chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came back to pharmacy two weeks later on 11/20/19, complaining of shoulder pain on her left arm, saying that it is painful when she tries to use her arm or raise her arm. I inspected her physical left arm but no signs of swelling or redness to my visible eye in the injection site area.
Fatigue, nausea, arm soreness, headache, achy Brain fog, dizziness, very vivid dreams
I experienced severe soreness in the muscles at and around the injection site, beginning about two hours after the vaccine was administered. This discomfort worsened during the next 24 hours. The site was painful to touch, as was lifting my arm. I experienced chills, body aches, and a dull headache during that first night (approximately 12 hours after the injection), and upon waking found I had a fever of 101 degrees. The fever slowly diminished over the next 24 hours, and the body aches lessened as well. By about 48 hours later, I still had some soreness at the injection site, but it had lessened substantially, and the other symptoms had resolved.
pt recv vax & devel an unspecified rxn;no further details known as of the date of this report;this is one of five patients reported from this site;
A pharmacist reported that a female, now 77 years of age, received an injection of TD Toxoids, (manufacturer unknown) as a child. Subsequently, she became "very sick". The pt recovered.
Patient was underage of approved age per CDC. Guidelines.  Due to miscommunication pt was mistaken for older sister in same room.
Two weeks post Moderna booster, I developed hives and rash - starting on neck/hairline, moving to groin/armpit/upper back. Took Benadryl. Have come back daily - usually start to appear on wrists, then move around the body randomly. Spread quickly in affected area. Often appear where I touch or scratch - like dermatographic urticaria. Still taking Benadryl at night to sleep and stop the itching. Have not changed any eating habits or products - nothing else environmentally. No known allergies other than mild seasonal nasal issues. Starting on daily Zyrtec. This is day 5 and they are not subsiding.
woke up with a headache; patient is pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant), PAIN IN EXTREMITY (Sore arm) and HEADACHE (woke up with a headache) in a 34-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (wine -3 drinks) on 02-Oct-2020. Concurrent medical conditions included Allergy to antibiotic (Erythromycin).    On 26-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 13-Jun-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant). 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Jan-2021, the patient experienced HEADACHE (woke up with a headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (woke up with a headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. 08 Oct 2020,Pregnancy test was Positive. 15 May 2017, the patient delivered live, full-term birth baby. 28 Jan 2020, the patient delivered live, full-term birth baby.
Extreme fatigue, Depression, Suicidal thoughts. Persisted over the course of 3-4 days with the worst day being 2 after the vaccination.
Seizure, eye rolling, tonic stiffing, vacant x3 second after 2 days, MD postictal lethargy.
This patient was in my office and given a pneumococcal vaccination. I have spoken with him. He left a message and I tried to contact him on 12/27. It appears that immediately after receiving the pneumococcal vaccination, he developed a very stiff and painful neck and was unable to move it from side to side. This was accompanied by increasing malaise, low-grade fevers and even some modest chills. Initially, he had no reaction at the site of the injection but then 48 hours later, he developed some swelling and redness over the site of injection on the right arm. There has been some gradual improvement in his neck stiffness but initially it was said he was unable to move his neck whatsoever. He has missed work for the remainder of the week. He is still eating and is had no nausea, vomiting, skin rash. His temperature has been as high as 100.5. This appears to be a reaction to the vaccination. His other list of medications includes the following: PLAQUENIL, ZOLOFT, ASMANEX 220, 2 inhalations twice a day, and XOPENEX when needed. I will report this to the drug manufacturer as an adverse effect from the pneumococcal vaccine. The vaccine lot number was 09787. It was obtained from the hospital stocks 5 days before his visit on October 26. 2010. When I spoke with him on October 29, he has been using both TYLENOL and ibuprofen for pain relief and suppression of fever. I offered an emergency room visit, or visit to my office but his descriptions of his events were fairly clear-cut. He did not wish to come to the office at this time but I did offer that I would be on call all weekend if had additional concerns.
received the first dose of Twinrix in November 2020 / patient had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old male patient who received HAB (Twinrix) 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 Twinrix (1st dose received in November 2020, batch number: 9RT94, expiry date: 24th May 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 21st May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter called to report that, the patient was late for Twinrix second dose, between the first and second dose 6 months had passed. Till the time of the reporting the patient had not received the second dose, which led to incomplete course of vaccination. No further events were reported.
My left eye was blurred. Called Doctor 10/28/2016 he check my eye. Sent me for a CT scan and blood work.  Results came back fine. Went to my eye Doctor on 11/02/2016. He did an eye exam. Found that my left eye changed from 04/2016.
This spontaneous report as received from a physician refers to a female patient currently over 71 years old. The patient's medical history included polymyalgia rheumatica that was being treated with chronic steroid treatment (steroid name, dose, and manufacturer were unspecified). Approximately in 20077 (reported as "about 7 to 8 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date were not reported), subcutaneously to prevent shingles. Secondary suspects and concomitant therapies were not reported. Approximately in 2012 (reported as "during the past 3 years") the patient experienced outbreak of shingles. She was given FAMVIR, ZOVIRAX ointment, and prednisone (manufacturer outcome) on unspecified date to resolve the shingles. There was no lab diagnostic studies performed. The outcome of herpes zoster was reported as recovering (also reported as "recovered"). The patient sought medical attention via visiting the physician. The relatedness between outbreak of shingles and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache  Narrative:  SIDE EFFECTS: VAX #1: 1/4/2021 localized: (a week after vaccination), arm down to hand and fingers were very sore and achy. Later that night, injection site was itchy. On 1/5/2021 I woke up and the area where I received my vaccine it has a large red spot the size of four of my hand fingers and is very tender, sore, achy, very sore to the touch. It feels very warm as well. Took Benadryl. VAX #2: day one developed fever 101 to 102, body aches, chills, HA, symptoms lingered into day 2
Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered.   Information about Batch/Lot number has been requested.
It was found out that late on the evening of 6/8/23, the Pfizer Covid vial had been expired. Pfizer was contacted and we were notified that once a vial has been diluted, it is good for 24 hours. At the time, the vaccines had been sitting out past the 24 hour mark. Pfizer reassured that this is not harmful to the child, as the dose was not effective at that time.
This spontaneous report as received from a certified medical assistant refers to a 15 year old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in April 2015, the patient was vaccinated with the first dose of GARDASIL 9 injection, (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On an unknown date in December 2016, the patient received the second dose of GARDASIL 9 injection, (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as no permission has been granted to contact the physician.
Swollen axillary lymph node on same side as injection; fatigue; body aches; headache; injection site soreness; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), via an unspecified route of administration in left arm on 13Jan2021 00:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, anxiety and penicillin allergy. The patient did not have COVID prior to vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), and montelukast sodium (SINGULAIR). The patient previously received the first dose of bnt162b2 (lot number EL1284) on 23Dec2020 12:00 PM in left arm for COVID-19 immunization. The patient experienced swollen axillary lymph node on same side as injection, fatigue, body aches, headache, injection site soreness on 13Jan2021 20:00. The outcome of the events was recovering. No treatment was received for the events. The patient was not tested for COVID-19 post vaccination.
Patient came to present the reactions to me, 3/21/2019, about the terrible pain and muscle spasms he has at the back of his legs the following day he got the injections last 3/4/2019. He came the next day to get his other medications and when I asked how he felt about the injection site, he said it was sore. He never mentioned about the pain of the legs for he thought it might be caused by something else. As of 3/21, he said he was 90% ok. Today, he talked about his other medication atorvastatin but every now and then getting the pain.
Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient?s guardian
Feverish feeling and chills with myalgias and weakness at 4am on 12/18/2020. Took 800mg advil and 1000mg tylenol. Felt perfect by 7 am. Despite this, fearing covid, I did not go to work, was rapid trsted covid negative that day and pcr tested that day retirning negative 2 days later.   Days later I began to have vague nagging chest pain with occasional sharp chest pain over my heart. I had what I would describe as chest tightness in addition in which it felt hard for me to expand my chest fully like pressure without being short of breath. This would last at most several minutes and perhaps occurred three or four times over a seven day period. Throughout this. I could exercise with no chest pain no increasing shortness of breath, including a PR on Peloton and two hours of tennis without cardiac symptoms. Yesterday, my smart internist heard a split S2 heart sound as I lay on my left side and held my breath; the EKG showed a depressed PR interval ad some ST elevstions consistent with pericarditis, which I am treating with motrin.   I assume this is a viral pericarditis. I had two types of Covid tests during that time period. My second dose of the vaccine was January 8. The feverish feeling occurred before dose 2, as did some of the chest oains  and tightness.
Redness, swelling, painful to touch rx BENADRYL 50 mg PO, kenalog 40 mg IM.
Typical soreness at injection site, but also 3 instances of brief sharp stinging sensation. First on my rib, I pulled up my shirt thinking an insect sting.  An hour or two later same sensation on my right ankle bone and thirds same day on my left shoulder blade.  Very sharp strange and startling sensation.  I didn't think to report it until today when a co-worker of mine, who had is first shot yesterday described  same side effect.  He described it like electrical shocks.  I thought it should be included in the records.
Patient suffered a vasovagal syncope without losing consciousness, pt suffers from anxiety and did not eat, only in the morning
Within 5 minutes of receiving vaccinations, he developed small erythematous papules (~0.5cm) mostly on the left side of his face, neck, and a few scattered papules on his back. He also developed facial flushing. No tongue or lip swelling. No difficulty breathing. Gave Benadryl 12.5mg PO. Pulse ox was placed, and his O2 sats remained within normal limits without desaturations. His vital signs were monitored over the course of one hour and remained within normal limits. After one hour of observation, his cheeks were less flushed. He had stopped developing new papules and was otherwise well-appearing w/o respiratory or GI distress. No other systemic symptoms.
My first period after the vaccine arrived 6 days early, which is quite abnormal for me. The day before I couldn't work at my desk due to pain in my low back and hip flexors, which is also abnormal. Then the period was heavier than normal lasted 3 days longer than normal. It looked like there were clots in the blood.   I mentioned this experience to a friend, who said several of his female friends also experienced bizarre periods after receiving the JJ vaccine. Was this drug tested on women of reproductive age before being released?
Stiff arm, severe pain, Nausea. Headache. Vomiting. Change in mood very sleepy, very fatigue. Hives in half my right arm were shot was given.
Pt reports tingling, numbness going down her arm and hand. Also, reports of pain if she or someone touches the top of her shoulder.
Two days after vaccine I was having trouble breathing, irregular heart beat, congestion, bloating, swelling. Went to hospital and nothing was found in tests. A month and a half later I was having similar symptoms and went to the hospital where they found I was having heart failure. My heart was preforming 10-15%.
Suspected Vaccination failure; 5 years ago I got Shingles in my right eye and still have it; macular degeneration! It is serious; Ruined vision in my right eye; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant and other: serious as per reporter), macular degeneration (serious criteria GSK medically significant and other: serious as per reporter) and visual impairment (serious criteria other: serious as per reporter). On an unknown date, the outcome of the vaccination failure and visual impairment were unknown and the outcome of the ophthalmic herpes zoster and macular degeneration were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, macular degeneration and visual impairment to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself.  The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles in right eye, probably 5 years ago from the date of reporting and still had it at the time of reporting. The patient's vision in right eye had ruined which now also had macular degeneration. The reporter stated that, it was serious. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Pt received flu vaccine on Oct 8, 2004. She said she received shot high in left shoulder and felt needle hit the bone and nerve. By early AM  , oct 10th, she went to hospital ER because pain in her entire arm was so severe and couldn't tolerate it anymore. Physician gave anti-inflammatory drug, abx, and pain killers She mentions seeing her orhtopedic surgeon on OCT20th.
Inconsolable screaming for 3 hours straight; Rock hard stomach for 3 hours; Stomach sensitivity/pain 3 hours; Blood in stool 24 hours after injection; Hospital used sapository to insert Tylenol.
Sore first few days.  Then on 3/14, I developed itching and swelling and redness at the injection site.
Patient inadvertently received Pfizer-BioNTech monovalent booster instead of Pfizer-BioNTech bivalent booster.
Developed an itchy rash on my trunk, back, arms, neck & bilateral groin. No other symptoms. May not be from the vaccine, but I?m not sure what else could have caused it. I haven?t tried a new food, medication, personal care product or detergent.  Took Benadryl.
Father of 9-yr old female mentioned pt feeling unwell after her second dose of Covid vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Father of 9-yr old female mentioned pt feeling unwell after her second dose of Covid vaccination.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
extreme pain from the injection site up through my shoulder & neck area on the side where the shot was administered. for about 48 hours I had limited range of mobility.  Kind of felt like I was paralyzed on my left side. After about 4 days of anti-inflammatory meds, heat, ice the pain was not as extreme but still remained constant although I do not believe any of the remedies I tried actually helped.
Within 30 min post vaccine pt. developed urticaria. No angioedema. No wheeze. See back in clinic given PO BENADRYL with complete resolution of symptoms.
Patient had TDaP and Pneumococcal vaccine on 07/28/14, noticed swelling at the injection site next day, today (7/30/14) swelling has improved but moved to the elbow. Also feels nausea, had vomited x 1 and felt dizzy. Denies any sob, fever, chills. Dizziness, nausea, vomiting and injection site swelling, arm swelling. CIPROFLOXACIN 500 mg BID, Ibuprofen 600 mg TID
This case was reported by a physician via sales rep and described the occurrence of reactogenicity event in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (in the past). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced reactogenicity event (serious criteria hospitalization). On an unknown date, the outcome of the reactogenicity event was unknown. It was unknown if the reporter considered the reactogenicity event to be related to SHINGRIX. Additional details were reported as follows: At medical booth at event, the health care professional (HCP) asked about whether there were higher rates of reactogenicity when SHINGRIX was administered in someone having had ZOSTAVAX in the past. The reporter was seemed to be seeing this in her practice, including one patient hospitalized related to SHINGRIX reactogenicity. No additional details were provided. The reporter did not agree to follow up from GlaxoSmithKline(GSK). This case was linked with case US2018GSK188799, reported by the same reporter.
Erythema, warmth at vaccine site on (R) arm and associated surrounding erythema/swelling of (R) upper arm; fever, malaise.