chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called to report a reaction to the SHINGRIX vaccine administered in left deltoid intramuscularly on 3/25/19. That was three days ago. She reports that the site of the vaccine became very red and edematous. A golf ball size lump developed and her entire arm was edematous and she could not lift it. Each day it seems to be getting worse - more red, hot, larger lump at the site. Currently, the vaccine site has a lump the size of a softball and her entire arm is tight within her shirt sleeve. She has been using ice packs and at times alternated hot to cold on the arm. I advised her to see her primary care physician locally as soon as possible. She stated that she is going to do that right away this morning.
Back Ache; Dizziness; Fever; Chills; Headache; This spontaneous case was reported by a nurse and describes the occurrence of BACK PAIN (Back Ache), DIZZINESS (Dizziness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 03-Feb-2021, the patient experienced BACK PAIN (Back Ache), DIZZINESS (Dizziness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). In February 2021, BACK PAIN (Back Ache), DIZZINESS (Dizziness), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Very red, almost like sunburn, skin flaking, hives, chest heavy, asthma like wheezing following morning
had a spike in blood pressure noticed the day after the vaccine at a medical check-up appointment. Came down the following day. Doctor prescribed increase in blood pressure meds before it came down the following day.
Large, raised bump that lasted 11 days at injection site. Very sore, some days itchy. Did develop a small red ring around the bump, but did not show every single day,
Approximately 7 mosquito bite looking hives on each leg and a few on each arm that itch. States has to be from flu shot b/c he hasn't done anything different. States they itch.
Information has been received on 01-FEB-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 20-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster with complications in the eye. On or about 20-JUN-2016, the patient was treated by a physician for the onset of an eye disorder, which was diagnosed as conjunctivochasis, which is often attributable to zoster infections in the eye. On or about 22-JUN-2016, the patient sought subsequent treatment from the same physician for ongoing and worsening symptoms of vesicular outbreaks, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gentamycin ophthalmic solution and VALTREX for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, zoster infections in the eye/herpes zoster with complications in the eye was considered to be medically significant. Additional information has been requested.
SMALL BURNING SENSATION ON INNER THIGH OF RIGHT LEG; TINGLING AND BURNING BEHIND KNEE (COMES AND GOES); CHILLS (ON AND OFF)/ COLD; FEVER; VERY TIRED; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-NOV-2021, the patient experienced chills (on and off) / cold. On 12-NOV-2021, the patient experienced fever. On 12-NOV-2021, the patient experienced very tired. On 13-NOV-2021, the patient experienced small burning sensation on inner thigh of right leg. On 13-NOV-2021, the patient experienced tingling and burning behind knee (comes and goes). Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills (on and off)/ cold, fever, small burning sensation on inner thigh of right leg, very tired and tingling and burning behind knee (comes and goes) was not reported. This report was non-serious.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years 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: "Had collapsed lungs 9 years ago" (unspecified if ongoing), notes: Had collapsed lungs 9 years ago. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Anti-viral details: Paxlovid from 10Aug2022 to 14Aug2022. After taking paxlovod she recovered and got back to normal. Then she suddenly got congested. Exhausted. And a sore throat. Her cough returned and she tested positive again. Device Date: 22Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
RECEIVED FIRST DOSE MODERNA 1/25/2021 RECEIVED SECOND DOSE PFIZER 2/19/2021
Pt complained of redness to injection site right deltoid, started evening of shots. Last night fever to arm and pt with fever of 100. Referral to Dr made 1/25/01 for treatment of possible infection.
Fever of 99 to 101 until 4pm 3/19.  Extreme fatigue.
lightheadedness/ dizziness; brain fog; patient can barely function; prolonged fatigue / unrelenting fatigue; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (lightheadedness/ dizziness), FEELING ABNORMAL (brain fog), IMPAIRED WORK ABILITY (patient can barely function) and FATIGUE (prolonged fatigue / unrelenting fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic anemia.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheadedness/ dizziness), FEELING ABNORMAL (brain fog), IMPAIRED WORK ABILITY (patient can barely function) and FATIGUE (prolonged fatigue / unrelenting fatigue). At the time of the report, DIZZINESS (lightheadedness/ dizziness), FEELING ABNORMAL (brain fog), IMPAIRED WORK ABILITY (patient can barely function) and FATIGUE (prolonged fatigue / unrelenting fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.  The physician believed that it was not related to patient's chronic anemia but he believed probably due to patient's age.   The physician believed second dose was on 24-Apr-2021.
rash over both arms and neck/chest area as well as sides of my face. small bumps from arms to fingers and most prevalent across necka nd chest
Shivering throughout night and part of next day Low fever at night muscle pain at night and next day slight headache at night
Initial unsolicited report received from a Consumer (patient's father) on 05-Oct-2015. This case was linked to 4 other cases with ids 2015SA154152, 2015SA154146, and 2015SA154190 (same reporter and vaccine). This case involves a female patient (age was not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (Quadrivalent Influenza Vaccine) (manufacturer: unknown, batch number, expiry date route and site of administration was not reported) on unspecified date over the week end. Medical history and concomitant medications were not reported. On unspecified date, patient had experienced little soreness after shot. Patient had received Quadrivalent Influenza Vaccine last year with no ill effect. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Pt. stated that she is experiencing more redness at the site than she usually feels. Injection site also feels hot and hard to the touch. Pt. feels that the injection site may have been off by a little bit, and possibly not injected into a muscle. The picture she showed this nurse, shows the injection site to be closer to the armpit than in the middle of the deltoid muscle.
Very ill; chills; fever; severe headache; nausea; diarrhea; lethargy; aches; tiredness; eye lid swelled; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 27Mar2021 at 12:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 15:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation and the patient received amoxicillin and was allergic to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 12:00, approximately 24 hours after the vaccination, the patient became very ill, had chills, fever, severe headache, nausea, diarrhoea, lethargy, aches and eyelids swelled up a little. The patient slept for 14 hours and felt much better the next day, but had lingering symptoms of aches, tiredness and headache. The patient did not receive any treatment for the reported events. The clinical outcome of the events very ill, chills, fever, severe headache, nausea, diarrheic, lethargy, aches, eyelids swelled and tiredness was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Patient asked to have both vaccines in the same arm. Per patient area was sore but then it got red, painful, and inflamed yesterday. Today she had a 3 inch band around her arm at the level of the injection. The area also became hot and she felt unwell. I counseled her to go in and see her doctor.
Information has been received from a physician concerning an approximately 4 year old female patient who "several years ago" at her 1 year appointment was vaccinated with varicella virus vaccine live (Oka/Merck). Follow up information from the physician indicated that approximately 1 year (date unspecified) post vaccination, she developed herpes zoster. The patient on an unspecified date about 1.5 years (dated unspecified) after the first occurrence, she developed a second occurrence of herpes zoster. The physician indicated that the vesicular lesions were located on the anterior chest and had re-occurred in the same place. On 08-JAN-(year not specified), a culture was obtained by a dermatologist of the lesions that grew only herpes simplex virus. The patient currently is not enrolled in the VZV ID Program. The physician indicated that 1 or both of the parents are physician's and they believed that these events were related to vaccination with varicella virus vaccine live (Oka/Merck). The physician indicated to the parents that she felt the child should have an immunologic evaluation, including HIV testing, as 2 occurrences of zoster within 18 months may be indicative of an underlying undiagnosed immunodeficiency. The physician indicated that the patient's parents were not sure such an evaluation was necessary, and to her knowledge, they had not agreed to an immunologic work up of the patient. The physician also reported that the parents were insistent that the patient had not had any previous varicella exposure before or after vaccination as well as in utero. It was reported that the patient's brother has had recurrent lesions as well. Current patient status was not reported. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Follow-up information received indicated that the patient was not under the physician's care.  The name and information of the primary care physician had been provided.  Additional information has been requested.
Case number PHEH2016US033577, is an initial spontaneous report received from a pharmacist on 20 Dec 2016. This report refers to a 35 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620601, expiry date: Jun 2017) at a dose of 0.5 ml intramuscularly on 20 Dec 2016. On the same day while administering the vaccine to patient, the pharmacist withdrew vaccine form multi dose vial (MDV) into syringe and then the vaccine splattered into pharmacist eye.  The pharmacist reported that, the plunger on the syringe was faulty. There was no product complaint for FLUVIRIN MDV. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious.
injection site itchiness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, VACCINATION SITE PRURITUS (injection site itchiness) and VACCINATION SITE ERYTHEMA (injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment included antibiotic ointment.   Reporter did not allow further contact
I received the vaccine at 6:00pm. The following morning around 9:30am became extremely nauseous out of the blue. I started throwing up and my whole body was in pain. I laid on the floor and then lost vision and began to shake. I could feel my head shaking but couldn?t ?wake up.? My roommate called 911 and the EMR came. They said it was a seizure and took my vitals, etc which were all back to normal after the event.
Day 1-3 fever, treated with Tylenol & Motrin; day 4-full body rash appears.
Patient reported an anaphylactic-type reaction; throat closed up, went to the ER.
Pruritis approx. 3 hours after immunization followed by rash over trunk and then arms, legs. Tingling in hands and feet approx. 12 hr after immunization followed by vomiting.
Guillian barre/ Bell?s palsy, roughly 8 days after second dose. 4 months later and I still have numbness and paralysis.  Covid vaccine arm rash within 5 days of first injection.
Left arm went numb immediately after getting flu shot. All joints felt inflamed and painful immediately after.  Left arm felt weak couldn't carry my daughter. Felt very itchy. Then 10/25/19 I started getting rashes all over my body and they would come and go. Horrible headaches since getting the flu shot.
Swelling, redness, itching around injection site. Symptoms relieved with Benadryl.
No additional AE information; HCP called in to report that a consumer received their first dose of GARDASIL 9 on 01/04/2018, and second dose on 02/28/2019. Caller reports the patient was administered a third dose of GARDASIL 9 on 11/15/2022. No further information provided to fur; This spontaneous report was received from a nurse and refers to an 11-year-old male patient. His medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 04-JAN-2018, the patient was vaccinated with 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U029623, expiration date: 26-OCT-2023 (strength, exact dose, site and route of administration were not provided) for prophylaxis. On 28-FEB-2019 and 15-NOV-2022, the patient received respectively second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration). No additional adverse event was reported.
Chills, flu like symptoms, fatigue, low fever, had to sleep for 4 hours.
pain under her arm; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received the second dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient received the second dose of the vaccine and noticed that the pain under her arm is still there. It started on Saturday 09Jan2021, and she was wondering how long that will persist. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Noticed after I gave vaccine that his first one was on 6/14/21.  I called patient because he had left before his 15 minute waiting period was done.  He said he thought that it was 2 weeks from the first one.  I said that according to the informatin on the CDC web site, he does not need to repeat the dose.
>35 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Patient complained of itching "all over" with a sparse rash on left forearm and right hand.  Rash resembles mosquito bites.
I contacted my physician and I have a varicella like rash. So far I do not have any blisters, but I have about four bumps within a very large bump taking up the back side of my arm, which look like they may blister up. I was told to take further action if I had more than ten blisters in the large bump. It is extremely painful, and hot to the touch.
Off and On High Fever (102.7) with sever chills, nausea, fatigue lasting six days. Chills stop, low grade fever continue for three more days, rash appears on my neck, back and front of my body. Doctor insist I get a Covid 19 test. It came back negative. This was my first pfizer vaccine.
This case was reported by a consumer via patient support programs and described the occurrence of cold in a 58-year-old female patient who received FLULAVAL Quadrivalent for prophylaxis. Co-suspect products included fluticasone propionate, ADVAIR DISKUS unknown for an unknown indication. On an unknown date, the patient received FLULAVAL Quadrivalent at an unknown dose and ADVAIR DISKUS 250/50 mg at an unknown dose and frequency. On an unknown date, 1 day after receiving FLULAVAL Quadrivalent and less than a year after starting ADVAIR DISKUS, the patient experienced cold. The patient was treated with NYQUIL. On an unknown date, the outcome of the cold was unknown. It was unknown if the reporter considered the cold to be related to FLULAVAL Quadrivalent and ADVAIR DISKUS. Additional details were provided as follows: The patient mentioned she was having cold since a week and a half. She caught it just the next day she had her flu shot. She was taking NYQUIL, which helps her breathe during night.
Within 3 weeks of second vaccine, began experiencing joint pain and swelling. Recently my lab markers tested for autoimmune response were elevated. I?m being evaluated for rheumatoid arthritis or other autoimmune disorder. I have never had a history of these issues prior to COVID vaccine. I also had COVID back in December so 2020.
within 5-10 mins of receiving vaccine she started to feel light headed and jittery and "floaty" - she says she feels like, "I am not here, right now" - there are no hives - no swollen lips or tongue - pt denies SOB. pt was sent to ED at 8:18 AM for further evaluation. no significant findings and patient was discharged at 10:22 AM
Td given 5/21/09 LDT - RTC 5/27/09 and large red warm localized reaction to Td.