chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had 2 seizures at nigh and 1 the next day; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had 2 seizures at nigh and 1 the next day) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy (Patient takes daily medication and has not had seizure in 6 or more).    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced SEIZURE (Had 2 seizures at nigh and 1 the next day) (seriousness criterion medically significant). On 31-Aug-2021, SEIZURE (Had 2 seizures at nigh and 1 the next day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  included daily seizure medication, unspecified. Treatment information was unknown.  Company Comment : This case concerns a 27-year-old, female patient with previous relevant medical history of Epilepsy, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 27-year-old, female patient with previous relevant medical history of Epilepsy, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.
A pt (age and sex unknown) received Tice BCG (indication and therapy dates unknown), and had subsequently experienced joint pain and nausea for approx 1 wk. The pt is afebrile. F/U information: Adverse events resolved.
exposed to a potential Covid-19 case in the post office; mild symptoms of Covid-19/exposed to a potential Covid-19 case in the post office; Sweaty; Clammy; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (mild symptoms of Covid-19, exposed to a potential Covid-19 case in the post office), HYPERHIDROSIS, COLD SWEAT, CLAMMY, and EXPOSURE TO SARS-COV-2 (exposed to a potential Covid-19 case in the post office) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0208L20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020, Situs inversus, and Surgery (for his peritonitis) in 1987.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 16-Sep-2021, the patient experienced SUSPECTED COVID-19 (mild symptoms of Covid-19, exposed to a potential Covid-19 case in the post office), HYPERHIDROSIS, COLD SWEAT, and CLAMMY. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to a potential Covid-19 case in the post office). At the time of the report, SUSPECTED COVID-19 (mild symptoms of Covid-19, exposed to a potential Covid-19 case in the post office), HYPERHIDROSIS, COLD SWEAT and CLAMMY outcome was unknown and EXPOSURE TO SARS-COV-2 (exposed to a potential Covid-19 case in the post office) had resolved.            No treatment medication was reported. No concomitant medication was reported. Patient medical history includes, he states that he that his organs are inverted. He thinks he is immunocompromised. This case concerns 68-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of suspected COVID-19. The event occurred approximately 6 months after the second dose of Spikevax. The re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of Spikevax is not affected by this report.
10/15/99:Pt. received vaccination.10/17:arm was sore and pt. did not feel well.10/19:pt. itching.10/21:rash started on arms and spread.10/24:rash worse.
This spontaneous report has been received from a registered nurse, referring to a vaccine RECOMBIVAX HB used for prophylaxis (there are not specific lot numbers, expiration dates and patients involved), who reported that the sections of :"dosage and administration" and "dosage forms and strengths" of the prescribing information for the vaccine are confusing, because the "dosage and administration" section does not clearly state the amount of vaccine contained in the 0.5 ml and 1 ml dosages, additionally the reporter stated that " it is difficult to differentiate between the 1 ml dialysis dosage and the 1 ml adult dosage, because there are two distinctly different doses and both contained in 1ml ". Additional information has been requested.
2 days after, lightheaded, weak, intermittent chest pain, blurry vision, shortness of breath next day headaches
PT REPORTED TICKLE IN THROAT, HEAVINESS IN THROAT.  NO OTHER SYMPTOMS.  HAD PT WAIT FOR 45 MINUTES.  REPORTED NO WORSENING.  OFFERED BENADRYL AND PT DECLINED.  AFTER TALKING WITH PT FOR SEVERAL MINUTES SHE DECIDED SHE WAS FINE TO LEAVE
I  went to a dental cleaning the morning of 09/28/2021 and endorsed ongoing gum bleeding over 3 hours after appointment which prompted me to return to the dentist for gauze/packingand compression to stop bleeding.  Presented to Hospital and was found to have severe thrombocytopenia.  In addition to bleeding, she also endorses increased bruising , bleeding with teeth brushing and blurry vision x 3 days.  Patient received her first Pfizer vaccine dose.  i never had a severe low platelet count like this in the past.   Treatment is  -start IVIG 1g/kg (60g) daily x 2 days -Status post dexamethasone 40mg today.  We will continue dexamethasone 40mg daily for total of 4 days - platelet transfusion unless patient develops new or worsening bleed. Discussed with APRN and RN -follow CBC w diff daily -monitor for signs of bleeding -Neutropenic precautions for ANC less than 1.00
tenderness at the shot site; very tired; This is a spontaneous report from contactable consumer(parent) reported for a 20-year-old male patient (reporter's son). A 20-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on (age at the time of vaccination 20-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not report any adverse events prior to vaccination. The caller was calling about the Pfizer COVID vaccine on behalf of her son. The patient was 20 years old and was extremely healthy. The patient was very strict on his health. The patient was a vegetarian, he was very health conscious. It was reported that after the first dose the patient had some tenderness at the shot site and felt very tired on an unspecified date. The patient underwent lab tests and procedures which included EKG: heart attack on 20May2021, troponin: elevated on 20May2021, troponin: elevated on 20May2021. Outcome of the event tenderness at the shot site was reported as recovering and other event outcome was unknown at this time of the report.   Information on the lot/batch number has been requested.
After administering the booster vaccination, the patient passed out and then regained consciousness and then passed out again. After she was alert, she was completely pale and lost color in her face and began to sweat. The ambulance was called.
Swollen at the injection site; Lump on Left Arm; Left arm was painful /it was painful to the touch/it more like a numb dull pain; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3246; Expiration Date 28Jan2021), via an unspecified route of administration in the left arm on 26Jan2021 12:15 (at the age of 78-years) as a single dose for COVID-19 immunization. There was a no medical history. The patient's concomitant medications were not reported. The patient received the vaccine on 26Jan2021 and in the evening her left arm was painful, she could not sleep on the arm. On 27Jan2021, before she took a bath, she still had the band aid on and it was still hurting a little, the area was swollen at the injection site, it was painful to the touch, she could feel a lump on the left arm, she still could not sleep on the arm. On 28Jan2021 the swelling went down and was still painful, but it was not a sharp pain, it more like a numb dull pain, she was calling to ask if that is normal. The patient treated herself with paracetamol (TYLENOL) prophylactically 2 hours prior to vaccination and on an unspecified date rubbed some alcohol on the injection site. The swelling was reported as just a little. The lump was completely gone but she still felt the dull pain. The clinical outcome of the event left arm was painful and swollen at the injection site was recovering; and lump on the left arm was recovered on 27Jan2021.
Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, leading to hospitalization for 3 days
Hives to Booster only, not to any previous vaccine. Prednisone and Zyrtec. Hives calmed but still persisting.
6/2/2000; Pt seen and examined and had rash on back, neck, stomach & arms spreading and itchy. Complaining of headache, abdominal pain, nausea & malaise. Diagnosed with several areas of vesicles and scratch marks. Official dx: Varicella.
Adverse events:  Constant pain and cramping in the gluteus maximus muscles, hamstrings and thighs that ranges from severe to excruciating and debilitating. Swelling and pressure in both legs which was diagnosed as Lymphedema fluid  Rash on both thighs, front and back  which was diagnosed as Livedoid pattern Pain is also present, but less severe and not constant, in the calves (sometimes stabbing pain, sometimes dull achy pain), left arm, neck, shoulders, hips and lower back. Body-wide muscle weakness Headaches which vary in intensity and frequency.  Sometimes sharp stabbing head pain, other times dull aching pain Difficulty thinking, concentrating and performing mental tasks Non refreshing sleep Severe fatigue  Body-wide muscle weakness Headaches which vary in intensity and frequency.  Sometimes sharp stabbing head pain, other times dull aching pain Difficulty thinking, concentrating and performing mental tasks Non refreshing sleep Severe fatigue Lightheaded Night sweats every night Difficulty breathing and shortness of breath for which the severity and frequency varies Cough with thick mucus output occurring one to four times a day. Hoarseness and laryngitis which occurs off and on Heart palpitations that occur off and on Gastrointestinal issues: stomach pain - almost constant, bloating - off and on, diarrhea - off and on.   Treatment:  I.V. treatments, doctor-prescribed supplements, acupuncture, physical therapy, muscle relaxants, Excedrin, yoga, exercise, Epsom salt baths and heat compresses.  As of this writing there is no treatment nor antidote available that I am aware of. Outcome:  Since the onset there has been improvement in the breathing problems and some improvement in the gastrointestinal issues.  The pain and cramping in the gluteus maximus muscles, hamstrings and thighs, the Lymphedema fluid buildup and the Livedoid rash on both thighs, front and back have gotten worse since the onset, and now seem to have stabilized.  The other symptoms listed remain unchanged.
Immunizations given approx. 9:35 am. Mom nursed infant before leaving office. Approx. 11:30 started getting fussy, but infant refused nursing, and was crying, but started " screaming" around 12:30, inconsolable X 2 hours, started calming down for only a minute or two at a time. Called the office at 2:30pm, instructed to give TYLENOL and put cold cloths on legs, and let us know in 20 min. if any better. Called back, stated no Better, instructed to come in. Arrived crying at 3:35 pm,  and settled with gentle rocking. Injection sites clear; legs seem uncomfortable to touch. 4:00 nursing well. Quiet and content. Instructed to use TYLENOL for pain symptoms if needed, per 4 hours. Left office with parents.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 2021, the patient experienced confirmed immunological vaccine failure.  Dr. had provided antibody test 4-6 weeks after receiving the Janssen COVID-19 vaccine of all office staff and immunosuppressed patients. This antibody test named as Quest. Laboratory data (dates unspecified) included: Quest antibody test (NR: not provided) NEGATIVE and showed 0 antibodies (negative test, healthy patient). The patient received the vaccination at the Stadium close to the place where the manufacturing blip occurred. MD told all of these patients to function as if they never got the vaccine at all. He suspected that those people got vaccines that were in prefilled syringes and kept out of the refrigerator for more than 2 hours, thus rendering them useless. He would like a medical director from JnJ to call  him to discuss this and have already called the CDC. According to MD patients who received Pfizer and Moderna produced strong results. Dr. had requested a medical director to reach out to him, directly regarding to those tests.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210545141-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a female physician assistant via a company representative referring to her father, a 66 year old male patient. The patient's concurrent condition and concomitant therapy were not provided. The historical therapy included PREVNAR 13 in November 2015, "one year ago". On 19-OCT-2016, two weeks ago, the patient was vaccinated with PNEUMOVAX 23 (dose, lot number and expiration date were unknown; route: injection) at the same time and in the same arm as an unspecified flu vaccine at an unspecified walk-in clinic. On an unknown date in 2016 after PNEUMOVAX 23 was administered, the patient experienced "local and systemic reactions". He experienced "fever, body aches, pains, swelling and chills". He also experienced "redness and warmth" near the injection site. The patient did not see medical attention. The patient present status was reported as "fine". No product quality complain (PQC). The causal relationship between PNEUMOVAX 23 and the events was unknown. Additional information has been requested.
No additional AE reported; expired VAQTA was administered to a patient; This spontaneous report was received from a registered nurse and immunization coordinator and refers to a 19 years old female patient. She had no illness at the time of vaccination. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 13-JAN-2021 (also reported as 11-JAN-2021, discrepant information), the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter, intramuscularly in the left deltoid, lot # S023220 was confirmed to be valid, expiration date was 20-OCT-2020 for prophylaxis. This vaccine had no prior temperature excursion. No additional adverse event reported.
5 MIN AFTER THE VACCINE, PT REPORTED: felt pain from the injection site, radiating down to L ankle, describes as overall throbbing except for L axilla which is more like a stabbing pain - then 5 min later, felt intermittent pain on R side;  about 5 min later had brief episode of neck pain & HA, which resolved spontaneously;  pt was observed for another 30 min (about 1 hour after the vaccine was given), and only felt pain at the injection site.
Patient experienced extremely swollen upper lip, general swelling around the face and body, and a red discoloration of her skin.
Complaint of chest pain with no other signs and symptoms.  Denied shortness of breathe.  Vitals assessed.  Patient became pale in color and continued to have chest pain.  Given Benadryl and sent to local clinic for evaluation.   Clinic reported additional services at local emergency room.  No additional health outcome diagnosed or treated.
I started to get  an earache in my left ear and I went to Urgent Care and I received a prescription for antibiotics. I went back the next day because I had severe pain in my mouth. I thought I had a toothache. I returned to the Urgent Care and they sent me to the Emergency Room. I was diagnosed with Shingles. I developed the rash on my face and in my left ear as well as in y mouth. It was very painful. I was prescribed some medication and some antiviral medication. It has been twelve weeks and I still have some discomfort in my mouth. I received the first dose of the Shingrix vaccine about eight weeks after the breakout. I have not had shingles before.
unable to sit up on my own to get out of bed for two days flu like symtpoms, lethargic, headache, diarrhea, extreme fatigue, difficult to catch my breath, painful arm, painful rash under my arm for 9 days in a square about three inches by two inches.  Black and blue and red at insertion needle point.
26Dec90 pt vax w/ MMR; 01Jan91 devel hard raised lump at base of neck.  4-5 days later devel 2 more lumps at base of neck. 1 lump sore for 2-1/2 weeks. 4th week lumps began to resolve + 5th week had resolved.
8/29/06, 15:09, pt called complaining of left deltoid swollen, redness and no axillary swelling. fatigue, arm pain, seizure, flu-like symptoms, nausea.
Patient received Moderna Covid Bivalent Booster dose 5 hours after expiration. Checked with manufacture and they do not have recommendations if to repeat dose or not-up to treating clinician. Clinician is aware of event and support organizations recommendation to repeat vaccination of bivalent booster.
p/vax exp marked swelling of lt arm inj site; red; mildly tender & very pruritic; tx: medrol dose pack;
Patient reported some swelling and chills, but chills were gone next day and it was only swelling at site of injection, so Pharmacist counseled patient to take some TYLENOL/ ADVIL to relieve pain and apply some ice pack to that site, and also patient reported that swelling getting better.
INDIVIDUAL RECEIVED 2 DOSE MODERNA SERIES WITH LAST DOSE ON 8/31/2021. RECEIVED TODAY'S DOSE AS A BOOSTER. THIS IS TOO EARLY.
Child received Hep A in office at 3pm.  Dr. received call at 0200 from mom stating that child was covered in hives.  Advised to give 1 tsp of Benadryl to ER if worse.  Mom called at 0850 child was fine.
This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. This report refers to 561 patients of an unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). On unknown dates, the patients experienced unspecified events which were reported as a life threatening events. At the time of this report, the outcome of the unspecified adverse events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.
This spontaneous report was received from a nurse practitioner refers to a 69 year old male patient. The patient has DARVON allergy, coronary artery disease, hypertension, depression, benign prostatic hyperplasia, osteoarthritis, lumbar stenosis and ZOCOR allergy. On 22-JAN-2013, the patient was vaccinated with a dose of live ZOSTAVAX, (lot number, expiration date and route was not reported). Concomitant medications included LIPITOR, PROSCAR, COZAAR, acetaminophen, LORCET, atenolol, aspirin, temazepam, bupropion hydrochloride, RAPAFLO and VIAGRA. On 22-JAN-2013, the patient received live ZOSTAVAX, from a local pharmacy and developed shingles. On 24-JAN-2013, the patient experienced severe right hip pain. On 29-JAN-2013, the patient developed a rash that looked like clusters. It had a dermatomal pattern that was on his right inner leg. There was also a rash on his right buttock. Treatment rendered for the events were VALTREX and PERCOCET. There were no laboratory diagnostics performed. The outcome of the events were reported as not recovered. The patient sought medical attention (office visit). Additional information has been requested.
REDNESS AND SWELLING TO INJECTION SITE, THEN GOT AXILLARY TENDERNESS
no adverse event; A patient was inadvertently administered an expired dose of M-M-R II.; This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.    On 02-MAY-2019, the patient was inadvertently administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), lot # N013296 and expiration date 28-APR-2019 (expired product administered) for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with diluent MRK, lot # N027783 and expiration date 17-NOV-2019. No adverse effect reported. The outcome of the event expired product administered was not reported.
A dose of COVID vaccine was wasted due to a separation of the syringe from the needle while the dose was being administered to the client.  After the needle was introduced into the patient, and as pressure was applied to the plunger the needle separated from the syringe (staying in the client?s arm) and the vaccine dripped onto the client?s arm, leg, and couch; client had to receive a second dose on opposite arm. Supply adverse event has been reported on supply kits provided to form 3500.
Pt awoke with redness, swelling and warmth of the arm where injection was given. Had fevers and chills that same night. No temp. taken.
Here in our office for her annual exam 3 days ago.  Received Tdap and MCV.  That night started with fever up to 103. Gets emotional, not herself when febrile.  Sore throat and postnasal drip.
In right arm (injection arm) slight neuropathy extending to by fingers.  Side effect started day of injection.  Side effect still evident as of time date of this report (March 15, 2021).
symptoms of dizzyness  started 3 weeks after receiving 2nd COVID vaccine and were occurring daily at the point she was seen in office on June 18, 2021 Instructions were given to increase hydration and salt intake, consider if symptoms could be related to oral contraceptive use;