chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ProQuad and DTaP izs at WCE 9/10/2020, fine after.  Went to bed at 7pm 9/11 and awoke at 10pm, couldn't sleep until 3am. Initially was awake and playing in bedroom for 2 hours, then started to be more agitated.  During that time was moving around a lot, seemed like 'needed to move her limbs'.  Mom moved to her bed and she started to act like an animal or insect or something was on her mom, was scared, was hitting it and trying to get it away, acting really scared.  Seemed awake.  Was holding her and was looking up to the ceiling, her eyes were tracing movements, and then every 30 sec-1 min would crowch and huddle into mom like she was trying to hide.  Sometimes pushed mom away as well.   - this am totally fine - no f/c - mentating normally and playing
Abdominal Cramps, mild diarrhea, slight fatigue  20210216, 6:30 PM Cold Sweats, fatique  20210217, 2:00 AM Abdominal Cramps, mild diarrhea, fatigue  20210216, 8:00 AM - 8:00 PM No treatment
I have floaters in both eyes, but more in my right eye, that is causing vision problem. They said it was Posterior Vitreous Detachment.
I had a sore throat and a cough. Two days later I tested for COVID-19 and it was positive. That day I went to urgent care and was prescribed Paxlovid. My sore throat lasted for about 5 days, and my cough lasted about two months.
Skin rash of bright red, raised dots on abdomen & arms. My husband had the same vaccine at pharmacy on 9/29/21 and broke out in the same rash (which he still has) on his trunk, legs & feet.  He was evaluated at the ER on 10/06/21, and they felt it could be vaccine related.  He is treating the itching with Benadryl cream.  We also both had the Pfizer COVID booster shot at the same pharmacy location on 9/25/21.
diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "diagnosed with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) diagnosed with covid, notes: diagnosed with Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported    Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event "dry cough" outcome was changed from not recovered to recovered.
Information has been received from a 71-year-old female with no pertinent medical history or allergies who on 16-SEP-2007 was vaccinated subcutaneous with 0.65 (unit not specified) dose of Zostavax (Oka/Merck).  Concomitant therapy included "medicine for bones" and aspirin (brand not specified).  On 29-SEP-2007 (13 days after vaccination) the patient experienced vertigo, headache and nausea.  The patient stated that she would be going to her physician on 02-OCT-2007.  No diagnostic labs were performed.  On 29-SEP-2007 the patient recovered from the adverse experience.  A product quality complaint was not involved.  Additional information has been requested.
Patient reports swelling and redness in arm accompanied by fever of approximately 104 in night of vaccination. Visited primary care physician for follow up to symptoms who patient says diagnosed her with cellulitis.
9/8/13 Patient contacted phcy by phone about 11:00 am. Stated that she woke up 9/7/13 with cold symptoms and stated her arm was very sore and red at the injection site.
pt recv vax 11SEP97 & 12SEP97 pt exp heat, localized pain & 7cm of bumps around the inj site;
after a hour and a half of receiving my daughters third set of shots she began to cry constantly, bang her head against her crib and the wall, she would not sleep. this went on for several days and each day i reported to the doctor who said he did not believe it was from the vaccine. but she was fine until she received those immunizations. today she is 28 months and has never been right since the shots. i am going to be having her evaluated at 30 months to see if the vaccines could have caused her some neurological problems.
I have been in Afib since approximately 2 hours after receiving the vaccine.  I do have a diagnosis of Afib but am not currently taking medication for it.  Until yesterday I have only periodic episodes.
Patient received Fluzone HD on 11/11/13 on 11/13/13 patient experienced an episode of shaking (chills) of lasted from Noon till 9 PM. Spouse felt his head and thought he had a fever. Called the pharmacy on 11/14. I asked him to take his temp it was 101.4. She called again and 5 PM his fever was 101.7. MD recommended Tylenol.
Known diabetic on insulin, developed seizures following hypoglycemia. Admitted to Hospital on 4/13/2003.
Rash on right thigh noticed few days after shot given, painful initially but now fading away.
on 1/9/21 started having muscle aches in left shoulder and neck, then proceeded to feeling extreme fatigue. on eve of 1/9/21 began to have nausea, continued fatigue. 1/10/21 had a headache and had a 99 temp and felt feverish thoughout the day and also with continued shoulder and neck pain that lasted through 1/11/21. Fatigue continued until 1/14. on 1/13 had cramping and menstrual bleeding when it was not during time of normal period.
In November of 2022, I started having neck pains and I treated it conservatively myself with anti-inflammatory medication, ice, and rest. It seemed to get better but didn't go away. so, in January, I saw my doctor who recommended physical therapy. I had 6 treatments of physical therapy over 3 weeks. The pain resolved on the right side but got worse on the left. Late February, the pain became increasingly severe in my neck, and I started developing numbness in the back of my head and into my jaw. On 02/27/2023, I went to an Orthopedic urgent clinic. They did an x-ray and they stated that I no longer had a C3 vertebrae. It had been consumed by a tumor. They took me to the emergency room by ambulance and I was admitted. On 03/02/2023 I had a surgery to remove the tumor and had an anterior and posterior cervical fusion to stabilize my neck. The diagnosis was Plasmacytoma in Situ. It's a white blood cell tumor that arose from the bone marrow in those vertebrae. I was seen by an oncologist, and I will begin radiation treatment today and I will have 25 treatments.
The patient had facial drooping and discomfort 2-3 days after the vaccines listed above. He was sent to the ED and diagnosis of Bell's Palsy was confirmed.
Pt has fever and body aches took a BENADRYL slept that night felt better next day still had headache, body ache and tired.
I started having heart pal[itations about 15 minutes apart I passed out. My husband took me to the ER had tests done told I was having Bradycardia, sinus node wasn't conducting correctly needed a pacemaker and I was diagnosed with Mobitz heart block. I was hospitalized for 3 days. I received the implant on Aug.2 for my pacemaker.
A few hours after the shot my hands and feet where tingling and felt clammy/ swollen.  After work i noticed that my heart rate would increase when walking around and that the heart beat felt heavy.  If i was lying down the heart rate would be slightly elevated compared to normal resting heart rate.  The heart rate beat felt heavy.  I went to bed early and slept through the night.  I woke up the next morning and felt fatigued, dizzy, slight body ache and nauseated.  no fever, no headache.  i tried to take a shower but symptoms got worse.  i was unable to go to work that day.  I took a few naps during the day and by late afternoon most symptoms where going away.  the last symptom was the issue with the hands and feet.  Heart rate returned to normal.   The next day i was able to return to work.
Pt says her cheeks and chin were flushed and red. She also developed a cough that lasted 4 days. The redness persisted for 1-2 days reported 2/14/17.
fever 102 & vomiting 9MAR93 640PM; fever 104.4 still vomiting 10MAR93 9AM;
Patient felt stomach pain, nausea, weakness, and sleepiness after about 5 hours after vaccination
This case was reported by a physician and described the occurrence of paresthesia in extremities in a female subject of unspecified age who was vaccinated with Seasonal Influenza vaccine, (manufacturer unspecified), pandemic vaccine H1N1 (non-gsk).  Concurrent medical conditions included under active thyroid.  Concurrent medications included SYNTHROID, birth control and unknown medication.  On an unspecified date in 2008 and on an unspecified date in November 2009 the subject received unspecified dose of Seasonal Influenza vaccine (unknown), on an unspecified date in December 2009 the subject received unspecified dose of Pandemic vaccine H1N1 (non-GSK) (unknown).  In 2008, at an unspecified time after vaccination with Seasonal Influenza vaccine the subject experienced paresthesia in extremities.  It was reported that in 2008, the subject received an unknown seasonal flu vaccine and experienced paresthesia symptoms in all four extremities for a short period of time and resolved.  On an unspecified date in 2009, less than one year after vaccination with Seasonal Influenza vaccine and approximately 2 weeks after vaccination with Pandemic vaccine H1N1 (non-GSK), the subject experienced paresthesia in extremities, fatigue, neurological symptom and weakness.  A neurologist reported the subject received a seasonal influenza vaccine (unknown manufacturer) in November 2009 and one month later in December 2009 received Pandemic H1N1 influenza vaccine (other manufacturer).  The subject developed paresthesia in all extremities a couple of weeks following administration.  Upon examination they had intact strength.  As of this report, the subject had experienced 60-70 percent improvement in paresthesia.  The physician did not have all the detail because the vaccines were not administered in his office.  At the time of reporting the paresthesia in extremities, fatigue and weakness were unresolved; neurological symptom had improved.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with related case 2018SA266210 for other patient under 65. This case involves patient (age under 65 years, gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that patient under 65 was accidentally injected with Fluzone High dose. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
about 10-15mins p/getting MMR booster; pt c/o trouble catching breath then collapsed on the floor hitting head hard; cerebral contusion & nose bleed; pt unconscious; taken to ER CAT scan abnormal;
While working on 9/28/16 "smelled strange smell" then began to get H/A, dizzy, nauseated and then vomited x 5. Has continued to feel very tired, no appetite, achy, slight H/A and nasal drainage. No cause for odor was found in her work environment.
Initial misuse report received from a healthcare professional on 09 October 2013.  A 3 year old child patient had received FLUZONE a 0.25 ml dose instead of a 0.5 ml dose. No adverse event was reported. List of documents held by sender: none.
Locally R deltoid Sore (where other two vaccines were given); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Locally R deltoid Sore (where other two vaccines were given)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies.   Patient has not been ever diagnosed/tested positive for COVID-19.  Patient did not have any chronic/long standing health conditions or any acute illness at the time or 1 month prior to vaccination.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Locally R deltoid Sore (where other two vaccines were given)). At the time of the report, VACCINATION SITE PAIN (Locally R deltoid Sore (where other two vaccines were given)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was not taking any prescription, over the counter medications, dietary supplements or herbal remedies at the time of vaccination or at the time of adverse event.   Patient had no left deltoid soreness.   No treatment was given to patient.   This case was linked to MOD-2023-725455 (Patient Link).
About 2 days after I got this vaccine, my arms became very weak and sore. Weak enough to the point where sometimes the arm that I got the vaccine in, I'd actually have to lift my arm with my other hand because it's too weak to lift it. They're painful all the time, aching painful. Before this last vaccine, I've never had pain or weakness in my arms. I have not taken any medication yet and I have yet to see my doctor for this health concern.
Patient here for nurse visit, nurse administered the MENACTRA first into the left deltoid patient tolerated with minimal complaints, nurse then HPV vaccine into right deltoid, patient became giggly and states "oh I feel dizzy", instructed patient to lie down onto back and notified Dr., upon arrival of Dr. patient was responding to questions with appropriate answers, patient kept stating "you got me high like at the dentist", patient was laughing often and appearing delirious BENADRYL, susp, total of 50 mg given in office. Improved/stable prior to leaving checked on that afternoon w mom, no concerns.
Confirmed breakthrough Case  COVID-19 (Moderna) 1 08/09/2021 Moderna 043B21A   COVID-19 (Moderna) 2 09/02/2021  Moderna  043B21A
Pt subsequently experienced uncontrolled screaming and irritability for approximately 4 to 5 hours. Copies of this report have been forwarded to Aventis.
Late menstrual cycle not due to pregnancy. I experience extreme bloating and tiredness. My cycle averages 27 days and is never so late unless pregnant. Bloating started about 2 wks before cycle due date with extreme bloating a week before due date
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, smoker, drug abuse, and asthma, and other pre-existing medical conditions included: she is neither pregnant at time of vaccination nor on breastfeeding and unknown for acute illness or hospitalization 30 days prior to vaccination. No risk factors and no family history of any disease (relevant to vaccination). The patient had no illness at time of vaccination and no past history of similar event. She did not have adverse event after any previous vaccination. The patient experienced hives when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 21-SEP-2021) 0.5 ml, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211137983 and 20210955494.
Itching after injection x 1 wk. Took BENADRYL 1-2 x/day Ibuprofen for dull achiness, 600mg bid, but also takes for H/A. Still has indurated area (never went away) pea shaped 5 mm wide, 1-2 mm raised. Still achy occasionally.
I started with a runny nose, sore throat, productive cough, fever, sweats, and muscle aches. I called my primary care doctor after I completed a home COVID-19 home test. I was prescribed PAXLOVID. I took TYLENOL, DAYQUIL and NYQUIL. My symptoms improved after about a week. The PAXLOVID helped a lot. I am still experiencing a sore throat and headache currently.
Patient falsified DOB when registering for vaccination, stating the minor was 10/16/2004. Guardian, consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 10/16/2007 which made the vaccine a contraindication.  No known adverse reactions noted.
No adverse event/pregnancy outcome report of vaccines inadvertently administered during pregnancy AVA and TYPHOID VICPs administered on 14 Aug 2008.  EDC: 24 April 200 Pregnancy Outcome: Delivery Date: 4/26/09 healthy infant girl, APGARS 8/9, birth weight 3065 See supplemental information for AVA in pregnancy (attached)
first dose in NOV2021, second not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 16th November 2021, batch no: X239D, expiry date: 7th August 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was 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 age at vaccination was not applicable for this report. The pharmacist reported that the patient received the first dose of Twinrix and the second dose had not been administered yet. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up.
on day 12 after receiving round one of vaccine, I woke to find injection site very swollen, very red and hot to the touch. It also had a burning sensation and was itchy.  I monitored it throughout the day and took a anti-histamine later that evening. The following day the redness had spread further down the arm but overall less hot to the touch and no longer burning or itchy.
Patient was congested on Monday with cold symptoms 4/24/17. She rec'd 3rd HPV on 4-25-17. Wednesday 4/26 c/o sore arm and injection site hard and warm to touch. C/O headache, too. Thurs. 4/27 arm continues to be sore, warm to touch and hard at site and continues with HA. Coughing too. Enc'd TYLENOL or anti-inflam. 5/1/17 arm pain, etc resolved over weekend.
Patient (16 yo) should have received Pfizer Biontech COVID-19 vaccine, but received Moderna COVID-19 vaccine instead.
Neck was getting stiff; Extremely tired; Red, raised area about the size of a quarter; Vaccine stung really bad when injected; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VACCINATION SITE PAIN (Vaccine stung really bad when injected). On 11-Aug-2021, the patient experienced ERYTHEMA (Red, raised area about the size of a quarter). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck was getting stiff) and FATIGUE (Extremely tired). At the time of the report, ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Patient reports constant scrotal pain that began 24 hours after his immunization and has persisted for 4 weeks.
No reaction on day 1.  On day 2, by 24 hours the entire left shoulder from arm to spine was hurting and a bit swollen,   Day 3: by 48 hours the pain reached from left shoulder to right shoulder, or from arm to arm.  After a week or so, the outsides (towards the arm) and the pain remained close to the spine on either side.  I thought it would get better, so I just didn't go to the doctor for a couple of months.  I remain in mild to moderate pain and can clean house, but cannot do heavy lifting and some yard tasks such as raking and turning compost.  The muscles remain tight and I cannot move my head side to side as I used to.   Please note: Dr declined to report injury on my request.
severe vertigo, nausea. after 2 weeks of vertigo took Benadryl suspecting it was the shot that caused the vertigo. Eased symptoms with in 2 days. Still have low level of vertigo but able to work now