chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health care worker professional concerning a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not reported. On multiple unspecified dates, ranging from August 2015 up to an including October 2015, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD, lot # reported as: 1002421, expiration date: 23-JUL-2016, lot#: 1009290, expiration date: 17-SEP-2016 (route, anatomical location and doses were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse reactions were reported. Lot numbers: 1002421 and 1009290 are invalid lot numbers for (Merck) PROQUAD. This is one of several reports from the same source. Additional information has been requested.
Approx 1 wk. after MMR, mom noticed swelling in front of (R) ear. Seen in clinic 11/4/10 with increased swelling. Referred to ENT-Dr 12/3/10- MRI of neck. Pt on Clindamycin-developed rash 6-8 hrs later. Antibiotic changed to (?) AUGMENTIN. Parotid massage, warm compress. 12/6/10-Parotid abscess.
SYMPTOMS: EXTREME HOT PAIN IN LEFT GROIN AREA SIGNS: EXTREME PAIN THAT WAS SIMILAR TO MY PAIN             EXPERIENCED WITH BACK LABOR, 9 years earlier. TIME: THE PAIN CAME ON QUICKLY & ONLY SUBSIDED           WHEN I WAS GIVEN MORPHINE OR NORCO  on 4.3.21 my pain originated deep in my left groin area. Once the pain started it accelerated to a pain level of 10 within 10 min. The pain wrapped around the top of my left leg and the pain never relocated to any other portion of my body. I did not reach any relief from the pain until I was administered 4mg of morphine. Pain started @ 1pm & morphine was given @ 3:30ish  on 4.4.21 I returned to the ER via ambulance this time.  (I was driven to the ER on 4.3.21) The pain was identical in location and pain level. It began hurting @ 2pm and I was given 10mg of morphine to relieve pain. The ER doctors ruled out my lady parts and deemed them healthy. They also stated that my organs are healthy & strong. I was discharged with Norco 5mg.  The pain returned on 4.6.21 and 4.9.21; 4.10.21 and 4.12.21. on 4.6.21 I had to take 10mg Norco w/600mg Ibuprofen on days where the pain was not felt I was taking 600 mg of ibuprofen. Although the pain is not elevated there is a definite "flutter" and intermitent pressure in the same location.
This spontaneous report as received from a registered nurse (also reported as clinical supervisor) refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 10-SEP-2020, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 11-NOV-2020, she received the second dose (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 13-JAN-2021, the patient was vaccinated with the third dose hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal free, 0.5 ml injection, lot # R028528, has been verified to be a valid lot number, expiration date 04-JUN-2021 (route of administration, anatomical location were not reported) for prophylaxis, therefore experienced inappropriate schedule of product administration. No adverse effects were reported.
I developed upper respiratory cough, malaise, fever, fatigue, sinus drainage, sore throat. I had two positive COVID-19 tests.  I did a virtual visit with a nurse and Pacxlovid was prescribed, my symptoms began to resolve within 48 hours but within one week I began to feel worse and sinus drainage bean to be cloudy.  I was prescribed Doxycycline after the antibiotic for ten days and symptoms resolved with no further symptoms.
Pt vaccinated with Pneumovax 23 developed injection-site pain following vaccination with vaccine.
WORSENED GUILLAIN BARRE SYNDROME; PAIN IN FOREARMS; SWOLLEN LEGS AND FEET; FALLING AND IMBALANCE; This spontaneous report was received from a patient and concerned an 87 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included Guillain Barre syndrome, alcohol intake red wine sometimes, non smoker, and no known allergies. Patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020) dose was not reported, administered on 16-MAR-2021 to his right arm for prophylactic vaccination. There  were no concomitant medications.  On an unspecified date, the patient experienced worsened Guillain Barre syndrome. In APR-2021, the patient was falling and had imbalance. In MAY-2021, the patient experienced swollen legs and feet. In JUN-2021, the patient experienced pain in forearms. Patient uses a walker to walk inside his home: " I have to walk beside the wall, otherwise I will fall on the floor and I have difficulty to getup"  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen legs and feet, pain in forearms, worsened guillain barre syndrome, and falling and imbalance. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received from a consumer concerns an 87-year-old male, with concurrent Guillain Barre syndrome (GBS) who was reported to have "worsened" GBS after an unspecified duration of receiving the Janssen Covid-19 vaccine.  The worsening was described as falling and had imbalance; swelling of hands and feet; pain in forearms.  No treatment reported; the events have not resolved.  The information available precludes a complete and meaningful assessment.  Based on the information available, and the clinical picture of concurrent GBS could represent the normal progression of the illness. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.
Rash consisting of hives or small red bumps suddenly appeared on upper body (arms, chest, upper back) the morning of 12/26/20. Rash continued to spread to lower back and stomach over the next few days with the left arm being the most affected area. Facial redness and swelling occurred however breathing was never affected.  Benadryl did not provide much relief. Visited an urgent care which classified it as an allergic reaction and started 5 day course of prednisone on 12/28/2020. Symptoms resolved upon completion of the prednisone. Total duration of symptoms was approximately one week. I had not used any new skin products or eaten any foods new to my diet and nothing else comes to mind as a potential contributing factor.
On 3/26/2021 I woke up in dire uncontrollable pain, level 10. I almost went to ER, but I called Medical Center and asked if I could come down for a pain shot, at 9:30 am. They told me to take Tylenol. I told her I have GERD and Tylenol is OFF the table. They then said they would call me back, but didn't call me back until 11:50 am. The RN again told me to take Tylenol, and I told her again I have GERD and Tylenol is OFF the table. She told me I couldn't come down to see them. I was left in dire pain, laying flat on my back, standing, or sitting. It was the most appalling experience I've ever had. I have already tried contacting CDC, and the lady kept sending me an automated reply saying I needed to go to the VERS site. I finally emailed her and told her to NOT REPLY again. I told her all the information I have stated here, but the lady didn't want to enter it into the system, purposely. What a total failure of the CDC, totally incompetent and ignorant. This just caused a public informative response failure on CDC's end. I also called the 800 number before sending all those emails to CDC, requesting a return call. They never returned my call !! Another CDC failure. I am deaf and use a captioned phone. The stupid recording went too fast for my caption phone to print out and I had to call that 800 number 3 times to understand the stupid menu. This is discrimination of the deaf. I'm sick and tired of it all. I explained this to the lady that sent me several emails, but she didn't want to hear it. More discrimination. Where does it end?  So HOPEFULLY this information gets into your system. Don't send me a reply stating I didn't fill out this form correctly, or I will permanently BLOCK your emails.  Thank you
This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 12th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain, rash, feeling bad and injection site rash. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, rash, feeling bad and injection site rash were unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, rash, feeling bad and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient was in her 50s. The field representative reported that another field representative with GSK was the patient. The age at vaccination was not reported. After the injection, the patient felt lousy with flu-like symptoms. She also had a rash and pain. The reporter thought there was rash and pain at the injection site, but there might be rash on other parts of the body as well.
CHILLS; TREMBLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, batch number: Unknown) dose was not reported, administered on 08-APR-2021 16:00 in right deltoid for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced trembling. On 08-APR-2021 22:00, the subject experienced chills.On 08-APR-2021 22:00, initiated treatment medications ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and the outcome of trembling was not reported. This report was non-serious.
No adverse affects reported; has not yet received the second dose in the vaccination series; has not yet received the second dose in the vaccination series/ Altered dosing schedule; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 29-FEB-2020 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028387, expiration date 27-JUL-2021; dose, frequency and route were not reported) for prophylaxis.         The patient had not yet received the second dose in the vaccination series at the time of report (circumstance or information capable of leading to medication error, inappropriate schedule of product administration). No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R028387; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a physician's assistant (PA) concerning a college student who was vaccinated with a dose of Varivax at the age of 11. In approximately September 2006, the patient experienced low titers. No further information was available at the time of this report. No product quality complaint was involved. Additional information has been requested.
At 8am day after vaccine, I experienced mild nausea and a slight headache. By 12pm, I had developed a low grade fever, chills, and headache. I took Tylenol ever 6 hours to help with the symptoms. By 6pm, my headache was so severe, I was almost in tears and I took a dose of ibuprofen. Fever rose to 100.6 and was not breaking with medication. 2 days after vaccine, most symptoms were gone. I had residual mild chills and sweating spells, along with fatigue. Day 3 post vaccination I had a hot, itchy rash from my shoulder to my elbow, severe body aches, and swollen lymph nodes under my right arm and on the right side of my neck. Day 4,  symptoms were gone. Swollen lymph nodes stayed for an additional couple days.
March 27, 2021- developed pain and swollen lymph node in left arm pit, resolved within 2 days April 28, 2021- menstrual period arrived 7-8 days early
normal effects during first 3 days: extreme fatigue, soreness, swelling and itching at injection site.  now 2 weeks later, there is a round feeling hard lump beneath the skin of the injection site. it's slightly warm to the touch and just slightly pink/purple. and sore if pressed.
Positive test result of mono; Severe fatigue; headache; Body ache; severe back pain; heaviness in arm; numbness and tingling in hands; soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (heaviness in arm), CARPAL TUNNEL SYNDROME (numbness and tingling in hands), INFECTIOUS MONONUCLEOSIS (Positive test result of mono), BACK PAIN (severe back pain) and FATIGUE (Severe fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 089K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (heaviness in arm), CARPAL TUNNEL SYNDROME (numbness and tingling in hands) and VACCINATION SITE PAIN (soreness). On 11-Jan-2021, the patient experienced BACK PAIN (severe back pain). On 13-Jan-2021, the patient experienced FATIGUE (Severe fatigue), HEADACHE (headache) and MYALGIA (Body ache). On 20-Jan-2021, the patient experienced INFECTIOUS MONONUCLEOSIS (Positive test result of mono). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form; VITAMIN B NOS ongoing since an unknown date at a dose of 1 dosage form and COLECALCIFEROL (D3) ongoing since an unknown date at a dose of 1 dosage form. On 11-Jan-2021, LIMB DISCOMFORT (heaviness in arm), CARPAL TUNNEL SYNDROME (numbness and tingling in hands) and VACCINATION SITE PAIN (soreness) had resolved. On 14-Jan-2021, BACK PAIN (severe back pain) had resolved. On 03-Feb-2021, INFECTIOUS MONONUCLEOSIS (Positive test result of mono), FATIGUE (Severe fatigue), HEADACHE (headache) and MYALGIA (Body ache) had 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.   No concomitant was provided.
Lethargic.- slept close to 48 hours, hives in the whole torso area, stomach cramps and headache - all of these symptoms are persisting for a 3rd day
Racing heartbeat; Low blood pressure; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 18Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient had 2nd dose of a vaccine yesterday (18Mar2021) experienced a racing heartbeat today (19Mar2021) and low blood pressure and wanted to know what to do next. The patient underwent lab tests and procedures which included blood pressure which showed low and heart rate which showed racing heartbeats on 19Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Administered vaccine from vial on 6-26-21 at 10:15 A.M.  Vial was kept in refrigerator entire time prior to administration.
On the morning of 03/31/2021, it started with a sore arm, headache, significant body aches, fever, and a general feeling of unwell. I just felt horrible. I treated myself with Tylenol and hydration. That lasted, unchanged, through Sunday. Monday, I started feeling better. I contacted my physician after three days. He informed me that it could last anywhere from six to ten days and that it was most likely an immune response to the vaccine. The fever reached 101 several times and it lasted for about five days.
Information has been received from a nurse concerning a 78 year old female with allergies to penicillin, morphine and eggs who was vaccinated (date of vaccination, site and route not reported) with PNEUMOVAX 23 (lot not reported) manufacturer unknown. Post vaccination, subsequently the patient's "arm doubled in size". It is unknown if the patient sought medical attention. Per the nurse the patient had recovered. No further information is available. Additional information is not expected.
pt had a positive COVID test on 2/14/22 ordered by facility; pt admitted to facility for rehab due to a fall  on Left hip; underwent a hemiarthroplasty; pt passed away in the facility of hypoxia
Vaccine's given 3pm. Febrile seizure at 8pm same day.
Swollen, warm local reactions of the injection site. Tdap tender indurated 100mm x 100mm redness 60 mm x 80mm tender. HPV site with tenderness extending 70mm x 40mm from injection site and redness 25mm x 25mm. MENACTRA site area of tenderness 30mm size.
fever; chills; headache; aching body; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer, the patient, reported a male of unspecified age received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on 10Mar2021, for COVID-19 immunisation. Relevant medical history included tested positive with the COVID-19 virus (2020-2020 and he beat it). There were no concomitant medications or past drug history reported. The patient reported that on the day of his first dose of the vaccination, after he got the vaccine, he felt symptoms that were similar to what he had when he had the virus; fever, chills, headache and aching body. The patient explained that he is fine now and has already recovered. The patient explained that he is apprehensive to get the second dose. The patient inquired if his body has enough antibodies to combat COVID 19 virus. The outcome of the events fever, chills, headache and aching body was recovered on unspecified date in Mar2021.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Janssen COVID-19 Vaccine EUA Patient received vaccine on 3/13/2021. Patient presented to physician office complaining of headache for over 3 weeks. Headache is worse when bending forward, and keeps patient awake and/or awakens him. Described as a constant pounding headache in the frontal and bitemporal area radiating towards his occiput. No nausea, emesis, vision changes, or personality changes. CT of Head demonstrates an acute left frontal subdural hematoma measuring 5 mm in maximum thickness. Patient's warfarin held, keppra started, vitamin K and PCC administered. Patient stabilized clinically and on CT and was discharged on 4/9/2021
On 11/17/00 (lot ENG3359A4), 12/15/00 (lot ENG3232A4) and 5/17/01 (lot unk), the vaccinee received her 1st, 2nd and 3rd injections of Engerix-B, respectively. On 3/6/02, 10 months after her 3rd injection of Engerix-B, Hep-B surface antibodies were found to be "nonreactive". The reporter stated that this lack of efficacy could have been associated with erroneous administration ("did not shake bottle"). As of 4/22/02, the outcome of the event was unknown.
Angioedema (lips, face, tongue, neck, chest and palms of hands).   Treatment Benadryl po 25 mg @ 1130 am 1/13/2021 Benadryl IV 50mg x 1 @ 1239 Pepcid 20 mg IV x 1 @ 1239 SoluMedrol 125 mg IV x 1 @ 1239 Acetaminophen po 325 mg @ 1412 Prednisone 60 mg po x 1 @ 1542
The injection hurt when administered and was most painful when the needle came out.  I said to the nurse that it seemed so high up on my arm and that it was the most painful shot I ever received - I barely felt the first dose.  The pain in my shoulder and arm continued and within a few hours it was excruciating.  I also developed a fever of 102 degrees, nausea and severe headache.  I could barely move my arm and the pain would wake me up during the night.  The pain became less severe over the next few days but it was still constant.  I went to my primary care physician on 5/11/21 and she prescribed Diclofenac with the hope that it would reduce inflammation and said it could be damage to the rotator cuff.  It helped somewhat but pain is back now more constant and severe.  I will be seeing an orthopedist
Low-grade fever 99.1-99.6 F, nausea, headache beginning day 10 after injection. Symptoms lasted 3 days. Visited urgent care center, missed 1 day of work due to illness symptoms.
rt thigh localized redness & swelling @ inj site (area approx 10cm diameter) & c/o joint pains 1 day p/vax;
Myalgia Narrative: Developed significant pain left trapezius and left side of neck following injection. Pain started to subside before she left clinic. On follow-up conversation pain completely resolved in 1-2 hours. No treatment required
Forgot to take the second dose; Spontaneous report received on 17JAN2020.  A pharmacist reported that a consumer "forgot to take the second dose" (PT: Product dose omission) while being on Vivotif capsule for immunisation. The consumer took first dose of Vivotif on 13JAN2020 and then forgot to take the second dose, which was due on 15JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer forgot to take second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Limited number of vesicles on face and right arm. topical Umbilical lesions.