chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe entire raised large patches of red rash with body hive like rash, severely itchy and painful, except face/head which began week of 12.26.2021 after Moderna Booster injection. I waited a week before making a primary care appt. with my PCP. I tried treating myself with Sarna, Aveeno Cream which did not relieve the severe blisters everywhere that break, bleed, itch, hurt. Inside of mouth large red patches, dry, pain, throat, feet and hands severely itchy with rash. Appt. with Doctor  January 6, 2022, prescribed: 5 day course of Prednazone; Fexofenadine 180 MG, 1 daily; hydroxyzine hcl 25mg 1.2 to 1, 3 times daily, initial visit. Since that visit in December the rash persists. I have kept my PCP notified of changes. She has reordered Fexofenadine and hydroxyzine since then since it has not gone away. She now has me on a trial of topical triamcinolone acetonide cream USP, 0.1% as needed for breaks. I have to use it on arms and legs, back and abdomen on reoccurent blisters. A referral to a dermatologist was made in early January, I have been waiting until February 28th, 2022. I have had this now: 7 to 8 weeks.
very little arm trouble the next day (barely); This is spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This consumer reported events for both doses of bnt162b2. This is for the first dose. An 86-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The first shot the patient had no issues. The patient told them he wanted them to give it to him slow. He had very little arm trouble the next day (barely). The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021407944 Same patient, different dose and event
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with VARIVAX was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Initial report received from a consumer who is also the patient daughter on 12 October 2012. An elderly female patient, whose exact age was not reported and medical history and concomitant medications were unknown, received a dose of FLUZONE HD (lot number, route and site of vaccination was unknown) on an unspecified date. On an unspecified date, the patient developed unspecified adverse event with "FLUZONE for over 65". Corrective medication was not reported and laboratory investigation was unknown. The patient's outcome was unknown. List of documents held by sender: none
gave previously frozen Tenivac to a patient; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on same date by the nurse.  This case was linked with 2019SA126878 (For patient recieved Tubersol)  This case involves a patient who received frozen vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (0.5 ml, lot number: U6021AA) on 07-May-2019.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to product storage error.  It was not reported whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I received the Pfizer booster shot at 1:30 pm on Thursday, 10/21/21. I continued working and was fine. When I got home around 3 pm, I felt tired and fell asleep. I was fine that night and the next morning. At 12 pm the next day, I had a bout of severe nausea and fought vomiting. I also had chills and was incredibly fatigued. I canceled my afternoon work and fell asleep for 2 hours. When I woke up the nausea wasn't as bad; I still felt fatigued and week and also achy. That night, the symptoms weren't too bad, just achiness and fatigue. I woke up the next day still fatigued and weak, but not as achy. That night (Saturday), my feet felt like they were on fire and, despite not having a fever before going to bed, woke up soaked. I woke up Sunday feeling achy. I am still fatigued and weak.
- Severe chills that started roughly 34 hours after the injection. The shivers and teeth chattering lasted several hours despite sitting on a heating pad and wrapping myself in several blankets. The chills prevented me from sleeping. - Soreness at the injection site that started 12 hours after injection and lasted about 48 hours.
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 03/03//22 at 3:15PM . Patient has not reported to Medical Clinic with symptoms at this time.
Since receiving vaccine, patient has had continuous headaches, malaise, nausea, anorexa and low-grade fever on a couple of occasions.  He has had a slightly pruritic, erythematous rash on both arms, which waxes and wanes.  Mild shortness of breath, but no wheezing.  He notes easy bruising, but no bleeding.  Feels better the day of doctor's appointment.  Exam is normal today except for eczematous rash in both antecubital fossae.  Patient says this is resolving.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 22-FEB-2017, the patient was vaccinated with a expired dose of VAQTA, lot number L046953, expiration date 14-JAN-2017, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. Additional information has been requested.
Four hours after flu shot pt developed temp of 104 degrees and blood pressure was 223/93. Went to ER where he was admitted, and given antibiotics. MD thought pt had pneumonia, then said it was from flu shot. Pt was given VANTIN 200mg to take at home, but didn't take it. Pt says he is now suffering from no energy and cold/sore shoulders from shot.
Fever, chills, headache, sweating, pressure in chest, body aches, skin burning.
After 2nd dose, about 24 hours later my period started (I?m about 4 days early). I usually have extremely heavy periods, but right now it?s thick blood clots. Having bad endo stabbing pain. My period lasted 12 days after taking my 2nd dose. Which was 3 days longer than usual. And now, 17 days later, I started menstrual cycle again (too early)! I have the biggest & most blood clots that I have ever seen & heavy period.
Three hours after administration of Fluarix Dr de Delva had profuse sweating, felt cold and clammy and vomited.  This lasted approximately two hours.
Presented with reddened area @ injection site with warmth to touch. VSS with BP 100/60, P 88, R 18. BS clear equally bilaterally. Given 25 mg BENADRYL PO with relief of sx. Per mother pt has had reaction to flu vaccine in past.
nausea, extreme dizziness.   The nausea lasted 24 hours.  The dizziness was constant for 3 days and sporadic for 6 days before subsiding completely.
hives; itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ZOSTAVAX with an associated reaction of urticaria (also had Zostavax when it first came out).   On 28th May 2019, the patient received the 1st dose of Shingrix .5 ml. On 1st June 2019, 4 days after receiving Shingrix, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter declined to provided date of birth.  The patient received Shingrix and noticed what appeared to be mosquito bites on her ankles that then spread to her arms and legs. The patient also had one on her forehead. She said some itch, but others did not.  They appear as single hives and not so much in clusters.  The reporter reported that she had a scheduled appointment with her physician in the coming weeks, and planned to discuss when him then.   Did not consent to follow up. The reporter declined to provide health care professional information.
Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.).    No concomitant medications were reported. Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23. Vials from documented lot numbers were used. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716063, US-MODERNATX, INC.-MOD-2023-716061, US-MODERNATX, INC.-MOD-2023-716062, US-MODERNATX, INC.-MOD-2023-716039 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Non-Significant Follow-up appended: No new information On 16-Mar-2023: Live Significant follow-up appended: Patient details updated, Onset date of vaccine updated, and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716061:Patient US-MODERNATX, INC.-MOD-2023-716062:Patient US-MODERNATX, INC.-MOD-2023-716039:Patient US-MODERNATX, INC.-MOD-2023-716063:Patient
red "pimple-like" dots below injection site. Redness down to elbow slight swelling
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 78-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left hand for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (FIRST BOOSTER, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "nagging pain at the injection site"; INSOMNIA (non-serious), outcome "unknown", described as "annoying to get to sleep". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: It was reported that, the patient did feel right when he got the shot, after the shot, have slight pain but the last 3 weeks, the pain instead of being like a two would go up mostly when sleeping to 5 or 6, annoying to get to sleep. The patient couldn't sleep with the pain in the area of the injection. The patient was right-handed the site is on his left hand, he don't do any work as well. Caller also mentioned there's other people experiencing this. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I'm feeling really miserable today; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I'm feeling really miserable today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced MALAISE (I'm feeling really miserable today). At the time of the report, MALAISE (I'm feeling really miserable today) outcome was unknown.            No concomitant medications were provided No treatment medications were provided   Reporter did not allow further contact
Began to notice pale spots on hands approximately 2-3 weeks after vaccine.  Over time, spots worsened and spread to arms, face and genitalia.   Dermatologist did biopsy and confirmed vitiligo depigmentation of skin.
I have popped up with a rash that looks a lot like shingles/it broke out into rash around my stomach and my back below the waist no actually above the waist.; I have popped up with a rash that looks a lot like shingles; It is painful; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. Medical history included broke some bones and not ongoing; and fell. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS).  There was no investigation assessment. Patient stated that she had the Pfizer shot on 12Jan2021. Yesterday or maybe the day before she had popped up with a rash that looked a lot like shingles. She saw on the website it can produce rashes. She was going to go to her dermatologist. It was painful in Jan2021. Last night and maybe yesterday it broke out into rash around her stomach and her back below the waist no actually above the waist. She was just trying to figure out if it is from the vaccination or if she should go to dermatologist. Patient stated she did see where it can cause rashes. In fact, it did not cause all over your body but since this is one specific area. She thought maybe it was something known and they could tell her what she need to do. Possibly the 15th or 16th.  She knew she had it on 16th but she may got a little bit of. It started on 15Jan2021.  Patient stated she had not done anything for the rashes. She didn't know what to do. She was going to physical therapist because she fell in August and broke some bones. But she was fine now. She was not taking any medication other than vitamins. Outcome of events were unknown.
This spontaneous report was received from a licensed practical nurse, regarding a female patient of unknown age. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 21-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, and route was not provided) lot number: N003993; expiration date: 20-OCT-2018, for prophylaxis. On the same date, after receiving the injection, the patient developed a "red, hot, and hard lump at the injection site". The patient sought medical attention by calling a physician's office and no intervention was performed to prevent serious criteria. She was prescribed MEDROL DOSEPACK and an unspecified antibiotic by her physician to treat the events. At the time of reporting, the outcome of the events was unknown. The reporter did not provide a causality assessment between the suspect vaccine and the events: injection site reaction, injection site warmth, injection site erythema, and injection site induration. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-00950513-1703USA012535.
Left arm red, warm,. swollen at injection site. 10 x 10 cm. Cellulitis. Tx with Keflex.
Patient presented to MD w/rash all over body. MD has attributed rash to vaccine upon examination and prescribed steroid TX 10/31/16 for 12 days.
Immediate tingling in hand of injection side.  15 minutes, tingling in hands and feet, dizziness, numbness around lips.  In one week from date of injection, Swollen axillary lymph node on injection side . In two weeks from date of injection, shooting pain down legs and heaviness in arms and legs. Referred to neurologist, and it was documented in his notes adverse reaction to Covid 19 vaccine.  He recommended that the second dose to not be taken.
pt recv vax 23JAN96 & devel a fever of 99, myalgia, fatigue, erythema @ inj site;
Had headache a few hours after injection, injection site hardened and had a rash, a day later I developed a high fever. My face swelled up and it was hard to breathe for a few hours. On the third day the swelling stopped but the fever took a few days to go away. It's been 2 weeks and a painless rash is still at the injection site.
arm swelling down the arm almost reaching the tip of the finger / arm swelling spread across arm /injection site swelling; bruised arm; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 7AR35, expiry date 30th June 2020) for prophylaxis.   On 29th August 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 31st August 2019, 2 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced extensive swelling of vaccinated limb and bruising of arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb and bruising of arm were recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and bruising of arm to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. Approximately two days later, the patient experienced extensive swelling of vaccinated limb, injection site swelling, swelling arm and bruising of arm. The reporter reported that, the swelling spread across the arm horizontally, then proceeded downward on the arm, almost reaching the tip of the finger. The swelling did also appear bruised. At the time of reporting, the symptom's were improving. The reporter consented to follow up.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 30-OCT-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 120, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
28JUN95 pt states that approx 10-15 mins p/shots on 222FEB95 pt became unconscious or unresponsive for approx 30 mins; could not wake pt breathing & pulse was fine; mom states called MD;
Pt came in presenting with rash to abdomen, arms and face. The mother noticed the rash on 9/14/2011 while giving the child a bath. The child received both varicella and MMR boosters on 9/1/2011.
chills, extreme headache, dizziness, nausea, chest pain, racing heart beats, racing thoughts, can't sleep, left inner ear pain, blurred vision, pain in left elbow, numbness in left hand for 12 hours, shortness of breath, general weakness - adverse events have lasted over 48 hours - Advil taken with minimal reduction in symptoms
Just 7 minutes after vaccine diarrhea started, threw up in the parking lot. Had problems with balance, comprehension, vision loss like glasses don't work, scared to drive. Weak, lost 20-30 pounds. Everything that pt eats tosses it up or has diarrhea, hallucinations, blood pressure issues that couldn't be controlled goes from 60/90 -> 210/126, depressed, very angry/mood swings, can't think. Symptoms worse for first 2 months but have leveled off. Had to start smoking to help bring BP back up. Stopped taking vitamin. Has had 7 doctor visits and 1 ER visit, 2 CAT scans, 4 MRIs, 1 EEG. Quit taking vitamins. Had bad infection on teeth. Teeth loose and had pus pockets so 2 teeth were pulled given azithromycin. 3/18 prescribed CIPRO and then prednisone and then stopped. 4/1 started tamsulosin for enlarged prostate.
Status epilepticus, received fosphenytoin.  11/18/08 Reviewed hospital medical records of 11/10/2008. FINAL DX: new onset seizure; status epilepticus Records reveal patient experienced staring & unresponsiveness while on playground at school.  Had recent cold s/s.  Generalized tonic clonic seizure activity when EMS arrived & continued for approx 10 min.  IV meds stopped seizure but continued to have mouth chewing, unresponsive to verbal stimulation, vomited x 1, postictal in ER.  Neuro consult done.  Admitted overnight for observation.  No further seizure activity & d/c to home on diastat only.