chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 doses 3 yrs ago. Was diagnosed with shingles last week/ suspected vaccination failure; shingles; Rash started in hairline crusted over; Lymph nodes were very swollen; ear pain; hairline crusted over; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In March 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, enlargement of lymph nodes, ear pain and crust. The patient was treated with amoxicillin + clavulanic acid (Augmentin). On an unknown date, the outcome of the vaccination failure, shingles, enlargement of lymph nodes, ear pain and crust were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, enlargement of lymph nodes, ear pain and crust to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 2 doses of Shingrix 3 years ago. The patient was diagnosed with shingles last week. Rash started in hairline, crusted over. Lymph nodes were very swollen, ear pain and had to start on augmentin. The rash was resolved. The reporter did not agree for follow up. This case was considered as suspected vaccination failure since details regarding laboratory confirmation was not provided.
Atrial Fibrillation; short of breath; chest pain when I tried to breathe; heart rate went to 158; very tired; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 27Sep2021 08:30 (Lot Number: fe3592), at the age of 75-years-old, as dose 3 (booster), single for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, back disorder from an unknown date and unknown if ongoing. No known allergies. The patient previously received first dose of bnt162b2, administered Arm Left, on 15Jan2021 04:30 PM (Batch/Lot No: ek4176), at the age of 75-years-old, for COVID-19 immunization and second dose of bnt162b2 administered Arm Left on 05Feb2021 08:30 AM (Batch/Lot No: ek4176), at the age of 75-years-old for COVID-19 immunization. The patient experienced atrial fibrillation on 05Oct2021 08:00; very tired on 28Sep2021; short of breath and chest pain when he tried to breathe on 02Oct2021; heart rate went to 158 in Oct2021. The clinical course was reported as follows: The day after 3 dose became, patient was very tired. He started to get short of breath about 4 days after dose. Then started having chest pain when he tried to breathe. On Tuesday a week and a day after 3 dose, her heart rate went to 158, he went to ER and was told he has Atrial Fibrillation and went home with prescribed medication. He works out on a regular basis. His heart rate is usually around 45 to 49, hardly ever over 60, two days after ER visit he felt much better and seemed to be back to normal. Not sure if related but was told by his doctor he might need to do something about his slow heartbeat, before this occurred. The events resulted in emergency room/department or urgent care. Treatment received for the adverse events which included an unspecified medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: 45 to 49 (heart rate is usually around 45 to 49, hardly ever over 60) on an unknown date and 158 in Oct2021. Therapeutic measures were taken as a result of atrial fibrillation, very tired, short of breath, chest pain when he tried to breathe and heart rate went to 158. The outcome of the events was recovered in Oct2021.
pt recv vax & awoke w/diarrhea (severe) & odd sensation about skin (like mild rug burn);also irritability by clothing;no rash/hives noted;sx alleviated the next day;
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient Received vaccination at ~10 am on 12/6/22 and complained of severe pain not improved after 30 minutes with ice/heat and ibuprofen at 12:50pm
Headache; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that she was still having side effects. She got the vaccine a week ago, on Saturday (unspecified date), and she was still having side effects. She wanted to know how long the side effects are going to last for "like what's the longest you have seen." It was clarified that she had the vaccine 9-10 days ago (unspecified date) and she had a headache ever since that doesn't go away. She asked is she should  still get the second dose if she was still having symptoms of the 1st dose. She added that she read that the side effects usually last a couple of days, but hers has not gone away. She queried how will she get rid of the of the headache and if everyone's symptoms eventually go away in the study; and if she will have this headache permanently. The outcome headache was not recovered.  Information about lot/batch number has been requested.
Patient received 3 doses of the Pfizer SARS-COV-2 vaccine (2/9/21, 3/4/21 and 8/19/21).  He was admitted to the hospital on 10/14/2021 for acute hypoxic respiratory failure secondary to COVID pneumonia.  He received remdesivir x 10 days and dexamethasone x 10 days.  He was not a candidate for Tocilizumb due history of immunosuppresants/kidney transplant.  He developed a pneumothorax during this admission and required a chest tube.  He developed sepsis an required vasopressors.  He was made comfort care and expired on 10/27/2021.
Fever, feeling of hot then cold, sweating, and very sore arm and shoulder on the same side as the vaccine was given, fatigue.  Feels similar to having the flu.  Six days later symptoms are still the same.
pt recvd vax 16NOV94 early PM;the same day in late PM exp soreness,myalgia & arthralgia;exp diffuse h/a,restless sleep followed by malaise next day;sx were not treated;all sx subsided by 48hrs following inj
COVID + 17Feb; COVID + 17Feb; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on 11Jan2021 07:00 AM at a single dose for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient was not pregnant. Medical history included COVID prior vaccination. The patient had no known allergies and no other relevant medical history to report. Concomitant medications were not reported. The patient experienced "COVID + 17Feb". She tested positive for COVID via Nasal Swab on 17Feb2021. She did not receive any corrective treatment for the adverse event. Outcome of the event was not recovered.  Information on lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Jan2021, and tested positive for the virus (COVID-19) on 17Feb2021.  Based on information available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  However, no complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.
Moderate erythema/warmth left bicep region no fever Tx rice PRK, frequent ROM, FU PRN
While seated in  post vaccine observation area, slumped in chair, losing consciousness.Lifted to stretcher and regained consciousnee. 911 called and responded transporting patient to hospital.
Began having non pulsatile, bi-lateral, tinnitus (ear ringing) along with increased head pressure and headache and nausea which continues to this day. Started course of methylpredisone pack prescribed by primary physician for possible inflammation which has had no effect. Referred to ENT for follow up next week.
I began to have random pain in my left foot below my outer ankle.  Feels like nerve pain.  It is a sharp pain that goes away quickly.  It started a few times a day, then increased to 20+ times a day so I went to the walk in.  He had no answers for me, but the pain seemed to go away after that.  Week later, it returned Aug 7,8 & 9th.  Then again Aug 27th.
This initial non-serious spontaneous case, was received on 19-Sep-2017, from a pharmacist concerning a 52-year-old female patient adult patient. The patient's medical history and concomitant medications were not reported. On 13-Sep-2107, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5 ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location: not reported). On 14-Sep-2017, 2 days after vaccination, the patient got extremely sick with symptoms such as hot and cold flashes and night sweats. On 15-Sep-2017, the subject had headache, nausea, chills, fever and sweats. The patient was treated with TYLENOL and asked to take rest. At the time of the report, the patient had not recovered (ongoing) from the events night sweats, flushing, sickness and was recovered from the events headache, nausea, chills, fever and sweats. The reporter assessed the events as non-serious. Follow up report received on 27-Sep-2017: The new events nausea, fever and sweats were coded. The indication of the vaccine from influenza vaccination to influenza prophylaxis onset date of the events headache, chills from 14-Sep-2017 to 15-Sep-2017 and outcome of the events headache, chills from not recovered to recovered were updated. The narrative was amended accordingly.
Cervical and axillary lymphadenopathy to left side of neck and arm, starting on 11/12/00. Cervical adenopathy present on 11/24/00, axillary lymphadenopathy resolved.
Fever up to 102 x 1 day. Rash around injection site where varicella was given. Aslo scattered papular rash over
Patient indeed did have a rash across her chest which she says is new in onset, shortly after getting the vaccine. Site itself was normal. Rash extended from top/between breasts up to her neck. Rash was fine, papular, and erythematous. No excoriations, no pus or bleeding. Did not itch, not painful. No fever or chills. Is reporting some sinus pressure, no headache. Unsure if the head symptoms are related- she does have bouts of sinsitis annually.
Upper respiratory symptoms about the 1st or 2nd of Feb 2021, Fever around 102 orally.  Tested positive for Covid-19.  Less than a week later, lower respiratory symptoms.  Went to ER and Chest X-Ray positive for Pneumonia.  O2 sats around  88-94.  Ran  fever most of the month of February.  Never lost sense of smell or taste.  O2 sats improved to 97-98 by the end of Feb.  Second Moderna vaccine received on 3/18/21.  L arm,  much more sore after vaccine than after the first one but no other side effects from it.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Severe, Additional Details: Patient had vasovagal reaction 5 to 10 seconds after administration. Patient was seated and head was supported in chair by both administering RPh and Mom. Epi-pen was on hand but not given. Both APRN's from minute clinic came into room to assist. Patient was lied down flat on the floor. Patient was slight hypotensive with 100 OSAT and pulse of 78. Patient lied down for 5 minutes, and then was able to sit up. She sat for another 20 minutes before she felt well enough to leave.
Patient was anxious, felt very warm, and said he did not feel well and could not see approximately 5-10 seconds after the injection.  Patient did not improve at which time I administered epinephrine 0.3mg IM approximately 5 minutes after the start of the reaction.  During this time I placed ice packs on his chest and rotated the ice pack placement to his upper back.  Technicians had a small fan on him, cooling measures helped him much.  Patient responded well after receiving the epinephrine, was able to see and his body temperature returned to normal.  We had called EMS and they arrived to take vitals.  By this time patient had markedly improved.  Patients father was called and arrived approximately 10 minutes after the start of the reaction.  EMS recommended that he be driven to the local hospital for observation but he refused.  I spoke with the patients father and recommend the same but I do not know whether he went to the hospital ER or not.  I jotted down some notes for the father to show the ER stating that I had administered epinephrine.  The father and his son the patient walked out of the pharmacy in no apparent distress.  Sincerely, RPh
Fever 101.8 tmax following morning, headaches following morning, stomach ache following morning, palpitations 2 days post vaccine
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-APR-2016 unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles. As a direct and proximate result of the patient's receipt of zoster vaccine live (ZOSTAVAX), the patient continued suffer ongoing injuries including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries; significant medical and related expenses as medical losses and costs included care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of singles was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
A non-serious spontaneous report of nosebleed has been received from a health professional concerning a three-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's past medical history includes nosebleeds. No concomitant medications were reported. The patient received FLUMIST on 04-Aug-2011. Immediately after administration of FLUMIST to the left nostril, patient had a nosebleed for a couple of seconds. Then the nosebleed quit. No further nosebleed. The outcome of the event was resolved.
Patient was given sisters DTaP that was on same tray as patients, as well as sisters PF Flu .25 mL.
HAD SHINGLES/Suspected vaccination failure; Shingles; Sciatica; rash; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sciatica, rash and pain. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the sciatica was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the sciatica to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. Last year the patient had a four-month battle with sciatica and had gone to pharmacy to get second dose of Shingrix.  The patient was broken out with rash on same side as sciatica and the pharmacist said patient did not had shingles. The patient's husband took a picture of the rash when it started and when patient went to doctor patient had shingles. The patient still had a pain a year later. The patient was doing PT (unspecified) right now till the patient got into back to doctor. The patient reported that shingles were not nearly as bad as they could had been without vaccine. The patient stated glad she got vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a 50 year old female consumer referring to herself. The patient did not have pertinent medical history nor drug reactions/allergies. On 02-MAR-2016, the patient was vaccinated with one dose of ZOSTAVAX, subcutaneously, lot # L039094, expiration date 08-JAN-2016, for prevention of shingles. The patient was not taking concomitant medication. On 03-MAR-2016, the patient experienced achiness (pain) after receiving ZOSTAVAX. The following day, on 04-MAR-2016, the patient experienced flu-like symptoms which included: chills, fever diarrhea, coughing and congestion (influenza like illness). The patient seek medical attention by an office visit but, no treatment was given and lab diagnostics studies were not performed. At the time of reporting, the outcome of pain and influenza like illness was recovering. The reporter did not assess the relatedness from pain and influenza like illness to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a bachelor of science in nursing (BSN) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In June 2015, the patient completed four doses of ACTHIB (dose, route of administration, lot # and expiration date were not reported). On 20-MAR-2017, the patient received the fifth dose of Haemophilus influenzae type b (Hib) vaccine as was vaccinated with LIQUID PEDVAXHIB (0.5ml, intramuscularly, lot # M036058, expiration date 19-MAY-2019) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a Other Health Care Professional. This case involves a 12 years old female patient who was vaccinated with MENACTRA (lot number and route not reported) and FLUBLOK QIV (lot number QFAA1803) via unknown route in the right deltoid on 05-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to drug administered to patient of inappropriate age. It was unknown whether the patient had any adverse event. 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 and Module VI of the 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.
A non-serious spontaneous report of influenza A, subtype H3 manifested by cough, fever (101.5 degrees Fahrenheit), headache and sore throat has been received from a health professional concerning a seven-year-old male, subsequent to FLUMIST. The patient's past medical history included a left femur fracture in July 2005. No concomitant medications were reported. On 10-Nov-2010, patient received FLUMIST. On 30-Jan-2011, the patient started with cough, fever of 101.5 degrees Fahrenheit, headache and a sore throat. On 31-Jan-2011, the patient's influenza test was positive and he was diagnosed with influenza A, subtype H3. The patient was treated with oral oseltamivir 4 ml twice/day for five days. The outcome of event was resolved.
First Dose was given on 12/29/2020 by pharmacy and vaccine was Moderna 2nd dose was given as Pfizer
On Wednesday I got the shot, but Sunday I was diagnosed with covid; This is a spontaneous report received from a contactable consumer (patient, pharmacy technician). Follow-up information received on 03Mar2021 was processed together with initial information.   A 22 (unit not specified) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date around after 4 days of vaccination, the patient was diagnosed with COVID-19. She wanted to know if she could continue with her second dose or had to take the first dose again to start over. And she stated that her HCP thought that was fine if she enquiry manufacturer. Outcome of event was unknown.  Information on Lot/Batch has been requested.
Case number PHEH2012US016141, is an initial spontaneous report received from a nurse on 13 Aug 2012. This report refers to an unknown patient (age and gender). The patient received MENVEO (batch number: unknown) intramuscularly on an unknown date. The vaccine was stored at 32 F on two separate dates of 30 Jul 2012 and 31 Jul 2012. The event outcome, seriousness and causality were not reported.
No additional AE reported; Caller is a nurse reporting that an expired dose of ROTATEQ was administered to the patient on 13SEP2022. Caller confirmed that the ROTATEQ has not been involved in a temperautre excursion through the date of administration. No additional information; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 13-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered) 2 ml, orally, lot # 1741381 with expiration date of 04-SEP-2022, for prophylaxis.  It was confirmed that the vaccine did not have a previous temperature excursion.        No additional event reporter, no further information provided.
Approximately 16 hours after administering the FLUZONE Flu vaccine U3703AA 6/30/11 to (R) deltoid the arm had an area of 2"x3" that is red & swollen & warm.