chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the Adacel experienced a temp excursion between 30-32 degrees/no AE; Adacel was administered to a 77 years 2 months old male patient/ no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA284333 (same reporter).  This case involves a 77 years old male patient who received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6202BA via intramuscular route in the right deltoid which was exposed to a temp excursion between 30-32 degrees.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SAG 3V (FLUAD).  It was an actual medication error due to inappropriate age at vaccine administration and incorrect product storage.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Date of vaccination: annually; This spontaneous report as received from a laywer refers to a currently might be 69 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On unknown dates (reported as annually), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (route, strength, dose, batch/lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered).   This case was split from a case in litigation (link#2003USA008689).; Sender's Comments:  US-009507513-2003USA008689:
Infant found blue and limp in bassinet with twin (who was crying to be fed). 911 called. Ambulance crew could not resuscitate infant.
On 09/14/2000 the patient developed varicella. Subsequently, the patient recovered. Two additional patients had a similar experience following exposure to varicella virus vaccine live. No further information is available.
Developed temp experienced a febrile sz; To ER lab eval revealed CBC count, culture, & urinalysis all w/in normal limits;
I did end up getting Covid in May. I had a stuffy nose, which was easily kept at bay with mucinex and nasal spray. Nausea and vomiting and malaise. I?m assuming this is the the reaction the message on my phone was about.Otherwise, I don?t know what the message was talking about, and no one ever answers the phone there.
Symptoms started about 11 hours after administration of vaccine. Resting heart rate averaging 120 bpm. Up to 160 bpm on exertion, involuntary movement of my whole body like restless leg syndrome, chills, fever of 101.8, vomiting, profuse sweating, hypersensitive skin causing burning pain when anything touched my skin, headache, dizziness. Benadryl, acetaminophen, and ibuprofen given around the clock at appropriate intervals with not much relief for the first 48 hours.
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-MAR-2017, the patient was vaccinated with PROQUAD (dose, frequency not reported, lot:M034692, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved.  This is one of the several reports received from the same reporter. Additional information has been requested.
Pt has been suffering with anosmia, mood disorder and rheumatologic sequala of long-covid since 12/2020.  Pt had significant worsening of pain and mood disorders following covid booster as listed above.  Pt has had worsening of pain in hand and shoulder joints following injection, requiring additional SSRI and anti-inflammatory medications.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 13th October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and fever. In October 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a fever for a couple of days but her arm was still sore five days after administration.    The reporter refused to provide additional information until he enters the adverse event into his system. The reporter was transferred to Medical Information for additional assistance.
a little tired; This is a spontaneous report from a contactable consumer. This female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6203), dose 2 via an unspecified route of administration on 20Feb2021 13:20 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a little tired on Feb2021. Outcome of the event was not recovered. No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Comvax given instead of Hib vaccine. Pt received Pediarix vaccine (double dose of Hep B was received by this pt) 9/28/05.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 26-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
she developed a fever of 104.8; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "she developed a fever of 104.8". The event "she developed a fever of 104.8" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Attempted transfer from agent (Name withheld) Support (#) has no caller on the line who was calling due to receiving the second dose of Pfizer Covid vaccine back in May and she developed a fever of 104.8. Stated that she went to emergency room and has a bill that the insurance company will not pay. Agent stated that she wanted assistance. Agent provided caller with legal department's fax number. Stated that she did not want the address.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Serious/significant swelling of entire upper arm, excruciating pain in entire upper arm, deep red color of upper arm, extremely hot to the touch of entire upper arm, fever (100 degrees), malaise, joint and muscle pain--all reactions lasting 7-10 days; then, after 5 days,  pronounced itch of whole upper arm.
fever/ fever was 102; pain at injection site; fatigue; slept all day; chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2019, the patient received the 1st dose of Shingrix. On 11th April 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, injection site pain, fatigue and sleepiness. On an unknown date, the outcome of the chills, fever, injection site pain and fatigue were recovered/resolved and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the chills, fever, injection site pain, fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows The patient received his first dose on and that same day he experienced all the adverse reactions. The fatigue was described as exhausted and slept all day. The fever was 102. The pain at the injection site lasted 2-3 days and all other symptoms lasted a day and a half. Consented to follow up. No phone number and address available. The reporter also mentioned his wife had adverse reactions too. Her experience was reported in separate report. This case has been linked with US2019177136 having same reporter.
CAN NOT WALK WITH MY RIGHT SIDE OF BODY DISABLED BY STROKE. TOO PAINFUL TRYING TO GET UP FROM BED OR CHAIR.
Lost hearing in right ear. Developed severe tinnitus with hearing loss on the date after vaccine was administered. Initially developed rash near injection site. Rash has spread down entire right arm.
Patient called clinic on 4/23 with complaints of achiness in wrists, swelling in hands. Denied fever, redness, warmth or swelling at injection site. On 4/25 went to ER with lower and upper extremity swelling, moderate joint pain.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.
Chllis head ache flu like symptons for  2-3  days after the JJ; Second vaccination was booster was  Pfizer-BioNTech 11/13/2021  2-3  days after  vaccation which ws the same experience with prior manufactor.  01/10/2022 symoptomatic covid experience chllis head ache flu like symptons for two weeks that included nausea, no vomiting and diareah, still maintained taste and smell.    Positive on the 01/12/2022 new diagnoise of COVID annual flu vacciantion on same day.  Periodic episodes of high blood pressure and dizziness.  J and J intial vaccination and Nov. 16-18  2021  Pfizer-BioNTech Booster similar blood pressure and head aches lowe end blood pressure and she is asking her to monitor it over a period of time.  Wave of nauseaness and chills are ongoing.
Soreness in the right arm; Itching; Redness; Swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in the right arm), PRURITUS (Itching), ERYTHEMA (Redness) and SWELLING (Swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included VITAMIN 15 for Vitamin supplementation, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness) and SWELLING (Swelling). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the right arm). The patient was treated with ACETAMINOPHEN for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in the right arm), PRURITUS (Itching), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv flu vax @ 11am on 06nov96; pt devel hives & facial/hand swelling by 6pm.  pt took benadryl, by the next am pt had increased facial swelling & eyes swollen shut. pt was taken to ER & treated w/ meds; hives for 11 days
Patient had the Varicella (chickenpox) injection on 10/15/08. Three bumps at injection site started a week later.  Then progressed into a large area of rash from shoulder to elbow on right arm, arm of injection.  Went back to doctor on 10/30/08 and received Desonide .05% cream.  Patient has been using this since twice a day and is slowly looking somewhat better.  We have noticed some extra bumps starting up higher on his shoulder and also have addressed them with the Desonide.  This is patient's second round of Varicella the first was when he was 10 months with no signs of an allergy.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Lymph Node Swelling-Medium
6 hours after - chills - increased pulse - about 15 next 2 days - fever, weakness, sweating.  Also noticed lower blood pressure, about 20 points.  Only took aspirin, symptoms begin to subside on 3rd day.  All items returned to normal in 4 days
Dry mouth; excessive thirst; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (Vaccine location: right arm) on 29Jan2021 20:00 at a single dose for COVID-19 immunization at a hospital. Medical history included insomnia, anxiety, sebbhoreic dermatitis, and Covid prior vaccination. Concomitant medications included retinol, dandelion, melatonin, and unspecified multivitamin. No other vaccine in four weeks. On 29Jan2021 11:00 PM, the patient experienced dry mouth/excessive thirst (this is a side effect she has not yet seen listed). Every other symptom was pretty par for the course. No treatment received for the events. No Covid test post vaccination. The patient recovered from both events on an unspecified date.  No follow up attempts are possible. No further information is expected.
Information has been received from a physician's assistant concerning a female (age unknown) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. An unknown vaccination was administered at the same appointment. Subsequently the patient fainted. At the time of this report, the outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. No further information is available.
Dizziness, nausea, high heart rate, fainting.  I have been diagnosed with Dysautonomia and POTS, I have been doing on going treatment since March and had multiple ER visits. IV hydration 2x a week. Now I have to take a Steriod (Fludrocortisone) everyday to keep my blood volume high. I never had any health conditions or problems before getting my vaccine, I had to quit my dream of being a nurse because I cant stay standing without fainting.
developed ++left arm soreness with pain 6/10 constant especially with movement non radiating night of 10/22/22 to left deltoid and noticed "golf bal"l size lump mid bicep brachi. + redness no streaking, + warmth, with edema. Urgent care 10/24/22 diagnosed with celluitis and treated with keflex 500 mg QID  x 7 days Evaluated employee health 10/20/22 improvement in lump to upper left deltoid subsideing no further redness, no streaking, no warmth, no edema, slight tenderness if pushes on it, + itching, pain 0/10. full ROM. denies any SOB, CP, fatigue, chills, fever, muscle aches, dizziness, working full duties without difficulty as unit clerk. keflex completed 10/29/22.
Generalized flushing of skin over face and extremities.  Hives noted on both arms and lower back. 0.5ml Benadryl 50mg give IM.  Hives resolved. Client dismissed from clinc 35 minutes post-Benadryl administraion.
On December 28, 2022, he was restless and unable to sleep.  On the 29th he had a low-grade fever.  He tested positive for COVID-19 on the 29th.  The doctor prescribed him an anti-viral and took that for 5 days.  He complained of pain in his legs and fatigue.  He had body aches.  In two weeks, he seemed to be feeling better.  But then he began to complain of difficulty breathing.  A month later he was still testing positive for COVID-19.  He was admitted to the hospital on January 23, 2023, and was discharged on January 29th but returned to the hospital today, January 31st, because of shortness of breath and high blood pressure.  He is still testing positive for COVID-19.  He is on a ventilator via mouth and nose.  They are treating him with antibiotics.
3 inch diameter area of erythema, warmth, itching. at site of injection. Localized inflammatory reaction vs possible cellulitis. Prescription given for Benadryl and Keflex. Reaction present on right thigh only
Loss use of right arm, Vaccine was given high up on arm near shoulder to the inside. Had trouble taking off t-shirt in the evening, Arm had been very sore around injection site for days but by the 24th could barely raise right arm to remove shirt. Felt like two torn muscles.   Since then, barely any use of arm, stays limp by my side. Painful and very warm. Have been resting and icing arm,  very little improvement so far (total  12 days since vaccine)
SWELLING AND PAIN LOCATED IN LEFT EAR. THE INNER EAR IS MADE FROM TITANIUM  PAIN IS A SLOW THOBBING WAVE LIKE PAIN THAT RADIATES TO THE CENTER OF MY HEAD THE TENITIS  IN THAT EAR HAS INCREASED 10X MORE THAN USEAL. I TAKE TYLONOL AND ADVIL TO RELIEVE THE PAIN.
Sore arms; Chills; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were unknown.   It was unknown if the reporter considered the pain in arm, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist stated that after receiving Shingrix patients often report sore arms, chills, and fever. She stated when patients return for the second dose they ask patients how they did after dose 1, and patients often report arm soreness, localized, nothing major, though it was more sore than getting a flu shot. The reporter consented to follow up. The case had been linked with US2020AMR204634 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR204634:same reporter
Developed fever, nausea, vomiting, diarrhea which lasted for 2 weeks.  At the same time, she also has had fatigue and body aches that come and go, and describes as feeling like her whole body is shaking.  She also reports increased sensitivity to pain.
Urticarial rash began 3 days after DTaP and Fluzone vaccine given.
experienced a blood clot in his left leg; received the 3rd dose Pfizer BioNTech Covid vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 64-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 2, MANUFACTURER: UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "experienced a blood clot in his left leg"; IMMUNISATION (medically significant), outcome "unknown", described as "received the 3rd dose Pfizer BioNTech Covid vaccine". Therapeutic measures were taken as a result of thrombosis. The patient had been placed on anticoagulants by a vascular surgeon. The lot number for bnt162b2 was not provided and will be requested during follow-up.
PATIENT BECAME FLUSHED AND HAD ITCHING TO CHIN: AIRWAY PATENT: NO SIGNS OR SYMPTOMS OF RESPIRTATORY DISTRESS, SHORTNESS OF BREATH OR CHEST PAIN: HEART RATE 62: 02 99% ON ROOM AIR: RESPIRATIONS 18: LUNGS CLEAR AND NO STRIDOR NOTED: PATIENT PROVIDED WITH WATER: PATIENT STATES SHE "SHE FEELS PRICKLEY ON THE FACE AND HEAD."
pt vaxed 8OCT91 w/OPV/Td/MMR & 1130AM 9OCT91 home fr school w/t102.5 & h/a;
p/vax pt devel sx of GBS;pt did have a viral infect 7 days prior to onset of sx;pt recv IVIG & recovered;
It was reported in an internet article, concerning a female who was vaccinated with GARDASIL (date, dose, route not reported).  The author of the article reported that "one girl who said she has suffered a headache non stop for 3 weeks now and it is destroying her quality of life.  This is one of several reports received from the same source.  No further information is available.
Child received HIB vaccine at 2pm. A few hours later, he developed diffuse urticaria over face and body and some difficulty breathing.
Shingles in left arm and left side of the chest. Had burning in arm by 1/28, 2 days post vaccine, and then developed severe pain and rash by 1/31, diagnosed with shingles 2/2. Still suffering and on medication.
Atopic dermatitis, was given topical triamcinolone topical cream. Red area approx 1.75 inches x 2.5 inches warm to touch mildly, vesicular in nature without eschar or ulceration.
Myalgia, Arthralgia, Fever, Chills, urticaria at injection site Narrative:
mild difficulty swallowing, similar to first dose. was given PO  Zyrtec 10 mg
5 DAYS AFTER IMMUNIZATION ARM DEVELOPED A RED RASH EXTENDING IN SOME PLACES FROM SHOULDER TO ELBOW.  WHEALS ARE PRURITIC