chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published article, concerning two patients who on an unspecified date were vaccinated with a dose of ROTATEQ. Subsequently, the patient experienced vaccine acquired rotavirus infection and severe combined immunodeficiency (SCID). The infants were diagnosed with SCID between ages 3 months and 9 months and had received 1-3 doses of ROTATEQ before the diagnosis. The infants had diarrhea, and most had additional infections (e.g., Pneumocystis jirovecii, rhinovirus, adenovirus, Salmonella, Escherichia coli and Giaridia) at the time of SCID diagnosis. SCID includes a group of rare, life-threatening disorders caused by at least 15 different single gene defects that result in profound deficiencies in T an B lymphocyte function. Vaccine-acquired rotavirus infection was confirmed by reverse transcription-polymerase chain reaction (RT-PCR) and nucleotide sequencing. ROTATEQ is contradicted in infants diagnosed with SCID. Consultation with an immunologist or infectious disease specialist is advised for infants with known or suspected altered immunocompetence before ROTATEQ is administered. SCID was considered to be life-threatening. No further information is available.
Made Long-Covid Symptoms much worse,  especially after the second shot. Severe headache, severe fatigue, dizziness, shortness of breath, intestinal pain, diarrhea, high blood pressure.
swelling & redness to rt thigh, excessive crying; this is second reaction to same vial of DTP in 24 hrs;
pt noted a reddened area around the side DT had been given;this was noted 15 days p/vax;area was approx 15cm;warm soaks to area;rxn to DT;
Patient presented to the ED on 10/27/2021 for COVID-19. Patient presented to the ED and was subsequently hospitalized on 10/31/21 for COVID-19 virus infection, dyspnea, hypoxia within 6 weeks of receiving covid vaccination.
Initial misuse report received from a healthcare professional on 5 June 2013. This is an invalid case as individual patient identifiers are not reported. Some patients (No information was provided regarding the patient) had received PENTACEL vaccine subcutaneously; also the reporter informed that the patient received only half dose. No adverse event was reported. List of documents held by sender: none.
Red, hot, slightly raised swelling around vaccination site, appeared 8 days after vaccination, slightly itchy, currently the red patch is the size of an open palm, has been visible for 3 days. Not painful or debilitating, just abnormal and slightly uncomfortable
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA002182: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004692: US-009507513-1802USA004686:
rash at injection site; Wrong route of administration; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th May 2022) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 13th December 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient developed a localized rash at the injection site after receipt of her first dose of Shingrix and it was suspected that it was given subcutaneously which led to intramuscular formulation administered by other route. The follow up consent was granted.
Information has been received from a nurse concerning a female patient who on approximately 27 Oct 2006 was vaccinated with a dose of varicella zoster virus vaccine live. On approximately 27 Oct 2006, the patient experienced a headache and flu-like symptoms. Unspecified medical attention was sought and the patient recovered after one day. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from a registered nurse concerning a female patient who on approximately 27-OCT-2006 was vaccinated with a dose of ZOSTAVAX (Merck).  On approximately 27-OCT-2006, the patient experienced a headache and flu-like symptoms.  Unspecified medical attention was sought and the patient recovered after one day.  A product quality complaint was not involved.  Additional information has been received from the nurse who reported that she was "clear as th whom this is referring to."  Additional information was received from the registered nurse who reported that the patient stated that she never expected to feel head achy and "like she was coming down with the flu."  In a follow-up telephone call with the patient months later, she reported no ill effects and hardly remembered the previous conversation.  No further information is expected.
Narrative:  Patient is a 95 yo bed bound M w/ significant PMH: Hx of cognitive impairment, migraines/ giant cell arteritis on daily low dose prednisone--followed by rheum, glaucoma, CAD s/p CABG (2013 at hospital) on ASA, hypertension, hyperlipidemia, diabetes (on pioglitazone and glipizide), chronic diabetic foot ulcers s/p right second toe amputation (11/12/19, 9/10/19)--followed by podiatry, and history of falls. DNR/DNI status. He was discharged from hospice in 12/2020 (terminal diagnosis of end stage coronary artery disease; end stage diabetes). Patient received his 1st dose of the COVID-19 vaccine on 5/26/2021 and 2nd dose on 6/16/2021 without complications. No status changes noted during RNP's 6/18/2021 visit or reported by son during 6/20/21 visit. Patient died on 6/23/21 at 11:09am. Per RNP and supervising MD, clinical presentation was most consistent with terminal diagnosis of end state coronary artery disease and end stage diabetes than an adverse effect of the COVID-19 vaccination series. Reporting given proximity of the patient's death and vaccine per EUA requirements.
A few weeks  after receiving the vaccines, I began to have inflammation in several parts of my body where I?d either received injections of ?Sculptra?, and dermal filler (numerous places on my legs and face wherever I?d received the injections almost exactly a year earlier), and in my left hip which I hadn?t realized before then that it was damaged. I didn?t have any initial swelling from the Sculptra when it was first injected the prior year, so in November when the swelling wasn?t going away, I went in to see the dermatologist that had administered it. She hadn?t seen this happen before and asked if I?d recently been sick or had a vaccine. That?s when we realized the connection between the two events and she told me to contact the CDC to report the reaction. Around that same time in September, I went to see an orthopedist about pain in my hip. It wasn?t until the pain hot so bad in January of 2033 that I got an MRI and they noted a lot of sweeping and edema in my hip bone and surrounding tissue.
HYPERPIGMENTATION OF THE SKIN; RASH; This spontaneous case (PVX2019-1333) report was received from a consumer on 23-May-2019. It describes a consumer who had rash with hyperpigmentation of the skin, after the administration of Vivotif for an unknown indication.  Case report: The consumer developed rash after 2 doses of Vivotif. She went to Clinic for rash, as she was not sure what it was. The rash was completely flat and did not bother her. However, it was labelled as hyperpigmentation of skin by the clinic which she visited. She stated that the rash was still there, and she did not know if it was getting better.  She did not take any treatment for the events.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that the consumer had rash and hyperpigmentation of skin after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had rash and hyperpigmentation of skin after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Woke up one morning in March with welts on my legs, arms, and trunk that looked similar to mosquito bites.  Thought maybe spider bites, and that seemed to be what the PA indicated it might be, but there were several, not just one or two.  Every day or few days after I would wake up with more.  Made an appt w/the PA who put me on a course of Prednisone (10 mg; 6 tabs daily X3 days, then 4 tabs x3days, 2 tabs x3days, then 1 tab for 3 days) and included one Loratidine (10 mg) tablet as well.  That seemed to work and the rash cleared up until day 11 when I woke up with just a couple of fresh welts.  I was then ready to travel for my daughter's wedding and during the two weeks, I broke out again mostly on my right buttock with welts again on my legs, trunk and arms.  I haven't had time to get back in to see the PA, but they are red and they itch.  Because SARS-CoV-2 is a novel virus, I wasn't sure if this could be some after-effect of either the shots or from having had COVID which I did in October a few weeks before I got my third shot in the series.  I'm a medical librarian and did search data to see if anyone has been reporting rashes of unknown origin in patients who have tested positive or had the shots, but I didn't find anything.
Presented w c/o generalized weakness causing fall; incidental COVID-19+ finding, asymptomatic
ON 09/22/08 PATIENT WAS SEEN IN HOSPITAL FOR REPEATED VOMITING AND BLOOD IN THE STOOL,WAS TAKEN TO GI FLOOR WHERE A BARIUM ENEMA WAS ATTEMPTED FOR REDUCTION OF INTUSSUSCEPTION AND WAS UNSUCCESSFUL AND EMERGENCY SURGERY WAS PERFORMED TO REDUCE THE INTUSSUSCEPTION AND AN APPENDECTOMY WAS PERFORMED 10/17/08 Reviewed hospital medical records of 9/22-9/24/2008. FINAL DX: Intussusception, surgically reduced. Records reveal patient experienced vomiting, crampy abdominal pain & bloody stool.  Emergent surgery to reduce IS & appendectomy.  Progressed well & d/c to home w/PCP & surgery clinic f/u. 10/10/08 Reviewed PCP medical records of 2/21-10/06/2008. FINAL DX: Intussusception, surgically reduced Records reveal patient experienced good health on day of vaccination.  Developed IS late 9/08.  Did well postoperatively.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 30-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date- 22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
feel nauseous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient himself) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got covid vaccine last Saturday and still felt nauseous on an unspecified date. Outcome of event was not recovered.   Information on the lot/batch number has been requested.
Woke up AM of 7/23/03 left upper arm area swollen and red with rash. Mom called doctor. Started Benadryl 1 1/2 tsp QID and Cortisone cream top tid (to continue through 7/26/03).
Pt developing t101.5, flu-like aches of back & neck 24 to 36hrs p/receiving 2nd dose of vax; 2nd day post inject t103F; post 1st inject flu-like ache & pain sxs self-resolving; no addtl tx or meds given;
Information has been received from a male who on 4-AUG-2008 was vaccinated with ZOSTER vaccine. The patient reported that after receiving vaccination, he experienced diarrhea in the morning, but also pain and sensitivity at the injection site for 2 to 3 days. The patient reported that his diarrhea was controlled by IMODIUM. The patient reported that his diarrhea had improved already but he still felt a little gas pain in his stomach from time to time. Lot # was not provided. This is one of two reports received from the same source, Additional information has been requested.
Within 30 min. after rec'ing Hep B vaccine, dev'd hive-like rash over upper body. + Pruritus. No resp. distress. Tx'd with Benadryl 50 mg. Started to improve w/in 30 min. Within 3-4 hrs. sx's resolved.
Headache 3 days of sore arm, 3 days of moderate headache  Narrative:
High blood pressure (both top and bottom numbers were in the hundreds),  asthma, elevated heart rate (also in the hundreds . Steroids were needed to regulate breathing. Two inhalers were administered.
12/30/2021, I felt the normal malaise after the vaccine. 12/31/2021, I was feeling better during the day & normal activity, but around 7PM I started to get a headache. 1/1/2022, trouble sleeping due to chest pain, chest pain got worse throughout the day. Worse when I took a deep breath and when laying on my back. Advil helped take the edge off during the day 1/1/2022, but by evening advil was not really helping. I went to the hospital at about 10PM 1/1/2022 because of concerns about the chest pain. While in hospital, I was diagnosed with Pericarditis and a-fib. I  have had paroxysmal a-fib for 2 years, but it had become persistent. 1/2/2022 I was more comfortable - the chest pain was manageable. 1/3/2022 and on, I have no chest pain. I was fatigued but feeling less fatigued as of 1/12/2022. Shortness of breath is better as well. I am now taking 1.2 mg colchicine per day, 1800mg ibuprofen per day, and metoprolol 100mg per day with follow ups with cardiology scheduled. My insurance deductible is $7000, and I have met it for 2022 due to this incident.
30JUN92 exp redness & swelling of the arms; also devel a low-grade fever & exp difficulty rotating wrist; subsequently recovered; No further details were provided;
18 month old patient received Quadracel instead of the intended dose of Pentacel with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 18 month old female patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] instead of the intended dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-May-2023, the patient received a dose 4 dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine Solution for injection lot U7564AA expiry date: 08-Nov-2024 via intramuscular route in the left thigh for immunization.  On 19-MAY-2023 18 month old patient received quadracel instead of the intended dose of pentacel with no reported adverse event (wrong product administered) on the same day following the administration of Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (VERO) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 18 month old patient received quadracel instead of the intended dose of pentacel with no reported 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.
My son is having a serious allergic reaction to the Gardasil vaccination. Within several hours of receiving it, his face began hurting, and his lips began swelling up. Then, he developed chills and a fever and broke out in canker sores within his mouth. He woke up during the night screaming in pain and soaked in sweat. Now, his face swelling has worsened. The shape of his nose is now distorted due to the swelling, and his left eye began swelling shut. He is now claiming that his heart is hurting. We took him to the doctor's office earlier this afternoon, but now that it has worsened further, we have taken him to a small local hospital. I know that nobody wants to admit that this is linked to the vaccination, but I have worked in the pharmaceutical industry for 20 years, and it seems highly probable that the administration of the Gardasil vaccination is the causation of these unusual and rapid onset of adverse health effects.
A few minutes p/vax recvd pt appeared to be "passed out"; mom took pt back into office where pt was jostled back to responsiveness;
Pt did not feel sick the first 15 minutes after receiving the shot, but throwing up and dizzy for two days after.  Pt wife reports vomiting day of vaccination (hours post vaccination). Continued to feel nauseas/loss of appetite for ~3 days, then felt better. No other ADR aside from N/V. Patient alert and oriented. All symptoms resolved ~3 days post vaccination, and patient is currently feeling well. Instructed to see PCP if symptoms reappear or worsen
body aches and 101 fever x2 days s/p vaccine dose 2  Narrative:
swelling in joints  - especially on toes and hands. So swollen I could not close my hands or grip. Swelling of lymph glands under right arm pit and on right side of clavicle and neck. I iced the joints and the lymph glands which seemed to help ease the swelling. This occurred after both doses were administered. Each time the reaction started around the third day after the vaccine was administered (both dose 1 and 2). And the swelling in joints and lymph glands lasted 21 days. Then the swelling subsided completely. I did get mildly sick with flu like symptoms July 23rd, 2021 and my lymph nodes swelled under my right arm and on the right side of my neck.  Lasted 2 days and as soon as the flu like symptoms passed, I felt better.
in the pt's words received my 1st (5/5/21) and 2nd (5/26/21) doses of Pfizer at County Fairgrounds. I want to document my experience as I had some pretty severe reactions to my second dose.   Evening of the 26th I got chills and a fever of 102.9F. I took one ibuprofen and the fever went away.   The next morning I had a slight headache. Around noon I got intense chest pains/pressure that lasted 30 minutes. I could not take a full breath as it was very painful.    On the 28th, I woke up with a terrible headache for no apparent reason. Some ibuprofen helped. After a few hours it was gone.   At 2am on the 29th, I woke up with very intense stomach cramps. I went to the bathroom and was able to pass out some stool over the course of about 30 minutes in the bathroom, and the cramps went away.   On May 31st, I got what seemed to be a blood clot in my left index finger. It went away after about 20 minutes but still felt sore the rest of the day.
Swelling of right leg at vaccine site; only faint erythema muscle in area about 4" x4"; normal gait and use of leg
No additional AE information reported.; Nurse reporting administration of improperly stored VARIVAX. See  02240320. No additional AE information reported. No PQC reported.     ?    Names of vaccines involved (including lot/exp): VARIVAX (W012167 and 04/12/2024)         ?    Temperatu; This spontaneous report was received from a nurse and refers to a patient of unspecified gender and age. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 02-SEP-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one dose, lot #W012167, expiration date: 12-APR-2024 (exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis. The vaccine underwent temperature excursion in -11.6 Celsius degrees (C) during a time frame of 25 minutes. No additional adverse event information was reported.
still experiencing daily swelling in my fingers (no pain) with diminished swelling from last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "Fluid retention"; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "High blood pressure". The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "still experiencing daily swelling in my fingers (no pain) with diminished swelling from last year".  Additional information: It was reported that the cause of the fluid retention in the patient's fingers (both hands) was not caused by the Pfizer Covid Vaccine (BNT162B2). The patient received the Pfizer Covid vaccine booster shot (FF2593) on 02Nov2021 without incident. It was reported that the cause of the fluid retention in fingers (both hands) appeared to be due to a paint remover. The patient was able to determine that the finger/hand issues began prior to receiving the first dose of the Pfizer Covid vaccine and while he was using the paint remover. Over time, the fluid retention (edema) spread to the hands/arms/shoulders and eventually resulted in an emergency room visit due to high blood pressure on 01Aug2021. The patient never had issue with blood pressure, and it had returned to normal levels without medication. The patient was still experiencing daily swelling in his fingers (no pain) with diminished swelling from last year. The patient was unsure if Pfizer Covid vaccine had any interaction effects with the paint remover's ingredients or known exposure symptoms to aggravate the situation.  No follow-up attempts are possible. No further information is expected.