chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of sleep disturbance in a 6-month-old female patient who received MENVEO (batch number M16004, expiry date unknown). Concomitant products included ROTARIX, ranitidine hydrochloride and TYLENOL. On 26th September 2016, the patient received MENVEO. On 26th September 2016, less than a day after receiving MENVEO, the patient experienced sleep disturbance, irritability and wrong vaccine administered. On an unknown date, the outcome of the sleep disturbance, irritability and wrong vaccine administered were unknown. It was unknown if the reporter considered the sleep disturbance and irritability to be related to MENVEO. Additional details were provided as follows: Initially the case was reported by the patient's mother and later the pharmacist reported it. The patient was scheduled to receive Hib or Hepatitis B vaccine (unclear), but was administered MENVEO in error. This led to wrong vaccine administered. The injection site of MENVEO was right thigh. On the same day, the patient received ROTARIX vaccine orally. The patient was fussy and did not sleep well yesterday night. The dose given was reported to the mother as the standard dose. The healthcare professional stated the patient's primary healthcare provider might have reported the maladministration previously. The expiration date of the vaccine was unknown.
Dark purple bruise at administering site, extreme swelling and redness around the site, tithing and tenderness. Administered on Nov 17th symptoms on Nov 18th. Dr visit on Nov 21 - medication prescribed by Dr.
extreme fatigue; Hot sweats and chills mild fever; Hot sweats and chills mild fever; Hot sweats and chills mild fever of 101.1; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Batch number: EN6205) via an unspecified route of administration in the left arm on 16Mar2021 at 19:30 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Batch number: EN6198) via an unspecified route of administration in the right arm on 26Feb2021 at 19:30, as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient did not received any other medications within 2 weeks of vaccination. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient experienced extreme fatigue, Hot sweats and chills mild fever of 101.1 and headache on 17Mar2021. The patient did not receive treatment for the reported event. The clinical outcome of the fatigue extreme, sweating, chills, fever and headache was unknown. No follow-up attempts are possible. No further information is expected.
Moderna Booster Vaccine given instead of Moderna Bivalent Booster that the patient asked for.
Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, ATORVASTATIN CALCIUM, LISINOPRIL and AMLODIPINE for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-369048, MOD-2021-369049 (Patient Link).
This spontaneous report was received from a registered nurse and refers to a 66 year old female patient. Concurrent conditions include asthma, former smoker and penicillin allergy. The patient's medical history included congestive heart failure and migraines. On 18-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose unknown) lot # J004387, expiry: 04-JAN-2015, intramuscular in the right deltoid. Concomitant therapies included IMITREX, NEURONTIN and other unspecified medication. On 18-SEP-2014, on the same evening the patient experienced right axillary pain. On 19-SEP-2014 the patient sought medical attention to a local emergency department and was hospitalized the same day for right arm swelling/cellulitis. The laboratory tests revealed white blood count normal as 5.8 (units not specified), electrolytes normal, CBC blood work labs results not reported and patient did not have fever. The patient was under observation and was treated with vancomycin (manufacturer unknown) intravenously (IV). The nurse stated it was unknown when the patient was released from the hospital (approximately in September 2014). The outcome of right arm swelling/cellulitis was unknown. The causality was unknown. The reporter considered the event right arm swelling/cellulitis to be medically significant. Additional information is not expected.
Polymyalgia Rheumatic; This is a spontaneous report from a contactable physician reported for himself. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in Dec2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine in December of last year, after that he was diagnosed with polymyalgia rheumatic on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event polymyalgia rheumatic with pneumococcal 13-valent conjugate vaccine can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 40 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 24-OCT-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
50 out of 100 vax w/ hepta B did not devel antibody titers. RPH reported pts were non-converters after 3 vax.  20 out of 120 had titers tested.  6 - neg, 12 - pos, 2 - unaccounted for.
Daughter is still having a bad reaction to her first Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Daughter is still having a bad reaction to her first Moderna shot.) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Daughter is still having a bad reaction to her first Moderna shot.). At the time of the report, VACCINATION COMPLICATION (Daughter is still having a bad reaction to her first Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
I was dreading the second dose because the first one was more dramatic so I thought it was gonna be worse but it wasn't, I had a painful arm but it was only half way down to elbow and I was fatigued and those kind of things but it wasn't as bad as the first time. I felt very relieved. The arm pain and fatigue lasted about a week.
After the injection, about 24 hours later I suddenly felt exhausted, hungry and very hot. My head began to hurt and my throat tight. Then  had the chills and took my temperature.  It was 101.5   I took two extra strength Tylenol and when to sleep. The following day I ran a mild fever and have a rash on my arm near the injection site.  I have had a runny nose, burning in my chest and and sinuses.  I feel pressure behind my ears.
Information has been received from a registered nurse concerning a 39 year old female with an allergy to aspirin and no other pertinent medical history who on 28-MAR-2006 was vaccinated SC in the right arm with a 0.5 mL dose of MMR II. There was no concomitant medication. It was noted that the patient was not immunized at the reporting nurse's facility and that the vaccine was given due to college requirements and an unknown vaccination history. On an unspecified date (approximately April 2006), the patient experienced muscle pain for three and a half weeks after vaccination. The patient described her symptoms as "tender to the touch and movement" and "a lot of pain." Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. Muscle pain was considered to be disabling by the reporter. No further information is available. Other business partner numbers include E2006-02659.
Itching, bruising at injection site. Also dark blood red blister and hardening of the skin at injection site. Resolved after 2 weeks.
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 68-year-old female patient who received SHINGRIX (batch number 2453L, expiry date 12th February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced erythematous rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The health care professional reported that the patient experienced torso rash which was red with no hives or itching that lasted for about a week. The patient received Benadryl and the rash resolved with out any further intervention. The health care professional was unable to provide the vaccine date. The health care professional stated that she called previously on the day of reporting and reported the patient had a rash reaction to a high dose flu vaccine, FLUZONE HD, and the ZOSTAVAX.
PAIN AND SWELLING OF INJECTION SITE. REDNESS AND INFLAMMATION OF INJECTION SITE. INDURATION OF THE SKIN AT INJECTION SITE. INJECTION SITE FEELS HOT. FEVER.
Face swelling: face becomes apparently greater in size with slight red coloring. Hives: big red rash-like bumps formed whenever I scratched the surface of my skin. These have been reappearing for the past 7 weeks or since the flu was received.
1/15 -  HAD SLIGHT HEADACHE AND BODY ACHES IN LATE EVENING AND CHILLS AND TEMP 100.1 AT 10PM. 1/16- 6AM HEADACHE; 10AM TEMP 100.2 WITH BODY ACHES AND VERY TIRED; 12 NOON VOMITED; 3PM TEMP 101.2. BODY ACHES, TIRED AND CHILLS. HAD SMALL AMT OF BLOOD IN STOOL (STOPPED ADVIL); 5PM TEMP 100.1 1/17 - 10AM TEMP 99; 11AM TEMP 98 AND REMAINED AFEBRILE WITH HEADACHE. 1/15 2:40PM- ADVIL 200MG+TYLENOL 500MG; 9:30PM 400MG ADVIL 1/16 6AM ADVID 400MG; 3PM TYLENOL 500MG 2 TABS 1/17 7AM TYLENOL 500MG 2 TABS
Runny nose; Sore throat; Loss of smell; Concerned she might have covid; This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), ANOSMIA (Loss of smell) and COVID-19 (Concerned she might have covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), ANOSMIA (Loss of smell) and COVID-19 (Concerned she might have covid). At the time of the report, RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), ANOSMIA (Loss of smell) and COVID-19 (Concerned she might have covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
About a week after receiving the booster i began having a strange feeling in my arm.  I began having involuntary jerking movements and numbness in my left arm that soon progressed to a grand mal seizure. I am currently on keppra and i am still having a numb feeling/jittery ness in my arm.
Initial case report received from a consumer via Novartis Medical Communications on 05 NOV 2009. A male patient (age unknown) was vaccinated for the first time with S-OIV FLUVIRIN (batch no. 9721502, expiration date JUN 2010) on 27 OCT 2009. On an unknown date, the patient experienced sore throat, headache, cold and body aches. At the time of this report, the outcome of the events was reported as unknown. This case was previously reported as MA2009-3820. Follow up information received on 21 Jan 2010. It was reported that the outcome of the events were complete recovery. No further information reported at the time of the report.
COVID/ SOME TWICE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. 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 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid/ some twice. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The outcome of covid/ some twice was not reported. This report was non-serious. This case is a duplicate of 20221222696. This case, from the same reporter is linked to 20221222695, 20221222719 and 20221222717. This report was associated with a product quality complaint: 90000262535 and 90000262538.
Patient reported chest pain, nausea, left arm numbness, headache, jaw pain, and shortness of breath, 3 days after 2nd dose of Pfizer vaccination. Vaccinated on 8/30, symptoms developed on 9/2.
pt recv vax 28OCT95&same day c/o numbness&tingling in arm,nausea,hot flashes,& not feeling well;sc gradually lessened by the next day&pt recovered;
No additional AE; Administered after temperature excursion; This spontaneous report was received from a nurse concerning a 5 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.    On 10-AUG-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S022915, expiry date: 19-JAN-2021; dose, frequency and route were not reported) for prophylaxis since the excursion occurred (product storage error). The temperature was reported as -6.9 degrees Celsius (highest temperature). The time frame was reported as 1 hour and 15 minutes (total time out of range). No previous temperature excursion was reported. The call was because of a data logger. No additional adverse event (AE) was reported.
I am walking around in pain; I want to get my tooth fixed; 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 53 year old male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I am walking around in pain"; TOOTH DISORDER (non-serious), outcome "unknown", described as "I want to get my tooth fixed". Additional information: Caller got a second dose of Product Pfizer-BioNTech Covid-19 Vaccine on Tuesday, scheduled to have a dental procedure on Thursday, stated: when I went to the dentist dental assistant told me that just a previous week a patient came in after having a second vaccine and he had Novocaine and he had two cavities and the dentist fixed it and he left and they said later on it the day he called and he was at the hospital because he had allergic reaction and they said that the doctor said that it was a Novocaine interacting with the vaccine shot. so I asked the dentist how soon after getting the vaccine I can get a dental work done and nobody seems to know so of course they indicated that I should contact the manufacturer and ask that question. He decided to wait. Caller Stated: so I am walking around in pain, I want to get my tooth fixed but at the same time I don't want to have an allergic reaction.  Information on lot/batch number has been requested.
Patient states arm has been sore/hurting since they recieved the vaccine in May. Went to a doctor, but was inconclusive about why the arm was still hurting. Says it always hurts if they sleep on that side.
Patient reported fevers, chills and myalgia after 1st dose of Moderna COVID vaccine 4/22. Poor PO intake and had syncopal episode on 4/24 when standing from the recliner. Initially admitted at hospital, and developed fever, leukocytosis, AKI. Transferred to other hospital for further evaluation and eventually developed acute hypoxic respiratory failure requiring intubation and mechanical ventilation, found to have new onsert heart failure with reduced ejection fraction. He is currently being evaluated for auto-immune and underlying infectious causes, with concern for glumerunephritis, cardiomyopathy and coronary artery disease. Patient extubated to NC as of today but remains in the ICU.
Patient reported itchy throat and then stated her throat felt like it was closing up.  Patient breathing rapidly and tongue look swollen.  Then difficulty breathing accompanied by wheezing.  Epipen administered and patient starting seizing.   Patient is okay now.
Lifelong autoimmune diseases; shingles; Vaccine injury; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: Lifelong autoimmune diseases) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and injury (Verbatim: Vaccine injury). The outcome of the autoimmune disorder, shingles and injury were not reported.   It was unknown if the reporter considered the autoimmune disorder, shingles and injury to be related to Shingles vaccine.     It was unknown if the company considered the autoimmune disorder, shingles and injury to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The patient had shingles, and nothing compared to the lifelong autoimmune diseases he/she had from a vaccine injury. The follow-up would not possible as no contact details were available.
2/9 received Tetanus vaccine (Tdap) from nurse at Public Health Department 2/16 developed runny nose 2/17 morning: post-nasal drip irritation in throat but took a job pre-employment test and returned home feeling fine 2/17 afternoon: full-on fever and headache, weakness, laid in bed 2/18 stayed in bed all day with fever, headache, nausea, raspy voice 2/19 felt nauseous and weak in my legs when standing in bathroom or trying to shower, had to sit down suddenly or I would have fainted 2/20 weak in legs while standing, nausea, thick (yellow) phlegm 2/21 went on job interview and felt fine except for a cough and thick phlegm and uneasy feeling in my stomach alleviated by eating just a few bites of a rice chocolate bar 2/22 weak in legs, nausea, jaw hurt when I opened it and ear felt full, had to leave shower or I would have fainted, cough, thick phlegm 2/23 weak in legs while standing, nausea, jaw hurt when I opened it and ear felt full, cough, thick phlegm 2/24 symptoms stayed the same so I saw PA and she said I had the flu the previous week and had an infection in my sinuses now. I was prescribed Doxycyclin antibiotic which I started on this day, along with starting Bupropion. I took two pills of each 2/25 symptoms got worse, still had jaw and a little ear pain, I became more nauseous and weak, eating seemed to help, but I was really nauseous, I took antibiotics and Bupropion again two times on this day, I vomited after a few hours of taking the antibiotic in the early morning on an empty stomach, I almost vomited the antibiotics up in the evening, I could not sleep on this night 2/26 morning: jaw and ear pain, my symptoms got worse over the course of the day, I was so nauseous that I didn't take any medication (I was still taking 20 mg of Prozac every other day) 2/26 afternoon: I developed a migraine headache, I have never experienced one of these before and it hurt so much I had to try and dull the pain with Tylenol (didn't help) and ginger (helped to relieve the nausea). My boyfriend put extreme pressure on a nerve in my hand and that helped temporarily. I went to bed with a heating pad under my head. 2/27 morning: my headache subsided and I felt less nausea, my throat was beginning to feel better, less coughing, less phlegm, my ear was hurting more and jaw still hurt. I decided the drugs were too much to deal with so I stopped all but the Prozac, which I reduced to 10 mg on this day.  I still felt weak when I was showering. I had to leave shower because I felt faint 2/28 I felt even less nausea, alleviated by eating. ear began to hurt more along with jaw pain 3/1 less nausea, more like a queasy stomach, alleviated by eating, upper back between shoulder blades began to hurt in afternoon, ear pain more evident along with jaw pain