chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9OCT91 fever of 100 ax, cranky & irritable, sx continued x 3 days w/worsening of sx; admitted to hosp on 12OCT91 w/dehydration, fever 102.2 core temp croup; presently being treated w/oral ATB & the croup tent;
This is a spontaneous report from a contactable physician, via Medical Information Team. A 56-year-old male patient receive PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included T-cell malignancy and stem cell transplant. The patient's concomitant medications were not reported. On unspecified date, after receiving the vaccine the patient developed a rare complication of HLH (hemophagocytic lymphohistiocytosis). The outcome of the event was unknown. Information on the batch number has been requested. Sender's Comments: Currently there is no plausible mechanism to implicate the suspect vaccine to the occurrence of the serious event "HLH (hemophagocytic lymphohistiocytosis)" due to insufficient information. The event more likely represents an intercurrent medical condition. 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.
Arm that received the vaccination was mildly sore for several hours the day after the vaccination; This is a spontaneous report from a contactable consumer. A adult male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date and dose 2 administered in right arm as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Allergies to medications, food, or other products was unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if Since the vaccination, the patient been tested for COVID-19 or not. His arm that received the vaccination was mildly sore for several hours the day after the vaccination. The event assessed as non-serious with outcome recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
p/vax pt devel few pox lesions abd;next day pox lesions pronounced all over body surface;T104 A, urticaria, dec appetite, fussy;mom states MD recommended varicella;tx w/ IV acyclovir.
Vaccine #1 1/17/2021 Moderna Lot # 013L20A Patient tested COVID + 1/3/2023, hospitalized same day and died the same day in the ED
This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 22-SEP-2014 the patient received the first dose of PROQUAD (Merck) (dose, route not reported, lot # reported as K006217, expiration date not provided) that was stored at -2.3C for 13 hours, 23 minutes. Concomitant medications were not provided. No adverse effects were reported. This is one of two reports received from the same reporter (other MARRS# 1409USA011630). Additional information has been requested.
Pt received FLUMIST on 10-8-08, but still tested positive for influenza B on 2-4-09.
Hard lump on arm. Very sore next 2 or 3 days sores on head and on hairline - Eye lid swolen on left side - Itching over upper body.
Did not receive the full dose; Vaccine dripped on patient's arm; Vaccine dripped on patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 38-year-old female patient who received Flu Seasonal QIV(FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.     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: 14-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: During administration of Flulaval, vaccine dripped on patient's arm and the patient did not receive the full dose of vaccine, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (In April 2018, received 1st dose). On 31st July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced headache, weakness, shivers and feeling bad. On 2nd August 2018, the outcome of the headache, weakness, shivers and feeling bad were recovered/resolved. It was unknown if the reporter considered the headache, weakness, shivers and feeling bad to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. In April 2018, the patient received SHINGRIX and was fine afterwards. After receiving 2nd dose of SHINGRIX, the patient went to work the next day, but by noon he experienced shivering, a bad headache and weakness. The patient felt bad enough that he thought he should have gone home, though he did not. The next day he felt much improved. This case has been linked with case US2018158113 and US2018158117, reported by same reporter.
Experienced light headedness and felt shaky few minutes after receiving the vaccine.  BP 142/70 O2 sat - 100%
This case was considered medically important (OMIC). Info regarding Prevnar was received from a public health nurse regarding a 10 month old female pt who developed pneumococcal bacteremia. On 3/11/05, at 8 months of age, the pt received a third dose of Prevnar. On the same day, the pt also received a dose of Polio vaccine, a dose of Tripedia and a dose of Comvax. Indication for Prevnar was immunization. Product was administered on 3/11/05. Dose regimen was 1 dose 1 time per day. Event Details: On 3/11/05, at 8 months of age, the pt received a third dose of Prevnar. On 4/24/05, at 10 months of age, the pt developed pneumococcal bacteremia (drug ineffective) after a blood culture perform in 4/05, was positive for Streptococcal pneumoniae. The pt recovered. No additional info was available at the time of this report.
BILATERAL VACCINE SITES WITH DIFFUSED MACULAR ERYTHEMATOUS AREAS, OBSERVATION, PATIENT TO APPLY COMPESSES TO AFFECTED AREAS.
Syncope and hypotension. No previous history of syncope. Syncopal episode 20 hours after injection . Other symptoms were chills, low grade fever, headache. No allergic rxn, no rash.  Hypotension lasted for several hours.
Diagnosed with Afib; Flu like symptoms; Felt differrent; This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number Y5J27, expiry date 8th November 2021) for prophylaxis.   The patient's past medical history included premature ventricular contractions. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance refer case US2019AMR192406).   On 17th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In October 2019, less than a week after receiving Shingrix, the patient experienced feeling abnormal. On 17th October 2019, the patient experienced influenza-like symptoms. On 19th October 2019, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation and feeling abnormal were recovered/resolved and the outcome of the influenza-like symptoms was not recovered/not resolved.   It was unknown if the reporter considered the atrial fibrillation, influenza-like symptoms and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. In the evening, the patient got flu like symptoms.  He felt better the next morning, but then worst that night.  By Saturday morning at 2am, the patient was thinking, he had atrial fibrillation and went to the emergency room. The patient were diagnosed with atrial fibrillation and during observation, the patient sneezed and his heart went back into normal rhythm. The patient did have a history of PVCs (premature ventricular contractions), but said this felt different. The reporter consented to follow up.
2" x 3" welt near injection site. Area is swollen, raised, warm, and itchy.
x4 days of mild induration around side of injection, some erythema, and pruritis.
Lower extremity arthalgias and myalgias mild-moderate. Given Ibuprofen 800 mg Tx's PRN.
Pt recv vax on 10/26/98; on 10/27/98 pt exp tremors of hands & face then falling asleep
Fever starting several hrs /p DTP, had a seizure approx. 12 midnight lasted < 5 minutues.
Information has been received from the Pregnancy Registry for Gardasil from a physician concerning a 15 year old female with a history of two conizations for severe dysplasia in 2006 with no drug reactions/allergies who on unspecified dates was vaccinated with first and second doses of Gardasil (lot# unknown). Concomitant therapy included Ortho-Tri-Cyclen. On approximately 31-JAN-2007, "end of January 2007", the patient experienced raised red spots on the back of arms, chest and legs. The spots come and go. When they go away, the spots turn white in color. Medical attention was sought. The patient has not recovered. On 16-MAY-2007 the patient received her third dose of Gardasil. The patient subsequently learned that she became pregnant. The date of the last menstrual period was 8-MAY-2007. Medical attention was sought. A beta-human chorionic gonadotropin test (unspecified) was performed and the results were positive for pregnancy. The estimated date of delivery is 12-FEB-2008. Additional information has been requested.
his sister died from the covid vaccine; This is a spontaneous report from a non-contactable consumer (patient brother) reported for his sister that a female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported his sister died from the covid vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. This case was reported as serious due to death. Description of complaint: The efficacy isn't living up to what its states and Pfizer does not keep up with the numbers with who it injures.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
I gave the Proquad ( MMR- Varicells) and the Varicella to patient on the same day.
May 23-June 2Right medial bicep; chronic staight line pain radiates elbow to shoulder, all around deltoids 2 x into Emerge cardiac symptoms Grade 4 at night- Grade 1-2 day & night.  All symptoms following appear at random locations,sporadic times 24 hours, intensity always 4+ . Noted in order of cumulative appearance. All are chronic Sharp linear pain in Left Lateral neck stays stationary. L temple 7 behind eyeball. Pains in liver, Spleen, L Kidney.  radiating  pain along Left & Right lower jaw and upper jaw  Left orbital socket lower onto cheekbone. R cheek horizontal between U & L jaw bone. straight line from R base of skull up to level with R ear tip.  R lateral calf 'creeping' pain from lateral maleolus to ribs
Initial and follow-up information has been received from a certified medical assistant concerning a 9 month old hispanic female who on 21-JUL-2006 was inadvertently vaccinated IM with a 0.5 ml dose of Pneumovax (lot # 653283/0001F) instead of PREVNAR. Concomitant therapy included PEDIARIX. No symptoms of adverse event were noted. The patient was advised to return to the office in 2 months for vaccination with PREVNAR. As of 23-OCT-2006, the patient has not returned to the office. Additional information is not available.
Within 20 minutes of shot experienced pain in weakness in right arm and lethargy.  Within 4 hours of shot I experience joint/muscle pain and weakness in my entire body from head to my toes.  I had so much pain even moving I needed to crawl on my hands and knees to get to the restroom.  This continued for between 7 2 and 96 hours AFTER injection.   My daughter received her 2nd dose the same time I did and experienced the same symptoms approximately 8 hours after the injection.   Approximately October 19, 2021 I began bleeding menstrually (early).  I saw the ob-gyn at Medical Center and was referred to OB/GYN Dr. for the first time on Nov 8, 2021 to address the bleeding.  She attempted putting me on a different birth control pill to stop the bleeding, which was excessive.  I bled through a pack of pads every 2 days through February 2022.    On February 7, 2022, Dr performed a pelvic ultrasound and a uterine biopsy trying to determine the cause of the bleeding.   My birth control pill was switched again and the bleeding finally got under control by March, 2022.    She felt it was in relation to the Covid vaccine I had received.  I was advised by her AND my PCM to report it as an adverse reaction.
Tachycardia; Experienced dizziness; Weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), DIZZINESS (Experienced dizziness) and ASTHENIA (Weakness) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia), DIZZINESS (Experienced dizziness) and ASTHENIA (Weakness). At the time of the report, TACHYCARDIA (Tachycardia), DIZZINESS (Experienced dizziness) and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Heart rate: high (High) tachycardia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
She began to feel feverish and have body aches several hours after vaccine. States joint pain was thing she was most concerned about. She presents today and is being evaluated by a provider. Temp = 99.2 today.
My back starting having spasms and I had a lot of joint pain and has not stopped since vaccination. This wasn't an issue until I was vaccinated. My arm hurt until about 4/11/2022. It is a 24/7 spasm. Medications and physical therapy has not helped. Now all the sudden my ankles are swelling up. I am still dealing with this at this time.
two weeks ago I got covid; two weeks ago I got covid; I got GBS; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE; and then dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE,  for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had both shots ending in Mar2021. He got GBS on an unspecified date in 2021 and two weeks ago (Oct2021) from the time of report, he got COVID. It does not protect 100% and no one seems to care that those getting GBS are suffering still. It is brutal and life changing. The outcome of the event GBS was not recovered; while for the other events, it was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Information has been received from a health professional concerning an 18 year old female who on approximately 19-MAR-2008 was vaccinated IM with the first dose of Gardasil (lot# not reported).  On approximately 19-MAR-2008 the patient experienced nausea.  The patient sought unspecified medical attention in the physician's office.  Subsequently, the patient recovered from nausea.  Per the reporter, the patient was followed up with the next day by phone and that she did not describe any additional adverse events.  No additional information is available.  Additional information has been requested.
Around 6pm she suddenly vomited. Her skin went pale with a green hue and her body was limp. She had sudden extreme fatigue and slept for a few hours after that.
Temperature is now up to 103 degrees; This is a spontaneous report received from contactable reporter (Consumer (patient's husband)).  A 51-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose number unknown, single (Lot number: HG4680) at the age of 51 years intramuscular, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "cancer" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Temperature is now up to 103 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: reporter clarified the expiration date as 28Aug2023 (unknown if expired vaccine was administered to the patient). Reporter stated there wass nothing specifically saying how much she (patient) got or anything like that. They have no idea because they did not tell them if they were getting one quarter milligram or anything like that. They did not write it down on their card. Reporter stated patient had some blood work done just two days ago.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
jitters in the face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (jitters in the face) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING JITTERY (jitters in the face). At the time of the report, FEELING JITTERY (jitters in the face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
the joint pain she experienced is something caused by the Pfizer BioNTech Covid-19 Vaccine/her ankle and hip joints pain started to worsen; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reported). A 84-years-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported and expiration date was not reported), via an unspecified route of administration on 24May2021 as second dose, single for COVID-19 immunization. Medical history included arthritis and fibromyalgia from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported and expiration date was not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization and experienced part of her hips started to hurt. On May2021 the patient experienced caller wanted to know if the joint pain she experienced was something caused by the biontech COVID-19 vaccine with, her ankle and hip joints pain started to worsen. She experienced the worsened joint pain a few days after getting her 2nd shot of the BioNTech Covid-19 Vaccine last 24May2021 and the pain persists until now and her ankle and hip joints pain started to worsen after the second shot of the vaccine last 14May2021. During the first shot, a part of her hips started to hurt and went away, on the following day another part of the hip started to hurt and went away again. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Break out in hives in area of shot and spread though out my body. It got so bad that I took Prednisone from March 25 to april 7th. I did a spin down of milligrams and I had couple days off of hives and they all came back.
Received second dose of COVID mRNA vaccine on 8/19/2021. On 2/6/2022 was admitted to hospital for COVID pneumonia.
Mom noticed a couple of red bumps of patient's belly on Thursday evening, 8/24/17, little round bumps. Then they continued to spread on torso, to back of neck, they were itchy, no fever, no blisters. Woke up Sunday, itching. Mom took her to Walk In Clinic on 8/27. Was told to give her BENADRYL, which helped them. When mom called me on Monday morning 8/28/17, she was going to buy more BENADRYL, and patient had some bumps on her cheeks now.
p/vax pt devel hives; generalized body aches; tiredness; swelling hands; ankles; knees; elbow joints; tx w/medrol dosepak x2; 3/21&4/4 hemoglobin & hematocrit low & CPK & LDH high; still had sl aching; no hives;
Sore arm 3 hr mark General fatigue around 6 hr Fever started about 11 1/2 hours up to 103.5F Chills headache nausea shakes. Took 440 Aleve @ 12 hr mark and 50 mg Benadryl at 15 hr Resolved at 17 hr mark.
Information has been received from a registered nurse regarding an unknown age and gender patient who on 17-OCT-2013 was administered an out of temperature range dose of ZOSTAVAX, batch # 0468AE (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
After 5 minutes after waiting 15 minutes to leave I left vertigo when I got back to my car, and I felt like I was going to vomit. I sat for a moment before heading home. While driving home I felt it again.   I hadn?t had breakfast yet so I went and ate then went grocery shopping. Over the course of the day it happened again about every 3 hours.
Two hours after the injection I became ill for the next 30 hours. I had a very high fever (103), chills, diarrhea, really bad overall body aches and pains and an extremely sore and painful arm at the site of the injection. This was worse than having the flu. It was so bad that I do not intend to get the second dosage.