chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a female consumer via company representative referring to her daughter as a 18 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date of August 2016, the patient was vaccinated with first dose of GARDASIL 9 (lot, expiry date, dose and route of administration were not reported) for prophylaxis. On an unknown date of 2017, the patient was vaccinated with second dose of GARDASIL 9 (lot, expiry date, dose and route of administration were not reported) for prophylaxis. The patient's mother reported that "her daughter had received the first two doses of GARDASIL 9 outside of the recommended dosage schedule". It was reported that, the patient was currently looking to get the third dose. No product quality complaint was filed.
1) Severe headache on 3/27/2021 - one day after second shot. Resolved within 24 hours with Tylenol. Headache happened again 5 days after shot.  2) Unusual heavy, bright red bleeding from vagina during/after sex - has never happened before. On 4/3 and 4/6 on cycle days 11 and 14 respectively after period. Period was 3/24-3/28.
mild itching; This is a spontaneous report from a contactable pharmacist (patient). A 72-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Jan2021 10:00 (Lot Number: EL9261) at the age of 72 years as single dose for covid-19 immunisation. Medical history included high cholesterol, osteopenia, hypertension (HBP), macular degeneration, known allergies: sulfa antibiotics, IVP dye, latex, Macrobid. Concomitant medications included losartan; simvastatin; vitamin d; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). Patient was not pregnant. No other vaccine in four weeks. Patient had no covid prior vaccination and did not test post vaccination. Patient experienced after first dose, mild itching in Feb2021. Ae resulted in doctor or other healthcare professional office/clinic visit. Treatment prednisone dosepak, steroid cream received. Outcome of event was not recovered.
Symptoms were first noted in March. This started two weeks after receiving the second Covid vaccine. She has red and itchy bumps. She saw a primary care doctor who diagnosed scabies. She was treated medically and it did not work. She saw a dermatologist who twice biopsied. A skin inflammation was diagnosed and Sarna was advised. Her primary care doctor prescribed prednisone: it made her puffy but did not help much. Her primary care doctor gave her a sulfa antibiotic and she completed it without benefit.  She has an ointment to mix with Sarna and it helps.  She cannot sleep. She has used Zyrtec: it does help her to sleep but nothing else. Allegra did not help. Individual lesions can last a week at a time.  She has a history of ?swellings? of her bones. She has had problems of her knees and heels. She has had injections of her knees, shoulders and heels. Her fingers sometimes hurt, and they have been injected. She denies any other swellings. She started Edarbyclor and Bystolic last year. She started Diltiazem in March or May. Baby aspirin was started in the early 2000s. Simvastatin in about 2003.  She recently completed a week of sulfamethoxazole-trimethoprim.
Chief Complaint: Syncopal episode.  Cough and shortness of breath. Additional Medical History:  This 67-year-old obese female with a history of coronary artery disease, COPD, diabetes mellitus, hypertension, hyperlipidemia, migraine, irritable bowel syndrome, seizure and sleep apnea was brought to the ED by an ambulance after she suffered a syncopal episode in a camper just prior to arrival.  The patient states that she has not been feeling well today.  She has been having a nonproductive cough and shortness of breath for the last 3 days.  She denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  The patient is uncomfortable at the time of this examination. She has a headache. Associated Symptoms: cough, headache, shortness of breath
Choking symptoms 20 min after receiving; coldness in her whole body; increased heart rate; swelling of R arm (size of ping pong for 3 days).
unbalanced/lost her balance; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 11:30 (Lot number: EW0158) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure " (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BALANCE DISORDER (non-serious) with onset 08Apr2021, outcome "recovered" (10Apr2021), described as "unbalanced/lost her balance". Additional information: Caller is reporting side effects after receiving first dose of the Covid-19 vaccine. She first stated she had dizziness. Clarifies that it wasn't dizziness. She was instead unbalanced. If she was sitting she was fine. When she stood she lost her balance and was sideways and bumped against the wall.   No follow-up attempts are possible. No further information is expected.
Symptoms included nonstop screaming and frantic, jerky, uncontrollable movements. Symptoms lasted 10 hours or more.
Cubital tunnel syndrome in injected arm.   Hands "fall asleep" occasionally, but this time it did not resolve, resulting in weakness in hand and arm that have only partially recovered in the weeks following.  Unable to use left hand since onset to use most tools, turn a valve, etc.  Uncertain at this point whether full recovery is possible, but progress seems to be stalled at perhaps 50%-75% capacity.  Icing helps with pain, along with regular acetaminophen and occasional ibuprofen.  Exercise (including ulnar nerve "flossing") helps with recovery but has plateaued.
CHILLS, FEVER,SHARP/PIERCING CHEST PAIN, ENTIRE BODY WEAKNESS, ENTIRE BODY ACHES, HEADACHE, DRY THROAT.
26OCt93 hoarse, sneezing, coughing; 27OCT93 sore throat; glands felt swollen; felt so sick; cont wracking cough heavy phlegm for 2 wks; absolutly immobilized by illness;
Localized systemic reaction X 3 weeks right hand to right side of neck.  PREDNISONE treatment X 5 days 20 mg BID.
shipment of Adacel vaccine arrived on 07-Nov-2019, shipment of vaccine was 1 day late with no AE; shipment of Adacel vaccine arrived on 07-Nov-2019, shipment of vaccine was 1 day late with no AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 41-year-old female patient who received a 0.5 dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6539AA, expiry date: 13-Nov-2021 via intramuscular route in the right deltoid on 07-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to the incorrect product storage and product distribution issue. It was reported that the shipment of vaccine was 1 day late. The shipment of Adacel vaccine arrived on 07-Nov-2019. It was shipped on 04-Nov-2019, exceeding the 2 day delivery time. An office personnel unpacked the delivery and 2 patients inadvertently received the Adacel vaccine on 07-Nov-2019.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
soreness at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site.). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site.) had resolved. Not Provided          No treatment information was provided.  No concomitant medication was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-068519 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068519:CROSS LINKED WITH DOSE 2
He developed gross hematuria 1/2022, so Xarelto was stopped at that time.  He then noticed 2 to 3 months of dark stools which precipitated an EGD (normal) and colonoscopy (severe diverticulosis of the entire colon, with pathology showing segmental colitis associated with diverticulosis) with one doctor 7/2022.  He was then referred to another doctor 7/2022 and diagnosed with autoimmune hemolytic anemia and started on prednisone.  He received healthcare in 2 different locations, so detailed records of all events are not available.
Tongue began burning as the injection was done.  Tingling on tongue, weird metallic also.  2 hours after the shot, I had a full body rash that lasted a couple of hours.  The rash did not require any medical attention but it was hot to the touch and it was slightly raised.  I took benedryl and the rash cleared up.  The severe burning mouth and tongue remains.  Since the moment of my shot, I have had non stop tongue pain and mouth pain.  It has not improved in the 5 weeks since I had it.  The Doctor said nothing could be done to treat it.  She said that Covid tongue could happen with a covid infection but not with the covid vaccination.   I have scalloped tongue, my tongue has been swollen, it gets strange lesions on it every few days.  It feels like when your burn your tongue on a hot cup of coffee.  Pain reliever helps somewhat but I dont want to be on pain killers everyday.  Lidocaine rinse works for about 15 min.   It is painful to eat, it feels like I am eating pop rocks candy when I eat food.  It has altered my taste.   It is very bothersome.  I had a diagnosed covid infection 18 weeks ago, but I did not have this burning mouth problem with the actual covid infection.
a lumpy ball that got sore; a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lumpy ball that got sore) and PAIN IN EXTREMITY (a little bit of a sore arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE MASS (a lumpy ball that got sore) and PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, VACCINATION SITE MASS (a lumpy ball that got sore) and PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Pt recvd DTP/OPV on 3JUL91; On 5JUL91 devel fever 99.8 w/APAP & lt del redness w/rash spread to back; Pt fussy & irritable; Seen by MD & given ATB & DPH; MD states was local rxn;
Inappropriate schedule of pneumococcal vaccine; This spontaneous report was received from a physician via an immunization record, from a case in litigation for zoster vaccine live (ZOSTAVAX) (2008USA012413), concerning a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-DEC-2000, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as "pneumococcal conjugate") (manufacturer unknown) dose 1 as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On 26-FEB-2001, she received the second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and on 26-APR-2001, the third dose of the vaccine was administered (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.    This is one of several reports concerning the same patient.; Sender's Comments:  US-009507513-2008USA012413: US-009507513-2112USA004906:
I received my first shot on 1/29. I had some severe arm pain and fatigue for the first two days but nothing out of the ordinary. In the early morning on 2/4, 7 days after my shot, I started getting chills, had a splitting headache and my left underarm was too sensitive to move. I went to bed, woke up the next morning, the chills were gone but the headache snd swollen lymph nodes remained. My headache subsided after a day, my swollen left arm lymph nodes  stuck around for 2-3 days. By 2/6, I developed the red ring on my arm that I had read to be Covid arm which seemed rare but happening per the news.  By 2/7-2/8 I was able to comfortably move my arm again and my rash subsided.   I received my second shot on 2/26 and happy to report I had minor arm pain again and fatigue but no other adverse reactions at this time. It?s now been 13 days.
1/19/21: Bell's palsy-moderate, left facial muscle paralysis especially of the smile and upper cheek. Started prednisone 60mg po q7days on 1/20/21 and Valtrex 1g tid.
Information has been received from a healthcare worker concerning a 43 year old female patient with environmental allergies and no known drug allergies who on 21-APR-1970 was vaccinated with a dose of MERUVAX II. Concomitant therapy included PROZAC; SYNTHROID; ALLEGRA; and VENTOLIN INHALER. According to the reporter, the patient "possibly" has a negative rubella titer after receiving MERUVAX II. At the time of the report the patient's status was not specified. The patient sought medical attention by an office visit. Additional information has been requested.
soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PAIN IN EXTREMITY (soreness of the arm). At the time of the report, PAIN IN EXTREMITY (soreness of the arm) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Pain in left shoulder and arm, increasing with movement.  Limited mobility raising arm, and teaching towards back. ( stops at 90 degrees rather than 180 which the left side does.  Unable to take NSAIDs due to GI bleed in hiatal hernia.  Cold compress , Tylenol. and exercises. Tried voltarian, and hydrocortisone creamed. Starting physical therapy.soon A month later and symptoms have not improved .
Patient reported swelling and tingling of fingers on her right hand an hour after Trumenba vaccination.   On exam, right hand was neurovascularly intact with minimal swelling.   No redness or swelling around vaccine site. Treatment included reassurance and monitoring.   Ibuprofen and cool compresses if needed for pain.   Follow up if worse, new symptoms develop or doesn't continue to improve.
Numbness in fingers, dizziness, elevated blood pressure, over a period of an hour. Treatment included eating, drinking fluids and rest.
Throat pain; Very very tired; Vomits; body aches/pain in the whole body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Throat pain), VOMITING (Vomits), MYALGIA (body aches/pain in the whole body), HEADACHE (headache) and FATIGUE (Very very tired ) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced VOMITING (Vomits), MYALGIA (body aches/pain in the whole body) and HEADACHE (headache). On 13-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Throat pain) and FATIGUE (Very very tired ). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Throat pain), VOMITING (Vomits), MYALGIA (body aches/pain in the whole body), HEADACHE (headache) and FATIGUE (Very very tired ) outcome was unknown.            The patient doesn't take any concomitant medication.   This case was linked to MOD-2021-220918 (Patient Link).
Patient states later in the evening after our pharmacy was closed that she developed a fever and her arm swelled from her shoulder all the way to her elbow and was also feverish to the touch and inflamed. This continued for 4 to 5 days. She took TYLENOL around the clock.
Myalgia, nausea, vomiting, abdominal pain, arm pain right upper, mild headache, Tylenol taken.
Felt sick, 3 days out; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, 1 day after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine and following day patient felt sick but 3 days out and all good. The patient was glad that he/she got it. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Nurse delivered/vaccinated patient with Boostrix Tdap that was purchased with special funds by mistake  Tday/Boostrix was the intended vaccine for use
Developed right sided rash and right forearm lump over beginning 5/9/21. Patient states feels like he has gout, but uric acid level is 3.6. Also complains of bilateral leg pain,. No obvious swollen joints.
Test was negative for any antibodies; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Test was negative for any antibodies) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pancreas transplant. Concomitant products included MYCOPHENOLATE SODIUM (MYFORTIC) and TACROLIMUS (PROGRAF) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Test was negative for any antibodies). The patient was treated with Immunotherapy (replimune) for SARS-CoV-2 antibody test negative. At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Test was negative for any antibodies) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided
pt recv vax 18MAR96 & 5MAY97 pt exp breakthrough virus consisting of approx 10 to 15 lesions;pt cont to break out & the lesions become a rash;It was noted about 25 children in day care had chickenpox & many children recv vax;
Immunized Friday evening 9/16/11, had a seizure on Saturday morning, legs got weak, had to sit, felt like someone threw water in her face. She has had grand mal seizures before, this was not like those.
Patient received Pfizer Covid Vaccine for pediatrics instead of Adult (12 yrs an older) dose. No side effects reported.
Woke up with severe swelling of lymph nodes under shot arm. Extremely painful to the touch and could not lower arm. This lasted approximately two days.
My period started February 7th and was insanely painful to the point where I was throwing up and cramping so bad that I could not walk for two days! February 8th and 9th I had to call in sick from work due to the pain.  My family doctor believe that I was miscarrying due to the amount of pain I described.