chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt began tremoring in the arms, legs and feet and was nauseated. Symptoms worsened about one hour after administration of vaccine and was seen by Urgent Care. Pt was given Zofran 4mg for the nausea and was advised to go to the emergency room for further follow up. Pt did not go to the ER as advised.
Started feeling chilled, then starting shaking uncontrollably. Fever of 102.6. Pressure headache. Lasted until midnight...morning temp. low grade 99.6. Feeling better today, but treating headache with ADVIL.
This spontaneous report was received from a nurse referring to a currently 20 year old female patient. Information about concurrent condition and medical history was not provided. The patient had no drug reactions/allergies. On an unknown date ("sometime before 2012"), the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were not reported). After the dose was administered, the patient had a "vagal responses". No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the outcome of the event was recovered. The causality was not provided. Additional information is not expected as no consent to contact the HCP.
Onset of fever on 4-14-07 and redness at injection site. ER dx's w/cellulitis and tx and given Rx of Keflex for 10 days.
Very achy, fatigue, malaise, scratchy throat  lasted about 12 hours.
Nine month old reported to our lab for vaccine administration. Staff gave KINRIX (combo) vaccine to child. Incident caught during our Health Department monthly count.
Fever of 102. Extreme fatigue. Headache. Feeling faint (nearly passed out multiple times). Chills. Body aches. Headache /overall bad feeling began about 30 min after shot. Continued to get worse. Following day, could not work or care for myself. Currently on the 3rd day and still have headache.
February 2023 I started having a scratchy throat in the evening, not a big deal. On the 24th I had another scratchy throat in the evening, just thought it was allergies because of the pollen season. Next day felt fine, no issues, went out did errands. Day after, Sunday, I felt ill. Sore throat, mostly on left side, headache on the left side, fullness left inside of my ear, nasal drip, and a gravelly voice. Monday I woke up I was pretty ill, I felt like I had been hit by a bus. I took a home test and it showed inconclusive so I did a second one and it was positive. I noticed they were outdated so I did another test later that day and it was positive. I reached out to my PCP via the online portal and said I possibly had COVID19. The nurse responded asking about treatments I was doing, never heard back. At that time I had a productive white phlegm cough, headache, sore throat, and was warm. By Wednesday I had a fever, highest was 101.2. I drank a lot of water, and took TYLENOL, used VICK'S vapor rub, checked my pulse ox. I only had a fever one day but I coughed up a lot of stuff. When it was starting to lighten up I developed this itch. I woke up from a deep sleep scratching my back. I thought it might be the detergent so I stripped the sheets. That wasn't it, so I continued to monitor. I woke up again from sleep, it seemed to happen mostly at night. It was all over my back and arms and there were some little pustules all over it. I wanted to see a doctor but my PCP wasn't responding so on March 13th I went to see a PA at a community clinic and she told the rash was because of COVID19 and gave me a prescription, as well as did some bloodwork. I didn't use it but used something I had for itching from bug bites in a can, that helped. March 20th I did another COVID19 oral swab test that was still positive. On March 27th, I came out of isolation, but masked until April 6th. April 7th I did an at home COVID19 test and it was negative.
THREE DAYS AFTER SHOT, HAVE TINGLING FINGERTIPS ON LEFT HAND, SENSATION ON AND OF FOR COUPLE OF DAYS. WEEK AFTER THE SHOT, STABBING PAIN UNDER LEFT ARMPIT ACROSS MIDDLE OF LEFT CHEST. LEFT HAND FEELING NUMB
Breakthrough case admission after 2 vaccines Pfizer 2/4/22 LOt# FJ6369;  Pfizer 2/25/22 Lot# FJ6369
Initially, left arm muscle soreness, moving on to pain in the back of the left shoulder in 1-2 days, and continued left shoulder pain since then, diagnosed with adhesive capsulitis.
She felt nauseate last night. She felt very ill. She came to work at pharmacy this morning on 8/11. At 10am, she requested to go home so Pharmacist in charge allowed her to go home early. She started with just a headache and body aches and then later on she fell very ill and have developed a fever. hopefully she will feel better and no fever and can return to work tomorrow 8/12/2021.
30 minutes after vaccine: severe headache, joint aches, left arm and left leg felt very weak. Felt better the next morning but fatigued.
Redness of the left upper extremity site starting 2 days after vaccine, initially with associated soreness and pain that resolved w/in 48 hours, but redness persisting and spreading distally.
Woke up 1/14 in am  and L deltoid area itchy. Noted localized pinkish/red rash measuring about 40 mm x 95 mm in circumference. No noticeable swelling present. Applying hydrocortisone area to site and will monitor.
This spontaneous report was received from a nurse practitioner referring to a 9 month old male patient. No pertinent medical history and concurrent conditions reported. On an unknown date the 9-month-old patient was vaccinated with VAQTA, intramuscular (dose not reported). No other concomitant therapies reported. The outcome of the event was unknown. The causality was not provided. No PQC reported. Additional information is not expected.
This spontaneous report was received from an medical assistant regarding an adult patient of unknown gender. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, the patient received a pediatric dose (Product administered to patient of inappropriate age) of VAQTA for prophylaxis (dosage schedule was not reported). No adverse effects were reported.
This case reported by a physician via sales representative and described the occurrence of bad rash in a child subject of unspecified gender who was vaccinated with KINRIX. On an unspecified date in 2012 the subject received unspecified dose of KINRIX (unknown). In 2012, immediately after vaccination with KINRIX, the subject experienced bad rash and pharmaceutical product complaint. At the time of reporting the outcome of the bad rash was unspecified. The sales representative called to report on behalf of physician who stated they vaccinated four child subjects with the same lot of KINRIX and all four of the subjects broke out in  a bad rash immediately after KINRIX was administered. Three of the child subjects were also given FLUARIX on the same day, but the last subject was not given FLUARIX with KINRIX that subject still broke out in a rash. The healthcare professional office stated "we are scared to use the remaining vaccine product", there were six does remaining to be returned to GSK for investigation. This is 4 of 4 subjects reported by the physician, for the other cases please see A1004132A, A1004135A and A1004136A. Quality Assurance (QA) results received on 20 December 2012. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results received on 19 March 2013. The results from the final technical assessment for the case was provided. Based on the fact that no precise technical problem was reported, no technical investigation was performed. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. QA results and safety assessment received on 4 April 2013. A search was performed in the GSK safety database to retrieve reports with KINRIX in association with the batch number AC20B235AA (and similar batches: AC20B235). There is as of today, no report linked to that batch other than the ones linked to the complaint in the GSK safety database. Currently available safety data and expert assessment of the risk did not suggest any safety concern. GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Considering all safety available information , it is unlikely that the reported events are related to a manufacturing problem.
The next morning my arm was so sore I could hardly move it. The pain went away by the next day. Then almost 2 weeks later a large red whelp formed on my shoulder going down my arm toward my elbow. It was hot to the touch and my arm started aching again. The red whelp stayed there for several days and was always hot to the touch.  It would itch too. It went away and so did the pain and itch but this reaction has caused me to decide I will not take the second vaccine as I have taken flu shots and other vaccines in the past but  never had a reaction like this. I want nothing more to do with this vaccine.
This case was reported by a healthcare professional and described the occurrence of lightheadedness in a 57-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) for pre-employment physical. On 19 August 2010 at 13:30 the subject received 1st dose of ENGERIX B (standard dose, unknown route, left arm). On 19 August 2010, 1 hour after vaccination with ENGERIX B, the subject experienced lightheadedness, dizziness and intermittent blurred vision. .The physician who discharged her noted nothing unusual. On 19 August 2010, the events were resolved.
Dizziness, ringing in both ears, clogged ears, fatigue, nausea.  Prolonged pain at injection site.
fluzone pfs, that was expired was administered, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 16-year-old female patient to whom INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Qiv], that was expired was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose 0.5ml total (strength: standard; formulation: unknown), Drug Treatment Duration: not applicable (NA) (lot number: UT7378MA and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization and on the same day, fluzone pfs, that was expired was administered, with no reported adverse event (expired product administered).  This situation is reported as a medication error due to inadvertently given expired product.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was 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.
Resident suddenly collapsed to ground unresponsive at 14:46, CPR initiated and continued until 15:32 when paramedic pronounced death.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 8/14/2022 Discharge Date: Aug 22, 2022  PRESENTING PROBLEM: Hypoxemia [R09.02] Hypotension [I95.9] Microscopic hematuria [R31.29] Compression fracture of body of thoracic vertebra (HCC) [S22.000A] Compression fracture of L2 vertebra, initial encounter (HCC) [S32.020A] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 90-year-old male with PMH significant for CVA and DM who presented with  with generalized weakness and SOB. Patient was noted to have COVID-19 in ER, CT showed no PE and no infiltrate. Patient was hypoxic and was placed on supplemental oxygen. Patient was started on dexamethasone and admitted. Patient did not qualify for remdesivir as there were no infiltrates.  Hypoxia quickly resolved and Decadron was stopped. Physical therapy recommended subacute rehab.  This was much delayed due to COVID so family eventually decided to discharge to home with home health care despite continued weakness.
Extreme body aches starting around 12 hours after injection of 2nd dose. Shoulder became very painful, 8/10 pain, at same time of onset of body aches. Cold/shivering onset around 10pm of first night, ongoing until early morning of 2nd day, when it switched to onset of fever and profuse sweating into the early morning. Body aches continued for next 3 days, with intermittent shivering/cold periods lasting several hours. Symptoms diminished slightly with ibuprofen. Feeling of being cold, off and on, lasted until day 3 after injection, and body aches diminished day 3 to a 2/10 pain/discomfort level.
Chills; High fever; Body aches; Splitting headache; Nausea; Sinus drainage; Earache; Stomach ache; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 15:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, a stroke in 2019 and allergy to penicillin and some antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HYDRODIURIL) and acetylsalicylic acid (ASPIRIN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 03:30, the patient experienced chills, high fever, body aches, splitting headache, nausea, sinus drainage, ear ache and stomach ache. On an unknown date in May2021, at day 10, the patient still had stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, high fever, body aches, splitting headache, nausea, sinus drainage and ear ache was resolving while stomach ache was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information regarding concomitant medications or concurrent conditions was provided. On or about 23-MAR-2015, the patient was admitted to the hospital for colitis and received treatment for the same. On or about 26-MAR-2015, the patient was administered PNEUMOVAX 23 at the hospital (dose, route, and lot # not provided). On or about 30-MAR-2015, she was readmitted to the hospital as a result of significant weakness in her legs. She was diagnosed with Guillain-Barre Syndrome during that admission to the hospital. The patient is now confined to a wheelchair and can no longer walk (also reported she lost most of the function in her legs). The lawyer claimed that the patient contracted Guillain-Barre Syndrome as a result of receiving the PNEUMOVAX 23 vaccine. The outcome of the Guillain-Barre Syndrome was not recovered. Upon internal review, Guillain-Barre Syndrome was considered medically significant. Guillain-Barre Syndrome was considered disabling as the patient was confined to a wheelchair.
lines under nails/beau lines; This spontaneous case was reported by a patient and describes the occurrence of NAIL RIDGING (lines under nails/beau lines) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 023M20A and 041L20A) for COVID-19 prophylaxis.     The patient's past medical history included AFib (saw her cardiologist 1.5 months after these symptoms concluded.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAIL RIDGING (lines under nails/beau lines). At the time of the report, NAIL RIDGING (lines under nails/beau lines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: heart rate was elevated from 45bpm to 55bpm.         Patient took about 6 other vaccines over the past year and a half. After the booster dose, the patient had lines under nails that upon growing out nail lift up and separate. The nails had grown back and continued to have smaller milder lines under the nails. No treatment medications was reported.   This case was linked to MOD-2022-661815 (Patient Link).
Patient Had lymphadenitis affecting left arm ( axillar, supraclavicular , and neck ) subsequently followed by lymphadenitis affecting right arm after ( axilla, neck and supraclavicular )second dose.
Rash on bilateral arms and shoulders. Rash noticed by client on 1/5/02 around the injection site and spread across shoulders and other arm. Pt denies itching, difficulty breathing, shortness of breath or rash anywhere else on her body. PHN referred pt to PP. Follow-up call to parent on 1/10/02 finds that rash is still present but is "doing fine". On 1/29/02, telephone call to parent who stated that the rash persisted until 1/21/02 (approx). The rash was never red but was raised; only on the upper body, shoulders and back primarily and somewhat itchy (but not intense). Other factors discussed; the pt had been treated and recovered from scabies but still had some lingering lesions. The pt was never taken to a doctor for care during this time. Recommended discussing this reaction with the pt's doctor and to consider checking prior to receiving future vaccines.
BROKE OUT IN A RASH AN HOUR AFTER THE SHOT.  MOM CALLED THE CLINIC TO REPORT IT AND WAS TOLD NOT TO COME IN AND THAT IT WOULD GO AWAY. SHE WENT IN ON MONDAY AND THEY SAID IT WAS A RASH.  SAW A DIFFERENT DOCTOR AT THE CLINIC ON TUESDAY AND FOUND OUT IT IS SHINGLES.
Information has been received from a physician concerning a 23 month old white/Japanese male who on 05/25/1999 was vaccinated with the first dose of varicella virus vaccine live SC in the left anterior thigh. On 04/06/2000, the pt developed a mild form of chicken pox. It was noted by the pts mother that the rash is not scabbing over. The reporter noted that the pt was not seen in the clinic. On 04/15/2000, the pt recovered. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of swelling of legs in a 4-year-old female subject who was vaccinated with INFANRIX(GlaxoSmithKline). Previous and/or concurrent vaccination included INFANRIX; GlaxoSmithKline; intramuscular given on an unspecified date; HAVRIX; GlaxoSmithKline; intramuscular, left thigh given on 26 April 2008; Ipol; Aventis Pasteur; unknown given on 26 April 2008; MMR II; Merck; unknown given on 26 April 2008; MMR II; Merck; unknown given on 26 April 2008. On 26 April 2008 the subject received 5th dose of INFANRIX (.5 ml, intramuscular, left thigh). On 28 April 2008, two days after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter insisted that HAVRIX was not co-suspect although it was given in the same leg. The reporter strongly felt there was a quality issue with INFANRIX. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 09 May 2008 via a healthcare professional, who reported that the subject's mother had to wrap a warm rag around the child's leg in order for the swelling to go down. The reporting healthcare professional considered the events to be clinically significant requiring intervention.
Redness, tenderness, painful at injection site. KEFLEX 500mg QID x 10 days, BENADRYL, Ibuprofen.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX lot # M013377, expiration date: 25-MAY-2017 (dose and route were not reported). The pharmacist reported that as she was administering a dose of ZOSTAVAX some of the vaccine leaked out of the needle and patient did not received full dose. The pharmacist also stated that it was due to a defective needle (also reported as product quality complaint (PQC): no). No adverse effects were reported. Additional information has been requested.
Nurse reported on 7/28 at 8:35am that patient is experiencing swelling redness, warm to touch at the injection site and redness on the upper abdomen (V/S BP 145/87 , P 78 , RR 16 Temp 97.8 F). Monitored patients symptoms. No further action required.
After receiving my vaccine, I woke up in the middle of the night with a high fever. I was shivering with pain from my head down. I had a horrible headache/migraine. For my fever, I took Tylenol. I completely lost my appetite too. This lasted about three days. It hurt for me to even get out of my bed to stand or even use the restroom. I called my PCP to see if I could take my migraine medicine, Relpax. My doctor told me that it was okay to take it. My PCP called me on day 3 to check on me. I was able to drink gatorade by this time and regained a little of my appetite. My fever went away, but my headaches remained. I continued to take Relpax, Tylenol and Ibuprofen l to ease the pain. I skipped my period in February and March and started having hot flashes. When my period returned in April it was a very heavy flow and I having chills. I was passing large clots during this time too. In May, I had a heavy flow also, but it was not as bad as the period in April.
Patient came to vaccine POD for 2nd covid vaccine.  Patient received the Moderna vaccine on 2/9/2021 and did not bring his vaccine card with him and told front door screener he received the Pifzer vaccine and then was brought to our Pfizer vaccinator.  She gave him his Pfizer vaccine and after review to get patient a new vaccine card it was found that patient had actually received Moderna vaccine the first time.  Therefore, patient was given the wrong vaccine to complete vaccine series.  Dr.  was notified and spoke with patient.  Notified  RN and PhD of this problem.  Patient will be called again tomorrow to make sure no reaction and will notify patient PCP of this event.