chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lump; Itchy; Red mark on the injection site; Fever close to 101.4 degrees F; Kidney stone; Has also been coughing since she got the injection; A spontaneous report was received from a consumer concerning a 58-year-old female patient, who developed kidney stone/nephrolithiasis, fever close to 101.4 degrees F/Pyrexia, a red mark on the injection site/vaccination site erythema,  an itchy/vaccination site pruritis, lump/vaccination site mass and coughing/cough.  The patient's medical history was included night sweats. Products known to have been used by the patient included alprazolam, atorvastatin calcium, biotin, macrogol 3350, black cohosh, calcium carbonate/colecalciferol, minerals/vitamins NOS (not otherwise specified), celecoxib, eszopiclone, fluticasone, HCTZ, levothyroxine, pregabalin, montelukast, oxycodone, paroxetine, fluticasone proprionate/salmeterol xinafoate, potassium, risedronate sodium, and topiramate.  On 22-Feb-2021, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012A21A) intramuscularly in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 26-Feb-2021 the patient got a kidney stone and the doctor gave her medications. On 27-Feb-2021 she got a fever close to 101.4 degrees F for two days. Aspirin was taken which helped. A red mark was noticed on the injection site on 1-Mar-2021 which was described as an itchy lump. The patient also experienced coughing since receiving the injection. Treatment medications for the events included aspirin, ciprofloxacin and tamsulosin. The event kidney stone/nephrolithiasis was medically significant.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, fever close to 101.4 degrees F, was considered recovered/resolved on 1-Mar-2021. The outcome of the events, kidney stone, a red mark on the injection site, an itchy lump, and coughing, was unknown.; Reporter's Comments: This case concerns a 58 Y/O F with a serious unexpected event of nephrolithiasis and nonserious unexpected cough, vaccination site mass, and expected fever, vaccination site erythema, vaccination site pruritus.  Event onset on Day 1 after first dose mRNA-1273. Treated with aspirin, ciprofloxacin and tamsulosin. Fever resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The morning after the booster was administered, the left arm became stiff, sore, and noticeably swollen near the injection site. Symptoms peaked the evening of December 2, 2021, with a large red area (hives-like in appearance) around the injection site, with a diameter of about 4 inches. The red area was hot to the touch, and was mildly itchy.  Swelling and heat reduced considerably by the afternoon of December 3. Redness and itching persisted until the evening of December 5. No such symptoms were experienced with dose 1 or 2 of the Moderna vaccine.
pt recvd vax 18JAN93 & had rash; MD was seen @ hlth check;
RED SKIN INFECTION/NAUSEA FEVER 100.9 /VOMITING
Nausea; Diarrhea; Fever; Chills; Fatigue; Splitting headache; Muscle aches; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Splitting headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine (Years ago.).   On 23-Feb-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 23-Feb-2021, the patient experienced VOMITING (Vomiting). On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Splitting headache) and MYALGIA (Muscle aches). On 25-Feb-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches) and VOMITING (Vomiting) outcome was unknown and FATIGUE (Fatigue), HEADACHE (Splitting headache) and NAUSEA (Nausea) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Employee of hospital received Covid-19 vaccine, was moved to respite area and began to "feel flushed" and had (2) syncopal episodes. B/P 160/93, HR =80, Pulse Ox-100%.    Employee transported to the ED via stretcher.
Severe shoulder pain beginning ~2 hrs after vaccination.  Progressed to cause immobility of shoulder joint with excruciating pain on any range of motion. ~76 hours post-vaccination, shoulder symptoms still severe, and patient developed fever along with skin erythema and subcutaneous edema extending over a matter of several hours from the shoulder joint (apparently via the biceps tendon sheath) down to the antecubital fossa.  Pt presented to ER, where bloodwork, shoulder X-ray, shoulder arthrocentesis were done due to concern about misplaced vaccination resulting in possible septic arthritis versus "pseudoseptic" arthritis.  Deltoid muscle never sore, tender, or swollen.  Pt admitted from ER. Inpatient shoulder MRI obtained pre-op showed abnormal amount of fluid in joint. Arthroscopy done under general anethesia to obtain cultures and to lavage the joint, with substantial improvement in pain and limitation of shoulder range of motion.  Fluid reflected substantial inflammation; stains and cultures negative for infection and pt. discharged from hospital 4 days after ER presentation.  Significant pruritis in the subcutaneous tissue noted post-discharge, lasting several days, rx'd with OTC antihistamine.  Physical therapy prescribed to regain shoulder range of motion and strength.  Patient gradually improving day by day, though still limited with respect to range of motion and strength 2 and 1/2 weeks post-vaccination.  Hope is for full recovery, but that remains to be seen.  NOTE:  Below in Item 13, the "Route" field is filled out as "Intramuscular" which was the intended route.  However, the vaccination was given high on the arm in the shoulder area, and is it apparent from all available evidence that the vaccine was actually adminstered into the shoulder joint. 11/30/09 Hospital records received for date 8/30/09 to 9/3/09. DX: left shoulder pseudo septic arthritis after pneumovax vaccine. Presented to ER w/ left shoulder pain, swelling, redness x5 days. Sx began 2hrs after vax. Assessment: (+)fever, pain. Arthroscopic I&D surgery, no infection found but significant inflammation.
Fever of over 102 for three days as of now. Rash that started over his eye and spread to his lower face area, chest, abdomen, back, and buttocks. Severe congestion. Copious amounts of clear nasal drainage. Treated with ibuprofen.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 16-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), May 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for  COVID-19 immunisation. The patient experienced chest pain (chest pain; lasted a few days), with outcome of recovered. Additional information: Reporter's 16-year-old son experienced side effects after his second Pfizer dose back in May. Side effects: chest pain; lasted a few days. Follow-up attempts completed. No further information expected.
Immediately after receiving dose, I felt light headed and very hot, sweats, like I was about to pass out.   Day after vaccine (11/20/2022) I am having body aches, fatigue, arm pain and selling around the vaccination site
14 yo. male with (L) 7th cranial nerve palsy onset 12-25-11. S/P FLUMIST 12-7-11.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. The patient developed redness at the injection site after receiving the vaccine.  Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
New onset Joint pain, and stiffness, of hands/ fingers bilaterally. Pain is localized and most severe in distal phalanges
This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 26-OCT-2015, the patient was vaccinated with a dose of ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies were reported. Then, on 09-NOV-2015, the patient was vaccinated with a second dose of ROTATEQ, orally (strength and dose were not reported)(K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016 with the same improperly aforementioned characteristics of storage. No adverse events were reported. This is one of several cases form the same reporter. Additional information has been requested.
Pt started to feel slightly lightheaded about 10 minutes after vaccination, then started to have some tingling in his face. He received 25 mg of oral diphenhydramine with good results within 30 minutes. Pt has a h/o anaphylaxis to allergy shots as a child one time, but then never had a reaction again.
Redness around neck, arms and  chest; body ache; muscle soreness; This is a spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received unspecified dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 43-years-old) as dose number unknown, single for COVID-19 immunisation. The patient did not have any medical history. Concomitant medication included meloxicam for an unknown indication from an unspecified date and unknown if ongoing. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 16:00, the patient experienced redness around neck, arms and chest, body ache, muscle soreness. It was unknown whether the patient received any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the redness around neck, arms and chest, body ache, muscle soreness was recovering at the time of the report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.  Amendment 30Jun2021: This follow-up report is being submitted to amend previously reported information: Patient state updated as two-digit, Dose Description updated as dose number unknown, single, Narrative sentence patient received second dose of BNT162b2 updated as patient received unspecified dose number of BNT162b2, Narrative updated. Narrative sentence The patient had not tested positive for COVID-19 since the vaccination was replaced with The patient had not tested for COVID-19 since the vaccination. And the sentence The patient did not received treatment for the reported events was replaced with It was unknown whether the patient received any treatment for the reported events.
Information has been received from a 30 year old pregnant female with allergies to eggs and perfume who on 4/6/01 was vaccinated with a 1st dose of MMRII. Concomitant therapy included verapamil HC1 (Calan), unspecified prenatal vitamins and amoxicillin 250mg BID times 10 days. The pt reported that within the 1st week, her arm began to swell and she developed a red lump. The pt reported that on 10/18/01, she had a small red bump and the muscle in her arm was sore. She states that follow-up blood work revealed that she was not immune and would need to be re-vaccinated. She indicated that she would wait until the birth of her baby to be re-vaccinated. Additional information has been received from the pt's physician. She had a history of 2 previous pregnancies, 0 live births. One pregnancy ended in a miscarriage at 19 weeks and the 2nd pregnancy ended in fetal demise at 21 weeks in 2/01. The date of the pt's last menstrual period was 7/29/01. Her estimated delivery date was determined to be 5/5/02. The pt's pregnancy was confirmed by a pregnancy test. The physician reported that the pt was not pregnant at the time of vaccination with MMRII. The physician reported that the pt had an upper respiratory infection at 6 weeks. On approx. 11/18/01, the pt had an ultrasound at 16 weeks. It was reported that the pt is still pregnant. Additional information has been requested.
Loss of Taste for a couple of weeks. Now everything I eat tastes bitter. I cant taste salt, sweet, or sour food.
Patient said that his arm hurt a lot just after getting vaccine and pain continued and got worse. He also said he was unable to lift his arm at all. Still hurts.
accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose?; accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose?; This non-serious spontaneous safety report, with company case number 2023SA234232, was received by partner on 31-JUL-2023 and forwarded to another company on 01-AUG-2023 from a physician.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose".  Further information is expected.  Significant follow-up information was received by UBC on 15-AUG-2023, from an HCP. The case is maintained as non-serious.  The causal relationship between Vaxelis and the reported events " accidentally received both VAXELIS and PedvaxHIB; she asks if there are any concerns since the patient received an extra HIB dose? " was assessed as Not applicable due to the nature of the event.  No further information is expected.
Intense flu-like symptoms including muscle aches, chills, and piercing headaches lasting two days. Extremely sore arm and armpit continuing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: When I first teste positive, I was asymptomatic; (2022) Positive, notes: Recurrence of infection with more syptoms than I had at onset. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid Covid-19 treatment from 07Jul2022 to 11Jul2022.  Clinical course: The patient had no known allergies. The patient had no other medical history. The patient did not receive any other medication in 2 weeks of vaccination. Patient was asymptomatic when she first tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tested positive for Covid-19 on 2/2/2022.  Expired 2/08/2022 with Covid-19 PNA,  acute hypoxic respiratory failure , AMS and aspiration PNA.  3rd pfizer vaccine 10/1/2021
Severe local rxn @ site of DTP inject; arm swollen 1 1/2 x size of other arm from shoulder to elbow; Erythema 10 cm in diameter; began evening of 1JUL91 approx 5-6hrs p/inject; inc in size; APAP & ice pack as well as DPH given;
This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route and anatomical location were not reported), lot # M034780 with expiration date on 15-APR-2019, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes. Previous temperature excursion was between 47 and 77 Fahrenheit degrees for 3 hours. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008599: US-009507513-1706USA001035: US-009507513-1706USA001033.
-pain, redness and swelling in right arm -achy all over, but especially in left hip joint area (where had a previous fracture), neck, and right scapula area. -headache -nausea (but no vomiting) - this may have been due to the Advil I took  -shivering in bed
11OCT95 pt recvd vax & that evening had a fever 102 became fussy & crying/screaming x 3hrs;next day pt woke up screaming & had emesis x3;9AM exp a sz episode-1min w/eyes fluttering x30seconds, tonic stiffness x 30 seconds then postical;
pt recv vax 1995 & 5/28/99 pt exp mild case of chickenpox;6/5/99 pt exp red, itchy hives that looked like one large cluster or 4-5 mosquito bites together;pt also exp sore throat, eyes swollen;taken to ER given epi, DPH & IV fluids;
Extreme fatigue, nausea, fever to 104 degrees, headache, rigors
This spontaneous report was received from a healthcare worker (who is a medical assistant) refers to an unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. The healthcare worker reported that multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # K026246 exp: 28-JAN-2017. The vaccine was stored at 47F and administered within in a time frame of 10 minutes. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Very painful at shot location; Area is swollen about 1 inch around the area of injection; The area is also very red, and itches; Area was tender to the touch.; The area is also very red; Area was tender to the touch and Very warm.; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration on the left arm on 18Mar2021 at 10:00 (at the age of 59 years), as single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included XIIDRA for unknown indication on an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration on the left arm on 25Feb2021 at 10:00, as a single dose for COVID-19 immunisation. On 18Mar2021 at 20:00, the patient experienced pain at the shot location, which was tender to touch, very warm, area was swollen about 1 inch around the injection site and the area was very red and itchy. It was reported that the events have been going on for 4 days. The patient had taken ice and treated with ibuprofen for the reported events which had taken the edge off but have lost sleep because of the discomfort. The clinical outcome of the events vaccination site pain, vaccination site tenderness, vaccination site warmth, vaccination site swelling, vaccination site erythema and vaccination site pruritis were not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from  an administrator concerning to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, some patients had been vaccinated with M-M-R-II (dose, route, lot number and expiration date were not reported) for prophylaxis. On unknown dates, the reporter stated that she knew of "outbreak of mumps" in several unspecified regions, additionally, the reporter indicated that some unspecified doses of properly stored M-M-R-II had been moved from  her geographic area to unspecified counties where the mumps outbreak had occurred. The reporter did not specify if any of these patients had been previously vaccinated with M-M-R-II. No additional information available. A product quality complaint was not involved.  The outcome of the event was unknown. The causal relationship between the event and M-M-R-II was not reported. Additional information is not expected as there is no consent to contact the reporter.
dose expired 2 days before administration; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-Aug-2022 Reporter's comment: The pharmacist intern reported that Twinrix was administered a patient (unknown data) and the dose had expired 2 days before the administration date (vaccine lot number and expiration date unknown, vaccination date unknown). The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used. The case was linked with case US2022116460, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022116460:Same reporter