chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the morning of Monday, 22 Apr 13, I felt flu like symptoms as far as body aches and listlessness, I just didn't feel well. No chills - no fever. On Tuesday 23 April 13, I was awakened by severe cramps and severe diarrhea. Had appt w/ doctor, he prescribed IMODIUM (2mg). It stops the urge to go but when it comes time I still have diarrhea. Today is 21 May 13 and I still have diarrhea. I've tried to plug it up w/ pizza, bread, bananas, cheese/cracker to no avail.
CLIENT GIVEN TDAP AND MENACTRA AND FAINTED FOR A 15 SEC AND VERBALIZED FEELING DIZZY. PT. LAID ON THE FLOOR AND COLD COMPRESSES APPLIED TO HEAD AND NECK AREA. PT. REGAINED COLOR AND STATED THAT SHE WAS NO LONGER DIZZY AFTER A SNACK. REMAINING 2 VACCINES GIVEN, HEPA AND VARICELLA, CLIENT BECAME DIZZY AGAIN AND PALE. SAME TREATMENT GIVEN. CLIENT RECOVERED. PT. RELEASED HOME WITH DAD WITHOUT SIGNS AND SYMPTOMS NOTED.
Information has been received from a physician and a medical assistant concerning a 22 year old female with a history of sinus infection (April 2007) who on 22-JUN-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. On 27-JUN-2007 the patient experienced abdominal pain and severe flu like symptoms. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Beginning Monday after the vaccine i began  haveing a minor allergic reaction to almonds. Tongue swelling a bit, canker sores, itchy throat and mouth. This has happened several times now and happens as soon as I eat almonds. This reaction lasts 20-30 minutes and varies in intensity each time. Not necessarily worsening each time and never needing treatment.
Information has been received from a registered medical assistant concerning a 16 month old patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 27-APR-2017, the patient was vaccinated with LIQUID PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.; Sender's Comments:  US-009507513-1704USA001797: US-009507513-1706USA004380: US-009507513-1706USA004381: US-009507513-1706USA004382: US-009507513-1706USA004383:
On Wednesday night I had severe back spasm, first time that I have it, on Thursday morning I had fever, really bad headache, body ache, cough; on Thursday night I took a COVID-19 Test (I took two). and it was Positive.  I called the doctor office, a telehealth appointment, the doctor prescribed Paxlovid and started taking that day. After two days I felt better, fever went down by the next day.
About 40 minutes after the injection I became very nauseous while driving home and it has persisted in a lesser way since then.
-Feb-March 2010 (age 24): Optic neuritis OS?had progressive blurring of vision, eventually leading to complete vision loss over 6 days (lost completely. -- > March 2010 MRI brain and orbits showed mild T2 prolongation of the LEFT optic nerve with faint asymmetric enhancement following IV contrast; also had a RIGHT frontal deep white matter lesion, also enhancing; also noted to have at least 3 nonenhancing lesions -- > IV steroids x 5 days and prednisone taper, with incomplete recovery  -- > Per patient, evoked potentials subsequently done were said to be normal. Thyroid levels were high and told by neurologist that brain lesions could be from thyroid problem. No further MS work up or follow done.  (Though a note from doctor  suggest that she is at risk for multiple sclerosis due to her brain lesions, and he recommended that the patient meet with a neurologist and discuss immune modulating agents.) -- > declined LP at the time   -2016: Started to notice increased fatigue, which has slowly progressed over time   -2019 (during third trimester of pregnancy): BILATERAL leg tingling, mostly at night when sleeping on her back   -January 18 2021: Had a gradual decrease in vision OS over 4 to 5 days (after first COVID19 vaccine) -- > February 1 2021 MRI brain and orbits showed enhancement of the intracanicular segment of the LEFT optic nerve, as well as multiple white matter lesions typical of demyelinating disease, nonenhancing -- > February 6, 2021 MRI C/T-spine showed a faint T2 hyperintensity with enhancement at C4-C5 -- > 3 days IV/PO solumedrol -- > vision near baseline but didn't recover 100%   She received her second COVID-19 vaccine February 5, 2021.
Pt said her started hurting the day after the vaccination. The pain spread the following week to her chest and back. Pt is taking naproxen and tylenol to relieve the pain. Breathing is normal but the pain in unbearable. Pt got ADACEL and FLUCELVAX at the same time.
He is only 21 months old We gave him the 5th dose of Prevnar 13; He had a Pentacel within 4 weeks with no AE; Initial information received on 28-Apr-2022 regarding an unsolicited valid non-serious courtesy case received from a other health professional.  This case involves a 21 months old male patient who experienced he is only 21 months old we gave him the 5th dose of prevnar 13; he had a pentacel within 4 weeks with no adverse e vent while receiving vaccine Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection, unknow strength, frequency, dose, expiration date and  lot number not reported via unknown route in unknown administration site for unknown indication.  On an unknown date the patient developed a non-serious he is only 21 months old we gave him the 5th dose of prevnar 13; he had a pentacel within 4 weeks with no ae (inappropriate schedule of product administration) (unknown latency) following the administration of Diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with Diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (He is only 21 months old We gave him the 5th dose of Prevnar 13; He had a Pentacel within 4 weeks with no Adverse Event).  At time of reporting, the outcome was Unknown for the event he is only 21 months old we gave him the 5th dose of prevnar 13; he had a pentacel within 4 weeks with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Adverse Event: Syncopal Episode s/p Vaccine Administration  Details: Pt presenting into exam room 1 for Pfizer COVID vaccine dose 1 around 6:20pm. Vaccine was administered into LT deltoid and pt stated that he is known to pass out after vaccines. I advised pt to stay in clinic for 15 mins or more if needed and pt agreed, and I also gave him 2 small bottles of water and highly advised him to drink them while he waited the 15 mins. I asked pt if he wanted to sit in our exam room but declined and stated that he would sit outside in our waiting area. After 5 mins (around 6:25pm), customer came and told us that someone was laying on the floor. Patient was found on other side of wall divider on the LT hand side of our waiting area laying on the LT side of his face and on his stomach. Pt aroused immediately to tactile stimulation and me calling his name. He was oriented X4 and stated that he was okay but wanted to lay on the cool floor for a moment. Pt was cool and clammy to touch and skin color pale pink. No hematomas or lacerations noted to face or head. No seizure activity noted. Stayed on floor for approx 3-4 mins and myself and another person stayed with him. There were 2 other patients present in the waiting room at the time, and the pharmD, also responded to make sure that we did not need any more help. After 3-4 mins of pt resting on floor, he agreed to get up and go into exam room 2 to lay on exam table. Patient said that he knew he was going to pass out because he heard ringing in his ears so he sat on the floor. He said the next thing he knew, I was calling his name and he was laying on the floor. Pt was escorted by me to room 2. AAOx4. V/S taken at that time: BP 120/80 HR 74 RR 16 O2 sats 98%. Skin warm and darker pink. Exam table put in incline position and pt resting there until 6:40p. Drank his 2 small bottles of water that was given to him and was stable upon leaving clinic. Offered to call someone to come get him but pt declined.
This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via unspecified routes of administration, on unspecified dates, as dose 1, single, and then as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the 2 doses of the vaccine and he is immunocompromised with blood cancer on an unspecified date. There was no response to the vaccine confirmed after having the (COVID-19) antibody test on an unspecified date. Five weeks after the second dose there was no antibody response. The patient wanted to know if there was any ongoing clinical trial study for patients with blood cancer. The patient researched it on the website and find no information who to contact. The outcome of the events was unknown.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
patient woke up the day after immunization feeling dizzy and drowsy. patient stated they were unable to get out of bed and felt light headed.
Body aches, brain fog, painful skin on touch,  chills, fatigue, head ache, flu like symptoms for 24 hours. Brain fog going on day 3.
Sick for 8-10 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US274037_LT (Novartis).  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Sick for 8-10 hours".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Muscle spasms in his upper torso / involuntary muscles spasms / still having them; This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included MCV4 vaccine with an associated reaction of no adverse event (received dose 1 on unknown date with no problems).   On 7th May 2021 15:30, the patient received the 1st dose of Bexsero (intramuscular). On 7th May 2021, the patient started Bexsero Pre-Filled Syringe Device. On 7th May 2021 15:30, the patient received Menveo (intramuscular). On 7th May 2021 18:30, 3 hrs after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced muscle spasm. On an unknown date, the outcome of the muscle spasm was not recovered/not resolved.   The reporter considered the muscle spasm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the muscle spasm to be related to Menveo. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the mother of the patient. The reporter claimed that her son had no health issues and was perfectly healthy before receiving  the Menveo booster shot for college. This was his last meningitis vaccine for college. The patient got Bexsero and Menveo both in the left arm. The reporter said about 3 hours after the shot the patient started having the involuntary muscle spasms, it affected his upper torso. The reporter said if he was standing up he was fine but if he sat or lounged or laid down he was prone to it, spasms looked like he was having a seizure. The patient could talk through it, no cognitive loss, appetite was fine. The reporter said they had been to the pediatrician and to the emergency room regarding this. On the day of reporting they had an EEG test done at the neurologist and they had not received the results. She offered to send a video of what it looked like. The patient's condition till the time of reporting remained unchanged. The reporter said that the physician's did not think that the MCV-4 (Meningococcal ACWY) vaccine was the one which was causing the muscle spasms since he had already had dose 1 before with no issues. The reporter was asked if she had the lot number/expiration date of the Bexsero she said no. It was the Bexsero that the reporter believed was causing the muscle spasms. Note: The reporter did not have the trade name of MCV-4 (Meningococcal ACWY) but she thought it might have been made by Pfizer, therefore it might have been GSK's product Menveo.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 11-JUN-1997, the patient was vaccinated with a first dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 23-JUL-1997, the patient was vaccinated with a second dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 27-SEP-1997, the patient was vaccinated with a third dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 17-APR-2000, the patient was vaccinated with a fourth dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). On 07-AUG-2015, the patient was vaccinated with a fifth dose of PEDVAXHIB (lot #, expiration date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Information has been received from a RN concerning a male pt in his late 40's with cerebral palsy who in 2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter stated the pt requested to be vaccinated with pneumococcal 23v polysaccharide vaccine. The reporter saw in the pt's record that he had previously been vaccinated with pneumococcal 23v polysaccharide vaccine approximately two or three times. The reporter recommended the pt should not be vaccinated again, but the physician wrote an order stating he had to have the vaccination. Subsequently, in approximately 2003, the pt developed a large cellulitis at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2004. Information has been received from a registered nurse concerning a 44-year-old Caucasian male patient with cerebral palsy who on 11-DEC-2003 at 10:00 was vaccinated in the right deltoid with a second dose of PNEUMOVAX 23 (Lot # 647272/0664W). The reporter stated the patient requested to be vaccinated with PNEUMOVAX. The reporter saw in the patient's record that he had previously been vaccinated with PNEUMOVAX. The reporter recommended the patient should not be vaccinated again, but the physician wrote an order stating he had to have the vaccination. On 12-DEC-2003, the patient developed a large area of cellulitis at the injection site. The cellulitis was described as a local reaction with redness, hot to touch, painful and the size of a softball. Unspecified medical attention was sought. The patient was treated with alternate cold compress and ibuprofen for symptomatic relief. Three to five days later, the patient recovered. A product quality complaint was not involved. Additional information  is not expected.
Flu like - low fever, chills, muscle aches, headache (left rear), fatigue,.  Lasted about  24 hours from onset.
The pt experienced focal urticaria versus fixed drug eruption over the injection site, right thigh lasting weeks. One month later, recurrent small area of urticaria.
Mom called office today stating baby had rash x 12 hrs. all over body, vomiting, diah and slight fever starting on 1-19-15 after receiving DTaP on 1/7/15.
Were administered improperly stored PROQUAD; No adverse effects; This spontaneous report has been received from a medical assistant referring to 4-year-old patients of unknown gender. The patients' pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided.   The medical assistant reported that, on an unknown date, the unspecified patients were vaccinated with unspecified doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin)  (PROQUAD) (dose numbers, route of administration and anatomical locations of administration were not provided); lot number S000623 with expiry date on 06-JUL-2020; lot number R030794 with expiry date on 22-APR-2020; lot number R030801, which was verified to be a valid lot number, with expiration date reported as 15-MAR-2020, but upon internal validation established as 22-APR-2020; lot number R021102 with expiry date on 20-JAN-2020, lot number R026353, which was verified to be a valid lot number, with expiration date reported as 22-APR-2020, but upon internal validation established as 15-MAR-2020 and  lot number reported as R037094 with expiration date 22-APR-2020, all for prophylaxis. Lot number R037094 is an invalid lot number for  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin)  (PROQUAD).  The doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were exposed to a temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-11.5 Celsius degrees) for a time frame of 46 hours and 15 minutes, which was not detected by the Digital Data Logger. There was a previous temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-10.6 Celsius degrees) for 2 hours. No adverse effects were reported.   This is one of two reports received form the same reporter.; Sender's Comments:  US-009507513-1905USA006062:
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. This case corresponds to a pharmaceutical product complaint. The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX. At the time of reporting, no additional information was available. This is case 11 of 15 (see case IDs A0860669A, A0860688A, A0860690A - A0860697A, A0860699A - A0860702A for the other reports).
Parent noted redness and swelling of rt arm on 7/20/05, woke up on 7/21, swelling was worse and pain in right arm. At time of office visit, right upper arm swollen to elbow, warm and tender on palpation with red streaks. Dx Cellulitis 2 hrs to immunization.
I started feeling bad about mid May, May 15 2021. I was feeling very out of sorts. I had started coughing, some of the coughing was to the point where I could not breath. I went to the DR and they put me on antibiotics. May 18th 2021, that was when I went to the DR. Then on June 1st 2021 I went to the DR as well and I think that is when they put me on Z-Pack. I continued to cough and get very exhausted regardless of the medication. Then July comes along - through the rest of June I could not even walk without getting winded and panting for my own breath. So then on July 6th 2021 I just couldn't go anymore and decided to go to the ER, at the Hospital and I was admitted. They did tests and I was in the hospital until July 8th 2021. My heart is apparently not pumping as it is supposed to. I thought maybe I had bronchitis because of the coughing but apparently not. The DRs say I have Cardiomyopathy, never having heart problems before I was really taken aback by this news. I was sent home with a life vest for my heart now that is scary too. The DRs tell me I am not allowed to do much of anything, basically sit around. I see an electrophysiologist and I see a heart DR. I saw my PCD on the 19th of July 2021 as well. I will see the electrophysiologist on August 10th 2021 as well. Oh I was also put on four new medications: Entresto 2x daily, Carvedilol 2x daily, Atorvastatin 1x daily, Spironolactone 1x daily. I was also taken off of Vyvanse and now I just kind of play the waiting game.
On 12/24 Throat constriction and both arms itched and burned. On 12/28 Injection site swollen, hot to touch and very red. Had body aches that lasted through 12/31. Went to Urgent care on 12/30 but the doctor refused to give me a copy of the visit. He evidently didn't want to deal with it. Vaers also has an adverse reaction I had to first shot on02/28/2021. E-Report Number: 334192.Date of report 03/04/2021. Needless to say, I won't be getting any more shots.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. Information regarding the patient's medical history was not provided. In 2011 (reported as 'last year on an unspecified date') the patient was vaccinated with dose 1 ZOSTAVAX (dose, lot number, and route not provided). No other co-suspects were reported. No concomitant medications were reported. On 10-OCT-2012, the patient received a second dose of ZOSTAVAX (dose and route not reported). The lot number for the second dose was reported as H012575 with expiry date 28-SEP-2012. The reporter did not state if the patient was experiencing any adverse effects. Additional information has been requested.