chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low platelets- 10k; This is a spontaneous report from a contactable physician. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at a single dose, for covid-19 immunization. Medical history included allergies: penicillins and, ICD-10 C24.1 ampulla of vater cancer. The patient's concomitant medications were not reported. The patient previously took levofloxacin and experienced allergies. It was unknown if the patient received other vaccines within four weeks. It was unknown if the patient had covid prior vaccination. The patient developed low platelets- 10k on 19Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone 20mg as treatment. The outcome of the event was unknown. It was unknown if the patient was covid-tested post-vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the event platelet count decreased cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Friday, 2 days after the vaccine, daycare called us around 03:00PM and indicated that she had a fever over 101. We called the pediatrician and they instructed us to give her acetaminophen for symptoms. Since Friday, she has been experiencing waves of on and off fevers as well. She started to have a slight cough and congestion however no runny nose. Over the counter COVID-19 test showed negative result. Pediatrician examined and did not find anything in ears, nose, throat, or lungs. They did not see anything concerning however some respiratory symptoms.
This case was reported by a nurse and described the occurrence of fever in a 2 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The patient had no relevant medical history, concurrent conditions, or concurrent medications. On 7/2/03, the patient received the first dose of Infanrix (lot DTPA578A9). This vaccine had inadvertently been left unrefrigerated for an unspecified period of time. On 7/3/03, 24 hours post immunization, the patient developed a fever and an injection site reaction characterized by swelling and redness. The patient was seen by the physician. The nurse considered the events were probably related to vaccination with Infanrix.
chilie; lymph gland swollen; rash; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chilie), LYMPHADENOPATHY (lymph gland swollen) and RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chilie), LYMPHADENOPATHY (lymph gland swollen) and RASH (rash). At the time of the report, CHILLS (chilie) was resolving, LYMPHADENOPATHY (lymph gland swollen) had not resolved and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 23-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a 67 year old male patient refers to his own experiences. The patient had drug reactions or allergies to unspecified oral steroids, NORVASC, felodipine, TEKTURNA. The patient's medical history included flu-like symptoms and an incident where he broke two of his teeth. The patient concurrent conditions included the pain from breaking his teeth which was "far to great to notice other symptoms from the vaccination". On an unknown date in the end of October 2013 the patient was vaccinated with ZOSTAVAX (dose, route, lot # not provided). Concomitant therapies included TOPROL XL, aspirin, doxazosin mesylate, lisinopril (manufacturer unknown) ZOCOR and unspecified antibiotics. On an unknown date in 2013 reported as "about 2 weeks after vaccination" the patient experienced joint pains and body aches. His aches were in knees, knuckles, fingers and hips. He explained that his knuckles ached "really badly" and complained that he experienced severe pain in his knees when he banded. Moreover he experienced (unknown date in 2013) "spiked blood pressure" as well and his blood pressure was high at "200 over 100" (units not provided) when he last visited physician. The patient mentioned also that on approximately 16-OCT-2014 (reported as "this morning") when he woke up he was not able to clinch his fist. The patient reported that the pains occurred all of the time (outcome: not recovered) and he could not take medications to help his pain due to other concurrent drugs. Therefore there was no treatment given for the events. On unknown date blood work was performed but the result was not provided. The patient sought medical attention and visited a doctor. The outcome of blood pressure was high at "200 over 100" and was not able to clinch his fist was unknown. The outcomes of aches in his knees, knuckles, fingers and hips were reported as not recovered. Relatedness between all events and ZOSTAVAX was not specified. Additional information has been requested.
No other AE; his doctor prescribed him GARDASIL 9; Information was received from a 56 year old male patient referring to himself. Information regarding concomitant medication, medical history and current condition was not provided.  On 01-JUN-2021, his doctor prescribed him hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dosage, frequency, lot # and expiration date were not reported) for prophylaxis (product prescribing issue). The patient had been unable to locate a pharmacy or healthcare provider that would administer the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). He had not had any doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse event.
pt recvd vax & 24 hrs p/2nd inject exp rash on lower rt forearm & rt side of neck;
2nd dose Pfizer 0.2ml administered to LA at 6:05pm, 10 minutes later while child is sitting and waiting on chair, he fainted and then started crying that his head was hurting. I immediately assessed vital signs, told co worker to initiate 911. Child was not sweaty or clammy, blood pressure 134/88, pulse of 88 with pulse oximeter. He stopped crying, I continued to assess child, no pallor, nausea, denied any dizziness or pain to any areas of his body. Mom stated, he gets nervous with  shots, B/P 130/70 before ambulance arrived. Instructed mom to sign up with program, information given. Child was not transported to hospital.
DISCOMFORT IN THE FACE; SWELLING IN THE RIGHT SIDE OF THE FACE; SORE ARM; This spontaneous report received from a parent concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced discomfort in the face, swelling in the right side of the face, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in the face, swelling in the right side of the face and sore arm was not reported. This report was non-serious.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (gave expired vaccine to patient) in a 59-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 067H21A) for COVID-19 immunization. No medical history reported. On Apr 19, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 19 2022, patient administered expired product (gave expired vaccine to patient). At the time of the report, administered expired product (gave expired vaccine to patient) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment details. Vaccine expired on Apr 3, 2022.
This case was reported by a pharmacist and described the occurrence of injection site wheal in a female subject aged between 20 and 29 years old who was vaccinated with FLULAVAL (GlaxoSmithKline) as a "tuberculin skin test" in error. On 25 October 2011 at 16:00 the subject received a dose of FLULAVAL (.1 ml, intradermal, right arm), and experienced wrong vaccine administered and inappropriate route of vaccination. According to the pharmacist, the subject was given FLULAVAL intradermally instead of receiving the tuberculin skin test (0.1 ml of FLULAVAL was administered). On 25 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced injection site wheal, lump injection site, injection site tingling and injection site redness. On 26 October 2011, the patient experienced squeezing in arm ("feels like arm is squeezed"). On 25 October 2011, the subject had reported that the wheal was a pea size lump and red and tingly. On 26 October 2011, the subject stated that the wheal was now larger and it felt like her arm was squeezed. The subject's healthcare provider recommended ice and BENADRYL, but the subject refused. At the time of reporting the wheal was worse, the squeezing in arm was unresolved and the outcome of the other events was unknown. Follow up information received from the pharmacist on 18 November 2011. According to the pharmacist, the subject was a 33-year-old female. The pharmacist now reported that the onset date of the earliest symptom was 24 October 2011 (previously reported as 25 October 2011), but did not change the previously reported date of vaccination from the 25 October 2011. The pharmacist noted that the events were resolved as of 10 November 2011. The pharmacist indicated that the events were serious but did specify a reason for seriousness. Therefore the case was upgraded to clinically significant.
Moderna COVID-19 vaccine EUA  Chills, sweating, swollen lymp, tiredness, fatigue
Finger tingling, dark purple bruise to left lateral AC x 2, one slightly above and one slightly AC, slightly left lateral to AC.
itchy, dizzy, difficulty breathing, allergic reaction.  Evaluated by EMS-Transported to Emergency room/department or urgent care.
Information has been received from a medical assistant concerning a 23 year old female with allergy to penicillin and amoxacillin and a history of cervical dysplasia who on 10-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot # 658556/1060U). On 12-AUG-2008 was vaccinated with the second dose of GARDASIL, (Lot # 660612/0229X), 0.5 mL, IM. The medical assistant reported that the patient experienced diarrhea after receiving the second dose of GARDASIL. The diarrhea began shortly after she received the second dose and has persisted. The numbness persisted. The patient sought medical attention, called the physician. Additional information has been requested.  11/21/08 Reviewed GYN medical records of 6/10-9/10/2008. FINAL DX: right arm myalgia from 2nd Gardasil shot Records reveal patient received HPV#1 on 6/10/08, lot # 1060U.  Experienced drowsiness & mild nausea which resolved.  RTC 8/12/08 for HPV #2, lot# 0229X, RA.  Had immediate numbness of right forearm & fingertips.  RTC 8/28 w/continued numbness & decreased right hand grip strength.  Referred to neuro.  RTC 9/10 w/same complaints.  Had not seen neuro yet.  No other records available.
Pt. rec'd 12 mo immunizations 01/22/18 at WCE o.v. mom reported on 01/31/18 that s/s began 01/29/18. Seen for check 02/01/18. S/s= (Rt) arm with positive erythema 3.5 cm x 1.8 cm; splotchy redness with firm 0.4 cm papule; afebrile. Monitor for tiredness fever tenderness = Re-check PRN.
02/18/2006 - to ER for redness, swelling, right deltoid - warm to touch, developed 6 hours after pneumovax injection.  Treated with Ancef IV, then Keflex for 3 days.
This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age and gender with intussusception. On an unknown date the patient was vaccinated with ROTATEQ (route, dosage, dose number and lot number unknown). It was reported that the patient experienced severe vomiting after receiving ROTATEQ. The patient was hospitalized (length of stay and hospital unspecified). The patient sought medical attention (hospitalized) and received treatment (unspecified). The patient's outcome was reported as recovered on an unspecified date. It has been determined that case # 1311USA000359 had an incorrect aware date. Since it has been already submitted to a regulatory agency it's going to be voided and copied on case # 1311USA002741. Therefore, case # 1311USA000359 is being deleted from our files and the cases consolidated into case # 1311USA000274. Additional information is not expected.
This spontaneous report was received from a registered nurse referring to to a 24 year old patient of unknown gender. There was no information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies reported. In the early 1990's, the patient was vaccinated with RECOMBIVAX HB, (also reported as manufacturer unknown by reporter) (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. The nurse reported that miscellaneous was selected as the product; while no MSD product could be specifically identified as the agent in question, MSD products were also not able to be ruled out.  On an unknown date, the nurse reported that the patient had "titers tested on 09-JUN-2017 which demonstrated negative for immunity". Treatment (unspecified) was given for the patient's adverse event. The outcome of hepatitis b surface antibody negative was unknown. Causality assessment was not provided.      Additional information has been requested.
Kidney bean shaped rash on right thigh, raised border, pink, variegated with the rash; also a satellite area to the left.  5 cm x 6.5 cm, somewhat urticarial
Yellow Fever (YF-Vax) administered IM in Right Deltoid. Patient monitored for 15 minutes post vaccination. No adverse side effects or outcome experienced by patient.
11/07/21 presents to Medical "due to scheduled induction for GDM on insulin and GHTN.  G1P0 at 37w2d". PMHx "GDM (gestational diabetes mellitus), hypothyroidism, obesity affecting pregnancy in second trimester, thyroid disease"
Patient received Moderna vaccine and was under the age of 18 years. No other adverse reactions occured.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient did not know exact date of first vaccination or the lot number and expiration date. The age at vaccination was not reported. The patient experienced some soreness in her arm. This case was linked with US2018176425, reported by the same reporter.
Cellulitis 12cmX 10cm area of celluitis. Site warm to touch.
p/vax pt started w/fever next morning & h/a, fever of 103;took APAP w/relief-temp WNL; c/o loss appetite, went to infirmary @ school;migraine;
Red spot she can still see at injection site; Hand hurting; lightheaded; bump at injection site; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand hurting), DIZZINESS (lightheaded), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (bump at injection site) and VACCINATION SITE ERYTHEMA (Red spot she can still see at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included METFORMIN and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Diabetes.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Hand hurting), DIZZINESS (lightheaded), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (bump at injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot she can still see at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Hand pain, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Hand hurting), DIZZINESS (lightheaded), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (bump at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Red spot she can still see at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As additional treatment for the events, the patient applied a cold compress to the vaccination site.
This case was reported by a pharmacist via sales rep and described the occurrence of chronic myeloid leukemia in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chronic myeloid leukemia (serious criteria GSK medically significant). On an unknown date, the outcome of the chronic myeloid leukemia was unknown. It was unknown if the reporter considered the chronic myeloid leukemia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with chronic myeloid leukemia (CML) after receiving a dose of SHINGRIX. The health care professional was interested on safety data to make decision on 2nd dose. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked to case US2019GSK057841, reported by the same reporter.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication.  In 2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was hospitalized. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries;  significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
This spontaneous report was received from a consumer (patient mother) refers to a 19 year old female patient. No medical history and concurrent conditions of the patient were reported. On 07-JUN-2001, the patient was vaccinated with VARIVAX (Merck) of dose 0.5 ml, subcutaneously (lot number: 16004 and expiry date: not reported). No concomitant medications were reported. It was reported that the patient received the completed doses of VARIVAX (Merck). On an unknown date, at the age of 19, patient developed a form of shingles and was diagnosed with Ramsay Hunt Syndrome. The patient had experienced hearing loss and facial paralysis. On an unknown date, unspecified laboratory tests were performed and results were not provided. The patient was given unspecified treatment for the adverse events on an unknown date. It was reported that the patient healed from facial paralysis and was still suffering from hearing loss. The outcome of Ramsay Hunt Syndrome was unknown. The causality of Ramsay Hunt Syndrome, facial paralysis and hearing loss was not reported. No product quality complaint (PQC) was filed. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
received a dose which inadvertendly consisted of saline only with no adverse event reported; Initial information received on 11-May-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who had received a dose which inadvertendly consisted of saline only with no adverse event reported after receiving vaccine yellow fever vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine produced by unknown manufacturer strength, dose, formulation, expiration and lot number not reported via unknown route in unknown administration site for Yellow fever immunization.  On an unknown date the patient developed a non-serious event of received a dose which inadvertendly consisted of saline only with no adverse event reported (wrong product administered) (unknown latency)  Action taken was not applicable.  Outcome: Unknown for the event received a dose which inadvertendly consisted of saline only with 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 the guidelines. 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.
right upper arm with redness, swelling, firmness, warmth beginning 2 days after vacicne admin