chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information received from patient's mother by phone. Per mother Pt. began having body pain at 2:00AM on 10-21-08, unresolved by TYLENOL. No fever. At 6:00 AM on 10-21-08 Pt. arrived at mother's house, fell on floor complaining of severe pain in flesh, bones and muscles. Also complained of headache, dizziness, "unable to move". Mother reports patient was sensitive to touch, was assisted to bed. Mother reports patient had pain, weakness X 6 days, was unable to attend school and stayed in bed and slept for 6 days taking TYLENOL every 6 hours while awake. (M) reports patient was able to ambulate to bathroom and kitchen to eat. Mother reports symptoms improved on 10-26-08 but did not completely resolve. Mother reports approximately 11-2-08 patient had worsening pin for 1-2 days in (L) shoulder, left sided chest pain, pain in abdomen and legs. Pain improved but continues to "come and go". Mother reports that on 1-22-09 patient was sitting in class and suddenly lost eyesight and reported dizziness and being unable to move. Was reported by witnesses to be mumbling and incoherent and was taken to hospital by ambulance. Mother reports patient had left sided pain, numbness and a "prickly sensation" all over but mostly in upper body. Patient had numerous tests including CAT Scan, EKG, blood tests and IV fluids/medication (potassium, ATIVAN). Mother reports all test came back "negative". Patient had appointment with MD on 1-23-09 and had more testing for "artery inflammation" and Lupus among others. Mother reports a.u tests "negative". Patient to have follow up with Neurologist.  3/3/09 Received vaccine records & ER medical records of 1/22/2009. FINAL DX: hyperventilation syndrome; panic attack; numbness. Records reveal patient experienced anxiety, syncope, hyperventilation while in class.  Tx w/IVF.  Improved & d/c to home.
pt brought to facility for short-term rehab post right femur fracture, ORIF; tested positive for COVID on 10/1/21 with c/o nausea; DNR; placed in isolation; found in the room by CNA with no pulse and not breathing; died in the rehab center
No adverse event occurred - patient requested vaccine, denying any previous Covid-19 vaccine injections.  We were notified by County Health Dept on 8/10/2021 that patient had previously received a Janssen vaccination elsewhere, thus requiring VAERS form
This spontaneous report as received from a consumer refers to a 53 year old female patient with chronic sinusitis. On 09-JUL-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # unknown) once intramuscular for physician recommended. Concomitant therapies included ZOLOFT, BYSTOLIC, WELLBUTRIN, SYNTHROID, ARMOUR THYROID TABLETS, pravastatin sodium, MIRAPEX, "water pill", estradiol and progesterone. Consumer reported that on 09-JUL-2013 after received PNEUMOVAX 23 she developed a small hive on her abdomen. Consumer stated she self medicated with ADVIL and the hive "went away after a couple of days". The consumer stated when she took Codeine (manufacturer unspecified) she hallucinates, when she takes CIPRO (manufacturer unspecified) she got a rash and when she takes BACTRIM (manufacturer unspecified) or SUDAFED (manufacturer unspecified) she developed a purple, blotchy rash and her whole body turns red. There was no lab performed for the event. The patient also did not sought medical attention. Additional information is not expected.
I had coughing, fatigue, slight headache, very mild congestion, and muscle spasms. I took an at home COVID-19 test and it was positive. I spoke to my doctor and he didn't prescribe me anything. He told me to drink water, get rest, and take tylenol and aspirin.
got covid after vaccination; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid after vaccination) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced COVID-19 (got covid after vaccination) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (got covid after vaccination) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive covid-19 test (Positive) Positive COVID-19 test.         No concomitant medications reported by reporter.  No treatment medications provided by the reporter.  Company comment: This case concerns an 83-year-old female patient who experienced the unexpected event of COVID-19 with seriousness criteria of hospitalization. The event occurred approximately 5 months after the first dose of mRNA-1273 and 4 months after the second dose of mRNA-1273. The rechallenge was not applicable. Because the event happened after the second dose of the vaccine after a 30 interval between 2 doses, lack of drug effect has also been captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns an 83-year-old female patient who experienced the unexpected event of COVID-19 with seriousness criteria of hospitalization. The event occurred approximately 5 months after the first dose of mRNA-1273 and 4 months after the second dose of mRNA-1273. The rechallenge was not applicable. Because the event happened after the second dose of the vaccine after a 30 interval between 2 doses, lack of drug effect has also been captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to location of vaccination site) with associated moderate headache. No tongue swelling or weakness. No breathing difficulty. This was followed by left arm numbness and mild left leg numbness. Left-sided paresthesias /numbness resolved within 3 hours of vaccination. The severity was mild-moderate without there ever being complete loss of sensation. No vision problems or weakness.
Injection site is sore; Mild case of diarrhea / On 23 April 2 bouts of mild diarrhea within an hour; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Mild case of diarrhea / On 23 April 2 bouts of mild diarrhea within an hour) and VACCINATION SITE PAIN (Injection site is sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021 at 12:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021 at 6:30 PM, the patient experienced DIARRHOEA (Mild case of diarrhea / On 23 April 2 bouts of mild diarrhea within an hour). On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Injection site is sore). At the time of the report, DIARRHOEA (Mild case of diarrhea / On 23 April 2 bouts of mild diarrhea within an hour) and VACCINATION SITE PAIN (Injection site is sore) outcome was unknown. Unknown          No relevant concomitant medications were reported.  No treatment information was reported..
Developed hives (R) arm, neck, back approx. 5 hrs after injection.
Presented to clinic approx 3 hrs after vaccine administration with hives to face and torso. Examined by physician given 7/5mL of BENADRYL in office. Instructions for follow up given to the mother.
Fever, Chills, Severe headache and unilateral left sided neck pain, severe malaise, fatigue, body aches, diarrhea and abdominal cramps
I?ve been running a constant 101 fever with spikes up to 103 degrees. I?ve had extreme body aches and weakness. I?ve also had a terrible headache with no relief. I?ve had brain fog and extreme confusion.
Otherwise regular period (25 years of regularity) was 14 days late. Meant to begin day after shot. Pregnancy tests negative, no other changes to medical or diet.
pt recv vax OCT 1993 & exp myalgia, arthritic pain & stiffness in the lt wrist, thumb & knee & an overall arthritic feeling; subsequent lab eval showed the pt to be anti-HBs pos; No further details were provided;
pt exp immed pain @ site of inject that radiated to elbow; called clinic & was advised to see MD; could not raise arm, carry, lift or sleep on lt side w/o pain; given med by MD;
Pt received Flu shot 8/30/17. Patient experienced discomfort swelling the next day. Went to ER 9/1 and had ultrasound. Nothing showed up. Went back on 9/5 due to increased swelling. Pt was hospitalized 9/5-9/11. Diagnosis: Right arm abscess and cellulitis.
fever, nausea vomiting, extreme fatigue unresponsive unable to wake him,  unable to drink water
This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 18th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced pustule, shingles and painful rash. On 25th March 2019, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash, pustule, shingles and painful rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, pustule, shingles and painful rash to be related to SHINGRIX. Additional details were reported as follows: Three to four days before the date of reporting, a rash appeared on the patient's back that was itchy and then presented on his front. The rash on his front had raised pustules filled vessels that were painful. The reporter thought the rash on the patient's front might be shingles.
Increase in heart palpitations. Had significant rise in how many palpitations I have. Woke up at midnight night after vaccination with heart palpitations that I struggled to get to come done. The for next 3 days, I had 5-7 a day with one incidence that I almost passed out from. Slowly decreased from there.  Also had fatigue and lack of energy for a few weeks. Just didn?t feel like myself.
Patient reported feeling nauseated and under the weather 48 hours after receiving the vaccination and then developing an infection on both lower legs requiring an oral antibiotic and topical antibiotic ointment.  Patient also reported being unable to stomach solid foods since receiving the vaccination.
A report was received from a member of staff for a health care professional on 12/5/03 concerning a 15 month old male vaccinee who inadvertently received 0.25ml Fluvirin vaccine on 12/4/03. On 12/4/03 the vaccinee received Fluvirin. No adverse symptoms occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
hundred patients received a dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial) had resolved.        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.   No concomitant medication were reported. No treatment information was provided by the reporter.
pt recv vax & devel a fever of 104 & rt inguinal lymphadenitis;pt recovered p/2 days;
This spontaneous report was received from a physician via company representative and refers to a 72 year old male patient. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. In approximately 2007 (reported as 9 years ago), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, anatomical location and route of administration were not reported) 0.65 ml. On an unknown date in December 2015 (reported as approximately 2 months ago), while the patient was traveling he developed a shingles rash, even though he had received ZOSTAVAX in the past. The patient saw an unspecified doctor, who gave him antiviral medication (unspecified). The patient experienced zoster of the eye and mild Bell's palsy resulting in a droopy eyelid. The adverse events had affected his eyesight, which the patient considered a significant disability/incapacity. The patient sought medical attention and visited a doctor. The outcome of the events was unknown. Upon internal review the events of a droopy eyelid was considered to be medically significant. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected, as there was no consent for follow up.
Low grade temp.; significant joint pain (neck, shoulders, elbows, wrists, knee (rt), hips); muscular pain.  Required ibuprofen 600mg with only partial relief.
Information has been received from a registered nurse concerning an "18 or 19" year old female who on approximately 31-MAY-2007 was vaccinated with a third dose of Gardasil. On 31-MAY-2007 several hours after the patient received the injection, the patient experienced fever, nausea and dizziness. On 01-JUN-2007 the patient had to be taken to the emergency department of a local hospital to be treated for dehydration. There were no adverse experiences reported after receiving the first and second doses. Additional information has been requested.
We all got Covid, even after immunizations.; We all got Covid, even after immunizations.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We all got Covid, even after immunizations.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Clinical course: The reporter was annoyed and stated that they didn't think there has been enough testing, etc done. In addition, he didn't believe the claims. They all got Covid, even after immunizations". Patient received Pfizer COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tired not feeling well, cold, hot flashes since 3/12/2013 10:00pm; swelling, soreness and redness at injection site 03/12/2013 10:00pm.
Upset stomach, chills, body aches, queasy "felt it go through her after she got it."
This case was reported by a physician and described the occurrence of a subject of unspecified age and gender being hepatitis A antibody negative following vaccination with HAVRIX, GlaxoSmithKline.  At the end of June 2007 the subject received 2nd dose of HAVRIX at 1440 elisa units to complete the series.  Three weeks after the 2nd dose was received the subject's physician checked for antibodies and determined that the subject was not protected by the HAVRIX vaccine.  This was considered to be a lack of effect.  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 07 August 2007 indicated that the subject was 37 years old at the time of reporting.  The outcome was not known and the event was considered by the reporter to be related to treatment with HAVRIX.  The 1st dose of HAVRIX was administered in May 2006.  No concomitant medications were taken.  A Hepatitis A IgM performed on 27 June 2007 was non-reactive.
arm pain, chills, fatigue, feels foggy Narrative:  Other Relevant History:
15 minutes after Hep A #2 area around both eyes got puffy & deep red. Hives on face from eye down to mouth.
pt recv vax;localized follicular sandpaper rash over mid thigh w/o redness;
numb arm/fingers on side of injection. Fluttering heart. Adrenaline type energy, then too sick / weak / dizzy to move (Still going for 3 days now). Insomia for 2 days.
12 year old patient received adacel shot before due date / No AE; Initial information received on 08-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA314534 (same reporter).  This case involves a 12 year old patient received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] before due date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunization.  On 30-Oct-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6518AA (Expiry date 05-Nov-2021) via unknown route in the right deltoid.  It was actual medication error case due to inappropriate schedule of product administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. Concomitant therapies were not provided. On 12-JUL-2016, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB "10 microgram/1 ml, 10X1 DS/V TF", with lot number L042846 and expiration date 15-SEP-2017, (dosage schedule, route and anatomical location were not reported), which was stored at 12 Celsius Degrees for 144 hours. The type of excursion and the storage criteria were reported as refrigerator (R) and the vaccine status in excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chest pain which continued to worsen as time progressed, heart palpitations, left arm and neck pain, fatigue, sweating of hands/feet, clamminess, shortness of breath, left breast pain, easily over exerted.  Visited primary care on 10/13/21 diagnosed with rib inflammation and new heart murmur was discovered. (Heart murmur was a new finding, have been to primary care doctor for many years and played sports many years / physicals; heart murmur was never diagnosed/heard). EKG done in the primary care office was normal. Was prescribed naproxen sodium.  Symptoms got rapidly worse (thought I was having a heart attack) so went to the ER on 10/14/21. EKG/ chest x-ray and blood work done was normal. Was admitted to hospital after heart rate jumped to 140-150 by just standing, also admitting doctor was concerned of heart murmur. Echo performed inpatient on 10/15/21 showed severe aortic valve stenosis.  Chest MRI done 10/16/21. Carotid artery ultrasound done 10/16/21. Heart catheterization procedure done 10/18/21. Open heart surgery done 10/20/21 to replace aortic valve with mechanical valve.  Discharged from hospital on 10/26/21.
had first vaccination 12MAR2021 and then tested positive for covid 22MAR2021/shortness of breath, headache, fever, and body aches/cough; Inflammation in the chest; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiry date: unknown) via an unspecified route of administration, unknown location, on 12Mar2021 13:00 pm at a single dose for covid-19 immunisation (age at vaccination was 59 years). The patient took the Pfizer Covid-19 vaccine because she did not want to get Covid. There was no medical history. No family history. Concomitant medication patient received included levothyroxine sodium (SYNTHROID) taken at 0.75 mg dose for hypothyroidism (had been taking for approximately ten years). No other vaccine was received within 4 weeks prior to the COVID vaccine. Historical vaccine included pneumonia vaccine she had a weird reaction to it around 6 years ago. She has no additional information, LOT, NDC, Expirations, or manufacturer for the pneumonia vaccine that she received. The patient's husband was sick for a few days before the patient started getting sick. It was just shortness of breath, headache, fever, and body aches. The patient took Tylenol and did not had dose or information. On Saturday afternoon the patient noticed this and she stayed in bed all day Saturday and Sunday. On Monday she went to Urgent Care because she was not able to take this. On 22Mar2021, the patient had a rapid test for Covid-19 and tested positive for covid. The patient's husband also tested positive and she thinks she got it from him. They both tested positive on the same day. There were no previous immunizations with Pfizer vaccine considered as suspect and no vaccines administered on the same day. The patient did not visit an emergency room or physician office. The patient went to the urgent care the same day when tested positive. They gave her prednisone for the cough and inflammation in the chest. She is taking Tylenol also, over the counter, and does not know the dose. The patient was feeling better. The patient is supposed to have another vaccine this Friday and does not know if she can get it or not. The patient added that she cannot imagine she is the first to call about this and is directed to her physician for medical advice. She offered medical information and stated that she will call her physician. The patient will be calling her physician regarding whether she will be receiving the second vaccine. The outcome of the events was recovering.  Additional information has been requested.