chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The adverse events started the week before 11/19/02.  I was having numbness in my left arm.  I also was having problems in steadying a shotgun and hitting the target in practice.  I felt very unsteady on a ladder. All of this is hindsight information.  In the early morning of 11/19/02 I was in an operating room as a medical student and started getting an exteremely bad headache.  On rounds at 6am I found myself running into doors/wall and the headache worsening.  I went home thinking I had a bad migraine from staying up all night. When I awoke at 10:30 am I was paralyzed on the left side of my body completely.  I crawled to the phone and called 911.  By the time I was at the hospital I was in status epilepticus.  I was given Dilantin, Phenobarbital, and Depakote to control the seizures. When they found what they though was a brain tumor they gave me Propofol and placed me in an induced coma. On 11/21 I underwent a brain biopsy which ruled out a tumor. My intracranial pressure increased to dangerous levels by 11/23/04 and a ventriculostomy tube was inserted to control the pressure. When all the infectious diseases came back negative I was placed on IVIG and steroids.  My outlook improved and by 12/11 I was removed from the induced coma.  I was transferred to another hospital on 12/16/02 for rehabilitation.  On 1/3/03 I was released from inpatient rehab and sent to outpatient rehab until 3/15/03.  Then On 11/23/03 I had a grand mal seizure after being back on rotations for 2 months.  I have struggled with simple partial seizures since then and just now are starting to get them under control.  Nurse follow up on 10/30/04 states: "No new information." Per annual report- Partial seizure disorder treated with 200 mgLemictal BID & 2g Keppra BID.  Pt has sensation problem in left leg, coordination problem in gross motor function such as playing sports.  Has also developed cluster headaches.  Pt is a medical student and having problems with concentration esp under time constraints. Medical records state encephalitis, apnea, rash and allergic reaction. msv
Information has been received from a registered nurse concerning a 23 week old infant who was vaccinated on 19-DEC-2006 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
A non-serous spontaneous report of administration of expired product was received from a health professional concerning a nine-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 01-Apr-2010, the patient received expired H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
No additional adverse events reported; PROQUAD that was administered after improperly stored; This spontaneous report was received from a certified medical assistant (CMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 14-OCT-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # T027115, expiration date 07-FEB-2022 (dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 8.5 degrees Fahrenheit for 18 minutes and 11.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. No additional adverse events were reported.
Injection site formed a hard lump and was itchy and hot the their day after the injection and lasted for a week.  Severe abdominal pain started on 10/19/16 and shingles rash appeared on 10/21/16 on back near T11 vertebrate.  Rash is resolving but abdominal pain continues.
Patient received Covid vaccine and after 5 minutes developed throat discomfort.  She was given 25 mg of Benadryl po. Tolerated well. She was kept for 45 min in observation and symptoms subsided. Patient was discharged in no apparent discomfort. Family member drove her home.
I have IBS and have never experienced a flare up before. I had a flare up after receiving my second dose and went 10 days without a bowel movement.; This is a spontaneous report received from a contactable physician (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscularly in Arm Right on 09Jan2021 at 09:15 (Lot Number: EL3302) as SINGLE DOSE for covid-19 immunisation. Medical history included anxiety and gastrooesophageal reflux disease (GERD). No known allergies were reported. Concomitant medications included sertraline 100mg (SERTRALINE) and omeprazole 40mg (OMEPRAZOLE). The patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscularly in Arm Right on 19Dec2020 at 09:00 AM (Lot Number: EJ1685) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 09Jan2021 at 18:00, The patient reported that, i have IBS (irritable bowel syndrome) and had never experienced a flare up before. I had a flare up after receiving my second dose and went 10 days without a bowel movement. On 19Jan2021, The patient underwent lab tests and procedures which included SARS 2 COVID rapid test: negative. Therapeutic measures were taken as a result of the reported event with Magnesium Citrate, Miralax, Metamucil, Mineral Oil Enema, Amitiza. The event was considered as non-serious. The outcome of the event was recovered on unspecified date in Jan2021.  Follow-up attempts are completed. No further information is expected.
Guillain Barre type neuropathy with paralysis of lower limbs. 60 DAY FOLLOW UP STATES THAT IT IS UNKNOWN IF PT HAS RECOVERED. THIS PT DOES NOT COME TO OUR OFFICE ANYMORE SINCE THE INCIDENT. SHE HAS CHANGED HER PRIMARY CARE PHYSICIAN.
Nick could not move the right side of his face, so we took him to the ER and he was diagnosed with Bells Palsy. Today is the 6th day of having it and he still can't move the right side of his face very well. He is currently on steriods and valtrex to treat it and we had a follow up appt yesterday & the Dr said if it is not showing improvement by Monday, he might need some reahabilitation for it. We have no idea if it was caused by the nasal vaccine (10 days earlier). 11/30/09 Records received for DOS 11/15/09 (ER Visit). Dx: Bell's Palsy.  C/O numbness right side of face. Discharged with instructions for eye care and F/u with PCP.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5 ml SD-PFS LLok wTip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 112 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient became white, clammy to touch, fainted briefly, had a pulse of 47 and a BP of 111/45. I called 911 and within 5 minutes they arrived.  She slowly came back. No meds were administered. BPs and HR checked every 5 minutes for 20 minutes. The EMTs did an EKG which was normal. She drank 2 bottles of water and a technician walked her to her car once she was able. Total time was about 30-40 minutes.
To emergency on day 3 with shortness of breath.  D-dimer negative, in a fib.  Has been on inhalers, with significant hoarseness and post nasal drainage since.
1. Pain in arm 2. Significant itching and redness 3. headaches  No medical treatment other than but benadryl  jel for itching and benadryl oral
got horribly sick; Initial information received on 08-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age and unknown gender patient who got horribly sick after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 1976, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, strength, expiry date and lot number) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date, the patient got horribly sick (illness) (unknown latency).  It was reported, got flu shot in 1976, got horribly sick and never had shot again.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event ( got horribly sick).  At time of reporting, the outcome was Unknown for the event  got horribly sick.
About 2 weeks after the second dose, i started to get hives and swollen areas.  They come out almost every day still. I went  maybe 4 days without this happening in the last 3 weeks otherwise it?s like every day. My eyes, bottom lip and side of mouth have swollen like a was having a bad allergic reaction to a bee sting. No itching.  And my arms legs and breasts have all gotten very itchy hives multiple times.
pain in her right arm from shoulder to elbow; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in her right arm from shoulder to elbow) 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 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her right arm from shoulder to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in her right arm from shoulder to elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Swollen lymph node; Felt flashed; Pain; Tired; Diarrhea; This spontaneous case was received on 29-Sep-2022 from nurse via Communications (reference number: SEQW22-03718) and concerned a 31-year-old, female patient.  The patient's medical history and concomitant medication were not reported.  On 28-Sep-2022, in the morning, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0,5 ml, route of administration: intramuscular, anatomical location: arm) for prevention of influenza disease. The batch number reported was 348378 and expiry date: 30-Jul-2023.  On the same day, at 23:00 p.m., after receiving Flucelvax Quadrivalent, the patient experienced swollen lymph node under the arm that the vaccine was administered, she felt flashed, tired and had diarrhoea. The patient was treated with Advil (mefenamic acid), for the pain.  On an unspecified date in Sep-2022, the patient recovered from events 'flush hot' 'tiredness', 'diarrhoea' and 'pain' as it was reported that the patient was feeling ok at the moment.  At the time of initial reporting on 29-Sep-2022, the patient was recovering from event of 'swollen lymph nodes' as the lymph node was going down.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 31-year-old female patient developed lymphadenopathy, hot flush, fatigue, pain and diarrhea on the same day after vaccination with Flucelvax Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.; Sender's Comments: A 31-year-old female patient developed lymphadenopathy, hot flush, fatigue, pain and diarrhea on the same day after vaccination with Flucelvax Quadrivalent. Based on plausible temporal relationship and information provided, causality for the reported events is assessed as possibly related.
Evaluated site of injection after 15 minute wait and saw patient had erythema  blotches on right arm and right neck area where pfizer vaccine was give.  Dr. notified of localized reaction and was re evaluated by provider.  Dr. ordered 50mg of benadryl orally.  Administered to patient and had patient wait an additional 15 minuets.  After 15 minutes Dr and I recheck patient and saw reaction had improved to were they were hardly visible.
inflammation; muscle pain; joints pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation), MYALGIA (muscle pain) and ARTHRALGIA (joints pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 INFLAMMATION (inflammation), MYALGIA (muscle pain) and ARTHRALGIA (joints pain). At the time of the report, INFLAMMATION (inflammation), MYALGIA (muscle pain) and ARTHRALGIA (joints pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient  proceed with second dose tomorrow or wait until side effects of the first dose are completely gone?   Reporter did not allow further contact
Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-028624 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-028624:same reporter, different patient - MOD21-04067
Recurrence of post-acute sequelae from Covid-19. Shortness of breath & racing heart rate (120-130bpm) on standing and with minimal exertion. Debilitating fatigue. Dizziness on standing. Tightness in chest. Intermittent tinnitus.   This is persisting & has not resolved.
left upper  arm inflammed and soreness, at site  cramps on left hand tingling and generalized muscle aches  heart rate up to 122 beats/minute overly tired No  energy took Tylenol to combat low grade fever
Within 24 hours pt developed chest, head symptoms and hoarseness. 2 weeks later still have aforementioned symptoms and woke up with ear problems. Pt states sounds like "running fridge". Pt's PCP said not caused by congestion so sent to ENT who gave prednisone which did not help. ENT sent to hearing specialist who reported severe irreversible hearing loss in left ear
Red, edematous, warm right upper arm down to elbow, encompasses 2.5 circumference of arm-lateral portion. Temperature 100F. Macular papular rash associated with this in same area with marked induration.
Arm is red and hot; Arm is red and hot; Swollen arm; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of and swelling arm were not recovered/not resolved.   The reporter considered the erythema of extremities, extremities hot feeling of and swelling arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient arm was red, swollen and hot from Shingles vaccine received on Sunday. It had spread. The patient wanted to know what he/she could do to return to normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
This spontaneous report as received from a pharmacist via a company representative refers to a currently 57 year old male patient. On an unknown date (reported as a child), the patient was vaccinated with MMR (manufacturer unknown) (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date, the patient needed proof of MMR (measles, mumps and rubella) immunity due to his occupation, had titers drawn which resulted negative. The outcome of the event was not reported. The relatedness between the event and MMR (manufacturer unknown) was not reported. Additional information has been requested.
She has a bit of soreness; This is a spontaneous report. A non-contactable consumer, the patient, reported a female of unspecified age received the first dose BNT162b2 (solution for injection; batch/lot and expiry information reported as not available) as a single dose via unspecified route on 15Mar2021, for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient denied any allergies to medications, food, or other products. The patient denied being diagnosed with COVID prior to this vaccine. It was unknown if the patient was pregnant at the time of vaccination. The patient has not been tested for COVID since the vaccine. The patient reported that she received the first dose today and she wanted to know if she should take acetaminophen (TYLENOL). The patient explained that she has a bit of soreness. The outcome of the event soreness was unknown.  No follow-up attempts possible as reporter declined consent to further contact; No further information expected and information about batch /lot number(s) cannot be obtained.
G62.0 DRUG INDUCED POLYNEUROPATHY 2/10/2023 RECTAL CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/30/2022 RECTAL CANCER R09.02 HYPOXIA 11/30/2022 RECTAL CANCER
No additional AE/PQC .; temperature excursion that was intermittent beginning 7/28/2020; This spontaneous report as received from a registered nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-AUG-2020, the patient was vaccinated with dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection, subcutaneously, lot # T002843, expiration date 23-JAN-2022 and lot# S032357, expiration date 14-OCT-2021 (strength and doses were not reported) for prophylaxis.  Since 28-JUL-2020, the dose of the vaccine was exposed to temperature excursion at max. -9.5 Celsius degrees (C) for 38 hours and 30 minutes. There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect was reported.
Day 4 after admin of JE vax #2 client dev. hives on both arms from shoulder to elbow front of arms only and hives front of legs from hip to thigh. Hives raised with small white center, client states hundreds. Rash lasted time 14 days (approx) ten resolved. Client didn't call office rash reported by husband at his next visit. Client only used cool clothes, rash very itchy didn't take any antihistamines no fever.
At about 10 PM on 1/13/2022, my wife became ill. At about 4 PM on 1/14/2022, I took her to Urgent Care, where she underwent a rapid test for COVID-19 and got a positive result. My wife had a breakthrough case.
1st dose on 12/31/2018, not had 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 31st December 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist stated that a patient had not received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The reporter unable to provide vaccine details because they did not administer the 1st dose. The reporter did not consent to follow-up.
Pt recvd vax & collasped & turned pale; breathing sl labored; BP 90/60, pulse 72 irreg; EKG done on NWG treatment room;
A mass developed the size of a grapefruit that was warm to the touch.  I was also very painful.  I also developed a cold sore.
Rash on my arm. It started at the top of the arm and went down all the way down/towards my elbow; Rash on arm it is itchy and red; Rash on arm it is itchy and red; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. Patient had second vaccine last Thursday 01Apr2021. On Monday the 05Apr2021 the patient started getting a rash on her arm, it was itchy and red and goes from the top of her arm down almost to her elbow, it did not stop itching. The patient put hydrocortisone and Benadryl on it and she went to the doctor and they didn't say much about it, just to keep doing what she is doing. Further reported It's itchy and red; and she trying not to itch it but it's hard because it's itchy. Every time she itch it get bigger and bigger. The outcome of the events was unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained.
Extremely heavy period that came early. Very bad menstrual cramps- worse that i have ever had. Been in extreme pain for 2 days.
Mom calls in stating patient's left arm is red, swollen and warm to the touch. States its softball size; is using arm oil but it is painful to the touch. Will try ice and Tylenol for now if no improvement in 24 hours. But if it's worse, will bring in for an appointment.