chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Condition aggravated, Confusional state
Clinical narrative: Went to sleep around 11pm, woke up at 2am shivering cold, despite being under heavy blankets. Felt pain in chest and kidney area. Heart racing. Headache. Got up to get Ibuprofen, but felt dizzy, weak, and too cold to get down the stairs. Felt confusion, fear. Condition worsened over the next hour. Considered calling 911 but feared related expenses. Again went to get ibuprofen. Getting back into bed I felt out of breath, like there was no air in the room/high altitude. Noticed my hands felt like ice upon my chest.. Fell back asleep around 5am, awoke the next day with a headache, neck ache, malaise and weakness. Slept most of day, headache resolved by 8pm with continued use of Ibuprofen. Malaise and weakness persist until time of writing.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fear, Feeling cold, Headache
Clinical narrative: Went to sleep around 11pm, woke up at 2am shivering cold, despite being under heavy blankets. Felt pain in chest and kidney area. Heart racing. Headache. Got up to get Ibuprofen, but felt dizzy, weak, and too cold to get down the stairs. Felt confusion, fear. Condition worsened over the next hour. Considered calling 911 but feared related expenses. Again went to get ibuprofen. Getting back into bed I felt out of breath, like there was no air in the room/high altitude. Noticed my hands felt like ice upon my chest.. Fell back asleep around 5am, awoke the next day with a headache, neck ache, malaise and weakness. Slept most of day, headache resolved by 8pm with continued use of Ibuprofen. Malaise and weakness persist until time of writing.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise, Neck pain, Palpitations, Peripheral coldness
Clinical narrative: Went to sleep around 11pm, woke up at 2am shivering cold, despite being under heavy blankets. Felt pain in chest and kidney area. Heart racing. Headache. Got up to get Ibuprofen, but felt dizzy, weak, and too cold to get down the stairs. Felt confusion, fear. Condition worsened over the next hour. Considered calling 911 but feared related expenses. Again went to get ibuprofen. Getting back into bed I felt out of breath, like there was no air in the room/high altitude. Noticed my hands felt like ice upon my chest.. Fell back asleep around 5am, awoke the next day with a headache, neck ache, malaise and weakness. Slept most of day, headache resolved by 8pm with continued use of Ibuprofen. Malaise and weakness persist until time of writing.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain, Sleep disorder
Clinical narrative: Went to sleep around 11pm, woke up at 2am shivering cold, despite being under heavy blankets. Felt pain in chest and kidney area. Heart racing. Headache. Got up to get Ibuprofen, but felt dizzy, weak, and too cold to get down the stairs. Felt confusion, fear. Condition worsened over the next hour. Considered calling 911 but feared related expenses. Again went to get ibuprofen. Getting back into bed I felt out of breath, like there was no air in the room/high altitude. Noticed my hands felt like ice upon my chest.. Fell back asleep around 5am, awoke the next day with a headache, neck ache, malaise and weakness. Slept most of day, headache resolved by 8pm with continued use of Ibuprofen. Malaise and weakness persist until time of writing.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Colonoscopy abnormal, Diarrhoea, Gastrointestinal disorder, Gastrointestinal inflammation
Clinical narrative: Had intense gut reaction, caused diarrhea for a month, colitis and inflammation in the small intestine (confirmed by colonoscopy). Still investigating gallbladder.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had intense gut reaction, caused diarrhea for a month, colitis and inflammation in the small intestine (confirmed by colonoscopy). Still investigating gallbladder.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Pain in arm for first two days after vaccine booster. Itching/hives all over body for several days following booster. Patient previously received J&J vaccine in June with no side effects.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired vaccine - stored under correct refrigeration for 32 days not 31
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Hypoaesthesia, Speech disorder, Throat tightness
Clinical narrative: Moderna vaccine given at 11:14. Approximately 3 minutes post Moderna vaccination, the patient reported mild, non-radiating chest tightness and throat tightness.  Able to swallow, speak. No SOB ,dizziness or lightheadedness. No headache. + Anxiety.  VSS. Afebrile. B.p 120/80's HR 75  25 mg po benadryl given at 11:18.  11:20, pt reported numbness to frontal head/forehead and left side of face and left palm of hand.  Good csm, not focal neurological deficits.  Continues to deny SOB.  Airway patient. speaking in clear sentences.  EMS called.   Patient transferred to Hospital via EMS with EMT and Paramedic.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised oedema, Tachycardia
Clinical narrative: 1st 0Covid 19 dose 9/8/21 ER, Hospital Admission 9/11 - 9/15/21 Body swelling/tachycardia treated IV steroids/Benadryl  -resolved Memorial Hospital
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Acute kidney injury, Anal incontinence, Atrial fibrillation
Clinical narrative: 1- Gastroparesis treated with erythromycin 250 mg. Started 2-3 weeks after Moderna booster vaccine. Symptoms: epigastric pain, nausea, fecal incontinence and emergency, diarrhea, nausea, bloating, malaise. 2- Atrial fibrillation with rapid ventricular response leading to CHF onset 2 weeks post vaccination. Symptoms: dyspnea, edema. 3- Acute renal failure onset 2 weeks post vaccination. Symptoms; dyspnea, edema, gained 17 lbs in 1 week admitted to hospital for dialysis. 4- Back pain onset weeks post vaccination.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Blood potassium increased, C-reactive protein increased, Cardiac failure congestive, Cardiomegaly
Clinical narrative: 1- Gastroparesis treated with erythromycin 250 mg. Started 2-3 weeks after Moderna booster vaccine. Symptoms: epigastric pain, nausea, fecal incontinence and emergency, diarrhea, nausea, bloating, malaise. 2- Atrial fibrillation with rapid ventricular response leading to CHF onset 2 weeks post vaccination. Symptoms: dyspnea, edema. 3- Acute renal failure onset 2 weeks post vaccination. Symptoms; dyspnea, edema, gained 17 lbs in 1 week admitted to hospital for dialysis. 4- Back pain onset weeks post vaccination.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Condition aggravated, Defaecation urgency, Dialysis, Diarrhoea
Clinical narrative: 1- Gastroparesis treated with erythromycin 250 mg. Started 2-3 weeks after Moderna booster vaccine. Symptoms: epigastric pain, nausea, fecal incontinence and emergency, diarrhea, nausea, bloating, malaise. 2- Atrial fibrillation with rapid ventricular response leading to CHF onset 2 weeks post vaccination. Symptoms: dyspnea, edema. 3- Acute renal failure onset 2 weeks post vaccination. Symptoms; dyspnea, edema, gained 17 lbs in 1 week admitted to hospital for dialysis. 4- Back pain onset weeks post vaccination.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Glomerular filtration rate decreased, Impaired gastric emptying, Interleukin level
Clinical narrative: 1- Gastroparesis treated with erythromycin 250 mg. Started 2-3 weeks after Moderna booster vaccine. Symptoms: epigastric pain, nausea, fecal incontinence and emergency, diarrhea, nausea, bloating, malaise. 2- Atrial fibrillation with rapid ventricular response leading to CHF onset 2 weeks post vaccination. Symptoms: dyspnea, edema. 3- Acute renal failure onset 2 weeks post vaccination. Symptoms; dyspnea, edema, gained 17 lbs in 1 week admitted to hospital for dialysis. 4- Back pain onset weeks post vaccination.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Myocardial infarction, Nausea, Oedema, Pleural effusion
Clinical narrative: 1- Gastroparesis treated with erythromycin 250 mg. Started 2-3 weeks after Moderna booster vaccine. Symptoms: epigastric pain, nausea, fecal incontinence and emergency, diarrhea, nausea, bloating, malaise. 2- Atrial fibrillation with rapid ventricular response leading to CHF onset 2 weeks post vaccination. Symptoms: dyspnea, edema. 3- Acute renal failure onset 2 weeks post vaccination. Symptoms; dyspnea, edema, gained 17 lbs in 1 week admitted to hospital for dialysis. 4- Back pain onset weeks post vaccination.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Troponin increased, Weight increased
Clinical narrative: 1- Gastroparesis treated with erythromycin 250 mg. Started 2-3 weeks after Moderna booster vaccine. Symptoms: epigastric pain, nausea, fecal incontinence and emergency, diarrhea, nausea, bloating, malaise. 2- Atrial fibrillation with rapid ventricular response leading to CHF onset 2 weeks post vaccination. Symptoms: dyspnea, edema. 3- Acute renal failure onset 2 weeks post vaccination. Symptoms; dyspnea, edema, gained 17 lbs in 1 week admitted to hospital for dialysis. 4- Back pain onset weeks post vaccination.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity, Rash, Vaccination site swelling
Clinical narrative: Patient called in the pharmacy on 12/10/2021 at 4PM with concern of redness and swollen around the vaccination area, stating 3-4 inches in diameter. The swelling and arm ache was observed on 12/7/2021 (day of administration). She observed the redness only on 12/10/21, when she became concerned and called the pharmacy. After listening to her concerns, we recommended to go to Urgent Care or call provider, and take Tylenol or NSAID, per CDC recommendation. After more research on her situation, we told patient she might be one of the individuals experiencing "COVID arm", experiencing rash like symptoms a few days after the vaccination.  We followed up with the patient on 12/13/21. Cont next page.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenitis, Malaise, X-ray of pelvis and hip
Clinical narrative: I received my first COVID-19 vaccine shot on 3/26/21. I started having rt. hip difficulty and IT band bursitis. I received my second shot on 4/23/21. For approx 8 weeks I suffered with severe joint pain and inflammation of my lymph nodes. General malaise that whole time. (Moderna Vaccine.)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Booster shot on 11/10/2021. By about 6:30 pm next day, had a body rash from waist up to half way up my breasts. Also in groin area. Pink rash and itchy. Applied Benadryl lotion and took 1 Benadrill pilL Thought was clearing up next morning, but came back about same time in evening. Rash was more along edge of body up around arm pits. Also, in groin area again and bands around lower chests to back. Rash lasted a total of 4 days.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest discomfort, Chest pain, Dyspnoea, Fibrin D dimer
Clinical narrative: Shortness of breath that has been gradually worsening in the last month, intermittent chest pain like a funny feeling of tightness.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Restrictive pulmonary disease, Spirometry abnormal
Clinical narrative: Shortness of breath that has been gradually worsening in the last month, intermittent chest pain like a funny feeling of tightness.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Fatigue, Headache
Clinical narrative: First nighe:  chills  Next morning, to weak to sit up to get out of bed. Weak all day. Slept most of the day. Itching, burning red bumps down spine, mid back, resemble shingles. (I have had both shingles shots)  This lasted several days.   2nd night: sweats, headache 3rd night: sweats, headache remained weak and tired for a week
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pruritus, Rash erythematous
Clinical narrative: First nighe:  chills  Next morning, to weak to sit up to get out of bed. Weak all day. Slept most of the day. Itching, burning red bumps down spine, mid back, resemble shingles. (I have had both shingles shots)  This lasted several days.   2nd night: sweats, headache 3rd night: sweats, headache remained weak and tired for a week
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Received 2 doses Moderna Cov19 2/8/21, 3/4/21 Immediately Began daily headaches - persist daily- moderate - severe- takes Butalbital daily
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Booster on 10/22/21. On 10/24/21 my blood pressure elevated to 191/100- and lower legs has 2+ pitting edema. I have B/P meds to take as needed. This was a Sunday and then Monday called my cardiologist. Placed on Lasix (water pill) and bed rest. apt made for angiogram and cat scan. Extreme fatigue Brain Fog
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oedema peripheral
Clinical narrative: Booster on 10/22/21. On 10/24/21 my blood pressure elevated to 191/100- and lower legs has 2+ pitting edema. I have B/P meds to take as needed. This was a Sunday and then Monday called my cardiologist. Placed on Lasix (water pill) and bed rest. apt made for angiogram and cat scan. Extreme fatigue Brain Fog
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue, Underdose
Clinical narrative: Upon administration of Moderna a booster dosage, Needle point detached from syringe causing patient to not receive dose (complete) of vaccine. Dose was re-administered as advised by CDC recomm. Patient monitored 15 min, and phone follow-up the next day - doing well post vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Culture urine positive, Dysuria, Pyrexia, SARS-CoV-2 test negative, Urinary tract infection
Clinical narrative: UTI for Staphylococcus resistant to antibiotic onset 1 month after Pfizer booster vaccine. Symptoms: fever and dysuria.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis abnormal
Clinical narrative: UTI for Staphylococcus resistant to antibiotic onset 1 month after Pfizer booster vaccine. Symptoms: fever and dysuria.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Vision blurred
Clinical narrative: blurred vision, chest tightness, and trouble breathing shortly after receiving first dose of Moderna. Patient experienced blurred vision, chest tightness, and trouble breathing shortly after receiving first dose of Moderna. She was given 1 dose from Epi Pen and was taken away by the paramedics.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pt when asked her age said 11 but mom wrote 12 on form. Pt was given the ped. dose instead of an adult dose.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event as of now.
Age: 39.0
Sex: M
Vaccine: YF
Symptoms: Chills, Cough, Decreased appetite, Dementia, Hypogammaglobulinaemia
Clinical narrative: Immediately developed two weeks of chills, cough and loss of appetite, which resolved spontaneously, but during work up he was diagnosed with a thymoma which was resected and later with hypogammaglobluinemia. We are now evaluating the patient due to progressive dementia that has been noted since 5/2020, and although the possibility of this being related to yellow fever seems very low, due to his immunocompromised state this is being investigated.
Age: 39.0
Sex: M
Vaccine: YF
Symptoms: Immunodeficiency, Thymectomy, Thymoma
Clinical narrative: Immediately developed two weeks of chills, cough and loss of appetite, which resolved spontaneously, but during work up he was diagnosed with a thymoma which was resected and later with hypogammaglobluinemia. We are now evaluating the patient due to progressive dementia that has been noted since 5/2020, and although the possibility of this being related to yellow fever seems very low, due to his immunocompromised state this is being investigated.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood magnesium, Flushing, Full blood count, Malaise
Clinical narrative: small fiber neuropathy
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Nausea, Palpitations, Presyncope, Thyroid function test
Clinical narrative: small fiber neuropathy
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, Blood folate normal, Blood thyroid stimulating hormone decreased, Complement factor C3
Clinical narrative: small fiber neuropathy
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complement factor C4, Electrophoresis protein normal, Glycosylated haemoglobin normal, Small fibre neuropathy, Vitamin B12 normal
Clinical narrative: small fiber neuropathy
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B6 normal
Clinical narrative: small fiber neuropathy
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Thirst
Clinical narrative: feeling that my throat was closing; My throat was feeling like getting swollen; I was slightly sick for a day or two; I felt extremely thirsty; I couldn''t even talk; Low fever; my knee and neck hurt and armpit hurt; lymph node in my neck swollen; sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6208) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "feeling that my throat was closing"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "My throat was feeling like getting swollen"; ILLNESS (non-serious), outcome "unknown", described as "I was slightly sick for a day or two"; THIRST (non-serious), outcome "unknown", described as "I felt extremely thirsty"; SPEECH DISORDER (non-serious), outcome "unknown", described as "I couldnt even talk"; PYREXIA (non-serious), outcome "unknown", described as "Low fever"; AXILLARY PAIN (non-serious), outcome "unknown", described as "my knee and neck hurt and armpit hurt"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node in my neck swollen"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweat".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101727151 Same patient and drug, different dose;US-PFIZER INC-202101727463 Same patient and drug, different dose
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Hyperhidrosis, Illness, Lymphadenopathy, Pharyngeal swelling
Clinical narrative: feeling that my throat was closing; My throat was feeling like getting swollen; I was slightly sick for a day or two; I felt extremely thirsty; I couldn''t even talk; Low fever; my knee and neck hurt and armpit hurt; lymph node in my neck swollen; sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6208) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "feeling that my throat was closing"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "My throat was feeling like getting swollen"; ILLNESS (non-serious), outcome "unknown", described as "I was slightly sick for a day or two"; THIRST (non-serious), outcome "unknown", described as "I felt extremely thirsty"; SPEECH DISORDER (non-serious), outcome "unknown", described as "I couldnt even talk"; PYREXIA (non-serious), outcome "unknown", described as "Low fever"; AXILLARY PAIN (non-serious), outcome "unknown", described as "my knee and neck hurt and armpit hurt"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node in my neck swollen"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweat".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101727151 Same patient and drug, different dose;US-PFIZER INC-202101727463 Same patient and drug, different dose
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Speech disorder, Thirst, Throat tightness
Clinical narrative: feeling that my throat was closing; My throat was feeling like getting swollen; I was slightly sick for a day or two; I felt extremely thirsty; I couldn''t even talk; Low fever; my knee and neck hurt and armpit hurt; lymph node in my neck swollen; sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6208) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "feeling that my throat was closing"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "My throat was feeling like getting swollen"; ILLNESS (non-serious), outcome "unknown", described as "I was slightly sick for a day or two"; THIRST (non-serious), outcome "unknown", described as "I felt extremely thirsty"; SPEECH DISORDER (non-serious), outcome "unknown", described as "I couldnt even talk"; PYREXIA (non-serious), outcome "unknown", described as "Low fever"; AXILLARY PAIN (non-serious), outcome "unknown", described as "my knee and neck hurt and armpit hurt"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node in my neck swollen"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweat".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101727151 Same patient and drug, different dose;US-PFIZER INC-202101727463 Same patient and drug, different dose
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody, Antinuclear antibody negative, Beta globulin decreased
Clinical narrative: I had a seizure and was diagnosed with GBS syndrome
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: CSF glucose normal, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count, Cryptococcus test
Clinical narrative: I had a seizure and was diagnosed with GBS syndrome
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Electroencephalogram normal, Electrophoresis protein abnormal, Endotracheal intubation, Herpes simplex test negative
Clinical narrative: I had a seizure and was diagnosed with GBS syndrome
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: I had a seizure and was diagnosed with GBS syndrome
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Plasmapheresis, Rheumatoid factor negative, Seizure, Treponema test negative, West Nile virus test negative
Clinical narrative: I had a seizure and was diagnosed with GBS syndrome
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White matter lesion
Clinical narrative: I had a seizure and was diagnosed with GBS syndrome
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Seizure
Clinical narrative: I had a seizure and was diagnosed with GBS syndrome
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HE WAS GIVEN THE JANSSEN BUT SHOULD NOT HAVE GOTTEN IT
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Hot flush, Nausea
Clinical narrative: Severe hot flashes; metallic taste off and on; nausea; had unrelated back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:45 (Lot number: 7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney disease" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: zofran". The following information was reported: HOT FLUSH (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe hot flashes"; TASTE DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "metallic taste off and on"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea"; BACK PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "had unrelated back pain". The events "severe hot flashes", "metallic taste off and on", "nausea" and "had unrelated back pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of hot flush, taste disorder, nausea, back pain.  Additional information: Patient experienced severe side effects after the first dose. Severe hot flashes, metallic taste off and on, nausea first two days. Hot flashes going on day four now. Also had unrelated back pain, receive something for back pain and nausea. Patient received unspecified other medications in two weeks. Facility type vaccine was Pharmacy or Drug Store. No covid prior vaccination and covid was not tested post vaccination. No other vaccine in four weeks. Unspecified other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Hot flush, Nausea, Taste disorder
Clinical narrative: Severe hot flashes; metallic taste off and on; nausea; had unrelated back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:45 (Lot number: 7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney disease" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Zofran, reaction(s): "known allergies: zofran". The following information was reported: HOT FLUSH (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe hot flashes"; TASTE DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "metallic taste off and on"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea"; BACK PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "had unrelated back pain". The events "severe hot flashes", "metallic taste off and on", "nausea" and "had unrelated back pain" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of hot flush, taste disorder, nausea, back pain.  Additional information: Patient experienced severe side effects after the first dose. Severe hot flashes, metallic taste off and on, nausea first two days. Hot flashes going on day four now. Also had unrelated back pain, receive something for back pain and nausea. Patient received unspecified other medications in two weeks. Facility type vaccine was Pharmacy or Drug Store. No covid prior vaccination and covid was not tested post vaccination. No other vaccine in four weeks. Unspecified other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Anticoagulant therapy, Cardiac monitoring, Coronary artery occlusion, Echocardiogram
Clinical narrative: 74-year-old male with a PMH of AFib s/p ablation, hypothyroidism, MVP s/p repair, gout, nephrolithiasis, Lyme disease, LAA thrombus and left lower extremity arterial thrombus who presents after testing positive for COVID-19 on 12/05 with chest tightness. According to the patient his symptoms started last Thursday 12/2 after attending a wedding several days prior. He get tested on 12/05 and reports this was positive. His symptoms were mild and included a mild cough, some body aches and fatigue. He denies any fever or shortness of breath. he did start taking 2 new OTC supplements " someone recommended for COVID-19"  In the ED, documented VS on admission 102/73, heart rate 66, RR 16, O2 sat 97% on room air with a temp of 98. his COVID-19 antigen was negative. CXR no acute pathology. Other initial laboratory data include minimally elevated LDH 247, he troponins were negative x3 his CBC is chemistry relatively unremarkable. His INR is 2.0. He is on Xarelto. His D-dimer is less than 150. UA is negative. EKG in ER documented read as some new septal T-wave changes. he is admitted to medical for further evaluation and treatment pending ID and Cardiology consult.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypotension, Intracardiac thrombus, Malaise, Pain
Clinical narrative: 74-year-old male with a PMH of AFib s/p ablation, hypothyroidism, MVP s/p repair, gout, nephrolithiasis, Lyme disease, LAA thrombus and left lower extremity arterial thrombus who presents after testing positive for COVID-19 on 12/05 with chest tightness. According to the patient his symptoms started last Thursday 12/2 after attending a wedding several days prior. He get tested on 12/05 and reports this was positive. His symptoms were mild and included a mild cough, some body aches and fatigue. He denies any fever or shortness of breath. he did start taking 2 new OTC supplements " someone recommended for COVID-19"  In the ED, documented VS on admission 102/73, heart rate 66, RR 16, O2 sat 97% on room air with a temp of 98. his COVID-19 antigen was negative. CXR no acute pathology. Other initial laboratory data include minimally elevated LDH 247, he troponins were negative x3 his CBC is chemistry relatively unremarkable. His INR is 2.0. He is on Xarelto. His D-dimer is less than 150. UA is negative. EKG in ER documented read as some new septal T-wave changes. he is admitted to medical for further evaluation and treatment pending ID and Cardiology consult.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral artery occlusion, Poor peripheral circulation, Pruritus, Pyrexia
Clinical narrative: 74-year-old male with a PMH of AFib s/p ablation, hypothyroidism, MVP s/p repair, gout, nephrolithiasis, Lyme disease, LAA thrombus and left lower extremity arterial thrombus who presents after testing positive for COVID-19 on 12/05 with chest tightness. According to the patient his symptoms started last Thursday 12/2 after attending a wedding several days prior. He get tested on 12/05 and reports this was positive. His symptoms were mild and included a mild cough, some body aches and fatigue. He denies any fever or shortness of breath. he did start taking 2 new OTC supplements " someone recommended for COVID-19"  In the ED, documented VS on admission 102/73, heart rate 66, RR 16, O2 sat 97% on room air with a temp of 98. his COVID-19 antigen was negative. CXR no acute pathology. Other initial laboratory data include minimally elevated LDH 247, he troponins were negative x3 his CBC is chemistry relatively unremarkable. His INR is 2.0. He is on Xarelto. His D-dimer is less than 150. UA is negative. EKG in ER documented read as some new septal T-wave changes. he is admitted to medical for further evaluation and treatment pending ID and Cardiology consult.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin warm, Ultrasound Doppler abnormal, White blood cell count increased
Clinical narrative: 74-year-old male with a PMH of AFib s/p ablation, hypothyroidism, MVP s/p repair, gout, nephrolithiasis, Lyme disease, LAA thrombus and left lower extremity arterial thrombus who presents after testing positive for COVID-19 on 12/05 with chest tightness. According to the patient his symptoms started last Thursday 12/2 after attending a wedding several days prior. He get tested on 12/05 and reports this was positive. His symptoms were mild and included a mild cough, some body aches and fatigue. He denies any fever or shortness of breath. he did start taking 2 new OTC supplements " someone recommended for COVID-19"  In the ED, documented VS on admission 102/73, heart rate 66, RR 16, O2 sat 97% on room air with a temp of 98. his COVID-19 antigen was negative. CXR no acute pathology. Other initial laboratory data include minimally elevated LDH 247, he troponins were negative x3 his CBC is chemistry relatively unremarkable. His INR is 2.0. He is on Xarelto. His D-dimer is less than 150. UA is negative. EKG in ER documented read as some new septal T-wave changes. he is admitted to medical for further evaluation and treatment pending ID and Cardiology consult.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood lactate dehydrogenase increased, COVID-19, Chest X-ray normal, Chest discomfort, Cough
Clinical narrative: 74-year-old male with a PMH of AFib s/p ablation, hypothyroidism, MVP s/p repair, gout, nephrolithiasis, Lyme disease, LAA thrombus and left lower extremity arterial thrombus who presents after testing positive for COVID-19 on 12/05 with chest tightness. According to the patient his symptoms started last Thursday 12/2 after attending a wedding several days prior. He get tested on 12/05 and reports this was positive. His symptoms were mild and included a mild cough, some body aches and fatigue. He denies any fever or shortness of breath. he did start taking 2 new OTC supplements " someone recommended for COVID-19"  In the ED, documented VS on admission 102/73, heart rate 66, RR 16, O2 sat 97% on room air with a temp of 98. his COVID-19 antigen was negative. CXR no acute pathology. Other initial laboratory data include minimally elevated LDH 247, he troponins were negative x3 his CBC is chemistry relatively unremarkable. His INR is 2.0. He is on Xarelto. His D-dimer is less than 150. UA is negative. EKG in ER documented read as some new septal T-wave changes. he is admitted to medical for further evaluation and treatment pending ID and Cardiology consult.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fatigue, Fibrin D dimer, Full blood count normal, International normalised ratio increased
Clinical narrative: 74-year-old male with a PMH of AFib s/p ablation, hypothyroidism, MVP s/p repair, gout, nephrolithiasis, Lyme disease, LAA thrombus and left lower extremity arterial thrombus who presents after testing positive for COVID-19 on 12/05 with chest tightness. According to the patient his symptoms started last Thursday 12/2 after attending a wedding several days prior. He get tested on 12/05 and reports this was positive. His symptoms were mild and included a mild cough, some body aches and fatigue. He denies any fever or shortness of breath. he did start taking 2 new OTC supplements " someone recommended for COVID-19"  In the ED, documented VS on admission 102/73, heart rate 66, RR 16, O2 sat 97% on room air with a temp of 98. his COVID-19 antigen was negative. CXR no acute pathology. Other initial laboratory data include minimally elevated LDH 247, he troponins were negative x3 his CBC is chemistry relatively unremarkable. His INR is 2.0. He is on Xarelto. His D-dimer is less than 150. UA is negative. EKG in ER documented read as some new septal T-wave changes. he is admitted to medical for further evaluation and treatment pending ID and Cardiology consult.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test positive, Troponin normal, Urine analysis normal
Clinical narrative: 74-year-old male with a PMH of AFib s/p ablation, hypothyroidism, MVP s/p repair, gout, nephrolithiasis, Lyme disease, LAA thrombus and left lower extremity arterial thrombus who presents after testing positive for COVID-19 on 12/05 with chest tightness. According to the patient his symptoms started last Thursday 12/2 after attending a wedding several days prior. He get tested on 12/05 and reports this was positive. His symptoms were mild and included a mild cough, some body aches and fatigue. He denies any fever or shortness of breath. he did start taking 2 new OTC supplements " someone recommended for COVID-19"  In the ED, documented VS on admission 102/73, heart rate 66, RR 16, O2 sat 97% on room air with a temp of 98. his COVID-19 antigen was negative. CXR no acute pathology. Other initial laboratory data include minimally elevated LDH 247, he troponins were negative x3 his CBC is chemistry relatively unremarkable. His INR is 2.0. He is on Xarelto. His D-dimer is less than 150. UA is negative. EKG in ER documented read as some new septal T-wave changes. he is admitted to medical for further evaluation and treatment pending ID and Cardiology consult.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Rash, Rash pruritic
Clinical narrative: photosensitive reaction; Difficulty sleeping; She took the second dose of Pfizer COVID vaccine and got a rash; extensive severely itcy rash down arms, and neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. Other Case identifier(s): NVSC2021US158433 (NOVARTIS).  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was 77 years old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 04Sep2021, outcome "unknown", described as "extensive severely itcy rash down arms, and neck"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "photosensitive reaction"; INSOMNIA (non-serious), outcome "unknown", described as "Difficulty sleeping"; RASH (non-serious), outcome "unknown", described as "She took the second dose of Pfizer COVID vaccine and got a rash"  Additional information:  After having 2nd COVID vaccine she got an extensive severely itchy rash down arms, and neck. MD (medical doctor) referred to this as a photosensitive reaction. Got vaccine on 02Sep and rash on 04Sep. Difficulty sleeping due to itchiness. Consumer was on Ibrance before Kisqali and had a terrible rash with blisters in their groin area and the doctor took them off the medication and put them on Kisqali. She took the second dose of Pfizer COVID vaccine and got a rash from that so the doctor tried to figure out of if the rash was from the vaccine or Kisqali.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Photosensitivity reaction, Rash, Rash pruritic
Clinical narrative: photosensitive reaction; Difficulty sleeping; She took the second dose of Pfizer COVID vaccine and got a rash; extensive severely itcy rash down arms, and neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. Other Case identifier(s): NVSC2021US158433 (NOVARTIS).  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was 77 years old, for Covid-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 04Sep2021, outcome "unknown", described as "extensive severely itcy rash down arms, and neck"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "photosensitive reaction"; INSOMNIA (non-serious), outcome "unknown", described as "Difficulty sleeping"; RASH (non-serious), outcome "unknown", described as "She took the second dose of Pfizer COVID vaccine and got a rash"  Additional information:  After having 2nd COVID vaccine she got an extensive severely itchy rash down arms, and neck. MD (medical doctor) referred to this as a photosensitive reaction. Got vaccine on 02Sep and rash on 04Sep. Difficulty sleeping due to itchiness. Consumer was on Ibrance before Kisqali and had a terrible rash with blisters in their groin area and the doctor took them off the medication and put them on Kisqali. She took the second dose of Pfizer COVID vaccine and got a rash from that so the doctor tried to figure out of if the rash was from the vaccine or Kisqali.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient on 8/24 was given her second dose of Pfizer COVID19 vaccine at 10:36AM. The vaccine given has already expired on 8/23/21 at 9:40PM. Patient denied symptoms of adverse reaction after the shot. Spoke with the Pfizer vaccine representative who advised to follow CDC guidelines and repeat the second dose from an unexpired and viable vial on the opposite arm. Provider spoke with patient and patient's mother who agree with plan. The repeat second dose was given on 8/28/21 at 9:44AM on the right arm.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient on 8/24 was given her second dose of Pfizer COVID19 vaccine at 10:36AM. The vaccine given has already expired on 8/23/21 at 9:40PM. Patient denied symptoms of adverse reaction after the shot. Spoke with the Pfizer vaccine representative who advised to follow CDC guidelines and repeat the second dose from an unexpired and viable vial on the opposite arm. Provider spoke with patient and patient's mother who agree with plan. The repeat second dose was given on 8/28/21 at 9:44AM on the right arm.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient on 8/24 was given his second dose of Pfizer COVID19 vaccine at 10:39AM. The vaccine given has already expired on 8/23/21 at 9:40PM. Patient denied symptoms of adverse reaction after the expired vaccine was given. Spoke with the Pfizer vaccine representative who advised to follow CDC guidelines and repeat the second dose using an unexpired and viable vial on the opposite arm. Provider spoke with patient and patient's mother who agree with plan. The repeat second dose was given on 8/28/21 at 9:39AM on the left arm.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient on 8/24 was given his second dose of Pfizer COVID19 vaccine at 10:39AM. The vaccine given has already expired on 8/23/21 at 9:40PM. Patient denied symptoms of adverse reaction after the expired vaccine was given. Spoke with the Pfizer vaccine representative who advised to follow CDC guidelines and repeat the second dose using an unexpired and viable vial on the opposite arm. Provider spoke with patient and patient's mother who agree with plan. The repeat second dose was given on 8/28/21 at 9:39AM on the left arm.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Pain, Pericarditis, Troponin normal
Clinical narrative: Red arm for several days 10/03/2021 -1:00 AM chest pain and left shoulder pain / could not take a deep breath / thought I was having a heart attack  1:00 PM went to ER / many tests in ER / Diagnosed with Pleurisy / Released at 7:00 PM with Ibuprofen 600 take 3 x day /  Treadmill test scheduled for next day 9:30 PM  ER Dr called and said I have Acute Pericarditis / prescribed Colchicine 0.6 twice a day for 3 months
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Echocardiogram normal, Erythema
Clinical narrative: Red arm for several days 10/03/2021 -1:00 AM chest pain and left shoulder pain / could not take a deep breath / thought I was having a heart attack  1:00 PM went to ER / many tests in ER / Diagnosed with Pleurisy / Released at 7:00 PM with Ibuprofen 600 take 3 x day /  Treadmill test scheduled for next day 9:30 PM  ER Dr called and said I have Acute Pericarditis / prescribed Colchicine 0.6 twice a day for 3 months
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exercise electrocardiogram, Myocardial infarction, Pericarditis, Pleurisy
Clinical narrative: Red arm for several days 10/03/2021 -1:00 AM chest pain and left shoulder pain / could not take a deep breath / thought I was having a heart attack  1:00 PM went to ER / many tests in ER / Diagnosed with Pleurisy / Released at 7:00 PM with Ibuprofen 600 take 3 x day /  Treadmill test scheduled for next day 9:30 PM  ER Dr called and said I have Acute Pericarditis / prescribed Colchicine 0.6 twice a day for 3 months
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Echocardiogram, Erythema
Clinical narrative: Red arm for several days 10/03/2021 -1:00 AM chest pain and left shoulder pain / could not take a deep breath / thought I was having a heart attack  1:00 PM went to ER / many tests in ER / Diagnosed with Pleurisy / Released at 7:00 PM with Ibuprofen 600 take 3 x day /  Treadmill test scheduled for next day 9:30 PM  ER Dr called and said I have Acute Pericarditis / prescribed Colchicine 0.6 twice a day for 3 months
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation, Pericarditis, White blood cell count, White blood cell count increased
Clinical narrative: Red arm for several days 10/03/2021 -1:00 AM chest pain and left shoulder pain / could not take a deep breath / thought I was having a heart attack  1:00 PM went to ER / many tests in ER / Diagnosed with Pleurisy / Released at 7:00 PM with Ibuprofen 600 take 3 x day /  Treadmill test scheduled for next day 9:30 PM  ER Dr called and said I have Acute Pericarditis / prescribed Colchicine 0.6 twice a day for 3 months