chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Covid symptoms started Again and I tested positive once again; A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing), notes: Other medical history Hashimotos Thyroiditis. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "Covid symptoms started Again and I tested positive once again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (11Oct2022) Positive, notes: I started Paxlovid on 11Oct2022 (same day As Covid-19 symptoms appeared and Tested positive); (16Oct2022) Negative, notes: I tested negative on 16Oct2022; (22Oct2022) Positive, notes: On 22Oct2022, Covid symptoms started Again and I tested positive once again. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Patient started Paxlovid on 11Oct2022 and stop date was 15Oct2022, Lot number gf1750, (same day As Covid-19 symptoms appeared and Tested positive). Symptoms cleared up and patient tested negative on 16Oct2022. Then, on 22Oct2022, Covid symptoms started again and she tested positive once again. (she Isolated herself for 10 days and was not Exposed to anyone, she did so as not to Infect anyone else, so she can only Imagine this was a "rebound" of Covid). Other medication in 2 weeks, No known allergies.   No follow-up attempts are possible. No further information is expected.
No symptoms developed. We realized that patient was vaccinated incorrectly. Vaccine was diluted with Sterile diluent instead of enclosed diluent.
This case was reported by a consumer and described the occurrence of catching a cold in a 76-year-old male patient who received FLUARIX. On 23rd September 2014, the patient received the 1st dose of FLUARIX. On 23rd September 2014, less than a day after receiving FLUARIX, the patient experienced catching a cold, tickle in throat and feel shaky. On an unknown date, the outcome of the catching a cold, tickle in throat and feel shaky were not recovered/not resolved. It was unknown if the reporter considered the catching a cold, tickle in throat and feel shaky to be related to FLUARIX. Additional information: The patient planned to follow-up with his pharmacist on 24 September 2014.
Paralyzed in left hand, numbness in left foot, electricity going up and down  left arm, burning sensation in back of hand, weakness in left arm and hand. Currently on long term disability. Employed as a city bus driver. Currently not working.  Currently being reviewed for Social Security disability.
Nausea  Vomiting  Headache  Low grade fever  Muscle aches
Four inch wheal and flared area bilateral thighs. Indurated, excoriated, non tender at injection site.
Following morning severe upper arm pain and inability to move it. End up second day migraine, body aches, fever and diarrhea.
Immediately following receipt of MENACTRA, TdaP and flu patient became weak. Decreased BP noted, pale, clammy, glucose was normal. Responded to lying down giving juice. Likely vasovagal reaction.
No adverse effects were reported; Improper storage of product in use; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (lot # N030413, expiration date 05-JUL-2020).  Information about pertinent medical history, drug reactions or allergies was not provided.      On 15-SEP-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S002874, expiration date 29-JAN-2021, route of administration was not provided) for prophylaxis. The sterile diluent used to reconstitute varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. Administered dose of vaccine experienced temperature excursion of 7.64 degrees Fahrenheit (F) for 20 minutes. There was previous temperature excursion of 19.34 degrees Fahrenheit (F) for 34 minutes. Digital data logger was involved. No adverse effects were reported.
Tingling/Hot burning throat/tachycardia and chest tightness.  Presented to ED. Given diphenhydramine. Observed and discharged.
pt recv vax; devel T 100-102 x 5 days; clear rhinitis x 2 days, loose cough at noc x 2 days; non pruritic; macular papular rash, stomach ache on & off; dec appetite, listless
Following the 7 month old's well child check in room #3, he was supposed to receive his third dose of the DTaP, Pneumococcal and rotavirus vaccines, in addition to his first influenza vaccine. RN was supposed to enter a different room (#4) and administer the MMR, Varicella, and Hepatitis A vaccines to a 12 month old patient. The nurse entered the wrong room (#3) and identified the patient by the wrong first name (no last name or DOB). It has been disputed whether or not the mother heard or confirmed the wrong name for the patient. The child's mother proceeded to hold the child while Nurse administered the wrong vaccines to the child. There were no immediate adverse effects nor have there been any reported to date (5 days later). The mistake was realized by the nursing staff and reported to the physicians within the hour, although the patient and his mother had been allowed to leave with an immunization record containing the wrong vaccines. In a follow up phone call that evening I personally notified the parents via phone and we have since met in person to discuss possible adverse effects, the child's future immunization schedule, and a review of the practice's protocol for identifying patients and administering vaccines. I have also filed a incident report with our parent organization and personally reviewed the protocol and best practices separately with our entire office staff.
breathing problems, squinting, bluish in color-felt cool to touch until got to ER; non-responsive; shaking 101.4 w/APAP; MD dx afebrile sz;
Outbreak of pimples on the skin of face and neck, it breaks out small and becomes larger, after 20 to 30 minutes it disappears, but it reappears in other areas of face and neck, causes itching and burning, the color of the skin in the affected area changes to red and once it disappears, the color of the skin returns to normal.
Had Pneumovax in R arm on 04/11. Pt reports R arm/shoulder pain, inflammation, warmth and redness. Denies drainage, fever. TX: Aleve.
I had COVID-19 on 01/17/2023. I was prescribed Paxlovid medication and took this for five days. I had severe headache, fever of 102 degrees, shaking chills, nausea and a bad cough.  I did have a home COVID-19 test on 01/18/2023.  The Paxlovid helped me a lot started to feel better after my first day.  I have recovered from my COVID-19 symptoms.
11/23/05 Child walking around at home, fell limp, gray color, eyes staring, slight tremors of arms and legs.  Lasted approximately 5 to 7 minutes.  Transported per ambulance from home to Emergency Room.  Fever 102, testing completed, discharged to home.  To follow up with pediatrician.
After receiving the vaccine, my period was so heavy that I bled through super + tampons within 20 minutes. This continued for a day or two during each of my period cycles. This happened in the months of March, April, May, June, August of 2020. July I did not have a heavy cycle.
Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension since 02-Nov-2021 and Endometrial cancer (Patient using Lenvima for endometrial cancer and also reported having diarrhea symptoms since starting lenvima.).Concomitant products included LISINOPRIL from 02-Nov-2021 to an unknown date for Blood pressure management, PEMBROLIZUMAB (KEYTRUDA) and LENVATINIB MESILATE (LENVIMA) from 26-Oct-2021 to an unknown date for Endometrial cancer.On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had not resolved. Not Provided .DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 02-Nov-2021, Blood pressure measurement: 177/94 (High) to a high of 177/94.On 06-Nov-2021, Blood pressure measurement: diasolic 80 and apposed to 90 (High) but diastolic has been in the 80's as apposed to the 90's lately.No treatment medication was provided. Patient also reported that diarrhea symptoms have been less severe lately.This case was linked to MOD-2021-388720 (Patient Link).
edema of the injection arm, and the arm was very painful to move.; edema of the injection arm, and the arm was very painful to move.; edema of the injection arm, and the arm was very painful to move.; edema of the injection arm, and the arm was very painful to move.; This spontaneous report was received from a physician (patient's mother) via a company representative referring to a female patient of unknown age. The patient's concomitant medication, concurrent condition, pertinent medical history, drug reaction/allergies were not reported.  On an unspecified date in February 2019 (reported as about 6 months ago), the patient was vaccinated with the first dose of series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, route of administration, lot# and expiration date were not reported) by the patient's pediatrician for prophylaxis.  The patient subsequently experienced edema of the injection arm, and the arm was very painful to move on an unspecified date in 2019. She received ibuprofen and ice packs were put on the arm, and the patient recovered two days later.  Causality between events rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
pt recv vax & then became pregnant;pt LMP was 19MAY97;pt had a miscarriage on 26JUL97;No further details were provided;
Pt presented with rash on trunk of body that was tingly and painful, upon inquest he also revealed he had been having nose bleeds and swollen gums. The pt had been out of zoloft ~5d prior to event. Recommended f/u with PCP and pt went to urgent care where he was given amoxicillin and a topical ointment for his irritation. He also refilled zoloft prescription after initial presentation. 5/24 phone f/u revealed pain was gone and rash had subsided.
Pt requested preservative free flu shot and while getting vaccine ready. I picked up pediatric box instead of adult flu shot.
Patient tested positive for COVID 3/27/21. Completed COVID vaccine series 1/22/21. Asymptomatic aside from minor headache 3/27/21.
No adverse effects reported; Intramuscular formulation administered by other route; This spontaneous report has been received from an administrator, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 27-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) via subcutaneous instead of intramuscularly (dose, frequency, lot number, expiration date and anatomical locations were not provided) for prophylaxis. No adverse effects reported.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Convulsions-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Seizure-Medium
pt recv vax 13JAN97 & 20JAN97 pt exp a gen sz, temp 100.4-102 & took a longer nap;pt was taken to ER & tx w/Ativan & Rocephin;blood tests & CT scan nl;pt seem OK during MD visit 22JAN97;EEG & LP nl;
Muscle aches, nausea and vomiting with 2 dry heaves, neck pain and lower back pain, headache, dizziness and blurred vision, post vax. Cleared within 2 hours.
Immediately felt a pain above my eye and pain in arm - body aches , fever , chills, pain with breathing in . Chest pain . I was sick for about 3 -4 weeks . Cough
Pt recvd 3 doses of Engerix-B & reporter indicated that in 1991 40% of the vaccinated employees have not responded; reporter also indicated that many people are involved & that addtl doses are planned;
sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 28Mar2021, outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
allergic to the vaccine; This case was reported by a consumer via Interactive digital media and described the occurrence of allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient reported that he/she was allergic to the vaccine.
Myalgia, Fever, chills and "very sore" at the injection site Narrative:  Other Relevant History:
Pale, nausea tingling, light headed Solu medrol 2mg/kg Weight 56.7 kg Benadryl 50 mg iv Ativan 1 mg iv
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 38 year old male pt who experienced Flumist administered incorrectly and both biceps mildly sore.  At 38 years of age, the pt received a dose on 12/15/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/15/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy.  On 12/15/03, the caller reported that after Flumist was administered to him, the liquid ran down his cheeks and upper lip and into his mouth, and some drained down his throat.  He stated the administration was incorrect.  On 12/16/03, 15 hours post-immunization, both of his biceps were mildly sore, and the continued to be mildly sore at the time of this report.  No additional information was available at the time of this report. Follow-up information received from the physician confirmed a problem with administration. He stated the administration was incorrect and he did not receive a half dose in each nostril. On 16-Dec-2003, 15 hours post-immunization, both of his biceps were mildly sore. On follow-up, the physician confirmed the "problem with administration." No additional information was available at the time of this report.
This case was reported by a physician and described the occurrence of hepatitis B antigen positive in an infant female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject was tested for hepatitis B antigen and the result was positive. At the time of reporting the outcome of the event was unspecified. No further details were provided. It was reported that this event occurred in 4 infant subject from different hospital facilities. Linked cases include A0942898A, A0942899A and A0942900A.
Pfizer-BioNTech COVID-19 Vaccine EUA . I have a fever, body aches and chills. I used aspirin to  alleviate symptoms.
This spontaneous report as received from a healthcare worker refers to a 27-year-old male patient. Patient's concurrent conditions, pertinent medical history and allergies were not reported. On 05-JUN-2018, the patient was vaccinated with a dose of PROQUAD, lot# N035172, expiration date 09-JUN-2019 (dose of the vaccine, route of administration was unspecified) along with a dose of VARIVAX (dose of the vaccine, route of administration, #lot and expiration date were unspecified). The PROQUAD, was reconstituted with sterile diluent. No adverse event was reported.
Day 4: woke up with headache and sore throat.  As the day progressed I developed: weakness, tiredness, joint and body aches, chills and nausea.  Was told by nurse to come in and have a Covid test.  Was tested for Covid at 2:00 p.m. the day symptoms developed.  Test came back negative.  Symptoms last for 8 days however sore throat went away after one day.  Headache, chills and nausea lasted the entire time.  Body/muscle aches were more pronounced early a.m. and late p.m..
Pateint said she was feeling perfectly normal before the vaccination in her R lateral deltoid at pharmacy on 8/5/21 at 11:00 am, and during the injection everything felt fine. She said there was no pain and even told the administering nurse that she was an angel. In the evening, approximately 10 h after the shot she developed tingling tips of her fingers of the RUE, (first in the 4th and 5th digits). The following day she had pain in her R ear with hearing loss and then a generalized headache and b/l neck pain. She may have a had a low grade fever at this time. The following day her entire RUE became completely weak and completely numb (heat, touch, pain) distally from the site of the injection. The hearing has mostly resolved, although intermittently her husband notices that she can't hear things as well as she used to. The headache and neck pain resolved several weeks ago. The weakness and numbness  have continued and she cannot move her fingers, wrist, elbow or shoulder at all. No other extremities were effected. No other symptoms.
A 52 year old female was treated with OncoTICE. After the first instillation she presented with gross blood in her urine. OncoTICE treatment was discontinued and the event was resolved.
She broke out in hives all over her body and made her face slightly puffy. The hives made her a little itchy. It became purple under some of the hives around the injection site. We were told to give her Benadryl.
Fever; Severe vomiting; Chills; Headache; Arm was sore; Fatigue; A spontaneous report was received from a medical assistant, concerning herself, a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed sore arm, fever, severe vomiting, headache, chills and fatigue.  The patient's medical history included COVID-19 at the end of Oct-2020. Concomitant product use was not provided by the reporter.  On 25-Jan-2021 at 07:50 AM, the patient received their first of two planned doses of mRNA-1273 (Lot # 012L20A) in the left arm for prophylaxis of COVID-19 infection.       On 25-Jan-2021, late in the afternoon, after the first dose of vaccine, the patient got headache and her arm was sore. The same evening, she experienced chills, fever of 100.7 Fahrenheit (was high in the hospital) and severe vomiting. Hence, she was hospitalized for two days from 25-Jan-2021 to 27 Jan 2021 and was treated with acetaminophen, fluids, ondansetron and potassium. On 28-Jan -2021, patient still had a little bit of headache and fatigued.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, headache and fatigue were considered not resolved at the of this report. The outcome of the events, sore arm, fever, severe vomiting and chills were resolved on 27-Jan-2021.  The reporter did not provide an assessment of the events, headache, sore arm, chills, fever, severe vomiting and fatigue.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information will be requested.
9/5/08 - Received Varicella vaccine SQ in right arm. 9/8/08 - Large red area around shot area. Seen at office. Instructed to go t ER if red circle got bigger today. 9/8/08 - To ER. Admitted to R/O cellulitis at varicella inj. site.   12/1/08 MR received for DOS 9/8-10/2008 with D/C DX: Cellulitis. Pt presented with pain, swelling and erythema at the site of varicella vaccine on the R arm. Tx with abx with almost complete resolution by d/c.
Parents report onset of rash, distal extremities later in the day after vaccine administration.  Went to ER at hospital, diagnosed with allergic reaction and treated with diphenhydramine.  Denied fever, change in eating habits, irritability or pruritis.  Rash progressed to trunk and parents went to second Emergency Room at hospital on 12/1/2010, diagnosed with urticaria and treated with diphenhyrdamine.  Per parents rash quickly resolved.
Patient grow hot and clammy.  He said he felt nauseated and itchy around the neck.  There was no redness or signs of rash on the neck or injection site.  Patient was observed for 45 minutes and given a cold compress for the back of his neck.  Patient grew cooler and no longer felt dizzy, nauseated or itchy.  He said he had experienced similar reactions after his chemotherapy.  Afterwards patient chose to shop around the store.  He checked back in after an hour and said he felt better.  We once again observed and saw no signs of redness or rash.
About one week after my second shot, my hair began falling out in significant amounts. This has been continuing for several weeks now.
felt pain on arm first day, next day felt flat red spots, warm to touch on stomach, 6/23/21 spots have worsened, they have spread.  scheduled appointment to see doctor.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. On an unknown dates (time frame: 21-DEC-2015 to 05-JAN-2016), the patients were vaccinated with improperly stored doses of VAQTA lot # K018181, expiry: 04-JUN-2017 and lot#: L039659, expiry: 15-MAR-2017. No previous temperature excursion reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 12-month-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 05-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, once, lot number U022321, expiration date 15-JUL-2023 for prophylaxis (route of administration not reported) No adverse event was reported.  The vaccine underwent a temperature excursion of -8.1 degrees Celsius for 4 hours. No previous temperature excursions were reported.