chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt devel arthritic type pain inj joints;had low grad fever & achy all over;also red, swelling in joint of fingers;@ one point needed help getting up off couch;MD states arthritis may be from hep b or infect or rubella;
Shingrix vaccine 7-13-21 Rash and arm pain 7-27-21 Gabapentin and valcyclovir Rx 7-31-21
Father falsified DOB of child on form. Stated DOB was 7/3/2009.  After giving vaccine, Rph determined actual DOB to be 9/3/2009.
When got home from clinic complained of dizziness/nausea. Laid down for 3-4 hours when got up arm was red and swollen. Took to Urgent care next day. Swelling in the morning - from shoulder past elbow, very red and in armpit. Mass on side of elbow - "moves down arm" went to wrist.
Pt to ED by EMS for change in mental status, weakness and cold like symptoms 3/16. COVID positive upon arrival 3/16, not requiring any supplemental oxygen and no respiratory symptoms noted.  RR even and non-labored. IV patent infusing Hep 11Ukg/hr. 3/18 pt A&Ox2, vss, iv is patent. 3/19 pt oriented x3, he denies any pain or sob. Pt complained of nausea and vomiting x2. 3/20 pt with no complaints, no nausea or vomiting noted. VSS. 3/21 Pt ANOX3 and continued to progress toward discharge. 3/22 pat was discharged with home care.
Patient developed redness, tenderness and swelling on the right thigh. Patient experienced crying. Doctor diagnosis is a local reaction to DTAP.
Pt vaccinated with Engerix and experienced generalized joint pain over several days; but forgot about it. She did not report symptoms. She recd the second dose & began to experience the joint pain again up to present.
Upon receiving the 3rd dose and within 5 minutes, my head felt like it was in a fog. I started to shake my head to clear the fog. My pulse started to get more rapid. It was becoming difficult to breathe. Plus I was starting to feel nauseous. I had two nurses standing in front of me discussing what they were going to do after work. They ignored me and weren't paying attention to me.   Someone came out from another room and did notice me. They asked me if I was okay and I said no. They laid me down, gave me an ice pack, and placed it on my neck. I felt like vomiting. They took my blood pressure. The female nurse seem to not want to monitor me for 30 minutes.   My stomach was hurting and I was sensitive to smell. My mouth was dry at that time. They did not offer me any oxygen and they did not recheck my O2 levels. They gave me this impression that they wanted to leave and go home. They wanted to discharge me quickly. I was not escorted out to my vehicle. They did not know if I was going drive or not even though I was not in a good condition.   I came home. I could barely eat that night. I still feel foggy. I've been drinking Pedialyte. I still have pain at the injection site, abdominal pain, chills, fatigue and body aches. I still have a headache and from one out of ten - the pain of the headache is at an 8.
Adult patient got a dose of Engerix B 10 mcg; Adult patient got a dose of Engerix B 10 mcg; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number 97kt7, expiry date 15th March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Engerix B pediatric 10 mcg and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional etails were provided as follows: The 36 years old patient inadevertedly administrated Engerix-B pediatric dose instead of the 20 mcg adult one, which led to underdose and adult use of a child product. No further events were reported. The reporter consented to follow up.
high fever; aches; chills; problems walking; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever), PAIN (aches), CHILLS (chills) and GAIT DISTURBANCE (problems walking) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (high fever), PAIN (aches), CHILLS (chills) and GAIT DISTURBANCE (problems walking). At the time of the report, PYREXIA (high fever), PAIN (aches), CHILLS (chills) and GAIT DISTURBANCE (problems walking) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, COVID-19: (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medications were reported concomitants medications were not reported   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: The source document does not contain any newinformation
Pt recvd neg measles titer following vax w/MMR was vaxed w/measles vax on 16AUG91; On 21AUG92 placed on therapy w/Grifulvin V; 4OCT91 titer for measles was 1:8; 22OCT91 2nd titer was neg for measles; no furhter details were provided;
He received the vaccines on 4/4/2022 as above. 1 hour later in a store, he felt faint, complained of a headache, sweating, shaking,pallor, and weak legs. He went to Grandmothe's and they called an ambulance. He was evaluated at a local ER. BP was low.  Was diagnosed with dehydration and given IV fluids, toradol, benadryl, and reglan. He was discharged and on the way out of the ER fainted. He was then admitted to the hospital. Neurology consult obtained - normal exam.   Of note it is not clear that he ate lunch that day or had had enough to drink.  He had been ill a month prior with a viral illness. On the day of the vacinations he had mild nasal congestion and allergy medication was sent to the pharmacy. No fever or complaints at the visit.
Patient presented with diffuse pruritus 10 minutes after receiving 2nd dose moderna vaccine.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with expired lot # (669475/0547AA) dose 1 oral ROTATEQ (expired date 1-SEP-2012) (dose and route were unknown) on 04-SEP-2012. No adverse symptoms reported. Additional information has been requested.
Left lung is beginning to hurt again; chest is killing him; can barely walk; pain all over; the knot on the arm is blood clot; knot under the skin on his arm; painful knot under the skin; nauseated; kept vomiting all the next day, threw up about 20 times; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (the knot on the arm is blood clot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones. Concurrent medical conditions included Autoimmune disorder in September 2020.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 15-Apr-2021, the patient experienced NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times). On 18-Apr-2021, the patient experienced SKIN MASS (knot under the skin on his arm) and PAIN OF SKIN (painful knot under the skin). On 19-Apr-2021, the patient experienced THROMBOSIS (the knot on the arm is blood clot) (seriousness criterion medically significant). On 20-Apr-2021, the patient experienced PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk) and PAIN (pain all over). On 17-Apr-2021, NAUSEA (nauseated) and VOMITING (kept vomiting all the next day, threw up about 20 times) had resolved. At the time of the report, THROMBOSIS (the knot on the arm is blood clot), PULMONARY PAIN (Left lung is beginning to hurt again), CHEST DISCOMFORT (chest is killing him), GAIT DISTURBANCE (can barely walk), SKIN MASS (knot under the skin on his arm), PAIN OF SKIN (painful knot under the skin) and PAIN (pain all over) outcome was unknown.            No concomitant medications were reported.   Treatment for the events included Elquis and I.V heparin.   This case was linked to MOD-2021-081600 (Patient Link).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Nausea and vomiting are consistent with the product safety profile.
Fever of 102.2, chills, headache, body aches, nausea, fatigue.
Got a full dose for his third shot and is not immunocompromised; inappropriate schedule of vaccine admiinistration; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Got a full dose for his third shot and is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine admiinistration) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Got a full dose for his third shot and is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine admiinistration). On 23-Oct-2021, ACCIDENTAL OVERDOSE (Got a full dose for his third shot and is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine admiinistration) had resolved.            No concomitant medication was mentioned.  No treatment medication was mentioned.  First dose was in March for her Honey.
Redness, swelling. Prescription of KEFLEX 250mg 1 PO QID x 10 days given 10-25-12.
Tingling around mouth 6-7 min post vax Observation and fluids Sxs resolved after 5 mins of close monitoring Allergies: Codeine, Latex, Iodine Contrast, Hydrochlorothiazide. No known food allergies, but consumed two foods new to her (yogurt parfait and Gatorade Zero) just prior to injection
INITIALLY presented to ER 5/2 with generalized fatigues,body aches,and subjective fevers after receiving his 2nd dose of Pfizer Vaccine against CoVID-19 on 4/28/21. Patient reports dizzy spells over the past few days with shortness of breath and then last evening developed a diffuse rash over his chest and extremities associated with itching and burning sensation on 5/1 evening. He denies any nausea,vomiting,abdominal pain,diarrhea.No chest pain or cough.Denies headaches.Denies h/o of prior allergic reaction/concerns to the first dose of the vaccine or any other vaccine.Denies any new exposure other than as stated the 2nd dose of the covid vaccine. Treated with IV steroids, IV Pepcid, and IV Benadryl with improvement. Upon discharge, directed to continue Prednsione 40mg daily for three more days for a total of five days of steroids, and follow-up with PCP. SUBSEQUENTLY, returned to ER  acute onset of decreased visual acuity, diffuse arthralgias, joint pain, myalgias, lightheadedness, palpitations, vertigo, muscle spasms, and difficulty moving both upper extremities. This was accompanied by sharp, 10 out of 10, nonradiating, diffuse anterior chest pressure. Nothing made this better or worse. The patient was driving at that time, and was unable to control his arms, which resulted in his vehicle leaving the roadway.  He was able to bring the vehicle to a stop before crashing. Since then, his symptoms have gradually improved, although they have not completely resolved. The characteristics are identical to the events that led to his previous admission.
a couple days after the vaccine, I developed a rash on the bottom of my abdomen, my neck, and my elbow creases. The rash was worst along my abdomen especially the right hip. The rash is red and looks like tiny red circles.
Tiredness; Device issue; Inappropriate dose of drug administered; Injection site bleeding; This is a spontaneous report from a contactable consumer (patient) or other non health care professional. This report based on the information received by Pfizer (Manufacturer Control No: 21K-163-3943518-00). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported ), dose 2 intramuscular on 17Mar2021 (at the age of 65-years-old)  as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at 40 mg (40 mg, 1 in 2 week) for rheumatoid arthritis . Patient  was only able to receive some solution of Humira, solution of Humira was leaking, misfire, tired and solution present on skin with Humira 40 mg/0.4 ml (Adalimumab).  Medical history included non-smoker, alcohol use: one glass of wine, occasionally, penicillin allergy, was manifested by felt dizzy and flushed. The patient's concomitant medications were not reported. The patient experienced inappropriate dose of drug administered and injection site bleeding and device issue on 04Jun2021. Patient had tiredness on 08Jun2021. Patient  was only able to receive some solution of humira, solution of humira was leaking, misfire and solution present on skin resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The outcome of the event Injection site bleeding, Inappropriate dose of drug administered and Device issue was recovered on 04Jun2021. The outcome of Tiredness was not recovered. Humira was Ongoing At least two months ago. Causality for humira 40 mg/0.4 ml (adalimumab) :The reporter's causality for the event(s) of blood on injection site and tired with humira 40 mg/0.4 ml (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of was only able to receive some solution of humira, solution of humira was leaking, misfire and solution present on skin was not provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
bad allergies; This is a spontaneous report from a contactable consumer, based on information received by Pfizer the contactable consumer(manufacturer control number: USASL2021048790). This is a split case for BNT162B2 from master case (a non-serious solicited report (USASL2021048790) reported to contactable consumer on 29/MAR/2021 by a consumer from a commercial program (PSP00180b)).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date. The patient's current medical condition included ongoing rheumatoid arthritis. The patient's concomitant medication included etanercept (ENBREL) weekly for rheumatoid arthritis from 2020, methotrexate. The patient received her COVID-19 injection, and that she had bad allergies. No treatment information was received. The outcome of the event was reported as unknown.   Information on the lot/batch number has been requested.
Information has been received from a 71 year old female with allergic reaction to penicillin, sulfonamide and codeine, who on 14-DEC-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck), in her hip rather than in her arm because the nurse said it would be less painful. No lot number was provided. The next day on 15-DEC-2009 the patient started experiencing pain in both of her calves. In January the pain started to go up to the thigh area of both legs, but was worse in the right leg. She still had difficulty walking and it had worsened. The pain had been worse in her right leg since onset of pain in December. Since having the injection she had had muscle pain in her leg and calf, kind of like a charlie horse, which was severe enough that she had difficulty walking. Thus far she had not seen a physician regarding the pain she was experiencing. The patient had not recovered at time of report. Muscle pain, pain in extremity and difficulty walking were considered to be disabling by the consumer. No further information is available.
Information has been received form a health professional concerning a 14 year old female with a viral infection and a sore throat for 2-3 days prior to injection who on 24-MAR-2008 was IM vaccinated with a pre filled syringe of GARDASIL (lot number 660387/1967U). On 25-MAR-2008 the patient fainted in the shower and bumped her head. The patient did not have a fever on 24-MAR-2008 when the vaccine was administered. The patient has had a suspected viral infection with a sore throat for the last 2-3 days. On 25-MAR-2008 the patient's temperature was 99.7 measured orally. The mother reported that the patient did not have any history of sncope, and the patient did not have any lumps following syncope and was going to be examined by the family physician. This is one of several reports from the same source. Additional information has been requested. This is one of several reports from the same source.
Redness, warmth and swelling to injection site radiating down left arm starting 3 days post vaccine administration. Seen by PCP, diagnosed with cellulitis and placed on Keflex. Symptoms have resolved.
Approximately 45 minutes post-injection, patient reported flushing and numbness around her mouth which lasted 30 minutes. No additional symptoms reported.
Information has been received from a doctor of pharmacist concerning a patient who a few years ago was vaccinated with a dose of ZOSTER (Oka/Merck).  The patient developed swelling and redness.  The reaction progressed to swelling from the injection site (shoulder) to the elbow.  Subsequently, the patient recovered.  This is one of the two reports received from the same source.  Additional information has been requested.
HEADACHE, TIRED, COLD, SHIVERING,  PAIN & SWELLING AT INJECTION SITE
A nurse reported the occurrence of joint pain in a 60 y.o. male who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had no relevant medical history, concurrent conditions or known drug allergies. He was described by the reporting nurse as being "very healthy." Concurrent medications included multivitamin, ginseng, fo-ti, gotu kola, red clover, dandelion, burdock root, Omega-3, vitamin E, and "natural" vitamin C. On 5/22/02, the subject received his first injection of Engerix-B (lot # not provided). An an unspecified time post-vaccination, he experienced muscle and joint aches in his shoulders, arm, neck, and back, and a burning sensation at the inject site, which felt "like a burning knife." The subject returned to the vaccine provider on 8/13/02 and described the symptoms he had experienced following the first injection of Engerix-B. The decision was made to administer the 2nd injection of Engerix-B (lot ENG5213A2; expiry 11/23/02) on 8/13/02. On 8/13/02, the subject reported to the nurse that he was experiencing a burning sensation in the joints and muscles of his arm, neck, shoulder, and back. As of 10/14/02, the outcomes of the events were unknown.
In January, staff were administered the COVID vaccine. After administering to this patient, the immunized realized they calculated their age incorrectly. Patient was two month under the age of 18, his mother was available to give consent. Patient experienced headache and soreness at injection site.
Chest pains, Abdominal pains, Tender and bruised abdomen, Feeling of Brusied chestbone, chills,  Shoulder and arm pain off and on, Back of head aches,  Started 1/8/22. With left side pain
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 01-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007093: US-009507513-1806USA007092: US-009507513-1806USA007090: US-009507513-1806USA007091.
I went into preterm labor at 20 weeks, 3 days on and delivered a live pre-term baby boy who died shortly thereafter. He weighed 11 oz.  My estimated delivery date was to be 06/25/2021. This was my second pregnancy, and I had not had my 20 week ultrasound yet. There is no known cause of why I experienced pre-term labor and an autopsy was not performed on my son. My first pregnancy was uneventful and I delivered at full-term.
Unable to lift right arm after receiving vaccine; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 09Sep2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included hypertension (Htn) and COVID-19. The patient had known allergies to nickel (Ni). Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 27Sep2021, the patient was unable to lift right arm after receiving vaccine. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were 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 unable to lift right arm after receiving vaccine was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown, the patient was vaccinated with a dose of M-M-R II lot # M022408, 02-MAY-2018, M032153, 22-APR-2017, M008588 16-FEB-2018, M002419 12-JAN-2018. No adverse symptoms reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.