chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/9/2021: Achy knees 2/10/2021: Knees swollen to twice their size 2/11/2021: Knees remain swollen, unable to bend or straighten knees. 2/12/2021-4/21/2021: Many tests (X-ray, Arterial Doppler Ultrasound, Duplex Ultrasound, ECHO, Blood work (i.e., D-dimer, lyme, etc.), CT scan,  begin PT, Fluid draining (3x in left knee, 2x in right knee), Steroid injection (1x in left knee), MRI) 4/22/2021: 1st appointment with Rheumatologist Since the first appointment, I have been on Prednisone (some relief), Sulfasalazine (no relief), Methotrexate (after one month of use I had persistent sore throat, 3 episodes of bronchitis, 1 episode of walking pneumonia, pink eye, ear infection)
Chills, fever, swelling at injection site 10 days, fatigue Narrative:  Other Relevant History:
mom reported 9JAN98 stating pt broke out in small bumps over entire body & was crying a lot-began 1st noc p/vax;no itching w/bumps, no temp, coughing, or congestion;poss rxn to vax;exp vomiting, loose stools;
The patient experienced the following reaction(s) during the immediate   of observation: Approx. 1436, pt. Began to c/o dizziness and feeling lightheaded. Upon observation, she was diaphoretic and pale. VS prone with legs elevated at 1510: BP: 100/80 HR 76, o2 97%, RR21.
Large reddish oval area at site of injection.  Oval area approximately 7 x 2 inches raised on arm.  Very itchy.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
He was so weak he could not get up; Blood pressure dipped; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got exposed to Covid on 14Mar2021; on 16Mar2021 he got the Pfizer COVID Vaccine. On 22Mar2021, he started showing COVID symptoms. He tested positive for COVID a few days later and today (29Mar2021) he was rushed to hospital by the ambulance because he was so weak he couldn't get up, his blood pressure dipped and his oxygen level 96, or whatever the EMT would have done. The reporter asked if the vaccine would help at all at this point and would the patient be eligible for the antibody treatment since he already had a dose of the vaccine, and stated "But it really hasn't even been 2 weeks, it's been 2 weeks tomorrow". The patient was hospitalized in response to the events (from an unspecified date to an unspecified date). The outcome of events was unknown.  Information about lot/batch number has been requested.
Based on information received on 18-Mar-2019, the report previously considered as non-valid became valid as patient involved was specified. Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves unknown age male patient who was vaccinated with injection of IPOL (batch number, expiry date, route and site of administration were not reported for both vaccines) on unknown date. The patient's past medical history, medical treatments and family history were not provided. It was an actual medication error case due to product storage error. In this case a temp excursion occurred with vaccines unopened ADACEL, MENACTRA, ACT-HIB, TENIVAC, DAPTACEL and with unopened and opened IPOL. It was reported that patient received IPOL that was in a temp excursion. The patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information was received on 18-Mar-2019 from other healthcare professional. Case becomes valid, patient information updated. List of documents held by sender: none.
patient got the flu shot once in whole life and patient got so deathly sick patient was laid out in bed for 3 days so not for patient; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a patient of unknown age who got the flu shot (INFLUENZA VACCINE) once in whole life and got so deathly sick patient was laid out in bed for 3 days (illness).  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown),  patient who got the flu shot once in whole life and got so deathly sick patient was laid out in bed for 3 days (illness).  No laboratory data was provided.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
fever devel 5PM on 12JAN94 again on 13JAN94; fever up to 103.3;
Patient has had the following symptoms since his vaccines 3/16/23; fever, shallow fast breathing, lots of drool like he doesn't want to swallow, weakness (legs and arms like a rag doll and trouble with head control even when laying down), uncontrollable crying (from 2AM-7AM).  He was sleeping for 15min intervals and then waking up screaming until he fell back asleep, didn't want to eat or take his pacifier, excessive sleepiness (maybe related to not sleeping last night but he hasn't been awake today more than two minutes at a time). Mom also witnessed patient staring with blank look along with fast respirations and heart rate. Video captured on mom's cell phone. Mom messaged office at 12:07 pm and patient was seen by provider at 1 pm.
Very healthy person.  I developed  several odd issues in the following order costochondroitis shortness of breath heart palpitations acid reflux extreme fatigue extreme brain fog
This spontaneous report was received from a physician through email via healthcare worker refers to a patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # J009833 (Expiry: 25-JAN-2015) (dose, route and frequency was not reported). On an unknown date the patient experienced significant pain, redness and swelling at the injection site. The outcome of the event significant pain, redness and swelling at the injection site was unknown. the reporter did not provide the causality between the event of significant pain, redness and swelling at the injection site and the suspect drug. This case is linked to case 1402USA006209, 1402USA007455 and 1402USA007456. Additional information has been requested.
Red patch in area of injection, worsened, mild tenderness, local inflammatory reaction HCT cream - CLARITIN 10mg.
p/vax pt c/o redness, swelling pain lt arm noc of vax;later c/o muscle aches, fatigue, fever;10 days out still c/o pain in arm w/twitching, aches, fever;
Initial itching on right Deltoid/injection site. Pt developed Erythema multiforme within Sun 10/27/08
Patient claimed within 1 hours after receiving the flu vaccine experienced behavior changes, paleness, weakness, dizziness, sweating.
Client was vaccinated approximately 1500. No immediate reactions, was monitored per protocol without incident, went home. Woke up at 0300 with chills, body aches, which persisted for approximately 12 hours. Client took 650 aspirin, experienced mild relief, symptoms for approximately another 2 days before resolving. Experienced malaise for the following few days, but 6 days after vaccination, developed hives. 1 at injection site, 1 on lower back; approximately 3 inches diameter. Remained for two days before resolving. No medications taken for the hives.
Patient developed altered mental status approx around mid morning on the 18th. He recalls getting into his car with his dog and he couldn't get his car started. He asked his neighbor.  He came home when his dog started barking. His wife came home from work and noticed him slurring his words and unable to complete sentences. His wife took him to his ER. He was found to have a temperature of 103. He was given IV fluids. CT head negative for acute events.
This report described the occurrence of Lyme arthritis and/or Lyme disease in an 82 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix on 6/8/99 and 7/9/99 "according to the client." This was considered to be a drug maladministration due to the fact that LYMErix is not indicated for immunizing individuals greater than 70 years of age. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "aches, stiffness, and swelling of his lower extremities." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited her employment options and opportunities." According to the attorney the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
Seen for a 4 month well child care visit on the morning of 3/15/04.  Developed fever and seizure requiring ER visit at 8:30pm on 3/15/04.   Has had subsequent diagnosis of seizure disorder and has required the care of a neurologist.
After receiving the seasonal influenza shot, she and her friend (both nurses) were walking through the store and she started feeling very flushed and felt as if she was going to faint.  She sat down. She became diaphoretic and began to vomit.  Her pulse was 90.  She described the feeling in her chest as similar to when she had a heart cath. and at the time the dye was injected.  She stated that her heart was pounding. After approximately 30 min. she was able to get to her car with help from her friend.  Her friend took her blood pressure and it was 138/83 at that time. Talked to her the next day and she stated that she had a very restless night and was still queasy all the next day and felt very weak. She reported that her upper GI distress continued throughout the day.
Vaccine related error. Patient received wrong age specific COVID-19 vaccine formulation. Received formulation for 6mos-4yrs instead of 5yrs-11yrs formulation. Parents opted not to redose with COVID-19 vaccine at this time.
Body aches; hot and cold; knot in arm; arm twitching; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 53 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "cholesterol" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "AFIB" (unspecified if ongoing), notes: Other medical history: high blood pressure, cholesterol, AFIB; "Known allergies: bees" (unspecified if ongoing), notes: known allergies Cipro, sulfa, bees. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro, sulfa, bees; Sulfa, reaction(s): "Known allergies: sulfa", notes: known allergies Cipro, sulfa, bees. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "Body aches"; MUSCLE TWITCHING (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "arm twitching"; HEADACHE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "hot and cold"; NODULE (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering", described as "knot in arm"; NAUSEA (non-serious) with onset 27Oct2022 at 03:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, feeling of body temperature change, nodule, muscle twitching, headache, nausea.  Additional information: Reportedly, dose received were more than 3. For most recent dose details Facility type vaccine was Workplace clinic. No covid prior vaccination and no covid tested post vaccination.
About 5 minutes after receiving the vaccine, the patient walked up to the pharmacy counter from the waiting area and said she is about to faint. I was able to catch her before she fell to the floor. She was laid down on her back and her legs were lifted (911 called). Her BP was 92/63 and PR was 65. She was conscious and alert this entire time. When checked again in 5 minutes, BP was 112/75. When fire rescue arrived, she was alert. She reported not hitting her head. Waited another 20 minutes, then left.
shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019139663, US2019AMR141887 and US2019AMR141889 reported by the same reporter.
(L) side of thigh red and swollen since yesterday, no fever. 8cm x 8cm dia. warm to the touch & firm.
patient complains of having nerve numbness and tingling from elbow down on same arm that he received his vaccination
Patient felt numbness and tingling in his L arm and felt numbness, tingling and warmness in his face. Felt his face and ears were getting red. No complaints of chest tightness or constricted airway. No signs of hives or redness on limbs or neck. Vitals were 117/70, 99%, pulse 78. Patient was given benadryl and had stated he felt his symptoms were starting to subside. Patient was instructed to wait longer than the given time however in minutes he felt his symptoms were coming back and progressing. At this time EMS was called and the patient was transported to a local hospital via ambulance.
about 3 weeks ago, the patient experienced a swollen optic nerve that continues as off 7-10-21.  loss of vision.  Also 3 days ago, he developed a whole body rash
Chronic mild nausea, loose stool, gastrointestinal upset - occasional mucus in stool.
This spontaneous report as received from a Registered Nurse (RN) who refers to a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL 9, intramuscular, lot # M018810, expiration date: 28-MAY-2018 (strength, dosage, and anatomical location were not reported) for prophylaxis. Other suspect and concomitant medications were not provided. No PQC was involved. No adverse effects were reported. This is one of three reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA011874.
Patient received vaccination and passed out.  Patient states that he has a history of fainting after receiving vaccination.  Patient was given water and cold compresses was applied to patients head to help cool him off.  Patient's vitals were obtained and everything was normal except blood pressure.   Blood pressure was found to be 99/42.  After approximately 15-20 mins patients BP was 100/60.
MMR SQ injection (L) thigh - within 5 minutes size of a plum hives - warm/raised/red area. Iced area 30-40 minutes. Resolved.
sore back; sore arm; maybe a slight fever; This is a spontaneous report from a contactable other hcp. A 71-years-old female patient received bnt162b2 (BNT162B2; formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 71-years-old) as UNKNOWN, SINGLE for covid-19 immunization. On an unspecified date patient experienced a sore arm and back and maybe a slight fever from the vaccine. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
no adverse event. moderna confirmed 216K22A was viable until 2/21/23 despite beyond use date of 1/22/23
At 4 months of age my sons left eye turned sharply inward toward his nose. I brought this up at the next Dr. visit and was told this was common in infants and that it should correct itself with time. Because my son was sick at his 6 month visit he did not receive shots on this day. I thought nothing of it until looking back at pictures. I found several pictures that clearly show my sons left eye turned inward within 48 hours of his 4 month shots. All pictures previous to this day his eyes are perfectly aligned. I realized at that time my son must have had a reaction to the shots and the scope of damage is unknown. On the day of his shots, my sons legs were very swollen and remained so for several days. He was very fussy but particularly if you touched or moved his legs to pick him up he would scream. The colic resolved around 7-8 months. His eyes corrected themselves around 10 months. He has had chronic ear infections and had surgery (at 11 months) to insert tubes. He has not received any further immunizations due to the fact that it could further compromise his health and well being.
Day 1: pain at injection site and swelling Day  2: increased pain, redness and swelling at injection site, pain in neck on side of injection, extreme fatigue, nausea, fever, joint aches Day 3: pain redness and swelling at injection site, mouth sores and nose sores
given 7 inches below the deltoid region / was given at inappropriate site; route of administration was subcutaneous; bruising right above the elbow / bruising from the shot is in her elbow; movement of her elbow is affected; This case was reported by a nurse via call center representative and described the occurrence of contusion in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 16th April 2021, the patient received the 2nd dose of Shingrix (subcutaneous). In April 2021, 3 days after receiving Shingrix, the patient experienced contusion and mobility decreased. On 16th April 2021, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. On an unknown date, the outcome of the contusion, mobility decreased, vaccine administered at inappropriate site and intramuscular formulation administered by other route were not recovered/not resolved.   It was unknown if the reporter considered the contusion and mobility decreased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Reporter was the patient and registered nurse herself. Reporter stated that route of administration was subcutaneous which led to intramuscular formulation administered by other route and was given 7 inches below the deltoid region which led to vaccine administered at inappropriate site. Reporter stated that being a nurse, had administered so many vaccine at her practice. It felt like pharmacist knew what she was doing, but clearly did not. She also stated, that she revisited the pharmacy and asked another pharmacist and he agreed that it was given at inappropriate site. The movement of her elbow was affected and sees bruising right above the elbow. The pharmacy did not provide her lot number, expiration date, or the dosage of the vaccine. She does not have fax number. The reporter consented to follow up.