chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is a 17 year old male who presented to the ER at my request after his mother called reporting that he had a fever of 103.5, vomiting, severe headache and some neck stiffness at home. In the ER he underwent a spinal tap which was found to be consistent with a viral meninigitis type picture. He was admitted for control of nausea, vomiting, and pain. Pt had received an MMR vaccination and Tetanus booster the day prior to the symptom onset and his mother had initially wondered the two could be related. Complaints of fever, malaise, and fatigue. No vision changes. Severe headache and neck discomfort. No congestion, rhinorrhea or facial pressure. No cough, wheeze or shortness of breath. Complains of nausea and vomiting. No diarrhea and no abdominal pain. No problems with urination. Generalized aches and pains. Temperature is 99.2, heart rate 72, respirations 16 and blood pressure is 128/59. Alert and oriented 17 year old male in no apparent distress, non toxic. Eyes:Extraocular movements are intact. CENT:onjunctivae clear. Tympanic membranes examination by the ER physician. Oropharynx is clear. Nares are patent. Neck: is supple this morning without rigidity. Chest: Clear to auscultation bilaterally without wheezes, rhonchi, or rales. Cardiovascular: Regular rate and rhythm without murmurs, rubs or gallops. Abodomen: Is soft, non tender and non-distended. No masses and no hepatosplenomegaly. Musculoskeletal: No clubbing, cyanosis or edema. Skin: No rash.
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On 21-OCT-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB. On 02-DEC-2013, the patient was vaccinated with the second dose of RECOMBIVAX HB. On 15-JUL-2014, the patient was vaccinated with the third dose of RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. Additional information has been requested.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The physician reported that she received an email from an unspecified colleague that a patient experienced a severe headache for 3 years after she was vaccinated with GARDASIL (dose, route and lot not reported). The outcome of a severe headache for 3 days after receiving GARDASIL was unknown. The relatedness between the event and GARDASIL was not reported. Additional information is not expected.
Pt. had no adverse events. Reporting that KINRIX was given instead of PEDIARIX: The KINRIX was not age appropriate - but pt has had the IPV and DTaP previously.
No additional adverse events; a patient was administered an expired PNEUMOVAX 23; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 11-MAY-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (lot number: R021045, expiration date: provided as 11-MAY-2020, but upon internal validation established 14-APR-2020) (exact dose and route of administration was not reported). No additional adverse event was provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021045; expirationdate: 14-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
redness & pain lt upper arm beginning 2 days p/vax; tx w/rocephin;
within 3 hours, severe arm pain started and all over body aches, headache. Pain was so severe it woke me from sleep but I was incapacitated and couldn't move. I could not get up out of bed for 3 days and did not eat or drink anything. On day two a rash appeared on my butt. I am still not sure if its herpes or something else. I took valtrex 3000 mg/day per guidance of my pcp. Severe fatigue persisted for 9 days along with severe migraine. after Day 9, nerve pain all over back but mostly in low back/SI and down legs, toes started. Then at 3 weeks I developed a huge rash all over my upper back/neck that is intensely burning, itching. I am very depressed and suicidialat this point. I had a hip surgery planned to fix my hip after two years of hell. I have to cacel everything as my body is in soo much pain.
sudden onset sensorineural hearing loss and labrynthitis left ear onset tuesday  6/1/21 complete hearing loss occurring over 6 hour period followed by vertigo with vomiting. loss of balance and coordination, nystagmus.  undergoing series of 3x intratympanic steroid injections, 1 week apart.
Vaccine error-vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.
Pt was found unresponsive at 4am 6/13/03.  Autopsy report received on 8/21/2003 states COD was SIDS.
This spontaneous report as received from a other health professional refers to a 3 year old patient. On 03-AUG-2017 the patient was vaccinated with GARDASIL 9 for prophylaxis. On 03-AUG-2017, 1 day after onset of therapy the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to GARDASIL 9. {Additional information has been requested. / Additional information is not expected.}
Day of injection, left arm soreness.  Day after injection, sore throat.  Two days after injection, hives on arms and legs, continued to progress to torso
PT REPORTS SHE EXPERIENCED RT SHOULDER PAIN WITH LIMITED MOVEMENT ON THE EVE OF 11/2/10. REPORTS BT THE EVE OF 11/3/10 SX NOT GETTING WORSE AND BY 11/4/10 WAS BETTER
body aches; High Fever; This is a spontaneous report from a contactable consumer. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown), via an unspecified route of administration in the left arm on 26Mar2021 at 08:30 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 27Mar2021 at 12:00, the patient experienced body aches and high fever. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body aches and high fever was recovered on an unknown date at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient experienced syncope approximately 7 minutes after injection. Pulse was checked, which was normal. Provided water and patient felt well enough to walk after about 20 minutes of sitting down and drinking water.  Called the patient about 1.5 hours later and they reported feeling okay and recovered.
Received Moderna COVID-19 vaccine around 8:00 am on 1/4/2021. Same day in the afternoon, developed left facial numbness and right facial weakness, which had exacerbated on the next two days. On 1/5/2021, went to ED of Medical Center. Was evaluated by ED doctor and ED attending and was diagnosed with Bell's Palsy. Neurology consulted. Steroids were not recommended as it would make vaccine not effective. Lyme test was obtained (reported negative). Was discharged later on 1/5/2021 and was advised to follow up with OMS and neurology.
Twelve hours after injection I of course had arm soreness, but I became suddenly dizzy, could not stand up, experienced nausea. I finally threw up which relieved stomach nausea, but I had dizziness with the room spinning, unable to stand up, and fever which lasted about three hours. After the three hour period, I still felt somewhat dizzy, had a headache, and fever and chills. The next day I had to stay in bed with a headache the whole day. After this, I experienced four more bouts of vertigo in the next week and went to a doctor who prescribed meclizine which I had to take for three days.
Fever, cills, fatigue, body aches and drenching night sweets x 10 days
Breakthrough case after Covid vaccination. Dose #1 2/24/2021 Dose #2 3/31/2021. C/O fever, chills, cough, wheezing, SOA, and chest pain/ onset 9/10/2021
Searing nerve pain, mostly in both legs; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), asthma and RBBB (right bundle branch block). The patient had a history of allergy to Phenergan. Concomitant medications included calcium levomefolate; drospirenone; ethinylestradiol betadex clathrate (SAFYRAL) and bupropion hydrochloride (WELLBUTRIN), both for unknown 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 COVID-19 vaccine. On 25Mar2021 at 03:30, the patient had experienced searing nerve pain, mostly in both legs. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event searing nerve pain, mostly in both legs was resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
I started that night I got vaccinated, my shoulders were swollen, and it felt Huge, the next morning I had the Flu symptoms for the first 3 days.  Body ache, chills, cramping, low grade fever.
1 day p/vax pt devel an inj site rxn characterized by redness & warmth;this is 1 of 2 pt from this  site to devel an inj site rxn p/vax w/lot# 4978148
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, ASCORBIC ACID (VITAMIN C ACID), CALCIUM and LISINOPRIL for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any treatment medication.   This case was linked to MOD-2021-022461 (Patient Link).
full blown varicella rash, +varicella antigen.  Saw Grandma 8 days earlier and she had shingles.
arm pain; malaise; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 11Feb2021, as single dose for COVID-19 immunisation, at Workplace clinic. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. On 12Feb2021, the patient experienced arm pain and malaise. No treatment was received for the events. Patient was not diagnosed with COVID prior vaccination. Patient has not been tested for COVID post vaccination. Outcome of the events was reported as not recovered.  Information on Lot/Batch number has been requested.
About one hour after getting the shot, my arm started to throb, and it was difficult to move it. Later in the day, I ate a normal dinner and went to bed. About 2:00 a.m. the following morning, I woke up, extremely cold and shivering. My teeth were chattering. I had a terrible headache, and took an ALEVE.  I doubled-up the blankets, and after I went back to sleep, I woke up later very hot and removing the blankets. The next morning, and all of that next day, I didn't feel well. I ate some chicken soup to settle my stomach, and had a bland dinner. I did feel better the next day.
The day following her 2nd shingles vaccination, patient reported experiencing a slight fever as well as redness/tenderness (about the size of a baseball) located BELOW the injection site. Patient (a retired nurse) insisted on applying pressure to the injection site by pressing on the cotton ball and rubbing it in circles because she felt this would better distribute it into her muscle following the vaccination. She did not treat the symptoms with a pain reliever or ice.
p/vax pt broke out w/varicella pt seen on 6/14/99 w/100 lesions (some vesicles & some crusted;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/06/21 pfizer,Lot#EL3246 2nd dose: 01/27/21Pfizer,Lot# EL9262 Diagnosed covid positive:08/09/21 Symptom onset:08/09/21 Exposure:Home Symptoms:sorethroat
noticeable bump, the redness is spreading (small to expanded area), its hot to the touch and this AM a rash and itchiness
Throw up (8/9 times 10 - 12 hours), Diarrhea (3 days), 1 - 2 degree temperature increase, worn out  2 days and very tired the next 2 days. No Treatment except liquid. After 4 days starting to feel normal.
7/01/2022 I had a hernia developing and the doctor began monitoring it. Basically, I am in a holding pattern and still monitoring. The doctor did not seem too concerned.
last time i got the flu shot, i got the flu; Initial information received on 01-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who reported last time i got the flu shot, i got the flu after receiving vaccine Influenza Vaccine.  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 dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, expiry date, dose, form not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient reported last time i got the flu shot, i got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It was reported "Never got the flu shot since then and I haven't had the flu since then!"  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
A couple days after my shot I started to develop a loud ringing in my ears, about five or six times a day. The volume of the ringing has decreased, but now it's a constant low ANNOYING hum.  It's been about three weeks, and I'm very worried about getting my second shot now, there was a HUGE forum about people who have had this reaction and had the second shot aggrevate it further.  https://www.drugdiscoverytrends.com/tinnitus-reports-grow-amid-covid-19-vaccinations/#:~:text=The%20U.S.%20Vaccine%20Adverse%20Event,(loss%20of%20hearing%20acuity).  Which I know, it's a forum, but still scary.
Moderate headache that lasted 2 days. Starting 5 days later, started to develop a burning sensation in my right armpit. By 4-28-2021, several clusters of sensitive and itchy red bumps appeared in my right armpit, on the back of my right shoulder, and right pectoral. Symptoms persist as of today, waiting to be seen by a doctor. It appears like shingles. I have had chicken pox as a child, and have not ever had shingles or the shingles vaccine.
I got my shot on March 5 and on March 9 I woke-up with super bad headache and vomited many times the morning of the 9th. My headache pain was an 8 out of 10 from March 9 to March 11 and remained super nauseous. I got some anti nauseous medicine from the doctor. On March 12, I woke-up perfectly well. This headache and nauseousness felt like my usual reaction to soybean ingestion. I normally have a delayed reaction when I ingest soy bean. Normally, if I ingest soybean, i react 7-12 hours later. I am positive that I did not have any soybean before or after my vaccination.
Information has been received from a physician concerning a 17 year old female with no relevant medical history who on 21-APR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). There was no concomitant medication. On approximately 21-MAY-2008, also reported as 1 month after the first dose was given, the patient experienced myalgia and arthralgia. The patient's myalgia and arthralgia persisted. No other doses have been given yet. Additional information has been requested.
Patient presented to hospital with vomiting. Initial bloodwork showed lactate of 8.5, WBC 13K, Mg 1.2.
Patient describes extreme arm soreness and radiating pain to elbow occasionally when using the arm.   The pain has persisted since the day after the vaccination till now, approximately 60 days post vaccination. Patient complains that arm is still sore when she rolls over on it at night.  Patient denies any redness, swelling, infection of arm.
A swollen nymph node appeared at the base of the neck on the left side at the collar bone. First notice, about the size of a lima bean. Node was monitored for stiffness or unusual pain, and over time, the node began shrinking to the size of an english pea, and then to the size of a black-eyed pea. During pre-screening for the second dose, patient was cleared to receive the dose, but advised to continue monitoring, and report any changes. Since the second vaccination, the node has returned to the size of a lima bean, with soreness. Now the soreness has reduced, and the node is still able to move around when probed.
Both the 17 yr- old patient and mother received the FLUCELVAX vaccine, that was administered by the pharmacist (me).  After leaving vaccination room (both the parent and 17-yr old patient), within 2 mins the patient indicated to mother that she was having trouble seeing, felt dizzy and needed to sit down. The mother got her safely to the chair, at this time the pharmacy tech noticed the patient needed assistance and alerted the pharmacist.  The pharmacist immediately went to the scene with EPI pen and ordered EMS on scene. The patient was conscious, able to talk and answer questions.  She did not have trouble breathing; therefore the EPI pen was not administered.   Patient was flushed, dizzy, indicated she had a rapid heart rate and blinking eyes as if to see better.   Patient continued to indicate she was not having trouble  breathing .  Pharmacist inquired about medications - patient is not currently taking medications.  when questioned by the pharmacist about what she ate recently, the Patient indicated that she did not eat breakfast and only had a potato yesterday.  EMS arrived on the scene and evaluated the patient and subsequently cleared the patient.
pt recv vax 5/29/98 & same day pt exp nausea, migraine, fever & achiness which subsided p/ 3 days;
Additional dose (0.5mL) was administered to patient who only qualified for Booster dose (0.25mL) due to confusion regarding new booster dose that was authorized the day prior.  Patient was notified the following  Monday (10/25/2021) of the dose mistake and reported that she had felt very tired over the weekend but was currently feeling well..
Chills, several nights Fever: 100.4 3 days Rash on arm (left)  Swollen glands on left side if body since vaccine Headache
Fever, nausea, chills, Tylenol and asprin, better after 2 days
Increased redness and swelling at injection site  on day 2, itching beginning on day 7-8, with redness increasing to entire upper arm including red raised ring at the perimeter.  Began Benadryl treatment on day 14 and symptoms began to subside.
I was feeling under the weather on 11/27/2021 so I went to a clinics and saw nurse practitioner because I was experiencing cold like symptoms with draining in my throat. I received a B12 shot and something to stop drainage around Holiday then at the end of December I saw another MD in the same clinic around the Holiday got eye drops and an antibiotic which subsided for a week or so. Then in January I start having the same symptoms and saw NP again, she said that this may be an allergy and I needed to see a specialist but she did prescribed some antibiotics and then when I saw the specialist he prescribed a stronger antibiotic and said if it does not go away in a week I will give you another prescribed antibiotic so at the end on March.
Sudden onset Parotid Gland swelling, Initial selling on 2/6/21 mostly  resolved then a prolonged period of swelling lasting 3 weeks starting on 4/2/21
Fever (around 100.5 degrees) and body aches on and off all day. Sweated all night but woke up running only 1 degree hotter than normal. Splitting headache for a few hours in morning, which went away with Tylenol. Soreness in left arm.
Fatigue; Weakness; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia and cataract. Concomitant products included fluticasone propionate (Fluticasone Nasal Spray).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue and weakness. On an unknown date, the outcome of the fatigue and weakness were recovered/resolved.   It was unknown if the reporter considered the fatigue and weakness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022106747   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comments: The reporter was patient. The reporter stated that approximately 2 years ago patient received first dose of Shingrix. The reporter stated that after receiving Shingrix vaccine Patient experienced weakness and fatigue. The duration of weakness and fatigue was reported as one week. The patient received Fluticasone Sensimist Nasal Spray as a concomitant product. The reporter consented to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022106747 In the source document Fluticasone Sensimist Nasal Spray given which was not avalable in dictionary hence captured as Fluticasone nasal spray as concomitant drug.; Sender's Comments:  US-GSK-US2022106747:Same case/same reporter
Pfizer-BioNTech COVID-19 Vaccine EUA. Itching and redness on the chest, back and side