chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered Kinrix twice; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (1st dose received on 28th December 2020, at the age of 4 year old).   On 16th August 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 16th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. The action taken with Kinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the extra dose administered was unknown.   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 registered nurse reported that, the patient was administered Kinrix twice, additional dose received on 16th August 2021, which led to extra dose administered. The registered nurse mentioned patient did not had any other vaccines for the Dtap and or IPV just Kinrix. The reporter did not consent to follow up.
I got my shot on Friday afternoon. On Sunday morning I kept hearing a constant ringing in my left ear.  I made an appointment for the ENT.  He ran some hearing test and a few other test.  The ringing continued for about two months.
16MAR96 pale red bump over rt side of top lip;whiny&complaining;felt feverish;22MAR96 noticed pale white bumps on torso;23MAR96 didn't want to eat nl breakfast or lunch;sz,v,t100.1,non-responsive,twitching body,limp;dx roseola
Information has been received from a published article. A 4 year old child was vaccinated with VARIVAX (Merck) (lot number, route and site not reported) 12 weeks prior to presentation. On an unspecified date, the patient developed breakthrough varicella which was complicated by pancytopenia which was refractory to all modalities of treatment necessitating Bone Marrow Transplantation. The patient's outcome was not reported. Upon internal review, pancytopenia was considered to be an other important medical event. No further information is available.
Got vaccine on Friday evening. On Saturday developed low grade fever; fatigue; sore arm for several days.
Patient developed bilateral abscesses one in each Quadricep, requiring incision/ drainage and IV antibiotics: approximately 3 weeks after administration. Also long standing nodule left thigh from vaccine at 2 months of age.
headache of all headache; Chills; Fever; A spontaneous report was received concerning a 84 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced head ache, chills and fever.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 15 Feb 2021, around 3pm, the patient received their first of two planned doses of mRNA-1273 (Lot: number:031M20A) intramuscularly on the left arm for prophylaxis of COVID-19 infection.  .  On 16 Feb 2021, the next day, the patient woke up with a "headache of all headaches", chills and fever. The patient took paracetamol in the morning. Five to six hours later he took ibuprofen and waited until 6pm to take more paracetamol and ibuprofen. He stated that his headache was so bad he was unable to do anything.   On 17 Feb 2021, the patient stated that the "head was better".   The outcome of the event headache was resolved.  The outcome of the events, chills and fever, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a Medical Assistant refers to a 4 year old patient. Medical history and concurrent conditions were not provided. On 03-JUL-2017, the patient was vaccinated with one dose of ZOSTAVAX lot# reported as M042854, the expiration date: 18-JAN-2018 (dose and route were not reported) instead of one dose of VARIVAX for prophylaxis (wrong drug administered). Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).    No adverse effects reported. No further information provided.
pt recv .11 dose of vax & exp erythema, swelling & pruritus bilat;pruritus lasted approx 9 days;sl erythema & minimal induration were present 3months;devel inflammatory rxn @ two sites of intradermal inj which were almost certainly allergic
Autoimmune Disease determined in July 2021 after 4 months of extreme back pain in the joints.
Patient said dizzy after received shot 1-9-13 4:30pm, ok at night, then dizzy again when woke up this morning 1-10-13. Had 1st flu shot 2012 and no reaction.
Pt recvd 2nd dose of vax 18AUG92 & w/in 1 hrs of vax had pain @ inject site; arm began to swell, became red & blotchy & was hot to touch;
pt recv vax 17MAR97 & devel rash on whole body w/redness & welts;
Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Swelling of face, lips, neck, hands and feet.; Hives; Fever; Joint pain; Muscle pain; Uncontrollable itching on palms of hands and bottoms of feet.; Headache; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date, as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Sep2021, the patient experienced swelling of face, lips, neck, hands and feet, hives, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache. The patient reported that hives were ongoing and other symptoms cleared up within a week to week in a half. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Sep2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events swelling of face, lips, neck, hands and feet, fever, joint and muscle pain, uncontrollable itching on palms of hands and bottoms of feet and headache was resolved on an unknown date in 2021; while that of the event hives was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Had Shingrix vaccine #1 on 10-08-2020, no adverse reaction. Had second part of vaccine on 12-22-2020, on 12-23-2020, had a rash on abdomen approx 3/4 inch wide, 3 inches long, about 3 inches above navel. Rash was smooth as rest of skin, no itching or pain. On 12-27-2020, I noticed a tiny scabby spot on part of the rash. Ever since 12-28-2020, the entire rash has been scabby. Still have no itching or pain, BUT I AM CONCERNED THAT THIS MIGHT AFFECT MY ABILITY TO OBTAIN THE COVID VACCINE. I need to know if this kind of adverse reaction to the Shingrix vaccine is something I should be concerned about when I am able to get the COVID vaccine. I am in the high risk group, due to age and underlying medical conditions.
strange tenderness on left side of breast; painful within her breast or lymph nodes; painful within her breast or lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E12A, 018B21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes). At the time of the report, BREAST TENDERNESS (strange tenderness on left side of breast), BREAST PAIN (painful within her breast or lymph nodes) and LYMPH NODE PAIN (painful within her breast or lymph nodes) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
I was experiencing shortness of breath and chest pains. That started in September 2021, but it may have been before that. I thought it was just me having anxiety. I have a smart watch and it said my heart was in A-fib on 2/10/2022. I went to the doctor on 2/11/2022. I was prescribed Eliquis 5mg 2xday and Metoprolol ER 1xevening. She referred me to see a cardiologist. Since I have been to the doctor, I have had 6 more episodes of A-fib. My left leg hurts all the time as well.
Large red, swollen area on arm below and above injection site, hot to the touch,  woke up with chills and pain. Area I?d approximately 3 inches 3 inches.
p/vax pt exp redness, swelling a warm area, fever of 100.3, high eosinophil count, diarrhea & lymphadenitis;took DPH & felt better;itchy;pt who is MD reported felt had a type 3 arthus rxn, feb state;considered other important med event;
Undiluted Pfizer booster (0.3mL) dose administered to patient's left deltoid approximately 6:30pm on 1/19/22. Pt contacted following day in the morning, no answer, wife stated he was at work. Pt reached around lunch time, disclosed mild body discomfort, took ibuprofen this morning with good effect, and worked a full day. Patient was informed of concentrated dose and indications for urgent evaluation if anything changes.
Moderna COVID-19 Vaccine EUA  pain and redness at needle site and at an approximate diameter of six inches; headache for approximately 30 hours beginning several hours after the shot
pt recvd vax 3JUL95 & 10JUL95 pt devel a full blown case of chicken pox;pt had more than 100 lesions;also exp stomachache, restlessness & listlessness;pt did not have a fever;No further details were provided;
No known side effects Patient received a higher concentration of Pfizer covid vaccine.  RN diluted the vial with 0.8 ml NS instead of 1.8 ml NS.  No negative outcome observed.
localized pain started in left arm; vaccine was administered low' in his arm; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE) and INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)).   On an unknown date, the patient received Arexvy (left arm). On an unknown date, 3 hrs after receiving Arexvy, the patient experienced pain in arm (Verbatim: localized pain started in left arm) and vaccine administered at inappropriate site (Verbatim: vaccine was administered low' in his arm). The outcome of the pain in arm was resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The registered nurse reported that patient administered RSV vaccine in left arm. The patient also co administered Covid-19 and Flu vaccine in the right arm. The date was unknown. The patient stared localized pain in left arm about 3 to 4 hours after administration. The patient described the pain was grade 3. The patient was not certain if the pain was due to the vaccine. The patient thought the vaccine was administered low in his arm and pain may be due to poor technique, which led to vaccine administered at inappropriate site. Now the pain was resolved. The follow-up could not be possible as no contact details were available.
This is a spontaneous report from a consumer (patient's parent) and follow-up from a contactable physician. A 3-year-old female patient of an unspecified ethnicity received PREVNAR (Lot Number: C60102), Hib vaccine (Lot Number: L006546), HAVRIX (Lot Number: F4KRS), and FLUZONE (Lot Number: U4978AB; Expiration Date: 30Jun2015) all intramuscular on 22Oct 2015 at single doses. Medical history included bronchiolitis on 21Dec2012, which required hospitalization for 24 hours. Concomitant medications were not reported. The patient previously received PREVNAR on 02Nov2012 (Lot Number: 918175) and 19Jul2013 (Lot Number: G47423): PEDIARIX on 02Nov2012 (Lot Number: AC21B408CA; Expiration Date: 23Jan2015), 11Jan2013 (Lot Number: AC210357BB; Expiration Date: 17May2014), and 19Apr2013; DTAP DT on 02Sep2015 (Lot Number: C9S96); Rotavirus vaccine on 02Nov2012 (Lot Number: A41FB288A) and 11Jan2013 (Lot Number: A41FB305A); MMR on 21Mar2014 (Lot Number: J004210); Varicella vaccine on 02Sep2015 (Lot Number: L004654); Hib vaccine on 11Jan2013 (Lot Number: H0103038) and 19Apr2013 (Lot Number: H020881); HAVRIX on 13Sep2013 (Lot Number: 2YA5A; Expiration Date: 22Nov2015); and FLUZONE on 17Oct2014 (Lot Number: U4794CA; Expiration Date: 30Jun2014). On 24Oct 2015, the patient experienced upset stomach and vomiting with outcome of recovered. The physician stated that the events were non serious and that the causal effect between the events and PREVNAR was unknown. Follow-up (20Nov2015): New information received from a contactable physician includes: medical history, past vaccine history, seriousness (non-serious), and causality (unknown).
Patient's daughter called the pharmacy on 11/15/14 and stated that her father's arm was very inflamed and very painful and that he had fallen in the floor but since he had fallen a few times lately before getting the vaccine, this is likely unrelated.
Sore in site where shot was given. Getting progressively worse as time has gone by, now, 2 months later I have constant and stronger pain in general area where shot was given. It has spread to a larger area around shot location.
received a Diluent DTaP/IPV from the Pentacel without the ActHIB today, no AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who received received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ192AAA expiry date:22-02-2021 and Diluent Vial Lot U6613AA Exp. Date: 22Feb2021,ActHIB Vial Lot: UJ192AA Exp. Date 22Feb2021,) via intramuscular route in the left thigh was inappropriately reconstituted.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was an actual medication error case due to inappropriate reconstitution technique (product preparation issue). It was reported that patient received a Diluent DTaP/IPV from the Pentacel without the ActHIB on 15-Nov-2019.  It was unknown whether the patient had any adverse reactions.  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 and Module VI of the 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.
coughing, chills, aches, swollen face, lips and eyes.  Eyes bloodshot and tearing.  Significant headache. Fluids, antihistamine
Got Pfizer COVID  booster dose. Then two weeks later got High dose flu vaccine.  No adverse event but instead  a good one: long standing warts on hands and feet,that have been so resistant to treatment that I had stopped.treatng them 6 months  before, immediately started shrinking.  Gone in a week and have stayed gone for more than, 6mo.
All joints hurt severely, fever 101, cough, headache, very tired and dizzy.
Beginning signs of Guillain-Barre including vomiting, weakness, elevated blood sugar. I was admitted to ICU, then transferred to another hospital and diagnosed with Guillain-Barre 3 weeks later.  Remained in hospital until Dec 27th.  Continued in a wheelchair for another 3 months, then therapy through the summer.  10/27/09 Hospital records received. Service dates 10/16/95 to 10/27/95.  Provide only medications list.  12/22/09 DC summary and hospital records received for date 11/30/95 to 12/21/95. Physical rehab dc summary DX: s/p GBS, type 1 DM, orthostatic HTN, neutrogenic bowel, decreased functional debility, muscle spasms. Pt was admitted to hosp. 10/26/95 for diabetic ketoacidosis, periorbital numbness, paresthesias. 10/26/95 pt had weakness and loss of reflexes.Pt dx w/ GBS 10/27/95. Assessment: weakness, bilat upper extremity tremors observed, rt side weakness. Rehab course improved orthostatic HTN, DM controlled. Pt able to perform ADL's independently with some supervision.
I am having shoulder pain which is there right now. I have constant pain in both of my shoulders. It started in the left and is now in the right. The pain could be from the fall that I had. For some reason I lost my equilibrium and somehow fell backwards hitting the door and my head. I called the police, and they came and picked me up. They know me already from previous falls I have had after previous vaccinations.  My back pain was really bad afterwards, so I went to see a doctor and they completed x-rays. The said nothing was broken. I take Tylenol from time to time but no other pain medications. I am unable to sleep because I could not lay down. I slept in my bed, but the pain wakes me up. I had a herniated disk years ago and the pain feels the same. I can't lie down to have an MRI.
Felt nauseated, vomited, headache, low grade fever until 6/16/21 in the evening
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left leg for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "Vaccine location: Left leg". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Patient received COVID-19 Treatment Paxlovid from 04Jun2022 to 08Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient was seated and experiensed lost of conciousness.  moved patient on to floor with legs elevated.  patient came to and recovered
Information has been received from a 68 year old male with allergy to quinolone products who on 18-NOV-2008 was vaccinated with ZOSTER vaccine, 0.65ml (lot # not provided). Concomitant therapy included ezetimibe (+) simvastatin, montelukast sodium and prostate medication (manufacturer unknown). On 19-NOV-2008 the patient experienced warmth, redness and a lump at the injection site. "Routine labs" were performed (results unknown). The patient's warmth, redness and a lump at the injection site persisted. Unspecified medical attention was sought. This is in follow-up to report(s) previously submitted on 12/21/2008.  Follow-up information received from a health professional concerning a patient with colonic polyp, cholelithiasis, diverticulitis and drug reaction to LEVAQUIN who received the first dose of ZOSTAVAX (Merck) (lot# 659673/0557X) into the left upper arm on 18-NOV-2008, the patient sought medical attention and was instructed to use BENADRYL if the symptoms persisted.  Subsequently, the patient recovered.  Additional information is not expected.
Pt reports that within hours of receiving TDAP she has had extreme tiredness, injection site redness, nausea, right should ache, right side neck pain.
reporting an expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information received on 16-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 32-year-old female patient who reports an expired dose of acthib was inadvertently administered with no reported adverse event while receiving vaccine hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine b rfhbp/nada/nhba omv (bexsero) for Prophylactic vaccination; and meningococcal vaccine a/c/y/w (meningococcal vaccine a/c/y/w) for Prophylactic vaccination.  On 16-Aug-2022, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection of dose 0.5 ml total (lot no.- UJ456AAA) via intramuscular route in the right deltoid region (expiry date: 03-May-2022 and 13-May-2022) for Immunization (Immunisation).  On 16-AUG-2022 the patient reports an expired dose of acthib was inadvertently administered with no reported adverse event (expired product administered) (one day latency) following the administration of HIB (PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.