chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative refers to a 11 year old female patient. The patient current condition included low blood iron. Information about patient's medical history, drug reactions or allergies and concomitant medications was not provided. On an unspecified date in 2016 (reported as last week), the patient was vaccinated with GARDASIL 9 (intramuscularly, dose#1, lot # L048237, expiry date not reported). It was reported that right after the first dose of GARDASIL 9 in 2016, "the patient passed out and had seizure like movement, described as tonic-clonic movements". The patient woke right up. The physician also stated that at the appointment when the patient received her first dose of GARDASIL 9, "her iron was low". On 04-APR-2016, the patient had an additional unspecified blood test and passed out again, just after the blood was drawn. The patient did not seek medical attention and no treatment was given to her for adverse events. No product quality complaint (PQC) was involved. No further information provided. The outcome of events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Upon internal review, the event seizure were determined to be medically significant. Additional information has been requested.
This spontaneous report as received from a registered nurse via a company representative refers to a female patient in her 60's. In April 2013(about 6 months ago) the patient was vaccinated with ZOSTAVAX (lot#, dose and route not reported). In April 2013 (about 6 months ago) the patient developed hives and a rash immediately after administration of ZOSTAVAX reported by the nurse. On an unknown date, the patient was recovered. The patient had sought medical attention by unknown type. Additional information has been requested.
This is a spontaneous report a contactable consumer reporting for the mother. An elderly female patient received pneumococcal 7-val conj vac (dipht crm197 protein) (unknown manufacturer) on an unspecified date in 2000, at single dose. Medical history included preservatives intolerance, it was a influenza vaccine shot that had thimerosal, her throat closed up but she never stopped breathing. This was 15 or more years before the report. The patient's concomitant medications were not reported. The patient experienced seizure on an unspecified date after vaccination with outcome of unknown. Pfizer is the Marketing Authorization Holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. No follow up attempts needed. No further information expected. Follow-up (14SEP2016): Follow-up attempts are completed. No further information is expected.
1 dose administered beyond the use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose administered beyond the use by date) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included SIMVASTATIN for Hyperlipidaemia.   On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021 at 10:57 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose administered beyond the use by date). On 07-Oct-2021 at 10:57 AM, EXPIRED PRODUCT ADMINISTERED (1 dose administered beyond the use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  This dose administered past beyond use date was the patient's 2nd dose. 2nd dose Use By Expiration 06-Oct-2021 by 2:45 pm.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow-up document contains no new information. On 14-Oct-2021: Follow up received on 14-Oct-2021, which contains significant information: patient demographics, suspect drug details, medical history and concomitant medication added.
Throughout years never had a reaction. The flu inj was not a problem but the Bolster Pneumonia in left arm was crucible occurring just less then 24 hours, arm swelled to 3 times size, heat was radiating and rigor of both arm where couldn't grasp a phone to call Doctor. As per annual follow up report: clinical indication Bacteremia and sepsis, cellulitis, left shoulder. Fever, chills, shaking, pain, nausea.
Nerve, muscle and joint pain on my entire body left side only. Numbness, weakness in left hand.
Body ache and pain all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache and pain all over) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache and pain all over). At the time of the report, PAIN (Body ache and pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Adacel administered to a 67 years old patient with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2023SA300988 and 2023SA300995.  This case involves a 67 years old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered 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 influenza vaccine INACT SAG 3V (FLUAD), varicella zoster vaccine RGE (CHO) (SHINGRIX) and pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 25-Sep-2023, the patient received a 0.5 ml dose (once) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot U7905AA, expiry date: 03-Oct-2025, Strength; standard) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization (product administered to patient of inappropriate age) (Latency: same day).  Action taken: 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.
Information has been received from a published literature article. Vaccination with attenuated varicella zoster virus (VZV) could lead to infectious complications in immunodeficient patients. It was reported two immunocompromised patients who developed initial or reactivated vaccine strain varicella, leading to unique vesicular rashes involving the vaccinated limbs, without becoming wide-spread or remaining limited to a single dermatome. Case 2-A 17 month old female with Hurler Syndrome, on day +6 after receiving an unrelated 7/8 Human Leukocyte Antigen matched cord blood transplant, developed a vesicular rash on her right thigh, which was the site for VARIVAX vaccination 4 months prior to transplant. A lesion was unroofed and the fluid revealed VZV by PCR. Subsequent analysis revealed the virus to be vaccine strain varicella. She was started on treatment with intravenous acyclovir and intravenous immunoglobulin and her lesions crusted over within 2 weeks. These two cases highlighted unusual presentations of vaccine strain varicella in immunocompromised patients. Vaccine strain varicella could cause a vesicular rash in a non-classical distribution. It was also notable that vaccine strain can trigger hemophagocytic lymphohistiocytosis in immune deficient patients. This is one of two reports received from the same literature. Additional information has been requested.
Pt developed urticaria (Hives) within 24 hours of receiving vaccine (HEP B)
This spontaneous report was received from a pharmacist via a company representative regarding a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were unspecified. On unknown dates, the patient was vaccinated with PNEUMOVAX 23 (dosing details were unspecified) for prophylaxis. Pharmacist reported that the patient may have received more than 3 doses of vaccine, all on unspecified dates. No adverse effects were reported. Additional information has been requested.
Headache, Arthralgia, Fever, fever, restlessness, joint ache, HA Narrative:
Positive event/ the day after the vaccine, I woke up with none of my usual issues/ my nose wasn't stuffy, I didn't feel like my body hurt or was achy, I could breath with no issue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 07Mar2021 at 11:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, shingles, pneumonia as a kid multiple times, migraines, allergies/allergic to everything environmental, food sensitivity/have a bunch of food sensitivities and anxiety believed to be caused partly by histamine intolerances. Allergies to medications, food, or other products were reported as "too many to list". The patient had been through allergies shots, allergy tests, blood tests on unknown dates and the patient reacted to everything. The patient woke up every morning and felt like could not breathe and just felt miserable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), zinc sulfate/lecithin/chromium picolinate (LIVER PROTECT), vitamin b complex (MANUFACTURER UNKNOWN), and ascorbic acid (VITAMIN C); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received unspecified allergies shots for unknown indications from unknown dates. The patient reported that this was a positive event. On 08Mar2021 at 06:00, the day after the vaccine, the patient woke up with none of the usual issues that the patient had. This continued through the day. On 09Mar2021, when the patient woke up and it was the same thing. The patient's nose was not stuffy, she did not feel like the body was hurt or was achy and could breathe with no issue. The patient joked that the vaccine had reset the patient's unpredictable immune system which seemed to react to everything. The patient did not know how or why but after the vaccine the patient felt the best she had felt in years - after multiple tests, medications, diet modifications that did not help, it was the weirdest thing and made such an impact which the patient wanted to share it. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event positive event/ the day after the vaccine, the patient woke up with none of the usual issues/ nose was not stuffy, did not feel like body hurt or was achy, the patient could breath with no issue was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
We are unsure if this is a cause/effect relationship, but we saw a drastic behavioral change in our 1-year old after vaccination.  The day following his MMR & chickenpox vaccination he would no longer suck on a bottle or a cup.  It seemed like he lost the sucking reflex.  He would chew on a nipple or a cup nozzle, but would not actually suck.  After a couple days we brought him to see a doctor.  The doctor thought he simply was ready to switch from the bottle to a cup, being bored with a bottle.  However, even with using a cup he would not suck.  After about a week of continuing to use cups alone, he starting sucking again on them. He also had a fever following the vaccination.  He seemed to recover from that fairly quickly.
57 year old male with medical history notable for tobacco use, GERD, who presents with complaint of increasing shortness of breath and abdominal pain over the course of prior 3x weeks, 2x days after receiving the J&J vaccine for COVID, and bilateral lower extremity swelling for the past week. On further evaluation was noted to have concerns of congestive heart failure with right heart strain, complicated by atrial fibrillation with RVR, and presence of intracardiac thrombus noted on CT angiogram of the chest
no adverse event; expired vaccine used; This spontaneous report was received from a registered nurse referring to a 19 month old male patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.  On 19-MAY-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S002460 (expiration date: 15-MAY-2020) for prophylaxis (no additional dosage regimen information was reported). No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S002460; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: No; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
measles like rash, upper arms, upper legs, thighs, buttocks, sides, breasts, upper abdomen appeared a couple of days after first injection, then within a few hours of second shot, heavier. There is little to no itching or discomfort, was accompanied by headache, which continue starting late evening daily. Fatigue and muscle and joint aches, plus low grade fever started 10 to 12 hours after each injection and lasted about 2 1/2 to 3 days.  Second shot was administered 3/24/2021 5:30 PM
Hip replacement; Arm was sore; Arm felt incapacitated; This case was reported by a consumer via call center representative and described the occurrence of hip replacement in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 5 months after receiving Shingrix, the patient experienced hip replacement (serious criteria hospitalization), pain in arm and weakness of arms. On an unknown date, the outcome of the hip replacement was unknown and the outcome of the pain in arm and weakness of arms were recovered/resolved.   It was unknown if the reporter considered the hip replacement, pain in arm and weakness of arms to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix approximately in October or November 2018 in left arm.  One day after receiving Shingrix, the patient's arm was sore. Her arm felt incapacitated.  It took her 4 days to be back to normal.  The patient was hospitalized from 1st March 2019 till end of June 2019 for a hip replacement surgery that went wrong requiring her to get a back surgery.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix. No further details were provided. The reporter consented to follow up.
Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023; no adverse event; beyond the manufacturer expiration date and the 30 BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023), EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD) and NO ADVERSE EVENT (no adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051C22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023), EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023) and EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD).    No relevant concomitant medications were reported.  Manufacturer expiration date was 13-Jan-2023 and the initial date the vaccine was placed in the refrigerator was on 09-Nov-2022.  No adverse reactions were reported by the patients. No treatment information was provided.
A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 09-Jan-2014. The reporter stated that expired FLUMIST QUADRIVALENT was administered which started on 09-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Right upper arm became red, warm, swollen (size of an avacado) about 7 days after vaccination.  No side effects from vaccine until then.   Pt. worried it is infected so recommended to see primary care provider to evaluate and get treatment if needed.
Diarrhea; Tossing up; Soreness in arm alternating left right, then behind knee; Soreness in arm alternating left right, then behind knee; I could hardly walk; Intense pain in hand, then elbows, then pack to shoulders alternating, sometimes intense, ache when I don't move intense when I do. It's been three freaking months and the left armached all last night; This is a spontaneous report received from a contactable consumer (patient). A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration, in arm left on 02Feb2021 (at age 74-year-old) as a single dose for COVID-19 immunization. The patient's medical history included asthma. The patient had known allergies to sulfa drugs. The patient's concomitant medications included amlodipine (within 2 weeks of vaccination). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number=EL9266), via an unspecified route of administration in arm left on an unspecified date, as a, single dose for Covid-19 Immunization and experienced Soreness in right arm. Patient previously took acetylsalicylic acid (ASPIRIN) and allergies with it. The patient had not received 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 has not been tested for COVID-19. It was reported that, the patient experienced soreness in his right arm (opposite of vaccination arm) 24 hours after injection of first shot which lasted. Then after second shot, on 16Feb2021, patient experienced diarrhea and tossing up, soreness in arm, alternating left right, then behind knee as he could hardly walk, then intense pain in hand, then elbows, then pack to shoulders alternating, sometimes intense, ache when he didn't move and intense when he does. The patient stated that, it's been three freaking months and the left arm ached all last night. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The reporter classified the events as non-serious. Treatment received for the events was reported as unknown. The outcome of the events was not recovered.
episode of supraventricular tachycardia (SVT) with heartbeat in the 290s range.; pale; clammy; scared; Initial information was received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case 2022SA414365.  This case involves a 16 years old female patient who experienced episode of supraventricular tachycardia (svt) with heartbeat in the 290s range. while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical treatment included MENINGOCOCCAL VACCINE A/C and TDAP on 11-JUL-2018. The patient's past medical history, vaccination(s) and family history were not provided.  On 26-Jul-2022, the patient received 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7268AA) (strength and expiry: unknown) via intramuscular route in the left deltoid prophylactic vaccination.   On 24-AUG-2022 the patient developed a non-serious episode of supraventricular tachycardia (svt) with heartbeat in the 290s range. (supraventricular tachycardia) with symptoms pale (pallor) clammy (cold sweat) and scared (nervousness) (latency 29 days) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported that "The ER doctor advised her to follow-up with her primary care physician. Two days later, on 26-Aug-2022, they saw a new pediatrician, who advised follow-up with a pediatric cardiologist. She saw the pediatric cardiologist on 27-Sep-2022".   Relevant laboratory test results included: Blood chloride - On an unknown date:  [slightly elevated levels] Chest X-ray - On an unknown date:  [normal] Electrocardiogram - On an unknown date:  [normal] Heart rate - On 24-Aug-2022: 270 beats/min then 298 beats/min [via pulse oximeter] then 204 beats/min then 88 beats/min  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  Corrective treatment-intravenous fluids and follow-up care  At time of reporting, the outcome was Recovering / Resolving for the event episode of supraventricular tachycardia (svt) with heartbeat in the 290s range