chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a 24 year old female patient with no pertinent medical history and no drug reactions/allergies who on 11-NOV-2011, was vaccinated with VARIVAX (Merck) (0.5 ml dose once, SC) (lot number 671080/0828AA, exp: 06/02/2013). There was no concomitant medication. The registered nurse reported that the patient found out that she was pregnant on an unspecified date post vaccination. As of 24-JAN-2012, the patient was 9 weeks pregnant. No adverse effects reported. The estimated Last Menstrual Period was approximately 22-NOV-2011. Estimated Delivery Date would be approximately 28-AUG-2012. The patient phoned employee health nurse. There was no laboratory test performed. Follow up information has been received from a physician concerning a patient who was vaccinated with VARIVAX (Merck). The physician reported that the patient was not tested for varicella antibodies before vaccination. The ultrasound was performed on 20-JAN-2012 for dating. Results of ultrasound were: normal IUP (Intra Uterine Pregnancy) and (+)FHB (Foetal Heartbeat). The patient had no previous pregnancies. There was no local reaction at vaccination site, varicella symptoms or herpes zoster symptoms post vaccination. Follow up information was received from the physician who reported that on an unknown date during pregnancy the patient experienced genital warts and gestational diabetes. The patient delivered live born normal male infant on 09-AUG-2012 (weight 5lb9oz) at the 38 week from last menstrual period. She also experienced severe preeclampsia and uterine atony during labor/delivery. The baby was reported as small for gestational age (MARRS # 1209USA009241). There was no feature of congenital varicella zoster syndrome in infant. At the time of the report the patient's outcome was not reported. The case for a baby was included in the MARRS # 1209USA009241. Additional information is not expected.
Noticed in the afternoon my arm was getting itchy. Removed the bandaid from the injection site, no other issues at that time. Later in the evening noticed significant raised red swelling approximately the size of a silver dollar and increased itching. Will be monitoring for a week as directed and following up with doctor if not resolved.
Case was vaccinated x3 for Covid and was hospitalized for Covid.  * Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Presented initially 10/25 with intractable nausea and vomiting and poor appetite in the setting of recent COVID 19 diagnosis. Developed symptoms and tested positive 10/20. URI symptoms and cough improving as are fevers and chills. Did not ever feel SOB. O2 86% on RA on arrival. On exam, rales throughout with sparse wheezing. CXR with COVID PNA.  - Given hypoxic and duration of symptoms <10 days, will initiate therapy with dexamethasone (day # 5 of 10) and remdesivir (completed five days on 10/19). Note mild AST bump to 44 on admission (likely 2/2 to COVID infection). Still well below the 10x ULN limit for remdesivir but will monitor.  - Currently stable on 2L via NC and will monitor, weaning as tolerated. CRP of 2.52 - DNR/DNI but is amenable to NIPPV, HFNC, and ICU transfer for pressors if needed.  - Encouraged self-proning, IS, ambulation.  - did run IVF 12/27-12/28 as pt had had no appreciable oral intake, so will try a bit of diuresis 10/30 - goes home on 2 lpm, so far stable, and hopefully getting through the time frame when we would expect worsening respiratory failure, as she had onset of symptoms 10/19.
I did not have an adverse reaction to the vaccine. In October 2022 I had to have both knees replaced. During physical therapy I fell and broke kneecap which required an additional surgery. As of today, I continue to take physical therapy to learn to walk without a walker.
Fever (~103.5 degrees F, 12.5 hours after administration), body aches, shakes. Fever 102.2 15 hours after admin, headache. Fever 100.5 20+ hours after admin, headache.
febrile sz 3MA 20JUL94 treated by MD in ER; 5AM 20JUL94 pt released approx 2 hrs later father contacted  21JUL94 @ 340PM stated pt was on advil & was fine; mom contacted 22JUL94 stated pt had red ear;
Momentary loss of memory and lapse of time. Memory loss. Hard to concentrate; Momentary loss of memory and lapse of time. Memory loss. Hard to concentrate; This is a spontaneous report from a contactable consumer (patient).  A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 15Mar2021 15:00 (Batch/Lot Number: EN6206), age at vaccination of 76-years-old, as single dose, for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, coronary artery bypass from an unknown date and unknown if ongoing (6 years ago or more), mycotic allergy from an unknown date and unknown if ongoing (allergy medicine for mold weekly).  The patient previously took erythromycin and experienced drug hypersensitivity. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in Right arm on 22Feb2021 16:00 (Batch/Lot Number: EN6198), age at vaccination of 76-years-old, as single dose, for covid-19 immunisation. The patient received unspecified concomitant medications (Other medications in two weeks: Too long to list - as reported). The patient experienced momentary loss of memory and lapse of time, memory loss, hard to concentrate, all on 29Mar2021; the events were serious as medically significant. No treatments were given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
10:30 AM slight headache, noticeable chills, diarrhea  4:00pm headache worsens, chills continue, slight ache throughout my body 6:00pm Extreme headache, chills increase, extreme aching throughout body, even skin hurts, extreme tiredness, low grade fever. All symptoms last for 36 hours.
Received first Guardisal injection in 2/07 and developed nodules on left index finger over the knuckle. Second shot received in 4/07.  Nodules surgically removed in 6/07 and received OT.  Third shot received in 8/07 and the nodules returned. She has decreased mobility of the index finger and fatigue daily.  She has had an endocrinology workup and a rheumatology workup. 11/28/07-records received 2/18/07-date of vaccine also during exam C/O right shoulder popping. HX of thyroid autoatibodies and NL TSH. 3/3/07-continues to complain of shoulder pain and again on 4/19/07. Visit on 5/18/07-C/O left index finger lesion for 2 1/2 months. Bump on finger has increased in size since February and pain only with bending. Chest pain left sided daily for months. Tenderness. DX: Fatigue arthralgia. Questionalble bone cyst. X-ray normal. 6/24/07 allergies. Vaginitis. 9/16/07-had finger surgery DX granuloma annulare. Recent exposure to CMV. DX persistent fatigue. Asthma.
Initial information has been received from a medical assistant refers to a 18 months old male patient (pertinent medical history or drug reactions / allergies were not reported). On 04-DEC-2012, the patient was inadvertently vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot number was not reported). Other suspect vaccine included a 0.5 ml dose PROQUAD (Merck) (lot number was not reported), subcutaneously (04-DEC-2012). No concomitant medications were reported. No adverse effects were reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
PAIN IN ARM; BAD HEADACHES; This spontaneous report received from a patient via social media  via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced pain in arm, and bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, and bad headaches. This report was non-serious.
Atrial Fibrillation requiring ER visit and hospitalization. Treated in hospital with medication.  Hip and joint pain requiring doctor visit. Not resolved after one month.
VACCINE WAS NOT STORED ACCORDING TO MANUFACTURER RECOMMENDATIONS (2-3 DAYS PAST THE EXPIRATION DATE).  PATIENT ENDED UP GETTING COVID AND DID NOT WISH TO REPEAT THE VACCINE ALTHOUGH THIS WAS RECOMMENDED.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided   This case was linked to MOD-2021-403721 (Patient Link).
Pt is an RN.  Pt developed a raised red warm area approx. 2cm at injection site within an hour of injection.   Tried application of ice.  Pt described nausea w/o vomiting for the first 24 hr period.  By 24hr the redness at the site had increased to 10cm, and became extremely tender and sensitive to touch and/or motion.  Pt tried application of a topical lidocaine patch to the affected area, which offered some relief.  Patient came to the pharmacy at approx. 48hr post injection (Saturday, Jan 25, 2020) She described the reaction and I observed the area, which still appeared as she described.  II told the pt that I would file a VAERS report, that if the reaction didn't resolve or worsened, to seek medical attention immediately.  I also advised that she notify her primary care physician, and seek her guidance on the remaining dose in the series.
Headache, Myalgia arm pain, h/a body aches chills fatigue Narrative:
black swirls across left eye, as if someone swirled ink across it.; This is a spontaneous report from a contactable Consumer (patient). A 67-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: was not reported) via an unspecified route of administration in arm left on 04Mar2021 15:30 as 1st dose, single for COVID-19 immunisation. Medical history included known allergies sulfa drugs, tomatoes, gluten. Concomitant medications were not reported. No covid prior vaccination and not covid tested post vaccination. On 06Mar2021, 12:00 PM the patient experienced black swirls across left eye, as if someone swirled ink across it. It just started this afternoon. There were several swirls, however, as I type this they have reduced in size. Unless it becomes worse, patient don't need to contact a doctor. No treatment was received. The clinical outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
injection site pain, cold chills, headache, body aches, fever of 100.4, nasua, lethargic, feeling unwell
PATIENT WAS GIVEN THE ADULT DOSE OF THE PFIZER VACCINE...PATIENT EXPERIENCED TYPICAL SORE ARM MILD FEVER/CHILLS SYMPTOMS ARE RESOLVING WITH NO FURTHER COMPLAINT AS OF TODAY
Right leg swollen, elevated erythematous, warm.  7x6.5cm.
received first covid vaccine, contracted covid 19/Infected lungs; received first covid vaccine, contracted covid 19/Infected lungs; This is a spontaneous report from a contactable healthcare professional and consumer (patient). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient received first COVID vaccine, contracted COVID 19 and was hospitalized for 7 days (also reported as 1 week). Reported infected lungs recently cleared-oxygen still required. The outcome of the event COVID-19 pneumonia was recovering while unknown for the other event.  Information on lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported rapid COVID-19 pneumonia  based on the known safety profile.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6204), on 11Apr2021 as dose 2, single (Lot number: EP7533) and on 09Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type-2 Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN, start date: 19Jul2022, stop date: 24Jul2022; LIRAGLUTIDE; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 102.8, notes: temperature (102.8); SARS-CoV-2 test: (20Jul2022) positive, notes: Officially tested positive 20Jul; (26Jul2022) Negative, notes: Had negative antigen test on 26Jul and 30Jul; (30Jul2022) Negative, notes: Had negative antigen test on 26Jul and 30Jul; (02Aug2022) positive, notes: Positive antigen test as of the morning of 02Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course includes, adverse event: Officially tested positive 20Jul at a (facility) and was prescribed Paxlovid. Started regimen the evening of 20Jul. Expressed metallic taste throughout 5-day regimen with temperature (102.8) and many symptoms. Had negative antigen test on 26Jul and 30Jul, after completing Paxlovid as of the morning of 25Jul. Limited congestion continued through 27Jul but no fever. No symptoms from 28Jul through the morning of 30Jul. Running nose and sneezing started afternoon of 30Jul, increasing through 02Aug. Positive antigen test as of the morning of 02Aug. Reconfirmed positive with second antigen test on 02Aug. Symptoms worsened from 30Jul but remain largely a head cold at this time, no fever.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 22nd May 2018, the patient received SHINGRIX On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was the spouse of the patient. The age at the vaccination was not reported. The patient had redness at the injection site described as the site's being really red. The reporter declined to answer any specific questions on behalf of her spouse. The reporter said her spouse might call GlaxoSmithKline in the future with further details. The reporter was called back to know who had administered the vaccine to her regarding her report, and she noted that her husband's health care professional was already aware of the symptom. This case was linked to the case US2018100625 and US2018GSK101153, reported by the same reporter.
Pt. states she received vaccine and left the park but started to feel her jaw clenching and some tightness in the neck so she came back and was seen and assessed by EMT.  Vital signs: BP 134/84, HR 78, O2 96%.  20 min. into observation  she verbalized sensation began to decrease,  When asked, she said that she could swallow.  When asked if she had difficulty breathing, she said no difficulty breathing and felt no other symptoms at the moment.  Pt. advised to contact PCP, go to the ER or an urgent care if any other symptoms arise.  Client and daughter verbalized understanding of instruction and cleared to leave by EMT.
Swelling of my arm around the injection  Redness around the injection and hot to the touch. Tender to the touch around the injection. This lasted for one week  07/15/2015 I developed a fungus in my mouth.  I took medication for this problem.  07/28/2016 I woke with debilitating body pain all over--neck, shoulders, hips and knees--no swelling or discoloration.  Unable to walk, bend, sit or stand up.
My 3 year old got his second Moderna vaccine today and he was upset and while we were trying to get him situated the nurse just quickly administered it and I felt some vaccine on my pant leg. I?m sure some was on his leg as well if there was enough to make it to my pant leg and the nurse administering it said she ?thought it was only a partial scratch? and then they ushered us out. I spoke to the doctor running the clinic and he said it was normal for some to leak out, there would most likely be a booster for him in the fall and it will end up being a 3 dose shot and that there was nothing they could do anyways as they would not revaccinate.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. On 27-APR-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K003410, 06-MAR-2016) (dose and route unspecified). This is one of several reports received from the same source. Additional information has been requested.
received both doses of COVID vaccine and one booster, she has Covid currently and it is the third time receiving it after getting the vaccine; received both doses of COVID vaccine and one booster, she has Covid currently and it is the third time receiving it after getting the vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 61-year-old female patient (not pregnant) received BNT162b2 multivalent nos (COVID-19 VACCINE MULTIVALENT NOS MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "Vitamin B deficiency" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "received both doses of COVID vaccine and one booster, she has Covid currently and it is the third time receiving it after getting the vaccine". The events "received both doses of covid vaccine and one booster, she has covid currently and it is the third time receiving it after getting the vaccine" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was Covid pills (still taking long to recover each time). Prior to vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19. No covid prior to vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fourth day after booster Shortness of breath, pounding and racing heart, sore calf.   Irregular heartbeat.  Hospitalized
1st shot 4/26/21 2nd shot 5/19/21 after 2nd shot I would have sporadic headaches that would go away with more than normal medicine; ie 3 advil instead of 2 7/22/21 had a migraine type headache, took migraine medicine --did not help 7/23/21 called pcp thinking an infection, prescribed steroid and antibiotic severe headaches persisted 7/30/21 had an MRI with contrast  --  diagnosed with CVST had to go to emergency room
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
Information has been received from a health care professional concerning a 5 year old male who was vaccinated with MMR, subsequently the pt developed autism. The pt sought unspecified medical attention. Upon medical review, the pt's experience was considered an other medical event.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 17-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1906USA000180:
Around 4 PM I started getting chills. I took Ibuprofen and it was much easier. It started coming back around 7:00 pm. I had super sensitive skin and chills that night and didn't sleep very much, if at all. I didn't go to work that day because I still had a fever in the morning. It broke mid-morning but I was nauseous all day and had a headache. I still had a headache the following day and I didn't want to eat the next day although I wasn't nauseous. Also on that third day- the redness and swelling started in my arm where the injection site was on the right arm. It was swollen, hot to touch. I called the Dr. again. I got a different doctor than the first dose. She thought it was an allergic reaction. She said to try antihistamines that day but if it didn't get better she did prescribe a different kind of antibiotic I took the antihistamines that day and it didn't get any better. So than I took the antibiotic and it got better. It was better by Friday evening.
Headache, Local symptoms: Pain-discomfort. General Symptoms: Headaches, joint pains, muscle pains, fatigue. Narrative: