chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female patient with allergy to monosodium glutamate, who approximately in August 2012 ("about two months ago") was vaccinated with a dose of VARIVAX (merck) (dose, route and lot # not reported). It was reported that, in August 2012, the patient developed an allergic reaction. The nurse also reported that the patient became very sick (date not known) and was in bed for several days missing work, following the vaccination with VARIVAX (merck). The patient sought medical attention by contacting the office. At the time of the report, the patient's outcome was recovered (date unspecified). Patient's allergic reaction and becoming sick was considered disabling by the reporter (patient missed work). Additional information has been requested.
Site: Redness at Injection Site-Mild, Additional Details: redness localized on injection site
SEVERE ALLERGIC REACTION WITH SEVERE BREATHING DIFFICULTY, THROAT CLOSED FOR ALMOST A MINUTE, COULD NOT BREATH
This case was reported by a consumer via interactive digital media and described the occurrence of dysautonomia in a male patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 61 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced dysautonomia (serious criteria disability). On an unknown date, the outcome of the dysautonomia was unknown. It was unknown if the reporter considered the dysautonomia to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: Two months after receiving flu vaccine, the patient was diagnosed as having dysautonomia. He lost his 90K a year job and was permanently disabled, physically and mentally for life. The patient stated he wished he never got vaccinated.
Heavy bruising, heavy menstrual bleeding, purpura on scalp, chest and stomach. Approximately 2 weeks later from first signs of onset, I developed 30 plus large bruises over entire body, specifically legs. I went to the doctor and they did a CBC test and discovered my platelets were under 8000. I went to the ER and they immediately admitted me. My platelets were down to 5000 when I arrived at ER. I received a platelet transfusion and was able to be released 1 day later because platelets raised to approx. 20000. Was diagonsed with ITP, Immune thrombocytopenic purpura From 2013-Current;  I have undergone many treatments to remedy this reaction, including bone marrow biopsy, weekly intravenous treatments, steroid treatments, and medications. I currently have to take medication, Promacta 25mg daily to stabilize platelet counts. I will most likely have to be on this medication for the rest of my life. It is extremely costly and could have long term side effects that are unknown at this time.
The injection spot became red and rashes on right side torso; The injection spot became red and rashes on right side torso; This is a spontaneous report received from a contactable consumer (Patient reported for herself). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: 0165), via an unspecified route of administration, administered in Arm left on 28Apr2021 16:45 (at the age of 56 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not having any known allergies. The concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient was not tested for COVID-19. The patient was not pregnant at time of vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: 8729), via an unspecified route of administration, administered in Arm left on 07Apr2021 05:30 PM as dose 1, single for COVID-19 immunisation and experienced mild fever and tiredness, nausea and shingles appeared on right arm. On 30Apr2021 after second dose the patient experienced the injection spot became red and rashes on right side torso. The outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
mistook Ipol vial for Tubersol vial and administered 0.1ml Ipol ID rather than the prescribed Tubersol 0.1ml, no symptoms reported; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 years old male patient who was vaccinated with a 0.1 ml dose of IPV (VERO) [IPOL] (lot N1K931M and Exp. Date 18-Nov-2019) via intradermal route in the right arm on 08-May-2019 instead of TUBERCULIN TEST [TUBERSOL].   The patient's medical history not reported and concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunization.  It was an actual medication error case due to wrong vaccine administered.  No adverse event reported.  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 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.  List of documents held by sender: none.
I had no reaction until 9 days after injection. Then I developed itching and a red swelling at injection site.
Information has been received from a medical assistant concerning a 6 year old female with rash to KEFLEX and some other unspecified antibiotics who on 08-JAN-2009 was vaccinated with a second dose of MMR II (lot # not reported). It was reported that the patient was reportedly initially vaccinated against a first dose of "measles, mumps and rubella" on an earlier unspecified occasion prior to January 2009, at a different medical practice. It was unclear whether the earlier vaccination, for the first dose, was with MMR II or whether it might have involved the monovalent vaccines of ATTENUVAX, MUMPSVAX or MERUVAX. There was no concomitant medication. On 17-AUG-2010 the patient had a negative titer for mumps antibodies. The patient sought medical attention at the physician's office. Laboratory tests included measles, mumps and rubella titers. As of 17-AUG-2010, the patient's outcome was unknown. Additional information has been requested.
Numbness on left side of leg and left flank. Tingling throughout area. Within 3 weeks of my vaccine I was numb from my waist down on left side. Was able to see primary physician who ordered tests at the beginning of May. Admitted June 6, 2021 to the Hospital.  Diagnosed Transverse Myelitis with underlying MS. 43 year old female with no history of ANY illness. I believe the vaccine caused the Transverse Myelitis and MS.
Pt. became fussy at 7:00 PM. At 8:00 PM temp was 101.2. Parents called doctor. They gave him TYLENOL. Fever came down to normal. He slept all night, is pleasant and no fever on 9/21/10 - Per mother's statement.
Pt started to have pain and itching 4 days after vaccination. The following day the injection site became red and swollen . Pt used cold compress, antihistamine, and corticosteroid cream to self treat. Pt went to see physician and determined there was no infection and given prescription for ibuprofen.
Temp to 104. Hyperirritable x 1d no treatment, mother reported event on 12/16/10.
Afib (Atrial fibrillation); (Congestive Heart Failure) CHF; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US210550_OS .  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Afib (Atrial fibrillation)"; CARDIAC FAILURE CONGESTIVE (medically significant), outcome "unknown", described as "(Congestive Heart Failure) CHF".  Clinical course: It was reported that patient had the 2 Pfizer COVID vaccines then had atrial fibrillation and congestive heart failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 30 minutes numbness and tightening of left side of face and throat. After an hour a headache set on and then neck pain usually associated when my blood pressure goes high. Upon taking blood pressure 3 hours after vaccine. blood pressure registered 107/190. I felt nauseated with head ache.
Within a few hours I felt cold chills, then felt hot, then itchiness around my eyes, then finally a bad headache.  Went back to the and was observed for about an hour. Was directed by the doctor to go to ER to get further diagnose. The PA from said should be back at normal state and decided to put me on quarters for 2 days and prescribed me ibuprofen and Tylenol.
April 1st she received Johnson and Johnson vaccine  Lot # 043A21A  10:20am Left arm   0.5mg -----------side effects started around 5pm 103 fever  Shaking Terrible headache. Worst of her life.  Not able to sleep at all that night.  Next morning was better. Slept all day the next day 24 hour mark was feeling better.  Did not seek treatment, did not take anything over the counter.
Patient complained of lightheadedness, dizziness feeling hot. Patient noted to be clammy. BP 84/55, HR 76, RR 24, O2 sat 97%. Pt given bottled water and graham crackers and tolerated well.  BP 141/79, HR 85, RR 20, O2 sat 96%. Pt reported he felt improvement of symptoms and no longer clammy.
On 3SEP92 pt awoke 830AM mom noticed was limp & did not move-was crying but could not stand alone; mom states appeared dazed; mom took to MD pt was examined & given rx for Pediaprophen;
Patient complains of Chills and body aches.  Onset 1-4-2004.  Temp 100.6
Information has been received from a physician concerning a 41 year old Caucasian female who on 3/13/99 was vaccinated with 1 dose of Hep-B and subsequently, the pt developed intense swelling and arm numbness all the way down her arm. The pt sought unspecified medical treatment. It was noted that the pt's reaction lasted approx. 3 months. On an unspecified date, the pt recovered. No further information is available.
PT REPORTED SMALL RED PIN SIZED BUMPS ON FACE A COUPLE DAYS AFTER VACCINATION. DESCRIBED NO OTHER SYMPTOMS, AND NO PAIN OR HEAT FROM RED BUMPS.
Within 24 hours of injection induration developed over site.  Within 48 hours after inoculation fever developed.  Fever was uncontrolled with either tylenol or motrin. Range was between 100-102.4.  This fever lasted for 5 days.  Severe head ache, injected sclera and blanching rash also accompanied course of fever.  There is still some induration and a red discolleration of skin over injection site.  Over the course of the five days of fever I was seen by the clinic who first administered the immunization (given Bactrum to take at home), and two visits to an ED (given Keflex and Prochlorperazine Mal to take at home).  Additional medications were given to me at the ED through an IV but I am not sure what those medications were.
Client was accidentally given FluMist vaccine at age 50.  No adverse signs or symptoms have been reported to my knowledge.
no adverse effects were reported; one dose of expired PROQUAD was inadvertently administered to the patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-AUG-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin) (lot # R011801, expiration date 19-MAY-2019, route of administration was not reported) for prophylaxis. The reporter verified that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly through administration. No adverse effects were reported. The outcome of the events was unknown.
Within 8 hours of administration. Hysterics. Sobbing. Head banging. Hitting head with toys. Inconsolable. Screaming.
fever; nausea; could not get out of bed; body aches; very sore arm; A spontaneous report was received from a consumer, concerning a male patient of 63 age, who received Moderna's COVID-19 vaccine and experienced many side effects a very sore arm, 48 hours of nausea, he had muscle and body aches, a fever of 102.3F, and could not get out of bed for 3 days.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an 21Jan21, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On an unspecified date, after second dose of vaccine, the patient experienced ongoing very sore arm, 48 hours of nausea, he had muscle and body aches, a fever of 102.3F, and could not get out of bed for 3 days. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was unknown..
On the afternoon after the shot, I left the pharmacy I had a 45 min drive home and my arm was feeling with a dull pain - but so painful I was worried that I wasn't going to be able to drive home.  Dull pain began at injection site but spread to most of the arm.  Very fatigued on my drive home.  The next day I woke up and kinda had general malaise and felt really tired and cruddy.  Possible headache.
given an expired ACT-HIB to a patient  (with no reported adverse event); Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who was  given an expired HIB (PRP/T) vaccine [ACT-HIB] (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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); and pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for prophylactic vaccination (Immunisation).  On 18-Sep-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot UJ798AB expiry date: 11-sep-2023 via intramuscular route in Right Quad Muscle for immunization and given an expired act-hib to a patient  (with no reported adverse event) (expired product administered) on the same day following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event given an expired act-hib to a patient  (with no reported adverse 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.
This was the Fluad 65+ Quad PF 2021-22 0.5 ML injection.  Within 30 minutes of receiving the shot, my throat started to feel swollen and scratchy, raspy.  Had to start taking Bendadryl, Pepcid AC, for 24 hours.  (in comparison, last year in 2020 prior to start of taking Moderna vaccines, I was administered the Senior Fluzone shot with just normal reactions of sore arm, fatigue, red rash on arm. I did not experience any throat reaction to that in 2020).
Mom stated that patient has been fussy and that last night patient woke up crying/screaming and arching back. Mom giving tylenol to help with discomfort, advised mom keep an eye on patient today and if it happens again to come in and be seen in office. First two vaccine sets mom stated patient was fussy, but no other reactions.
This case was reported by a healthcare professional, via another manufacturer, and described the occurrence of stomach pain in a child subject of unspecified gender who was vaccinated with DTPa (with small D + P), manufacturer unspecified, Menactra. On an unspecified date, the subject received unspecified dose of DTPa (with small D + P) (unknown, unknown arm) and unspecified dose of Menactra (unknown, unknown arm). Two seconds after vaccination with DTPa (with small D + P) and Menactra in the same arm, the subject experienced sharp, burning stomach pain. According to the reporter, four other child subject's experienced the same event (sharp, burning stomach pain) two seconds after administration of DTPa (with small D + P)and Menactra in the same arm (see case id's A0887425A, A0887433A, A0887435A and A0887436A for the other child subjects reports). After the 5th patient complained, the vaccinations were administered in separate arms and there were no further adverse reactions. At the time of reporting the outcome of the event was unspecified.
Patient came back to pharmacy next day after shot complaining of sore arm, arm swelling, and redness around injection site. Patient has been using ibuprofen and cold compresses to help.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (racing of her heart/beating loudly) and FEELING ABNORMAL (felt like it was going to come out of her chest) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (racing of her heart/beating loudly) and FEELING ABNORMAL (felt like it was going to come out of her chest). At the time of the report, PALPITATIONS (racing of her heart/beating loudly) and FEELING ABNORMAL (felt like it was going to come out of her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Additional information received on 10-May-2021 contain no new information.
3/8 Red rash on the chest and abdominal area. Itching at groin and rectal area. Injection site looks fine. Took Allegra at 10 AM. 3/9 Called PCP to report. Continue Allegra until it disappears. 3/10  Saw Allergist/Immunologist Red rash continue on the chest and lower abdomen and both hands. Changed Allegra to Zyrtec. 3/12 Rash spread to legs, face and tongue.Rash on chest and ab area unchanged. MD classified the incident as Mild rash. Continue with same treatment. May increase Zyrtec 2x/day. 3/17 Rash gone but hyperpigmented areas on the affected areas. Continue with Zyrtec 3/18 Dicontinued Zyetec 3/21 Woke with face hot, red and feels tight. Rash seen on face. Eyes look swollen and  redness. Lymph
pt recv vax & fainted, pt was sitting on exam table & went back to lying position;BP 140/70, P60, & regular resp even & unlabored;skin arm & dry;pt opened eyes & lifted head p/10sec;pt alert & oriented;
A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a 30-month-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4387234-00.  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Aug2021 (Batch/Lot number: unknown) at 40 mg single (40 mg), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 04May2022, outcome "recovered" (May2022) and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective and suspected covid-19 are possibly related to the suspect BNT162b2.
Patient stopped by pharmacy on 5/03/18 and presented with swelling, tenderness, and redness at injection site.
Fever, nausea, emesis, general malaise, aches, cardiac arrhythmias.
Information has been received from a registered nurse concerning a "20 to 25% of female patients who were vaccinated intramuscularly (IM) with Gardasil. Subsequently, "in the past few months" (reported on 20-AU-2007), the patients had vasovagal reactions. The nurse reported that these patients were mostly in their teens and older. All patients were fine after about 10 minutes of lying down. The patient sought/received medical attention while in the office. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow-up it was reported by the registered nurse that she did not have an exact number of patients who had a vasovagal reaction. The office did not keep a list. The registered nurse listed the following Lot numbers related to the Gardasil vaccine and the vasovagal reactions; 657737/0522U, 658222/0927U and "03884".
Caller states she received her second vaccine dose of Pfizer, yesterday May 1, 2021 and started experiencing s/sx that night such as fever, runny nose, cough and swollen eyes. Caller states she woke up today and the swelling has not resolved. Advised caller to seek medical treatment so they can assess and advise her further