chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adolescent male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient was 16 or 17 years of age at the time of reporting. The age at vaccination was not reported. The patient experienced severe pain at the injection site. The patient refused to receive the second dose because of this event. The pain lasted for two weeks after the shot. The reporter agreed for follow up.
Arthralgia, Fever, CoughWheeze, joint pain, lower back muscle spasms, cold feet and hands, paresthesia in hands Narrative:  Other Relevant History:
Information has been received from a physician and a school nurse concerning a 7 year old male who on 15-JUN-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the child was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 25-OCT-1999 and 05-SEPT-2002. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005, the child developed a "more sever case" of chickenpox, noted to be breakthrough with 50 to 250 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
Within a few days following second Covid vaccination began experiencing fairly severe IBS-D symptoms.  Where previous bouts have ended in a few days to a week, this has continued for close to six weeks.  Doctor has prescribed Uceris and Bentyl, but no change.  Have tried limited diet.  Weight loss of close to 10 pounds. Obviously cannot be sure the vaccination caused this reaction, but want to submit this in case others have had a similar experience.
My joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, my joint is at a 2. My right ankle became swollen. Usually, my ankles don't swell. I've also had four migraines during this time -- I typically have migraines every two to three months. I experienced fatigue which caused me to take multiple naps throughout the day. I experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, I have brain fog for 2 - 3 days. Basically, I feel like I'm having a prolonged fibromyalgia and Sjogren's episode. The symptoms are still persisting.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 18-APR-2016, the patient was vaccinated with improperly stored dose of MMR II 0.5 ml injection, lot# L027432, expiry date: 22-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Cellulitis (L) deltoid. Cool compress. BENADRYL, antibiotics.
Information has been received from a medical assistant referring to a 4 year old female patient. No relevant medical history or concurrent conditions were reported. On 14-AUG-2015 the patient was vaccinated with VARIVAX (Merck) lot # L001330, expiration date 13-JAN-2017; dose and route not reported) which had been exposed to temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.
Complete change of taste 2 hours after the shot administration: 1. No taste for glucose (e.g. doesn't feel sugar in candies or cookies), but feels fructose in fruits 2. Sour taste after milk products 3. Sour products became less sour (e.g. can eat lemons and does feel sugary taste there) 4. Almost no taste for vegetables
Low fever, sore arm, a lot of achiness, really tired.  Lasted for about 36 hours until I felt back to normal.
This spontaneous report as received from a medical assistance refers to a 73 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L012521, expiration date: 01-FEB-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
7 days after vaccine, developed rash on chest, back, and back of neck. Also experiencing mild chest discomfort: shooting pains that come and go. Saw pediatrician who determined it was likely a reaction to the vaccine.
Intermittent ringing in ears - Begin approximately 2 hours after injection and lasted for about 6 hours Body aches - began approximately 12 hours after initial injection and lasted for approximately 24 hours Lethargy/very tired - Begin approximately 12 hours after injection and lasted approximately 24 hours
Pfizer-BioNTech COVID-19* Vaccine EUA. early Saturday morning I had chills, it took less than an hour to warm up. Saturday I was tired all day. Saturday night I  started getting a headache. Sunday morning I was very tired, had a headache, and just net feeling well. Sunday night I had a fever, took Tylenol for that. Monday my throat was sore with the post nasal drip ( I believe that was my allergies..the neighbors were mowing their lawns) Still tired. monday night things were better.
Lump at injection site, low grade temp, diarrhea, headache, dizziness, nausea, achiness.
Day 1: mild sore shoulder  Day 6: mild soreness returns Day 7: moderate soreness, itch, redness, swelling Day 8: swelling, redness & soreness increases, warm to the touch. Saw Dr  at 3pm ordered prednisone, antibiotics and over counter allergy meds for 5 day treatment
BRAIN FOG; CANT FOCUS; COULD NOT SLEEP; NUMBNESS AT THE BASE OF THE SKULL; SEVERE HEADACHE; BODY GETTING HOT; BODY ACHES; LEG PAIN; BODY FATIGUE; MUSCLE PAIN; NAUSEA; PALPITATIONS; FAST HEART RATE; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fast heart rate. On APR-2021, the subject experienced palpitations. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced body fatigue. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative, Not reported, Headache (NR: not provided) 6-7/10 pain level, Leg pain (NR: not provided) 9/10 pain level, 7-8/10 pain level, and MRI (NR: not provided) NORMAL. On 06-APR-2021, the subject experienced body getting hot. On 08-APR-2021, the subject experienced brain fog. On 08-APR-2021, the subject experienced cant focus. On 08-APR-2021, the subject experienced could not sleep. On 08-APR-2021, the subject experienced numbness at the base of the skull. On 08-APR-2021, the subject experienced severe headache. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) NORMAL, CT scan (NR: not provided) NORMAL, and ECG (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body getting hot on 08-APR-2021, and fast heart rate, had not recovered from severe headache, brain fog, cant focus, nausea, body aches, leg pain, muscle pain, body fatigue, numbness at the base of the skull, and could not sleep, and the outcome of palpitations was not reported. This report was non-serious.
was dipped in a rash because her body was covered in a rash from her head to her feet for a couple weeks; patient with history of egg allergy received Fluzone; patient with history of egg allergy received Fluzone; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a female patient of unknown age who experienced broke out in rashes all over body (Rash), while she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  Medical history was tested positive for an egg allergy.  At the time of the event, the patient had ongoing Asthma but had no incident since 2012.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] [lot U2743AA and expiry date not reported] via unknown route in unknown administration site.  On an unknown date, (Latency unknown) following vaccination the patient was dipped in a rash because her body was covered in a rash from her head to her feet for a couple weeks (rash).  It was also a case of contraindication to vaccination and product use in unapproved population  The patient visited emergency room due to this.  Patient stated that she received the flu shot but a couple of weeks later she broke out in rashes all over her body. Consumer states her face did not have a rash but her hands and the bottom of her feet did.   Relevant laboratory test results included: Food allergy - On an unknown date:  [Positive]  Final diagnosis was dipped in a rash because her body was covered in a rash from her head to her feet for a couple weeks.  It was not reported if the patient received a corrective treatment.  On an unknown date, the outcome of the event was reported as Unknown.
Dizziness, Headache, Myalgia, malaise Narrative:  Other Relevant History:
Information has been received on 11/28/01 from a RPh concerning a 24 year old male with no past medical history and no known allergies who "approx. 2 weeks ago" was vaccinated with a dose of MMRII. On 11/28/01, it was reported that "a few days ago" the pt "broke out" in generalized rash, papular-vesicular, all over the body and had a fever. The pt sought unspecified medical attention. There was no other information provided. Additional information has been requested.
Primary vaccinee playing basketball with SPV site uncovered. Friend who was playing basketball with vaccinee developed a Jennerian pustule.  Reported through military overseas.  Limited details available.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It ws reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported.  It was unspecified whether the patient had sought any medical attention. There was  no product quality complaint involved.   Follow up information has been received from office manager, who stated she may call back for fax information as it become available. Also , reported that M-M-R II was not mentioned int he original call, but did experience a temperature excursion. No further information was available at that time.   Follow up information as received from office manager refers to a 4 years old patient. On 13-JUN-2014 the patient was vaccinated with a dose of improperly   stored M-M-R II (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of several reports from the same source. Additional information has been requested.
4/24/99  pt c/o stiffness given tylenol , 4/25-26/99 c/o stiffness & in eve redness area, warm to touch, er md stated delayed allergic reaction or infected at site.
HPI: reports feeling ?woozy? 30 minutes after getting Moderna COVID-19 vaccine, 2nd dose in series. Reports she became lightheaded when she stood up to leave. No syncope. No chest pain or SOB. No airway complaint. No headache. Reports she did not eat breakfast or lunch. PMH: HTN Allergies: tree nuts, some fruits, latex Meds: triamterene/hctz 37.5/25mg, Epipen as needed  ROS: otherwise negative.  PE: Constitutional: No acute distress. Able to sit in a chair without difficulty. Skin w/d.  Respiratory: No increased WOB. Cardiac: radial pulses strong and regular.  A/P: Lightheaded. Likely secondary to not eating any meals today and then receiving IM injection, mild vasovagal response. No allergic reaction evident. Given graham crackers and juice, which she ate without difficulty. Felt completely fine within 10 minutes and preferred to leave in order to attend a meeting. Encouraged to seek attention for new or worsening. Will report.
My first 2 Moderna vaccines did not give me any adverse reactions. It was upon my 3rd (booster) dose that I noticed some strange symptoms right about 2 weeks following the shot. The first symptom was an itchy scalp, legs, and palms. This went on for about a day before I noticed that I was developing hives in my groin area, scalp, hands, legs, and some patchy spots on my abdomen. I did not initially link it to possibly being a vaccine reaction, and took Benedryl to lessen the symptoms. After about a week of on and off taking Benedryl, which helped greatly but made me constantly drowsy, I switched to a non-drowsy Zyrtec. It is important to note that I had no change in diet, activity, clothing, food, no new medications or supplements, no changes in soaps or detergents (I am a creature of habit and routine). I did not immediately inform a medical professional as the symptoms, while persistent, have been lessening (though at a painstakingly slow rate). Just recently I visited Dr. and informed him of the situation, to which he referred me to this site to report my symptoms. At this time, it has been roughly 3 months of symptoms. Half a dose of Zyrtec once a day allows for the symptoms to almost completely disappear. Though, if I scratch or irritate my skin even mildly (even just scrubbing lightly in the shower) , hives will appear for a few minutes before dissipating again. I am going tomorrow for blood work as well. I am currently off Zyrtec per my doctor as to not skew the bloodwork. I've noticed some hives come and go but not as intense at it was 3 months ago. It seems this reaction is extremely slow to work out of my system. I've never experienced any reaction like this before in my life and the only change that I can think of was the booster shot. I hope that you can find this information helpful in the event others may be experiencing similar symptoms.
A mother reported that her 9 month old son received an injection of Prevnar on 6/23/00. On 6/24/00, he experienced 2 episodes of vomiting, producing "large" amounts of emesis. He also developed a fever of 99.5F, which was treated with acetaminophen. He recovered.
Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Oct-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 04-Feb-2021 and Second dose on 21-Mar-21) outcome was unknown.            Concomitant drugs were not reported.  Treatment details were not given.   This case was linked to MOD-2022-600558 (Patient Link).   Reporter did not allow further contact
SYNCOPE, LOW BLOOD PRESSURE, PASS OUT APPROX 10 MIN AFTER ADMINISTRATION.
Shortness of breath started around 5/20/22. ED visit report states respiratory distress is present.
Dizzy, Nausea, Sweating, Tremors, Headache. IV Fluids; Valium, Reglan, Benadryl.
Two hours after the injection, I have a very bad headache. Two Advil cut it within 2 hours. My arm has been sore for the last 9 days, and I cannot sleep on my left side due to soreness. The injection site has been itching for the past 2 days. Tonight it is warm to the touch, with a large red rash about 3 inches in circumference around the injection site. It is still itching and is still is sore.
Patient reported swelling and itching at injection site. Swelling has started to decrease. She has used Advil to manage symptoms. I advised OTC antihistamines to manage itching and to watch for any signs of reaction expansion.
Patient developed chest tightness 2-3 days after vaccination. On day 5 (5/27/21) pt developed tachydysrhythmia and was admitted to the hospital. Patient re-presented to hospital on 6/13/21 with persistent episodes of tachycardia.
Mother reported child fell out while playing basketball,  she thought he had fever, and he felt bad. She took him to the ER  late that night after immunization given earlier in the day. Mother contacted clinic on 09/02/20 and reported that she thought he may have had a reaction and took him to the ER where he was tested for COVID.
10/27/03 PM: lump at site, sore. 10/28/03: itching, no rash. 10/29/03: Broke out with rash, hives started with left arm then spread to chest and right arm, hands, to trunk, legs. Seen in ED in PM. Taking Benadryl. Symptoms worse, returned to ED 11/5/03, given Prednisone for 5 days. Symptoms improved. Day after Prednisone stops symptoms worsened. 11/18 Seen by MD, Medrol dose pack, Allegra, Kenalog spray and cream. Symptoms improving. Skin remains red and scaly.
Patient vaccinated 10/28 2:40 pm noticed rash 2x2" around 6pm 10/25 said rash itching.
In the crown area of my head, (I have locs, just getting my hair done). I started seeing a small patch in the crown of my hair, now all around the crown area is really short. I have to slick my hair down to wear it a certain way. I dont know if me worrying made it worst, i dont know. I was very distraught about that. It is not falling out anymore, but its short. I am seeing a dermatologist and he has me on topical drops. Also taking a tablet medication.
Approximately 3 days after receiving the MMR vaccine, pt developed a rash on both upper arms and a lump in her L antecubital area. She report that she hasn't changed anything else (ie detergents, etc,).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was not information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 06-JUN-2016, the patients were vaccinated with improperly stored doses of M-M-R II, lot # L034730 with expiration date 09-SEP-2017 or lot # reported as L041455 with expiration date 22-OCT-2017 (albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine were stored in a refrigerator and experienced the temperature excursion of 66.3 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Patient left message on voicemail to report her face was very red/flush following her vaccine. This message was left approximately 3 hours after administering the vaccine. Upon questioning the next morning at 9:30 am, she had no trouble with breathing or swelling of any areas. Some reaction was subsiding. Advised benadryl prn. Second inquiry with patient at 2:00 pm, patient is " back to normal".
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot number M68769), intramuscular at 0.5 ml, single and GARDASIL, via an unspecified route of administration at 1 DF, single, both on 21Jun2016. The patient medical history and concomitant medications were not reported. On 21Jun2016, the patient experienced faint with outcome of recovering, fell off the table and hit her head on the floor with outcome of unknown, contusion with outcome of recovering, weakness with outcome of recovering, she did not feel well with outcome of recovering. The adverse events occurred in the exam room at the doctor's office and the patient fainted while sitting on the exam table and she fell off the table and hit her head on the floor, she had a contusion as a result and for about two to three days she did not feel well after having TRUMENBA and she was also administered with another vaccine GARDASIL at the same time. The nurse stated that because there was another vaccine was administered at the same time so they did not know that what was actually causing this. No follow-up attempts possible. No further information expected.
whole body aches; fever; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "whole body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Description of event: Patient has whole body aches, late fever 1 week post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Edema, erythema, warmth at vaccination site, decrease range of rash on left arm/shoulder at clinic 7/14 <24 hours after vaccination. Concern cellulitis- Rocephin 500 mg IM, dexamethasone 4 mg, erythromycin 150 mg QD X 4 days, Advil and cold compresses.