chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had general malaise unknown cause. Onsite EMS was called vitals BP 178/96  99%O2  HR 78 Patient refused evaluation or care and released against medical advise.
NO ADVERSE EVENTS REPORTED, BUT VIAL USED TO GIVE VACCINE TO PATIENT SAT AT ROOM TEMPURATURE FOR 77 HOUR AFTER BEING PUNCTURED BEFORE BEING GIVEN TO PATIENT.
Redness and rash in oval around injection site. 1.5 inches top to bottom, 4 inches left to right.
Mom fed pt @ 230AM; awoke 3-4 hrs later & found pt w/o pulse & or respirations; No CPR done;
05/20/2005 Mom called - reported 05/19/2005, headache started at 3PM.  Neck hurts, aching, not feeling well in general.  Abdominal pain.  Symptoms relieved by Tylenol, eating Okay, no nausea/vomiting.  Did not take temperature.
30 MINUTES AFTER THE SHOT MY FACE BECAME NUMB, MY TONGUE BECAME HARD AND THE TOP OF THE TONGUE FELT LIKE THERE WERE LITTLE SWORDS, MY BREATHNG BECAME A LITTLED LABORED. WHEN I GOT OUR OF MY CAR AND WAS ALKING INTO Y HOME I FELT VERY WEAK. I WAS VERY AFRAID! I CALLED 911, EMT'S DID MY VITALS, BLOOD PRESSURE HIGH, OXYGEN 95 WHICH IS NOT Y NORM(99). AFTER MUCH DISCUSSION THEY WERE WORRIED I WAS HAVING A STROKE, THE AMBULANCE TOOK ME TO THE HOSPITAL. DID CAT SCAN. BLOOD TESTS. WATCHED ME. I WAS THERE ALL DAY. SENT HOME AT ABOUT 5:30PM HOSPITAL.
Fever of 99.8, nausea, and mild stomach pain 5 days following vaccine administration. All symptoms resolved within 24 hours
horrible rash at the injection site; looked like she was burned; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (horrible rash at the injection site) and INJECTION SITE PAIN (looked like she was burned) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (horrible rash at the injection site) and INJECTION SITE PAIN (looked like she was burned). At the time of the report, VACCINATION SITE RASH (horrible rash at the injection site) and INJECTION SITE PAIN (looked like she was burned) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not reported.
Headache, Fever, Diarrhea, NauseaVomiting, chills, night sweats, sore throat Narrative:
Arm is still itching at the injection site; Arm is still red at the injection site; Arm is still swollen at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm is still itching at the injection site), VACCINATION SITE ERYTHEMA (Arm is still red at the injection site) and VACCINATION SITE SWELLING (Arm is still swollen at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 VACCINATION SITE PRURITUS (Arm is still itching at the injection site), VACCINATION SITE ERYTHEMA (Arm is still red at the injection site) and VACCINATION SITE SWELLING (Arm is still swollen at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Arm is still itching at the injection site), VACCINATION SITE ERYTHEMA (Arm is still red at the injection site) and VACCINATION SITE SWELLING (Arm is still swollen at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided
This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a 61-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020) for prophylaxis. Concomitant products included Losartan and BYETTA. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced joint pain, general body pain and activities of daily living impaired. On an unknown date, the outcome of the joint pain, general body pain and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the joint pain, general body pain and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included unspecified thyroid medication. The patient received SHINGRIX vaccine on an unknown deltoid. The healthcare professional (HCP) reported that, the patient experienced joint pain and generalized body aches following the 1st dose of SHINGRIX. The patient's activities of daily living were limited for a few days. The HCP stated that the patient did not contact the pharmacy at the time of the reaction and only mentioned her experience when she was contacted to schedule the 2nd dose of SHINGRIX. Therefore, the HCP did not have specifics regarding onset times and durations.
First my arm started to ache Then pain in lower back Then uncontrolable shivering and freezing - lasted 4 hours Next muscle pain, not just aching, severe pain and hard to move lower body - lasted 4 hours Next shooting joint pain, again not just an ache, severe shooting pains in lower body joints and feet - lasted a couple of hours Next 48 hours I was so tired I couldn't open my eyes Next 24 hours I was able to get up for two hours at a time, then sleep for two hours. Today? I am trying to work a normal day?
Genital and oral fever blisters; Genital and oral fever blisters; Restless leg syndrome; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drug was reported.  No Treatment  drug was reported.  Patient recently discovered that she might be autoimmune.
Stiffness; soreness in his shoulder and arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hernia" (unspecified if ongoing), notes: Hernia, Was in his belly; "Blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; LEVOTHYROXINE; LISINOPRIL; TAMSULOSIN HCL. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness"; MYALGIA (non-serious), outcome "unknown", described as "soreness in his shoulder and arm".  Additional information: Stiffness: It occurred probably within 2 weeks of the last shot which was around 01Arp2022. Caller then stated it was actually 31Mar2022 that he got the last shot, the second booster and not 01Apr2022 as previously stated. Does not know exactly when he noticed it. It was within 2 weeks of the shot. Had surgery on 20May2022 and when he was going into surgery, he was aware of them. Outcome: Was really a weird thing that was couple of times, he thought. Thought he was coming out of it persisted and he thought he was coming out of it. It is a hard thing to describe. It progressed from stiffness to soreness and has been a really weird thing. He sleeps on his side and when he had surgery, he had to sleep on that sore shoulder all the time. It was hernia surgery and he couldn't sleep on the right side. Clarified that it was his left arm that had the stiffness and soreness in the shoulder. His left side has taken a beating. Soreness in shoulder and arm: He states that when they test the arm and stuff and when he has a checkup, they have to put out his arms to see how much he can lift with his arm. They put their arm on his arm and when he puts his arm straight, that is where he really feels it, when his arms are straight out and he is trying to push his arm up. It is like trying to lift something with his arm. When his arm is straight out, he can really feel it. He is doing it right now and he can't do it. It is just not right. It may have been the pneumonia vaccine or something. He has gotten all kinds of vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Confusion, Fever & CoughWheeze Narrative: Employee reports had severe chills/could not get warm and later around 2 am she had increase in body aches, chills, headache, cough/shortness of breath and per her family confusion/delirium. The patient was transported to the Emergency department. Pt had labs, head CT and IV. Pt reports fatigue, chills, and not feeling well for another 3 days duration. Spoke with patient 1/7/21 and she reports she is feeling back to baseline.
body aches; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (COMIRNATY), 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: PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7/22/22 urgent urination and incontinence began 7/25/22 headache 7/26/22 headache, slow speech, slow movement 7/27/22 headache, vomited 7/28/22 fell onto back, tired, very weak, mental confusion 7/29/22 too weak to climb stairs, mental confusion; transported and admitted to local hospital with fever of 103, ferritin 75,000, low white blood cells, low platelets. 7/30/22 Diagnosed with hemophagocytic lymphohistiocytosis , treated with 16 mg dexamethasone daily. received platelets, cryoprecipitate. Hospitalized through 8/10/22. Rehab facility through 8/17/22
The vaccinee "is a normal, healthy, 18 month old with no known allergies", who received concomitant HIB and IPV on 8/21/00. On 8/21/00, the pt also received her 4th left leg dose of Infanrix. On 8/23/00, the pt returned to the doctor's office presenting with a 6" area below the injection site that was red with a purple tinge and warm. The pt did not have a fever or pain. She was very fussy. She was treated from 8/23/00 to 8/28/00 with hydroxyzine hydrochloride (Atarax) 0.5mg po prn every 8 hours. As of 11/2/00, the outcome of the event is unknown.
change in my sense of smell; Change in sense of smell and taste; This is a spontaneous report from a Pfizer sponsored program. A 34-year-old contactable other healthcare professional, male consumer (patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3302) intramuscularly into the left arm on 14Jan2021 09:30 AM (at the age of 34-year-old) as single dose for COVID-19 immunisation. The patient medical history included that the patient was diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products, penicillin. Concomitant medications were not reported. On 15Jan2021, the next day, the patient noticed a change in his sense of smell, particularly in-regards to tap water. Not sure if it actually was vaccine related or not, but he was curious if there have been any other complaints of this, as well as looking to share the information to help further the knowledge of how the vaccine effects different patients. Change in sense of smell and taste beginning day after first dose of vaccine. Decrease in ability to smell and most things that he can still smell had a very foul smell. He would describe the smell as a corrosive metallic smell. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatments received for the adverse events. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine nor any other medications received within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, he has been tested for COVID-19. Outcome was not resolved for both the events.  Follow up #1 (02Mar2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included reporter contact address updated.  Follow up #2 (07Apr2021): This is a follow up-spontaneous report from a contactable other healthcare professional consumer. This other HCP consumer (patient) reported in response to HCP letter via follow-up letter which included age at vaccination (34 years), race and ethnicity information, vaccine details, reported events, relevant medical history, lab data and clinical course of events.  No follow up attempts are needed. No further information is expected.
Presented with fever and body aches X 4 days. Tested positive 1 day PTA. DX with acute respiratory failure and Covid-19 PNA. His oxygen saturation was 79% on room air. He was treated with dexamethasone IV, N/C, singular, Lovenox along with bronchodilators with colitis and associated antibiotics P.R.N.. With his current treatment his symptoms improved and he was able to be weaned of oxygen. Patient's other Medical issues remained stable during hospitalization and required minimal or no interventions.
Patient had fever of 38.2, 11/02/2005 am, upon onset, no fever at home. Also swelling in face and over body which started 11/02/2005 al per mom Fever started when swelling began. Fine red rash over body and pustules in head. DX was allergic reaction to egg in flu, varicella, and rash to hours to MMR. Admitted to Pediatric floor, 11/02/2005 am. DC DX: Allergic Reaction. Admitted with SOB, face and eyelid swollen times 2 weeks. One hour after immunization eye became swollen and discharge (yellow and clear). Temp in ER 99.
Information has been received from a physician concerning a 14 year old female who on 19-NOV-1996 was vaccinated with the first dose of MMR II (lot # not provided).  26-AUG-1999 the patient received the second dose of MMR II (lot # not provided).  On 05-DEC-2009 the patient developed mumps (date diagnosed 17-DEC-2009).  Patient did not develop fever and had parotitis.  It was reported that on an unspecified date patient was exposed to mumps through her father who lives in the same house hold.  No blood work performed.  Patient's outcome was unknown.  Follow up information has been received from the physician who reported that the 14 year old patient (also reported as 13 year old at onset date) experienced mumps on 25-NOV-2009 (previously reported as 05-DEC-2009).  The date diagnosed was reported as 27-NOV-2009 (previously reported as 17-DEC-2009).  The patient was afebrile and experienced right parotitis.  On 27-NOV-2009, a blood work test showed IgM <1:10, IgG 7.30 and serum amylase 137.  At the time of the report the patient's outcome was unknown.  No further information is available.
Patient was administered the ZOSTAVAX vaccine at 11:10 on 10/07/2009. After about half hour patient experienced allergy rash symptoms on the arms. Patient took 1 tablet of BENADRYL 25 mg. Later in the evening pt noticed rash on forehead, body and arms. Patient took half a tablet of BENADRYL 25 mg at bedtime. Next day, morning, 10/08/2009, allergy and rash symptoms subsided completely and patient had only injection site redness.
sore arm, headache, painful joints, water retention, shortness of breath, untreatable UTIs, asthma
At first it was just red and itched. Patient was recommended to get some hydrocortisone over the counter. The itching started on the shoulder and then moved down to the forearm. It has continued non stop since the shot.  He now comes in today and the area on his arm about 3 inches above elbow and 3 inches below elbow on the inside of the arm is dry and scaly and itching as usual.  There is a circle of scaly skin surrounding the entire area and scaly right in the center on the inside of the elbow.
Bruising at site of injection, swelling, numbness in vaccinated arm and tingles.
No adverse event; Patient received the pink cap instead of Blue cap for 2nd dose; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the pink cap instead of Blue cap for 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 7-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 05-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the pink cap instead of Blue cap for 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the pink cap instead of Blue cap for 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the pink cap instead of Blue cap for 2nd dose).    No concomitant medications were provided. Patient received first monovalent Moderna COVID-19 vaccine dose on 7-Apr-2023 with unknown lot number and expiration date. No treatment medication was provided.
had difficulty swallowing initially back of his neck off immediately became inflamed and rash broke out at least 5 days of muscle aches, joint aches, pain
This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 66-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included breast cancer. Concurrent medical conditions included arthritis. On 18th June 2018, the patient received the 1st dose of Shingrix. In June 2018, less than 2 weeks after receiving Shingrix, the patient experienced urinary tract infection. On an unknown date, the outcome of the urinary tract infection was recovered/resolved. It was unknown if the reporter considered the urinary tract infection to be related to Shingrix. Additional information was reported as follows: The patient recevied Shingrix vaccine on left arm. On 18th June 2018 morning, the patient as vaccinated with a dose of Shingrix. On 27th June 2018, the patient was diagnosed with urinary tract infection but thought  that it was present prior to the date of diagnosis but after the date of vaccination. The patient had denied permission to contact her physician.
Mom called to report pt having a rash 8APR91 a wk p/immun given; P/talking w/mom states pt ran temp of 102.6 on 6APR91 & broke out w/rash on 8APR91; Mom states called the MD & was directed APAP;
Started menstrual cycle 10 days early & I'm always on schedule. Heavier than usual also. also extreme exhaustion & Low Grade Fever still on Monday 9/20/21.
This spontaneous report as received from a nurse practitioner and refers to a 16 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 dose form reported as: 50 mg (also reported as unknown) for prophylaxis. On an unknown date, the patient experienced injection site swelling and bruising for an unspecified reason. The outcome of the event and the relatedness between the event and GARDASIL 9 were not reported. Additional information has been requested.
15min p/vax pt returned to office w/mom reddened cheeks, face, forehead, nose chin;inj site reddened fifty cents size area;no other diff seen by MD waited in office 30min, sx almost completely subsided;
Report  fever (101.1) HA, body aches, left arm pain  10 hours post vaccination and funny taste in mouth 10 minutes after vaccination. Funny taste resolved.  Treatment: Tylenol with mild improvement. Outcome does not interfere with ADLs.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX (lot # K021484 and expiry date on 03-NOV-2016; dose and route of administration were not reported).  No adverse effects were reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015 from a certified medical assistant, who reported that she would have to research for the request made for the patient identifiers, lot number and expiration date and the dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 12-months-old patient of unknown gender. On 23-JUN-2015 the patient was vaccinated with a dose of (Merck) VARIVAX (lot # was confirmed as K021484 and expiry date was 03-NOV-2016). This is one of several reports received from the same source. Additional information has been requested. Patient's details, product, event and narrative were updated.
chest pain, nausea, vomiting, migraine  for 3 days, fatigue, excessive sleep
patient reported not feeling well last night, vomiting and stomach upset. She felt feverish but did not check her temperature. I checked today and she was normal. She reported extremely sore arm, very painful.
8 year old female child presented for COVID-19 Pfizer Booster vaccine (3rd dose); she was given Pfizer-BioNTech COVID-19 (mRNA) vaccine for Children ages 6months-4 years instead of age appropriate Pfizer-BioNTech COVID-19 vaccine (mRNA) vaccine for Children ages 5-11 years.
Vaccine was administered after expiration date - no adverse events Exp. date was 12/2/13.