chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 13-month-old caucasian male patient who on 10-JAN-2000 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot N633012/12763) IM in the thigh.  On 18-JAN-2000, the patient developed a serious measles rash, a fever and was sleeping poorly, moody, and tugging at his ears.:  The patient sought unspecified medical follow up information from a registered nurse indicated that subsequently, the patient recovered.
Patient received HPV9 and had a fingerprick for capillary blood collection performed, within minutes of these procedures she had a syncopal episode followed by a partial seizure involving the right side that lasted approximately 2 minutes and included bladder incontinence.
Pt reported swelling, chills, aches, fever 102F. She went to her doctor and told she had cellulitis and was given 2 courses of antibiotics. This was reported by pt to customer service line. Pt is improving slowly as I talked to her mother 11/7/14, 7:45 AM.
I went out of town. Tested negative on June 17. Arrived on June 18. I returned on June 25th. The evening on the 26 I was sore and I thought it was due to me working out and I still felt stiff and a little achy. I wasn't really concerned but on the 28th I figured I should check. I tested on June 28, and it was positive. I then made a doctor's appointment on June 28th I saw a NP. Then she prescribed PAXLOVID and a cough syrup promethazine DM. I was also instructed to take MUCINEX. I was down for about three days and then I did a 4-mile walk. At that point I wasn't feeling 100% but I was able to work through it along with wearing a mask everywhere I went. I retested on July 4th, and it was hardly positive and then I tested on the 5th, were negative.
cough and mild headache on day 3 after the vaccination not severe just annoying dry cough for about 4 or 5 hours and headache for about 2 hours not severe enough for me to go to the clinic unless it does not go away.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 04-SEP-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
PT RECEIVED HEPATITIS A, MENACTRA, GARDISIL, AND VARIVAX VACCINES ON 8/8/07. PT SEEN IN OFFICE ON 8/10/07 FOR REACTION ON LEFT ARM. GARDISIL AND VARIVAX WERE GIVEN IN THE LEFT ARM. AREA OF VARIVAX INJECTION WARM, RED, AND SWOLLEN. NO VESICLES, NO FEVER. LATERAL SURFACE OF LEFT ARM WITH 4CM X 3CM AREA OF ERYTHEMA, WHICH WAS RESOLVING AFTER APPLICATION OF COLD PACK X10 MINUTES. PT RXED ZYRTEC 10MG PO QHS X5-7 DAYS AND LOCOID LIPOCREAM TO BE APPLIED BID UNTIL AREA OF ERYTHEMA RESOLVED, TO USE ICE PACKS PRN.
BLOOD CLOT IN LUNG; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered (dose number in series was 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, (dose number in series was 2), administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in lung (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211240684-covid-19 vaccine ad26.cov2.s-blood clot in lung . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt recv vax & w/in 10min of vax pt exp a hypersensitivity rxn, characterized by acute resp distress w/cyanosis (pulse oximetry, 69% on room air), hypotension, diaphoresis, nausea, dizziness, pallor & sense of doom;tx DPH,oxygen & resp
Within 5 mins of receiving the MMR patient experienced redness over entire right thigh, including swelling and hives.
Information has been received from a Certified Medical Assistant regarding a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On 24-MAY-2017, the patient was administered with an unspecified dose of GARDASIL 9 for prophylaxis (lot # M036059 and expiration date 03-JUN-2019; dosage schedule, anatomical location and route of administration were not reported) that was mixed with a sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Information has been received from a health professional concerning a 41 year old female, with an allergy to bupropion hydrochloride Zyban and a history of no immunity per lab work, who on 5/28/1997 and 7/16/1997 was vaccinated with a first and second, 0.5ml, subcutaneous dose in the right arm of varicella virus vaccine live (lot 52162/1358D). Concomitant therapy included amitriptyline hydrochloride and birth control pills (unspecified). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that a titer in April 2005 was 0.40. The patients status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 5/28/1997 the patient was told no pregnancy for 3 months, the side effects were reviewed, and that she would receive the second dose in 4-8 months. On 8/20/1997 the patient experienced ankle  discomfort and had a second opinion. In April 2005 a documented immunity level was required for admission to nursery school. Additional information in not expected.
Severe Fatigue, Nausea, Severe Headache, Light Headed, Unable to concentrate, Sleep difficulty, Body Aches, Weakness. Palpitations   Majority of effects lasted for 24 to 30 hours, with Fatigue and Brain "Fog" lingering a week or more.
erythema and swelling of right upper extremity with mild pain without functional impairment or systemic symptoms
24 hours after vaccine my left arm developed a raised  red, welt that was sore and hot to the touch, I also became extremely lightheaded/dizzy for over 30 days afterward, I had a rapid heart rate (well over 100bpm) that happened numerous times throughout the day even when laying still, BP spikes, weakness all over body - especially left arm, very tired, my right hip became extremely sore at the joint, pins/needles in both hands and feet, nausea, brain fog, constipation, unsteady gait, shakiness, ache behind right eye- all symptoms lasted for at least 30 days.  One month after the vaccination, I developed a strange skin reaction at the injection site where a red line appeared under the skin and there were a few blisters on the surface; the skin eventually turned dark and started to peel, sting and itch for over 1.5 weeks (still like that, but healing).
syncope -- Pt fainted after receiving both vaccines approximately 5 minutes after administration. Pt recovered and regained consciousness in 10-15 seconds. 911 dispatch was called. EMT team worked up patient and took vitals. Everything resulted within normal limits.  Pt reportedly hadn't eaten anything since the night prior and  EMT team lead assessed it was the most probable reason for syncope. Lead EMT felt comfortable letting the patient go home with a designated driver, with no further reported incident.
Missed the fourth dose of Vivotif; Spontaneous report received on 11MAR2020.  A medical assistant reported that a consumer (unknown age and gender) "missed the fourth dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. On an unknown date, the consumer started taking the Vivotif. It was reported that the consumer had received 3 doses of Vivotif (dates not provided). On an unknown date, the consumer missed the fourth dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed taking the fourth dose of Vivotif (missed dose). Vivotif must be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed taking the fourth dose of Vivotif (missed dose). Vivotif must be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Patient was given the pediatric dosage of covid 19 vaccine.  The pediatric dose was undiluted and patient was given 0.3 ml.  Patient remained in the office following vaccine, and had no reactions.  We contacted patient several hours later, and she denied symptoms.  She was advised to call the office if he experienced symptoms, or go to ER/Urgent care if severe symptoms.
I first started having cold like symptoms with a sore throat and I took a COVID-19 home test that was expired and it was negative. The next day I had a mild fever and sore throat. I took another different home COVID-19 test and I tested positive with that and it being Sunday I was not able to contact my physician so on Monday morning I called the physician and he called me back. He inquired about my fever and sore throat and what I was taking for it and advised me to take TYLENOL and that relieved the sore throat and I got better. We talked about PAXLOVID but he stated that the side effects were bad and that I should just use over the counter medication and as of today I feel normal.
2nd dose resulted in fever, chills, headache, body aches sore arm one day after. Two days later my arm has red slightly itchy 5 by 2 patch at injection site. First dose resulted in dizziness and nausea 3 days later with need to go by ambulance to er
Headache, Myalgia, Diarrhea & Nausea Vomiting  Narrative:
Within 5 mins of flu administration, child complained of itchy throat and nausea. Appeared pale and sleepy. Had emesis twice.  Given oral benadryl and examined/vitals taken. Normal vitals including pulse ox and BP. Symptoms resolved within 15 mins. Observed in clinic for >90 mins. Cont to have normal vitals. Father cautioned about possible biphasic reaction.
Immediately suffered elevated WBC and flu like sx for approx 1-2 mos, then fatigue, cognitive impairments and Lower GI problems. The latter sx kept progressing until I had to apply for disability in 1997. Also developed some type of arthralgia which is now very bad, while GI sx are improved but still have diarrhea and cannot eat very many foods. Became intolerant of food. Existed for 4-5 years on baby food. Steroids were helpful but nothing else has helped. Have been on a narcotic for pain for 3-4 years now. Per follow up report received on 06/21/2005:  Patient still has not recovered. Information from medical records state lactose intolerant.  12/30 follow up -   not sure if connected but its when I get sick, still cannot eat much of anything, severe abdominal symptoms- live on baby food- can't work due to weakness, fatigue, arthralgia; lost my teeth due to malnutrition from osteoporosis.
arm soreness nausea chills headache elevated blood sugars  No treatment necessary and outcomes subsided within 48 hours.
The first night I had a headache, chills, soreness and bruising at the injection site.
Vaccine date was past the expiration date, expired vaccine was administered inadvertently on 5/25/22.  No noted adverse effects.  Vaccine was readministered on 5/27/22 during second office visit as per direction of state immunization nurse.
By 10 pm on the evening of the shot, I had a very red and bumpy rash about 2 inches in diameter and 1 inch in height between by breasts. I have never had a rash there before nor have I ever had anything that looks like this.  By around 2 am, I had soreness in my neck and radiating down the entire left side of  my body.   A crinkle in the sheet hurt and I needed to attempt to smooth it out but it was difficult and painful to move. By 4 am the soreness was much diminished. Around 7 am fever, body aches, and headache started. I attempted to sleep it off but the symptoms got so severe around 12 noon that I took Advil. I continued to sleep through the day. I had no appetite and felt nauseous.  Around 2pm I felt well enough to eat something.  By 6 pm I felt mostly normal with only a slight headache. Through the 2nd day I continued to have the rash and it did not change but did become slightly itchy.  Tiredness continued but I was able to make it through most of the 2nd day without irritation or exhaustion. I did go to bed earlier than normal on the 2nd day. Third day rash is the same but itchiness is intensified.
Patient reported she awoke the following morning after receiving her second dose of the  Moderna vaccine and her left eye was "bloodshot". Patient denied pain or visual disturbances.
She scratches herself so hard that her skin almost kills her; Hardness at injection site; Injection site is very itchy; Swelling at injection site; Redness at injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (She scratches herself so hard that her skin almost kills her), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Injection site is very itchy), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SCRATCH (She scratches herself so hard that her skin almost kills her), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Injection site is very itchy), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at injection site). At the time of the report, SCRATCH (She scratches herself so hard that her skin almost kills her), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE PRURITUS (Injection site is very itchy), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (route, dose, lot # and expiration date not reported). No adverse effect had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On unspecified dates, the patients were vaccinated with improperly stored injections of two different lot # of VARIVAX: lot # M041513 and expiration date 11-OCT-2017 and/or lot # M045204 and expiration date 11-NOV-2017 (dose and route of administration were not provided) for prophylaxis. In addition, all vaccines were reconstituted with properly stored sterile diluent(DILUENT MRK).  The patients' concomitant therapies were not reported. On an unspecified date, the data logger registered a temperature ranges between 6° Fahrenheit (F) and 14°F during a time frame of 2 hours 15 minutes with no previous temperature excursion. Adverse effects were not reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA007841:
Based on the additional information received on 04 Aug 2014, this case initially considered as non-serious was upgraded to serious. Initial report received from literature on 22 July 2014. A 46-year-old female patient, whose concomitant medications were unknown, had received a dose of influenza vaccine (unknown manufacturer, dose, batch number, route and anatomical site of administration were unknown) on an unspecified date. The patient had a medical history of treated human immunodeficiency virus (HIV) disease. It was reported that the patient developed a diffuse, pruritic rash one day following vaccination against the influenza virus. Physical exam and histopathology were consistent with a lichenoid drug eruption. Corrective treatments were not reported. The outcome of the event is unknown. Documents held by sender: none. Follow up information received from literature article on 04 Aug 2014. The following verbatim obtained from article abstract: Lichenoid drug reactions to vaccinations are rare but well-documented events. The vast majority of these reported reactions have been triggered by Hepatitis B vaccination (HBV). We describe an impressive generalized lichenoid drug reaction following the influenza vaccination. A 46-year-old woman with a history of treated human immunodeficiency virus (HIV) disease developed a diffuse, pruritic rash one day following vaccination against influenza virus. Physical exam and histopathology were consistent with a lichenoid drug eruption. This is only the fifth reported case of lichenoid drug reaction, and only the second generalized case, following influenza vaccination. The patient's underlying HIV disease, known to be a risk factor for both cutaneous drug reactions and more severe manifestations of lichen planus, likely predisposed her to this generalized hypersensitivity phenomenon. The following case report obtained from the article: The patient had no history of previous reaction to drug or vaccinations of any kind. Concomitant medications included efavirenz, lamivudine, zidovudine. On physical exam, the patient had a diffuse eruption of hyperpigmented, slightly violaceous polygonal papules and plaques with white, lacy reticulations that spared her face, palms, and soles. No changes were noted on the buccal mucosa. Histopathology revealed a lichenoid interface dermatitis with eosinophils, most consistent with lichenoid drug eruption. Immunohistochemical stain for Treponema pallidium was negative. CD4 count one month prior to vaccination was normal at 706 cells/mcL. Viral load was suppressed at 128 copies/nL. The patient was treated with high potency corticosteroids, two oral prednisone tapers, and narrow band UVB therapy. While therapy was being initiated, the lesions progressed to include the face. Narrow band UVB therapy and clobetasol ointment were continued, and metronidazole 500 mg PO BID and topical tacrolimus 0.1% ointment were added to the regimen. Approximately 6 months after initiating therapy, all active lesions had resolved with marked post-inflammatory hyperpigmentation.
patient received her first dose of Engerix-B in October 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (1st dose received in October 2022).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient received her first dose of Engerix-B in October 2022). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-JUN-2023 The second dose had not been given yet due to the patient thinking it was to be 6 months after the first dose. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.