chrisvoncsefalvay/vaers-outcomes huggingface dataset:
His arm was slightly sore after the injection on the day he got it; could not move nor lift his arm; muscles ached so bad; not been able to sleep since then; He is upset; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an un-specified date (at the age of 49-year-old) at a 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his arm was slightly sore after the injection on the day he got it, could not move nor lift his arm, muscles ached so bad, not been able to sleep since then, he is upset. Reporter is a 49 year old male patient who has received his 1st dose of the Pfizer COVID Vaccine on Tuesday last week. He mentioned that he has a side effect that has been on going for 6 days, with the 7th day being tomorrow. His arm was slightly sore after the injection on the day he got it. By the next day, he could not move nor lift his arm. His muscles ached so bad and he has not been able to sleep since then. He mentioned that he has never had anything like this before the vaccination. He thought he was doing the right thing but now he is in a very bad situation. He is upset because he can't even work. He and his family is very concerned because of this. He mentioned that there is absolutely no way in heck he is getting the 2nd shot. Outcome of the events was unknown.  Follow up (PRD14Jun2021/SRD15Jun2021): This is a follow up spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported that: When consumer was again informed about the role of Pfizer Drug Safety and requested to probe, consumer stated, consumer really just want to know, consumer really concerned about what happened. Consumer want to know whether he is going to be okay or consumer need to go to the hospital. Consumer don't want to file nothing for no safety or no stuff like that, consumer want to know whether he is okay. Because consumer thought consumer was doing the right thing by getting this and now consumer can't even move my arm for 6 days, so consumer am very concerned about it.  Information regarding the Lot/Batch number has been requested.
Systemic rash and swelling (chest, stomach, neck, head- 3 days so far), allover muscle soreness (1 day), feverish (a few hours on the night of the shot)
Admit Date: 10/16/2022  4:50 PM Discharge Date: 10/20/2022     Admitting Physician: MD Attending Physician: MD Discharge Clinician:  MD Primary Care Provider at Discharge: MD   Hospital Course:  Patient is a 77 year-old female with a medical history of COPD on 0-2L home O2, OSA on CPAP, CHF EF 55%, afib s/p pacemaker, HTN, HLD, CKD3a, hx PE/DVT on eliquis and recently diagnosed breast cancer. She came to the ER for shortness of breath.   Patient tested positive for COVID and is thought the chronic obstructive pulmonary disease exacerbation was related to this.  She was started on Decadron and remdesivir.  She was also started on azithromycin and continued on her home inhalers.  Patient finished 5 days of dexamethasone and remdesivir.  Patient was given prescription for 5 more days of dexamethasone to complete total 10 days of treatment.  Patient continued to get higher supplemental oxygen.  Patient was discharged home with COVID at home program who will be monitoring patient at home.   Patient was encouraged to use CPAP at home for obstructive sleep apnea.  Patient's other medical problems remained stable. Patient was discharged to  COVID at Home program  in stable condition.
VARIVAX given 10/14, on 10/28/16 rash appeared 2-4 mm papules, few with small vesicles, appeared on arms and legs. Confluent, pink, blanching rash on abdomen, lower back and axilla.
Flu vaccine on 9/28/2023 felt fine just painful injection and arm sore, by Sat 9/30/23 my right leg felt slight pain in my thigh to my groin area, by 10/3/2023 evening time I could not walk and put pressure on my right leg, a knot appeared in upper thigh, by Wed 10/4/2023 I could not bare the pain any longer and went to the Emergency Room, ULTRASOUND AND xRAY COMPLETED WITH LAB WORK. I was told nodule calcification soft tissue posterior I could not walk at all, and the pain was unbearable with pelvic pain, leg pain, from thigh to foot, numbness, with sharp pain with any movement or pressure applied,  I was out of work 2 days with this condition that I have never encountered.
Fainting; Weakness beyond control; Migraines; puking; Heart issues; Brain fog; Digestive issues; Major fatigue; Lung problems; Sick all the time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: Ew0153) at the age of 50 years as dose 2, single and administration date 12Mar2021 10:00 (Lot number: Er2613) as dose1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis failed c spine surgery" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VALACYCLOVIR HCL; FLUOXETINE. Other medications in two weeks also included Clariti (unspecified). No other vaccine in four weeks.  The following information was reported: SYNCOPE (disability, medically significant), outcome "not recovered", described as "Fainting"; ASTHENIA (disability, medically significant), outcome "not recovered", described as "Weakness beyond control"; MIGRAINE (disability, medically significant), outcome "not recovered", described as "Migraines"; VOMITING (disability, medically significant), outcome "not recovered", described as "puking"; CARDIAC DISORDER (disability, medically significant), outcome "not recovered", described as "Heart issues"; FEELING ABNORMAL (disability, medically significant), outcome "not recovered", described as "Brain fog"; GASTROINTESTINAL DISORDER (disability, medically significant), outcome "not recovered", described as "Digestive issues"; FATIGUE (disability, medically significant), outcome "not recovered", described as "Major fatigue"; LUNG DISORDER (disability, medically significant), outcome "not recovered", described as "Lung problems"; ILLNESS (disability, medically significant), outcome "not recovered", described as "Sick all the time". The events "fainting", "weakness beyond control", "migraines", "puking", "heart issues", "brain fog", "digestive issues", "major fatigue", "lung problems" and "sick all the time" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Blood n nasal test. Therapeutic measures were taken as a result of syncope, asthenia, migraine, vomiting, cardiac disorder, feeling abnormal, gastrointestinal disorder, fatigue, lung disorder, illness. Ae treatment: They can't figure me out she was a hot mess. The patient had no covid prior vaccination. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage].
received the first dose of Shingrix on 12Dec2019 / not received the second dose yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. HCP consented the follow up via email address, no other information provided
Patient stated that left arm was painful >2 wks after injection; Denies local reaction, such as redness, irritation, swelling, fever
Cellulitis of upper rt arm. Rt upper arm 10 1/4 cm left upper arm 8 1/2 cm.
expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient to whom  expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immunosuppression.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOCOCCAL VACCINE POLYSACCH 23V) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 20-Sep-2022, the patient received an expired dose 0.5 ml (dose 1) of suspect HIB (PRP/T) VACCINE, powder and solvent for solution for injection, strength not reported  (lot U6999AB; expiry date: 23-Jul-2022) via intramuscular route in the left arm for immunization with no reported adverse event (expired product administered) (latency: on same day).  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 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.
A non-serious report was received from a consumer concerning his 20-year-old daughter. No medical or drug history was reported for the patient. The patient received FluMist on 27-Dec-2008. The following day she developed a sore throat with swollen lymph nodes. The symptoms resolved after two days. Additional FluMist dosing is not indicated. The reporting source did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
THE MORNING AFTER RECEIVING VACCINATIONS, PATIENT STARTED WITH WELPS TO FACE AND NECK THAT STARTED TO SPREAD ALL OVER THE BODY.  MOM GAVE BENADRYL BUT IT CONTINUED TO GET WORSE.  SHE ENDED UP TAKING HIM IN TO ER WHERE THEY HAD TO GIVE HIM PREDNISONE ORALLY TO TAKE FOR 3 DAYS.  PT ALSO HAD LOCAL REACTION TO RIGHT LEG WITH REDNESS AND WARMTH TO AREA.
Ear infection Throat infection Nausea/vomiting Fatigue Diarrhea  Then after antibiotics and Mucinex treatment with no improvements  Severe headache sent me to ER with no findings other then doctors are thinking it is Viral meningitis that could be causing it.  I am still having headache nausea and diarrhea and  Almost passed out yesterday from cooking  My activities are very light or I pass out.
child was given an expired dose of PENTACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician and other health care professional via Regulatory authority (Reference number- 00683484) and transmitted to Sanofi on 15-Jul-2021.  This case involved 7 month old female patient was given an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE for Prophylactic vaccination.  On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: U6842BA and UJ337AA, expiry date: 05-Jul-2021) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered)  It was reported that, "Caller is wanting to know if it is a valid dose and if child needs another injection".  This case was an actual medication error case (expired vaccine used) (latency same day)  At the time of reporting, 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 the 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.
Patient received 2nd dose of Pfizer Vaccine today at 2:32pm at temprorary vaccination Site Patient started C/O SOB, Abominal Pain, and Weakness. Patient states that the SOB and abdominal pain were experienced prior to vaccinations but got worse. Patient shared medical history of CHF, DM and Hypertension. Patient requested to be transported to the nearest ER. 911 Called by writer. Pulse Ox 98%, RR 20, BP 130/80. Temp WNL.  Patient alert and responsive oriented x3. Patient Transported to ER.
Pt received immunizations at 10:30am. Crying all day. At 6:30pm pt's face turned red, hives, swelling. Pt started "gasping for air." Also with diarrhea. Total rxn lasted 1/2-1 hr. EMT reported "mouth red inside." Sx self-resolved.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2015, the patient was treated by a physician for Guillain-Barre syndrome and peripheral neuropathy. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
rash on both arms at the site of the nicotine patch; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (lot number: EL3249) first dose on 19Jan2021 10:00 o left arm at single dose for want to be safe. Co-suspect product included nicotine transdermal system patch (lot number: 50430, expiration date: Mar2023) at 21mg; apply to the skin daily from Dec2020 (since 12Dec2020 or 15Dec2020)and ongoing for help stop smoking. Medical history included surgery on her neck in Dec2020 and states everything was fine and Diabetes. This surgery predates treatment with the vaccine. Family Medical History was none. Concomitant medication included ongoing insulin human, insulin human injection, isophane (HUMULIN 70/30) for Diabetes taking for over 10 years. The patient previously received Flu shot on 10Dec2021 (age 79-year-old female) for immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. She just got the vaccine today (19Jan2021). Everything went fine. The shot didn't hurt. The process went really smooth. She just wants to get rid of this virus. She waited the time period there and then went home. When she was changing clothes after she got home, she noticed a rash. She had been wearing a nicotine patch. On both arms, in both places where she had worn the patch on her arms there is a rash. Clarified she received the first dose of the Pfizer COVID 19 vaccine 19Jan2021 at 10:00AM in the left arm. She noticed a couple of hours later a rash at the location of where she had previously worn the nicotine patch on both arms. She has been on the patch for a month and has not had any rash before. Adds she is supposed to use alternate arms and change daily. The rash is where she used it the last time. She did wash those places this morning before she had the shot so she thinks there shouldn't be any residue. She just changed it to a new location and there is no rash at the new location of the patch yet. Adds there is no pain or itching, just a rash. She is scheduled 09Feb2021 for the second dose. Mentions she was not sure if she should report but she didn't want another elderly person to get the rash and be scared. She imagines that Pfizer already tested the vaccine with tobacco. Event did not require a visit to physician or ER. The outcome of the event was not recovered.
knee replacement surgery; This spontaneous case was reported by a consumer and describes the occurrence of KNEE ARTHROPLASTY (knee replacement surgery) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced KNEE ARTHROPLASTY (knee replacement surgery). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, KNEE ARTHROPLASTY (knee replacement surgery) outcome was unknown.            Patient had taken second Moderna COVID-19 vaccine 2 days ago and had a knee replacement surgery and went to visit doctor and received a cortisone shot on knee. No concomitant drug was reported.
Patient came in to receive a shingrix injection but was administered a Moderna (spikevax) vaccine inadvertently.
Moderate dizziness that began as soon as I got out of bed in the morning that lasted the entire day without relief, along with a mild intermittent headache. I could not drive, read, or focus on anything (visually or mentally) throughout the entire day due to the symptoms.
Blood pressure began declining shortly after my shot. Ultimately it dropped to 96/56 at which time I took an Adderall and Zirtec. Blood pressure remained unchanged until approx 10pm at which time it slowly began to rise and was normal at 6am this morning
This spontaneous reprot was received from a physician regarding unspecified number of patients of unknown demographics. There was information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB lot # J013394, Expiration date- 23-AUG-2016, (dose strength and route was unknown). No concomitant medication was reported. No adverse event reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Extreme fatigue, chills, fever of 99.5*, injection site showed red oval approx. 4" x 3".  Symptoms did not occur until aaprox. 29 hrs. after vax administered. Early to bed, some relief next morning.  Arm still red on 10/22, some fatigue.   No symptoms by 10/23.
FATIGUE, HEADACHE, CHILLS AND FEVER.    FATIGUE STARTED AT 6:00 PM  THE EVENING OF 2/10/21 AND LASTED UNTIL 8:00 PM  THE EVENING OF 2/11/21.   WOKE UP ON 2/11/21 AT  6:30 AM WITH CHILLS AND FEVER (101.1),  TOOK EXCEDRINE AND SYMPTOMS NEVER RETURNED.   THE HEADACHE STARTED AT 5:00 PM ON 2/10/21 AND LASTED UNTIL THE MORNING OF 2/12/21.
This spontaneous report as received from a licensed practiced nurse refers to 2 patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 12-NOV-2015, the patients were vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Client inadvertently given Modern Covid-19, after receiving Pfizer Covid-19 3 weeks ago.
Pt was due for flu shot. Father was holding pt, when injection went to be administered, pt became frightened and moved her arm away from RN. RN unable to administer full amount of vaccine. Pt father notified by phone call later that another dose needed to be rescheduled for full dose.
pt recv vax 25SEP97 & 6NOV97-14APR98 pt exp MS sx in JAN98;
2nd booster, dose #4 , was given too soon ; w/grace period 2nd booster was given 5 days too soon; pt felt well after administering vaccine and no concerns
suspected vaccination failure; My dad still got them and does not prevent them from happening; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's father. The age at vaccination was not reported. The patient received shingles vaccine but still experienced shingles.  The reporter stated that the vaccine did not prevent shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case had been linked with the case US2021AMR176054 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176054:Same reporter
Pt recv vax on 1/15/99; on 1/18/99 pt exp knot on LA