chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Information has been received regarding a case in litigation from a lawyer and refers to a female patient of unknown age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 16-AUG-2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date was not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation (date not reported), the patient was treated by a health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered not recovered. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Mother called on 8/15/05 to report patient's left arm having a large red swollen area.  She described it as hard and a little smaller in size than her fist.  She described it as being hot to the touch and somewhat painful.  Instructed mother to give tylenol/motrin and to use ice/cold compresses to help with swelling.  Will follow up on 8/17/05.
He died suddenly at home on February 1st, 2022. He had gotten his booster shot on 1/20/22. His first 2 shots were in Feb/March of 2021 and those were Moderna. His booster was 1/20/22, and it was Pfizer. I do not know if he had any symptoms between receiving the booster and his death. He didn't complain of anything. I saw him the morning of 2/01/22 and had conversed with him over text that morning as well. He made a phone call to my sister at 2:30 that afternoon and seemed fine. When I arrived home at 6:50 that evening, he was deceased.
Post 1st day, I felt sharp "electrical" sensations on my right arm & wrist. Alternating to left arm. The "electrical feeling occurred on the legs. This was very short and fast, not ongoing. I felt the sensation on my left leg and numbness started to occur on my left lower leg. The numbness radiated and has not gone away. There is no prickly/spider type sensation as normally felt if leg falls asleep. It is a numb feeling, similiar to loss of feeling or sensation after a surgery incision. I describe it to be anywhere 10-20% feeling gone. It is mainly on the calf below the knee. It feels wierd when clothes or anything touches the leg. No swelling, discoloration or pain. My left leg is STILL NUMB! Please contact me!
Ringing in head.  Patient stated that it sounds like locusts are in his head 24/7.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL 9 injection (lot number/expiry date and dosage not reported). On an unknown date, on an unspecified time, the patient experienced an unspecified adverse reaction. No Product Quality Complaint (PQC) was involved. Action taken with GARDASIL 9 was unknown. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and GARDASIL 9. Additional information has been requested.
15 minutes after, angioedema of lip, which resolved in 1 hour. For 48 hours she had myalgia, fever, vertigo and visual changes (saw 5 objects when there was only one).
Vaccine given 11/17/21  1250 pm. No symptoms noted  after receiving vaccine.  No known history or reaction to Flu vaccine.  Family Care Provider,   reported in the morning of 11/18/21 that patient had a fever of 100.7 that morning, he was unsteady on his feet, he had a fall and she sent him to Hospital ED. Later in the day on 11/18/21,  FCP said patient was doing well, and that she was told it may have been a reaction to the flu vaccine. He was discharged home. In the morning of 11/19/21  FCP stated patient had a fall again that  morning, he was unsteady and she sent him back to Hospital ED.
RED SPLOTCHY RASH OCCURRED  ON CHEST AREA AND UPPER ARM AND SHOULDERS SATURDAY NIGHT 10/5/2019 RIGHT BEFORE BED BUT WAS GONE THE NEXT MORNING.  PATIENT SAID IT DID NOT ITCH.
Covid-19 Positive on 01/04/2023, Admitted to the medical center on 01/06/2023, Expired on 01/12/2023
expired vaccine used; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. No adverse events reported. No temperature excursion of the product was reported. Date place in refrigerator: 18-Nov-2021  .
Patient was treating at home with diphenhydramine after she developed hives on entire body. It progressed to itching in throat, mouth and nasal irritation and hives on palms of hands. Went to urgent care 10/19/20 and received prednisone and triamcinolone ointment 10/21/20 - Patient returned to urgent care. They continued her prednisone (issued 5 more days worth). They also added lidocaine to swish and spit for mouth blisters.
Moderna COVID?19 Vaccine EUA: Had a major effect to my menstrual cycle. I was 10 days late to having my period and when I got it my cramps were heightened and there was a very heavy flow.
Cold/flu like symptoms and developed into sinus infection. Received antibiotics and symptoms went away within 3-4 days. Tested negative for Covid-19 using at-home test.
Initial misuse report received from a healthcare professional on 09 January 2014. This is an invalid case as individual patient identifiers are missing. It was reported that the patient (no information was provided regarding the patients) inadvertently received 2 doses of FLUZONE HD 1 week apart. No adverse event was reported. Documents held by sender: none.
administration of an adult dose of Engerix-B to a child / 4 yeard old patient; administration of an adult dose of Engerix-B to a child / 4 yeard old patient; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 4-year-old male patient who received HBV (Engerix B adult) (batch number 4F472, expiry date 6th November 2022) for prophylaxis.   On 5th May 2021, the patient received the 2nd dose of Engerix B adult. On 5th May 2021, unknown after receiving Engerix B adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional details were reported as follows: The reporter stated that 4 years old patient was vaccinated with an adult dose of Engerix-B, which led to the adult product administered to child and overdose. The reporter was asked information regarding the administration of an adult dose of Engerix-B to a child. The reporter consented to follow up by email but did not provide address.
huge cellulitis on arm; itchy all over for 1 week; Fever for 3 days; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pruritus and fever. On an unknown date, the outcome of the cellulitis was unknown and the outcome of the pruritus and fever were recovered/resolved.   The reporter considered the cellulitis, pruritus and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever for 3 days post Shingrix vaccine, huge cellulitis on arm requiring treatment with antibiotics. The patient itchy all over for more than 1 week post immunization. The reporter consented for follow up.
Red, Fever, Itching, upper arm swelling at the injection area,  day 6 I  got a red ring lower on my arm
Headache, Fever, NauseaVomiting, FATIGUE; COLD CHILLS Narrative:
Anaphylactic reaction, initially unresponsive to IM epinepherine, IV famotidine, IV steroids. Symptoms worsened, requiring intubation, mechanical ventilation, ICU admission
pt stated that the night after the vax the left side of his face started drooping, he had severe headache behind left ear and some slurred speech.  The next day his symptoms got worse so he took Benadryl since he thought he was having an allergic reaction but he continued to get worse.  The third day his speech was getting worse, his face continued to swell and droop and he still had severe headache on the left side.  Pt ended up going to the ER where they did a CT, EKG, Chest X-Ray, blood work, gave him IV fluids and steroids. The ER Dr. consulted a Neurologist which told him he had the symptoms of Bell Palsy so they did the stroke protocol but ended up telling him his symptoms were from taking the Covid Vaccine.   He was told to finish his medicine that they prescribed which is steroid and antibiotic and if he did not get any better to come back for FU.
pt recv vax 11JUL95 & 3NOV95 MD gave vax again by mistake & pt exp chest pain, felt that there was liquid in lungs, has trouble sleeping & devel nose bleeds;f/u MD revealed that the pt was vaccinated w/measles vax 3NOV95;
Suspected vaccination failure; has suffer with them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's mother. The age at vaccination was not reported. Since 1st July of unknown year, after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pfizer-BioNTech Covid 19 Vaccine  Description 1.26.2021:  It first started with swelling hands then tingling in bilateral fingers and hands. That progressed to tingling in feet and toes. The nerves coming into my arm pits were very painful and I couldn't put my arms against my body. Petechia rash on my torso. Numb left lower lip and jaw area, numb right shoulder, numb shins and calfs. when the numb lip began my PCP had me go to the ED for evaluation. All blood work and Electrolytes came back normal. All this lasted over a week and the petechia spots are still on my torso, but seem to be going away.
Information has been received from a certified medical assistant concerning a 42 year old male with no allergies who was vaccinated with a dose of MMR II. The patient had a negative for the rubella. Office had no this vaccination history for this patient. Rubella titer test was taken from about a week ago on approximately 01-JUN-2009 and the result was negative. The patient was seen for a physical to seek medical attention. Additional information has been requested.
Had the first dose; Had an accident and she fell and broke her ribs; Had the first dose; Had an accident and she fell and broke her ribs; Had the first dose; Had an accident and she fell and broke her ribs; This is a spontaneous report received from a contactable consumer(patient). A female patient of an unspecified age received the first dose of BNT162B2 (lot number EN6206), via an unspecified route of administration in left arm, on 25Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose on 25Mar2021 and she was scheduled today to get her second dose. However, the patient had an accident and she fell and broke her ribs on an unknown date and she wanted to reschedule her second dose on next Wednesday, that will be on 21Apr2021. The outcome of the events was unknown.  No follow up attempt possible. No further information expected.
back muscle pain one week later/pain down patient's left arm; back muscle pain one week later/pain down patient's left arm; This is a spontaneous report received from contactable reporter(s) (Consumer (patient's husband)).  An 88-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, single (Lot number: HG4633) at the age of 88 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Oct2023, outcome "unknown" and all described as "back muscle pain one week later/pain down patient's left arm". Therapeutic measures were not taken as a result of back pain, pain in extremity.  Additional information: Patient's doctor said that he had patients with similar problems of pain after COVID Pfizer shot. Patient have had multiple Pfizer shots (COVID) with no aftereffects.
Dry heaves  Vomiting  Water diarrhea non controllable  Headache  Drowsy
Patient was given a booster shot on 11/4/21 at the Pharmacy.  That pharmacy is now closed and we have taken their prescriptions.  APRN called on patients behalf saying that patient is having trouble with her arm for months now that she has gotten the shot.  I was given this information second hand so I don't have all the details.
A physician reported that an 18-month old female received her second dose of Prevnar on 06/13/2001. On 06/19/2001, she was seen by her pediatrician for a chronic cough. Physical exam revealed rales on her left side, but otherwise, the child was in no acute distress. She was diagnosed with pneumonia and treated with Zithromax. The physician noted that if condition continued, a diagnosis of asthma may be considered. On 07/05/2001, she was again seen by the physician for an irritability cough, shortness of breath, wheezing, not sleeping well and some retractions. The child was in mild to moderate respiratory distress. Her exam was consistent with reactive airway distress. She received Albuterol via nebulizer and responded well. There was a decrease in her respiratory rate and an increase in breath sounds. On 07/12/2001, the child was seen for a recheck. Physical exam was within normal limits and her lungs were entirely clear. The physician indicated that "her original pneumonia most likely was an episode of asthma". She was placed on Flovent 44 mcg BID and Albuterol PRN. The physician noted "It is my opinion that this is not a vaccine related reaction".
A report was received from a health care professional on 14 October 2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin subcutaneously on an unspecified date. On an unspecified date an unspecified number of vaccinees under 4 years of age received Fluvirin subcutaneously. The reporter indicated the the exact number of vaccinees was unknown but was believed to be less than 20 vaccinees. Vaccinees aged between 6 and 35 months were given 0.25 ml and 0.5 ml was given to vaccinees greater than 35 months. No adverse symptoms had been noted. Update 1, 07 November 2003. A follow up report was received from a consumer indicating that an 11 month old male vaccinee inadvertently received Fluvirin on 10 October 2003. No adverse reaction had occurred at the time of the report. Cross reference with: PJP200300808.
Received Dtap, vaccination in right arm, Next day developed localized itching, redness and swelling at right deltoid area.
Sore arm pain - first few days; Almost two weeks later, I noticed a large red rash in the area of injection and it was expanding, warm and red. I called an on-call nurse. They encouraged me to call the (on the 27th) doctor to see if it was cellulitis. They thought it was a delayed reaction to vaccine and suggested to take Benadryl and told me to call back if it didn't clear up in the next day or two. It cleared up by the next day (28).
Swelling (hard ball swelling beneath skin). Red area (4-6 inches in diameter).
Shortly after the shot I went to get some food after that I started having a fever and a gout episode followed shortly after. I was bed ridden for 8 days and then was hospitalized for 7 days.
Patient fainted, banged head on wall behind her, began to shake, and fell to ground.  Became alert a few seconds after.  Was taken by ambulance.
Pt was in for a blood borne exposure with a metal object. Tetanus was given in L deltoid IM with alcohol cleansing of the inj. site. Returned 48 hours later with c/o L arm soreness, swelling, N/V, decreased ROM of L arm. 2-3 cm redness, 7-10 cm firmness.
Patient consented to receive J&J vaccine without notifying provider that he had received another dose of the same vaccine on 3/10/2021.
Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm; swollen and tender right axillary node under right arm; swollen and tender right axillary node under right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140), intramuscular on 22Dec2020 10:30 at first single dose at arm right for covid-19 immunisation .  Medical history included breast cancer, allergy to penicillin, levaquin, neosporin, cocoa butter.  Concomitant medication included vitamin c [ascorbic acid].  The patient experienced swelling, and warmth at injection site, right arm, swollen and tender right axillary node under right arm on 28Dec2020 16:00.  No treatment for events. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Patient developed shingles after receiving the chicken pox vaccine. I noticed the bumps on the 15th but did not think it was shingles. Shingles were diagnosed on July 20, 2015. She has had fever, severe rash on the back of her neck, and fatigue.
10/3/09 Evening-had fever per mom's call on 10/5/09. 10/4/09 Mom noticed son's arm was warm to the touch, hard, swollen, reddened, and painful to the touch. 10/5/09 Arm continues to be swollen, red, and hard. PHN discussed E E S Chorj; PHN advised mom to have child seen at stat  care or pcp per Dr.
Narrative: 72yo male pt homeless died at hospital on 12/8/21 after determined to be DNR as pt had gone into multi-organ failure. Pt had received 3 covid vaccines on 3/5/21, 4/5/21, & 9/9/21 (full dose). This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Three weeks post vaccination, the patient developed chickenpox with a fever which lasted one day. It was reported that the lesions covered her body. Unspecified medical attention was sought. Additional information has been requested.
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (were under treatment for this illness). Concomitant products included ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ), MELOXICAM (MOBIC), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 02-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was provided.  Reporter stated they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days.
Case received second covid vaccine on 03/04/2021. Hospital on 8/7/21 with respiratory distress . Positive COVID lab on 8/7/21. Case expired at hospital on 8/18/2021.
Arm: prolonged pain, tenderness, swelling and redness (for about 5 days) Other: headache, muscle and joint pain, chills, nausea, dizziness (for about 18 hours) oxygen level: averaged 96 but dropped to 93 one time (but that might have been equipment error)
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # J012520 exp. 30-JAN-2016 (dose and route were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
"SM received Pfizer covid vaccine dose number two at 1020. Felt ""odd"" after vaccine with HA.  She returned to our area with complaints of selling tongue and throat with continued headache and hot feeling. Remained in alcove for monitoring. VS 1117 HR 102, BP 148/84, 100% 1125 HR 85, BP 126/82 99% 1130 HR 75, 124/85, 100% Admistered 25mg of Benadryl at 1119.  Tongue swelling decreased at reassessment at 1135.  Patients spouse was called to pick up and drive home as SM was tired due to Benadryl administration.