chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a local and minor rash on the arm; Spontaneous report received on 13JUL2020.  A healthcare professional reported that a patient "developed a local and minor rash on the arm" (PT: Injection site rash) following immunization with ACAM2000. On an unknown date, the patient was administered Emergent's smallpox vaccine. The consumer developed a rash on their arm. It was reported that the reaction was small, local, and minor thus, the patient was prescribed Z-pak (azithromycin) on 13JUL2020. Additionally, the prescriber cleared the consumer to go back to work stating that no medical leave was required and they can perform at their regular full duty. At the time of report, the outcome was unknown.  Company Comment: A consumer developed a local and minor rash on the arm (injection site rash) after receiving ACAM2000. In response to the event, the consumer was prescribed with Z-pack, and further details of the event is limited. Local injection site reactions like erythema and rash are known effects of ACAM2000, and the causality of injection site rash is assessed as possible.; Sender's Comments: A consumer developed a local and minor rash on the arm (injection site rash) after receiving ACAM2000. In response to the event, the consumer was prescribed with Z-pack, and further details of the event is limited. Local injection site reactions like erythema and rash are known effects of ACAM2000, and the causality of injection site rash is assessed as possible.
Fever, felt so bad I couldn't get out of bed, muscle pain, vomiting, shivering, hot, dizzy like vertigo, nausea and worst headache on my life that will not go away with my migraine meds.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient says she was dizzy. Was given some crakers and lots of ventilation. She appeared to be getting better and was given some crakers. After a few mins, she felt she was getting worse and that her throat was tightening. Was then given EPIPEN and felt better after a few mins.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were reported as follows: This case has been linked to case US2018GSK184858, reported by the same reporter.
Patient reports temporary loss of muscle function (he could not get out of bed); when he gained strength back and got up he felt very weak and dizzy. He has a follow-up appointment with his primary care doctor in a couple weeks.
patient experienced uncontrolled urination about 60 seconds after the vaccine administion.   He thinks he may have passed out briefly but remained in his chair.  Administration was at 2:25pm 7-3-21.  He had not eaten much today other than fritos & cheetos according to his spouse.
Frequent fasciculations all over my body, they do not cause pain but are bothersome physically and psychologically.
Woke up the morning after my third booster (Pfizer Bivalent) with a bad headache and loud ringing in my ears.  The headache went away by mid-afternoon on 9.15.2022 but the constant ringing remains.
1/28/2023 this started with a scratchy throat in the evening.  1/29 tested positive on At Home COVID-19 Test, as symptoms got worse.  Dry cough, with headache and head congestion. Virtual Visit 1/30 proscribed Paxlovid and to treat symptomatically.  Started to feel better on 1/31 with symptom gradually improving over the next 5 days.  By 2/6 I felt recovered.
Fever, chills, bone pain, muscle pain, vomiting, joint pain and feeling like wrist and ankle joints are dislocated, body sweats, headache, fatigue  all started 10 hours post shot and lasted 2 days.  Bone pain last 3 days
Client vaccinated with Janssen vaccine at local pharmacy on 3/21/2021.  No adverse effects.  Tested positive and symptomatic for Covid on 5/13: chills, fever x 4 days, diarrhea, SOB, extreme myalgia.  Symptoms resolved in 8 days.  Retested positive still on 6/3 but no longer has symptoms and has completed 10 day isolation.  Source of infection unknown.  Client thought she had very bad bronchitis when first got ill and went to doctor for same.    Reporting this incident because client fully vaccinated yet contracted Covid.
2 HAVRIX vaccines, adult and pediatric dose; 19 months old, adult dose administered; This case was reported by a consumer via call center representative and described the occurrence of overdose in a 19-month-old male patient who received HAV (Havrix 1440 adult) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAV (Havrix pediatric) for prophylaxis.   On 1st December 2021, the patient received Havrix 1440 adult, Havrix Pre-Filled Syringe Device and Havrix pediatric. On 1st December 2021, unknown after receiving Havrix 1440 adult, Havrix Pre-Filled Syringe Device and Havrix pediatric, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the patient's mother. The age at vaccination was not reported. The patient received Havrix pediatric and Havrix adult dose on the same day, which led to overdose. The patient received Havrix adult doe which led to adult product administered to child. The reporter chosen not to answer any questions to file safety report. The reporter did not collect consent and health care professional information.
I woke with a migraine headache on the 2nd day after my vaccine and the migraine lasted 28 days in a row, 24 hrs each day. I lost my appetite  which led to a 30 lb weight loss, I was dizzy,  and fatigued. Furthermore, I was given tramadol, but it did not help and contributed to the dizziness so discontinued that after 1 week.
pt recv vax; pain & soreness in ears; swollen cheek/jaw;transient leg ache & lt wrist pain on the 17th;
Patient got only one injection 2 years ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years prior to the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter asked how they proceed with additional vaccination. The reporter did not consent to follow up.
Received PEDIARIX on 9/2/10 in (L) leg & Hib & PREVNAR - all in left leg - 9/2/10. 9 mo OV - 11/23/10 - received flu vaccine in Lt leg. 2/3/11 - appt to check "bump in leg" - noticed since 9 mo PE. 2/12/11 - "infection on leg" with pustule - lanced - Rx. BACTRIM. 2/17/11 -  blotches, on BACTRIM x 4 days - sent to dermatologist. 2/11 - "punch incision", pus drained "sterile abscess reaction" per MD.
I had extreme vertigo causing dizziness daily which also included migraines.  The symptoms lasted for almost a week and was bad. Then it let up. I went to the walk-in clinic and was examined and given valium to treat the dizziness. The symptoms got better about an hour after taking the valium but did not go away completely. It took about 5 days as the symptoms were extreme in the beginning, I did not recover but did return to baseline where I would get vertigo occasionally.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
COVID-19; norovirus; This spontaneous report was received from a physician and referred to a 6-month-old male patient. Concomitant medications, pertinent medical history and drug reactions/allergies were none.  On 07-FEB-2022 and 11-APR-2022, the patient was vaccinated with the first and second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally for routine immunization (strength, dose, lot #, and expiry date were not provided), respectively.  On 13-JUN-2022, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally for routine immunization (strength, and dose were not reported; lot # 1742476, expiry date was not provided, upon internal validation established as 18-MAR-2023).   Later that day (on 13-JUN-2022), the patient developed vomiting and diarrhea. The next day, the father of the patient and also the babysitter of the patient developed vomiting and diarrhea.  The patient received electrolytes NOS (+) glucose (PEDIALYTE) and paracetamol (TYLENOL) and modified feedings. The father and the babysitter of the patient did not require any medical treatment.  The physician stated that he knew that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was a live vaccine and he decided after the father and the babysitter developed the same symptoms as the patient, that he should report this adverse event.  On 15-JUN-2022, the patient was starting to feel better, and also that the father of the patient and the babysitter were also feeling better.  On an unknown date in June 2022, the patient was admitted. He tested positive for both COVID-19 and norovirus. It was reported that the nanny had recently come back from a cruise and most likely passed both on to the patient. The physician attributed patient's symptoms to the COVID-19 and norovirus rather than the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine.  The causality assessment between COVID-19 and norovirus and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Mother said on 1/21/03 around 6:00 PM, baby had a seizure; lasted about 3-4 minutes. Took baby to emergency room. States baby had a temperature of 102 when they reached the hospital. States doctor said temperature had gone down. Mother said child had not had a temperature over 99 since receiving the shots on 1/14/03. had given baby Tylenol pediatric. Mother said doctor told her the seizure was not caused by the shots. If the shot caused the seizure, it would have happened before today. The high temperature was caused by Bronchiolitis and cold. This information was reported on 1/28/03.
RASH BEHIND RIGHT KNEE.  NO ITCHING, NO FEVER, NO H/A.  NO OTHER COMPLAINT.
Varicella vaccine break through. Diagnosed in office on 6/2/09 with varicella. Had about 20 pox.
The exposures were Nov 30th at a gathering about 16 people total came up with a positive reading from this. I had postnasal drip and a scratchy throat on Dec 2. I played a 3-hour concert that night and standing so I wasn't feeling so bad. The next day I started feeling fatigue and with a call from a fellow member and they said they tested positive. I felt like I had a minor cold at first just very tired. I tested myself and found that I was positive as well. December 4, I had a telehealth visit from my doctor and received a prescription for PAXLOVID. The medication helped so much by the second day I could tell that I was starting to improve. The medication had a really bad after taste, but I was told that it's normal to have a bad after taste.
Significant pain and swelling at site of injection, swelling increased over 24 hour period starting in tricep area, and then consuming entire left arm traveling down elbow and forearm.  Right arm is now twice size as the left arm, hot to the touch, and difficult to move due skin tightening from the swelling.
Pt had localized redness & itching, but also experienced itching on arms & legs treated with BENADRYL.
gross swelling of the deltoid the shot was administered in- hard lump the size of a grapefruit with visible disfigurement
Outbreak of chicken pox s/p vaccine papules vesicles scabbed lesions especially on trunk, legs, ext.
Information has been received from an office manager concerning a male who in 2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The office manager reported that "within the past two weeks", on approximately 28-JUN-2010 the patient developed a case of shingles. The outcome of the patient was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Patient received 0.5 ml of Moderna 6 mo-5 yrs instead of 0.25 ml
Stings; Hard time chewing; tastes like metal; whole body was about to shutdown; whole arm goes numb; Felt like almost passing; first dose was J&J (Janssen) and the 2nd dose is Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Stings), MASTICATION DISORDER (Hard time chewing), DYSGEUSIA (tastes like metal), SENSORY LOSS (whole body was about to shutdown ) and HYPOAESTHESIA (whole arm goes numb) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: janssen (intramuscular). Past adverse reactions to the above products included No adverse event with janssen. Concurrent medical conditions included Pollen allergy (Environmental allergies).    On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was J&J (Janssen) and the 2nd dose is Moderna). In January 2022, the patient experienced PAIN (Stings), MASTICATION DISORDER (Hard time chewing), DYSGEUSIA (tastes like metal), SENSORY LOSS (whole body was about to shutdown ), HYPOAESTHESIA (whole arm goes numb) and PRESYNCOPE (Felt like almost passing). On 28-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose was J&J (Janssen) and the 2nd dose is Moderna) had resolved. At the time of the report, PAIN (Stings), MASTICATION DISORDER (Hard time chewing), DYSGEUSIA (tastes like metal), SENSORY LOSS (whole body was about to shutdown ), HYPOAESTHESIA (whole arm goes numb) and PRESYNCOPE (Felt like almost passing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. Concomitant medication was not provided.
No symptoms initially. In evening, aching, headache and nausea. Following day aching worsened and in evening 100.6 fever. Aching is similar to what I experienced when I had COVID July 2020.
sweating; Pain; Chills; Body ache; head ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), PAIN (Pain), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (head ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: follow up received on 02-Mar-2021 included vaccine details has been updated.
PMH Afib, BiV PPM, HTN, pHTN, hypothyroidism, hemorrhoids, hearing loss, macular degeneration, squamous cell carcinoma, Parkinsons brought to ED after her caregiver found her in bed in AM w/a "dark substance in her bed" and minimally responsive.  On admission vomiting x1, no cough, no SOB, abnormal CXR, covid+ Admission originally planned by IMS, but CCM asked to take over due to rapid decline.Pt w/ shallow breathing,  guarded prognosis.In the morning on May 1, 2021 around 830 in the morning patient found to be without any pulse or breathing.   DNR DNI with pupils fixed and dilated without any spontaneous breathing.  No pulse palpated.pronounced dead at 8:30 a.m.
Post vax, the pt lost consciousness and had rigidity of both upper and lower extremities, rolling up of eyeballs for a few minutes, pallor and sweating.
PATIENT WAS RETURNING FOR SECOND MODERNA VACCINE, BUT INSTEAD RECEIVED JOHNSON & JOHNSON IN ERROR.
Strange headache; Right arm muscle pain at injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01May2021 14:15 (Lot number: EW0171) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOCETIRIZINE DIHYDROCHLORIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot Number: EP7533Administration site: Right armAdministration time: 14:45), administration date: 03Apr2021, when the patient was 37 years old, for COVID-19 immunisation, reaction(s): "Vaccination site pain".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01May2021 16:00, outcome "recovered" (May2021), described as "Right arm muscle pain at injection site."; HEADACHE (non-serious) with onset 02May2021 09:00, outcome "recovered" (03May2021), described as "Strange headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02 May2021 at 9:00 the patient experienced a strange headache and took Acetaminophen (TYLENOL), but it continued to get worse by noon. It was not a regular headache. The patient took Diclofenac and felt better until about 9 PM then again needed to take one more Diclofenac. She woke up in the morning and was feeling fine.  No follow-up attempts are possible. No further information is expected.
Chills, cough, sweats, runny nose, vomiting, loss of appetite, sneezing, headaches
Pt states that one hour after an influenza vaccination that she had hives, nausea, vomiting and dyspnea. The pt states that she went to the ER and was treated without further adverse event. The pt was told that this was most likely related to eggs and that she should not receive additional influenza vaccinations. The pt does not eat eggs - she states that she had eggs as a child and did not like them so she has never eaten eggs since. Pt was given a permanent medical exemption to influenza Nov2006.
Symptoms started 7/2/22 with a cough. Home positive test on 7/2/22. In house positive test on 7/5/22. Treatment includes admission with potential monoclonal antibodies.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medications were reported. No treatment medications were reported. This case is for 171th patient out of 190 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
14 hours after immunization was seen in ER with fever 101 and parents reporting she was swollen and puffy all over. ER physician reported only redness and tenderness at imm site, but she was treated with acetaminophen, diphenhydramine and dexamethasone. Later on 1/1 at 1400 had pallor and low temp and was taken to ER again.
Excessive high pitched crying & screaming for 2 hrs, unable to console, t103-fever continued for 3 days following vax; Pt given DT on 12JUL no fever or crying p/vax;
GENERALIZED RASH AND ITCH IN EXTREMETIES AND BACK.  EYES, FACE AND NOSE EDEMA AND COUGH 3 HRS AFTER VACCINATION.
5 days after receiving Pfizer #2 Covid vaccination (EWO151):  experienced moderate to severe thumb joint pain; thenar region/median palmer region soreness and pain; ulnar bursa soreness; radiating pain to forearm tendons; Hand numbness overnight; Diminished grip strength which comes and goes in varying intensity, affecting my ability to hold a pen, a glass, open a jar lid and ADLs.