chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an approximately 24 (currently 50) year old female physician with Lyme disease and severe latex allergy (developed approximately in 1985), who in 1985, was vaccinated with a dose of RECOMBIVAX HB (lot number, dose and route not reported). Concomitant medication included unspecified antibiotics for Lyme disease. Physician stated that she received RECOMBIVAX HB while in her surgical rotation, and she had since suffered from "myocytis" and an autonomic nervous disorder. She reported that shortly after receipt of RECOMBIVAX HB (in 1985), she started "passing out" in during her surgical rotation in medical school. She reported that she consulted a cardiologist and neurologist at the time and the results of the tests did not show any cardiac arrhythmias or any specific neurological disorder. Muscle biopsy revealed a non-specific inflammatory process and her laboratory tests had demonstrated a consistent elevation in her muscle enzymes and no evidence of an autoimmune disorder. She reported that at the age of 31 (in 1992), she developed fibromyalgia and due to ongoing muscle pain, she underwent a muscle biopsy 10 years ago (in January 2002), which revealed a non-specific inflammatory process. Presently (in January 2012), she reported that 15 minutes after moderate exercise her cardiac output decreased, and she "nearly lost consciousness as a result". She did not want her physician to be contacted because these events had been ongoing "for years". The patient sought medical attention by physician examination. Performed lab studies included: electrocardiogram, muscle enzymes and autoimmune profile. The patient's outcome was not recovered at the time of report. Therapy with RECOMBIVAX HB was not reintroduced. The patient's adverse events were considered to be disabling by the reporter. Additional information has been requested.
Drop foot, back surgery, neuropathy in both feet, ocular issues, chronic pain, loss of mobility
Small red bumps on pelvic bone and one on neck, itchy. Aveeno baths, fluids.
Patient described sore arm that turn into her hand feeling stiff. Specifically her middle finger joints became inflexible. Symptoms resolved over the next week.
This case was reported by a healthcare professional (nurse) and described the occurrence of fever in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included meningococcal acwy vaccine (non-gsk); Novartis; unknown; right arm given on 12 July 2013. On 12 July 2013 the subject received 1st dose of CERVARIX (.5 unknown, unknown route, left arm). On the morning of 13 July 2013, 1 day after vaccination with CERVARIX, the subject experienced fever. On the morning of 14 July 2013, 2 days after vaccination with CERVARIX, the subject experienced fatigue, headache, myalgia. Within days of vaccination with CERVARIX (specific date not reported), the subject experienced arthralgia, injection site pain, injection site redness, and swelling injection site. On 13 July 2013, the subject experienced bad feeling (awoke "feeling really bad"). On 14 July 2013, the subject experienced premature onset of menses and sore throat. The subject sought medical attention through her doctor's office on 15 July 2013. The subject reported to the nurse that she woke on 13 July 2013 and felt "really bad and the issues have progressed over the weekend." The nurse noted that the subject had a regular menses cycle of one week that ended on 4 July 2013 but began again on 14 July 2013. The nurse was considering whether the 2nd and 3rd injections of the series should be continued. Relevant test results included body temperature taken on 13 July 2013 and the result was 101.5 degrees Fahrenheit. At the time of reporting the outcome of the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with CERVARIX.
Initial report received from a health care professional on 17-Oct-2013. A 04-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of PENTACEL intramuscularly in the left thigh on 19 August 2013. On 22 August 2013, he was seen in the office for an abscess on the left thigh. On 03 September 2013, it was noted that the injection site had a bruise the size of 4.5x3.5cm. On 07 October patient was again in the office and had the abscess drained. Patient has not been back to the office for a follow-up visit as of this time. The patient had received PENTACEL on 21 March 2013, Lot # C4374AA and developed a nodule at the injection site, 2 months later the nodule became an abscess. Laboratory details and corrective treatments were not reported. At the time of this report, the outcome was unknown. The patient required doctor visit. Documents held by sender: None.
for first few weeks the following :  sporadic: cold sweats, next stiffness, chest tightness, fevers. consistent: brain fog, muscle aches, joint pain, headaches, difficulty in concentration, losing words and tongue-tied. poor and restless sleep.   with time the sporadic side effects went away and i have still been left with and i am still having brain fog, confusion, losing some of my words, difficulty concentrating, fatigue, losing words and tongue tied.
Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) had resolved.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. no concomitant medications were provided. No treatment information was provided.
Initial misuse report received from a healthcare professional on 01 February 2013. A 12-year-old male patient was administered MENACTRA and later it was found that he had received a dose of MENVEO 15 months ago as well. No adverse event was reported. List of documents held by sender: none.
Anaphylaxis to include difficulty breathing, throat closing, chest tightness and flushing of the face and upper body. Treatment consisted of Epinephrine (IM), Atrovent, Xopenex, Benadryl, Pepcid, Prednisone. She was admitted to ER for 4 hours for treatment observation and discharged on prednisone, pepcid, epi pen and benadryl.
Non severe hives on face with flushing. Continued until next day. Currently taking benadryl for symptoms
Information has been received on 06/23/03 from a physician concerning a male child with no past medical history who was vaccinated with a dose of varicella virus vaccine live (site unknown) (0.5mL), SC. There was no concomitant medication. Subsequently the pt "broke out with a few lesions." The reporting physician was concerned "because his pt, a heart transplant recipient, will be in contact with this child". The pt sought unspecified medical attention. Additional information has been requested.
Headache; fever 101; aching. I am reporting this the day following the vaccine.
Patient asked for me to look at her right arm. There was a slightly raised, red area about 2 inches wide and 4 inches long with irregular borders. It was warm to the touch. She received a SHINGRIX vaccine on 5/18/18 and was concerned about the reaction she was still having from the vaccination. She did report that her arm was sore and she felt ill and tired the next day, but that went away the next day. She wanted to know if she should have the area looked at; "she wasn't dying or anything". We discussed what she should do. I recommended that if she was really concerned to have it checked out. However, I recommended she keep an eye on the area. If it got worse or spread, to seek treatment. I also recommended icing or cold compresses if the heat bothered her. Patient agreed with the recommendation and will follow up with her provider if needed.
8 x 11 cm area of redness including injection site w/in 24 hrs of injection; no induration, tenderness, or fever;
Narrative: Per clinic, "The patient is a 72 year old MALE with c/o's of rash after recieving the shingrix shot yesterday morning. He states he developed itching and rash last night . The itchiing kept him up all night long. HE has no difficulty swallowing, no shortness of breath, no swelling of his tongue. Rash allergy to shringx given Medrol dose ack, no systemic signs of illness."  Symptoms:   Rash & RASH  Treatment:   METHYLPREDNISOLONE TAKE 6-5-4-3-2-1 TABLETS BY MOUTH AS DIRECTED ON INSTRUCTION SHEET
on 4/24 noticed very small drop of pinkish blood in urine stream. 4/30 went to dr, he tested urine for blood,tested positive. Scheduled a CYSTO for 6/3/2021. (scope prostate, bladder). Evening of 4/30/2021 noticed small blood clotting of blood in urin streem. same thing the morning of 5/1. Looked up Bladder Cancer, said that DNA can cause changes ib bladder related to blatter cancer.   Dr now on vacation, but if the blood clotting in urin stream continuse will contact DRs Office.
approx 3yrs p/vax pt devel breakthrough rash. addl info requested
Pt reports rash, swelling of the (L) upper arm 14 days after the 2nd vaccine. Used OTC NSAIDS + Benedryl. Feeling better now.
worst flu I have ever had; weakness; sweats; headache; body ache; dizziness; This case was reported by a nurse via call center representative and described the occurrence of influenza like illness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza like illness, weakness, sweating, headache, general body pain and dizziness. On an unknown date, the outcome of the influenza like illness, weakness, sweating, headache, general body pain and dizziness were recovering/resolving.   It was unknown if the reporter considered the influenza like illness, weakness, sweating, headache, general body pain and dizziness to be related to Shingrix.  Additional details were provided as follow: The patient received Shingrix and experienced weakness, sweats, headache, body ache, dizziness. The caller describes it as the worst flu the have ever had.  The caller reports that symptoms have improved but not totally resolved yet.  The reporter consented to follow up. The caller requests that any follow up be directed to herself.
Sick from covid; Sick from covid; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick from covid) and COVID-19 (Sick from covid) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced ILLNESS (Sick from covid). On 04-Aug-2021, the patient experienced COVID-19 (Sick from covid). At the time of the report, ILLNESS (Sick from covid) and COVID-19 (Sick from covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had symptoms on 02-Aug-2021 prior to being tested positive for COVID on 04-Aug-2021.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Non-Significant follow up appended
This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD (Merck) rHA lot # L024122 with expiration date of 30-DEC-2016 and lot # L042818 with expiration date of 26-APR-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported at time of vaccination with PROQUAD (Merck). The Certified Medical Assistant (C.M.A), reported the following temperature excursion for PROQUAD (Merck): -10.6 degrees C for 1 hour and 26 minutes. The vaccine underwent an additional temperature excursion of -6.7 degrees C for 2 hours and 25 minutes on an unspecified date. No product quality issue was involved. Additional information has been requested.
12 y/o pt received pedi dose of pfizer instead.  No ADE reported to writer at this time.
Patient stated that he passed out the next day after the Shingrix vaccine. He didn't know for how long. He fractured his left foot. He couldn't get out of the bed the whole day. Patient reported this adverse reaction 1 month after he received his vaccine.
Breakthrough case admission after 2 vaccines Pfizer 4/2/21 Lot# ER8730;  Pfizer 4/23/21 LOt# Ew0162
Rash on (R) & (L) upper extremities, (R) & (L) lower extremities. Tx: OTC antihistamines PRN and triamcinolone acetonide topical cream 0.5%.
Diagnosed with a case of Pityriasis rosea by general practitioner, symptoms started roughly 10 days after receiving Jansen vaccine. No possible cause could be identified.
Patient was complaining of feeling light headed immediately after taking the shot.  The patient requested medical assistance after seating in the observation area for30 minute.  Fire Department was on location and checked the patient vitals. The patient was given an all clear by EMT?s and was also advised to go the hospital if things worsened. No further actions were taken.
Arrhythmias, low blood pressure and low heart rate   started a week after shot and lasted for a month.
2 x 2 in bruise on left should at injection site areas of yellowish/white on bruise, warm to touch. Pt told to talk to MD.
As soon as the vaccine was completed and the bandaid was put on, the patient started having what looked like seizures. He arched his back and reached his arms out to either side, lifted his head and started making a noise. He was sweating profusely. I held him and kept him from falling out of the chair and called for my technician to call 911. Once he called the patient came to after about 2 minutes. His breathing was not hindered so I felt it was not an allergic response. I checked his pulse and started asking him questions such as if he knew who he was and what was going on. I gave him some water and kept checking his pulse. I laid him on the ground while we waited for EMTs to arrive. Once they arrived they took over and checked his pulse and heart rhythm. His pulse was low (in the 40s and 50s) and his pressure was low. He denied going on the ambulance and his brother came and picked him up and took him to the hospital. Total time from beginning to end was about an hour.
Mom alleges that child's breast asymmetry was caused by HPV vaccine (left breast smaller).?
pt recvd vax & exp severe h/a in the top of head-not relieved w/APAP or ABC compound; pt had chills & fever up to 100; rash on both upper arms & chest & abdo;
Developed a rash following first vaccine dose.  First developed on lower back, then appeared on left forearm, and then back of right hand.  Small hard blisters, itching, sandpaper-like feel to skin.  Did not respond to topical cream or Benadryl.  Still present.
Low grade fever, body aches, stabbing pain from shoulder to elbow and tingled down to fingers. she is now unable to lift her left arm over her head. She is unable to extend or lift her left arm. She really can not use her left arm without excruciating pain . The pain is from the arm and site where the injection was.
The first day after the vaccine I felt a total lack of energy as well as muscle soreness and general aches. By the second I was pretty good. On the 11th day It all came back and more. Dry and soar throat, headache , total loss of energy, no apatite, muscle aches. This has gone on now for 5 days.  On the 2nd day I had a covid test- came back negative. On the 4th day I had another at a different facility, came back negative. Could this still be a reaction to the first vaccine and should I have the second?
UPON VACCINATION THE HUB OF THE NEEDLE BECAME LOOSE AND AN UNKNOWN AMOUNT OF VACCINE LEAKED OUT ONTO PATIENTS ARM. PATIENT WAS ADVISED AND OFFERED A REPEAT DOSE. PATIENT REFUSED TO REPEAT THE DOSE.
Received flu vaccine at 9 am on 11/02/01, 2 hours later started sneezing and became sinus congested. In another 3 hours she had itching eyes and than started to feel more and more body itching. Did not develop rash or have trouble breathing. Around 4PM took a Benadryl tablet and started to feel better. She reported this on 11/5/01 at which time she was feeling fine.
Pt was seen by chiropractor 3 mo after pt received Flu vaccine and was diagnosed as to having shingles. Chiropractor said she had seen several similar situations recently.
PATIENT CONTRACTED COVID >2 WEEKS AFTER LAST DOSE OF VACCINATION SERIES
Breast swelling in left breast, Left breast still swollen; Left breast implant ruptured; 500cc of fluid taken off left breast; Slept all day; Left breast is tender; Left breast has some pain/streteched; mild fever; Chills; injection site tenderness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day) and BREAST TENDERNESS (Left breast is tender) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast implant user.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site tenderness). On 12-Feb-2021, the patient experienced BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day), BREAST TENDERNESS (Left breast is tender), BREAST PAIN (Left breast has some pain/streteched), PYREXIA (mild fever) and CHILLS (Chills). At the time of the report, BREAST SWELLING (Breast swelling in left breast, Left breast still swollen), BREAST TENDERNESS (Left breast is tender) and BREAST PAIN (Left breast has some pain/streteched) had not resolved and DEVICE BREAKAGE (Left breast implant ruptured), BREAST DISCHARGE (500cc of fluid taken off left breast), SOMNOLENCE (Slept all day), VACCINATION SITE PAIN (injection site tenderness), PYREXIA (mild fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted the doctor and advised for diagnostic mammogram . Concomitant product use was not provided by the reporter.  It was reported that patient had surgery to take care of breast to remove the breast implants and allowed them to heal.
migraine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.            Action taken with mRNA-1273 in response to the event were not applicable. Treatment medication were not reported. Concomitant medication were not reported
Fever to 102, Headache, L upper arm swelling, pain, and erythema at site of injection.
Large, raised rash at injection site, about 2 x 3 inches. Doctor advised watching and waiting with ice, Advil, etc. Rash larger than most reactions but not out of the ordinary.
Monday morning she had very some red bumps over most over body, by Tuesday they had spend to every part of her body and then they got and more splotchy. It was very intense on her legs. Wed they got bad on her face and she seemed to be in a lot of discomfort with this. Started her with hydroxyzine and then the doc prscribed prednisolone on Thursday today.
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization,  I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve  about 25-30 minutes after taking the medication - my throat and chest were not as warm.  the facial flushing lasted about an hour or hour and a half.   The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
Headache, Myalgia, Fever, TENDERNESS AT SITE, CHILLS, SOMENELENCE, FATIGUE Narrative:
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000: