chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was given three Anthrax shots between March 03 and July 03. I did report a headache at the time, but was told that was in relation to a neck injury. When I came home in August, I still had headaches, and my body began to hurt all over, I could not sleep and as of today, still have problems. My short term memory was affected, and at times, I would get brain fog. As the months passed, I began to get worse. I finally saw a pain doctor who told me I had chronic fatigue. He gave me medications, but they didnt seem to help. Over the next few months, I saw other doctors who told me it was in my head, or that I had fibrolyalgia. I also developed tremors where my hands and legs shake. Finally, I had enough. I felt like I had been hit by a truck and dragged 100 miles. I felt like I had the flu constantly. It was hard for me to walk because of the pain, or at times, even get out of bed. I went to see another doctor. She did blood work on me, and found that at least 10 of my bodily functions were malfunctioning. My thyroid, insulin, testosterone and 7 more. I have to get infusions now, and also testosterone shots. I take oxcontin for the pain, requip now because I have this creppy crawling feeling on my legs at night and sometimes goes up my body. I take Xyrem to help me sleep. I take other meds alos and supplements. I am no longer able to work. She diagnosed me with Fibromyalgia and told me that the Anthrax shot did this to me. There is no other explanation. She said she had worked at the VA, and this was common to the anthrax vaccine. My life is hell now. Always feeling like I have the flu and everything else going wrong with me. Im 35, this shouldnt be happening. I do have blood reports to prove this and a doctor attesting to this. 07/03/06-36 pages of records received from patient. Anthrax vaccine received 03/38/03. On 06/17/03 patient submitted a formal statement to the U.S. Army stating that on 04/02/03 "while doing P.T. sit ups he felt neck pop/crack and immediately became in pain". Trouble sleeping unable to turn head to left at time with arm soreness upon awakening.  Also indicated he had been advised he will be send back for a medical board and discharge. Notes also include H&P dated 06/03/04 indicate original injury in Fall of 2002 with "crunch" base of skull and left arm lasting 304 months. Pain in knees, elbows, buttocks, hips, hands, low back, neck. Oxycodone did not help.  Past surgeries include ortho on L knee and R elbow in 1990.  DX of cervical neck pain, insomnia, fatigue and anxiety. RX with Klonipin, Paxil and Ambien. Physical therapy treatments in 6/04. Per annual follow up no further information is available.  Follow-up: Emergent BioSolutions has no further information on this report. In the event that additional relevant medical information is received, a follow up report will be submitted. 60 day Follow-up Information 06-NOV-2006: Anxiety, mood swings, low killer cells, low testosterone, pituatary, insulin resistence, Epstein Barr virus, headaches, fatigue, fibromyalgia, chronic fatigue, seiazures, hypothroidsin
droopy; Sleepy; doesn't have an appetite; knot on arm and it sore; This spontaneous case was reported by a consumer and describes the occurrence of EYELID PTOSIS (droopy), SOMNOLENCE (Sleepy), DECREASED APPETITE (doesn't have an appetite) and PAIN IN EXTREMITY (knot on arm and it sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL, HCTZ, PRAVASTATIN, MEMANTINE and METFORMIN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced EYELID PTOSIS (droopy), SOMNOLENCE (Sleepy), DECREASED APPETITE (doesn't have an appetite) and PAIN IN EXTREMITY (knot on arm and it sore). At the time of the report, EYELID PTOSIS (droopy), SOMNOLENCE (Sleepy), DECREASED APPETITE (doesn't have an appetite) and PAIN IN EXTREMITY (knot on arm and it sore) 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.   No treatment medications provided
On 09/08/18 patient presented with some hives. By later in that same day she was covered in hives with swollen, hurting, feet and ankles. We brought her to an Urgent care where they administered DECADRON and suggested follow up with peds. 09/09/18 we went to pediatric office where they suggested an allergic reaction to amoxicillin (course began on 8/31/18), and prescribed 5 ml of prednisone for 5 days, as well as CLARITIN. The hives subsided for the most part by 09/11/18, but then she got bruising, and began presenting with different joint pain. On 09/11/18 she could not open her hands without pain, and was still limping due to foot and ankle pain. We returned to peds office on 09/12/18 where they they ordered labs and prescribed a longer course of prednisone. Almost every joint became involved. Labs for the most part were normal, with a slightly elevated sed rate, not all have been reported to me yet. RAST test to penicillin was negative. By 09/16/18 walking is greatly improved with some limping throughout the day. Hands are completely healed. Bruising is gone. Hives pop out randomly. Should be mentioned that she stopped the amoxicillin on 09/08/18.
Severe allergic reaction; I broke out with rash; BNT162B2 intravenously; This is a spontaneous report from a contactable consumer. A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot: EW0182) intravenously on 16May2021 14:00 (34-year-old at the time of the vaccination) as single dose in left arm COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported to be allergic to Amoxicillin and Penicillin, other than that no related allergy. No prior vaccination was reported within 4 weeks. Consumer stated to report some basically a severe allergic reaction that she had to the COVID-19 Pfizer Vaccine and that was administered on 16May2021. Only they did lab testing and blood work when she broke out with rash that was it but other than that no. she has been at the ER (emergency room). They had given antihistamine and steroids but the rash, it only spread, and it's been prevalent for a week now today and it's probably getting worse. Outcome of the events unknown.  Follow-up attempts are needed. Further information is requested.
Fever, dizziness, vomiting, chills, stomach cramps, fatigue, joint and muscle aches/pain, chest pain, slow breathing and mouth numbness for 2 days.  fatigue lasted 5 days
Pitting edema lower extremities, shortness of breath, elevated blood pressure, weakness, severe headaches, lightheadedness, skin redness of arms, skin discoloration of legs, intensified cervical and thoracic spine pain
Pt stated she felt pain then begun feeling the room darkening and became dizzy. Pt felt she was dreaming and could hear her mother talking. When she came to she was aware of her surrounding but felt tired. BP 100/70 POX 99. Pt has h/o vasovagal episodes c/w vasovagal event
Flu like illness 11/15/13 -> 11/20/13. Yellow fever headache 11/22/13 onset 11/26/13 fever, myalgia, dark urine, confusion arthralgia. Treated in ER with IV fluids. Found to have elevated transaminase, bilirubin, hypometria, thrombocytopenia (all new).
Headache, Arthralgia, Fatigue Narrative:  Other Relevant History:
my daughter is in labor and they are talking about having to give her a C-section; mother is in labor; This is a spontaneous case received from a contactable consumer. It was reported, similar events for 2 patients (Mother and Foetus) and this is the second of two reports (Foetus). A 31-year-old of female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN5318) as an unspecified dose for covid-19 immunizatioin. It was reported that, mother had COVID vaccine in last week and was in labor today, also done a rapid hiv test, which resulted false positive. Stated that, the medical staff were talking about having to give her a c-section. Mother underwent lab tests and procedures which included hiv test: positive, hiv test: unknown result on tested her again/currently waiting for test results. Reporter stated, wants to know if its is possible that, rapid HIV test got a false positive because of the received covid vaccine last week. The outcome for the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021129930 same drug, different patient and similar event
I noticed my left underarm was bothering me on Saturday night, a day after I received my 2nd shot.  The lymph nodes were swollen and sore to the touch. Today is Tuesday, and it is still bothering me.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353403USA. A female patient between the ages of 19-24 years who experienced Intussusception (confirmed) (serious, since 11-Sep-2012, until 11-Sep-2012); Constipation (confirmed) (serious, since 12-Sep-2012, until 12-Sep-2012) while enrolled in a study. The patient was an active recruit. Adenovirus vaccine was administered on 11-Sep-2012. For the event of Intussusception the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity was not assessed, outcome not resolved, seriousness of disability/ incapacity. For the event of Constipation the patient was treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity was not assessed, outcome not resolved, seriousness of disability/ incapacity. Treatment medications included: promethazine (25mg, Q6H, PO) started on 11-Sep-2012, stopped on 11-Sep-2012 for nausea; mag citrate (5.75%, now, PO) started on 11-Sep-2012, stopped on 11-Sep-2012 for unknown indication; acetaminophen (325mg, Q6, PO) started on 11-Sep-2012, stopped on 15-Sep-2012 for pain; bisacodyl (5mg, QD, PO) started on 11-Sep-2012, stopped on 15-Sep-2012 for constipation. At the time of the report the outcome of the AEs were: Intussusception: not recovered/not resolved, Constipation: not recovered/not resolved. The medical history of the patient was not specified. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included DTP (since 11-Sep-2012); Meningococcal Vaccine (since 11-Sep-2012); Hepatitis A vaccine w/Hepatitis B vaccine (unknown; since 11-Sep-2012); Influenza vaccine (since 11-Sep-2012). The patient's past medication were unspecified. Action taken with suspect drugs: not applicable. Lab tests 11-Sep-2012, CBC with diff: RDW-11.5, WBC-10.9, lymph-16.8, 11-Sep-2012, ESR: normal, 11-Sep-2012, HCG quant: 5.0. This case was considered serious based on the following criteria: (Disability or Permanent Damage). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the Adenovirus vaccine.
Symptoms began about 4 hours after the shot = Extremely swollen sore arm with a 2mm blister over injection site.  Temp 100.6, Aches all over. DIzzy. Head ache. Sudden severe head congestion, with intense clear mucous drainage from nose, & throat. Running eyes, hacking cough, and extreme fits of sneezing.  Overwhelming sneezes came 8-10 in a row, with little, or no chance to breathe between the next sneeze. Once I was eating and the sneezes started. I almost inhaled a food bolus, because I could not get my breathe.  I was turning blue. The sneezes were very scary. I made calls for help to 5 different health care providers, and was referred to the next and the next. Finally the following day I did get a telehealth appointment w/P.A. at Office.  Her Rx helped some symptoms.  Today, 12 days after the shot, I am still sneezing, but it is slowing down.  Sadly I could not get
I was given a flu shot in my left shoulder at pharmacy in Oct. 2015. From that moment until now I've been having shoulder pain.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date in 2018 (reported as a recent date), while in the hospital the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date in 2018 (reported as "8 days after the first dose" after discharge), the patient was vaccinated with another dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
A report has been received from a Physician via agency concerning a 40 year old, Female subject, who had been receiving Nasal FLUMIST, 1 in 1 total. FLUMIST started on 04-Nov-2011. The patient experienced UPPER RESPIRATORY TRACT INFECTIONS and CONJUNCTIVITIS which started on 10-Nov-2011 and HEADACHE which started on 05-Nov-2011. The patient recovered from the event of UPPER RESPIRATORY TRACT INFECTIONS and HEADACHE on 16-Nov-2011 and The outcome of the event of CONJUNCTIVITIS is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between UPPER RESPIRATORY TRACT INFECTIONS and FLUMIST, CONJUNCTIVITIS and FLUMIST and HEADACHE and FLUMIST.
pt recvd vax 11DEC92 & JAN93 pt began to exp malaise; 2FEB92 lab eval revealed CBC nl, SGOT & SGPT 3.5 times nl, GGT 211 (5x nl), total serum bilirubin 2.3, direct serum bilirubin 1.5 & serum alkaline phos 173 & 125;
A hard lump on the skin, left forearm. Very similar to a swollen lymph node, but not in an area where clusters of lymph nodes are located.
cramps; dry heaves; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps) and RETCHING (dry heaves) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN), OMEPRAZOLE, IBUPROFEN (ADVIL 12 HOUR) and GLUCOSAMINE for an unknown indication, ACETYLCYSTEINE, BETAINE, SILYBUM MARIANUM SEED, TARAXACUM OFFICINALE ROOT, THIOCTIC ACID (PURITAN'S PRIDE LIV A NEW) and METABOUP PLUS.    On 10-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 MUSCLE SPASMS (cramps) and RETCHING (dry heaves). On 12-Feb-2021, MUSCLE SPASMS (cramps) and RETCHING (dry heaves) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
redness, 2 1cm nodules at site of injection.  started on day of injection.  persistent 10 days after injection.
This case was reported by a consumer via sales rep and described the occurrence of unwell in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included Herpes zoster SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced unwell, incomplete course of vaccination and product availability issue. On an unknown date, the outcome of the unwell was recovered/resolved and the outcome of the incomplete course of vaccination and product availability issue were unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional information was received as follows: The age at the 1st dose of SHINGRIX vaccination was not reported. The patient was very upset with vaccine manufacturing company. On the reporting day, the patient annoyed, as she felt very ill for 2 days after the first dose and she had cleared her schedule for 2 days to recover from the second dose, only to find it was not available anywhere in her area. The patient was due for the second dose of SHINGRIX but not one pharmacy in her city where the patient get her medications and they did not know when they would get it. Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX due to product availability issue, which led to incomplete course of vaccination. The patient would personally start a class action lawsuit to get her money back and damages if this did not resolve in time for her to get her second dose in the therapeutic window of time recommended. The patient would be interested to know what the manufacturer would recommend to get the 2nd dose in the near future. It occurs to the patient that the responsible thing to do would be to reserve the next batches that manufacturer release for those who had already had the first dose, and were on a deadline to get the second dose. This case has been linked to the case US2018GSK127087 and US2018GSK127086, reported by the same reporter.
patient reports lip tingling and swelling, 2 hrs later reports chest tightness.  Patient given 0.3mg epinephrine injection.  Pt transferred to ED with EMT.  In ED patient given NS bolus, Pepcid, Benadryl and solumedrol.  Discharged at approx. 1615
Information has been received from a physician concerning a 17-week-old male who on 12-Sep-2007 was vaccinated with a dose of Rotateq (lot# 656838/0968U). Suspect vaccination included PedvaxHib (manufacturer unknown). Concomitant vaccinations included Pediarix and Prevnar (it was noted that the patient did not receive MMR II and Varivax). On 14-Sep-2007, the parents put the infant to sleep on his back. The infant had a pacifier and no blankets in the crib. At midnight, when the parents checked on him, he was fine. When the parents checked on him at 6am on 15-Sep-2007, he was unresponsive and cold. 911 was called and the baby was coded. The infant was dead on arrival to the hospital. The cause of death was sudden infant death syndrome. No product quality complaint was involved. This is one of several reports from the same reporter. Sudden infant death syndrome was considered to be disabling and life threatening. Autopsy results will provided when they become available. Additional information has been requested.  10/9/07 Reviewed pcp medical records which reveal patient was in good health on day of vax.  Vax records reveal RO lot # correct as reported & was Dose #2.  Other vax updated in VAERS database. 11/16/07 Received autopsy report which states COD as sudden unexplained death during infancy.
RIGHT UPPER THIGH WITH LOCALIZED REDNESS AND SWELLING & IMM SITE; WARM COMPRESSES, BENADRYL.
Presented to clinic today for COVID 10 Moderna Vaccine, second injection.  After about 15 mins of reciving the vaccine pt felt slight pressure on the chest, retrosternal that resolved within few minutes.  She denies associated sob, difficulty breathing.  However, reports this kind of chest pressure "on and off."  Reports that she felt as it had to release "gas" and felt better afterwards.
Large knot, redness, itching, sore Began as tenderness, then itching, then red circular patch.
vision loss; hearing loss; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was reported. On 07-NOV-2017, the pt was inoculated with zoster vaccine live(ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) as recommended for routine adult health maintenance for the prevention of shingles, at the pharmacy. On an unknown date, the pt was treated at the physician's office for vision loss and hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causality was related.  Upon internal review, the events of vision loss and hearing loss were determined to be medically significant.; Sender's Comments:  US-009507513-1910USA005081: US-009507513-1910USA005084:
BODY ACHES; TIRED AND FATIGUE; HEADACHE; FEVERISH; FLU-LIKE SYMPTOMS; COUGH; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood clotting disorder, and sulfa drug allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced flu-like symptoms. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tired and fatigue. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced feverish. On 15-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired and fatigue, headache, body aches, feverish, and flu-like symptoms, and the outcome of cough was not reported. This report was non-serious.