chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated she felt "funny" ~10 minutes after vaccination, felt "cold in chest and waves of tingling", initially diaphoretic with BP 175/110, HR 110. AFter 15 minutes patient stated she felt better but noted vision was still slightly blurry.  After 45 minutes vitals were BP 175/90, HR 88 with ongoing periods of blurry vision and tingling in extremities.
Initial unsolicited report received from a consumer (patient's husband) on 11 November 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of Fluzone QIV (batch number, dose, dose in series, route and site of administration was not reported) 12 October 2015. Illness at time of vaccination was not reported. The patient had allergy to gelatin. Concomitant medications were not reported. On 13 October 2015, next day following the vaccination, the patient experienced pain in arm, tiredness, fever. Then next week, on unspecified date, patient developed bronchitis. Patient did see a health care provider at an urgent care facility and was put on antibiotic. Did not improve so returned to own primary care physician for evaluation and treatment. placed on another antibiotic. Symptoms cleared up for short time but thencough and wheezing returned. Returned to own primary care physician and given steroids. Continues to have cough and slight wheezing to 11 November 2015. The patient required emergency room and physician visit. Lab data was not reported. The patient received corrective treatments with antibiotic and steroids. On unspecified date, four days after onset the patient was recovered from pain in am, tiredness, fever. Patient was not recovered from bronchitis, cough and wheezing. List of documents held by sender: none.
This case was reported by a consumer via out of hour services and described the occurrence of jaw pain in a 53-year-old female patient who received BOOSTRIX (batch number TF422, expiry date 15th December 2019). The patient's past medical history included accident (hit top of head with bike rack, prior to vaccination with BOOSTRIX). On 26th March 2018, the patient received BOOSTRIX (intramuscular). On 27th March 2018, 1 days after receiving BOOSTRIX, the patient experienced jaw pain, pain and stiffness. On an unknown date, the outcome of the jaw pain, pain and stiffness were not recovered/not resolved. The reporter considered the jaw pain, pain and stiffness to be possibly related to BOOSTRIX. Additional details were provided as follows: The patient was administered BOOSTRIX in the right arm. The patient experienced stiffness and achiness described as affecting full body that got worse in the morning. The patient had denied permission to contact their physician.
At approximately 1458, patient reported feeling lightheadedness, staff RN x 2 proceeded to lay patient down on the ground and elevated feet.  Patient immediately felt "better" and denied any shortness of breath or difficulty breathing.  Alert and oriented x 4.  Patient vital signs were taken at approximately 1500 (see vitals on patient chart).  Upon stabilization, patient was transferred to gurney where he was closely monitored and provided with water.  Patient was kept for an additional 50 minutes and was closely monitored by RN for any worsening symptoms.  Patient denied any pain, shortness of breath, and lightheadedness upon discharge.
She went to the restroom about 45 minutes after the vaccine and saw a slightly raised and reddened area on the left side of her neck.  She returned to vaccination site and stated a few minutes later that she had itching to the left arm and a few minutes after, itching to the right arm.  She felt fine and had no difficulty breathing and no elevated heart rate.  Her PCP was called and advised her, that  if she was having difficulty,  to go to the emergency room for evaluation.  She declined and stated she felt fine and wanted to go back to her office to work and that there were other people in her office should she have any problems.
dizziness; vertigo; cold sweat; throwing up; nausea; high fever; Possible inner ear disease. She thinks it was from inner ear virus; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), COLD SWEAT (cold sweat), DIZZINESS (dizziness), LABYRINTHITIS (Possible inner ear disease. She thinks it was from inner ear virus) and VOMITING (throwing up) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Meniere's disease. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-1997, the patient experienced LABYRINTHITIS (Possible inner ear disease. She thinks it was from inner ear virus). On 16-May-2021, the patient experienced VERTIGO (vertigo), COLD SWEAT (cold sweat), VOMITING (throwing up), NAUSEA (nausea) and PYREXIA (high fever). On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, VERTIGO (vertigo), COLD SWEAT (cold sweat), DIZZINESS (dizziness), LABYRINTHITIS (Possible inner ear disease. She thinks it was from inner ear virus), VOMITING (throwing up), NAUSEA (nausea) and PYREXIA (high fever) outcome was unknown.            Treatment medication was not provided by the reporter  It was reported that patient was rushed to the hospital on 16 May 2021.  Patient visited an ENT, and the ENT doctor said possible inner ear disease, but it was not diagnosed.  Patient had MRI, CAT scan, and IV saline  results not mentioned.  Patient has an existing condition like Meniere disease.
Post vax, next am had bruising at site and induration and redness. Affected area began to spread each day further down upper left arm. Clinic reports no muscle aching, fever, or headache. Advised to notify PCP, take Tylenol and use cool compresses to site.
JOINT PAIN; FEVER; GENERAL FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced joint pain. On 03-MAY-2021, the subject experienced fever. On 03-MAY-2021, the subject experienced general fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, joint pain, and general fatigue. This report was non-serious.
Increase in symptoms of trigeminal neuralgia--pain/sensations/numbness, increased inability to sleep
On 05/13/2022 I was having abdominal pain that went all the way around like a belt. I had difficultly walking and sitting up. My pain score was around a 7 or 8 and continued to get higher while I was in the hospital. I went to urgent care and was sent to the hospital and admitted and was release 3 days later. It says that I had a possible small bowel obstruction vs enteritis. I feel about 75% better but I am still having some fatigue.
BREAKTHOUGH CASE Patient Covid + on 10/23/2021 patient received Pfizer on 02/05/2021 and then received Janssen on 03/18/2021. Per H & P :  Gross hematuria, recurrent  Atrial fibrillation with intermittent RVR  Severe cardiomyopathy with EF of 15-20%  Acute blood loss anemia, monitor hemoglobin  Tobacco abuse  Debility  Urinary retention s/p Foley catheter placement  Severe valvular disease with severe MR, severe TR and moderate aortic insufficiency  S/p recent TIA   The patient was seen by neurology  Foley catheter was placed  Bladder irrigation as needed  Monitor hemoglobin  Transfuse as needed  Monitor kidney function  IV antibiotic Continue with current treatment. Medication, lab and chart reviewed.          Chief Complaint   Acute recurrent gross hematuria  History of Present Illness     None this is a 74-year-old male with a past medical history significant for severe cardiomyopathy, severe valvular heart disease, atrial fibrillation, on anticoagulation who was sent from ECF because of recurrent severe gross hematuria.  The patient also confusion which was most likely secondary to UTI and multiple medical issues.  The patient does not have any fever chills no nausea no vomiting no abdominal pain.  Patient was seen by urology, Foley catheter was replaced.   Past medical history:  Hypertension  Recently diagnosed severe systolic CHF with EF of 15-20%  New onset atrial fibrillation, recently diagnosed  Hypertension  Debility  Hematuria Per ID Consult Note:   COVID-19 pneumonia.  Congestive heart failure and cardiomyopathy.  Tobacco abuse.  Debility.   Recommendations  Continue dexamethasone.  Add remdesivir.  Continue oxygen support/respiratory support.  Consult pulmonology.  Cardiology is following. History of Present Illness : 74-year-old male who was admitted with a chief complaint of weakness and urinary retention.  That was corrected however he was found to be very debilitated and weak and gradually he became hypoxic chest x-ray showed bilateral infiltrates and a COVID-19 test was positive.  The onset of illness about 4- 5 days ago.  No diarrhea no abdominal pain dysuria polyuria or hematuria.  No hemoptysis or chest pain.  On questioning the patient tells me he feels okay but he is certainly becoming more hypoxic and requiring more oxygen.
7PM temp inc-sz x 25 seconds; gave bath; ambulance came; fever 104 @ hosp-given APAP & motrin @ hosp & temp to 100; last APAP a/sz was given about 3PM;
Pt had 1 minute of tonic-clonic seizure, fever to 104 deg. F. at time of seizure seen at the ER and was diagnosed with otitis media. Ceftriaxone was prescribed.
Patient received this second dose of Moderna vaccine from our public health clinic and his first dose was Pfizer 21 days prior to this vaccination.  The patient left the clinic after 15 minutes of observation with no signs of distress.
5/1/03: 2 red papules on ear. 5/2: Scattered, erythematous, papule-like rash on abdomen and back. A few scattered papules on face. No fever, no vomiting , no diarrhea, no itching. On 5/2 at about 4 PM Mom and pt were seen in clinic parking by MD to determine if the rash was infectious. MD determined the rash to be more likely an MMR-like rash.
2 weeks after taking the vaccine, the top knuckle her of left hand started swelling. Then it shifted from finger to finger. She has a hard lump on her joints, which she developed on her knuckles. She went to the doctor who stated it was unusual. Her fingers are stiff, very hard to bend and they are red.
chills; fatigue; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Ibuprofen for symptoms relief.   This case was linked to US-MODERNATX, INC.-MOD-2021-114771 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114771:Wife case
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Information has been received from a registered pharmacist concerning a 79 year old female with high cholesterol and allergy to cephalosporins and macrolids who on 06-DEC-2011, was subcutaneously vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (Lot# 671611/1161AA, expired on 18-OCT-2012). Concomitant therapy included CRESTOR, STATIN, and ESTRACE. The pharmacist reported that the patient came to the pharmacy on 09-DEC-2011, complaining that she had developed a reddened area surrounding the ZOSTAVAX (Merck) injection site and a reddened area on her face. It was noted that the pharmacist reported that this area did not appear to be rash. Pharmacist reported that the patient also had a "red bump about size of a pencil eraser" on the patient's lower cheek. Pharmacist mentioned that the patient did not complain of itching or pain in either area. No lab diagnostic tests were performed. The patient did not any received treatment. At the time of the report the patient's recovery status was unknown. Increased stress for the patient was considered to be disabling. Additional information has been requested.
Menstrual spotting post-menopause. I haven't had my period in over 4 years and I had spotting last night.
Hives after 5 minutes in the sun. Extreme itching, anti itch cream, stay out of the sun or cover up. Sun block doesn't prevent, seems to be getting worse. I have seen allergists and dermatologist .
Drive through - within 2-3 days in the am, aching pains in legs, back and ankle, body was stiff and sore. Allergies flared up. I had a little sinus problem before the vaccine and anxiety as well about the vaccine. I saw the doctor. I can't say it's the vaccine, but I went to see the doctor because I couldn't sleep. Went to Ear, nose and throat doctor. Went to sleep doctor for insomnia.
Patient received shot and 5 mins later started having a seizure.  I went out and held his head while 911 was called.  Seizure lasted 15 seconds.  5 mins later he had another seizure that lasted 30 seconds
12/20/2018, started with vertigo/near-syncope, manifested over several hours to include chills, fever (101.7 F), achy joints, swollen/painful injection site, nausea, vomiting, diaphoresis, diarrhea.
PATIENT EXPERIENCED CHILLS, SHAKING, AND IRREGULAR BREATHING. THIS BEGAN ABOUT 2 HOURS POST VACCINATION AND LASTED ABOUT 1 & 1/2 HOURS. AFTERWARDS PATIENT CALMED DOWN AND BEGAN TO FEEL WELL ENOUGH TO SLEEP FOR AWHILE. UPON WAKING SHE FELT MUCH BETTER EXCEPT FOR A POSSIBLE MILD FEVER.
Extreme fatigue; Headache; Sore throat; Mouth sores; Diagnosed with lichen planus; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; gums and palate swollen and red; Aches; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mono as a teenager. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7S34) via an unspecified route of administration in the left arm on 29Mar2021 at 17:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation and received hyoscine (SCOPOLAMINE) for an unknown indication on an unknown date and experienced drug allergy. On 20Apr2021, day after 2nd shot, the patient experienced aches, chills and fever and over in 24 hours. On 29Apr2021, 10 days after 2nd shot, the patient experienced gums and palate swollen and red. On 30Apr2021, next day, the patient started with fever, extreme fatigue, headache, sore throat, aches, chills, mouth sores developed next to the negative tests for the following: strep, mono, elevated WBC, COVID, flu A or B and was diagnosed with lichen planus. Now, 7 days later, the patient still had unexplained fever, headache and mouth sores. By the way the patient did not agree with our privacy policy as it relates to anything besides the effects of the vaccine, but she felt this needs to be reported in the public interest. On 03May2021, the patient underwent PCR test (nasal swab) and the result was Negative. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the mouth sores and included treatment with oral steroid. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events aches, chills, fever, gums and palate swollen and red, extreme fatigue, headache, sore throat, mouth sores and lichen planus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Intense abdominal cramping, headache, thigh cramping, nausea one hour after injection
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (at the temperature of 34-35-unit unknown) unspecified doses of PEDVAXHIB (lot # K0256533, expiry date 07-AUG-2017 or lot # K015463, expiry date 10-JUL-2017)(dose, site and route of administration were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician referring to a 17 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 15-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fahrenheit degrees for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768.
Nephrology Dr: Diagnosed with acute kidney disease in August, I had to be hospitalized for 11 days, as the doctors figured out what the issue was (no family background of kidney issues). After 2 months it was downgraded to chronic kidney disease. Currently preparing for a kidney transplant.
localized hives type welt reaction/ type welt reaction about a three by three size on my arm; First dose of Shingrix April 11th, 2018 / Has not received the second dose; This case was reported by a physician via call center representative and described the occurrence of welts in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced welts and incomplete course of vaccination. On an unknown date, the outcome of the welts was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the welts to be related to Shingrix.  Additional information was provided as follows: The patient reported a localized hives reaction with the first dose. The patient had a huge localized hives type welt reaction, about a three by three size on her arm. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. No consent to follow up with doctor. No lot number and expiration date. No additional information was provide.
No adverse event; expired dose administered; This spontaneous report was received from a registered nurse concerning to patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 28-AUG-2020, the patient was vaccinated with an expired dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ML dose which had a lot# R009162 expiration date 06-JAN-2020 (route of administration and anatomical location of administration were not informed) for prophylaxis. However, at the reporting time the patient had not experienced any adverse event.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R009162; expirationdate: 06-JAN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient felt weak, nauseousness, and like she may faint fifteen minutes after injection.  She had the same experience with COVID-19 first and second doses.  Benadryl provided and patient monitored.
Pt called the pharmacy informing that his tongue was swollen and felt like he was choking. Pt went to the ER and was prescribed a rescue inhaler, Corticosteroid tabs, antihistamine and H2 Antagonist.
I am 57 years of age, and I had not had a menstrual period in 12-13 months as of April 2021. I received my first Covid19 vaccine on 3/11/2021. I received the Pfizer vaccine. I received the second vaccine on 4/1/2021. Approximately 2-1/2 weeks after the second vaccine, I saw some menstrual spotting and, consequently, I had a light period lasting about 7 days. I made an appointment with my OB/GYN out of concern for having a menstrual period after 12-13 months, and I was due for an annual exam. My OB/GYN appointment went well, all was good. My doctor advised that sometimes women do see a menstrual period after a 12-13 month period of time. At the time, I didn't think that it may be related to the Covid19 vaccine. However, I did see news reports about women having periods after the vaccine. So, I thought that I should report it.