chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The information has been received from an office manager and a physician concerning a 13 years old male with no concurrent condition, no pertinent medical history or drug allergies who on 15-AUG-2011 was vaccinated with his first dose of GARDASIL (lot number 1009AA) and on 17-OCT-2011 was vaccinated with his second dose of GARDASIL (lot number 1317AA). No concomitant medications or vaccines. The reporter stated that after the first dose, the patient tolerated well. On 17-OCT-2011, the evening of the second dose, the patient experienced high fever/106 degree fever and seizure. The seizure was witnessed by the mother, a registered nurse. No treatment was needed. The patient did not go to emergency room. Mother simply called the physician the next day and related the incident. A list of neurologist names was given to the mother. The patient recovered from the fever and seizure. As the physician did not witness the seizure, she could not say if it was life threatening or disabling. The third dose would not  be given. Upon internal review, seizure was considered to be an other important medical event. This is one of several reports receive from the same source about siblings. Additional information has been requested.
Pt recvd 1 dose of Engerix-B & devel pain @ inject site & pain along migraine tract;
Shortness of breath, vitals wnl. Given albuterol 2 puffs
Initial case was received from a health care professional on 22 November 2013. A 6 patients both male and female (age unknown) had no medical history reported, received a dose FLUZONE ID 20 November 2013 (batch number U4728AB). Patient had not reported concomitant medication. It was reported that on 21 November 2013 patients reported that they had redness, swelling, itchiness at injection site. Patient had received ibuprofen and BENADRYL as a corrective treatment (route, site and dose not reported). At the time of report the outcome of event was unknown.
Sore arm; Tired; Intense itching at injection site; red spot (on my arm); Malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) in a 64-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) in a 64-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported.
Patient developed local reaction. Presented as a large, red, egg shaped welt on the back of her arm. It also itched. On 11/10/16, the patient reported that the welt is more pink in color, and is starting to get better. Patient did not seek medical treatment.
Initial report received from a non-healthcare professional (patient's parent) on 05 June 2014. A male patient of unspecified age and gender had received a dose of FLUZONE, (batch number, dose number and route of vaccination not reported) in left arm on an unspecified date in October 2013. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced bruise and a reoccurring scar that falls off and comes back at the injection site. Corrective treatment and laboratory details were not reported. At the time of this report the outcome was unknown. Documents held by sender: none.
The evening that I received my vaccine I felt feverish and head a headaches and body aches and chills. I didn't feel ok until 4 pm the next day. Then I just felt fatigued for about a week. On 11/3 2021 I fainted randomly while with a patient. I had no warning signs, and my blood sugar was normal. I called my doctor the next day and made an appointment. They ran a bunch of tests including a COVID-19 test. The COVID-19 test was negative. My PCP told me she has had other patients who have fainted after the vaccine as well.
pt recv vax & devel fever;the following day pt devel a rash on the thigh of the injected leg 1mm from the puncture site & onto he rt side of the abd;pt also had a vesicle on the thigh;DPH was resolving the rxn as of the date of this report
Patient noted lump on (L) deltoid area yesterday from where immunization (TDAP) shot was administered on 3/10/16. Area tender to touch, (+) erythema, no drainage, lump measured 3x3cm. 46 y/o female presents for reaction to DTAP that was given 6 days. Pt noted last night that she had a lump that was sore to the point that every time she lifts arm was painful in last 24 hours. Today massaged which help. Pt here today for eval. No fever, chills. Circular raised and tender to touch over site w/vascular appearance and pt had malaise. Pt also had pain w/ROM 6 days after injection.
Symptoms: Fever (101.5 degrees F), chills, headache Duration: about 24 hours Treatment: Ibuprofen for fever reduction Outcome: Recovered
Incredible pain in right ovary so bad I thought it might have burst or been a burst appendix. Had to go to emergency care on April 5th. April 6th got period. Should not have had period so soon. Highly irregular. So much pain.
Muscles tired; Fatigue; numbness in face; feeling off; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 38-years-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Em9809) via unspecified route of administration in Right arm on 14Feb2021 at 08:45 AM as dose 1, single (age at vaccination 38 years old) for covid-19 immunisation. Patient medical history included attention deficit hyperactivity disorder from unknown date. Patient had no known allergies. Patient did not received any other vaccine in four weeks. Patient did not received other medications in two weeks. The patient had not diagnosed with covid prior to vaccination and had not been tested post vaccination. On 23Feb2021 at 12:00 AM patient experienced fatigue, numbness in face, feeling off, muscles tired. Patient did not received treatment for adverse event. The outcome of events were not recovered.  Follow-up attempts completed. No further information expected.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: \"bones hurt\"-Medium, Additional Details: Patient called to look into information to report side effects for vaccine. She stated her bones hurt, sore arm, hard bump at injection site. She also reported shortness of breath. I informed him to go to emergency room if she was having shortness of breath (Saturday) and she stated if it did not improve by next day she would. The patient did not seem short of breath on the phone while we were discussing.
One episode vomiting just after receiving vaccine, hives, facial/eye swelling treated with BENADRYL and IM steroid.
Presented to hosptial on 1/8 with altered mental status and decreasing urine output over the last few weeks. Had been treated OP for UTI with 2 different courses of antibiotics. CXR concerning for pneumonia with COVID-19 +. No respiraotry issues on admission. Started on bicarb drip to improve metabolic acidosis. Urine culture + for staph aureus and switched to rocephin. Oxygen requirements were up and down during stay. Mentation continued to be poor and unable to take much oral intake. Attempted NG tube palcement without success. WBCs increased and antibiotics were broadened. Family declined peg tube placement. Patient continue to decline with increasing O2 requirements and hypotension with less responsiveness. Family requested DNR, expiring approximately 48 hrs later.
This spontaneous report as received from a physician via a company representative refers to a 62 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (frequency, dose and lot # not reported), "injection". On an unknown date the patient experienced red rash under her yes, her nasal passages were inflamed and she also developed a shingles-like rash on her fingers, after receiving ZOSTAVAX. On an unspecified date, the patient sought medical attention by office visit. The outcome of the adverse events was reported as recovered/resolved on an unspecified. Additional information has been requested.
Patient experienced a "rug burn" like sensation on her left upper thigh where her clothing touched the evening of 02/13/23. The affected area started at about a "half-dollar" in diameter and expanded up to 3 inches in diameter over a 2-3 hour period of time. The next morning the burning sensation was gone. Then later on the evening of 02/14/23 the same thing happened on her lower abdominal region (starting at an inch in diameter and expanding to 4 inches in diameter) and again the burning sensation was gone the next morning. Then on the evening of 02/21/23 on her upper right thigh there was an "itchy" spot that started burning after she had scratched it. It stayed around 3 inches in diameter and the burning seemed to subside by bedtime.
No adverse event occurred.  Booster dose was administered 10 days earlier that the 6 month point
12 yr old pt got infanrix; got  infanrix/ instead of boostrix.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th June 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 16th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 12 year old patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administered and wrong vaccine administered.  The reporter mentioned that, the patient had never received boostrix before.  The reporter consented to follow up.
Felt hot, tightness in chest causing some difficulty in breathing, h/a, nausea, weak; P/vomiting undigested food a few hrs later, felt better; Did not seek Medical tx;
Woke up Saturday morning and could not hear in my right ear.  Went to Urgent Care and was referred to Hospital ER.  Visual exam, blood work and CAT scan all normal.  Given Prednisone and referred to Otolaryngologist.  Auditory test confirmed significant loss of hearing in right ear, especially at higher frequencies.  Given MRI scan with contrast with no abnormalities.  Attributed to non-specific ototoxicity possibly due to virus.  Little to no improvement since.  Follow up scheduled for May 2020.
This spontaneous report was received from a Medical Assistant referring to a 20 years old female patient. On unknown dates, patient was administered 3 doses of GARDASIL or GARDASIL 9 (doses and route unknown, unspecified lots and expiration dates and could not confirm whether GARDASIL or GARDASIL 9) by an unspecified Gynecologist. On 30-JAN-2014, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot# and expiration date unknown), and on 14-MAY-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose and route unknown, lot # N013698, expiration date: 19-DEC-2019) respectively for prophylaxis (inappropriate schedule of drug administration). On 14-MAY-2018, after the vaccination, the patient was dizzy and had to lay down for 30 seconds and then the dizziness went away. The causality assessments were not provided.
Last shot given hurt and he cried right away, area turned red, by Wednesday arm was swollen from elbow to shoulder, bright red, hot and tight, mother gave Advil around the clock, fever ~ 100F after Advil.  By thursday early am, swelling up from wrist into back and under arm purple.  Mother called on-call nurse line who advised ER visit.  MD there advised cold pack to arm (right arm) swelling still there 05/23/2003.
brain pain and the neck pain being a possible encephalitis; some nodules under the arm and leg; right shoulder pain at the site of an old shoulder injury; pain under her arm and into her right breast that started on Saturday with nodules; nodules in her right leg that hurt; headache at the base of her brain and in front; intense neck pain; joints aching/all her joints ache; felt queasy; had sharp pain in both eyes; brain fog; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EM9810) , via an unspecified route of administration on 09Feb2021 at 11:30 (at the age of 67 years old) on left arm at single dose for covid-19 immunisation at a mall vaccination facility.  The patient medical history was none.  There were no concomitant medications. The patient stated she had some pretty severe reactions after getting the first dose of the Pfizer COVID 19 vaccine on 09Feb2021 at 1130AM in the left arm. The patient experienced "brain pain and the neck pain being a possible encephalitis" on an unspecified date with outcome of unknown , intense neck pain on 10Feb2021 to 13Feb2021 with outcome of recovered , joints aching/all her joints ache on 10Feb2021 to 18Feb2021 with outcome of recovered , felt queasy on 10Feb2021 to 12Feb2021 with outcome of recovered , had sharp pain in both eyes  on 10Feb2021 to 12Feb2021 with outcome of recovered , brain fog on 10Feb2021 to 13Feb2021 with outcome of recovered , some nodules under the arm and leg on 13Feb2021 with outcome of not recovered , headache at the base of her brain and in front on 10Feb2021 to 13Feb2021 with outcome of recovered , right shoulder pain at the site of an old shoulder injury on 13Feb2021 to 13Feb2021 with outcome of recovered , pain under her arm and into her right breast that started on Saturday with nodules on 13Feb2021 and ongoing with outcome of recovering, and nodules in her right leg that hurt on 13feb2021 with outcome of not recovered. She was afraid of getting the second dose and inquired advice about getting the second shot. Relevant tests were none.
Redness, mild swelling L deltoid (started 11/27/02) left arm at DTaP site.
Pt reported a headache since the day after getting the vaccine but did not report until 4.22.21. Pt was seen on unspecified date and found to have elevated blood pressure which was already being monitored. Lisinopril was started per MD. Headache improved and patient was using Ibuprofen and Tylenol which also helped. Headache worsened with vomiting episodes and MD changed med to Excedrin Migraine. Pt was tested for COVID-19 - negative antigen test but positive PCR NP swab. - Pt sent to ER due to continued vomiting/headache.  Pt was also COVID-19 positive in October 2020 and had tested negative with nasal swabs (not NP) until completed on unspecified date
Hand, wrist, toe, ankle joint soreness and stiffness started about 4 weeks after injection. At 5 weeks, ankles began swelling (reduce to normal overnight with feet elevated).
Her arm is just sore this time and she is tired; Her arm is just sore this time and she is tired; His daughter received twice the dose/ They put two and a half dosage given and they didn't diluted it correctly; They put two and a half dosage given and they didn't diluted it correctly; This is a spontaneous report from a contactable consumer (patient's father/ parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (9:00 or 09:10 this morning AM) (Lot Number: EW0180; Expiration Date: 01Aug2021) as single dose (at the age of 15-years-old) for COVID-19 immunization. Medical history included allergic to peaches. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 16:00 (Lot Number: EW0167) as single dose (at the age of 15-years-old) for COVID-19 immunization. The patient received the second dose today (of the vaccine) and father was notified by the pharmacist that she received twice the dose of the vaccine today. The pharmacist called and said they put two and a half dosage given and they didn't diluted it correctly. Her arm is just sore this time and she is tired. She got her first shot and it was fine then. The patient underwent lab tests and procedures which included body temperature: fine on 07Jun2021. The patient did not receive any treatment for the events. The outcome of the events was unknown. The events were assessed as non-serious. The patient did not have any other vaccine after COVID vaccine.
suspected vaccination failure; getting them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got every year since 4 years ago from the date of reporting).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles every year for last 4 years from the date of reporting. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Menorrhagia that started same day of vaccination.  Pt had similar episode on 2/17/21 after second dose of Pfizer COVID-19 vaccine for which her Gynecologist started pt in oral contraceptives with resolution of menorrhagia
INFANT WAS NOT ADMINISTERED THE HIB COMPONENT OF THE PENTACEL VACCINE AT THE TIME OF VACCINATION.  NO ADVERSE REACTIONS NOTED.
VAXELIS was administered to 6 patients after product experienced an excursion was was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from a HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and Inquiry number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541, MCM-004563, MCM-004564, MCM-004565, and MCM-004566, due to same reporter.
Pt developed herpes zoster 36hrs post vaccination w/ Left sided progressive red rash over L scalp, forehead, nose, eye and shoulder rash.  No lip/tongue swelling, no shortness of breath.  Pt also developed left eye swelling and blistering. Herpes zoster ophthalmicus without ocular involvement.  - + Hutchinson sign, vesicles involving forehead upper eyelid, but also extending out of V1 distribution. Not typical for HZO. - No epi defects or fluoescein staining. Pt given valacyclovir 1gTID x10days.
She reports that she had numbness and tingling from elbow to shoulder within about 15 min of the injection, then it got worse by 45 min- 1 hour, then finally subsided by later that afternoon around 4:30PM.
The pt experienced redness, slightly swollen area with welts. States arms are sore, and chest is red.
9 months after vaccinated I stared with the muffled hearing loss in right ear dec 9 2021 and dec 11 right eye blinking on its own not able to control, right cheek and right side of mouth numbness, right side of mouth is going to the right not able to straighten, left eye not able to close independently, right eye is droopy.