chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a Twinrix vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 58-year-old male patient who received HAB (Twinrix) (batch number P9LT9, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose 22nd March 2022, batc number 9AX5P and expiry date 23rd November 2023).   On 21st June 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 21st June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine 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 Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: After receiving 1st dose of Engerix B, three months latre did not receive another dose of Engerix B but received Twinrix. The reporter did not consent to follow up. Additional Supportive Information: After receiving 1st dose of Engerix B, the patient received Twinrix vaccine, which led to wrong vaccine administered.
Acute myocardial infarction; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health professional and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2021 due to ACUTE MYOCARDIAL INFARCTION. At the time of the report, ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was hospitalized for approximately 3 days and was treated in the Cath lab.  No concomitant medications was reported.  No treatment details were provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Couldn't get up out of bed or open her eyes on Saturday (day after the vaccination); Fever of 100.4 on Sunday; Sweating; Shivering; Arm is red at injection site; Could barely move her right arm; Queasy/nausea; Vomiting; feeling faint/Dizzy; Weak; Body aches (bones and muscle); Body aches; Body aches (bones and muscle); Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 97LJ7) for prophylaxis.  On 02-JUN-2023, the patient received the 1st dose of Shingrix (right arm). On 02-JUN-2023, 6 hrs after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Arm is red at injection site), injected limb mobility decreased (Verbatim: Could barely move her right arm), queasy (Verbatim: Queasy/nausea), vomiting (Verbatim: Vomiting), felt faint (Verbatim: feeling faint/Dizzy), weakness (Verbatim: Weak), bone pain (Verbatim: Body aches (bones and muscle)), general body pain (Verbatim: Body aches), muscle pain (Verbatim: Body aches (bones and muscle)), headache (Verbatim: Headache), sweating (Verbatim: Sweating) and shivering (Verbatim: Shivering). On 03-JUN-2023, the patient experienced bedridden (Verbatim: Couldn't get up out of bed or open her eyes on Saturday (day after the vaccination)) and fever (Verbatim: Fever of 100.4 on Sunday). The outcome of the injection site erythema, injected limb mobility decreased, felt faint, weakness, bone pain, general body pain, muscle pain and headache were not resolved and the outcome of the queasy, vomiting, bedridden, sweating, shivering and fever were resolved.  It was unknown if the reporter considered the injection site erythema, injected limb mobility decreased, queasy, vomiting, felt faint, weakness, bone pain, general body pain, muscle pain, headache, bedridden, sweating, shivering and fever to be related to Shingrix.  It was unknown if the company considered the injection site erythema, injected limb mobility decreased, queasy, vomiting, felt faint, weakness, bone pain, general body pain, muscle pain, headache, bedridden, sweating, shivering and fever to be related to Shingrix.  Additional Information: GSK receipt date: 05-June-2023 and 06-JUN-2023 The consumer was the reporter. The patient received the first dose of Shingrix. On the day of vaccination at evening, the patient experienced queasy, nausea and vomiting, dizzy and felt faint.  The patient also was shivering and sweating. The patient experienced body aches in body and muscle, headache, and weak, arm was red at injection site and could barely move her right arm.. The patient could not get out of bed on Saturday or open her eyes.  The patient also experienced a fever on Saturday but was unable to find a thermometer to document the value and on Sunday she had a fever of 100.4 for the entire day. The reporter consented to follow up.
Migraine headache; Pain and swelling in right arm where 1st vaccine was shot. Slight Redness in the same arm of injection. Slight Fever ~ 100 F for the 1st two days after vaccine #1. Body chills. Body aches. Tiredness. I felt a bit weak during the first night of the vaccine.  I also felt a slight tightness on my chest or slight pain in my chest the first night.
calf muscle pain; calf muscles have become extremely tight; This is a spontaneous report from a contactable Consumer, the patient. A 68 Year(s) old Male patient received BNT162B2 {PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch number: Unknown} via an unspecified route of administration in left arm on 14Feb2021 at 12:00PM, as a second single dose (age at vaccination was 68-year-old) for COVID-19 immunization at  Clinic. The patient's medical history and concomitant medications was unknown. Patient not had any allergies to medications, food or other products. The patient previously took first single dose of BNT162B2 {PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch number: Unknown} via an unspecified route of administration in left arm on 24Jan2021 at 12:00PM for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 And not had been tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks and any other medications within 2 weeks prior of covid19 vaccination. On 17Feb2021, the patient felt that calf muscles had become extremely tight which resulted in extreme pain when getting out of a bed or getting up from sitting for more than 30 minutes. Noproxin was taken as a Therapeutic measure for muscle relaxation and physical therapy. The patient had not recovered from the event at the time of reporting. No follow up attempts are possible,  information about batch number cannot be  obtained. No further information is expected.
The injection was given into the shoulder joint rather than the deltoid muscle. This has resulted in an  inflammatory process that has caused pain and injury to my left shoulder (e.g., tendons, ligaments, bursae, nerves).  I now have persistent shoulder and upper arm pain, weakness, and limited range of motion that has worsened in the two weeks following the injection.  I am dealing with chronic shoulder and upper arm pain, and am unable to carry out daily activities that were not an issue prior to vaccination.  When the symptoms did not subside, I sought medical treatment from my primary care provider on July 15, 2021.
Chills, fever 100.2, body aches, sore and red at site of shot radiating out about 2 inches around(18-19 hours after injection..  Lymph node on ride side of collar bone swollen hard node (3rd day)
Severe arm pain and swelling, arm was hard at the injection site, fever, chills, body aches, headache for more than 24 hours
almost passed out; felt discomfort; He was very cold; chills; This case was reported by a consumer and described the occurrence of chills in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, presyncope, discomfort and cold. On an unknown date, the outcome of the chills, presyncope, discomfort and cold were recovered/resolved.   It was unknown if the reporter considered the chills, presyncope, discomfort and cold to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received his 2nd dose a month ago from the date of reporting.   He was very cold and had chills on the day of administration that lasted for 24 hours.  He almost passed out the day after administration.  He reported that he felt discomfort for 2 weeks.   He was not able provide specific details regarding the discomfort feeling. Did not consent to follow-up.
PT SAT ON THE BENCH AFTER RECEIVING MODERNA AND A COUPLE MINUTES LATER, WE HEARD A THUMP. PT PASSED OUT  WITH HIS HEAD ON THE CONSULT ROOM DOOR AND WOKE UP SECONDS LATER WITH NAUSEA AND SWEATING.  GAVE PT WATER AND MONITOR FOR 30 MINUTES.  PT REFUSED MEDICAL HELP, NOTIFYING A FAMILY MEMBER AND FOOD.
shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EN5318; expiration date: unknown), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunisation . The patient 's medical history was none. Concomitant medication included NP [pending clarification]. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she did not have side effects from the shot. The patient added that 2 days after the shot (01Feb2021 08:00 AM), she got shingles. The patient reported that the event as non-serious. She received treatment for the event (medicine) and the adverse event result in doctor or other healthcare professional office/clinic visit. The patient has not been for COVID-19 since the vaccination. The outcome of the event was recovering.
stomach turning, became hot, lt arm throbbing whole arm & hand, ringing in ears, diaphoretic;
Patients started complaining about feeling itchy on abdomen and legs. upon assessment of patient no visible redness, irritation, or bumps present on patient's skin. Vitals were taken at 0955 BP: 118/70, HR: 76, RR: 20, O2 Sat:96%. Offered patient water and called provider to request if Benadryl could be given to patient who stated itching was getting worse. Provider stated was ok to administer 10mL of Benadryl HCl 12.5mg/5mL PO at 1002. Patient was monitored for 15 mins after, vitals were rechecked at 1015 they read BP: 122/76, HR: 76, RR:20, O2 sat: 98%. Patient stated she felt better after given the medicine, the itch was going down.
Rash from neck down to left and right shoulders across upper chest and down the sides. Rash is hot to the touch and was noticed <36hrs after dose. Heavy fatigue and body aches within 12 hours. Dry mouth and headaches within 8hrs.
Progressive Left arm pain/shoulder soreness that began 5 days prior to hospital presentation. Seen in ambulatory clinic 7 days prior to presentation, given ibuprofen and percocet without relief. New swelling and erythema brought pt to hospital. Around time of vaccination, the pt was using triamcinolone for left forearm rash (described as small, more-spotty and resolved quickly). MRI revealed an abscess (10 x 6.8 x 1 cm) deep to the deltoid muscle and along the lateral aspect of the left proximal humerus. He also has another abscess within the posterior deltoid muscle (3.1 x 2.1 x 2.8 cm). There is surrounding myositis, fasciitis and cellulitis.
Information has been received from the registered nurse. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who on 21-FEB-2013 was administered a dose of GARDASIL (lot # 668261/1397AA and expiration date 09-APR-2013) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Low back pain on Day 2, got progressively worse through Day 14, then began receding.  Day 7, injection site became red, inflamed to about a 6" radius with pain to the touch. Day 8 and Day 9, radius expanded and redness and swelling wrapped around the arm.  Pain and stiffness radiated up through shoulder and neck and lower back pain was intense days 7, 8 & 9.
In late March 2021 and early April 2021, I started getting spike headaches. I didn't get them everyday. They were very sharp, brief, and intense. They only lasted for a few seconds. I did try stopping them by stop taking some of my different medications, but that didn't make a difference. By December 2021, the headaches had progressed. I had started to get them everyday and a couple of times through out the day. In January 2022, they diminished. By the end of January 2022, I wasn't having anymore headaches. I had went to see a neurologist on 2/14/2022. He said my blood vessels looked normal. I don't have the headaches anymore. I haven't had those type of headaches before. I had some dizziness as well. In May 2021 and June 2021, I was experiencing some brain fog.
24+ hours after receiving vaccine; S&S: burning rash all over the body, swelling of lips, tongue, mouth. Pt went to urgent care clinic & was given: steroid shot; MEDROL dose pack & KEFLEX. Recommended OTC diphenhydramine. Shot given: afternoon 10/8/12 reaction: evening 10/9/12 spoke w/ pt 10/12/12. Swelling gone decreased rash.
first dose administered under age 18; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered under age 18) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for an unknown indication.     The patient's past medical history included No adverse event.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered under age 18).   At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered under age 18) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
9/3/2021 @ 2000:  I developed aches, pains (FLU like symptoms), and fever, these symptoms lasted for 2 days requiring alternation of Tylenol and ibuprofen.  In addition to these symptoms on 9/4/2021 I developed a large knot (abscess) in the armpit of my right arm (injection side).  It grew to a size between a golf ball and baseball, causing great discomfort and pain, using moist heat compresses to help relieve the pain.  On 9/11/2021 this knot in my armpit had fully dissipated.  On 9/15/2021 @ 1700 I developed a headache, earache, and toothache on my left side.  From 1700-2300 the pain gradually got so bad I was using Tylenol and ibuprofen as well as ice packs to tolerate the pain.  9/16/2021@ 0645 I called and left a VM at my dentist?s office requesting to be seen ASAP.  Dentist office called back and I was able to be seen at 0830 that morning.  X-rays done shown that I had abscesses on teeth #13 & #14.  The dentist began doing a root canal on #13 this process was going to take 3 visits due to the abscess.  After my appointment sedation wore off much faster than the dentist office had said and from that point until I was able to call the office again the next morning 9/17/2021, I returned back to the dentist office in excruciating pain. After 2 hours of trying to numb the area to try and treat unsuccessfully, my dentist called an oral surgeon in town to see if I could get into see them ASAP.  The receptionist at the dentist office had to drive me to the oral surgeon?s office because I was in such pain.  The oral surgeon did x-rays and a CT of my head and teeth and found multiple abscess.  At this point the only thing that could be done to get me out of pain was to surgically remove the two teeth that were exposed by the dentist.  I was put to sleep under general anesthesia and teeth #13 & #14 were surgically removed by an oral surgeon.  I was prescribed an antibiotic and pain medication.  9/21/2021 @ 1430 I had a follow up appointment with oral surgeon.  Wait 4 months for mouth to heal before I can do anything for missing teeth repair.  Oral surgeon has suggested implants to replace missing teeth, this process can take up to a year for work that will need to be completed. Antibiotic prescribed is hopefully clearing up other abscesses, today I have no additional pain.
started crying 1 1/2hr p/shots, high pitched scream cried for 1/2hr @ a time;calm done for 5-10min scream some more lasted 10hr;no known fever didn't feel warm, unable to take temp;now only fussy when tired or hungry;much happier;
Sat. night, 14th, I had uncontrollable chills at about 7 pm. At 10:30 pm or so, started running a fever. Then Sunday, I continued to have fever off and on and chills off and on. I would have chills, sweats, and my fever would go anywhere from a degree or so above normal temp to 102.5 (highest) Sunday - Wednesday. It was 85 or 90 degrees outside and I was cold, Teeth, skin and back all hurt. I couldn't think straight. My eyeballs hurt. Thursday - Friday - I quit running a real high fever; but my body still ached, teeth and eyeballs still hurt. Saturday, the 21st, I got the Monoclonal antibodies injection. The day after the infusion, when I woke up Sunday I felt much better. I had had a telehealth visit either Tuesday or Wednesday before the injection. Thursday, I called the physician to ask the doctor about the infusion and she set me up. Chicken Soup - only other treatment. I can't smell or taste yet.
egg-sized swelling at area of vaccine with cervical lymphadenopathy, body aches and fever.  Called nurse line and spoke with on-call physician.  Advised to take ibuprofen and fexofenadine and has improved.
hearing loss at low frequency with severe distortion and  pressure.  1+ week duration, then respite 2-3 days, then scheduled office visit, then reoccurred for about 10 days then over for about 10 days as of this entry.  physician noted redness upon ear inspection and prescribed antibiotics  - 2 courses - symptoms had cleared by the time second course arrived and began.  comment - this was very unusual and not experienced before - the audio distortion was very unique. a bit of disorientaation but no fever, pain or imbalance.  injection site discomfort/pain after second  - about 4 days
Pain and soreness in all 4 extremities.  Thankfully, It is not a sharp or stabbing type though.  It is more like I've been holding on something as tightly as I could while swinging it around for hours . While I've never done this activity, I imagine it would be the same feeling if I had just spent the day having to swing a sledgehammer to break down boulders or concrete.
Guest did not report adverse reaction until 10-16-2010, she said the symptoms of severe muscle pain and stiffness started back on 9-12-2010 could not move arm above head
Narrative:  Patient received 1st dose COVID-19 vaccine (Pfizer) on 03/04/2021. About 1 week later, reports having heart palpitations. Patient did not receive treatment for this.
feeling cold; Feeling sick; Sore body feeling as hit by a truck" and a horrendous pain; bad headache; high fever 103.8F; This spontaneous case was reported by an other and describes the occurrence of FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F). At the time of the report, FEELING COLD (feeling cold), MALAISE (Feeling sick), PAIN (Sore body feeling as hit by a Mack truck" and a horrendous pain), HEADACHE (bad headache) and PYREXIA (high fever 103.8F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.8 (High) High fever of 103.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Arm,  muscle,  shoulder pain since injection.  Limited range of motion, soreness, tenderness, tingling  left side
Information has been received from an Office Supervisor referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with PROQUAD lot # M036295 and expiration date 13-FEB-2018 for prophylaxis (route of administration, dose and anatomical location were not provided) with properly stored sterile diluent (lot number and expiration date were unknown). Additionally, it was reported, that the vaccine was exposed to a temperature between 15 Fahrenheit degrees to 36 Fahrenheit degrees for 4 hours. There was no previous temperature excursion. The call was not placed because of a Digital Data logger report. It was no reported product quality complaint involved. Additional information has been requested.