chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager via a company representative refers to a 5 week old male patient. Concurrent conditions and medical history were not reported. The reporter stated that on 01-SEP-2015, the physician vaccinated by accident to the patient with a dose of GARDASIL (lot # K010215,e expiration date May 2017) 0.5 ml (Route and dose were not provided). Concomitant medication was not reported. No information was provided on the vaccine the baby was supposed to receive on 01-SEP-2015. No adverse effects are being reported. Additional information has been requested.
nurse practitioner found the patient unresponsive in the passenger's seat; right after the injection, the patient leaned forward and looked flushed; mom said she does get anxiety with injections; pale; clammy; flaccid; diaphoretic; became limp with no radial pulse\pulse rechecked and weak radial pulse was noted; Initial information received on 08-Aug-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 13 years old female patient and nurse practitioner administered the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after that found the patient unresponsive in the passenger's seat, right after the injection, the patient leaned forward and looked flushed, mom said she does get anxiety with injections, pale, clammy, flaccid, diaphoretic and became limp with no radial pulse\pulse rechecked and weak radial pulse was noted.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine solution for injection (frequency: once, strength: standard, expiry date: 27-Jun-2025 and lot U7643AA) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient found the patient unresponsive in the passenger's seat (unresponsive to stimuli) (unknown latency). This event was assessed as medically significant.  On an unknown date the patient leaned forward and looked flushed (flushing), she does get anxiety with injections (anxiety), pale (pallor), clammy (cold sweat), flaccid (hypotonia), diaphoretic (hyperhidrosis) and became limp with no radial pulse\pulse rechecked and weak radial pulse was noted (radial pulse decreased) (unknown latency).  Relevant laboratory test results included: Radial pulse - On an unknown date:  [pulse rechecked and weak radial pulse was noted no radial pulse]  Action taken: not applicable.  A sternal rub was corrective treatment was received for the event (unresponsive to stimuli).  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the events.; Sender's Comments: Sanofi company comment for information received on 10-Aug-2023: This case involves a 13 years old female patient and nurse practitioner administered the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after that found the patient unresponsive in the passenger's seat, right after the injection, the patient leaned forward and looked flushed, mom said she does get anxiety with injections, pale, clammy, flaccid, diaphoretic and became limp with no radial pulse\pulse rechecked and weak radial pulse was noted. Further information regarding tolerance, allergic history, concomitant medication and current condition excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
None. Vaccine given too soon - was 3rd dose HPV. 2nd dose 5/29/07, 3rd 8/16/07.
symptoms in her legs; brain fog; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (symptoms in her legs), FEELING ABNORMAL (brain fog) and HEADACHE (headaches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (symptoms in her legs), FEELING ABNORMAL (brain fog) and HEADACHE (headaches). At the time of the report, LIMB DISCOMFORT (symptoms in her legs), FEELING ABNORMAL (brain fog) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were provided by the reporter.
Felt sick and feverish the day after the vaccine was administered. Did not work for two days. Have had headache since day of vaccine. Currently taking Aleve.
My child (3 weeks old) refused to drink my breastmilk (from the nipple and bottle) after the vaccine was given to me (mom).  He would latch for about 3 seconds and then scream, throw his head back, arch his back, and spit up all that he had just taken in.  In an effort to feed him, I provided him with frozen breastmilk from before I had received the vaccine for 48 hours.  While giving him this milk, he ate just fine again.  My pediatrician recommended pumping and dumping my milk during this time period which is what I did.  After 48 hours he did start latching and eating from the breast again.
pt had fever to 106.1 & seizure. May have had lumbar puncture.
A report has been received from a Physician concerning multiple patients of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient experienced ONE TO TEN PATIENTS RECEIVED FLUMIST AND TESTED POSITIVE FOR INFLUENZA A. The outcome of the event of ONE TO TEN PATIENTS RECEIVED FLUMIST AND TESTED POSITIVE FOR INFLUENZA A is unknown. The report was considered to be non-serious.
I received the 2nd dose of the Pfizer COVID19 on 1/12/21 at approx. 1:30pm. The next day (1/13/21) at approximately 05:30am I awoke feeling feverish with chills and aches. I treated this side effect 400mg ibuprofen Q6HPRN twice during the day and had an Epsom salt bath. The next morning, I was fully recovered.
after each immunization she experienced fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (after each immunization she experienced fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 012M20A, 062E21A and 038A22A) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (after each immunization she experienced fever). At the time of the report, PYREXIA (after each immunization she experienced fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On the third dose, she told the health care professional that she would like to receive half dose of the vaccine since after each immunization she experienced fever and she said that she knows better. Health care professional administered the full dose anyway.  She received the flu vaccine on November/December 2019 and 4 weeks after the 5th dose of the Moderna Covid-19 vaccine. Fifth dose 04 Nov 2022 Lot number 016H22A last dose of the Moderna bivalent vaccine.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731727:Monovalent case for same patient
Received Pediarix (Hep B, IPV, DTaP) , Prevnar, Hib on 9/16/03. Two days later-onset explosive diarrhea lasting 3 days, 2 emesis, no fever, no other family ill.
Severe pain in shoulder and back next day after shot was given on 11/01/05. Went to doctor on 11/07/05 and he prescribed a dose pack and muscle relaxant. Went back to doctor 11/14 or 15/05 prescribed pain meds.  Went to ER on 11/29/05 as pain had gotten worse, I felt this might be a heart attack.  Pain went from shoulder to neck and jaw area.  Discharged from ER after determining it was not heart related.  Pain is still in the left shoulder and surrounding area.
pt recv vax 2JAN96 & JAN96 pt devel 40 chicken pox lesions;
No problems after shot until 12 hrs later.  Then chills, fever bad headache, nausea  for 2 days. Took Tylenol and stayed in bed
This spontaneous report as received from a physician refers to a 58 year old male patient. The patient's medical history included eczema and chickenpox as a child at 6 or 7 years old (approximately in 1961). On 07-DEC-2013 the patient was vaccinated with ZOSTAVAX, (unknown dose and route of administration). It was reported that the patient developed chickenpox after being administered ZOSTAVAX. On 09-DEC-2013 the patient broke out in hives and went to the emergency room and was diagnosed with chickenpox. The patient visited doctor on 12-DEC-2013, 20-DEC-2013, and 27-DEC-2013. On those visits, the doctor reported that the patient was "still breaking out but getting better." On 02-JAN-2014, the doctor reported that the chickenpox had gotten worse, with more itching. The patient had a physical in March 2014, and the doctor reported that he had mild dermatitis on both arms. On 12-APR-2014 the doctor prescribed nystatin (manufacturer unspecified) for the mild dermatitis. It was also reported that prior to vaccination, the patient was last seen in June 2012. The outcome of broke out in hives on 09-DEC-2013 was reported as "still breaking out but getting better and the outcome of chickenpox had gotten worse on 02-JAN-2014 was reported as not recovered/not resolved. The outcome of mild dermatitis on both arms is unknown. Additional information has been requested.
Low grade fever; Felt unwell; Vertigo episode; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-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 right arm on an unknown date in Jan2021 at 14:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 4 weeks prior to the vaccination. On an unknown date in Jan2021, at 07:00, first day after shot the patient experienced low grade fever and felt unwell for 3 days. On an unknown date in 2021, 5 days after shot the patient had a vertigo episode that lasted for over 2 months. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events low grade fever, felt unwell and vertigo episode were recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (Soreness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form. On 27-Apr-2021, MYALGIA (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-207618 (Patient Link).
Patient exhibited fatigue, diarrhea, cramps, fever, blood in stool, night sweats. Patient met with Pediatrician on 10/21/2013. Blood and stool samples taken. Pediatrician recommended patient see a Gastroenterologist. Patient met with Gastroenterologist on 10/25/2013. Blood and stool samples taken. Physician felt patient showed signs of Ulceration Colitis. Patient received colonoscopy and upper GI on 10/30/2013. Colonoscopy showed inflammation of the entire colon.  Upper GI was normal.  Patient was diagnosed with ulcerative colitis.  Patient given Prednisone and Balsalazidr disodium.  Symptoms finally started improving on 11/1/2013. As of today, 11/6/2013, patient still has diarrhea.  Symptoms continued for almost a month.
chills; headache; body aches; Malaise; This is a spontaneous report from a contactable Nurse. This Nurse reported in response to HCP letter sent in across referenced case which included that. A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231; Expiration Date: Apr2021), dose 2 intramuscular, administered in Deltoid Left on 11Jan2021 17:30 (at the age of 65-year-old), as dose 2, single for COVID-19 immunization in hospital. Medical history included Crohn's disease from 2011 to an unknown date. The patient's concomitant medications were not reported. On 11Jan2021 the patient received Tylenol per oral prior to vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK5730; Expiration Date: Mar2021), dose 1 intramuscular, administered in Deltoid Left on 21Dec2021 (at the age of 65-year-old), as dose 1, single for COVID-19 immunization. No pneumococcal vaccine was vaccinated within four weeks before BioNTech Vaccine and was not Pfizer vaccine. On 11Jan2021 08:00, the patient experienced chills, headache, body aches, malaise. The patient did not receive any treatment for the events. Emergency Room and  Physician Office visit was not required for events. No primary infection site applicable. No predisposing factors were there. No culture performed. No seriousness criteria provided. The clinical outcome of the events was recovered in 2021.  Follow-up attempts completed. No further information expected.
Sore arm; This case was reported by a physician and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported via web form. The age at vaccination was not reported. The patient had sore arm that the patient related back to her second Shingrix vaccination which was given in Sept 2020. The patient denied any nodule or visible abnormality. The reporter did not agree nor denied follow-up.
I started having extreme itchiness after mosquito bites.   It itched so bad I dug into my skin to try and get it out.  It was red and swollen.  Sometime after that my fact started having unusual break outs that are also itchy and red and swollen.  I am still having the face breakouts and I am getting read on my cheeks after I shower.  Went to a dermatologist and she thinks it might be rosacea.  I took prednisone and it helped but now that I['m not on the prednisone it is coming back.  I also took an oral medication, Imervectan and waiting on a topical cream, hoping that will help.
she got her menstrual period which she has not had in 2 1/2 years; headache; fluid in her ear was cloudy; nausea; extreme vertigo; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (she got her menstrual period which she has not had in 2 1/2 years), VERTIGO (extreme vertigo), MIDDLE EAR EFFUSION (fluid in her ear was cloudy), HEADACHE (headache) and NAUSEA (nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included AFib. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VERTIGO (extreme vertigo) and NAUSEA (nausea). On 07-Feb-2021, the patient experienced MIDDLE EAR EFFUSION (fluid in her ear was cloudy). On an unknown date, the patient experienced MENSTRUATION IRREGULAR (she got her menstrual period which she has not had in 2 1/2 years) and HEADACHE (headache). At the time of the report, MENSTRUATION IRREGULAR (she got her menstrual period which she has not had in 2 1/2 years), VERTIGO (extreme vertigo), MIDDLE EAR EFFUSION (fluid in her ear was cloudy), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-013852 (Patient Link).
4 hours after vaccine, started feeling itchy. Observed rashes and hives spreading around my body centralized around my torso. Symptoms disappeared 3 hours after taking anti histamines. Symptoms have been reoccuring every other day  till today 3/12 and disappeared after taking anti histamines.
Headache,  fatigue, nausea, pain at injection, stiff neck and shoulder.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, lot #, route and site of administration not reported). On 16-NOV-2013, the patient developed something what looked to be herpes simplex virus (HSV). The outcome of event was not reported. The relatedness between ZOSTAVAX and the event was not reported. The patient sought medical attention via a phone call to the office. Additional information has been requested.
I experienced soreness in my arm, tiredness for a couple days but then a month later I start experiencing gastrointestinal issues with pain in my stomach, acid reflux and broken up and loose bowel movements.
I received vaccination in left deltoid. That night I noticed significant pain and swelling. I did not sleep well. On 6/8/07 upon awakening I noted that my arm was swollen, a bruise was forming around the injection site. I was also unable to move my arm more than an inch away from my body. I tried OTC pain relievers with no relief. I was unable to sleep or move on that side. I went to the ER, was given NSAID and pain killer. 2 1/2 weeks after injection I still have a lump of muscle in my arm. My arm at time feels unstable which is new, and I still have some lingering pain. My pain level at it's worst following injection was 8/10.
felt sick, nausea, had diarreha, then it was hard to swallow, i needed water, it became hard to breath, i became very hot, my heart rate was very fast. had to lay down. this was all in about a 15-20 min. time span..i was in a public theater lobby. i was in bad shape...a person near by called an ambulance. i was taken to the emergency room.
swelling; lumps and bumps on her lips; lumps and bumps and grainy feeling in her lips is ongoing; toothache; cystic pimple at the injection site around her mouth; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 19Mar2021 as dose 2, single (at 56-years-old) for covid-19 immunisation. Medical history included allergy to sulfa. Concomitant medication included hyaluronic acid (RESTYLANE) taken for an unspecified indication from 07Jul2021 to an unspecified stop date; hyaluronic acid, lidocaine (RESTYLANE L) taken for an unspecified indication from 07Jul2021 to an unspecified stop date; hyaluronic acid (JUVEDERM VOLUMA) taken for an unspecified indication from 07Jul2021 to an unspecified stop date. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on 19Feb2021 as dose 1, single (at 56-years-old) for covid-19 immunisation. Patient was injected with 1 syringe of Restylane Kysse in the lips and 1 syringe of Restylane Lyft in the cheeks, and 2 syringes of Voluma, injected around the mouth area, on 07Jul2021.Patient had immediately experienced swelling in the areas, the same date of injection, 07Jul2021. Patient swelling was subsided after a couple of days (exact date unknown) and in Jul2021, patient started to feel lumps and bum on her lips when she applied lipstick (exact date unknown). she palpated the area and could feel the lumps and bumps and it also felt grainy. Patient also reported that, within a couple days of the injection, she developed a cystic pimple at the injection site around her mouth (exact date unknown), on her nasolabial fold and it subsided after a few days (exact date unknown). Patient reported that, in Jul 2021, last week sometime (exact date unknown) she developed a toothache. The lumps and bumps and grainy feeling in her lips is ongoing, as well as the toothache. she notified the injecting HCP who told her to wait a full 2 weeks before coming back in to the office. she only took vitamins and supplements (unspecified) daily. Patient had not received fillers in the past. She denied any other vaccinations in the past 6-12 months, also denied that any illness leading up to injection date. she had a dental cleaning on 09Jun2021. Patient had not received treatment. The outcome of the event swelling and mouth cyst was recovered and for rest all it was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
pt recvd vax & 2 hrs p/vax exp nausea, vomiting, diarrhea, muscle aches, h/a; these sx lasted 3 days & subsided w/o treatment;
Several hours after immunizations patient had 2 short febrile seizures. He presented to the local ER & MD diagnosed with (B) OM.