chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sleepiness; Body aches; Low grade fever / 99.7°F fever; Extreme fatigue; Nausea; This spontaneous case was received on 03-Nov-2022 from other healthcare professional via regulatory authority (reference number: SEQW22-05377) with additional information received on 11-Nov-2022 (reference number: SEQW22-05708) (being processed together) and concerned a 27-year-old, female patient.   The patient's concurrent conditions included mast cell activation syndrome, triggered primarily through gastrointestinal issues. The patient's concomitant medications included famotidine, cetirizine and cromolyn sodium, all used for an unreported indication.   On 02-Nov-2022, at 14:20, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration, anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 942370 and expiry date: 23-May-2023.  On the same date, within an hour, at 15:13, after receiving Flucelvax Quadrivalent, the patient experienced low grade fever, which was followed by fatigue, nausea and mild body aches by 16:00. At that point, the patient left for home. Around 17:00, the patient had a 99.7 degrees Fahrenheit (F) fever, severe body aches, sleepiness, extreme fatigue. The effects remained until the patient went to bed.  On the same date, the patient recovered from the events of sleepiness, fever, and nausea.   On 03-Nov-2022 (as of this date, as reported), the following day, the patient got better and only had fatigue and mild body aches. No medications were taken for treatment.  At the time of initial reporting on 03-Nov-2022, the patient was recovering from the events of 'general body pain' and 'fatigue extreme'. The patient was still feeling symptoms, although less and milder that the day of administration.  The reporter assessed the events to be related to Flucelvax Quadrivalent. The patient reported the events as a reaction to the flu shot.  The case was assessed as non-serious.  Company comment: A 27-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed pyrexia, fatigue, nausea, general body pain and sleepiness. Information regarding the related diagnostic findings has not been provided. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The patient reported the events as a reaction to the flu shot.; Sender's Comments: A 27-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed pyrexia, fatigue, nausea, general body pain and sleepiness. Information regarding the related diagnostic findings has not been provided. Based on plausible time relationship, causality is assessed as possibly related.
abcess @ inject site; pt seen in ER on 18MAR93; reported to clinic; MD prescribed 10 days of ATB & reported 10cm x 12 cm erythema @ inject site;
Confusion; Tinnitus; Memory issues; Fever; chills; Hives; Night sweating; Restless legs; Achy joints; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: Wagg388 FC3181), first dose via an unspecified route of administration, administered in left arm on 10Sep2021 15:00 at the age of 45-year-old as single dose for covid-19 immunization. Medical history included Covid positive in December 2020, nothing chronic, some food allergies, corn, onions, peanut, bean from an unknown date and unknown if ongoing. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks. The patient experienced confusion, tinnitus, memory issues, fever, chills, hives, night sweating, achy joints, shortness of breath all on 12Sep2021 01:30, restless legs on 12Sep2021. Confusion for a week, tinnitus got worse and hasn't subsided memory issues, ongoing fever & chills, hives during the night three times 1st week after dose. Night sweating off and on restless legs, still ongoing achy joints, still ongoing shortness of breath, still ongoing. He had scheduled a doctor's appointment to see if he could remedy some of these. The case was reported as serious per disability. The event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment for adverse events. No covid tested post vaccination. The patient underwent lab tests and procedures which included Covid-19: positive in Dec2020. The outcome of events was not resolved. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient hadn't been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Approximately two days after receiving the vaccine, the area around the injection site got red, swollen, hard, warm to the touch and itchy. Then spot would come and go. Then approximately 4 days after the vaccine I got red spots below the first area.
Headache going on 3 weeks; Sinus swelling; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 38-years-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified, route of administration in left arm on 14Feb2021 at 03:30 PM (at the age of 38-years-old) as single dose for COVID-19 immunization in Clinic/Veterans. The patient had no allergies, medical history and concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 16Feb2021, patient experienced headache (going on 3 from weeks), sinus swelling and dizziness (began at the end of 2nd week). Physician prescribed steroids to the patient. Outcome of the events sinus swelling, and dizziness was unknown while of headache was not recovered.  No follow-up attempts are possible. No further information is expected.
serious lymph node swelling and serious pain in lymph node;  lymph node swelling in injection armpit, other armpit, and neck; serious fatigue; rash in armpit of injection arm (bloody looking spots); serious headaches; overall muscle pain
Symptoms: c/o chest pain, lightheadedness, vitals WNL. Intervention: rest, reassurance - symptoms resolved.
Patient called stating that he received the pneumonia vaccine in his right arm yesterday. He states that this morning, he developed soreness and stiffness of his right armpit. He states that the area of the vaccine is not painful. He rates pain as 4/10- states it is an "inconveinece". There is no redness, rash, wound, swelling. He denies chest pain or shortness of breath. He states that he is unable to tell if his lymph nodes are swollen - states nothing feels out of place. Denies fevers
Swollen gland on opposite arm after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0266208 and 01SM20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine). At the time of the report, LYMPHADENOPATHY (Swollen gland on opposite arm after the 1st vaccine) outcome was unknown.            No treatment information was provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: TCR received.Nobody received the call. Left voicemail with call back number and Argus case number.; Reporter's Comments: Based on the current available information which includes a g temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded.
she received the GARDASIL vaccine nine years ago but did not complete the full dosing schedule; missed dose; This spontaneous report as received from a female patient of unknown age, reporting on herself. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On aproximatelly 2012 (reported as nine years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  lot#, expiration date, formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location were not reported) for prophylaxis. At the reporting time, the patinet did not complete the full dosing schedule, as she had not recieved more doses (Inappropriate schedule of vaccine administered).  No adverse event was reported. No PQC reported.
Information has been received from a physician concerning a female in her early 30s with a family history of multiple sclerosis who in the "week of 20-MAR-2006" was vaccinated with a first 1.0ml dose of Recombivax HB. The "week of 20 Mar 2006", within 24 hours of vaccination, the patient experienced myalgia in her lower extremities. She described it as her legs felt like she was walking in water. It was noted that symptoms lasted 1 day. It was also noted that she recovered on 04-APR-2006. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient was given a Tdap vaccination after today's examination, but according to the medical chart the patient received the vaccination in December of 2013.
sick rt away, fever down & slept more;then got real sick again t104 first part of JUNE;bad h/a few days saying ouchy;then the rt foot started turning, head neck stiff;walking like an old man;still stiff neck & leg problem;weaker;to ER
I am experiencing a water like sound in my left ear. This feels like like my eardrum can be touched by finger or Qtip that make a louder popping or similar to water in the ear. This has came and gone over the past few days. Also very sore at the injection site for about 3 days after shot. I have not been treated for the ear problem.
Chest pain, hives, and swelling of the lips a few minutes after leaving the physician's office.
This spontaneous report as received from a pharmacist refers to a currently 52 year old female patient. Pertinent medical history included: angioedema and allergy to yeast. Concomitant medication included: hormone therapy, sleeping agent, antianxiety medication (names of medications were unspecified). On an unspecified day (reported as over five years ago), the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route, lot # and expiration date were not reported). The pharmacist reported that the patient was asplenic (reported as now) and it was not known whether the patient's spleen was removed prior or after receipt of the dose of pneumococcal vaccine (manufacturer unknown). On 03-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (route intramuscular, lot # K010465, expiration date 23-MAR-2016, dose not reported). On 03-MAR-2015 (reported as within 2 hours), the patient experienced hypersensitivity reaction which was described as a swollen face, body rash and trouble breathing. The patient was treated with BENADRYL. The patient sought for medical attention via calling a pharmacist. There was no lab diagnostics and studies performed. The outcome of spleen removal was unknown. The outcome of hypersensitivity reaction described as swollen face, body rash and trouble breathing was recovered/resolved (reported as within 24-48 hours, on an approximately 05-MAR-2015). The relatedness between the events and PNEUMOVAX 23 and pneumococcal vaccine (manufacturer unknown) was not provided. Upon internal review, the event of spleen removal was considered to be medically significant. Additional information has been requested.
Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 20Apr2021 at 09:15 (at the age of 30-years-old) as a single dose indicated for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose indicated for COVID-19 immunisation. The patients medical history was not reported. The patient's concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19.  The patient did not receive any other medications/ vaccines within two weeks prior to the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 20Apr2021, the patient experienced sore arm and fatigue. The patient did not receive any treatment for events. The clinical outcomes of both the events were recovered.   No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot number K012924 and expiration date 29-NOV-2015; lot number L006382 and expiration date 25-MAY-2016) dose, frequency, route of administration not provided,  which were post defrost cycling. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Muscle twitching at site of injection at both vaccination sites (Dose 1, Pfizer-BioNTech Covid-19 Vaccine Lot# EP7533, left arm, intramuscular). Fasiculations of up to 3 per minute directly located where vaccine was injected. Occurs daily in intervals of 30minutes, up to 4 times per day. It occurs in both arms since it was first noticed on May 24th (38 days after 2nd dose of vaccine). It prevents sleep and causes distress.
2-3 hours after vaccine, dizziness, stiff neck, tingling in face/upper lip, racing heart, nausea, off-balance, later (over the next 2-3 days), tingling in hands, dizziness/nausea, itchy rash on neck/chest, "brain fog" with difficulty concentrating, temp to 100F, motion sickness. The neck stiffness and hand tingling lasted 5 weeks. The dizziness/motion sickness and feeling nausea/dizzy when looking at phone/computer has continued longer but seems to be improving. She remains unable to work.
Information has been received from a laboratory technician concerning a female patient who was subcutaneously vaccinated with a dose of PNEUMOVAX 23 vaccine on 13-OCT-2008. The patient called office on 16-OCT-2008 to report "an area at the injection site 2 & 1/2 to 3 inches around that was red, sore, swollen, and warm". Her treatment and outcome were unknown. This is one of several reports from the same source. Additional information has been requested.
This solicited report was received from a patient's mother regarding her 13-year-old daughter who was enrolled in a market research. On an unknown date the patient was vaccinated with GARDASIL 9 (lot number, expiration date, dose, route of administration and anatomical location were not reported). On response to the question "For which of the following reasons has your child not received an additional dose of the HPV vaccine?", the mother selected the option 'Other' and described that as, on an unknown date, she thought the vaccine was making her daughter her feel funny when she got it (feeling abnormal). The outcome of feeling abnormal was unknown. The reporter considered the event to be related to GARDASIL 9. Additional information is expected.
received 3 Shingrix shots.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date the patient received 1st dose) and Shingrix (on an unknown date the patient received 2nd dose).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received 3 Shingrix shots.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-APR-2023 The patient received three shots Shingrix. The patient wanted to know if there would be any adverse effects The reporter did not consent to follow up. The patient received 3rd shot shot of shingrix which led to extra dose of vaccine administered.
Within 60 seconds of receiving the shot, I felt chest compression and pain and my throat swelled so that I had to wheeze and struggle for breath. I was able to talk, although I would cough as I spoke. My face turned very red and I had hives on my neck. The pharmacist gave me an injection of Benadryl 50 mg and the shortness of breath subsided. After about 15 minutes, I could breathe normally although my chest still felt tight. When I stood to go, I realized that I could not balance and I was at risk of falling. This felt different than low blood pressure or blacking out. I simply could not understand which way was "up." I wasn't thinking very clearly. 90 minutes after the vaccine, I felt well enough to drive home. 7 hours later, my chest still feels a bit tight and I had a little wheezing an hour ago, but it went away.
Blisters on left toes pinky toe and two toes next to it. I could not put the Manufacturer in the blank above. Seqirus, A CSL Company
Second COVID19 vaccine was administered the evening of 4/16/21 around 6 pm. Extremely mild left arm (injection arm) pain that first evening. Felt more tired than usual so went to bed around 10 pm. Morning of 4/17/21, woke at 7:30 am with a high fever (101 degrees), chills, sweating, fatigue, headache, mild nausea. Fever and chills were very severe until around 2 pm, then tapered very slowly but remained impactful until bedtime around 11 pm. Between 8 am - 2 pm, I was sleeping on and off with a lot of sweating, chills, fever. Intermittent but not severe nausea during that timeframe as well. From 2 pm - 11 pm, was still having chills and sweating. Starting around 6 pm, muscles around hips and lower back were very sore--not painful but extremely uncomfortable. Slept from 11 pm on 4/17/21 to 8:30 am on 4/18/21. On the morning of 4/18/21, mild shortness of breath was noted while doing light stretching. Still felt slightly feverish and prone to sweating, but mostly feeling better. By 4/19/21, just slight shortness of breath occurred in the morning, but by that afternoon I was able to do a light workout/lift weights. On 4/20/21, no shortness of breath and full, deep breaths are felt. No other lingering symptoms.
Patient reports extreme swelling and pain that causes impaired mobility of her arm. She states that the swelling spreaded to her elbow and she had to place ice packs for 6 hours the day she recieved the vaccine. She has taken ibuprofen and vicoden. She called the pharmacy the following morning and was counseled to continue using cold packs, and take aleve instead of ibuprofen and also to take benadryl, and monitor the swelling.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
Admit for SOB and diarrhea, husband currently hospitalized with COVID. Vaccination complete March 2021. Vit-D, Vid-C, zinc. Did not require O2. Discharged home.
I had Chronic Spontaneous Urticaria after my booster.  Itchy and hot rash all over my body that would pop up in random places for weeks.  It started on my legs one night and then spread everywhere, my neck, back, chest, feet, it was very uncomfortable.   Started approx 9 days after I got my booster.  I've never had anything like that happen before and am not allergic to anything and did not change my diet or try any new products that would have caused an allergic reaction.  I even switched my diet and all toiletry products to see if that was it but it still kept happening, I couldn't go to work for a couple weeks because of it.  Sometimes I would feel my throat start to slightly feel like it was closing up, which was scary, but I never got to the point where I felt difficulty breathing, just a strange feeling in my throat.  I also had my eyes swell up one day.  I also felt not normal, cloudy headed and sometimes had small headaches.  The rash was strange in that it would come up like red hot scratch marks on my arms, back and chest sometimes.    I went to dermatologist and he gave me pepcid and zyrtec and atarax to take daily and that slowly made it go away over a week or so but I am still taking those meds to this day at the instruction of my doctor and am worried that the rash will come back.  I went to the dermatologist to get this prescription and have him treat me on 11/24/21.
Information has been received from a pharmacist referring to a 74 year old female patient. There was no concurrent condition, medical history or concomitant therapy. The patient had no drug reactions/allergies. On 18-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M000592, expiration date 12-OCT-2017) intramuscularly. On an unspecified time November 2016, the patient reported that the injection site being "hot, red and painful". The patient's husband, who was a retired physician stated that it was "cellulitis". The patient began to treat with oxycodone (lot#, expiration date and manufacturer were unknown) and CEFTIN (lot#, expiration date and manufacturer were unknown). The symptoms had not yet improved. No lab diagnostics studies were performed. Causality was not provided. Additional information has been requested.
First shot was fine - no symptoms.  Second shot - severe flu type symptoms, headache, body aches, chills.  Had trouble sleeping the following night of the vaccine with nightmares, unable to sleep at all, just plain felt miserable and had difficult time getting out of bed.
Dizziness, BP 114/71 HR 94, then 10 minutes later BP 105/66 HR 92. Given water, apple juice, and crackers. Discharged to parents 20 minutes later in stable condition, BP 106/66 HR79.