chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss; Inner ear problems, A lot of vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a  patient of an unknown age and gender 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 DEAFNESS (Hearing loss) (seriousness criterion medically significant) and INNER EAR DISORDER (Inner ear problems, A lot of vertigo). At the time of the report, DEAFNESS (Hearing loss) and INNER EAR DISORDER (Inner ear problems, A lot of vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  After the Moderna shots, patient had been having inner ear problems and a lot of vertigo and hearing loss.  No treatment information was provided.  Company comment : This spontaneous case concerns a patient of unknown age and gender with no medical history reported , who experienced the serious unexpected event of Deafness(serious criterion-Important medical event), unspecified days after the dose of mRNA-1273 Vaccine. The patient also reported to have inner ear problems and vertigo after the vaccination. No further information regarding clinical course of the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported , who experienced the serious unexpected event of Deafness(serious criterion-Important medical event), unspecified days after the dose of mRNA-1273 Vaccine. The patient also reported to have inner ear problems and vertigo after the vaccination. No further information regarding clinical course of the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a pharmacist refers to a 6 unspecified infants of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 01-JUL-2015, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535 and expiration date 27-AUG-2016, lot number K010535 and expiration date 27-AUG-2016, lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Red dot rash on both legs and a few red dots on torso. They looked like chickenpox but did not itch and not painful. Sorted over two weeks. Now going away with cortisone.
There are no symptoms of the patient, it is that the vaccine was out of date at the time of administration.
Reconstituted the Pfizer medication with incorrect amount of saline. Reconstituted with 0.22 ml instead of 2.2 ml. Gave one dose and than realized there are not enough doses and noticed the error.
I went in for a physical in November, I was told I had a heart murmur. My doctor ordered an ultrasound that showed that did not show anything alarming. I was having a lot of abdominal pain in December 2022; I made an appointment with my doctor. I thought I may have a kidney stone; my urine was tested it was negative. The doctor thought I may be constipated. I made an appointment with a gastrointestinal doctor who ordered an ultrasound of my intestines, they found that my spleen was enlarged, and my liver was enlarged and fatty. I have appointments in May and June to have further testing done.
Mild headache progressing to intense throbbing headache with flashes of white light, lasting for several hours, severe myalgias, high fever, episodes of delirium, right shoulder and right neck burning pain, chills, sweating, intense fatigue, rash on arms/stomach/back/thighs
Elbows and wrist joints very sore and elbow on right stiffer than left. A few rashes on elbows and some finger joints.  Itchy rash near ankles and sole/side feet. I don't know if this has anything to do with the booster but wondered. I'm waiting to see if it gets better in the next few days.
reconstituted with sterile water instead of  saline diluent; reconstituted with sterile water instead of  saline diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: Reporter was a pharmacy intern who was reporting potential wrong solution used in reconstitution with Hiberix.  She stated that, Hiberix might have been reconstituted with sterile water instead of with the accompanying saline diluent.  The number of lyophilized vials and saline diluent did not match which led her to this conclusion.  It was unknown if dose was administered to the patient. The reporter consented to follow up. Additional supportive information: Hiberix might have been reconstituted with sterile water instead of with the accompanying saline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
No adverse events reported by client. TUBERSOL (PPD solution) .5cc administered IM in right deltoid.
Swelling, tenderness, lump at site of injection. Redness encompassing most of the triceps area.
Bad fever for three days (over 101.3); Muscle aches; Headache; Chills/shivering; Fatigue; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient).    A 28-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8733, expiry date: 30Mar2021), via an unspecified route of administration on 30Mar2021 (at the age of 28-year-old) as dose number unknown single for COVID-19 immunisation. Medical history included allergies to medication: penicillin and food or other products: olive from an unknown date and unknown if ongoing. The patient had not pregnant at time of vaccination. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, patient experienced bad fever for three days (over 101.3), muscle aches, headache, chills, shivering, fatigue, nausea and vomiting. The patient was treated with Tylenol. The patient underwent lab tests and procedures which included body temperature: over 101.3 on bad fever for three days (over 101.3). The clinical outcome of events was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TERRIBLY SICK AND HE CAN STILL FEEL IT YET; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced terribly sick and he can still feel it yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terribly sick and he can still feel it yet. This report was non-serious.
Pt. hospitalized for Kawaski's disease.  8/14/07 Received med recs from provider but no vax record.  Reporter states vax info is correct as reported & will not send further records. 8/24/07 Received hospital medical records which reveal patient experienced fever, rash, red eyes w/purulent discharge, cough, vomiting/diarrhea, decreased oral intake & irritability x 2 days. Transferred from outlying hospital & admitted 8/4-8/9/07.  Tx w/IVIG x 1 & high dose ASA.  D/c to home on low dose ASA w/cardio f/u. FINAL DX: UTI, Kawasaki disease.
No other concerns issues noted; Nurse calling to report that a patient was administered and expired PNEUMOVAX 23 (pfs) on 11/28/2022./ EXP: Jan 27th 2022; This spontaneous report has been received from a nurse referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 28-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot# T009743, expiration date 27-JAN-2022, strength, dose, anatomical location and route of administration were unknown) for prophylaxis (expired product administered). No other concerns issues noted (no adverse event).
Fever, stomach pain, nauseas, diarrhea, shingles and painful rash starting on Monday November 15. Patient still in treatment with Zovirax 800mg, Augmentin 875mg, Relafen 500mg, Bactroban for topical use.  The shingles are inside and outside the nose.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced sore arm.. The reporter did not consent to follow up.
7/30--8/3 61 yo gentleman known to me from 2014 admission with history of hemorrhagic CVA , admitted with syncopal episode/ presyncopal episodes and falls in outpatient setting. Pain in left hip after previous fall- no obvious deformity, prior THA reported.  Rule out fracture. COVID 19 - with fever, leukocytosis.  Fatigue and malaise present.  On room air. Low procalcitonin lever. AKI with metabolic acidosis- likely prerenal. Recent rehab stay for cocaine use. Completing day 3 of 3 remdesivir.
This was my Pfizer booster shot.  Last of my second doses was 3/10/21. Like with the second shot, I was achy all over and could not get warm. This started around 1:00 pm. My booster shot was yesterday at 5:45 pm. But the big difference was a significant allergic reaction characterized by a red rash all over my torso, legs, feet,  itching, and my feet and eyelids swelled.  I also had the worst heartburn I have ever had that doubled me over.  I could not lie down but had to remain upright to make the pain bearable, This heartburn latest 6 hours.  It?s 10 pm and I would say I started to realize the aches and chills were done by 8 pm.  The rash remains. I still feel remnants of the heartburn but it is very mild compared to what is was.  I am taking Benadryl internally and using a topical on my feet and the worst areas on my torso.  .
Initially, sore arm and some upper trunk muscle soreness on the day after vaccine.   3 days later, admitted to the hospital after witnessed fall by husband - cardiac arrest. Seizures seen today.  Unsure if directly related to the vaccine, as there are several days between vaccination and the arrest, but no new medications or issues since vaccination.
9/21/17 receive flu shot, more painful than usual 9/22/17 right arm at site of injection extremely painful, in tears because it hurts to move my arm to remove or put on a shirt 9/23/17 -10/4/17 pain subsides, only hurts when using the muscle in which injection was shot in. 10/3/17 8:15am Went to doctor to have arm looked at. Doctor stated that it was shot too high in arm and it hit deltoid ligament. Must take ibuprofen around the clock, ice compresses, and taught physical therapy stretches to aid in recovery.
I received the shot in my right arm and waited 15 minutes, then walked out to my car. When I got in my car I noticed that my right jaw and cheek felt numb so I went back into the facility and told the nurses and they had me wait an additional 30 minutes. They also submitted a report. During that waiting time a part of my tonight and mouth also felt numb. I did not experience pain, nor swelling. After 30 minutes there was not a change so I went home. It lasted for another hour or two. Did not have other issues or symptoms with my jaw following that. After my first vaccine dose I did have jaw pain and submitted a VAERS report: #243828.
pt recv vax Monday AM approx 10:00;Tuesday devel hives all over body-head to foot;intense itching;no resp problems;hives began dec in number & size by morning;ate eggs for breakfast became worse;no prev problems w/eggs;had flu shot w/o rxn;
2 days of fever at 102; Body aches; Headache/ lingering headache; Extreme fatigue/ moderate fatigue; Dose received 3/ Dose number=3; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.   A 48-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 27Nov2021 at 10:45 (Batch/Lot number: FJ1620) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications included: GLUCOSAMINE; BIOTIN; ACV; CALCIUM, VIT D and OMEGA-3. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: EJ3247, Route of administration: Unspecified, Anatomical site: left arm, administration time: 12:00), administration date: 09Mar2021, when the patient was 48 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE, Lot number: ER8734, Route of administration: Unspecified, Anatomical site: left arm, administration time: 12:00), administration date: 29Mar2021, when the patient was 48 years old, for COVID-19 immunisation. The following information was reported:  PYREXIA (non-serious), PAIN (non-serious), HEADACHE (non-serious), FATIGUE (non-serious) all with onset 27Nov2021 at 22:00, outcome "recovering", described as "2 days of fever at 102, body aches, headache, extreme fatigue. 3rd day fever and body aches mostly gone, lingering headache and moderate fatigue". Therapeutic measures were not taken as a result of pyrexia, pain, headache and fatigue. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
This spontaneous report was received from a license vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (confirmed not GARDASIL 9) (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received concerning a 3 day old female who on 2/15/99 was vaccinated with 1 dose of varicella virus vaccine live and 1 hour and 15 minutes, post vax, the pt experienced vomiting, chills, shakes and mild fever of 100F. The pt recovered early the next day. No further information is available.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L000454 with exp. 06-JAN-2017, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative:  Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
tightness in chest, felt like when i get stung by a bee and my asthma is acting up. started about 7 minutes after receiving the vaccine, did not go away after about 1 1/2 hours felt increased tightness/shortness of breath/wheezing.  used my albuterol mdi and felt better.  lasted about 2 1/2 hours and then began to feel the tightness start again and felt need for albuterol inhaler, took albuterol again and a pepcid po.  continuing to monitor and will inform primary MD also.
I have had an IUD for several years and have not had a period (bleeding). Ever since the vaccine, I am bleeding HUGE amounts during my period.
Prior to administration of Rabies immunization #2, the donor reported a reaction to her first Rabies immunization, received on 06/07/2020.  Donor noticed "red bumps" (i.e., a rash) on her inner right thigh on 06/08/2020.  the rash was approximately 3" x 3".  Rash resolved on its own by 06/09/2020.
Information has been received from a nurse referring to an unspecified number of patients (gender and age not reported). On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (lot# and dose were not reported). No adverse effects were reported. Additional information has been requested.
Caller is a medical assistant calling to report a temperature excursion.; Product Name: ROTATEQ / Dose/Frequency: 0.5 ml; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 14-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 0.5 milliliter (incorrect dose administered), administered by oral route (formulation, strength and vaccination scheme were not reported; lot number S040483, which has been verified to be valid, expiration date reported and validated as 19-JUN-2021), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), administered at a dose of 0.5ml (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T001206, which has been verified to be valid, expiration date reported and validated as 03-JUN-2022), both vaccines were administered as prophylaxis, and experienced temperature excursion.  This is one of several reports received from the same reporter.
member had a red circle mark on her arm. The following day, the member was unable to walk, and has pain in her leg. member feels crippled after this incident, and has multiple issues since this. Member was told that they may have given her the incorrect shot. She was supposed to get a flu shot. She had to go to the hospital, she suffered seizures, while at the hospital
fever spiked to 99.7; felt bad; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who experienced fever spiked to 99.7 (pyrexia) and felt bad (feeling abnormal), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever spiked to 99.7 (pyrexia) and felt bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
allergic reaction- diffuse hives started 6/20/21, ER visit, arrived 1:59pm, symptoms started approximately 30 min prior to arrival. also took a tylenol but no prior issues with tylenol in the past
Patient was inadvertently administered the Moderna vaccine before his 18th birthday.  A headache was the only adverse effect that the patient reported having post vaccination.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
pt c/o red, swollen vax area, h/a, stiff neck, body aches;felt very tired;
Developed shingles. Seen by M.D. on 8/26/15.
Woke up about 12hrs after vaccine and felt incredibly nauseous and had chills. I was walking downstairs to take Tylenol and I felt like I was going to pass out. Luckily I sat down and then proceeded to pass out, although I am not sure what really happened. My mom found me about 10 seconds later confirming I wasn?t out for that long, but she was slapping my face and talking to me and I was unaware. She reported that my eyes were open. When I came to I was having cold sweats, I was clammy, and my ears were ringing. I was very scared and I don?t know what happened to me. I felt like I was dreaming when I woke up, but once my Tylenol kicked in I felt better. But it still was a very strange out of body experience.
RIGHT LEG WENT NUMB AND STILL IS NUMB TO THIS DATE (4/2/21).  A FEW DAYS AFTER SHOT MY LEG WENT NUMB.  ON 3/27, RIGHT ARM WENT NUMB.
Patient received expired dose of Moderna. Expiration date 6/20/21 dose administered on 6/22/21
Sharp, burning pain at injection high on left shoulder. Within minutes, arm and shoulder were disabled and crippled. Condition has persisted since 10-17-15.
Patient reports feeling dizzy, weak, could not stand. Pt was removed from car and placed on stretcher. Pt Vital signs were take and within normal limits. Pt recovered and was sent home via personal vehicle.
Began to have a headache on the left side over the temple region the next day after the flu vaccine. Pain was max of 6 out of 10, worse with lying down. Had difficulty with word finding and couldn't remember his PIN number for the internet.  No weakness or numbness in arms or legs. No slurring of speech.  Pt did have nausea and vomiting about 4 times on 09/21/2012. Decreased appetite and loss of up to 10 pounds over 3 days.  Presented to Emergency Department on 09/24/2012.