chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt felt sick & weak p/vax;worse next day, fainted, fell, mouth bleeding;when conscious was afraid to get up, went to bed, had urge to throw up but did not;sweated profusely, lost control of bowels;became sick went to MD-felt sz not r/t vax;
8/8/21 Exposure to grandson who was covid + 8/9 Covid PCR neg test 8/11 ill 8/13 + Covid PCR test 8/24 potential to RTW
Arm pain at injection site. Treatment from MD was cold compress and NSAIDs. Arm pain began day after injection.
Received DTaP, IPV, MMR on 6/16/04. Started sore throat 6/18/04 along with fever, 6/2104 ears draining coughing, fever let up 6/20/04. Parent states this started Wednesday night after shots.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 29-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient through other manufacturer (Pfizer Inc.) concerned a 47 year old , female. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination and had no history of past drug. The patient stated that she was no taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 42A21A expiry: UNKNOWN) dose was not reported,1 total was administered on 05-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 5 decade old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received second dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, and were not reported, batch number: 067F21A expiry: UNKNOWN) dose was not reported, administered on 22-NOV-2021 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 2).   On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2) The patient started taking treatment with non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 26-APR-2023 to 30-APR-2023 for covid-19 treatment.  On 14-MAY-2023, the patient again experienced covid-19 (covid-19 rebound infection) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
7x8cm red, induration, lt deltoid @ site of inj, warmth;
Development of rash that started on the right side of the face starting about 4 hours after the injection,, then spread over the next 24 hours to the trunk and extremities.  Most florid and confluent on the face.  Minimal itching.  No other systemic symptoms.  Feels well otherwise.
Fever >102 onset 6-8 hours after vaccination. No other symptoms: no rash, no cough, no runny nose. Temp up to 103.8 R 11/19/2004 5AM
Swollen, red, and sore immediately under the injection site. Patient states that it is achy and warm. She will report to a doctor if it gets worse or doesn't get better soon. She thinks it might run its course. Suggested she may need steroids if it doesn't get better in a day or so.
Initially after receiving the vaccine I had pain in my left elbow where I received the injection. The pain remained there for weeks which was a little over a month. I didn't have symptoms of arrhythmia, but when I had tests did the results showed that I have Ventricular Ectopy and PVCs. I was sent for a cardiac follow-up where more test were did. I have never had arrhythmia before getting the vaccine. I also have hypertension too now. I have an appointment next week to see what medications the doctor will prescribe me for my health conditions now.
Muscle pain, arm pain that is continuous, generalized muscle aches and pains to the whole body
This case was received from a health professional on 27 July 2007. A four-year-old female patient with no known medical history developed injection site redness, progressing to entire limb swelling and redness, a few hours after receiving an intramuscular right thigh injection of Daptacel (lot number C2569AA), subcutaneous right thigh of IPOL (lot number Z0548-2), and subcutaneous left thigh injection of MMR (Merck, lot number 1168F). The patient had received the vaccinations on 25 July 2007 and began to experience redness at the injection site within a few hours, later developing "entire limb swelling and redness". The event was treated with cold compresses, and at the time of the report the patient had not yet recovered.
This spontaneous report as received from a Healthcare worker refers to an unspecified number of patients of unknown age. The pertinent medical history and concurrent conditions of patients were not reported. On unknown dates, the patients were vaccinated with incorrectly stored ZOSTAVAX lot # L039096, expiry date 08-JAN-2017 and Lot # L0395505 expiry 16-DEC-2016 (dose and route not reported). The vaccine was exposed to the temperature of -10 degree Centigrade for 10 days. There were no previous excursion reported. The reporting healthcare worker was not aware of any adverse events. No additional information was reported. This case is one of the several reports from same reporter. Additional information has been requested.
Flu like symptoms; body itch; skin pain; muscle pain; bone pain; joint pain/stiffness; joint pain/stiffness; low grade fever; breast pain on left side (same side as injection); tinnitus; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Patient historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 11 hours after the second COVID injection, the patient experienced flu like symptoms, Symptoms included total body itch, skin pain, muscle pain, bone pain, joint pain/stiffness, low grade fever. Also had significant breast pain on left side (same side as injection) and tinnitus on an unspecified date. Symptoms lasted 18 hours. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hives, using Allegra, Benadryl, baking soda baths, calamine lotion, Benadryl gel
Developed a spongy "water bubble" in right armpit.  Was slightly tender when pressed and had no noticeable lumps or nodules.  Slowly dissipated over the following 7 days.
12 days after injection my left arm has a large island shaped type rash that is 4inches long and 1.5inches wide. I noticed for the last couple of days a tiny red spot but thought it may have been a dry skin spot and this morning it turned into a large spot that is hot to the touch but does not hurt or itch.
Menstrual bleeding (I have not had a period in 3-4 years) Pain and knot at injection site (after 5 days it is worse)
I had wide spread muscle and joint paint.  I was fatigued.  I had to go to the ER.  The ER doctor said it was myofafeial pain syndrome or fibromyalgia.
A report has been received from a Physician concerning a child, subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced cough. The outcome of the event of cough is unknown. The report was considered to be non-serious by the reporter.
No other adverse events reported.; ROTATEQ series being initiated for an infant at 20 weeks of age; This spontaneous report has been received from a licensed vocational nurse (L.V.N.) referring to a 20-week-old patient of unknown gender. Information of concomitant medications, pertinent medical history, concurrent conditions and drug reactions/allergies was not reported.  Due to other issues, the patient did not receive his/her first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (1 dosage form (reported as 1 dose), strength, lot#, expiration date were unknown) orally for prophylaxis until 08-MAR-2023 (product administered to patient of inappropriate age). No other adverse events were reported (no adverse event). No product quality complaint. No further information was provided.
Blood sugar 400-590 x 3 days. Treatment: Insulin, no physical education.
Patient never came back to the clinic but went to the onsite nurse approximately 1-2 hours after receiving her vaccine.  She complained of shortness of breath and chest pain.  The nurse took the following vitals: BP 120/76, HR 97, O2 sat 97% and approximately 24 breaths per minute (clear).  The nurse instructed her to go to the ER.  Once patient left, the nurse came to let us know.  The last status update we received was when the nurse said she was headed to the ER.
Stroke of unknown origin on 02May2021, that caused Permanent disability; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: Ew0169) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol at that time only, minor other unrelated health concerns" (unspecified if ongoing), notes: High cholesterol at that time only, minor other unrelated health concerns; "known allergies: New stings" (unspecified if ongoing), notes: known allergies: New stings; "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 02May2021 at 08:00, outcome "not recovered", described as "Stroke of unknown origin on 02May2021, that caused Permanent disability". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 30 day(s)). The event "stroke of unknown origin on 02may2021, that caused permanent disability" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: If COVID tested post vaccination: Yes. COVID test type post vaccination was Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident.  Clinical course: It was reported that Serious: patient received more than 3 doses. No other vaccine informers. Stroke of unknown origin on 02May2021 that caused Permanent disability. Then on 19Aug2021 diagnosed with acute kidney failure determined to be caused by terminal multiple myeloma. AE resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment AE with Stroke rehab.
Became pregnant 21 FEB 2007 with quantitative hCG of 29 (urine hCG neg)
A nurse reported that an adult female inadvertently received an ID injection of Tetanus Toxoid Adsorbed, Ultrafined on 7/3/00. Some of the injection may also have been given SC. That day, she developed "slight" induration at the injection site. She then developed redness at the injection site. She reported to the ER but no treatment was given. She applied cold compresses to the site. As of 7/5/00, a "large" red area at the injection site persisted.
Within 20 min of receiving vaccine she became nauseated 10 min later she passed out with generalized weakness and dizziness. Taken to the ED. Was tx with BENADRYL and SOLUMEDROL and observed. Within an hour her symptoms had resolved and she was discharged. Perhaps a vagal response rather than an allergic rx.
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown date, between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were vaccinated with GARDASIL that was improperly stored  (dose, strength and route of administration were not provided). Co-suspect or concomitant therapies were not reported. The lot number reported for GARDASIL were: L012190 with expiration date on 13-APR-2017, K006960 with expiration date on 19-FEB-2017 and K023432 with expiration date on 18-JUN-2016. This is one of several reports from the same source. Additional information has been requested.
T 104.8 /win 1st 24 hrs.Lt deltoid became very red & swollen-went to ER advised Advil & cold compresses 3Apr91.Saw MD placed on Keflex for possible infection 5Apr91.
1530 received the dose; 1540 began having to clear the throat  164/104-69-20;  1547 increase cough; 1549 slight chills given warm blanket and given Solumedrol 125mg IV and Benadryl  25mg IVP. She had pre-medicated with Benadryl 25mg and 2 tablets of Pepcid
Information has been received from a physician concerning a 17 year old male patient who on 04-MAY-1994 and 01-OCT-1997 was vaccinated with the first and second doses of MMR II. On 19-JAN-2010 the patient experienced left parotitis and pain in the left cheek. It was noted that the patient had exposure to class fellow with mumps. The patient had blood work performed on 19-JAN-2010. On 19-JAN-2010, the patient was diagnosed with mumps. At the time of the report, the patient's outcome was unknown. No further information is available.
After the vaccine, she says she regulary gets them; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included fever blister.   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had fever blisters, but reported they had not been occurring often. Then after the vaccine, she says she regularly gets them. Once one resolves, another one pops up. The reporter consented to follow up.
Soreness in shoulder arm and then neck. Lifting arm feels like holding weights. Pain especially when lying on shoulder but pain all the time. Has been 18 days now. Ultrasound, doctor visit, ice and muscle relaxers but little help.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-JUL-2014, the patient was inoculated with ZOSTAVAX at a physician's office as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 26-OCT-2015, the patient was treated by a physician at an urgent care center for a persistent and severe vesicular rash, which was diagnosed as shingles. He was prescribed acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Swelling on my ankles. No medication, was advised to relax and elevate feet.
Client received Pfizer for first dose on 3/4/21 and Moderna for second dose on 3/26/21.  Client was monitored for 30 minutes with no initial reactions. Client was given Departments number if she experienced any reactions and told to call 911 for any s/s of anaphylaxis.
Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from healthcare professional. This case involves six-year-old male patient who received an expired 0.5 ml dose FLUZONE QUADRIVALENT lot UT5897KA, expiry date 30 June 2018 on 21 Aug 2018 in right deltoid. It was a case of actual medication error due to Expired vaccine used. It was unknown if any adverse event occurred. 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. Documents held by sender: none.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:11 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
approx 6wks after 2nd vaccine tightness in chest, wheezing on exertion, and eating certain foods appeared as allergy. Did not have any of this prior to vaccine. coughing , dry throat  still occurring
Patient presented to ED on 02/13/2023 with c/o flank and back pain to his left side. Visualized are multiple blistered areas to his left flank/abdomen. He c/o neuro pain to the area. Pt was prescribed Valacyclovir and Oxycodone.
Initial report was received 17 December 2008 from a health care professional. A five-year-old male patient had received an injection of IPOL, lot number A0273 (lot number invalid, route/site of administration not reported) on 25 August 2008 and an unspecified amount of time later, he developed erythema, pruritis and tenderness at the injection site. The patient had no known allergies. The patient experienced the same symptoms after receiving FLUZONE SV 2008-2009, (lot number, route and site of administration unknown) on 04 December 2008 (captured in case 2008-04031). According to the reporter, the patient recovered from the events. This patient experienced another event which has been captured in case 2008-04031. Documents held by sender: None.
Fatigue, body aches, joint pain, nausea, anxiety. 9/10/07-records received for DOS 8/16-8/17/07-C/O episodes of nausea, diaphoresis and bodyaches since last night. C/O pain at injection sites. Last night developed acute episode of fever and chills, body aches and lethargy.Assessment: allergic reaction although clinically stable questionable psychosomatic rule out anxiety attack.
Slept through getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Slept through getting the shot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No reported medical history reported.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced SLEEP DISORDER (Slept through getting the shot). On 04-May-2021, SLEEP DISORDER (Slept through getting the shot) had resolved. 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.   Concomitant medication details not reported by the reporter. Treatment details not reported by the reporter.
When she first got the vaccine she had a bright red strawberry colored, it was the size of a dime and then got to the size of a quarter at it's largest size; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "recovering", described as "When she first got the vaccine she had a bright red strawberry colored, it was the size of a dime and then got to the size of a quarter at it's largest size".  Additional info: Patient stated, she had a bright red strawberry coloured. When she first got the vaccine it was the size of a dime and then got to the size of a quarter at it's largest size it was like the size of he opening of a cup or a mug, it was getting better now and fading in color.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (17Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.