chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around approximately 8:30 started having rigors, muscle aches, headache, and chills. Then at approximately 12:00 am worsening symptoms of rigors, muscle aches, headache, and chills. New onset of nausea, vomiting, diarrhea, sweating, fever of 103 degrees fahrenheit, SOB, racing heart, and fatigue. Multiple episodes of vomiting and diarrhea from 12:00 am until 4:30 am. Unable to tolerate anything by mouth. Mouth dry, lips dry, and limited urine output. At approximately 5:00 am client admitted to ER. Client received 2 liter's of fluid and IV Reglan. Labs draw and elevated WBC noted but all other labs within normal limits. Blood glucose elevated at 237. Client administered insulin via insulin pump per physician request. Client has history of insulin dependent type one diabetes. Client discharged to home at approximately 8:00 am. Prescription given for oral Reglan and to return to work after 01/24/2021.
CHILLS; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 190 pounds, and height was 74 inches. The patient's concurrent conditions included no alcohol, and non smoker, and other pre-existing medical conditions included no known allergies no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042a1a, and batch number: 042A1A expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 21:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-APR-2021 03:00. This report was non-serious.
A report has been received from a Pharmacist concerning a 60 year old, female subject, who had been receiving QLAIV (intranasal), 0.1mL into each nostril. FLUMIST QUADRIVALENT (intranasal) started on 23-Oct-2014. It was reported that pharmacist dispensed the FLUMIST vaccine to the wrong patient population which started on 23-Oct-2014. The outcome of the event of wrongful administration is unknown. The report was considered to be non-serious. The reporter and company physician considered that there was no causal relationship between wrongful administration and QLAIV.
Patient complains of redness, localized swelling, and pain at injection site that has persisted for 3 days.
Redness, swelling and induration of L upper arm. Approximately 4 inches X 4 inches. Has double in size over last 24 hrs. Vaccine given 48 hrs ago (approx).
administered an expired PENTACEL to a patient (with no reported adverse event); Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 6 weeks old female patient who was administered an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine for prophylactic vaccination; pneumococcal vaccine for prophylactic vaccination; and hepatitis B vaccine for Prophylactic vaccination.  On 28-Sep-2023, the patient received a Standard expired dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 mL total (lot UJ754AB, expiry date- 26-SEP-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Rash, conjunctivitis os, joint pain, neuralgia; states had rubella vax p/birth of first child 18yrs ago;
auto immune pancreatitis; IGG4 shot up to 280; my pancreas shut down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 73-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for Covid-19 immunization. The following information was reported: AUTOIMMUNE PANCREATITIS (medically significant), outcome "unknown", described as "auto immune pancreatitis"; IMMUNOGLOBULINS INCREASED (non-serious), outcome "unknown", described as "IGG4 shot up to 280"; PANCREATIC DISORDER (non-serious), outcome "unknown", described as "my pancreas shut down". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin G: my IGG4 shot up to 280, notes: develop Auto immune pancreatitis (AIP) and my IGG4 shot up to 280 after the third shot i was sick for a very long time. Therapeutic measures were taken as a result of autoimmune pancreatitis, immunoglobulins increased, pancreatic disorder. Clinical information: After taking 3rd shot of Pfizer vaccine (1st booster), patient developed Auto immune pancreatitis (AIP) and IGG4 shot up to 280 after the third shot, patient was sick for a very long time, patient never was diabetic, patient's pancreas shut down and now have to take Creon which is very expensive forever.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
sore arm in the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (sore arm in the injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm in the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   concominant treaments were not provided , lab data and past history, allergises were not provided.  Benadryl was given as a treatment drug
Patient got two vaccines this day.  The HEPLISAV-B vaccine was given first without any issues, but when Havrix was given, patient looked over and after seeing some blood come out from injection site, he started to lean away from me and closed his eyes.  He was out for about 20 seconds.  His mom was there at the time and said that he usually has that type of reaction when he gets his blood drawn.  After waking up, he asked if the shots where given and I said yes.  We also let him know that he fainted and was out for about 20 seconds. His mom went and got him some apple juice and had him sit at the pharmacy for about 10 minutes before they left.  I offered to call for medical attention, but they said they were fine and this is normal when he sees his own blood.
101-102 degree fever, shivers, full body aches, pain in arm at injection site, very painful headache for 2-3 days on and off, nauseous around 5am after receiving injection.
lump at injection site from first vaccine has not gone away; physically can't move his shoulder to the up position; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site from first vaccine has not gone away) and MUSCULOSKELETAL DISCOMFORT (physically can't move his shoulder to the up position) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE MASS (lump at injection site from first vaccine has not gone away) and MUSCULOSKELETAL DISCOMFORT (physically can't move his shoulder to the up position). At the time of the report, VACCINATION SITE MASS (lump at injection site from first vaccine has not gone away) and MUSCULOSKELETAL DISCOMFORT (physically can't move his shoulder to the up position) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
9:55 AM - Following administration of 3rd vaccine (Hepatitis A), client became pale, sweaty, put head back (was seated in chair) - near syncopal - no loss of consciousness. Nurse Practitioner applied sternal rub. Client laid down on exam table with feet elevated, cool compresses to head. Vitals: 94/60 (BP), 68 (pulse), 20 (respirations). By 10:00 AM was alert, oriented. At that time was given juice to drink - had not had anything to eat or drink prior to coming for vaccines. Had client wait additional 20 minutes. Had no further complaints. Client declined any further assistance - left the clinic at 10:20 AM.
little tired; sore shoulder/very sore shoulder/very mildly sore shoulder; mild headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 17Feb2021 at 08:30 (at the age of 40-year-old) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient medical history and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 at 07:30 (at the age of 40-year-old) as dose 1, single for COVID-19 immunisation Prior to the vaccination, the patient was not had COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that after 1st injection, the patient did not experience any side effects. After 2nd injection, on dame day (17Feb2021), the patient experienced a little tired, sore shoulder, mild headache. On day 2, a little tired, very sore shoulder, mild headache and on day 3, very mildly sore shoulder. The patient was not received any adverse events. The outcome of the events was reported as resolved on an unknown date.  Follow-up attempts completed. No further information expected.
5cm tender hot induration over major area of vaccinia immunization site. Had 4 days with right FLS x 24 hours (resolved) day of initial immunization 07/19/06.
NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (NO ADVERSE EVENT) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (NO ADVERSE EVENT) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    Concomitant product use was not provided by the reporter.  It was reported that Doses were administered after the 30-day BUD between 8 to 15-Jun-2023. 7 doses were administered, though the clinic was not open on the weekend, so no doses were administered during that weekend. All doses were given to adult patients. There were no reported symptoms or side effects.  Treatment information was not provided.  This case contains information about patient 2nd out of 7 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:(Master case Patient no-1)
Information has been received from a woman in a physician's office concerning a pt who on 16Aug96 was vaccinated with a dose of varicella virus vaccine live. On approx 19Jan06, two weeks ago, the pt developed chickenpox. No outcome was reported. The reporter also noted that the pt's sister experienced an adverse experience following vaccination (WAES0602USA00380). Additional information has been requested.
Patient was given 0.2 mL of Pfizer vaccine, lot FL2757, ages 5Y- <12Y on 8/24/22 at 3:00 PM. Medical Assistant who administered vaccine notified provider and office administrator at approximately 4:00 PM. Office Administrator and provider contacted Pfizer for further information regarding how to follow up on incident. Provider contacted the patient's mother  at 7:45 AM on 8/25/2022 and no adverse reactions were reported. Mother stated patient was doing "fine" and that "her arm doesn't even hurt."
(L) deltoid area 4 cm red, swollen, warm to touch, tx: symptomatic tx, f/u w/PCP in 48 hrs or sooner of fever or getting worse.
headache; body ache; chills; runny nose; sore throat; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself; occupation/specialty: hospital worker) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at 18:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that the paper works she had stated that the side effects would start within an hour, but in her case, she experienced side effects over 24 hours that's Friday on 01Jan2021, such as headache, body ache, chills, runny nose, sore throat, and diarrhea. She wanted to know if she was infected with Covid, because of her job or she was having side effects because of the vaccine. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Initially no complaints after injection of COVID vaccine (#1 of 2) and was released after 15-20 minutes of observation. Pt returned to clinic 1/2hr to 1hour later with c/o 1 diameter flat pink rash to R cheek, itching to body, tightness to R side of throat x3 brief episodes lasting seconds prior to returning to clinic and tingling to fingertips of L hand (reported tingling r/t anxiety; also has h/o neuropathy L hand). Pt kept for 1hr observation and was given 1 tab diphenhydramine 25mg x 1po. x3 status check stable prior to dc. VSS, aaox4, no sob, non duress, color pink, no difficulty breathing/swallowing, no swelling to mouth/tongue/thrt/other, CTAB A/P/
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a 39 year old female pt who experienced blood in her urine.  At 39 years of age, the pt received a dose on 12/15/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN). Pt was not taking concomitant therapy.  On 12/18/03, the pt had two occurrences of blood in her urine (blood urine).  She stated that when the Flumist was administered in her left nostril, it all came out as a stream (pharmaceutical product complaint) and "all drained down the throat and was swallowed."  When it was administered in the right nostril, it came out as a spray, but some of it drained down her throat.  She wanted to know if swallowing Flumist could cause blood in the urine.  The pt indicated that she did not have any blood in her urine on 12/19/03. She stated that she has scheduled an appointment to see her physician.  No additional information was available at the date of this report.
on the 17th had major pain running down my back of my neck and back as well as the backs of my legs and the backs of my arms.  (note: I have a very high pain tolerance... but a low tolerance for medications)  This reaction was very very painful ....  took me about 3 days to get back to normal but the pain in my arms caused some numbing of my fingers for a while and it took a week or so to feel back to normal.  (recovered from this fully) Also server migraines seem to be occurring more frequently than before (once every 3-6 months before) now seems to have more like every few weeks a nasty headache to a migraine ( had one so sever that I couldn't function for a day.... haven't had a reaction like that in many  years but also had other underlying trigger ... so the vaccine may have contributed but not the only factor)... still having issues with headaches/migraines
Pt received both vaccines on Friday, 7/29/22, at 3pm. In the car of the way home, mom noticed he started clearing his throat but he had no complaints. At home, within an hour of getting the vaccines, he looked pale per mom, developed hives on his face. The hives quickly spread to all over. Mom gave an adult dose of Benadryl and the hives "quickly resolved" per mom. He continued to have fatigue and achiness for >24 hours. Mom called and spoke with a nurse at our office on Saturday, 7/30/22, at 10am. Symptoms had resolved other than the fatigue and achiness. The nurse advised they watch him and set up appt with physician to discuss plan for vaccines moving forward. Pt saw Dr  on Wednesday, 8/3/22. All symptoms had resolved. Pt has a hx of anaphylactic reaction after 4yr old vaccines. He saw Hospital allergist after that and they felt it was the pertussis he had reacted to and advised not getting any further doses. Dr did an exam but no further testing. Advised they get another appt with allergist again for eval and advice on vaccines moving forward. Dr also advised no further vaccines until he sees allergist.
Sore arm, area of injection is raised, warm, and red (even after 48 hours); flareup of fibromyalgia symptoms (approximately 36 hours), chills - couldn't get warm but no fever (began about 9 hours after injection and continued approximately 18 hours. Fatigue still lingering, and a sense of depression.
Pt reports newly noted tremor first noted 1 week after vaccination with the Moderna vaccine while doing activities which required fine motor skills (playing blocks with his child). He notes that following the immunization, he felt that his muscles were tense and slow to relax for a few days following the immunization.
Patient had sudden cardiac arrest; currently on a ventilator with very poor prognosis 3/11/21;  1st COVID vaccine given 3/2/21
Day after I experienced Arm pain and stiffness.  2nd day after the arm pain and stiffness was combined with a large red area that is warm to the touch--temperature at redness/shot area was 99 degrees versus my body at 98.2.
Pt. had dizziness, light headed and rapid heart beat. Pt. blood pressure was elevated and pt. had to pick her up. She was given rest and water. Ambulance offered but pt. refused - pt. did not have any known indications from.
Preface: I have taken all the vaccines in the past, including all flu, all covid (including bivalent), meningitis, and pneumoccal, and DPT) and never any adverse reaction at all, other than very mild discomfort in the arm that the vaccine was given  - so I am just pointing out that i have no problem w vaccines and am not reticent to get them. Onset of symptoms: around 430 pm, my arm started hurting a bit; by 600 pm or 630, i had pain in my leg muscles, my left arm, and felt a bit feverish and had slight chills. So, so far no big deal. But by 800 pm, I was definitely sicker than w any other vaccine: fever, chills, aches and pains, nausea, light headed, pain in leg and arm muscles, etc. I went to bed. When I woke up at 1:00 AM (now 5/20/23), i got up to go to the bathroom and was extremely nauseous, clammy skin, sweating - my clothes were soaking wet, and dizzy. I fainted and was too sick to even touch my phone numbers to dial EMS. I was so dizzy, nauseous, and clammy, sweating, etc, that I could not move for a half an hour. At 130 am on my cell phone time, I was finally able to move my fingers and call EMS.  I also walked very carefully to my bed. Once lying down in my bed, I could not get up or move w out feeling waves of nausea and dizziness. When the EMT's arrived, after 2 AM, they would only take me to a hospital that I didn't want to go, so I ended up not going. The EMT's said my blood pressure was 47 systolic - I am sure of this (I have a PhD in cardiac electrophysiology and I know the higher number is systolic. My O2 saturation was 97, normal. My daughter, 29, came and watched over me. By 830 AM on 5/20/23, I went to Urgent Care. They gave me an EKG and nausea medicine. The EKG was apparently normal. My blood pressure was my normal BP of around 100/60 and my heart rate was 72.  By the afternoon of 5/20, I was able to eat bland saltine crackers and gingerale by the afternoon. Since the late afternoon of 5/20, I have not felt any ill effects, as far as I know.
This spontaneous prospective pregnancy report as received from registered nurse refers to a 24 year old female patient. Patient had no previous medical history. On 09-JUL-2014 the patient was vaccinated with VARIVAX 1 single shot subcutaneous injection lot # J012383 and expiry date 03-OCT-2015. No concomitant medications were reported. The nurse reported, before administration of (Oka/Merck) VARIVAX, the patient was asked if she was pregnant and said no. On the same day, a few hours after she receiving (Oka/Merck) VARIVAX, she took pregnancy test and was confirmed as pregnant. The patient became pregnant. The last menstrual date (LMP) and estimated delivery date (EDD) was unknown. The pregnancy outcome was outcome pending. No adverse effect was reported. Patient sought medical attention and no treatment was provided. The outcome of a few hours after receiving (Oka/Merck) VARIVAX, the patient called office stating she took a pregnancy test and she was pregnant and no adverse effect was unknown. Additional information has been requested.
Patient said that a day or so after her vaccination, she noticed a ring around her left arm.  It was about 3 inches wide and was above her elbow but below the vaccination site.  It was tender to the touch and itchy and lasted about 3 weeks before it resolved.