chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician and company representative refers to a 16 year old male patient. The patient's pertinent medical history included attention deficit hyperactivity disorder and Allergic runny nose. It was reported that the patient had drug reaction or allergies to Penicillin (manufacturer unknown). On 10-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly (lot # M007764, expiry date not reported) for vaccination. Concomitant therapies included VYVANSE. On 05-OCT-2016 the patient was vaccinated with second dose of  GARDASIL 9 (inappropriate schedule of drug administration) intramuscularly (lot # M016193, expiry date not reported) for vaccination. On unknown date in August 2016 and October 2016 (reported as within hours of each dose) the patient experienced severe headache which caused the patient to be unable to perform their activity of daily living for the first day after administration. It was reported that the patient reported these events on an unknown date in 2016 when the patient was seen in the physician's office. The patient did not receive any treatment for the events and no lab diagnostic studies were performed. The action taken with the therapy with GARDASIL 9 was unknown. The patient had recovered from both the episodes of the headaches the day after the day following administrations. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Additional information has been requested.
Vitiligo; This is a spontaneous report from a contactable reporter (nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 13Feb2021 (Lot number: unknown) at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing), notes: DMT2; "Depression" (unspecified if ongoing); "Multiple allergies" (unspecified if ongoing), notes: Allergies; "GERD" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Fish allergy" (unspecified if ongoing), notes: Known allergies: Fish and "Fruit allergy" (unspecified if ongoing), notes: Known allergies: bananas, kiwi, star fruit, mangos, coconuts. Concomitant medication(s) included: JANUVIA; GLYBURIDE; SINGULAIR; MONTELUKAST and METFORM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: unknown; Route of administration: unspecified; Anatomical location: Left arm), administration date: 23Jan2021, when the patient was 51 year(s) old, for COVID-19 immunisation.  The following information was reported: VITILIGO (non-serious) with onset 26Mar2021, outcome "recovering", described as "Vitiligo". The event "Vitiligo" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vitiligo.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. Treatment included for event Vitiligo was MD visits, topical (unspecified medication).  The lot number for BNT162b2 was not provided and will be requested during follow up.
Minutes right after the vaccination, I had burning in my left eye, like a nerve in my head burning.  I was offered Tylenol by the pharmacist, which I denied.  When I stood up, I got really light headed.  I went back to work anyways and the symptoms lasted for 2 hours.  I came home and noticed my left butt cheek started to ache and feel sore.  I  did not take any medications.  I went to bed and woke up with full blown flu like symptoms- extremely weak, fatigued, body aches and soreness, muscle stiffness, headache,  intermitten light headedness, and left eye could not focus properly. These symptoms lasted for about 24 hours and most went away, however I was still unable to focus with my left eye. On 6/5/2021  I had a very bad explosive severe headache,  I had loss of balance, loss of vision in left eye and could not speak coherently and decided to go to the ER.  In the car en route to ER, I felt like I was paralyzed and could not move.   I was diagnosed with migraines, given a RX for Compazine, and to follow up with the PCP.  I went to the doctor on 6/7/2021 with extreme fatigue, difficulty walking and balance, light headed and left eye focusing issues.  I was referred to an opthamologist.  On 6/8/2021 I went to the opthamologist and had an eye exam and retinal screening and was referred to a better hospital.  On 6/9/2021 I went to a hospital to be seen by an opthamologist and neurologist and I did lots of blood work,  an MRI of my head, neck and brain  which showed my optic nerve was swelling and causing my brain to swell as well.  I was diagnosed with inflammation of the optic nerve.   I am being followed up by the neurologist.  I have been having intermitten  episodes of severe headaches and would have body paralysis for about 30 minutes and it  would go away.  I am having these episodes about once a week.  Every time I have an episode, I would go see my doctor who would run more tests.  I have been tested for epilepsy which is negative.
1st dose- severe ache in neck back & rib case; 1st dose- severe ache in neck/ back & rib case; 1st dose- severe ache in neck/ back & rib case; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 13:15 (at age of 46-year-old) as single dose for covid-19 immunisation. Medical history included Environmental asthma, and Allergies to cat, horse, smoke and pollen from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. The patient did not take concomitant medications (patient did not receive any medication prior two weeks of vaccination). Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 13:15 as single dose for covid-19 immunisation and experienced fuse excruciating ache and pain in left elbow wrist and fingers. Patient was not received any other vaccine prior four weeks of vaccination. The patient experienced 1st dose- severe ache in neck, back and rib case on 15Apr2021 at 14:00. Since vaccination patient not tested for covid-19. Patient visited to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care for the events. Therapeutic measures were taken as a result of the events, treated with poison ivy Cortisone oral. The outcome of the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Pain from the shoulder to elbow; Neck pains; Middle 3 fingers are tingling and/or losing feeling; Dull pain/achiness/upper body aches and pain; Middle 3 fingers are tingling and/or losing feeling; Heaviness; This is a spontaneous case reported by other health professional (pharmacist) to agency (reference number: SEQ20-00436) and initially received on 29-Jan-2020, concerning a 60-year-old, female patient.  The patient's medical history included occasional seasonal allergies and polycystic kidney.  The patient's concomitant medications were not provided.  On 12-Nov-2019, the patient was administered Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: right deltoid, batch number: 261983, expiration date: Jun-2020 and route of administration: intramuscular) for prevention of seasonal influenza.  On 14-Nov-2019, 2 days after getting the flu shot, the patient experienced neck pains, ongoing pain from the shoulder to elbow, dull pains, achiness, heaviness and the middle 3 fingers were tingling and/or losing feeling. It was also reported that the patient had ongoing upper body aches and pain.  On an unspecified date, the patient was treated with Tylenol (paracetamol).  At the time of initial reporting, the patient had not recovered from the events. The patient was still experiencing symptoms, so she was advised to contact a physician.  All the events were considered as serious due to criterion of medical significance, per reporter.  The reporter did not provide causality assessment to Flucelvax Quadrivalent.  Company comment: A 60-year-old female patient developed pain in extremity, neck pain, hypoaesthesia, pain, discomfort and paraesthesia after vaccination with the suspect product Flucelvax QIV for prevention of seasonal influenza. Reportedly, 2 days after getting the flu shot, the patient started developing events. Chronology seems plausible. The patient's medical history included occasional seasonal allergies and polycystic kidney and concomitant medications were not provided. With information presented, causality is assessed as possibly related for pain in extremity, neck pain, hypoaesthesia, paraesthesia and pain while discomfort is assessed as not related due to other reported events which could explain discomfort.; Sender's Comments: A 60-year-old female patient developed pain in extremity, neck pain, hypoaesthesia, pain, discomfort and paraesthesia after vaccination with the suspect product Flucelvax QIV for prevention of seasonal influenza. Reportedly, 2 days after getting the flu shot, the patient started developing events. Chronology seems plausible. The patient's medical history included occasional seasonal allergies and polycystic kidney and concomitant medications were not provided. With information presented, causality is assessed as possibly related for pain in extremity, neck pain, hypoaesthesia, paraesthesia and pain while discomfort is assessed as not related due to other reported events which could explain discomfort.
Patient received her second dose of Moderna COVID vaccine on Tues, 4/27, then developed palpitations on night of 4/29. She woke up that night at 3am with vomiting and 7/10 chest pain. Chest pain was described a substernal and symptoms occurred at rest. Additionally noticed an elevated heart rate. Her chest pain did not subside so she presented to the Hospital ER where she was noted to have elevated trop from 1.8 to 3.5. TTE at bedside showed reduced EF to 40%, global apical hypokinesis.   At healthcare facility, cardiac cath was normal and EF appeared normal on wet read of repeat TTE. She was started on captopril (transitioned to lisinopril on DC) and metoprolol. She will be discharged with follow up with physician.
chills; Aches; headache on right side going down to ear; red sore in back of throat that looks like a burn; red sore in back of throat that looks like a burn; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8733), via an unspecified route of administration in right arm on 27Mar2021 at 11:15 (at the age of 57-year-old), at single dose for COVID-19 immunisation. Medical history included known allergy with penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included magnesium sulfate (reported as magnesium sufinate), ergocalciferol (VIT D), calcium and atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Starting night of 27Mar2021 at 20:00, the patient experienced temp 90, chills, aches, headache on right side going down to ear, red sore in back of throat that looked like a burn, diarrhea. All, but temp stayed to 29Mar2021: Monday. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab test which included temp on 27Mar2021: 90. The patient did not receive treatment for the reported events. The clinical outcome of the events was recovering. This report was reported as non-serious by reporter.  No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO ADVERSE REACTION, PATIENT HAD A SORE ARM
Patient is an 82-year-old female who came to the emergency department today complaining of shortness of breath.  Patient also reports that she has cough, low oxygen and recently received her second Covid shot and when EMS picked her up she was 83% oxygen saturation on room air.  Patient has what sounds like pooling secretions in her throat and patient had suctioning done by respiratory which caused her to bleed blood noted in teeth and around mouth.  Patient reports that her throat has been hurting her and that is why she has been unable to eat.  Patient's daughter is at bedside and is historian for majority of the assessment.  Patient's daughter reports she has not been eating or drinking for the last 2 days. Labs in ER showed WBC 11.61, lactate level 3.3, creatinine 2.0, procalcitonin 5.33, magnesium 1.5, BNP 2100, glucose 474.  Chest x-ray showed no acute findings.
I started getting symptoms of runny nose, cough, sore throat. The next day I had a fever of 101.3. My husband had COVID 5 days before. I had positive COVID-19 test. I called my doctor and was prescribed Paxlovid. My symptoms are still continuing with runny nose and cough but no fever.
1. Have been getting my period every 1.5 weeks since my second dose. Very heavy bleeding and cramping. Has not gotten better.  2. Very bad lower back pain, knee pain, ankle pain, and feet pain and tingling since second dose. Limited range of motion in my legs and constant stiffness and pain. Interferes with daily life. Has not gotten better.
Case number PHEH2014US018325, is an initial spontaneous report from a pharmacist received on 10 Sep 2014. This report refers to a 73-year-old male patient. Past medical history and concomitant medications were not reported. On 09 Sep 2014, the patient received 5 ml dose of FLUVIRIN (batch number: 1411201) intramuscularly instead of 0.5 ml dose. No adverse events were reported following the maladministration. No additional information was available.
patient received vaccine @ 3:10pm on 8/11/21, approximately 7pm that night hives began to appear all over her body and her face swelled around her eyes, she reports she had a little difficulty breathing that night but her throat/tongue did not swell, the next day late afternoon/evening she went to clinic for treatment, afterwards she came to the pharmacy to let us know what happened
Had immediate "funny feeling" down her arm. Two days later she noticed a lg. bruise at the site & muscle tightness up to her neck. She saw her physician she was given FLEXERIL & MOTRIN. If no improvement, possible PT.
That night, after receiving the vaccine I developed severe body aches and joint pain, and a mild headache. I took gabapentin and advil for the pain, and used iced packs, which only seemed to take the edge off. On the evening of 01/01/2022 I developed itching on my face. So, I went to the mirror to look at my face and saw the left half of it was as red as a raspberry. Also, I had developed a rash across my neck, chest, arms and back. I called the COVID line and they told me to go to the ER. I wanted to avoid that so I could avoid COVID exposure, so I told them I took allegra and benadryl, and had an epipen for safety, they said it was okay, but still urged an ER visit. I waited until that Monday 01/03/2022 to call my doctor's office when it opened. They told me to continue the allegra and benadryl, and to increase the NSAIDS along with taking pantoprazole to coat my stomach. If I did not improve, I would need to start steroids, but I did not want to because I didn't want to lessen the effectiveness of the vaccine. As of yesterday 01/05/2022 my rash has subsided and the body aches have subsided, but the joint pain and the mild headache still remain.
I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/30/21 after the completion of a full Janssen vaccine series (Dose 1 on 5/5/21). The patient later died on 6/03/21. Cause of Death is listed as ?Upper gastrointestinal hemorrhage?.   Comments:=======================nnJune 01, 2021 at 3:07 PM  by HD nn6/1 3:06 Supervisor Review completed by HD): ICP needednPT resides at ..nPT admitted to hospital-  as asymptomatic. No dates were provided. shows specimen collected via hospital on 5/30 and no notes regarding admittance.nClosed as medical barriers.nnn=======================nnJune 01, 2021 at 2:34 PM  by CNA, case is hospitalized since 5/30. Head of Nursing sent her to hospital for vomiting and is not currently in the ICU or being treated for any respiratory issues related to COVID,
Patient's parent filled out all forms with age 12 and acknowledged that patient was over age 12. After immunizing technician gave vaccine and pharmacist was processing, the error was caught that the patient is 4 days shy of 12 years old. Patient did not report any adverse effects.
Headache, SkinRash, fatigue Narrative:  Sought medical advice from PCP. Allegra
male recvd vax;28 days later,wife devel vesicular lesions;husband recvd 2nd dose & devel a pruritic skin rash,which may have been urticaria;
This spontaneous report as received from certificated medical assistant referring an unspecified number of patients whom on an unknown date, were vaccinated with a dose of RECOMBIVAX HB, the reporter was unable to provide lot #/expiration dates and administrations dates for the vaccine. It was reported that the vaccine was exposed to 1 F for 3 hours. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
1st vaccine in 11/19 and 2nd today (29Jul2022); This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in November  2019).   On 29th July 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 29th July 2022, the dose was .5 mg/ml (.5 mg/ml daily). On 29th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.    Additional Information: GSK Receipt Date: 29-Jul-2022 Reporter's Comments: The patient stating that she got her first shingrix vaccine in November 2019 and then just got her second vaccine on 29th July 2022 (greater than 6 months later). The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix 2 month after 1st dose, later than the recommended standard schedule, which led to lengthening of the vaccination schedule. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022112810:Same reporter
Queasiness, in the morning.  Progressed to slight chills in the afternoon and upset stomach.  Skipped food knowing I would throw it up.  By 7 PM, chills were extreme (shivering in bed under blankets sweating), several dry heaves thinking I might puke, but nothing in my stomach.  Went to sleep by 8 pm.  Woke up several times over the next few hours with chills and feeling queasy.  Finally down at midnight.  Felt mostly normal by Friday, with some slight stomach discomfort.  Went away by noon.
Vasovagal event, change in level of consciousness, reports feeling tired. Pt transferred to WC to gurney. Pt reported feeling better after laying down for some time.
Flu-like symptoms, extreme chills ( shivering ), sweats for 2 days
Inflammation of Shoulder Joint; Inadvertently administered vaccine in shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site joint inflammation in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site joint inflammation (serious criteria hospitalization) and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site joint inflammation and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site joint inflammation to be related to Shingrix.  Additional details were received as follows: The patient's age at vaccination was not reported. The patient was inadvertently administered Shingrix in the shoulder, which led to vaccine administered at inappropriate site. The patient was taken to the emergency room and was currently in the hospital due to inflammation to shoulder joint.  The reporter stated that, the patient was initially admitted with septic shoulder, but it was not septic and was a working diagnosis on admissions. It was then confirmed as inflammation of shoulder joint.  The reporter was unable to provide if this was 1st or 2nd dose of Shingrix, date of administration, batch number and expiration date of vaccine.  The reporter was asking about any information with this type of reaction with Shingrix vaccine and any available recommendations for the health care professional. The reporter consented to follow up.
Received the first dose of the vaccine on a Sunday, May 16, 2021 around 12:30 pm.  I was told by the pharmacist NOT to take anything pain reliever for the symptoms which I did not.  That night I got the worse headache I have ever had and at the same time my ears and sinuses be having a lot of pressure. The next morning I still had the headache, sore arm and severe pressure in my head and ears.  Starting sometime that day the headache began to fade but the pressure in my head did not alleviate.  Began noticing a hissing sound in my ears that day and have had it most days since.  I have never had hissing in my ears or pressure in my head before.
pt recv vax & nurse suspected vax may have been given IV by accident b/c of presence of blood on syringe needle; pt observed for several mins then sent home w/no untoward effects
Rapid heart rate, chest pressure/tightness on left side of chest. Night sweats.