chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up in the middle of the night with intense pain in my left arm, unable to life my arm the following morning.  Throughout the day I could not touch my arm and barely managed to put a jacket on from the pain.  I couldn't lift my arm higher than my ribs the entire day.  At 5pm the day after the vaccine I had chills, body aches, fatigue, and felt nauseous.  The next morning I had a redness around my armpit on my left arm, with an itchy rash on the posterior side of  my armpit.  The redness and itchiness is improving but still present today.  I have been receiving and responding to the V-Safe check in's, but didn't experience the chills, muscle aches, fatigue until after I filled out that days assessment.  I tried typing it for the next day but had to walk away from my phone mid-survey and it wouldn't let me submit a report that day.
pt recv vax13JUN96 & exp pain in upper lt arm;afternoon 14JUN96 pt devel edema in the arm;by 830PM that evening pt devel edema in fairly red, swollen, hot & tender;10PM that evening pt lt work & presented to ER:devel cellulitis & induration
Pt has had 3DTP & 1DT in life; had only crankiness p/1st DTP, had t103-105 fever controlled by APAP 1 day following 2nd DTP; had fever 103-105 controlled by APAP x 2 days p/3rd DTP; had Dt on 4th vax 13JUL88 & no sz event hx in pt;
Right after vaccine, I had a low grade fever for a day; and then I had pain and swelling at the injection site (that lasted two weeks). My shoulder had a swelling and quite a bit of tenderness. I also got Lymphadenitis - my lymph nodes on my right side under arm were swollen for 5 1/2 months. That was painful - it was hard to put my clothes on. The pain and tenderness finally stopped about 2 weeks ago.  August - I started having mucous charge and thick mucus coming down from my sinus and bad fevers - 103.9 was highest it got with loss of appetite. I was very weak with muscle aches and pains. I was breathless - very breathless. I went to the doctor and figured out it was bacterial sinusitis.  My neutrophil  count 600 cells per microliter - 10 to the power of 3; it's come up now. I was really low though from late August to early October. I have never had low neutrophil counts. They started with Augmentin - for 10 days and then I spiked a 103.9 and so they gave me Prednisone for five days and I was still pretty bad, getting worse. So then they gave me Clindamycin; - for 10 days. And finally Azithromycin; Doxycycline for 14 days. After all of that I'm doing better. I had to take two different courses of Azithromycin  because I was still having a fever. I do still  have mucus drainage from my nose but it's much better. My neutrophil count also came up. I am still a little breathless.  Urgent Care - for IV fluids.
Info has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 4/22/05, the pt developed mild breakthrough varicella. Unspecified medical attention was sought and at the time of this report, the outcome was unknown. Additional info has been requested.
no additional AE; Patient was inadvertently administered expired dose; This spontaneous report was received from a medical assistant referring to a 60 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.       On 28-JAN-2021, the patient was inadvertently vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S036494 with expiration date 09-JAN-2021, 1 ml (route was not reported) for prophylaxis (expired vaccine used). The product has not been involved in any temperature excursions. No additional adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Soon after my arm got painful into my fingers and in my armpit that subsided. Friday night I had a high fever with chills, soaking through my sheets. Saturday I got up to go to the bathroom and my daughter found me on the floor. I am not sure how long I was passed out for. Today I feel a lot better, sore from falling. I did not hit my head because I fell on laundry basket. I do have some numbness and tingling in both hands today  and low energy.
Diarrhea; This is a spontaneous report from a contactable (Patient). A 69-year-old non-pregnant female patient received BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, Lot number: unknown), via unspecified route of administration, administered in left arm on 03Feb2021 at 15:43 (at the age of 69-years) as unknown, single dose for COVID-19 immunisation. The patient medical history included breast cancer survivor for 11 years. The patient was allergic to Viox & Celebrex. Concomitant medications were not reported. The patient did not receive any other vaccine four weeks prior vaccination and did not take any other medications prior two weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. On 03Feb2021, patient experienced diarrhea. No treatment was received for the event diarrhea. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL injection, 0.5ml, intramuscular (lot #, strength and indication not reported). The patient was vaccinated with the second dose of GARDASIL (lot #, strength and indication not reported) on 30-AUG-2013 and third dose of GARDASIL (lot #, strength and indication not reported) was administered less than 12 weeks later on 19-NOV-2013. No adverse events were reported. Additional information has been requested.
swelling at the injection site; redness at the injection site; pain at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 Vaccine.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   MRI with contrast dye.  No treatment information provided.  No conmeds reported.
Information has been received from a physician concerning a 10 yr old female who on 21Feb97 was vaccinated with a dose of varicella virus vaccine live (620626/1400D). On 13Jun05 the pt developed 50 lesions described as moderate chickenpox, with lesions in the mouth and vagina and a fever of 101.4. Unspecified medical attention was sought. It was reported that there was no recent exposure to chickenpox. The pt's present status was unk. There was no product quality complaint involved. Additional information has been requested.
Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date; Received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date) and EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported. Excursion duration: 72 hours post expiration date. Vials were unpunctured but after punctured used within 12 hours.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with a doses of ROTATEQ following a temperature excursion (reported lot # A41DB544A, expiration date: 27-FEB-2017) (dose and frequency were not reported) orally. No apparent adverse effects were reported. The outcome of event was not reported. This is one of two reports from the same reporter. Additional information has been requested.
Normal labor and delivery on 11/2/2021. Birth weight 6lb15.5oz. Hospital admission within 6 weeks of receiving the COVID vaccine.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
The Pfizer shot was given at 1:30. We shopped at the store for 15 minutes (they didn't have a waiting area to sit down). We left the store. As I (her mother) was driving home she passed out and her head almost hit the dashboard. I grabbed her head and pulled into a parking spot. She was white as a ghost. I called 911. The ambulance arrived 6-8 minutes later. She was speaking incoherently to the paramedics and her blood pressure was extremely low. They transported her to the Medical Center. Her blood pressure was monitored and she was given a bag of fluids. We were there over 2 hours before she was released. They said it was Vasovagal Syncope and the paramedic said he had a few similar calls shortly after the Covid-19 shot had been administered (I hope they are all reporting it).  A friend of ours called us and told us his daughter passed out after the Pfizer shot just last week. She was at  (college in out of state) and got her shot there. They didn't report it or anything. I think this needs to be looked into. Especially in regards to younger people.
Developed a rash/redness in arm where shot was given.  It was also swollen.  I noticed the symptoms on around Day 5 and they lasted for the next 5 days or so.
pt recv 2 doses of vax & 10SEP96 lab eval revealed lack of seroconversion;23JUN97 pt was re-vaccinated;5AUG97 lab eval again revealed lack of seroconversion;
Patient tolerated fine at time of injection, however after 1-2 days she began to feel pain from her shoulder up to her neck
Pt tolerated injection well. After approximately 5 mins following vaccine administration, pt was noted to have had a vaso-vagal response/seizure-like activity in the waiting room. Pt was assisted to supine position on the floor with feet up on a chair. Vitals were assessed. Pt was assisted to a patient care room with mother and sister. Dr. assessed and evaluated patient. After 30 minutes in the room and drinking H2O, patient was discharged with mom. A note was written for her to return to volleyball practice although late.
At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes like before with the first vaccine.  The muscles of my eyes and eye lids feel weak and difficult to focus. I started having extreme nausea and could not go to work. No appetite either. I now have Oscillopsia and feel sick.
itching; dizziness; twitching in arm; This case was reported by a physician via sales rep and described the occurrence of pruritus in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced pruritus, dizziness and twitching of limbs. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the dizziness was resolved with sequelae and the outcome of the twitching of limbs was unknown.   It was unknown if the reporter considered the pruritus, dizziness and twitching of limbs to be related to Bexsero.   Additional details were provided as follows: The reporter stated that, the patient received a dose of Bexseo and started twitching in his arm  and developed dizziness. The patient recovered after few minutes.
Headache; Extreme tiredness; Felt dizzy; Chills; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The relevant medical history was not reported. The patient had known allergies to sulfa (sulfonamide). Concomitant medications included fluoxetine hydrochloride (PROZAC), diazepam (MANUFACTURER UNKNOWN), eleutherococcus senticosus root (GINSENG), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3) and Multivitamins from on an unknown date, for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 15:00 i.e. 2 hours after the vaccination, the patient felt dizzy, out of it and chills. Fine for a week i.e. On 24Mar2021, patient experienced extreme tiredness, hard to exercise and headache. stop happening 3 weeks later. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event felt dizzy and chills was recovered on an unknown date in Mar2021. The clinical outcome of  extreme tiredness, hard to exercise and headache was recovered (stop happening 3 weeks later) i.e. on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
soreness in her arm; she has "light cold" symptoms that include runny nose and watery eyes; she has "light cold" symptoms that include runny nose and watery eyes; she has "light cold" symptoms that include runny nose and watery eyes; This is a spontaneous report from a contactable consumer and concerns a female patient of unknown age who reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 06Mar2021, as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient reported soreness in her arm, she has light cold symptoms that included runny nose and watery eyes. No fever was reported. She wanted to know if she could safely return. The outcome of events were unknown. The patient wanted to know if the vaccine could cause a positive Covid test (nasal swab).  No follow-up attempts were possible; information about lot/batch number could not be obtained.
18AUG92 recvd 1st dose of Engerix-B & later that same day exp asthma-like sx & clearing of throat; reported indicated that the events were immed life-threatening; sx diminished during the noc;
A non-serious spontaneous report of acting different, unhappy, upset and agitated has been received from a physician concerning an eight-year-old male, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 20-Oct-2011, the patient received FLUMIST. About one hour after receiving FLUMIST, the patient became very agitated, unhappy, upset and was acting very different. The patient's behavior became normal by bedtime. The symptoms subsided in less than 24 hours. The events acting different, unhappy, upset and agitated recovered.
Pentacel was given in a partial dose. Only the HIB component was given with 1% Lidocaine.  Patient had no adverse reactions.
I couldn't sleep the night of the day that I got the vaccine due to body aches and chills, and general feeling of discomfort. The next day I had a low fever that lasted the entire day, along with the body aches, chills, headache, nausea and soreness around the injection site -- basically, I felt flu-like. The fever didn't break until the following night around 1:30-2 a.m. -- so, 24 hours after symptoms started, and heading into the second day following my vaccination. I noticed the lymph nodes in both arm pits were painfully swollen, as well, which was not a side effect that I was warned about, so it freaked me out. The node in my left arm pit -- the arm where I got the vaccine -- was  more swollen and painful than the right arm. And that swelling did not leave until three days after my vaccine.   In short, I was feverish and ill the night I got the vaccine, and all of the following day after getting the vaccine. I still felt nauseated and had a headache two days after my vaccine -- which is when my lymph nodes in my under arms were also noticeably swollen and painful -- but the fever was gone. Three days out from the vaccine, the flu-like symptoms were gone, except for headache and fatigue. All told, I missed two days of work, and was "down for the count" feeling sick for three days.
Confirmed pregnancy on 1/25/21, estimated due date 8/22/21. Diagnosed with placenta previa on 3/22/21. On 7/28/21, experienced vaginal bleeding. Was admitted to hospital with vaginal bleeding, placenta previa and macrosomia which all required urgent c-section. During c-section, also noted placental abruption. Baby was born prematurely, underdeveloped lungs and required a NICU stay of 7 days.
Pt received Pfizer vaccine and walked to observation area. RN observed pt to be fainting with convulsing movements for approx 30 seconds. Pt recovered to full cognitive alertness almost immediately, stated that she had felt dizzy, felt like she was fainting and does not remember what happened after that. Vitals and O2 sat stable, pt did not eat breakfast or hydrate today. Pt denied having symptoms but was transported to ED for further evaluation.
She had an anaphylactic reaction and almost died; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (She had an anaphylactic reaction and almost died) in a 61-year-old female patient 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 ANAPHYLACTIC REACTION (She had an anaphylactic reaction and almost died) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 14 days due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (She had an anaphylactic reaction and almost died) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient had an anaphylactic reaction and almost died. She was in the hospital for 2 weeks.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 61-year-old female patient with no medical history reported, who experienced the expected serious (hospitalization, medically significant) event of Anaphylactic reaction (reported as She had an anaphylactic reaction and almost died) that occurred in the context of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. Latency could not be assessed as the date of vaccination and onset date of the event was not available. Patient was hospitalized for two weeks. No further information regarding risk factors, clinical course, medical history, investigations, additional vaccination details and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 is not affected by this report.   This case was linked to MOD-2021-296245 (Patient Link).
A small reddish bump on my arm at the injection site, my arm is sore any tender to the touch. The bump is getting larger in size.
lt thigh swelling, induration 7x7cm itching;no fever;no loss of function;rx w/atarax;
Case number PHEH2014US012541 is an initial spontaneous report received from a nurse on 19 Jun 2014. This report refers to an 11 year old female child. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12098, expiry date: 03 Jul 2015) intramuscularly at a dose of 0.5 ml on 17 Jun 2014. On 18 Jun 2014, she developed swelling and redness at vaccination site which was about the size of a baseball. The outcome, causality and seriousness were not reported.