chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles; severe pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles at the age of 20). Concurrent medical conditions included decreased immune responsiveness.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: severe pain). The patient was treated with gabapentin and ibuprofen. The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUN-2023. This case was reported by a patient via interactive digital media. The reporter reported that age plays a factor in possibly getting shingles due to weakened immune system.  The patient had shingles when he/she was 20.  Now patient had inward shingle no rash, but severe pain in patient case.  The patient age was 73 years. The patient got shingles after taking the shots this year.  They had spread all over patient abdomen. Each outbreak was worse than the last.  The patient just went today to doctor.  The doctor prescribed a medication patient had never heard of, increased gabapentin and ibuprofen 800mg hope it all helps.  The patient think shingles were strange in that they come and go so quickly.  The patient think it was not fun. The follow-up could not be possible as no contact details were available.
Sore arm and headache. Tx: Drink water, apply heat or ice and take TYLENOL P.R.N.
Vomiting began 46 hours after vaccine administration.  Patient vomited up water as well as food for 4 hours.  No fever present, no diarrhea.  Patient was lethargic.
Feels Warm at injection site; 3X3 rash at injection site; Itchy at injection site; Swollen at injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (Feels Warm at injection site), VACCINATION SITE RASH (3X3 rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M208) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Feels Warm at injection site), VACCINATION SITE RASH (3X3 rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE WARMTH (Feels Warm at injection site), VACCINATION SITE RASH (3X3 rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details was not reported by the reported. Treatment details not reported by the reporter.
This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients (demographics not provided). On an unknown date unknown number of doses of VAQTA that were exposed to a supported temperature excursion were administered to patients after the temperature excursion. Doses, sites and routes of injection, lot# and expiration dates were not reported. No adverse effect was reported. Additional information has been requested.
69-year-old F with medical history of hypertension, diabetes on insulin, and hyperlipidemia who experienced headache, burning to the injection side, and chest tightness immediately after her 1st dose of the vaccine.  Denies shortness of breath, palpitations, dizziness, or any other symptoms.  She did not look in any acute distress, her lungs clear to auscultation bilaterally, cranial nerves 2-12 intact and no pronator drift.  Vital signs 98%RA, HR 76 , BP 150/90.  She was observed in the medical tent for total of 30 minutes and given water and was reassured.  She felt completely asymptomatic prior to discharge and confirmed that her headache, burning side, and chest tired were all completely resolved.  She was ambulatory before discharge and was advised to call 911 or go to the nearest emergency room if any she she verbalized understanding and agreed to the treatment plan.
Knots, swelling, stiffness at ankles, knees and hands. Arthritis; prescribed Naproxen. Nurse follow up on 06/08/04 states: add, arthralgia.
1st shot - tired, fatigue.  Had it on Thursday, pretty much slept all weekend and took Monday off work and took it very easy Tuesday Wed.  Discontinued my working out (running several miles, training) for >14 days. 2nd shot- April 30, Injection site soreness in my left arm again but felt fine, even ran on Sunday afternoon, then it VERY suddenly hit me around 430 pm- nauseated, tired, dizzy, progressively weaker from run, to walk, to barely being able to sit up-felt very wrong.  2 hours later - my entire GI system went crazy - intense pain / cramping, very forceful multiple episode vomiting (I have only vomited a few times in my life, most recently a few years ago when I got very motion sick on a flight, and it was NOTHING like this), and severe diarrhea.   This continued all night- I had to lay on my left side and every 30 minutes or if I moved at all, my entire guts cramped up, and I had very forceful vomiting and diarrhea, to the point I could taste blood and there was blood in the toilet.  I was extremely cold.  Temp only 98.8 though.   This lasted for 14 hours.  After that, the cramping lessened although still everything passing right through me.   I could not get out of bed for 2 days, but gradually felt better and by the weekend could walk a few miles.
I was on the telephone I was standing and working on the phone and all of sudden I buckled and my legs went under me and I felt like I was losing strength and I called for my daughter and I said to her I have to lay down and she started asking me stroke questions and  later told I didn't make since. My doctor is very responsive and called me later that night and I told him what happen and he state that I "needed to go for a brain scan".
1-2 days later patient reports searing neurological pain on the right, lateral flank. Describes the quality like scrubbing and shooting pain. In an area where patient has previously had herpes zoster but no rash is present. A course of acyclovir was prescribed and was ineffective. Gabapentin prescribed for a "post-herpetic" type neuralgia. Pain remains constant +1 week since vaccination.
rash; This case was reported by a consumer via  interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (1st dose received in 2019, refer case US2021AMR180459).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and experienced persistent rash since than. The patient get to went away, then it pops up somewhere else. The reporter said it was terrible but still better than shingles. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR180459:Same patient, different dose
Pt vaccinated with DTP 8-12 hrs later developed fever 101-103 with episodes of brief startle with staring but not thought to be true seizure; observed in hospital 36 hrs, became afebrile and neurologically normal. Given tylenol
Generalized red lacy rash on trunk, back, abdomen, upper thighs. Urticaria like plaques on left AC fossa, left wrist, upper lip, nose
Acute kidney injury diagnosed with blood test showing abnormal lab results. Symptoms that lead to blood work was: severe fatigue, shortness of breath,  nausea, dizziness, syncopal episode x 1, headache
pt recv vax 23JUN98 & approx 6mo p/vax dose 1 & same day as dose 3 pt devel numbness & tingling;over the priod of the next 3 days pt also devel apin @ inj site;
NO ADVERSE REACTION TO VACCINE.  VACCINE WAS GIVEN AT AN EARLIER AGE.
booster; Head ach; dizziness; stomach issues; swollen lymph node under my left arm; low grade fever with chills; low grade fever with chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 10:00 (Lot number: FC3183) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0162, Location of injection: Arm Right), administration date: 19Apr2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "headache", "dizziness", "stomach issues"; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Mar2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "stomach issues", "dizziness", "headache". The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:00, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 06Dec2021, outcome "recovering", described as "Head ach"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "recovering", described as "dizziness"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Dec2021, outcome "recovering", described as "stomach issues"; LYMPHADENOPATHY (non-serious) with onset 06Dec2021, outcome "recovering", described as "swollen lymph node under my left arm"; PYREXIA (non-serious) with onset 06Dec2021, outcome "recovering", CHILLS (non-serious) with onset 06Dec2021, outcome "recovered" (2022) and all described as "low grade fever with chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness, abdominal discomfort, lymphadenopathy, pyrexia, chills.  Additional information: Patient did not receive any other vaccines in four weeks. Patient did not received vaccination prior to covid and covid test was not performed during post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
I starting developing a severe rash 20 minutes after the vaccine was administered. I went home and the rash was followed by hives, high Fever, body aching, terrible headache, by 7:30pm I took 80mg of MOTRIN and 25mg BENADRYL. However, the fever persisted and by the time my husband got home I was hallucinating due to the high fever, at that point he had to apply eye pads on my front head and wrist. This event last about half hour that I started to get back to normal. My body was heavy and painful, rash last few days and I continue BENADRYL 25 mg for 3 days.
Syringe/needle malfunction during vaccine administration: Vaccinator inserted needle into patient's arm.  When began to inject dose, all of vaccine leaked out at the hub where needle attaches to syringe.   Vaccinator estimates patient received very little, if any, of this dose.  Another dose was administered, and this dose was considered wasted.  The syringe is BD brand 3 mL, packaged with 25G 1" needle.  Vaccinator discarded into sharps bin before we could investigate if perhaps the luer lock threading mechanism was defective.
4/15 Headache (Tylenol) 4/16  Headache, fatigue, fever, muscle aches (Tylenol) 4/17  Fatigue, muscle aches, hives, rash and pain around injection site (No treatment)
Headache, sore joints, petechiae rash on legs, feet, ankles, elevated C-reactive Protein, decreased lymphocytes
Read our brain/when I think about something and talk about that matter, example, when I am washing my dishes, and in my mind, I search for, it comes to my phone, and it is exactly what was in my mind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), 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: MENTAL DISORDER (non-serious), outcome "unknown", described as "Read our brain/when I think about something and talk about that matter, example, when I am washing my dishes, and in my mind, I search for, it comes to my phone, and it is exactly what was in my mind".  Additional information: Caller stated I am not kidding; this was really serious about that. I got the COVID 19 vaccine, the Pfizer for the COVID. After that, I want to know if this medication can read our brain. After receiving the medication, and this also happen to other people, when I think about something and talk about that matter, for example, when I was washing my dishes, and in my mind, I search for, it comes to my phone, and it was exactly what was in my mind, you know. I talk about everything that happen, but it was not only for me, I saw many people reporting this. I know that tech was improving but this was a lil bit scary. When asked if this was after a booster or a primary series dose, the caller did not clarify the type of dose and just mentioned she know people that report this after just two doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 14 month old infant patient. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
administration of quadracel which was expired with no reported adverse event; Initial information received on 17-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who for whom administration of Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) Vaccine [Quadracel] which was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) for Immunisation.  On 17-Jul-2023, the patient received a dose of 0.5 ml of expired suspect Diphtheria-15/Tetanus/5 Hybrid AC pertussis/IPV (MRC5) vaccine suspension for injection (lot: C5916AA) with unknown strength & expiry date via intramuscular route in the left thigh for Immunization with no reported adverse event (product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome.  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 guidelines. 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.
Pt vaccinated developed swelling-lips, face lt arm & lt hand. Seen in ER 13NOV90. Vsikeril injection in ER Hydroxyzine pam 50mg TID x 7 days. Seen in MD office 15NOV90 for f/u
developed rectal bleeding on 4/3/21, admitted to hospital on 4/5/21, discharged on 04/07/21 post EGD and Colonoscopy with blood transfusion x 2 units,  no findings on upper/lower endoscopy, Meloxicam for arthritis discontinued, doctor advised bleed may be due to NSAIDS.  Prescribed Protonix
Two minutes after receiving Pfizer vaccine, member complained of lightheadedness and nausea. Member was given juice and graham crackers and V/S were taken: 1004: 104/60, 77, 98% (room air), 1006: 114/71, 79, 100%, 1009: 127/46, 78, 99%, 1012: 93/52, 85, 99%, 1014: 105/37, 83, 99%. Member stated symptoms resolved after drinking juice and crackers. He stated he did not eat anything today prior to receiving vaccine. Member's mother was at his side. Clinic manager was also called to member's side. Member was transferred to observation via wheelchair for further observation in stable condition, alert and oriented x4, no signs of respiratory distress, denied all complaints.   In observation room nurse noted:  After episode of nausea and lightheadedness, pt continued to improve in observation area.  He remained 30 minutes as VS continued to improved (final check was BP=111/71, HR=60, O2=99%, RR=20).  He stated feeling better and facial color much improved.  He left the clinic via wheelchair with his mother and brothers.
blood clot upper left shoulder around the neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4441194 (Genentech).  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation; rivaroxaban (XARELTO) (Batch/Lot number: unknown). Relevant medical history included: "Malignant neoplasm of unspecified part of unspecified bronchus or lung" (unspecified if ongoing), notes: Malignant neoplasm of unspecified part of unspecified bronchus or lung. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset May2021, outcome "recovered" (Jul2021), described as "blood clot upper left shoulder around the neck". On unknown date it was reported that patient experienced: May2021 the patient had a CT scan of the chest. There was a blood clot upper left shoulder around the neck. At the time the patient was taking Xarelto. They (not known if this was the HCP or the reporter) believed that this blood clot was not due to Xarelto but rather due to COVID19 vaccine Pfizer. In Jul there was a scan and no blood clots remained. The patient underwent the following laboratory tests and procedures: computerised tomogram: (May2021) blood clot upper left shoulder around the neck, notes: There was a blood clot upper left shoulder around the neck; (Jul2021) no blood clots remained, notes: In Jul there was a scan and no blood clots remained.
Concomitant vaccines were IPOL, Fluzone and one unspecified vaccine. On 04-OCT-2001, the pt received her first injection of Havrix. In January 2002, 3.5 months post immunization, she developed encephalitis which required hospitalization. The reporting physician believed that the encephalitis was not related to Havrix administration. As of 07-JAN-2002, the outcome of the event was unknown.
Several hours after injection I spiked a fever of 100.9.  All joints and muscles ached.  Felt awful!
Patient was here for Flu vaccine but it was processed as Covid 19 pediatric dose.  Mom filled out and signed on Covid -19 ped dose. After administering the flu vaccine, mom asked if patient was given Flu vaccine. He was doing fine but he had his first covid 19 ped dose 8 days before.
Syringe was not tightly bound to needle, so on first attempt, the contents of the syringe leaked out.  As far as the vaccine administrator could tell, no vaccine entered the patient's arm on that first attempt.  The patient was then given a second injection which was administered without difficulty.
calf muscle cramps in both legs; leg discomfort during day time hours; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EWO151), via an unspecified route of administration, administered in Arm Right on 20Apr2021 09:45 as dose number unknown, single for covid-19 immunization. Medical history included sinus and known allergy: yes from an unknown date. Concomitant medications included mometasone furoate (NASONEX) taken for an unspecified indication; azelastine hydrochloride (ASTELIN) taken for an unspecified indication; and montelukast sodium (SINGULAIR) taken for sinus and allergy related, all start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. On 28May2021 06:30, the patient experienced calf muscle cramps in both legs and no treatment was taken. The patient reported that she never had experienced cramps prior. On an unspecified date in 2021, the patient had experience leg discomfort during day time hours and began consuming tonic water containing quinine. This has been part of her daily routine for weeks now since the lower leg discomfort was worsening. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Suddenly on 24APR92 early PM, mom took pt to ER w/c/o fever 104, pulling @ ears, n&v x 2;  poss acute viral infect; pts face flushed; pos tears;