chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated with ACAM 2000 (lot VV04-003A) vaccinia live virus vaccine on June 12 2009.  Normal take documented on June 18, 2009. No adverse side effects noted on June 18. On June 22 07:30 am, patient presenting with small amount of red papules with small white pustules on both arms and on inner thighs.  Also, one small pustule on upper chest.  Patient also presenting with sunburn on both arms.  No headache, no fever, no malaise, no nausea, no vomiting. Patient's vaccination site now appears as a robust take with some satellite lesions at the vaccination site and on both arms as noted above. Patient reports some mild nausea at night-time June 21. Benadryl by mouth prescribed and patient given 24 hours home rest by physician in am of June 22.  On June 22, 2:00pm, patient reports that the small red papules with a whitish pustule are increasing in number on inner thighs, both arms, upper chest, upper back, abdomen. No fever, no nausea, no vomiting, no malaise, no headache. Dermatology appointment coordinated for patient by physician, and patient given instructions to report to ER if symptoms get worse. On June 23 2009 at 09:00am patient is seen by dermatology and Claritin is prescribed.  Pt receives appointment with primary care physician at 1030am and Zyrtec is prescribed. Patient is given one week home rest order. Patient to follow up with primary physician in one week.  On June 24, patient reports no new lesions on body. Patient reports that redness is decreasing and itching is decreased. No draining lesions. Patient says she feels better. No fever, no nausea, no vomting, no malaise, no headache.  7/16/09 Medical records received DOS 2/08/08 to 7/15/09.  Assessment: Vaccinia from Vaccination. Patient presented with diffuse vesicular rash on extremities and trunk. Mild nausea. Lesions become dry, macular. New lesions on hairline, neck.  8/19/09 Consultant report received DOS 6/23/09 to 6/25/09. Final Diagnosis: Non-Viral Pustulosis associated with recent inoculation with vaccinia. Patient presented with 1-3mm, erythema-based papules having white to clear tops over arms, chest, upper back, and anterior thigh, particularly sun exposed areas with intense pruritus.
Severe headache, severe nausea, dizzy, severe lightheadedness, severely weak, fatigue,  hot sweats, feeling faint at times, pain at injection site, labored breathing at times, chest pain,  eye pain, upper teeth pain, clenched jaw at times.
No additional AE reported; a six year old patient was accidently administered GARDASIL 9 on Jul 25, 2022; This spontaneous report was received from a medical assistant referring to a 6-year-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 25-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) once (lot #1780876, expiration date: 09-NOV-2023; strength, dose, anatomical injection site and route of administration were not provided) administered for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) reported (no adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2207USA007948:MSD
This spontaneous report as received from a Certified Medical Assistant refers to a 4 week old male patient. Medical history and concurrent conditions were not provided. On 14-SEP-1994, the patient was vaccinated with the first dose of RECOMBIVAX HB strength: 5/0.5 micro-g/ml, 0.5 ml, intramuscular (lot number and expiry date were not reported). On 17-OCT-1994, the patient received the second dose (inappropriate schedule of drug administration) and on 14-MAR-1995, the patient received the third dose. There was no concomitant medication provided. On 16-JUN-2015, the patient had a negative Hepatitis B antibody titer (values and units not reported). The patient sought medical attention, visited the office and did not received a treatment. It was also reported that the therapy was no discontinued. The outcome of Hepatitis B antibody negative was unknown at the time of the report. The relatedness between the event and RECOMBIVAX HB was not provided. Additional information is not expected because the reporter refused additional contact.
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose number unknown, single (Lot number: FJ4989) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 27Jul2022 to 01Aug2022.
One day after injection site became red and swollen. ? of cellulitis so pt was started on antibiotics. On 7/14/15 site was better and pt was advised to stop antibiotics.
rash; This case was reported by a consumer via sales rep and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was presented with rash after administration with Shingrix. The reporter did not have patient information at the time of reporting.
Low-grade headache, minor upset stomach, very weak, red swelling and fever in right arm, redness spread all around right arm down from shot place and elbow. Very weak till October 28th,05. Eating or drinking anything caused minor stomach upset.
About 26 hours (a Friday afternoon) after the 2nd COVID shot, I suddenly began to feel bad and found I had 2.5 degrees of fever.  My shoulder where the shot occurred became painful and a pinkish rash formed there.  The temp rose to 3.5 degrees over the next seven hours and remained that high until mid morning Saturday.  Then it oscillated between 1.0 and 3.0 degrees until Sunday morning.  Finally it began to fall and reached normal Sunday afternoon around 4 pm.  The rash disappeared on Monday and the shoulder pain stopped on Tuesday.
mom called 20AUG98 to report child became flush p/vax;approx 930AM rash devel;no fever;
Hives at location of injections, grandmother and mom states baby had SOB Had reactions to Hep A, MMR, & Varicella
Patient was supoosed to receive his first Moderna vaccine but instead administered half the dose. The error was brought to me  and as per CDC guidelines patient was given one more half dose (0.25ml) of Moderna to complete the full dose.
No additional AE reported; PROQUAD expired on 4/14/2022 and was administered on 4/22/2022; The PROQUAD did have a previous temperature excursion on 2/23/2022; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-APR-2022, the patient was vaccinated with a dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, dose: 0.5ml, lot # T035389, expiration date: 14-APR-2022, administered subcutaneously in right arm for prophylaxis (strength was not provided) (expired product administered). Prior to being administered, on 23-FEB-2022, the vaccine underwent a temperature excursion (product storage error). Temperature and duration of excursion were not reported. No additional adverse event reported (no adverse event).
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with a doses of MMR II (dose, route and lot# were not provided) that were improperly stored. No adverse symptoms reported. The temperature excursions with these vaccines were found to be supported with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse concerning a female who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown) prior to learning the patient had leukemia. Upon internal review, Leukemia was considered to be another important medical event. It was unknown if the patient sought medical attention. Additional information has been requested.
Injection site edema. A physician reported that an unidentified child received Prevnar vaccine and subsequently developed swelling at the injection site. No further information was available as of the date of this report. This report was received via Merck & Co, Inc.
Pt recv vax on 11/5/98; on 11/6/98 pt exp red whelps on entire body, itching &swelling around lips & face; tx=steroids & Zyrtec; dx=hives, allergic vasculitis
pt recv vax; constant crying for 24 hr; no fever/sz; intermittent irritability x 36 hr w/ PO intake;
Hemophagocytic lymphohistiocytosis; This is a literature report for the following literature source(s): (Privacy).  A 53 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Interstitial lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (hospitalization, medically significant), outcome "recovered", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 4 days after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 Centigrade); ferritin greater than or equals to 500 ug/L; hemophagocytosis in bone marrow or spleen or lymph nodes. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis, which included Dexamethasone, Anakinra, IVIG, rituximab given as treatment. Patient received ventilatory support for 3 months; discharged to rehab facility. The patient underwent the following laboratory tests and procedures: body temperature: greater than or equals to 38.3 Centigrade; serum ferritin: greater than or equals to 500 ug/L; H-score: 213.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
On 1/5/18 patient was given PENTACEL for his first dose. Patient was seen again on 1/19/18 for another immunization but was given another dose of PENTACEL. Few short days after I (his mother) noticed a change in behavior. Patient at that time no longer wanted to sleep for more than 2-3hrs at a time. He was more fussy and not his happy self. Here now at 17 months he has a delay in motor skills and speech.
headache, cold, hot, stomach queasy, overall soreness, tearing eyes, arm hurt
I now have Atrial Fibrillation. In October 2020 I had an EKG for my cataract surgery. The results were fine and there was no sign of Atrial Fibrillation. I have never been on any medication in more than 20 years and considered myself to be very healthy.  I received my first vaccine shot in February 2021 and my second shot on March 11th, 20201.  At my annual physical examinations on October 21, 2021 I was diagnosed with Atrial Fibrillation. My heart rate goes from 41 to 130 in a matter of minutes even when I am resting. The cardiologist I am seeing is giving me the option to shock my heart or ablation. Doctors that I have spoken to indicate that there is a possibility that my Atrial Fibrillation is a result from the vaccine.
SORE ARM; LOW GRADE FEVER; This spontaneous report received from a patient 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 not reported, batch number: Unknown) dose was not reported, administered on APR-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 sore arm, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and low grade fever was not reported. This report was non-serious.
Reports was at health office around 11:00 AM - received Tdap and MMR - around 3:00 PM started itching and felt like would seizure.  Went to MD complaining of shortness of breath.  Vitals = 156/84, P = 72.  Diagnosis: Systemic allergic reaction with bronchoconstriction.  Given epi .2cc subq (L) arm at 1540 - Given epi .2cc SQ (R) arm at 1550 - Kenalog and Decadron given IM (R) hip.  Patient given Benadryl PO 50mg every 4 hours after and was discharged to home from MD office.
I broke out in a very itchy rash with blisters on my right forearm then in my left forearm.; I broke out in a very itchy rash with blisters on my right forearm then in my left forearm.; I was very sick for 8 days; This is a spontaneous report received from a contactable consumer (patient). A 55-years-old-female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiration date: Not reported) via an unspecified route of administration in right arm on 01Mar2021 at 15:15 at single dose for COVID-19 immunisation. The patient Medical history included allergic to sulfa drugs, chocolate and peanuts. The concomitant medications were not reported. It was reported that she have several medications she take daily. The patient was very sick for 8 days and a few days after that she broke out in a very itchy rash with blisters on her right forearm then in my left forearm. She is still dealing with the rash and itching on her left forearm on 01Mar2021 at 8:00 PM. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient visited emergency room. It was reported that she was given a shot please medicine. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma (she used an albuterol inhaler as needed two years ago).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with PREDNISONE at an unspecified dose and frequency and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 04-Jan-2021, the patient reported red bumps on her back. She went to a health care provider who purportedly misdiagnosed the area as poison oak/ivy and she was prescribed prednisone. She sought a second opinion and was diagnosed with Shingles by another health care provider who prescribed Acyclovir (three times a day), which she was still taking at the time of the report. At the time of the report (27-Jan-2021) she described the area as now being dried up, scabbed up and red.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information.
0950 pt reported feeling "hot and sweaty and dizzy " 10 minutes after receiving vaccine dose. Instructed to lay down on floor as also reported "feeling like I am going to pass out".  Pt placed on gurney via backboard and placed in Trendelenburg position. transported to medical observation area. vs taken upon arrival to medical observation BP 116/79 P 93 pox 95%, strong pulse, pallor noted.  Pt stated "feeling better" and color improved to pink , strong pulse noted. Pt placed in supine position on gurney. 0958 Pt continued to improve with HOB elevated to 45 degrees and pt given graham crackers and 4 0z apple juice . BP 133/89 P 90 pox 95%. 1010 Pt reports feeling much better, drank 4 oz water and ate more graham crackers. Pt reported that he had not eaten breakfast and only drank a cup of caffeinated coffee prior to receiving vaccine. Reports "feeling much better" with the water , juice and crackers. BP 124/84 P 89 pox 97%.  1025pt sitting in chair and reportins feeling "back to normal" BP 125/84 P 83 pox 96%. Pt discharged with instructions to f/u with pcp if any other symptoms today. instructed to remain hydrated today and to eat healthy lunch and dinner.
Information has been received from a pharmacist concerning children a day care who were vaccinated with varicella virus vaccine live. Subsequently, there was a chicken pox outbreak at the day care. The pharmacist reported that many of the children were vaccinated with varicella virus vaccine live from the following lot numbers prior to the outbreak (lot#6229690423E, 6122141124B,6173130769D,6179110778D,6192731357D, and 6277481059H). The records of testing prior to release of the lots were checked by Biological Quality Assurance and found to be satisfactory. The lots comply with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. Per F/U 6/18/02: There were 24 cases of chicken pox breakthrough at the day care. Additional information has been requested.
SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Child presented @ clinic 48 hours post vaccination with red, indurated R deltoid with 4 cm area of coalescing bulli on skin surface, per MD chart note.  Hydrocortisone cream 1% BID, PRN prescribed.
Delayed rash at injection site, 8 days post-vax. Took 5 days to resolve.
Severe shoulder pain still persisting, after 24 hrs.  Limits use of right arm shoulder movement.  Pt went to urgent care for assessment/treatment of possible SIRVA on 3/19/2021.  Diagnosis was acute pain of right shoulder.  Reports s/s slightly improved after 4 days.  Still reported some limited ROM
Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission.  She remained intubated for 12 days.  Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure.  Family made decision to transition to comfort measures only.  She died shortly after extubation.
Slight fever (99 degrees); Feeling flushed; Little tired; Did not sleep well; Soreness on upper arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, flushing, tiredness and poor sleep. On 18th September 2020, the patient experienced fever. On an unknown date, the outcome of the injection site pain, fever, flushing, tiredness and poor sleep were unknown.   It was unknown if the reporter considered the injection site pain, fever, flushing, tiredness and poor sleep to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. The patient received Shingrix on left deltoid. The patient experienced soreness on upper arm where it was injected, and it was feeling better at the time of reporting. One day after receiving Shingrix, the patient experienced a slight fever of 99 degrees F. The patient also feels flushed, a little tired and did not sleep well last night laid in bed for 2 hours in morning on the day of reporting. At the time of reporting, the patient was up and moving around and feeling a little better. The reporter consented to follow up.
Info has been received from a woman in a physician's office concerning a 9 year old white male, with no medical history and no allergies, who on 3/20/98 was vaccinated with a 1st dose of varicella virus vaccine live. Concomitant vaccine included a 1st dose of MMRII. There was no illness at the time of vaccination. On 2/19/06, the pt broke out with varicella, described as a mild case. It was reported that a full recovery was expected. Medical attention was not sought. Additional info has been requested.
no adverse effect; patient received improperly stored proquad; This spontaneous report was received from a pharmacist refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # R028531, expiration date: 02-APR-2020, therapy type: rha) (dose, strength, frequency, route of administration not reported) for prophylaxis (product storage error). The vaccine was reconstituted with a properly stored sterile diluent. The vaccine underwent temperature excursion from 6 degree Fahrenheit to 14 degree Fahrenheit (9.5F) for 5 minutes and 15 degree Fahrenheit to 46 degree Fahrenheit (44.8 F) for 40 minutes. There was no previous temperature excursion. There was involvement of a data logger. No adverse effects were reported. No product quality complaints were involved.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011525: