chrisvoncsefalvay/vaers-outcomes huggingface dataset:
original live shingles vaccine that was ineffective; This spontaneous report was received from a 74 years old female via Pfizer, referring to the patient herself. The patient's medical history, concurrent conditions and historical drugs were not reported. The patient's concomitant medication included etanercept (ENBREL).  On an unknown date (reported as a few years ago), the patient was vaccinated with zoster vaccine live (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient considered the original vaccine zoster vaccine live (manufacturer unknown) was ineffective. The outcome of the event was unknown. The causal relationship between the event and zoster vaccine live (manufacturer unknown) was related.
Pt developed fever of 104.7 without other symptoms necessitating evaluation for occult bacteremia.
Anaphylactic type reaction requiring Epipen. Shortness of breath, closure of airways, vomiting, pale face, redness and swelling at injection site
One week after 1st shot, woke up with  Moderna "Covid Arm",  large red  circle at the injection site. It was itchy but not painful to the touch, treated it with topical spray. Today is 2nd day, "rash" grew  from 2" to 3" around, still itchy but not painful.  I was concerned until I read a helpful article at website which said to report it to you, assist you with research. The article says it goes away in 3-7 days, so I will mark "No" under "is patient recovered" below, as it has not yet.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 24-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008942, 1312USA008943, 1312USA008944 (Same reporter link). Additional information has been requested.
Large, oval shape area around the injection site that is swollen; large, oval shape area around the injection site that is red; itching at the injection site; A spontaneous report was received from a health care professional concerning, an 72-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness /  vaccination site pruritis, swollen in oval shape/vaccination site swelling and redness/vaccination site erythema.   The patient's medical history included blood pressure and cholesterol . There was no concomitant medication provided.  On 16 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:  28L20A)via unknown route of administration in left arm for prophylaxis of COVID-19 infection.   On 24 Jan 2021, the patient noticed that large area around the injection site is swollen and red  in oval shape and also experienced itchiness. The patient put hydrocortisone on it .  Action taken with mRNA-1273 in response to the events was considered to be unknown.  The outcome of the events swollen and red and also itchiness is considered to be recovered / resolved.
pt recv vax & pt contracted hep b;it was reported that it was unclear as to which hep b vax was recv in addition to how it was stored;
Welts on body.  It appears the welts are at points where I had compression, the waist line, and on the inside of my thighs where my underwear is.  Clicking in my right ear.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
Pt received varicella vaccination on 4/8/97 and developed chickenpox on 10/19/00. Still with lesions now.
other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 74 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 20-JUL-2017, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider at a grocery store for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider at an urgent care, and other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Symptoms started with low grade fever (about 99 degrees); vomiting in crib early AM Aug 26. Patient continued to have side effects over 19 days. She also continued with low-grade fever for 3 nights. She developed a runny nose, with sore throat, congestion in throat/phlegm, and developed a strong wet cough that was active during day and most evenings. She exhibited low energy, low interest in normal activities with somnolence for the first 7 days. The cough continued for 19 days even though her normal daily activities improved or resumed. The cough has been most bothersome in the evenings and my child has been unable to resume sleep after waking up with coughing episodes most evenings since the vaccine event. Notably, she has had external skin rashes (appears like Measles, Rubella or Varicella photos for mild case) on her skin for about 12-24 hours duration within 1 week of vaccine date: face and chest. There was noteably a red and inflamed area on the side of her nose which appears to be painful. She also had a rash that was red, round and pustule-filled where she had extreme itchiness in the diaper area and caused her distress. Appointment with pediatrician made on 9/12/16. Otitis media was confirmed with impetigo diagnosis. Waiting for culture result of the diaper area swab.
nurse gave 1 children only the Dtap-IPV part of the Pentacel vaccine, ActHIB vials were not given; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with 2019SA195802.   This case involves 1 child patients of unknown demographics who was vaccinated with a dose only the Dtap-IPV part of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ123AAA and Exp. Date 29-Sep-2020) ACT-HIB part was not given via unknown route in unknown administration site on an unknown date.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate reconstitution technique.  (DTap-IPV- lot number U6397AA and Exp. Date 09/29/2020 and ActHIB UJ123AA and Exp. Date 09/29/2020)  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
15 MINUTES POST VACCINATION BY THE DOCTOR, PATIENT STARTED NOT FEELING WELL.  HE SAID HIS HEART WAS BEATING FAST.  CHECK BP (113/73 PULSE 79)  PATIENT THEN STARTED HAVING PRESSURE/PAIN IN CHEST AND NECK (PRESSURE MOVED FROM LEFT SIDE TO RIDE SIDE) FOR ABOUT 15 MINUTES.  VITAL SIGNS WERE NORMAL BEFORE AND AFTER  PATIENT RELEASED TO GO HOME, ADVISED TO CALL 911 IF ANY SYMPTOMS REOCCURRED.
High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.
On Tuesday I broke out in small  hives on my lower arms and then it they became large hives.  The next day I broke out in rash on my extremities only.  Extremely itch and spread.
felt bumps on tongue which was like her previous allergic reactions to medicines.  posterior pharynx clear to MD exam.  took 50 mg of benadryl and felt better.
Narrative:  approx 24 hrs after 2nd Covid vaccine administered patient became increasingly short of breath, increased confusion, and "couldn't move". Taken by ambulance to ER. Unknown outcome as of this report.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had no concurrent condition, medical history or concomitant therapy. On 14-AUG-2017 the patient was vaccinated with ZOSTAVAX (Lot number N037016 is not valid for ZOSTAVAX) that was reconstituted with an expired sterile diluent(manufacturer unknown) (Lot number K015794) prophylaxis. On an unspecified date in August 2017 the patient experienced dizziness. No treatment or diagnostic lab was performed. The outcome of dizziness is unknown. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006979:
Was given a Flu Shot at 2 months of age in error.  At this time the baby is exhibiting no side effects.
This report describes a hypotonic-hyporesponsive episode in a 6 month old male who received Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the subject received his first injection of Engerix-B. W/in 24 hrs, he experienced a hypotonic-hyporesponsive episode characterized by hypotonnia, placidity, non-responsiveness, and decreased blood pressure. The infant was seen by a physician and recovered.
Tired, fatigue, cloudy thoughts, pain in arm. The 9th day I am itchy at injection site. It has swollen today more then the entire time. I have been nauseous and weak the entire time, but today I felt like passing out. Mentally and physically it has been hard to take care of myself since the shot has been administered.
This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL (.5 ml, unknown route and site). At an unspecified time after vaccination with FLULAVAL, the subject experienced red spot at injection site and itching. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 5 out of 70 subjects who received FLULAVAL experienced the events as noted. The facility used a single dose syringe vaccine last year and did not have any complaints of this nature. This is case 1 of 5 (see case IDs A0885964A - A0885967A for the other reports).
This case was reported by a physician via sales rep and described the occurrence of delirium in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced delirium (serious criteria GSK medically significant). On an unknown date, the outcome of the delirium was recovered/resolved. It was unknown if the reporter considered the delirium to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced delirium set in around 6 hours and was gone by 15 hours. The reporter gave consent for follow up. This case is linked to case US2019GSK076490, reported by the same reporter.
Arm really really hurt; A spontaneous report was received from a consumer which refers to a 56-year-old female patient who received the Moderna COVID-19 vaccine and experienced arm pain at the injection site which resulted in worsening arm pain during the day.   The patient's medical history was not provided. Concomitant medications were not reported.   On 28 Dec 2020, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided). Sometime later, on the same day, in the morning 7.30 a.m. the patient experienced pain at the injection site, and pain in the injection arm which progressed during the day. The patient reported that her arm really, really hurt for which the patient took 4 advil and iced at the injection site, but the pain still remained and got worse during the day.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, arm really, really hurt, was not recovered.; Reporter's Comments: Based on the current available information and a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the events cannot be excluded
Administered on 8/16/21. On 8/21/21, I began experiencing numbness and tingling in right arm. I also have bilateral tingling in hands.
Patient called on 11/3 in the AM reporting redness, inflammation and warmth to touch in RA at site of PPV23 injection.  Admits never received PPV23 before.  Instructed by RN to come to the health department for assessment or make an appointment with private MD.  RN did not see or assess patient.
Tender lump right biceps at injection area, no redness or itch. Immunization site documented as left, lump is right, patient reports getting it in the right arm and noticing at the time is was charted as in the left arm.
Fever of 101 Shakes  Heart rate up to 123   Rash with blisters appeared next day, 7/12/2019 on ankle
FEVER, ACHY, SORE JOINTS, HEADACE, RED SORE SWELLING IN UPPER LEFT ARM.
Large welt, body aches, fevers, chills, uvula swelling, difficulty breathing, treated with prednisone.
Started out with body aches and chills, then progressed into fever 101F, then progressed into redness, pain, swelling, heat at injection site which progressed down my arm throughout the next 4 days. Numbness in left 4th and 5th finger.  Went to Urgent care twice.  Also had generalized body redness that looked like a sunburn.  The second time was placed on high dose prednisone taper and Antibiotics four times a day for 10 days.
blatter infection or kidney infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (blatter infection or kidney infection) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINARY TRACT INFECTION (blatter infection or kidney infection). At the time of the report, URINARY TRACT INFECTION (blatter infection or kidney infection) had not resolved.            It was reported that the patient went to the doctor and got tested two times with negative results. She hadn't recovered when she got the second dose. The patient reported that her symptoms got worse two weeks after the second dose. It was reported that she is scheduled to visit a urologist per her doctor's request. No treatment medications were reported.  Correction done 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.; 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.
Experienced large local reaction after vaccination with Tdap on 10/31/06. Begin to have pain in arm same night on day she received the vaccine, that gradually worsened with pain, swelling, erythema and induration. Recommended OTC Ibuprofen and cold compresses to injection site for pain relief.  Reviewed systemic allergic s/s that would require emergent medical attention.
Severe right arm and shoulder pain, increasing over the next 7 days, followed within one week by progressive right arm weakness, numbness.
About 36 hours after the injection I woke up with swollen dry cracked lips.  The swelling did not effect my breathing or airway.  I did not need immediate attention. I took an antihistamine for 3 days.  On day 3 I went to an urgent care.  The PA felt it was a reaction and suggested taking a Pepcid as well as the zyrtec.  It cleared up on 2/18.  On Wednesday 2/24 at about 8 pm I noticed my lips were starting to swell again.  I took a zyrtec and a pepcid.  I woke up on 2/25. My lips were very swollen and itchy and red and the area around my lips were very red.  I did not feel any breathing issues.  I went to an urgent care.  They felt it was a delayed reaction to the vaccine and gave me a shot of prednisone and I took 25mg of Benedryl.
Patient states that on 11/1/22, she woke up (9AM) with swelling/redness/pain/rash/itching at site of injections,  Patient presented to pharmacy at 12:25PM on 11/3/22 asking about symptoms and what she should do. Patient states that since 11/1 (when first woke up with symptoms) she has noticed the rash is spreading/original symptoms worsening. Rash was visible, red,  hot to touch and felt uneven when presented to pharmacy. Patient was instructed to seek medical attention asap at 12:35PM. Patient agreed and left pharmacy.  At 3:06PM on 11/3/22, the pharmacy received a prescription for this patient for Bactrim DS 800-160mg ( 1 tab twice daily for 5 days). RX was written by local urgent care MD. Patient picked up the medicine at 3:48PM and stated the MD at urgent care was treating for possible infection.
This spontaneous report as received from a health worker to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patients were vaccinated with a dose of VAQTA (lot # and expiration date were not reported) (route and dose were not reported) which was improperly stored. No concomitant medication was reported. No adverse effect was reported at the time of this report. Additional information has been requested. This is one of several reports from the same source.
Client was given the H1N1 Flu mist after being screened.   Client indicated that she was not pregnant at this time.  Client waited her 15 minutes as instructed and then went to the public restrooms.  Client was found conscious on bathroom floor by an RN who assisted client to a sitting position.  EMS was present at H1N1 Flu Community Clinic and took over care for the client.  Client complained of being lightheaded and weak. Client's BP was slightly low per EMS, client was assisted to the floor and legs were elevated.  This action assisted with client's BP returning to normal.  Client's children and her mother were present.  EMS offered to tranport client to local hospital.  Client agreed and was transfered.  Client has a pregnancy test at the hospital and was confirmed postive for pregnancy. 12/16/2009 ED visit 11/2/2009 patient with c/o's lightheadedness and dizziness 12/16/2009 OB-GYN visit for 11/6/09 initial visit
pt recv vax 24OCT95 & 3hr later devel severe nausea, diarrhea, w/occasional vomiting;w/in a few hr became very weak & could not stay awake;sx subsided by the next morning & w/in 4 days regained full strength
Left eye hurts; Deep indentations on both sides of the face; Swelling of the face; Swelling of the neck; Swelling of the throat; swelling of the tongue; Arm hurt; Right arm hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Right arm hot), SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck) and PHARYNGEAL SWELLING (Swelling of the throat) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine drugs). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt) and VACCINATION SITE WARMTH (Right arm hot). On 18-Mar-2021, the patient experienced SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck), PHARYNGEAL SWELLING (Swelling of the throat) and SWOLLEN TONGUE (swelling of the tongue). On an unknown date, the patient experienced EYE PAIN (Left eye hurts) and SKIN INDENTATION (Deep indentations on both sides of the face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Right arm hot), SWELLING FACE (Swelling of the face), SWELLING (Swelling of the neck), PHARYNGEAL SWELLING (Swelling of the throat), SWOLLEN TONGUE (swelling of the tongue), EYE PAIN (Left eye hurts) and SKIN INDENTATION (Deep indentations on both sides of the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had allergic reactions to Bees.
I received my first Pfizer booster for COVID-19 on 2/28/2022. On the evening of 11/5/2022, I had a very sore throat and developed sinus congestion and postnasal drip. I woke up the morning of 11/6/2022 and I still had a very sore throat. I took a home test for COVID-19, which yielded a positive result. I then took another home test a little while afterwards and got another positive result. I then called the doctor's office, and they told me that I definitely had COVID-19 and that a lab test would not be necessary. They did not prescribe me anything or make recommendations regarding treatment of symptoms at this point. My symptoms worsened. I have arthritis, and my joint pain became worse. I also had jaw pain, which is unusual for me, and pain in the upper teeth. I had a cough, a fever and chills, and pretty extreme fatigue. I then called my doctor's office on 11/9/2022, and on 11/10/2022, they prescribed me PAXLOVID  which I began taking that evening. Up to that point, my symptoms had improved slightly. However, they improved greatly within 24 hours of my beginning the PAXLOVID. I then continued to improve, and by 11/16/2022, I had a negative result on a home test. Before I got the PAXLOVID, I was treating my symptoms with AFRIN nasal spray. I also alternated between ibuprofen and acetaminophen. If it weren't for AFRIN, I would not have been able to breathe because of the severe congestion. At the time of this writing, I would say that I still have yet to make a full recovery, as I am still flushing out the congestion. Also, my full pre-COVID energy level has not yet returned.
8X6 cm area of induration over R deltoid with 13x10 cm of erythema, non-tender, no expressible d/c. Received DAPTACEL 4/9/09 R deltoid