chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Cholesterol and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), FLUTICASONE PROPIONATE (FLOVENT) for Asthma, PRAVASTATIN for Cholesterol, CETIRIZINE, MONTELUKAST, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (itchy) and RASH (rash). On 15-Feb-2021, PRURITUS (itchy) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-098863 (Patient Link).
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years eight months old female patient who received 0.25 mL dose of vaccine FLUZONE QUADRIVALENT lot UT6259KA, expiry date: 30-Jun-19 via unknown route in the right deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations were given. It was an actual medication error due to vaccine underdose. It was reported that three-years-old female got the 0.25 mL dose. No side effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
On day 12 s/p smallpox vaccine, pt noted painful lesions dorsal aspect, R index finger. Lesion initially papular & progressed to vesicle, then pustule. On 2/23/02, lesion was unroofed by CDC smallpox lab & diagnostics (EM) performed, 2/25 were consistent with  vaccinia virus. Dx: autoinoculation vaccinia virus. Lesion has continued to resolve without event. Primary reaction noted at vaccine site on L upper arm.
Injection site pain so excruciating I couldn?t stop crying, unable to control body temperature, migraine, feeling light-headed, fatigue. I rested. This lasted 1.5 to 2 days.
Since approximately 4 weeks after the Covid-19 vaccine, I have been experiencing very painful joints, muscles and fatigue. I have not been able to sleep well or do normal household responsibilities without severe pain in my muscles: hips, back, shoulders, arms and legs and regular headaches. Normally I used to take multiple fast-paced walks (with my dog) and go multiple loops around our neighborhood and walking paths prior to the symptoms appearing and now I can only manage to do one loop around and am exhausted and in much pain. Even simple things like sitting at my desk/home office or watching a movie (for about 90 minutes or less) my hips and legs will get extremely stiff and painful when I stand up. After a few months of increasing pain, I made an appointment to see Dr. and was seen on December 2, 2021. She diagnosed me with pinched nerves and recommended I see a physical therapist. I am now seeing a physical therapist and am working on core strengthening. The pain levels are manageable, however I cannot do more than one loop around my neighborhood, and when I sit for more than 30 minutes, I still have severe pain in my hips, back, shoulders, arms and legs and still have trouble sleeping due to shoulder discomfort or other muscle/joint pain. I do not have as frequent headaches at this time, however I am still getting them.
Mom states that two days after receiving vaccines, child was hospitalized for vomiting, diarrhea, high fever and "extreme drowsiness"- The child remained in the hospital for two days. The child was also seen by a private pediatrician before and after hospitalization.  6/13/08 Reviewed hospital medical records of 4/12-4/13/08. FINAL DX: acute gastroenteritis; dehydration; leukocytosis w/neutrophilia. Records reveal patient experienced vomiting w/bilious emeis & abdominal discomfort x 2 days.  Seen by PCP & tx w/meds but no improvement.  Urine output decreased & oral intake reduced.  Tx w/IVF  & antiemetic meds.  Improved & d/c to home w/PCP f/u.
Patient states that she felt the vaccine go through her body. She says that after about 20 minutes she developed  dizziness and throat tightness. She developed erythema across her chest.  BP 180/108. O2 sats 98%. No SOB or difficulty breathing
Estimated date of delivery 01/14/2022 Pregnancy history- 1st pregnancy I had head to toe covered in Hives- face chest, stomach, legs. Itching. Face was hot to the touch. There was no known allergen that was consumed to cause this reaction.
(L) deltoid area w/redness in circular distribution around injection site. Not warm or tender some itch reported by pt. Redness extended 3x4cm.
This spontaneous report was received from a registered nurse referring to a patient of currently 53 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Rash; generalized pimple-like and red on chest to stomach with fever and itching. Pin-prick skin color at site of injection. Mother thinks due to allergy to alcohol wipes; happens each time at each site with previous vaccines.
PCV13 in 2015 and had pneumonia in 2017; PCV13 in 2015 and had pneumonia in 2017; This is a spontaneous report from a Pfizer sponsored program. A 95-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in 2015 at single dose for immunization. Medical history included had pleurasie in lungs when she was young and is susceptible for pneumonia; blood disorders. Concomitant medication included atorvastatin calcium (LIPITOR); BP medications and pills for blood disorders. The patient previously took PPSV23 in 2013. It was reported that the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)  in 2015 and had pneumonia in 2017. It was reported that the patient took another flu shot (not specified). It was also reported that the patient is still very active. Outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.
Approximately 30 minutes after injection got migraine then began experiencing chest pains that began moderately progressively worse.
Varicella - Information has been received from a woman in a pediatrician's office concerning multiple patients who were vaccinated with varicelle virus vaccine live (site unknown).  Subsequently the patients developed breakthrough varicella post vaccination.  The patients did not seek medical attention.  It was noted unclear if it could be a storage problem.
redness (rash) and inflammation of arm, elbow, and leg. Tender to the touch.  Started at day 6 after 1st Moderna Covid-19 dose
fever as high as 102.1 aches  chills nausea  taste was also off, spicy soup tasted sweet
This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 90-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 01:15 as dose 1, single (Lot number: EN6199), in right arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 29Oct2021 at 14:15 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 16Jun2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 90 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication included: Centrum [Minerals Nos; Vitamins Nos]; Nature Made Calcium Magnesium Zinc; Aspirin; Maxzide; Norvasc; Prinivil; Nature Made Super B Complex; Nature Made B12 Vitamin; Nature Made Vitamin C; Nature's Bounty Iron; Antihistamine Allergy Relief; Atorvastatin; Ocuvite [Ascorbic Acid; Beta carotene; Cupric Oxide; Sodium Selenate; Tocopheryl Acetate; Zinc Oxide]; Simethicone. Past drug history included: Prednisone, reaction: "Body rash"; Prednisone, reaction: "Allergies: Prednisone"; Toradol, reaction: "Nausea"; Toradol, reaction: "Allergies; Toradol". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
First two days body aches, headache, nausea, arm extremely hurting. Couldn't get out of bed. Now on day three and still have the nausea and headache. Arm still hurts. Taking Tylenol Extra strength for pain.
Swelling in the bicep; This case was reported by a pharmacist via call center representative and described the occurrence of muscle swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced muscle swelling. On an unknown date, the outcome of the muscle swelling was unknown.   It was unknown if the reporter considered the muscle swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was selected as per the vaccine indication. The reporter stated that the patient experienced swelling in the bicep. The doses were given within the past 2 months from the time of reporting and the swelling started within day after the vaccination. The reporter did not have any further information about the patient. This case has been linked with case US2019167103, reported by the same reporter.
My right arm was painful at the injection site for 3 days after the vaccination.  Then on Wednesday, February 3, 2021 about 3:45pm I experienced shortness of breath and some chest discomfort.  At approximately 6:00pm, I felt a strong pulsating at my left temple which continued through the night.  I took my blood pressure and it was 150/90 and pulse was 103 which is the highest reading I have ever had because I am on blood pressure medication.  I took 2 aspirin, my Proventil Inhaler, and another Losartan 50 mg even though I had already taken my daily dose in the morning.  I rested and continued to monitor my vitals.  At about 11:30pm, I took my blood pressure and it was 160/110 and pulse was 109.  I then took 2 more aspirin and my Clonazapem and fell asleep.  In the morning on February 4, 2021, I tried to get in to see my doctor, but she advised to go to the emergency room.  I went to an Urgent Care facility and the checked me and did an EKG and that was normal.  But they also advised me to go to the emergency room.  So I did go and they did another EKG, chest x-ray, and several blood tests.  They came back normal but they wanted me to stay overnight for observation.  On February 5, 2021 they did an echocardiogram and a stress test, which were normal.  I was released from the hospital that afternoon.  I have a follow up appointment with my Primary Care Physician on February 12, 2021.  My blood pressure and pulse continue to be a little higher than normal.  At this point, the pulsating, shortness of breath, and chest discomfort have improved.  On Saturday, February 6, 2021, I noticed felt itchiness, redness and swelling at the injection site on my right arm.  It is still itchy, red and swollen as of February 8, 2021.  I am putting hydrocortisone cream on it.
21APR97 began to break out in papular & pustules on inside having halo appearance;started on neck then spread back, arms & chest, shoulders-seen 24APR97 dx chicken pox;
Patient seemed to have fainted 1 minute after vaccination, then had a seizure, and then had an episode of syncope following the seizure.
Covid/Covid the first two weeks/COVID infection was a fairly mild case; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid/Covid the first two weeks/COVID infection was a fairly mild case) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (Covid/Covid the first two weeks/COVID infection was a fairly mild case). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in July 2022 for COVID-19, at a dose of 5 days. In July 2022, COVID-19 (Covid/Covid the first two weeks/COVID infection was a fairly mild case) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive and (Negative) Negative.         No concomitant medications were reported.  The patient had the original first two COVID vaccines and then two boosters and they were all Moderna.  It was reported that the last booster patient had was in early April of 2022. Patient did have COVID the first two weeks of July in 2022 and he heard on the news that after having COVID, it's best to wait 3 months or so before getting another booster.   The patient states his COVID infection was a fairly mild case. He took Paxlovid and got a rebound. He tested positive, then took Paxlovid for 5 days, then tested negative for a couple days, then tested positive for another 5-7 days. Patient had a little cough a little while after that, then everything was good.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 10-MAY-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, lot # M041990 with expiration date 28-JUN-2019 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA011219: US-009507513-1705USA011218: US-009507513-1705USA011216: US-009507513-1705USA011217.
Started out flu-like symptoms, chills, fatigue within 12 hours. After 48 hours progressed to chest tightness, trouble breathing and dizziness. Symptoms subsided then returned at work the next day. Talked to doctor and was referred to local ER.
I had taken my child to her 4 month well baby appointment at a new pediatrician. The nurse was supposed to carefully examine the immunization records. However, it appears she did not. My baby had taken the RotaTeq vaccine on January 06 and was told to be sure she took RotaTeq again on February 8. I had this schedule to be done and to my dismay an error was made. The nurse gave my baby Rotarix instead. The doctor and the nurse have not called me back to explain how this occurred and the did have Rota Teq in the office. my baby has been fussy, running a fever and very irritable. They have her scheduled for 6 moths shots but she will not even be 6 months at that time. (March 31).She also requires and additional rotavirus vaccine by 24 weeks which was not accounted for nor schedule for, I am quite disturbed as my baby has vomited all day and this vaccine did not agree as well with her as the Rota Teq did. I do not trust this nurse anymore as she tried to downplay this event and never called me back nor did the main provider. I checked the state immunization registry prior to her appointment and afterwards as I noticed a variance (which I mentioned in office) in the two oral vaccines. The nurse should have paid more attention to which vaccine was to be used and she should have used the correct vaccine.
Developed chest pain and elevated cardiac enzymes 11 days after SPV. Diagnosis: Myocarditis. Also developed non-viral pustulosis 2 weeks after vaccine. Patient received his primary smallpox vaccine on 3/11/05. He was clinically well at the time and received no other simultaneous vaccinations. He had no immediate adverse events. On 3/19/05 he noticed swelling and pain in the left axillary node and by the next morning the left arm gradually began to throb from shoulder to wrist. Shortly afterwards, he developed a vice-like substernal chest pressure. Two hours later, he went to the ER where he was given 3 SL nitroglycerin tabs that relieved the pain. He was also given ASA and 4mg morphine. His initial set of cardiac biomarkers were CK 433, MB 29, and Troponin 26.6. He was started on Heparin, nitro and integrilin drip and transferred to hospital for further evaluation and management. Due to his positive family history for CAD and high risk NSTMEI versus STEMI cardiac cath was performed which was negative. On 3/28/05, he reported all chest/arm pain and LAD had subsided. He reports, however, that a pruritic, macular papular rash has erupted on his anterior and posterior trunk and on the buttocks. Reports no other associated symptoms.
I had a red rash that appeared 11 days after the first dose of the Moderna vaccine. It is hot, red and itchy. This is also accompanied by diarrhea.
This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator). On 13-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Apr-2021, PRODUCT STORAGE ERROR (drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator) had resolved. On 13-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 12-Apr-2021, at 8:30 AM, an individual drew up doses of vaccine from a vial and placed syringes loaded with doses vaccine into the refrigerator. The patient received their second dose of the vaccine by IM injection at 2:15 PM on 13-Apr-2021.  No relevant concomitant medications were reported.  No treatment information was provided.
Vaccine was given in right arm, after the vaccine, the right arm was sore, the next three days I was unable to move it. On 07/17/2011 I was admitted to the hospital due to a huge red, painful, swelling spot at the vaccination site, and a fever of 102.0. The doctors diagnosed my problem as cellulitus, an infection under the skin caused by the vaccine. I was given antibiotics to get rid of this adverse event which later caused a c-diff infection and I was hospitalized again. I then began to experience arrythmia problems resulting in a pacemaker implant.
Drug Allergies: Cymbalta; Pneumonia Vaccine; This is a spontaneous report from a Pfizer-sponsored Program. A contactable Physician reported that a 40-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at single dose for pneumococcal immunisation and duloxetine hydrochloride (CYMBALTA), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported Drug Allergies: Cymbalta; Pneumonia Vaccine on an unspecified date. The action taken in response to the event for duloxetine hydrochloride and outcome of the event were unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)has submitted the same report to the regulatory authorities.
Approximately a few months after my 1st booster shot I took a blood test and it showed that I have a problem with my thyroid. I did not have any symptoms at all but I was just wondering if the vaccine triggered the spike on my thyroid.
Clinic Assistant gave both vaccines in his right deltoid. Patient reported fever, mild chills, aches, anorexia to a significant degree that started later in the day the vaccines were given and lasted greater than 72 hrs, also noted progressive pain, swelling and redness at the injection site. No history of issue with flu vaccine in the past.
Seen for OV 6/18/21 A week after second vaccine enlarged lymph node on back of neck base of skull. Pt  to schedule  follow up appt for  lump.