chrisvoncsefalvay/vaers-outcomes huggingface dataset:
difficulty breathing; terrible pain throughout body including back; horrible pain in hands/pain in feet; hands and fingers have become locked and that he cannot fully open his hands; redness and a prickling sensation like pins and needles that started in a few finger and has now; redness and a prickling sensation like pins and needles that started in a few finger and has now; dry mouth; dry throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands) and ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoedema, Kidney disorder (Stage 3 kidney disease), Ulcer, COPD, Acid reflux (esophageal) and Heart disease, unspecified.    On 01-Apr-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 DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands), ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now), PARAESTHESIA (redness and a prickling sensation like pins and needles that started in a few finger and has now), DRY MOUTH (dry mouth) and DRY THROAT (dry throat). At the time of the report, DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands), ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now), PARAESTHESIA (redness and a prickling sensation like pins and needles that started in a few finger and has now), DRY MOUTH (dry mouth) and DRY THROAT (dry throat) outcome was unknown. Not Provided      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.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: Patient recieved covid shot, and fainted within 8-15 minutes. He bumped his head while falling and had redness at the site. We called the ambulance to make sure patient will be okay. Paramedics mentioned that his blood pressure was low.
Patient was given 0.2ML of the 30mcg formula instead of the 10mcg formula.
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2015, the patient was treated at a medical center for a persistent vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This spontaneous report was received from a registered nurse who is also the mother of a male patient of unknown age with allergy to penicillin, and no pertinent medical history. On an unknown date also reported as "as a child" the patient ws vaccinated with VARIVAX (Merck) (lot number and expiration date not reported) (dose and route were not specified). There was no other suspect therapies or concomitant medications. The reporter stated that in July 2013 the patient had varicella titers drawn which were negative. It was stated that her son received a second dose of VARIVAX (Merck) the same day that the titers were drawn (in July 2013). Additional information has been requested.
Patient received the second dose of Moderna on 5/7/21. He had fever and chills later that night after the vaccine. He developed an ACUTE Stroke to right MCA on 5/9/21 while on Eliquis. He did not miss any doses of his Eliquis. He has no history of strokes.
Hives, redness at site, shortness of breath, lips swollen, dizziness.
Pt. stated that as he was driving home after recieving  the covid vaccine the left side of his face became numb , he also said the left arm was sore and stiff and tight feeling. He said it lasted a few days and was gone by Thursday 10-21-2021. He did not seek medical care and feels good now. He did stay in office for the 15 min. after injection with no c/o.
Got PCV 13 the 24th of March, the 27 of March I started getting chills, fever, ached all over like the flu - cough with green phlegm. I got worse every day, finally went to the hos. admitted. Pneumonia and congestive heart failure. I was ok when I got the shot. Still recovering very weak.
Fever PM of date given 16JUN92; t104 high pitched cry went to ER MD related it was related to vax; pt sent home; fever 104 next day seen by MD poss sz;
Had a cold; lost his appetite; started losing sense of taste \ couldn't taste anything; started losing sense of smell; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (started losing sense of taste \ couldn't taste anything), ANOSMIA (started losing sense of smell), INFLUENZA LIKE ILLNESS (flu-like symptoms), NASOPHARYNGITIS (Had a cold) and DECREASED APPETITE (lost his appetite) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Apr-2021, the patient experienced AGEUSIA (started losing sense of taste \ couldn't taste anything), ANOSMIA (started losing sense of smell), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DECREASED APPETITE (lost his appetite). On 25-Apr-2021, the patient experienced NASOPHARYNGITIS (Had a cold). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, AGEUSIA (started losing sense of taste \ couldn't taste anything), ANOSMIA (started losing sense of smell), INFLUENZA LIKE ILLNESS (flu-like symptoms), NASOPHARYNGITIS (Had a cold) and DECREASED APPETITE (lost his appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
diagnosed with Covid after receiving primary series and booster; diagnosed with Covid after receiving primary series and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history, reported as no underlying medical conditions. The patient's 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 "diagnosed with Covid after receiving primary series and booster". Clinical course was reported as, Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was made aware on 3-25-21 that the pt. had been admitted to the hospital for a Stroke . Informed Dr. of same.  Per pt. daughter pt. was admitted to Hospital on 3-24-21.
Pt recv vax on 10/9/98; on 10/10/98 pt exp nausea & vomiting
on 1/22 developed dizziness as well as itching and redness at the injection site.  On 1/24 developed redness and itching on abdomen and trunk.
Headache started during the night, contacted PCP and was advised taking Tylenol was ok. Took Tylenol at 10am, it subsided and ended around 5pm.  Experienced sluggishness and feeling tired all day. Some brain fog of having to concentrate for long period of time. Nausea started in the morning and has continued throughout the day. Lack of appetite.  Sore arm started evening of the 4th, pain continues 24 hrs later but it is getting better.
34 y/o female, with past medical history of Covid (1 year ago), who presents with dizziness and dry mouth onset post vaccination. Patient states that this is her first vaccination in the two-dose series. Patient denies previous reaction to vaccination in the past. Vaccination site to the L arm. NP and Paramedics at patient side. Patient provided with a bottle of water. All vitals within normal limits (122/71 BP, 99% RA, 73 HR, 10 Resp, Glucose 90). Patient placed in wheelchair and brought to lay on the Trendelenburg cot. At this time patient was placed on 3L O2 by nasal cannula. Patient at this time states that she is somewhat scared of needles and when she had Covid over a year ago, she suffered from dry mouth lasting 6 months. Patient states that the dry mouth she is experiencing now is the same after her infection. Patient states that a mint usually improves her symptoms. Patient denies sore throat, difficulty swallowing, difficulty breathing, itch or rash. Patient provided with a mint and continuously monitored by the NP and paramedics. Within 30 minutes patient symptoms improved, dizziness resolved, and dry mouth subsided with the use of the mint. Patient was able to ambulate to the bathroom with NP and female Paramedic at side. Patient states that she feels better. Patient was cleared to go home after being observed for 30 minutes.
Fever - temperature to 104.4 degrees, decreased with Tylenol and Motrin.
Approximately 36 hours after second dose, patient complained of sever skin itching.  Parent observed raised hives/welts covering torso and limbs.   Rash subsided after one dose of Benadryl and did not return.
once of their office has administered an expired dose of ACTHIB with no reported adverse event; Initial information received on 10-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 months and 14 days old female patient to whom once of their office has administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Nov-2023, the patient once of their office has administered an expired dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UJ837AA; Expiry date: 30-Oct-2023) via intramuscular route in the Left anterior lateral thigh (left thigh) for Immunization with no reported adverse event (expired product administered) (latency: on same day). This dose was administered as a part of a 15-month wellness visit. Reporter stated that the Biohazard team did a pickup.  Action taken : not applicable.  Outcome : Unknown.   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 the Directive and Regulatory Authority 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 case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received ENGERIX B. Co-suspect products included HAVRIX and INFANRIX. On an unknown date, the patient received ENGERIX B at an unknown dose, HAVRIX at an unknown dose and INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, HAVRIX and INFANRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Patients may have been given these vaccines that were exposed to temps above the range for 563 hrs (Still investigating).
Initial information received on 18-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 18 years old patient who was inadvertently administered an extra 0.5 ml dose of ADACEL lot C5243AA via unknown route in the right arm, on 18-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation. It was an actual medication error case due extra dose administered. It was reported that ADACEL was inadvertently administered to a patient who received ADACEL two weeks ago. It was unknown whether the patient had any adverse reactions. 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. List of documents held by sender: none.
Joint pain, inflammation, some swelling  in all joints including fingers, hands, jaw, shoulders, elbows, wrists, knees, neck.  Assuming there is also joint pain in feet, ankles, toes, but with the radiation induced plexopathy from cancer treatment, I am not able to feel my feet, ankles and cannot tell if the joints are painful.  Impact: can barely get out of bed in the morning ? joints are stiff, achy, painful.  My right should has to be manually manipulated to move it.  I can pick up the coffee pot with the right arm but it is painful.  My hands are stiff at the wrists, in each finger and it is painful.  The fingers and hands can move (I can type) but individually each joint is sore including wrists.  It is much worse in am, gets a little better throughout the day.  Flexibility responds to Ibuprofen, but I can still feel the pain/stiffness in joints with a regular dose of NSAID.  I was waiting for it to go away, but instead the pain and discomfort grows each day ? the stiffness is progressively worse.
About 4 hours or so after second dose - I had nausea and I had vomiting but just a couple of times this vaccine. When I woke up the next day, I felt okay. But by noon, I felt really bad: all over body aches; right hand got very inflamed and painful. 24 hours after that it all was gone (the feeling I was hit by a truck)  except the right hand stayed inflamed for about a week to get back to "pre-vaccine" normal (with its inflamed symptoms).
Baby in for first set of vaccines. Pulled out a single dose of Hep B pediatrics and should have set up and given ACT-HIB vaccine instead. Parent of baby called and she will bring baby back to clinic this AM to get her first dose of HIB vaccine.
Patient reported blisters in nose started Thursday night and blisters in mouth started Friday morning.  Went to hospital.  Patient reports being diagnosed with urinary tract infection and blisters.
This spontaneous report as received from a registered nurse refers to a patient of unknown age who was wheelchair bound due to a previous spinal injury. The patient was vaccinated with a first and second dose of PNEUMOVAX 23 (dose, route and lot number not provided) within 1 year respectively in January 2012 and on 19-OCT-2012, and received influenza virus vaccine (unspecified) (manufacture unknown) concomitantly in the same arm. No concomitant medications were reported. On 20-OCT-2012 ("about 24 hours after the vaccination) the patient developed fever of 100.3 F and unable to move his legs. The patient was hospitalized and subsequently discharged following a full recovery. Additional information has been requested.
Lost some movements; Left arm still hurts; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 05May2021 (as reported) (Batch/Lot Number: Ew0182) as dose 2, single (at the age of 55-years-old) for Covid-19 immunisation. There was no medical history. The patient has unspecified concomitant medications (other medications in two weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 05May2021 (as reported) at 12:00 AM (Batch/Lot Number: Ek10173) as dose 1, single for Covid-19 immunisation. The patient had no other vaccine in four weeks. The patient lost some movements and left arm still hurts on 01Jul2021. No treatment was administered for the events. The patient had no Covid prior vaccination. The patient was tested for Covid via nasal swab (PCR) on 11Aug2021 and resulted negative. The events had not resolved.
First nausea, then vomiting, fever and headache during the day, took 400mg ibprofin around 1PM. At night: chest pain, night sweats, continued nausea, fever and headache, took 500mg acetaminophen. Second day: headache and nausea continued, took 400mg ibprofin. Second night: extreme night sweats.
15mo M with rash, small bumps- left and right side and lower back. Improving currently from yesterday but still present. Denies itching or fevers. He continues to eat, drink, void/stool normally. He received MMR and Varicella vaccines on 31Jan2022, symptoms developed on 15Feb22.
Starting four hours after the vaccine, My arm pain was constant and searing. It was so bad that I couldn?t move my arm at all without pain. That night I couldn?t fall asleep at all and a fever started around 10pm. The next morning I threw up and had diarrhea. had 102 fever for 24 hours straight and then it dropped to 101. I eventually started taking Tylenol and about 8 hours later my fever broke. The next day I have severe arm pain, fatigue and headache.
Difficulty breathing, wheezing, sore throat. Went to ER on 10-1-09 and given breathing treatment which ended her symptoms.
Information has been received from a physician concerning a 6-year-old female who, on an unspecified date, was vaccinated with a dose of Varivax. In April 2006, the patient developed a mild breakthrough case of varicella. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
pt recv vax 12OCT95 & 17FEB97 pt devel chickenpox;subsequently pt recovered;
I had a fever of 102.1 for hours and the chills. Vomiting and no apatite all day. The head ache made it hard to focus and walking felt unstable. The body aches all over my body and every joint hurt.  This second dose was worse than the first with the head ache and stability issues.  The symptom's were like back in Oct 2020 when I had covid19.  This time I didn't go to an urgent care like I did when I had the first Moderna covid19 vaccine since I kind of knew this would happen.
Headache, arm soreness, chills, body aches, and mild fever (100).
This spontaneous report as received from a healthcare worker refers to a pediatric patient of unknown age and gender. On an unknown date in 2014 the patient was vaccinated with a dose of VARIVAX (0.5 ml, subcutaneously, LOT#, dose and expiration date not reported), which was exposed to -12C for 15 minutes between the dates of 22-APR-2014 and 08-MAY-2014 (VARIVAX stored improperly). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 12-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N008077, expiration date: 09-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
have received an expired dose of Flulaval QIV; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number DJ247, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 5th November 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had received an expired dose of Flulaval quadrivalent vaccine on 5th November 2021 and the expiry date was on 30th June 2021 which led to expired vaccine used.  The consent to follow up granted and follow up was given on email. The reporter informed that there were 2 patients reported: 1 female patient that was reported on adverse event 71255 and other patient with no details available that was reported on this case adverse event 71258. The case was linked with US2021232167, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232167:same reporter