chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a 17 year old male patient (consumer's son). On 01-NOV-2013 the patient was vaccinated with GARDASIL (dose, route of administration and lot #batch# were not reported). No medical history and concomitant medication were reported. On 11-NOV-2013, the patient experienced pain, vision loss and nausea after receiving the GARDASIL. It was reported that the patient could open his eyelids but experienced pain when he tried to move his eyes. On an unknown date of November 2013, he was seen by an ophthalmologist, who diagnosed as optic neuritis and inflammation of the optic nerve for both eyes. He was referred to a neurologist. On an unknown date of November 2013, a vision field test was done and some loss of vision was noted. On 13-NOV-2013, the patient was taken to see a neurologist and an MRI was done and it showed inflammation. The patient then underwent a lumbar puncture to decrease the intracranial pressure (dates unspecified, November 2013). The patient sought medical attention (office visit). The patient was also given intravenous steroid therapy at the hospital (name of hospital not provided). It was reported that the patient was not admitted to the hospital but goes almost daily for treatments. The consumer also reported that as a consequence of the lumbar puncture, the patient experienced increased pain and nausea. The patient eye pain has increased since it was first noticed. The outcome of the reported events was reported as not recovered. It was also reported that both physicians have stated optic neuritis and inflammation of the optic nerve for both eyes have developed from receiving the GARDASIL. Upon internal review the event 'vision loss' was considered to be medically significant. Additional information has been requested.
Information and follow up has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 18 year old female with sulfonamide allergy and a history of low grade squamous intraepithelial lesion who on 12-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported). There was no concomitant medication. On 09-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot# not reported) and then learned she was pregnant after a positive pregnancy test. The patient's estimated LMP was 04-FEB-2008 with an EDD of 13-NOV-2008. On 20-MAR-2008 the patient had an ultrasound to check dating. On an unspecified date, the patient began taking prenatal vitamins (unspecified). It was reported that the patient had no previous pregnancies. Subsequently the patient experienced no adverse event and on an unspecified date she sought unspecified medical attention at her physician's office. Follow-up information has been received from a completed questionnaire. On 08-NOV-2008, 38 weeks from her LMP, the patient delivered a live normal male infant weighing 7 pounds 8 ounces via spontaneous vaginal route. The infant was 20.25 inches in length and 13 inches in head circumference, with an Apgar score of 8/9. No congenital anomalies, complications or abnormalities were reported. Medication during her pregnancy included prenatal vitamin (unspecified) once daily. There were no complications, infections or illnesses during her pregnancy and delivery. Pediatric medical records were received and reviewed and the following experience was identified: On 12-DEC-2008, the 35-day-old infant presented to the clinic with his mother. His mother noticed purulent material in his eyelashes for the past month. He was doing well otherwise and had breast feeding every 3 hours. He has not had any fevers, illness or problems with constipation. There was no passive tobacco smoke exposure. Physical examination regarding his eyes revealed: Positive red reflex bilaterally. No conjunctival infection but he has purulent material in the eyelashes bilaterally. Assessment was plugged tear ducts bilaterally. Planned therapy for plugged tear duct included TOBREX suspension ophthalmic, 1 drop in each eye qid for 5 days if the purulent material builds up quite a bit, massage for his tear ducts with a warm wet washcloth several times per day. Follow-up 2 month and 4 month well-child check did not have any concerns regarding his plugged tear ducts bilaterally. Plugged tear ducts bilaterally was considered to be a congenital anomaly. Pediatric medical records were also received and reviewed and an experience related to Hep B vaccine was identified and is described in WAES report # 0903USA05166. Additional information is expected. Medical records are available upon request.
Pt had localized reaction.  Golf ball size lump, hot, red, and sore.
Approx. 10 minutes after vaccine administered I became suddenly tachycardic while sitting in a chair.   Heart rate up to 140.  I started to feel some chest heaviness with some difficulty breathing.  Felt like my heart was galloping. Was transported to ER and monitored for 2 hours.  I was orthostatic with talking, and walking.  Heart rate to 135 walking to the bathroom despite having had a liter of IV fluid given.  I was discharged home with instructions to follow-up with my doctor.   I have an underlying problem with exercise intolerance with elevated heart rates.  It seems that the elevated heart rate made my symptoms worse. Otherwise I have just a mild headache and mild fatigue.   No previous adverse reactions to vaccines.
Headache, fever, body aches, GI issues, cough feels like something is restricting the back of left lung when taking deep breath, no smell or taste.
Patient had extensive swelling in arm and tenderness. Dx with cellulitis tx with BACTRIM. Had large amt. of redness. Patient seen in ER prior to office visit.
Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In February 2021, the patient experienced COVID-19 (Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid). At the time of the report, COVID-19 (Caller states he had been fighting Covid for 2 years and 9 months now. He could not  get over Covid) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that he had been fighting Covid for 2 years and 9 months now. He could not get over Covid. He received Moderna vaccines in the past. He had Covid right know but then explained that he actually had Covid before receiving his vaccinations. Not clear if caller had Covid also after the vaccination.  Treatment information was not provided.
she grabbed a 5ml vial of Tubersol, thinking it was Fluzone Quadrivalent, inadvertently administering 0.5mL of Tubersol to patient, no advesre event; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2019SA295030 (same reporter).  This case involves a 49 year old patient (gender not reported) who received 0.5 ml dose of TUBERCULIN TEST [TUBERSOL] instead of a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot C5588AA and expiration date 17-Jun-2021) via an intramuscular route in the left deltoid on 22-Oct-2019.  Medical history not reported and no other vaccines were received by patient.  It was an actual medication error case due to Wrong product administered.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
99.7 fever for one day, tired, injection site tenderness, swelling, and bruising for five days
A week after receiving the first shot I started getting "attacks" where I woke up at 5 am unable to breathe, with rigors. My whole body hurt. I would be extremely lethargic afterward for a day or 2. A week after receiving the shot I had an attack during the day, triggered by drinking half a beer and I went to the ER. I started having trouble breathing, my heart was pounding and my face and neck started turning red.
DAY 1: shaking jaw and body, chills, feeling cold, numb hands all came on suddenly at 10pm.  Next day, headache and somache ache all day. Next day recovered except chest feeling weak and hard to breathe deeply.
pt recv vax 23OCT95 & 6NOV95 pt exp a zoster-like rash w/25 lesions on the  left, mid abd;pt rash consisted of red, papular lesions which were fluid filled;cult was taken for PCR analysis-inadequate specimen to determine if it was wild type
area #redness 5x6 1/2cm; center dark red 2x3cm; early cellulitis - Advised Benadryl/Dad call with update in 24hrs
Patient is a 92-year-old female patient who was brought to ER after she had a fall at home. She did not lose any consciousness.  No headaches, dizziness, chest pain, or shortness of breath.    She also had a COVID test done on admission, which came back positive.  She has been asymptomatic and is on room air.  No shortness of breath or other complaints.
Client given 0.5mL Moderna instead of 0.25mL (booster) dose.
MAJOR DIZZINESS; RIGHT OCCIPITAL NEURALGIA (HEADACHE, TINGLING IN THE HEAD); This spontaneous report received from a consumer concerned a 78 year old male. The patient's weight was 165 pounds, and height was 73 inches. The patient's concurrent conditions included: thrombocytopenia, and low level of platelets. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: gabapentin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for right occipital neuralgia. No concomitant medications were reported. On 12-APR-2021, the patient experienced right occipital neuralgia (headache, tingling in the head). On an unspecified date, the patient experienced major dizziness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, CAT scan (NR: not provided) Right occipital neuralgia, MRI (NR: not provided) Right occipital neuralgia, and Platelet count (NR: not provided) 139. The action taken with covid-19 vaccine ad26.cov2.s, and gabapentin was not applicable. The patient was recovering from right occipital neuralgia (headache, tingling in the head), and the outcome of major dizziness was not reported. This report was non-serious.
This spontaneous report as received from registered nurse refers to a 56 year old male patient. The patient current condition included smoker. On 29-OCT-2016, midday, the patient received the first dose of PNEUMOVAX (Lot # L003189, expiry date: 23-JUN-2016). The patient was seen in the emergency room on the evening of 29-OCT-2016 for left shoulder pain which was the same arm of the vaccination with PNEUMOVAX. The patient mentioned that he also lifted a whole trailer of wood that day. The patient was given an injection of TORADOL and dispensed oral TORADOL. The patient was not admitted to the hospital. On an unknown date in 2016, the patient underwent left shoulder x-ray and the results were unknown. The outcome of the event Vaccination site pain was unknown. The reporter did not provide the causality between the event Vaccination site pain and the suspect therapy. No product quality complaint (PQC) involved. Additional information has been requested.
Information has been received from a physician concerning a 12 month old pt who was vaccinated with MMRII and varicella virus vaccine live and subsequently, the pt experienced a "very high fever" and was hospitalized. It was noted that the reporter was wondering what to do about the 2nd dose of MMRII. Follow-up information has been received from a physician stating that the child was in for her 1 year old well visit on 1/9/01. The child was well at the time of the visit and received the vaccinations. On 1/10/01, the mother described the child as "shaking of hands, feet, and lip for 45 minutes, with some difficulty breathing and gasping for air". The physician stated that the child may have had a febrile seizure, however, it was not witnessed by anyone but the pt's mother. The child was taken to the ER where her temperature was 103F. She was treated with acetaminophen (Tylenol). The child had a 'barking cough' and a CXR was done and reported as normal. A CBC and blood culture were also done and came back normal. The child had recovered and was discharged from the ER to home with discharge dx of "fever, secondary to immunization". The child has no history of seizure or febrile seizure, but does have a history frequent otitis media infections. It was noted that the pt has had another episode of fever of 104F with cold symptoms. Upon internal review, the shaking of hands, feet and lips for 45 minutes, difficulty breathing and gasping for air, and fever secondary to immunization were considered to be "Other Important Medical Events".
Injection given left upper arm 10/9/07. Area developed large painful lump, arm swollen and remains swollen and painful with residual lump still present 12/10/07. Pt ordered for arm physical therapy.
Information has been received from a person at a physician's office and a physician concerning an 18 year old female who was vaccinated at the age of 15 months on 06May1986 with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). A day or two later, the pt developed a measles like rash and fever. Medical attention was sought but no treatment was needed. The condition resolved and the pt recovered. A second dose of the vaccine was not administered. The physician noted that the pt's mother informed him of the reaction, but that he never saw the pt for the reaction. Additional information is not expected.
"didn't feel well"; Fever; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th June 2021, less than a day after receiving Shingrix, the patient experienced feeling unwell, fever and pain in arm. On 11th June 2021, the outcome of the feeling unwell and fever were recovered/resolved. On 13th June 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fever and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported that she received dose of Shingrix vaccine. Later that day the patientdid not feel well, had a fever and a sore arm. The first two symptoms lasted about 24 hours. The reporter stated she had a sore arm for a few days. The lot number and expiration date was unknown. The reporter did not consent to follow-up. The reporter declined to provide health care professional information. This case is linked to the case US2021AMR171305,reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR171305:Same reporter
Nausea, lightheaded, tonic-clonic movement, syncope x 5 seconds. Treated by placing patient supine after consciousness regained; orthostatic BP & HR: supine 2:38 pm: 96/56 P 77; sitting at 2:48 pm: 89/64 P 91; standing at 2:55pm: 98/68 P 109.
2" x 1" red splotch at injection site; Significant soreness/tenderness in the underarm
pt recv vax between 9-1130AM came to nurses office @ 12:30 w/ c/o feeling dizzy, flushed, T96.6, pulse 100, c/o seeing double, eyelids fluttered;school nurse felt might be starting to have sz;sent to ER;
PATIENT CALLED AND SAID SHE RECEIVED HER FLU SHOT ON 11/8/2021 AND REMOVED THE BAND-AID ON 11/9/21 AND THERE WERE TWO BLISTERS AT THE INJECTION SITE,  ONE ABOUT AN INCH LONG AND A CIRCULAR ONE.  BOTH BLISTERS HAD A LIQUID IN THEM.  PATIENT SAID IT DID NOT HURT BUT SHE HAD NEVER HAD THIS TYPE OF REACTION TO A FLU SHOT BEFORE.
Nighttime came I started feeling fever and severe headache and I don't get headaches. it was on the left side and in my left eye in a stabbing pain. I could not think. I took 2 Advil to try and calm the headache but the headache did not cease. I threw up and the pain was getting more severe. I called an ambulance, I called 3 times before they got here. I went to the ER. The fever continued until after i left the ER. I had fever when I got home. The headache ceased and now I have spots and many colors that go across my eyes and I  cant see off and on. I cant go outside because of the sunshine hurting my eyes. I have no appetite, I cant eat. I have dry mouth but I am drinking so much water and ginger ale for the nausea. I am weak as I cant eat.
Case completed primary series of vaccination for Covid in April 2021, then contracted Covid in hospital in January 2022.  Hospitalized at: COVID-19 Assessment & Plan Hospitalized from 12/29/21 for treatment r/t Leukemia, where she was exposed to Covid positive caregiver.  Several negative tests, including on 1/13. Onset sore throat and dry cough 1/18. COVID-19 PCR positive. She was not hypoxemic, and is on room air with excellent O2 sats.   She is high risk for severe disease.   Treated with off-label remdesivir for 3 days.  Also treated with sotrovimab 500 mg x 1 dose IV,   Discharged home 1/21/22.
Pt reports muscle pulling in back and back nerves burning. When to emergency room morning of 10-2-2011 and got shots. Called today to report same and says is also nauseous now.
Very very itchy and way too lumpy/itching; Very very itchy and way too lumpy/mosquito like bites lumpiness from his right hand, to his elbows; Swelling; Raised up in a rash, like he was allergic to something; This is a spontaneous report from a contactable consumer (patient) via regulatory agency. A 83-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 15Jul2021 (at the age of 83-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included diabetes. The concomitant medications of the patient were not reported. The patient experienced very very itchy and way too lumpy/itching, very very itchy and way too lumpy/mosquito like bites lumpiness from his right hand, to his elbows, swelling and raised up in a rash, like he was allergic to something on an unspecified date in Jul2021. The patient reported that after he was administered with the first dose of Pfizer COVID vaccine previous week (he did not specify the date) he experienced a reaction in his right arm, from the elbow right up to the shoulder, it was "very very itchy and way too lumpy". He stated, the pharmacy scheduled him to receive the second dose that day. He requested information on the recommended timing for the second dose. He reported that as result, he had experienced itching, swelling, and "mosquito like bites lumpiness" from his right hand, to his elbows, and shoulder. He stated that the itching is mostly gone, but he could still feel the lumps up and down his right arm. He was concerned about taking the second dose of the vaccine which he was due for that day, because he was afraid that he may had a more severe reaction than the first as he had heard and read. He was concerned as he was a diabetic and does not know how the vaccine will affect the medications he was on. He asked Is the second dose going to cause him to have a worse reaction "he don't want to die". He stated that that day was his third week from the first shot after, on the back of his elbow up his upper arm was very itchy and raised up in a rash, like he was allergic to something. He was scheduled for the second dose today. Due to the rash he was asked to call and notify. Stated it was from his elbow to shoulder and very itchy. It was going away then. He stated that he was informed that the second shot is stronger than the first one. He stated that he was scared to get the second shot because he doesn't want to go through all the trouble he had with his arm after the first one over again. The events were reported as non-serios by the reporter. The outcome of the events very very itchy and way too lumpy/itching and raised up in a rash, like he was allergic to something was reported as resolving, the outcome of the event very very itchy and way too lumpy/mosquito like bites lumpiness from his right hand, to his elbows was reported as not resolved and the outcome of the event swelling was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Since having the shot, I have noticed a great amount of swelling in my neck, even making it hard for me to breath at night when laying down to sleep.  I also feel heart palpatations, even when laying down and it feels like irregular or racing heart rate, to the extent that I have to sit up and focus my mind on calming my heart rate.  I also feel easily out of breath even in doing small activities.  I have a lack of energy and I am sleeping a lot and still always feeling tired, I also have brain fog unless I drink a ton of coffee.  I have no mental clarity for much of the day.  I wonder if I will ever regain my full health prior to getting the shot.   I also got really sick about 2 weeks after the shot with a really sore throat and chills and I didn't get better even when taking antibiotics.  It's been a few weeks, and I am still not feeling normal.