chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs; soreness of the arm; This is a spontaneous report from a contactable consumer (patient work in detention center). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284, Expire Date: 30Apr2021), via an unspecified route of administration on 05Jan2021 07:45 in the right arm at single dose for covid-19 immunisation. Medical history included covid-19 from 26Dec2020 was recovering. The patient's concomitant medications were not reported. The patient experienced soreness of the arm on 05Jan2021 with outcome of recovering, loss of smell and taste on 06Jan2021 04:00 with outcome of not recovered, headache on 06Jan2021 with outcome of recovered, coughs on 06Jan2021 with outcome of not recovered, low grade fever on 06Jan2021 02:30 with outcome of unknown, flu-like aching on 06Jan2021 01:00 with outcome of recovering. The detail clinical course was provided as consumer calling regarding the COVID 19 vaccine. He received first dose of the Pfizer COVID 19 vaccine on 05Jan2021 07:45am in the right arm. He noticed by the afternoon his arm was sore. He worked overnight so at 01:00AM 06Jan2021 he noticed achy, like flu ache in his muscles. He took his temperature and it was 99.4 around 02:30 in the morning. Then at 04:00am he noticed he couldn't smell or taste anything. He went home and fell asleep. When he woke up he had a headache and coughing. He took Dayquil which helped with the coughing and then the headache went away. He has had the coughing all through the COVID infection. The patient underwent lab tests and procedures which included body temperature: 99.4 on 06Jan2021 02:30, COVID 19 test PCR positive 26Dec2020. The events were reported as non-serious. Mentioned he was told if you already had COVID the side effects of the vaccine may be worse. He was planning to receive the second dose 26Jan2021.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical histories, concurrent conditions and drug reactions were not provided. On an unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L041204, expiration date 20-OCT-2017 (Dose, route and anatomical location were not provided). No other suspect or concomitant therapies were provided. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 03-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.      No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Info has been received from a case in litigation concerning a male pt who was vaccinated with a dose of MMRII. Subsequently, the pt was dx'd with eczema. No further info is available.
Information has been received from a nurse practitioner concerning a 14 year old female with no pertinent medical History and no known drug reactions/ allergies, who was vaccinated with the second dose of GARDASIL.  The nurse practitioner reported that on 02-FEB-2009 the patient experienced migraine headache after receiving the second dose of GARDASIL.  Subsequently, the patient recovered from migraine.  The patient sought medical attention and was seen at the practice.  Additional information has been requested.
Injection site redness; injection site urticaria; Injection site warmth; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE URTICARIA (injection site urticaria) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for Product used for unknown indication: TRAMADOL, METHOCARBAMOL, uceris and Heparin. Past adverse reactions to the above products included No adverse event with Heparin, METHOCARBAMOL, TRAMADOL and uceris. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Allergic to cats, Cockroach allergy (Dust mite reaction allergy is manifestated by watery eyes, sneezing and coughing.), Drug allergy (Non-steroidal anti-inflammatory drugs allergy), Drug allergy (Metrocarbamol allergy), Drug allergy (Heparin allergy), Drug allergy (Tramadol allergy), Drug allergy (Uceris allergy ) and Topical adhesive allergy (Bandage adhesives allergy manifestated by broke out rash). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 06-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE URTICARIA (injection site urticaria). At the time of the report, INJECTION SITE WARMTH (Injection site warmth), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE URTICARIA (injection site urticaria) had not resolved.            No treatment medication information was provided.
R arm became painful from fingertips through shoulder and into R chest wall. Tingling in fingertips and arm off and on. Saw physician 11-12-09 we thought it was a reaction to the vaccine and gave her Mobic and Darvocet. 11-16-09 still has symptoms - same -maybe a little better will be seeing a Neurologist soon.
Became lightheaded while bicycling, near-syncope, when stopped on road where construction was going on; thereafter unable to run 2 miles when had done so easily Aug 19 2021, and after 36 cardiac rehab sessions running 25-30 minutes on treadmill each session post stenting which occurred March 22 2021. All lightheadedness, weakness, near syncope w repeated lifting and bending ceased after the stenting procedure.
Swollen lymph nodes in same arm as injection (11/10-11/12), fatigue (11/10-11/11), headache (11/10-11/11), muscle pain (11/10-11/11), chills(11/10-11/11), fever(11/10-11/11), and rash (torso, back, shoulders; 11/10-11/12).
Had shot and then still got the darn stuff /Suspected vaccination failure; Had shot and then still got the darn stuff / First time in my face / 4 years ago it came back on my torso; Very painful; 4 years ago it came back on my torso / That put me to bed..... For 2 weeks at least; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and bedridden. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and bedridden to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received the Shingle vaccine and then still got the shingles and was very painful. The patient had it 1st time on his/her face and often then 4 years ago it came back on his/her torso, that put the patient to bed for at least 2 weeks. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
drug ineffective; COVID-19; Device issue; Injection site papule; Injection site induration; This is a solicited report received from contactable Consumer (the patient)  for a sponsored program. Other Case identifier(s): 21K-163-4186569-00 (Abbvie).  A 35 year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscularly, on 05Apr2021 (Batch/Lot number: unknown) at the age of 34 years as a single dose  and received the second dose of  bnt162b2 (BNT162B2), intramuscularly, on  26Apr2021 (Batch/Lot number: unknown) at the age of 34 years old as a single dose, both for COVID-19 immuniz ation; unspecified adalimumab (HUMIRA) (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE with onset 2021, outcome "recovered", described as "drug ineffective"; COVID-19  with onset 2021, outcome "recovered", described as "COVID-19"; DEVICE ISSUE (non-serious) with onset 2021, outcome "not recovered", described as "Device issue"; VACCINATION SITE PAPULE (non-serious) with onset 2021, outcome "not recovered", described as "Vaccination site papule"; VACCINATION SITE INDURATION  with onset 2021, outcome "not recovered", described as "Vaccination site induration". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (2021) positive. The reporter stated that it was possible that the events device issue, COVID-19, injection site papule and Injection site induration were related to the Pfizer BioNTech Covid-19 Vaccine. The reporter's causality for the event(s) of PEN MISFIRE with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of COVID-19, RAISED AT INJECTION SITE and HARD AT INJECTION SITE was not provided.  The The action taken for adalimumab was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided a possible causal association between the reported events drug ineffective, Covid 19, vaccination site induration vaccination site papule are assessed as related to the suspect BNT162B2. Device issue may not be related to BNT162b2.
Vaccine was giving on 8/23/2016. Per mom a few days after receiving vaccine patient stop talking for about 30 days.
Sore arm after injection and bruising, woke up in a brain fog, started feeling bad with body aches around 11:00 am, got very cold, pulse rate in 100s from 8:00 am until 9:00 pm then in the 90s, blood pressure 157/97 around 12:30 pm, had blotchy skin on neck and chest around 12:00 pm, still extremely tired with slight headache on 4/17/2021
pt admitted w/anaphylatic react to flu shot; started on NTG paste p/ c/o chest pain-h/a;
Initial report received from literature on 27 May 2014. The following is the verbatim for the article abstract: The Brighton Collaboration is a global research network focused on vaccine safety. The Collaboration has created case definitions to determine diagnostic certainty for several adverse events. Currently nested within multi-page publications, these definitions can be cumbersome for use. We report the results of a randomized trial in which the case definition for anaphylaxis was converted into a user-friendly algorithm and compared the algorithm with the standard case definition. The primary outcomes were efficiency and accuracy. Forty medical students determined the Brighton Level of diagnostic certainty of a sample case of anaphylaxis using either the algorithm or the original case definition. Most participants in both groups selected the correct Brighton Level. Participants using the algorithm required significantly less time to review the case and determine the level of diagnostic certainty [mean difference=107s (95% CI: 13-200; p=0.026)], supporting that the algorithm was more efficient without impacting accuracy. The following is the verbatim for the article full text: A 12-month-old male patient had medical history of atopic dermatitis, egg allergy (prick +) and report of hives after eating carrots. The patient visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, the Influenza, Inactivated Vaccine (TIV) was administered per 2-part protocol to right quadriceps. 1. TIV 0.05cc intramuscularly: The patient was noted to have full -strength, which was monitored for 30 minutes. No other adverse reaction was noted. 2. TIV 0.20cc intramuscularly: Within 30 minutes of the 2nd dose, the patient experienced urticaria of neck, anterior torso, and both arms. He also became fussy and started crying. Baby B had increased work of breathing, coughing, stridor, retractions, mild erythema, and angioedema of uvula. The following lab values were noted; Respiratory rate 24 BPM before first vaccine and 42 bpm after second vaccine; O2 saturation 97% before first vaccine and 93% after second vaccine; Pulse 124 bpm 97% before first vaccine and 137% after second vaccine; Systolic blood pressure 110 before first vaccine and 176 after second vaccine. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone, and albuterol. The child went home, and the night after the clinic visit, the child experienced diarrhea, mild wheezing, and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts, or carrots, and there were no changes in the home.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 25-JAN-2016 the patient was administered improperly stored GARDASIL (lot # K011562, expiration date 08-APR-2017) (dosage, strength and route unknown). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Administered HPV (Gardasil) vaccine #1 in child's left deltoid. Patient fainted. I put ammonia under her nose. She woke up but was very pale and complained of her legs hurting. She then put her head between her legs and she began to feel better.
Patient received 1st dose of vaccine.  Minutes after, while in the observation area, pt appears to have had a vasovagal reaction with a brief loss of consciousness, pt fell to the floor, had very brief shaking activity followed by immediate arousal by patient as medical provider has seen in other vasovagal incidences.  Pt was alert and oriented upon arousal and pale.  EMS was called by a store patron.  Upon EMS arrival, Patients blood sugar was taken and found to be 55, pt does not have a history of diabetes.  Pt stated he had had a waffle that morning for breakfast and had not eaten since the morning (time of event is estimated around 11am).  Vital signs within normal limits.  Patient stated he felt like he was having an anxiety attack prior to event.  Parents decided to take patient to the hospital for further testing.  Mother stated patient was discharged from the hospital that day and tests were normal.
Pt. had received his Moderna 1st dose vaccine. Approximately 2 minutes after receiving the vaccine he asked for staff and stated he was not feeling right. They asked the patient to sit all the back on the couch while they were walking to him for an assessment the Pt. became very pale and stated he was going to pass out. Pt. was sitting on the couch in the Covid Clinic when he had a syncopal episode that lasted approximately 30 seconds. When the patient lost consciousness he did not fall or hit his head. Staff asked for the rapid response team to be paged and began to obtain pt. vitals until the rapid response team arrived. Once the rapid response team arrived a summary of events was provided and transferred pt. care. Pt. had a second syncopal episode with the rapid response team and was taken to the infusion center for continued care and assessment.
Dizziness, Myalgia, Arthralgia, FEVER, CHILLS, DROWSY Narrative:  Other Relevant History:
Within two weeks my son developed chronic ear infections that lasted for 4 months. The only hope we had was to get him tubes after months of antibiotic oral and injected. He then regressed in his speech until he was basically mute. He started to fall down a lot from the ear infections to the point he could no longer walk. He became extremely irritable and inconsolable at times. He went from being a happy healthy boy meeting and exceeding all milestones. To a very sick little boy who regressed beyond comprehension and basically was unable to speak or walk. At 13 months old he started to crawl again because he couldn't walk without falling after every step.
Weakness in deltoid muscle at injection site worsening over past month.  No deficit in strength but subjective weakness.
Previous Vaccine: Both Pfizer (Little side effects) - decided to get Moderna Booster  12/11/21 - 7:00 p.m. | 11 hours after Moderna Booster - Chills and fatigue. 12/12/21 - 5:00 a.m. | 21 hours after Moderna Booster -  Chills, Sweats, Aching, and headache.  Serious pain at the injection site - muscles very sore - I did move the shoulder a lot during the day but it didn't seem to reduce the ache.  - took some Ibuprophen and it improved as the day progressed.  12/12/21 - 7:00 p.m. | 1d + 11hours after Moderna Booster - Chills returned and very fatigued.  took 2 more Ibuprophen and went to bed. 12/13/21 - 3:30 a.m | 1d + 21.5hrs after Moderna Booster - Serious sweats, chills, slow to get going.  Shoulder still very sore.  Took 2 more Ibuprophen.  Tried to go back to bed but couldn't 12/13/21 - 5:00 a.m. - trying to go to work, sweating a lot.  Hoping that issues mellow out as the day progresses.
Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, experiencing increased joint pain on left wrist and thumb as well as swelling at base of thumb and inability to move, pinch, grab, stretch left hand. Occasionally pain spread up left forearm to elbow.
Received vaccine on afternon of Nov. 2. On Nov. 4 woke up in a.m. short of breath. As day went on, I became lightheaded and weak. During the afternoon, I developed a sharp pain in my left side that became worse every time I took in a breath.My whole back, esp. left side, hurt by late afternoon and I had continous spasms over my entire upper and lower back. I was in extreme pain and could not stand up straight to walk and had my daughter drive me to Urgent Care late in the afternoon.  Pain lasted several days altho lessened in intensity by 11/10/05. Urgent Care MD could find no cause for pain, gave me RX for pain med and sent me home.Extreme pain at home through the night.         ( I called my MD's office earlier in the day to report that I wasn't feeling well, asked if this was normal and was told that some discomfort was normal after flu shot but to call again if I continued to feel ill.)Went to Urgent Care after clinic closed for the day.
This spontaneous case reported by a consumer, describes the occurrence of myalgia (muscle pain), chills, pyrexia (fever) and fatigue (tiredness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced myalgia (muscle pain), chills, pyrexia (fever) and fatigue (tiredness). At the time of the report, myalgia (muscle pain), chills, pyrexia (fever) and fatigue (tiredness) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
My throat was itchy, and I was coughing. Then, I had an anxiety attack. I stayed at the vaccination location for 40 minutes until I felt better. When I got home, the first and second day I felt tired and nauseated. Sunday, I felt normal and on Monday I woke with a migraine, very nauseated, really dizzy, had blurry vision, and I couldn't stand without holding onto the wall. Tuesday, I had the exact same side effects plus an itching/burning throat. I went to the ER on Tuesday, and everything was normal. CT scan was taken on Tuesday. I no longer have headaches, and I am no longer nauseated. Throughout the whole ordeal I had no energy. I can no longer tolerate the heat, I always get really hot.