chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reports getting diagnosed with shingles approximately 7 days after getting the shingrix vaccine.  This was the first dose.  She has had a  previous episode of shingles in the past.  The location was the abdomen and much of it was beneath the skin according to the patient.
Pfizer Covid 19 vaccine vial was mixed with 1.4 instead of 1.8 ml of diluent and a dose was given to the patient. Spoke to patient 04/11/2021. He stated he was feeling fine. Provided counseling regarding possible side effects and what to do if he experiences any.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 13-JAN-2017, the patient received RECOMBIVAX HB strength 10/1.0 microgram/ml, at a dose of 1.0 mcrg/ml (lot # M039642 with expiration date of 30-JUL-2019) intramuscularly for prophylaxis. On 24-JAN-2017, the patient  inadvertently received RECOMBIVAX HB strength 10/1.0 microgram/ml, at a dose of 1.0 mcrg/ml (lot# M036156 with expiration date of 23-FEB-2019) intramuscularly for prophylaxis. No adverse effects reported. Furthermore, no product quality complaint was involved. Additional information has been requested.
COVID test positive Wednesday morn; COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN8705), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 21May2022 as dose 4 (booster), single (Lot number: FU4989) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Pre-diabetic" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Known allergies: Statins" (unspecified if ongoing); "Known allergies: Yellow dye" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; OMEPRAZOLE; WELLBUTRIN; EZETIMIBE; BIOTIN; CALTRATE VITAMIN D3; ELDERBERRY [SAMBUCUS NIGRA]; ZINC. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 20Jul2022, outcome "not recovered", described as "COVID test positive Wednesday morn". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: Paxlovid taken Sunday 10Jul2022 evening thru Friday 15Jul2022 morning. Bit breathless Saturday Sunday prednisone and nebulizer added Monday 18Jul2022. Improved until Wednesday late afternoon (20Jul2022). COVID test positive Wednesday morning (after nearly disappearing Sunday 17Jul2022) Dyspnea, headache, malaise Thurs 21Jul2022. Dyspnea, headache, loss of taste and smell Friday 22Jul2022. AE treatment: Prednisone (Medrol pack) and nebulizing Albuterol.
Patient phones the Hospital and reports that on 2/18/2010 dose received at 2:30pm and client broke out in hives at 5pm over arms, legs. Itching. Denies throat feeling swollen or tightness. Instructed to contact ER/Dr. if S/S worsen. Also take OTC antihistamine. Denies any allergy to egg or egg products.
I was vaccinated in the hospital 2 days after my first son was born. I was told I needed to be revaccinated since my "rubella shot never took" despite telling them I didnt want it many times I was told I had to have it and gave up the fight. I nursed my son for 8 months. He had explosive diarrhea and vomiting daily from when he was a few days old until he was 3 years old and we started interventions. With each vaccine he received he would regress from any progress he'd make. He was speech delayed, throwing 4 hr long tantrums and not making eye contact. He was diagnosed with autism at age 3. One of the vaccinations at 15 months old left him crying until he passed out and his temperature got so high that it broke my thermometer. Last reading was over 105. He developed many food allergies and was at one point up to 20 different foods.
Three weeks after varivax, the pt became ill with varicella rash about 30-40 spots. Mom not sure about fever.
Case number PHEH2014US024336, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 73 year old male patient. Historical condition and concomitant medication were not reported. His past vaccinations (unspecified) were well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in left deltoid at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. Patient did not experience any adverse event. No adverse event was reported following this medication error. Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
States her right arm was "knotted," swollen, bruised, sore and tender to touch within 24 hours of getting last dose of hepatitis B vaccine. States that dose "stung" more than others she's received. Firm, indurated, bruised area approximately 2.5 cm x 3 cm noted right deltoid area at/near injection site. Smaller firm, indurated, bruised area approximately 1.5 cm x 1.5 cm noted proximally and medially on right upper arm. States she felt like "vaccination drained to that area." No increased temperature or redness noted. Denies fever/chillls. States she takes a daily baby ASA. States she has never had a similar reaction to any vaccination. States she does not need medical evaluation or treatment at this time.
Spike in blood pressure and numbness/tingling down arm within minutes after the injection. The following morning, swelling on face and jaw as well as inside and around the mouth, including the tongue. Took Benadryl to relieve symptoms.
28OCT AM devel urticaria on trunk of body, macular rash went to hosp ER-told to take DPH;29OCT AM devel swollen tongue, airway obstruction to ER given short & long acting Epi
In the evening I noticed my nose was running and I was very tired with a cough.  I had fitful sleep that evening.  This was just returning from a trip.  5/12 Symptoms stayed about the same.  5/13 I had overwhelming fatigue and tested with an At Home COVID-19 Test.  Positive results.  5/15 Talked to doctor who proscribed Paxlovid.  When I started taking Paxlovid, the fatigue and the runny nose really diminished.  By 5/17 I felt much better, the nose had stopped running and there was very little coughing.  Symptoms got gradually better until 5/22 I was felling recovered.
Patient's arm was swollen and red at injection site immediately after vaccination. Redness and swelling continued for several days worsening to cover an area from shoulder to elbow, with limited range of motion in the arm since it hurt so badly to raise it. Patient expressed having a constant headache at her forehead for nearly a week. She was lethargic and cranky with fits of crying in between. (Highly unusual for her).  She simultaneously (evening of vaccination) developed a rash on the backs of her thighs that became rough and eczema-like within a day. The areas (arm and legs) were hot to the touch, red, and her legs were cracking and inflamed.   Consulted her pediatrician who said the reaction was in line with this vaccine. She suggested topical hydrocortisone cream (1%- otc) followed by Aquaphor 2xs daily for the legs. The eczema persisted for several months. The redness and scaly skin subsided in late August. Her legs sustained pigment loss where the reaction occurred.   Her 4th dose of of DTaP on 9/29/2020 caused an immediate relapse, and more severe reaction including a low grade fever. We are currently treating the same location on backs of her legs for the resulting eczema. This time the area appears to be more tender and bleeds.
Fever (102.3), Mild Headache, Extreme Aches and Chills. Weakness needing help getting off couch to use restroom.
Flu-like symptoms; Feels weak; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ASTHENIA (Feels weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ASTHENIA (Feels weak). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ASTHENIA (Feels weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.  This patient reported she used her walker all the time due to the weakness. She spoke with her physician and her physician was not sure if it is a reaction to the vaccine.   This case was linked to MOD-2021-050765 (Patient Link).   Reporter did not allow further contact
Pt received vaccine in left arm on 7/14/03 - seen on 7/16/03 with erythema 5 x 5cm over on left upper arm, no complaints of pain or itch. No treatment recommended. Localized reaction.
Left arm became red & by Thursday wasn't better after 2 days. Pharmacy advised me to go to clinic. Doctor prescribed KEFLEX for injected arm. Red the size of palm of my hand. Very warm.
The patient reported a red, itch, swollen, warm welt measuring 4 inches across at the injection site. Patient took oral diphenhydramine and applied aloe vera gel to the site.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:18 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 80.47 at vaccination on 28-Feb-2021 and 80.55 at 28-Mar-2021.  On 28-Feb-2021, Excursion time was 09 AM and 01 PM, temperature was 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials was sent to clinic. Vaccine BUD dates was 26-Mar-2021.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials was sent to clinic. Vaccine BUD dates was 22-Apr-2021.  Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Case number PHHY2015US139890 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 582265) website on 20 Oct 2015. This report refers to a 55 year old female patient. Medical history was not reported. Current conditions included asthma, sickle cell disease and beta thalassaemia. Concomitant medications included VICODIN, PERCOCET, ADVAIR 250, SINGULAIR, FLONASE, ALLEGRA, Vitamins D3, folic acid, biotin and calcium. The patient was vaccinated with FLUVIRIN (batch number: 141301) intramuscularly into the arm on 02 Oct 2014. On 03 Oct 2014 the patient developed rash that was large as an apple, itching and pain in arm. Further the patient developed redness on the shot area. The outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality of the events was not reported.
The vaccine was given higher than usual deltoid IM injection. The next day after vaccine, began experiencing shooting, burning pain from left scapula to left elbow to left wrist. Experienced numbness/tingling to left 4th and 5th fingers and along left side of wrist. The pain awoke me from sleep and have had little to no relief using Ibuprofen, TENS unit, heat or ice as treatment.  Since CDC said the side effects of vaccine may last 4 days or so, I waited it out and finally went to see doctor (at Dr's office ) on 10/16/21. I was examined and prescribed Norco for pain as it was too soon after vaccine to receive steroids.
Said friends wife has been really sick since; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Said friends wife has been really sick since". Additional information: The patient is afraid to get second dose.   No follow-up attempts are possible. No further information is expected.
Varicella vaccine breakthrough.  Diagnosed with Varicella in our office on 3-21-08.  Had 40-50 lesions, papules and vesicles.  Afebrile.
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO.   I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
Approximately 11 hours after the injection, patient awoke with all over body aching, joint ache, fevers to 100.6-oral, severe fatigue and malaise.  Left deltoid very sore, warm, slightly red--2 inches in diameter at the start--increasing to approximately 4 inches in diameter at the worst of the reaction.
very sick; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (medically significant), outcome "unknown", described as "very sick".  Clinical course: Patient got the vaccine and each time she got it she got very sick bedridden 3 days. Side effects after the vaccine was serious. She got very sick herself and couldn't work.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the event Malaise and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Patient was a resident of Health and Rehab Center who tested positive for Covid-19 on 01/13/2022 at facility.  Patient was not hospitalized for illness and expired at facility on 01/15/2022.
This case was reported by a consumer and described the occurrence of stomach pain in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 20 July 2011 the subject received 1st dose of ROTARIX at 1.0 ml, orally. It was discovered that the ROTARIX vaccine administered was prepared with diluent from chicken pox and measles vaccine. This was the wrong solution used for drug reconstitution. On the afternoon of 20 July 2011, less than one day after vaccination with ROTARIX, the subject experienced stomach pain and irritability. At the time of reporting the events were unresolved.
the numbness it is definitely seems to be getting worse; Balance is off; have the phantom sensations; feeling somewhat disconnected mentally; my left arm has pain; Symptoms related to facial numbness in my face and left side arm and leg; have a tension style headache - no migraine symptoms; Vision is so hard to focus; This is a spontaneous report received from a contactable consumer (patient).   A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: F128734), via an unspecified route of administration in arm right on 29Mar2021 at 09:45 (at the age of 54-year-old), as a dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis. Past drug event included Neurontin, Accutane, rapiflo and experienced known allergies. Concomitant medications in two weeks included siponimod (MAYZENT), diphenhydramine hydrochloride (BENADRYL), vit d, 83 aspirin taken for an unspecified indication. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 29Mar2021 at 15:00, the patient with multiple sclerosis day of equal to the symptoms related to facial numbness in his face and left sidearm and leg. Balance was off the patient have not fallen but weirdly any touching on his face leaves residual sensation for minutes and was somewhat painful. Arm and leg do not necessarily have the pain but do have the phantom sensations and general numbness. Stated that, the patient was feeling some-what disconnected mentally and not sure what to do about that. Although the shot was in his right arm, his left arm has pain where the shot would have been - weird. Next day on 30Mar2021, for the numbness it was definitely seemed to be getting worse. Also, now he had a tension style head-ache, no migraine symptoms on 29Mar2021. Blood oxygen level was 98 percent. Numbness really only set on this morning with the facial residual sensations, Temp was 97.8f, HR was 83bpm. Stated that, the patient really had to think about doing things with his body and he hope that makes sense. No chest pain or breathing issues. Balance way off vision was so hard to focus. The events resulted in physician office visit. Treatment was not received for the events. On 30Mar2021, the patient underwent lab tests and procedures which included Temp was 97.8f (body temperature), resulted as 97.8 Fahrenheit, HR was 83BPM (Heart rate), resulted as 83, Blood Oxygen level is 98 percent (oxygen consumption), resulted as 98 percent. The outcome of the events was reported as resolving.   No follow-up attempts were possible information about lot/batch number could not be obtained.
Have Rheumatoid arthritis, have had a very bad flare since first of Apr2021.; joint pain; nodules on both hands; hearing loss; autoimmune disease; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration in left arm on 02Mar2021 at 01:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization in a public health clinic/veterans administration facility. Medical history included rheumatoid arthritis, high blood pressure (BP) and gout. There were no known allergies reported. The patient had unspecified rheumatoid arthritis medications and were stopped 2 weeks prior to the COVID vaccine. There were no concomitant medications. No other vaccines was received by the patient within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and post-vaccination, the patient had not been tested for COVID-19. The patient experienced rheumatoid arthritis which had a very bad flare since 01Apr2021. The patient had joint pain, nodules on both hands which were not present before and had hearing loss due to autoimmune disease in 2021. Patient received steroid treatment via unspecified oral medications and injection for these events which resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage. The outcome of events was not recovered at the time of report.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.