.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: Itchiness starting about 7 days after first dose mild during the day but very hard to sleep at night itches all over body
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 10 days after receiving my moderna COVID booster I developed what I think is 'dermographia,' Itching or applying pressure to anywhere on my skin leaves raised welts which are very itchy. I am effectively controlling symptoms by taking 10mg zyrtec daily. Even on zyrtec, when I itch/apply pressure to skin it leaves marks (definitely more than usual), they just aren't so itchy. As such, I have not yet tried stopping zyrtec to reassess baseline symptoms. It's been ~20 days since symptom onset.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor, Presyncope, Syncope, Wheelchair user
Clinical narrative: After receiving first dose of Pfizer, patient became pale, c/o feeling dizzy.  Patient helped into wheelchair to stretcher.  Patient fainted, then woke up and still c/o feeling dizzy. At that time two doctors were available and assessed the patient. Vital Signs: BP 90/63; Temp 97.9; Pulse 59; Resp Rate 18; Doctors thought patient had a vagal response and was okay. Patient was watched for one hour. During that time patient felt better and denied dizziness. Vital signs at discharged: BP 96/72; Pulse 79; Resp Rate 18.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. states that after receiving the 3rd dose of Pfizer 11/22/2021 (also received Influenza/Left arm), started experiencing symptoms 11/23/2021 of severe Left arm pain at the shoulder to the elbow with difficulty lifting arm. No noted Primary visit/communications. Pt. still experiencing symptoms.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 y.o. female registered online for a Pfizer booster dose but upon arrival on site changed vaccine choice to Moderna. Pt was given Moderna clipboard and sat at Moderna booster station. Vaccinator gave the 17 y.o. pt a Moderna booster shot. When attempting to chart the dose in COLOR software, vaccinator realized  the pt should have received  Pfizer booster shot as per CDC guidelines. Pt and pt's mother made aware of medication error. Pt speaking in clear sentences. A&O x 5. Denied any sx of difficulty respiration, SOB, dizziness. Pt and pt's mother encouraged to contact Health dept with any future questions or concerns.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria, Vaccine positive rechallenge
Clinical narrative: Two weeks after having second dose of vaccine in April 2021 and then booster in December 2021, patient began experiencing hives and rash that have persisted. She continues to have itching and rash when she scratches. Patient has gone to urgent care and was placed on steroids.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Headache, Pain
Clinical narrative: Lump appeared under armpit (side of injection site). Severe headache, body aches.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, burning at injection site. 3inch diameter around site is red and hot to the touch.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Erythema, Flushing, Lip swelling
Clinical narrative: On 1/5/2022, Patient woke up with a flush face, with a fever, swollen lips and red patched on her face. I immediately called her pediatrician and explained all of the symptoms. She advised me to give her an antihistamines/ Tylenol. The Tylenol helped a little with her fever, which would be up and down. On 1/6/202, Patient still had swollen lips and now her eyelids were swollen as well. I then gave her about 4 dose of Benadryl, which did not help with the swollen of her lips and eyelids. On 1/8/2022, I took Patient to the ER, upon arrival she had 102 fever and her lips were swollen and the swollen in her eyelids had went down a little but they were red from the allergic reaction. She's saw a doctor, and was given, dexamethasone (Decadron), Ketorolac Tromethamine (Toradol), and lactide ringer IV Bolus. They did a chest x-ray which showed no acute pleural pulmonary diseases and bloodwork was normal as well and Covid-19 test, came back negative.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Swelling of eyelid
Clinical narrative: On 1/5/2022, Patient woke up with a flush face, with a fever, swollen lips and red patched on her face. I immediately called her pediatrician and explained all of the symptoms. She advised me to give her an antihistamines/ Tylenol. The Tylenol helped a little with her fever, which would be up and down. On 1/6/202, Patient still had swollen lips and now her eyelids were swollen as well. I then gave her about 4 dose of Benadryl, which did not help with the swollen of her lips and eyelids. On 1/8/2022, I took Patient to the ER, upon arrival she had 102 fever and her lips were swollen and the swollen in her eyelids had went down a little but they were red from the allergic reaction. She's saw a doctor, and was given, dexamethasone (Decadron), Ketorolac Tromethamine (Toradol), and lactide ringer IV Bolus. They did a chest x-ray which showed no acute pleural pulmonary diseases and bloodwork was normal as well and Covid-19 test, came back negative.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Lip swelling, Pyrexia, SARS-CoV-2 test, Swelling face
Clinical narrative: On 1/5/2022, Patient woke up with a flush face, with a fever, swollen lips and red patched on her face. I immediately called her pediatrician and explained all of the symptoms. She advised me to give her an antihistamines/ Tylenol. The Tylenol helped a little with her fever, which would be up and down. On 1/6/202, Patient still had swollen lips and now her eyelids were swollen as well. I then gave her about 4 dose of Benadryl, which did not help with the swollen of her lips and eyelids. On 1/8/2022, I took Patient to the ER, upon arrival she had 102 fever and her lips were swollen and the swollen in her eyelids had went down a little but they were red from the allergic reaction. She's saw a doctor, and was given, dexamethasone (Decadron), Ketorolac Tromethamine (Toradol), and lactide ringer IV Bolus. They did a chest x-ray which showed no acute pleural pulmonary diseases and bloodwork was normal as well and Covid-19 test, came back negative.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Dyspnoea, Dyspnoea exertional, Nausea
Clinical narrative: 001/03/2022:  Event occurred after 2nd vaccine.   Presents to the ED today for shortness of breath with nausea vomiting.  Patient states she has had shortness of breath x7 days, states is hard to take a deep breath and she feels worsening shortness of breath when she gets up to exert herself even taking a few steps.  Also reports that she has had nausea with vomiting over the last 7 days.  Chest x-ray consistent with bilateral pneumonias.  Course of remdesivir.  remains in hospital on 01/10/2022. History of  ESRD on hemodialysis
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test positive, Vomiting
Clinical narrative: 001/03/2022:  Event occurred after 2nd vaccine.   Presents to the ED today for shortness of breath with nausea vomiting.  Patient states she has had shortness of breath x7 days, states is hard to take a deep breath and she feels worsening shortness of breath when she gets up to exert herself even taking a few steps.  Also reports that she has had nausea with vomiting over the last 7 days.  Chest x-ray consistent with bilateral pneumonias.  Course of remdesivir.  remains in hospital on 01/10/2022. History of  ESRD on hemodialysis
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Hypertension, Palpitations, Rash
Clinical narrative: Raised, Red, Itching patches across entire body consistent with allergy response as well as hypertension, and racing heart. These events started 7-10 days post dose and was described by a nurse as a possible delayed immune response.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Raised, Red, Itching patches across entire body consistent with allergy response as well as hypertension, and racing heart. These events started 7-10 days post dose and was described by a nurse as a possible delayed immune response.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Severe generalized hives, itching, and dermatographia occurring ~10 days post injection
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cor pulmonale acute, Pulmonary embolism
Clinical narrative: Acute hypoxemic respiratory failure due to COVID-19; Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Patient refers episode of dizziness and lightheadedness immediately after receiving COVID vaccine.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Injection site erythema
Clinical narrative: Patient refers episode of dizziness and lightheadedness immediately after receiving COVID vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: within an hour of being vaccinated, I developed a tremor in my left hand and arm that would not go away for 24 hours. Additionally, I developed a fever that lasted for 4 days, extreme fatigue, chills, and headache
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: On 12/15/2021, my daughter developed a severe case of diarrhea more prominent than usual. I watched her symptoms closely and we saw the doctor on 12/17/2021 to check to see if it was a parasite. On 12/18/2021. the diarrhea stopped so we stopped doing the panel for parasites.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient Contracted COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash
Clinical narrative: Rash beginning on neck near jaw line, proceeding to spread all over face, including eyelids, ears and down chest
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient Contracted COVID-19
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Joint stiffness, Joint swelling, Paraesthesia
Clinical narrative: I had a Left KNEE replacement on February 23, 2021 right after the shot there was a tingling sensation right to my left knee.  I had been doing Great walking with no issues. Now my knee is stiff and swallow everyday and I am having issues walking.  My knee has not been the same. Saw the Dr. and I am taking anti flammatory meds which should not be.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tenderness, Urticaria
Clinical narrative: severe itching scalp, started within 12 hours of vaccination , raised areas on scalp, then scalp became very sensitive to touch, hives started 1-2 days later, only a few on various parts of body, hives and itching of scalp have continued up to this date, some days on entire body others only on various parts of body.   Treatment- zyrtec 2x daily, benedryl 1-2 times daily - with some effect but hives continue
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED OUT OF EFFECTIVE DATE.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache
Clinical narrative: 725pm - patient complained of dizziness and headache. patient was alert and calm. vital signs stable (blood pressure 120/70, heart rate 80, oxygen saturation 99%). 738pm - patient complained of chills and headache. patient was alert and calm. blood pressure 150/80, heart rate 72, oxygen saturation 88%. 744pm - patient insisted to go home with her husband. she refused to go to hospital for check up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED OUT OF EFFECTIVE DATE.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED OUT OF EFFECTIVE DATE.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED OUT OF EFFECTIVE DATE.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED OUT OF EFFECTIVE DATE.