chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient's wife. The age at vaccination was not reported. The patient experienced every listed side effects. The reporter wants to know how long this side effects could last.
Visit Diagnoses and Orders: 1. Enteropathic arthritis (Primary) -     AMB Referral to Infusion Center   2. Adverse reaction to COVID-19 vaccine -     AMB Referral to Infusion Center   3. Attention deficit disorder, unspecified hyperactivity presence     Discussion:   Reviewed rheumatology note, patient had adverse reaction to COVID-19 vaccine, plan is for her to start treatment with immunosuppressing medication > Remicade. Rheumatology recommending patient receive Evusheld EUA acknowledgment was discussed and signed by patient and provider; advised patient this treatment is investigational and not approved but is approved for Emergency use. A copy of the fact sheet was given to the patient, we also reviewed online resources. Referral placed to the infusion center   I have personally reviewed acknowledgement, Full fact sheet for providers Approximately 30 minutes were spent on this visit:             Pre-visit work: 10 Documentation: 5             Face-to-face exam/evaluation, education/counseling, orders: 20             Referral/communication with other healthcare professionals: 0 Review of separately obtained history: 0 Independent Results Interpretation: 0
Swollen lymph nodes on arm pit  2 days after moderna booster.  I was seen at urgent care to make every thing was ok and the doctor said he was sure it was a reaction from the booster and to keep an eye on it for a few days. No follow up unless conditions worse .
Metallic taste in mouth since dose 1 on March 27. As of April 28th I still have the taste. It gets worse at night before bed.
Information has been received from a Nurse Practitioner (N.P.) concerning a 31 year old female who on 06-FEB-2009 was vaccinated intramuscularly in the left arm with her first 0.5 ml dose of GARDASIL (661046/0546X).  Concomitant therapy included YASMIN, TOPAMAX, WELLBUTRIN, ALLI, aspirin and vitamins.  On 06-FEB-2009 the patient developed pain in her injection arm after her initial dose of vaccine.  The pain has persisted at the same intensity since then.  The arm was not warm, not swollen, and not red.  The pain was from the neck to below the elbow and at the time of reporting was from the shoulder to the elbow.  The pain has been described as "feeling like she has been working too long at the computer."  The patient also experienced numbness in the left arm the night of 09-FEB-2009 which resolved the morning of 10-FEB-2009.  She has treated the pain with TYLENOL, aspirin, heat, and BEN GAY with no relief.  Patient is considering not completing the series because of this reaction.  Additional information has been requested.
Annual FLUMIST on 8/24/2011 with onset of pruritic, red raised patchy macular rash to torso and legs on 8/26/2011 (day 2) that spread to her legs, neck, and face by 8/28/2011 (day 4). She denied any current or prior illness within last 2 weeks or exposure to. She advised prior side effects from 2/5/2007, 10/11/2007, 9/5/2008, 9/11/2009, and 10/26/2010 FLUMIST consisted of body aches and post nasal drip 24 hours later. These symptoms resolved within a day or two; however she denied PND or body aches with 8/24/2011 FLUMIST. She presented to medical on 9/2/2011 for persistence of pruritic macular rash (as above) advising NAFTIN and ketoconazole (prescribed meds for prior skin eczema-contact dermatitis) were effective. She described the difference with this rash vs prior rashes was that this rash was more confluent and hive like in appearance covering more surface area than usual and was to parts of her body not affected by past reactions (face, neck). This macular rash also began to weep on her chest; however she had been scratching this area. There were no papules, pustules or vesicle formations to the affected areas. She denied any headaches, fevers, chest pain, shortness of breath, lymph node swelling, or other systemic symptoms. She denied any new clothing, environmental, food or chemical contacts, soaps, detergents, animal contact, or other known triggers. Providers documented skin with angry appearing red, raised plaques to bilateral cheeks, neck, chest, shoulders, left side torso and right thigh. Suspected diagnosis was atopic dermatitis and was treated with MEDROL dose pack, triamcinolone 0.1% cream, and oral BENADRYL with full resolution of reaction about 5 days later.
My son passed out, was pale, sweating profusely,  and running nose proximately seven minutes after receiving the vaccine.
Initial consumer (patient's mother) received on 29 Mar 2010: This patient received S-OIV FLUVIRIN (batch no. unknown) unknown dose intramuscular on an unknown date in 2009. It was reported that 15 months old patient received Novartis H1N1 vaccine on an unknown date in 2009. No other information was provided. The outcome of the event was not reported.
bronchial spasms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Dairy Allergy" (unspecified if ongoing), notes: Dairy Allergy; "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BRONCHOSPASM (non-serious), outcome "unknown", described as "bronchial spasms". The event "bronchial spasms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Age at Vaccination 38 year. My doctor called them bronchial spasms. She had them for up to a year after. The worst was 24 hours after 1st dose. It was horrifying. She will never get any version of this type of shot again. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient had diagnosed with COVID-19 and since the vaccination, the patient had tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300063074 same patient, different dose and event;
Pt recvd 2 doses of Engerix-B 2 hrs p/2nd dose exp h/a, dizziness, flu like sx, nausea, vomiting, diarrhea, neck & back pain, somnolence, tachycardia, palpitation & legs were numb @ noc;
Moderna booster 0.25 mL dose was administered after the 12 hour punctured expiration time. Vial was punctured on 12/28/21 at 13:58 PM and the dose was given to patient on 12/29/21 at 11:06 AM.
Ten minutes, post vax, pt complained of severe itching over most of her body, with red blotches an back and arms. Face and ears were flushed. Treated with Benadryl at 04:50 and at 05:00, the symptoms started to decrease. At 05:30, they were minimal. At 05:35, she was driven home by her employer. At 10:00, contacted her by phone and all symptoms of itching and blotches, were gone.
Serious skin rash all over arms, hands, head, face, and neck. Similar to ant bits with blisters and itch like crazy. These are still cropping up 9 days later.
no adverse events noted, patient was incorrectly given 0.3 ml of pfizer (5-11). spoke with manufacturer and was given the go ahead to give patient the correct dose on the same day.
Patient stated she she experienced post-vaccination symptoms after receiving the 2nd dose of Pfizer vaccination in her left arm on Wednesday 3/16/22. She stated that she started to have the typical symptoms including the sore arm, fever, body aches, chills at night, and numbness in the left arm. She stated that started to feel better on Friday 3/18/22. However, on Saturday 3/19/22, she began to experience a "stroke-like" symptom which she described as "numbness in her left arm" and "currents from her left shoulder up to the left side of her face."  She called the pharmacy to ask for a referral to a Prescriber that can "bill the agency." She initially stated that she does not have insurance, however her 2nd dose of Pfizer was billed to her Medical. We informed her that she can call the clinic of her choice and ask if they accept her insurance,  and to be seen for a thorough assessment/evaluation of the symptoms she described to endure her safety and peace of mind.
UrticariaPruritus, Diarrhea & NauseaVomiting
Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under jaw.  Soon after, she felt flushed with itching in feet and swelling of feet. I observed a mild redness to face and upper chest. I saw no swelling of neck, lips or oral cavity. I ordered 25 mg. benedryl po be administered at 3:10 PM.  A few minutes later, she felt tightness in chest. At that point (3:15 PM) an EMT tried to inject an Epipen but only left the pen in for less than 1/4 second before she withdrew the pen. I then administered another Epipen directly after and the pen was in her thigh for over 3 seconds. The patient was transferred light and sirens to ER. She received no further Epi in the ER and received steroids, benedryl, and famotidine  according to the ER Resident. She was doing well 90 minutes after vaccination per Dr.
Child was 11yr9mo old. Vaccine given to child under age 12. Parent had entered child's age on the registration form as age 12. Clinic manager notified. Error realized after child left clinic & date of birth data was being entered into the state vaccine registry. Began contact attempts with mom on on 7/12/21, 7/13/21 and spoke with mom on 7/14/21. Mom reported child had "a little bit of a fever, body aches & some dizziness but is doing fine now". Informed mom about error and that child would have to wait till age 12 to receive follow up Pfizer vaccine dose.
11 days after first injection, awoke with vertigo, nausea, nystagmus.  Dizzy, lightheaded, brain fog, disorientation, blurry vision and fatigue. Saw family physician, prescribed antivert and referral to vestibular therapy.  Nearly resolved by the beginning of week 4.  Received the second dose on May 5, 2021 and exactly 11 days later, all the above symptoms returned and have been persisting since this time on a daily basis.  Brain fog and fatigue have diminished but the dizziness and imbalance as well as the blurry vision have persisted. Continue with vestibular rehab, treat with Dr. and taken various supplements and medications.
2 hours post flu shot c/o throat felt tight, tongue thick and swelling. Clammy and nauseated. 911 called; 0.5 mL epinephrine administered. Symptoms subsided 45 minutes later. EMS left participant. Went back to work.
7 days after my first shot of maderma,bad congestion, headache fever a very bad cough.drainage is green and when I go into a coughing spell,it hard to breathe.i still continue having all of this even though I went to the doctor the other day.and fatigue is so terrible with a sore throat and ear hurting.
Phone visito Visit History for 3/12/2021  Problem List* Health Maintenance* Results/Data* Review Flowsheets*  History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss of smell/taste.  o Visit History for 3/12/2021  Problem List* Health Maintenance* Results/Data* Review Flowsheets*  History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss Issues Addressed/ Plan   Diagnosis Plan  1. Viral upper respiratory tract infection (s/p covid 19 vaccine) predniSONE 20 MG Oral tablet  albuterol (PROVENTIL HFA) 90 mcg/actuation Inhl inhaler (afebrile) Counseled on supportive measures Has declined covid 19 test Informed: if conditions worsens: present to ED (immediatetly)  3/25 pt's son in the room, updated and answered all questions at this time.  4/2 Pt's husband also inpatient and covid+. Spoke with daughter today and updated r/t quarantine.  2. Nursing Education/Concerns: Care team met with family (husband, son and daughter) on 3/18/21 to discuss care goals/plan of care moving forward. Pt's code status officially updated to DNR only with trial intubation. 3/18/2021 spoke updated pts daughter on phone at 1031.  Report given to SNF- they were made aware that she needs the second pfizer vaccine  3. Interdisciplinary involvement  Social Work/Case Management: From home with spouse. STR- Referral out. STR reviewing. Will not take patient before her 10 day exposure quarantine is over. 4/9.  STR- Bed offer for tomorrow pending insurance auth and negative COVID. sent for auth. Patient aware. Son updated.   COVID exposure - exposure to covid positive visitor on 3/26 and 3/29  - discussed with infection control. Will test on 3/31 and if negative will test again on 4/7 (day 9 of quarantine) unless symptoms develop in interm. Acute hypoxic respiratory failure secondary to acute on chronic systolic LV failure requiring prolonged ventilation and SNF placement after discharge. Encephalopathy, dysphagia, anemia, tachy, AKI
Fever, headache, body ache, chills, loss of apetite, nausea. symptoms alternated between intense and moderate for about 60 hours.
Day after vaccine - started to have discomfort at injection site - site was reddened about size of fist.  On 6-16-08 - discomfort continued.  Redness had increased on arm from shoulder to elbow.  Arm was swollen, including under arm area.  On 5-17-08 swelling, redness, discomfort continued with low grade temperature of 100.  Missed 3 baseball games.  By 5-19-08, symptoms subsiding, still slight swelling.
Approx 30 minutes after vaccination, started feeling stomach upset, cramping. Approx 1.5 hours after vaccination, started feeling joint pain. Continued to work until the end of shift 1930. took Benadryl at 32130. Fell asleep; awoke next morning with aches; nasal congestion. Took Sudafed & came to work again (12/18/2020, 0700). Face started itching; then arms @t 0800 but continued working and finished shift. took Benadryl to relieve itching. Awoke early in morning to severe itching. Increased dose of Benadryl and fell asleep. Continued itching on Sat 12/19/2020 and having difficulty breathing. Used inhaler, Pepcid and Prednisone with good effect. Took off work Monday 12/21/2000,  Tues 12/22/2020 and Wed 12/23/2020 (no meds taken). Returned to work on 12/24/2020, no fever, no exposure
Dizziness (h/o vertigo). BPs 142/75 (pulse 87), 135/72 (pulse 87). O2 sats 96%.
Information has been received from a physician concerning an approximately 77 year old female patient with penicillin allergy who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot number unknown). Approximately a week after receiving ZOSTAVAX (Merck), the patient presented with diarrhea. On an unknown date patient was admitted to a hospital and diagnosed with acute refractory diarrhea and acute renal failure. The patient was still in the hospital and not recovered at the time of reporting. The patient's acute refractory diarrhea and acute renal failure were considered to be immediately life-threatening, disabling and other important medical events by the physician. Additional information has been requested.
Anaphalatic shock, loss of consciousness, tremors, hypotension, nausea for 5 minutes.  ER visit.
ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 1 MI RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Employee had a reaction possibly with nausea, vomiting, diarrhea & small amount of tightness in chest. Works in health care area in housekeeping. Employee has had problems with egg-based vaccine in past.
pt recv vax; r n reported pt passed out & exp "oth AE" following vax;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Severe, Additional Details: Muscle weakness in legs. Started two to three weeks after administration and patient states the symptoms were severe. He did not notice any difference if he changed physical activity. Patient stated his symptoms have lessened over time but is still experience muscle weakness in legs, especially when standing, continues to occur every 4-5 days.
This is a spontaneous report from a contactable nurse, the patient. This nurse reported similar events for three patients. This is 1st of 3 reports.  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 as a single dose for COVID-19 immunization.  Medical history included ongoing arrhythmias, which started about 3 years ago (2018) and got worse over time.  Ongoing concomitant medications included metoprolol (MANUFACTURER UNKNOWN) taken arrythmia from Sep2020. On 13Jan2021, the patient received the vaccine. Afterwards her right wrist was itching. She took diphenhydramine hcl (BENADRYL) for the itching. Then, she felt different when she got home and was lightheaded. She also had a headache. She took acetaminophen/diphenhydramine (TYLENOL PM) before bed for the itching and headache.  In the morning of 14Jan2021, she felt really bad. She did not have itching, but it started back up again later. She also took acetaminophen for the headache as the headache was on and off. She called her cardiologist due to her cardiac history, and asked if she could come in. On 14Jan2021, she had an electrocardiogram done and was diagnosed with post COVID vaccine supraventricular tachycardia (SVT).  On 14Jan2021, she had head and chest congestion. She felt stuffed up. She was coughing but she had no mucus. She thought that when the arrhythmia occurred, she coughed because of the SVT. The cardiologist ordered her to wear a 24hour HOLTER monitor, the results of which were unknown. The clinical outcomes of the wrist itching and post-COVID vaccine SVT were not recovered; while the events of felt different, lightheaded, and headache were recovered on 13Jan2021. The outcome of felt really bad was recovering.  The outcomes of the cough and head and chest congestion were unknown. The events of felt different, lightheaded, felt really bad, and post-COVID vaccine SVT were reported as serious for being medically significant. The seriousness of the other events was not reported.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events supraventricular tachycardia, lightheadedness and feeling abnormal.  The patient's underlying arrhythmias may also predispose the patient to developing supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021042313 same reporter, same drug and event, different patient.;US-PFIZER INC-2021042339 same reporter, same drug and event, different patient.
swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; swelling, rash, red itchy spots, blisters; cold and cough; This spontaneous report was received from a pharmacist and refers to a 37-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # U004713, expiration date 10-FEB-2023, for prophylaxis (exact dose, dose number, vaccination site and route of administration were not provided).  On an unknown date in 2021, the patient had a cold and cough. On 03-OCT-2021 (also reported as yesterday), the patient began developing following symptoms: swelling, rash, red itchy spots, blisters. The symptoms started at or around injection site and on an unknown date in October 2021 (reported as now) have spread to other unknown areas. The symptoms were at the time mainly in 3 locations, but reporter did not specify exact locations. The patient sought medical attention. The outcome of the events was reported as not recovered.  The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
This spontaneous report as received from a female nurse of unknown age via company representative refers to herself. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, expiration, dose, route unspecified). On an unknown date the patient developed neck aches, swelling at the injection site and chills on the following day after receiving a dose of PNEUMOVAX23. The nurse also received a flu vaccine on the opposite arm on the same day. The patient had sought medical attention. Received 2 bags of IV fluid for treatment. The event outcome was reported as recovering. Additional information has been requested.