chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received the diluent containing DTaP-IPV and not the Act HIB component of Pentacel; Initial information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 2 months old female patient who was vaccinated with 0.5 mL of diluent containing DTaP-IPV and not the Act HIB component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency once) (DTaP-IPV diluent U6327AA expiry 19-Sep-2020 and HIB powder lot UJ097AA expiry 19-Sep-2020) via intramuscular in the left leg on 05-Apr-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the patient received DTaP-IPV, but not the ActHIB.   Treatment Act HIB would be administered separately.  It was not reported that the patient had any adverse event or not.  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.
Information has been received from a pharmacist concerning a 68 year old female with no pertinent medical history or drug allergies who on 13-NOV-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 14-NOV-2007 the patient developed an itchy spot that was about 2.5 x 2.5 inches. The patient sought medical attention by contacting the pharmacist. No labs or diagnostic studies were performed. The patient was treated with diphenhydramine HCl (BENADRYL) capsules and hydrocortisone (CORTISONE) ointment to help relieve the symptom. The itching was a little less but did not go away. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Chills started 4 pm, uncontrollable by 8 pm. Temperature not checked until 10 pm, temp was 101.4.  Chills continued even while under enormous piles of blankets, coats, hot water bottles until temp peaked at 102.4.  Fever lasted 24 hours. Fatigue lasted through fourth day after shot. Took 3-4 hour naps each day.  I could not work. Level 3 fever, Level 3 chills, Level 3 fatigue.
severe headache, dizziness, bronchial chest pain, extreme fatigue, weakness, body pain
Shingles to right neck, ear, back of head on right side.; This is a spontaneous report from a contactable consumer. A 73-years-old non-pregnant female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 14:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diverticulosis, HTN, hypothyroidism, arthritis pain lower back from an unknown date and unknown if ongoing. Patient had allergy to adhesives tape. Concomitant medications included duloxetine (DULOXETINE), colecalciferol (VIT D3), cyanocobalamin (VIT B12), levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took celebrex and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Apr2021 patient experienced shingles to right neck, ear, back of head on right side. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment with Valtrex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch cannot be obtained. No further in-formation is expected.
During routine COMPREHENSIVE METABOLIC PANEL on 04/06/2021 due to treatment with NASID and Infliximab treatments for ANKYLOSING SPONDYLITIS a sudden drop in KIDNEY FUNCTION from EFGR >60 mL/min/1.73 to 41 mL/min/1.73 was noted. Subsequent tests have shown marked loss of KIDNEY FUNCTION to most recent low of 28 mL/min/1.73. In addition CBC indication for RBC (3.92) Hemoglobin (11.4) and Hematocrit (33.5) have all moved below minimal standards. No other procedures or changes in medication occurred during this period.
Headache presented soon after dose. Tiredness presented soon after dose. Headache worsened through night. 99.9° fever presented ~8 hours after vaccine. Intermittent coughing presented ~10 hours after vaccine. 103.5° fever presented ~10 hours after vaccine. Intense chills presented ~10 hours after vaccine. Nausea presented ~12 hours after vaccine.
Pt recv vax on 10/13/97; on 10/15/97 pt exp little red blisters on upper arm to armpit; tx=Caladryl
No adverse event 17 year old was given vaccine not yet FDA approved. Delay in receiving #2 vaccine
pt recvd flu vax & 2 days later presented w/jaundice & was hospitalized for workup of poss cholestasis;PT underwent liver biopsy, but results are unk;
Information has been received from a physician concerning a female teenager who was vaccinated IM with a first dose of Gardisil. The patient "passed out" when she received the injection. The physician is planning to give the doses as recommended. Unspecified medical attention was sought. Shortly after vaccination, the patient recovered. No product quality complaint was involved. Additional information is not expected.
A report was received from  a health care professional on 11/21/2002 concerning eleven vaccinees between the ages of 56-64 years who were inadvertently administered 1ml Fluvirin on an unreported date. On an unreported date eleven vaccinees were inadvertently administered 1ml Fluvirin. No adverse reaction was reported. There was insufficient information to determine the reporters causality assessment. Update1. 12/31/2002: A follow up report was received form a health care professional indicated that a 81 year old female vaccinee was inadvertently administered 1ml Fluvirin on 11/21/2003. Cross Reference with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200900, PJP200200899, PJP200200898, PJP200200907.
Developed severe, widespread urticaria and angioedema of her face and hands. This started approximately 20 hours after receiving the vaccine (and starting zithromax) and lasted about 3 days.
Irregular menstrual period; This is a spontaneous report from a contactable consumer (patient). This 38-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. With the first dose of the vaccine she started experiencing an irregular menstrual period. The outcome of event was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377753 the same patient and product, different doses and partial similar adverse events
sore arm. Fever 103.8,  head ache, body aches, lightheadedness
About an hour or so after I started experiencing stomach cramping and then nausea.  I also got the chills. I laid down and 3 hours later I felt better. My arm is sore, but so far it hurts less than my covid vaccine shot.
Fever or Chills  Cough  Fatigue  Headache  New loss of taste or smell  Sore throat  Congestion or running nose  Nausea or vomiting
Patient is a 92 y.o. male who presented to the Hospital ED from home on 12/29/2022 after caretakers observed new confusion and fevers up to 102 °F.  In the ED he was found to be in new onset atrial fibrillation with RVR and positive for SARS-CoV-2. He was admitted with additional concern for aspiration pneumonitis related to a known Zenker's diverticulum. Clinical course complicated by encephalopathy, dysphagia, and ongoing hypoxia.   Pt and family opted for no NG/PEG tube placement and likely moving towards more comfort care.    Pt w/ clinically worsening despite aggressive interventions. Family met w/ Palliative care and comfortable w/ moving forward w/ comfort care and Hospice referral. Comfort meds in place.   Pt passed peacefully on 1/16 @0542
Information has been received from a pharmacist employee concerning a female who was vaccinated with a single dose of ZOSTAVAX0.65ML, Intramuscularly. The reporter heard of a patient who on an unknown date developed Cellulitis in the arm opposite of the arm that she received the ZOSTAVAX. Additional information has been requested.
Significant local reaction to DTaP. Dense raised red rash surrounding injection site extending up shoulder and scapula and to the elbow (onset eve day after injection) (seen by doctor). Treated with Keflex 500mg BID x 10 days.
Immediately upon vaccination, within about 30 seconds, I developed tight muscles around my jaw, facial areas (temples) , neck and trapezius with some headache symptoms. Tight fascia on head. I discussed with my MD and he suggested conservative management. Symptoms are still present today.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, the mother of a male patient, who received a fourth dose of Prevnar on an unspecified date. Also, on an unspecified date, the child developed autism. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified ate, the child received a fourth dose of Prevnar. Also, on an unspecified date, the child developed autism. The patient's outcome is unknown. The reporter declined to provide any further information in order to conduct follow up.
Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-APR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-OCT-2016, the patient was treated at an urgent care center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
While sleeping had heart attack, seizure, went into cardiac arrest.  No warning signs and did not have a previous heart condition.   CPR was performed, shocked four times at home once in ER and placed on a ventilator.  Catheterization procedure performed, full blockage of the right coronary artery received two stents. After surgery was in ICU on a ventilator for three days then  went to step down unit for two days.  Now being treated by cardiologist, pulmonologist, neurologist and primary care physcian.
Patient received vaccine on Friday afternoon. Developed injection site redness, swelling, warmth. Later that day she had a fever of 102F at home. Called the after-hours hotline and was referred to the ED.  She went to the ED on 2/4 with localized band-like erythema (about 4 cm wide) across upper arm around site of injection, swelling, warmth. Prescribed hydroxyzine 50mg four times daily, cool compresses, and tylenol as needed.  Symptoms improved and upon re-evaluation in AM clinic on 2/6, redness and swelling resolved with post-inflammatory light hyperpigmentation present.
bilateral subsegmental PTEs; right flank pain under ribs; This is a spontaneous report received from a contactable HCP.  A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0153), via an unknown route, on 30Apr2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation, administered at Pharmacy/drug store. The patient was not diagnosed with COVID-19 before vaccination. Relevant medical history included hypertension (HTN), gout and osteochondritis dissecans (OCD). No relevant concomitant medications were provided. The patient did not have allergies. No other vaccine was received in four weeks. The patient presented to the emergency room (ER) with right flank pain under ribs. Found to have bilateral subsegmental pulmonary thromboembolisms (PTEs). The onset date of the events was provided as 20May2021. Both events were reported serious because requiring hospitalization for 3 days (admission date not provided) and as life-threatening conditions. The patient was treated with enoxaparin then apixaban. Nasal swab was done on 21May2021 and resulted negative. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EW0172) on 21May2021 for COVID-19 immunisation. The patient was treated with enoxaparin then apixaban. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of all reported events cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Swelling, palpable lump at injection site - redness, warm to the touch. Ice/ibuprofen being used.
Since vaccination I did a lab test which found protein in my urine. Pain around kidney area and urine is foggy.
Narrative:  81yo male patient with the following: -Atherosclerotic heart disease of native coronary artery without angina pectoris -Nonrheumatic aortic (valve) stenosis -Chronic obstructive pulmonary disease, unspecified -Obstructive sleep apnea (adult) (pediatric) (ICD-10-CM G47.33) -Unspecified hearing loss, unspecified ear (ICD-10-CM H91.90) -Obesity, unspecified -Low Back Pain -prostate cancer Pt received covid vaccines on 1/7/21 & 2/25/21 at outside provider. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Started with underarm/side of body swelling and pain to touch on side I was vaccinated on, on 1/23. Progressed to full body soreness and swelling. Some burning to touch on underarm skin. Symptoms subsided by 1/28
Developed major gluten allergy after vaccination.  ONLY known precipitating factor for development of gluten allergy at 55 years oif age.  Quite sure the immune stimulation from vaccination activated a latent propensity to gluten allergy.
ache; SORENESS; HAEMATOMA; nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (ache), ARTHRALGIA (SORENESS), HAEMATOMA (HAEMATOMA), HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A / 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced HEADACHE (headache). On 15-Feb-2021, the patient experienced NAUSEA (nausea). On 16-Feb-2021, the patient experienced PAIN (ache), ARTHRALGIA (SORENESS) and HAEMATOMA (HAEMATOMA). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (ache), ARTHRALGIA (SORENESS), HAEMATOMA (HAEMATOMA), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator.    The patient is on blood thinner.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Email response from  the consumer.
c/o hives on back, arms & rt cheek; hx noticed by sister 3PM today; itching;; erythemous splotchy hives, tearful; no SOB, no resp distress; weepy for exam, skin large patchy hives, dx urticaria;
HPV .5ml IM Rt deltoid/5 sec after injection at 1157. Pt became limp, lethargic NSQ pull code button & call for help. Staff MD arrive to assist. Nurse and asses patient.
R arm swelling/erythema, tenderness, upper arm circumf x 2cm.
30 hrs after vaccination, pt had sudden onset of severe nausea, anxiety, and dizziness.  The dizzines persisted up to the time of reporting.
Throat swelling, itchy tounge and lips, difficulty breathing, dizziness, full body hives, vision difficulty, hospital visit
Patient has been unable to take a deep breath - has sensation of dizziness - has sensation of fainting
Initial report received from healthcare professional on 09 December 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received ACT-HIB (lot number and expiration date were unknown) (route, site and dose number not reported) on an unknown date. On an unknown date, patient was administered ACTHIB with sterile water used. It was the opinion of our Medical Director that use of sterile water or 0.9% NS might lead to dissociation of the protein-polysaccharide conjugate. In the absence of clinical data showing that normal immunogenicity was retained using these diluents, we cannot support this practice. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
PATIENT RECVD FLU SHOT (FLUVIRIN-Sequirus) AND FEW MINUTES LATER HAD BLOOD DRAW TO CHECK POST IMMUNITY MMR TITERS. DURING BLOOD DRAW PATIENT BECAME UNRESPONSIVE FOR A FEW SECONDS AND THAN DEVELOPED SEIZURES FOR FEW SECONDS AND THEN RECOVERED. EMERGENCY RESPONSE WAS CALLED AND PATIENT WAS FOUND TO BE STABLE AND DISCHARGED. NO ED VISIT. FOLLOWED WITH PCP.
Chest tightness, wheezing due to shortness of breath, as well as itching, slight edema, and redness at injection site. This reaction occured appr. 10 minutes after injection whilst the patient was smoking a cigarette. Patient responded to the SOB with her VENTOLIN inhaler, which resolved her shortness of breath. After that she rested around the pharmacy for 1 hour before heading home and then took a BENADRYL (about 80 minutes after injection). Complete resolution of symptoms after 2 hours per patient.
Bilateral leg weakness, progressive arm weakness, weakness in jaw muscles, shortness of breath, deep tendon reflexes of +3 with negative Babinski sign, decreased peak flow.
This is a spontaneous report from a contactable consumer or other non-health care professional (patient) reporting for herself. A 68-year-old female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201, expiration date: unknown), via intramuscularly administered in left upper arm on 19Feb2021 07:30 AM (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient medical history included thyroid condition and blood pressure high. Patient declined to report concomitant medications saying she takes a bunch of medicine, is still taking her medications now and sees no change and that here are so many. The patient did not take prior Vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer suspect. On 20Feb2021, patient experienced soreness in shoulder, very sore, Itchy throat, and Sore throat. Patient reported soreness in shoulder, very sore, not the first day but the second day, 20Feb2021, and on the second day she had some kind of itchy throat and sore throat. It went away by the evening of 20Feb2021. She woke up with it on the 20Feb2021, used cough drops to soothe her throat. Patient used Ricola herb cough drops with expiration date 16Mar2023 and applied heat to her arm which helped. The outcome of all the events was recovered on 20Feb2021.  Follow-up attempts are completed. No further information is expected.
caller states the pt started having trouble talking and reading the next day after taking the vax.  He wasnt able to put a sentence together.  Pt knew the word he wanted to use but couldnt get it out.  On 3/12/2021 is better w/ speaking but still struggling to read.  Pt has not been treated for his symptoms since he is out of town but will FU w/ PCP when he returns home.
Shoulder and arm pain that day which worsened over the next several days and has not resolved. Was seen by orthopedist in March and again today (November 22). MRI is being scheduled.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates since 29-SEP-2016, the patients were vaccinated with unspecified numbers of improperly stored doses of VARIVAX, (dose and route of administration were not provided; lot # M024681 and expiration date of 18-MAY-2018). It was also reported that the administered doses experienced a temperature excursion during 316 hours at a temperature of 9.9 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. A data logger issue was involved. No adverse events and no product quality complaint (PQC) were reported. Additional information has been requested.