chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect; Improperly stored dose of VARIVAX; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, past drugs and allergies were not reported. Concomitant therapies included sterile diluent.  On 12-AUG-2019, the patient was vaccinated with one improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R027995 has been verified to be a valid lot number and expiration date was 01-OCT-2020; strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The sterile diluent that was used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. The temperature excursion was seen at temperature of 6-degree Fahrenheit to 14-degree Fahrenheit (7.5 F) for 30 minutes. Previous temperature excursion was noted at temperature of 6-degree Fahrenheit to 14-degree Fahrenheit (10 F) for 28 minutes. This call was because of digital data logger.
Robust take vs cellulitis w/ lymphangitis.  Allergic dermatitis of neck/shoulder/upper chest.  Treated with PO benadryl and QID dicloxacillin.
Post vax pt devel 1cm hive like eruption locally stabilized 1 1/2 cm size reduced w/ice application;
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 17-SEP-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916 which was determined to be valid; expiration date reported as 16-SEP, and determined to be valid as 16-SEP-2021) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268:
I just started having problems breathing, I couldn't catch my breathe and heart rate went sky high. I ended up going to the ER, they have me some steroids and breathing treatments, monitored my heart rate for three hours.  I stayed in the ER for 4 hours and discharged me. The next day I was feeling a little week but breathing better and heart rate was back down to normal.  I have a cough that's lingering a dry cough.
2 episodes of sycope; 2 episodes of vomiting; extreme muscle fatigue; weakness; fast heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTS syndrome" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE, Lot number: Not reported), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Lot number: Not reported), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Lot number: Not reported), for Covid-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 01Nov2022, outcome "unknown", described as "2 episodes of sycope"; VOMITING (non-serious) with onset 01Nov2022, outcome "unknown", described as "2 episodes of vomiting"; MUSCLE FATIGUE (non-serious) with onset 01Nov2022, outcome "unknown", described as "extreme muscle fatigue"; HEART RATE INCREASED (non-serious) with onset 01Nov2022, outcome "unknown", described as "fast heartbeat"; ASTHENIA (non-serious) with onset 01Nov2022, outcome "unknown", described as "weakness". The patient underwent the following laboratory tests and procedures: Heart rate: (01Nov2022) Fast. Therapeutic measures were not taken as a result of syncope, vomiting, muscle fatigue, asthenia, heart rate increased.  Clinical course: other medications in two weeks: Zyrtec, vitamins. 2 episodes of syncope, 2 episodes of vomiting, extreme muscle fatigue, weakness, and fast heartbeat on 01Nov2022.  No follow-up attempts are possible. No further information is expected.
I went to my eye doctor for my annual exam. They noticed I had a blood vessel break in my retnea so they sent me to a specialist. I didn?t think anything about it until my husband came home from his second shot and his blood vessel had popped in his eye. My husbands you could see right away mine was at the back of my eye and could not be seen. Once I saw his it hit me that it could of been from the shot, too coincidental!
patient received the moderna omicron vaccine on 9/26/22 and requested another omicron vaccine on 12/29/22 and this was not caught and a second omicron vaccine was administered
Itching and burning rash on neck and upper chest that appeared 6 days after second injection and lasted for 5 days.  Had this reaction after first injection but only lasted 2 days.
Redness, swelling, itching 7 days later. At least 2" diameter  around injection site
My 10 year old granddaughter received a flu shot at her physician's office on 10/23/07 at 4:25 pm.  At 6:50 pm she became very dizzy and had broken out in a rash.  She said the rash was very itchy and began to scratch.  The rash covered her body including her face.  She and her mother live with us.  There was nothing different in her home environment, no change in soap, washing powder, etc.  She had not eaten anything new.  The emergency room doctor thought the rash was due to her flu shot.  She received Prelone syrup at the ER.  The rash was very faint today, 10/24/07.  I am concerned since she has taken the flu shot each year since she was born and she now has a reaction.  She has no know allergies.  Was there something new in the preservative this year?  I called the doctor's office and got the lot number of the flu vaccine.  The lot number is U24378A.  Should she not have a flu shot from now on?  I will appreciate any information you can give me.
Breakthrough case. Around family who tested positive for COVID-19. Started feeling really tired with body aches and a headache. Took a Home COVID-19 test, and it was positive. Had a telehealth visit with Dr. at the clinic and was prescribed PAXLOVID. Started feeling a little better about a week later. Took another COVID-19 test and tested negative.
Headache, Rash, UrticariaPruritus, Fatigue, small knot at injection site Narrative:
Within the hour of receiving the flu shot I began to ache all over. I went to a meeting and when I got home 4 hrs after I received the shot I had a fever of 101.4 and was severely fatigued.  My only symptoms were fatigue, very bad muscle aches and a fever. This lasted 3 days and then symptoms continued at a lesser degree for a week.
Unable to sleep the night of the vaccine due to sore arm and being uncomfortable. Next day whole body pain, sore arm, swelling around collar bone, chills, shaking, fever, headache, hardly able to walk around
Significant pain, swelling, unable to lift arm in which vaccine was given. Fever to 102 shortly after receiving vaccine.
p/vax pt devel sz earlier today;spit out pacifier & had unusual cry;eyes rolling back & tongue curled & hands shaking;would not sit up & was jerking all over x 5min;had some staring straight ahead;T105 ax;R44;poss meningitis;head trauma;
Pt vaccinated with MMR 4 days after inject given - temp 103 & grand mal seizure.
Recv'd vax in ER post laceration to finger. DT given in L deltoid with 5/8" needle. Subsequently pt returned to ER with L arm pain, swelling and induration. Sx consistant w/ vax given SC instead of IM documented by use of 5/8" needle (cont)
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age. On 16-JUL-2013, the patient was inadvertently vaccinated with both doses of PROQUAD (Merck) and VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
I did let the nurse know right after I got the vaccine It did feel like  a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work).  They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me.  After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of  like I had a hangover and of course my arm was really sore.  The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
Patient was administered vaccines at 4:20 PM, and while waiting to schedule his next appointment, he felt dizzy, saw spots and stumbled backwards. His face was pale, although he denied any chest pain, shortness or breath or difficulty breathing. He was immediately brought into the exam room and placed in a chair. I examined him, and he had a normal physical exam. His vitals were taken and initially revealed a BP of 86/51 and subsequently came up to 98/55 with a HR of 65. His pulse ox was 98% on RA throughout. He had some water and was able to describe the entire incident. He was alert and oriented, and reported after sitting for 10 minutes that he felt much better. His color came back, and he felt well subsequently. Mom reported after the incident that this has happened before, and he had to sit down for 20-30 minutes after another vaccine in the past. No other issues.
Arm pain for two days, body temperature of 99.7 f  Third day: tiredness , chills , 98.5 f, stomach pain  Fourth day: tiredness , chills, stomach cramps.  Fifth day. Tiredness, stomach pain, chills Sixth day:headache, ear pain, sneezing, sore throat, tachycardia. Seventh day: Headache, ear pain, sneezing, sore throat , tachycardia. Eighth day: Headache, ear pain, sore throat, sneezing, tachycardia. Anxiety. Ninth day: Headache, ear pain , sore throat . Anxiety and bad mood.  I take ibuprofen 600mg every day , my vitamins , lots of fluids.
site of the injection getting bigger; site of the injection got red; site of the injection itches and bothers them because of the itching; site of the injection is swollen; site of the injection stings; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (site of the injection getting bigger), VACCINATION SITE ERYTHEMA (site of the injection got red), VACCINATION SITE PRURITUS (site of the injection itches and bothers them because of the itching), VACCINATION SITE SWELLING (site of the injection is swollen) and VACCINATION SITE PAIN (site of the injection stings) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced VACCINATION COMPLICATION (site of the injection getting bigger), VACCINATION SITE ERYTHEMA (site of the injection got red), VACCINATION SITE PRURITUS (site of the injection itches and bothers them because of the itching), VACCINATION SITE SWELLING (site of the injection is swollen) and VACCINATION SITE PAIN (site of the injection stings). At the time of the report, VACCINATION COMPLICATION (site of the injection getting bigger), VACCINATION SITE ERYTHEMA (site of the injection got red), VACCINATION SITE PRURITUS (site of the injection itches and bothers them because of the itching), VACCINATION SITE SWELLING (site of the injection is swollen) and VACCINATION SITE PAIN (site of the injection stings) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Non-serious Case
The injection site reaction looks like a cellitis inflamation. The area is a very big heat, swelling and induration; patient do not report fever o any other symptoms.
During the clinic today a participant had a seizure. The nurses on site responded right away and an ambulance was called. The nurse called and reported it to the office at 1:10PM today. She stated that the participant donated blood, ate, got her flu shot and then sat down for a massage. It was during her massage that she had the seizure. The nurses reported that the participant was tachycardic and clammy. They sat on the floor with her and held her until she called down and was taken to the hospital by the paramedics.
Patient had swelling in left axillary area that kept worsening after influenza vaccine was given. Patient was examined by Dr. on 9/30/10 at 4:30 pm and treated with ALEVE. Patient still has swelling as of 10-1-10 AM per mom by phone. Pt's mom will keep in contact by phone.
Allergic reaction to peanut butter first observed.  Patient had previously eaten peanuts without any problems, but this was the first time eating them after the vaccine.
Starting on Friday she complained of right-sided headaches and pain in her knees and feet.  There was no joint swelling or limitation of movement.  She has also had a painful swelling at the site of the vaccination.
Headache & NauseaVomiting Narrative: I have chills, a terrible headache and nausea.
Approx. 30 minutes after injection developed 103 degree Fever, was weak and shakey. Next am woke with headache; temp was down to 99 degrees.
Started on 12/6/2021: Hives all over body, itchy and inflamed skin. Comes and goes. Physician follow-up. Sent request for an eczema cream.
Severe hives, severe itching, swelling and redness at injection site. Joint pain. Ongoing progressive symptoms even after ten days.
1257 Patient reports feeling lightheaded; tongue tingling; throat tingling/itching 1300 BP 130/60; HR 87; SPO2 97% 1315 Patient administered Benadryl 50mg PO 1330 BP 110/60; HR 63. Patient drowsy, states legs feel heavy, patient feels unstable 1337 EMS called; patient evaluated and declined transfer; EMS assisted patient home
Pt recv vax on 9/22/98; on same day pt exp itching of injection site; on 9/23 urticaria of site &stomach; pt tx=Benadryl &cortisone cream;pt to E.R.-tx=Cortisone shot &pediapred; urticaria spread to body.
Uncomplicated pregnancy, EDD 03/25/21, elective c section 3/18/21, birth weight 3200 grams, baby found to have premature closure of ductus arteriosus,  severe pulmonary hypertension,  RV dysfunction, severe neutropenia requiring Neupogen, 34 week 3D ultrasound had been normal
Nausea; Ache; Chills; Fever; chest tightness congestion; woke up sweating; cough; fatigue; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer.  A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK5730), via an unspecified route of administration on 23Dec2020 at 10:00 as single dose for COVID-19 immunization.  There was no medical history and  no concomitant medications.  The patient experienced ache on 25Dec2020, at 08:30 with outcome of not recovered;  chills on 25Dec2020, at 08:30 with outcome of not recovered; fever on 25Dec2020 with outcome of recovering;  chest tightness congestion on 25Dec2020 with outcome of not recovered;  nausea on 27Dec2020 with outcome of recovering; woke up sweating on 25Dec2020 with outcome of not recovered; cough on Dec2020 with outcome of unknown; fatigue on Dec2020 with outcome of unknown.  Therapeutic measures were taken as a result of ache, chills, fever, chest tightness congestion, nausea, woke up sweating, cough and fatigue. Details were as follows: Patient received the vaccine. Then he noticed  on 25Dec2020 at 0830AM body aches and chills. Then later a chest tightness. Then the next day 26Dec2020 it got worse and he noticed fever. He didn't take his actual temperature. He did notice in the middle of the night he woke up sweating. He has not had a COVID test. He has not been treated, but has taken acetaminophen (TYLENOL) and ibuprofen and nasal spray. He also mentioned that he experienced chest congestion and one day of nausea. The patient added that the aches were the worst in the night and at first waking up in the morning. With regard to fever, it got a little better but it seemed to depend on temperature, first he was cold and then sweating. The fever seemed like it improved.
The pt enrolled in Lyme protocol 013 and received 3 Lymerix shots on 4/10/97, 5/6/97 and 4/13/98. No adverse events were recorded on the case report form for the vaccines. The pt's last study date of contact was 5/22/98. For the investigator, there were no complaints reported on his follow-up. Per the pt, on 7/31/00, on an unspecified date, he developed a cough and was treated with Claritin. His cough increased, so he was seen by an allergist who dx'd him with "adult asthma" at the end of 1997 or early 1998. The pt reported that "he saw another doctor who prescribed 3 inhalers (2 for regular use) and 1 for (emergency use). After the 3rd shot of Lymerix, in the end of 1998, he developed lower back pain, intermittent swollen finger joints, finger stiffness and fatigue. The events were described as occurring fairly constantly with varying intensity. In 1/00, the pt saw an allergist and, since he had not improved, he adjusted his medication. Investigator indicated, pt also reported to her in 8/00 that he had bilateral knee pain and stiffness, starting in 1/98. He reported his joint complaints have not been evaluated by a physician. The events are currently ongoing. He stated that he planned to make an appointment with a rheumatologist in "the near future."
Soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Asthma. Concomitant products included METHOTREXATE for Rheumatoid arthritis.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm). At the time of the report, PAIN IN EXTREMITY (Soreness of left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medications also included an unspecified asthma inhaler.
I had already noticed the day before a "sandpaper" feel to her cheeks but on the 4th, her cheeks became really red & bumpy. She was "cranky" that afternoon & tired; she laid down on her own to take a nap which rarely happens. Over the next few days her cheeks became even more irritated, she was scratching herself all over & I noticed the sandpaper feel on her arms & legs. On the morning of Fri July 9, she had tiny red bumps on her torso & back & her cheeks were extremely flared & rashy when she woke in the AM. I called the Drs office when I realized she was probably having a reaction to the MMR vax. She was also scratching more on her arms; big patches of rash. I took her in around 10:30am & she was seen by Dr at her Pedi office. Dr. told me that the rash doesn't look like a "normal" reaction rash but the red spots were broken blood vessels under her skin so she ordered a complete blood work test to make sure her platelets were ok. At the time I was unaware that the MMR could cause a decrease in platelets. But when I researched online, her rash looks just like pics referring to Rubella/Measels rash. That Fri afternoon (4:30), I received a call from Dr saying that patient's blood tests came back ok. The rash continued to spread & had covered her bottom by Sat morning (7-10-10) I took pics to document her rash covered body on Sat afternoon. Dr prescribed Mometasonbe 0.1% cream for her which I have been reluctant to use after reading the warnings/side effects. It is currently Sun morning (7-11-10) & she woke itchy & scratching all over but continues to have an appetite & otherwise normal except with complaints of feeling tired & maybe a very low grade fever. Her cheeks are still warm to the touch.
patient spit up 5 to 10 minutes after the administration; patient spit up 5 to 10 minutes after the administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of regurgitation of medication in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number YL9YN, expiry date 20-APR-2025) for prophylaxis.   On 03-AUG-2023, the patient received Rotarix lyophilized formulation. On 03-AUG-2023, 5 min after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: patient spit up 5 to 10 minutes after the administration) and accidental underdose (Verbatim: patient spit up 5 to 10 minutes after the administration). The outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 03-AUG-2023 A nurse reported that they administered the Rotarix(Liquid presentation) today on 03 August 2023 to a pediatric patient but the patient spit up 5 to 10 minutes after the administration. Nurse wanted to know if any recommendations re dosing for Rotarix(Liquid). The patient spit up 5 to 10 minutes after the administration which led to accidental underdose. The reporter did not consent to follow-up.
This is the second day of flu like symptoms and a low grade fever. The date listed in the beginning was the date of my second shot. After the first shot on 3/13 I only had mild symptoms like two days of soreness in arm and moments of unexplained anxious feelings after a couple of weeks.