chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot # and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 13-FEB-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Received flu vaccine in right deltoid on 10/24/14 at 10 AM. At 2 PM developed pain in right arm, up arm to neck, lower back and up left side of back, used hydrocodone for pain. Warm Epsom salt baths did not help. Pain and muscle spasm lasted until 11/12/14. Pain lasted until 10/28/14.
L upper arm with redness, swelling and tenderness after approximately 12 hours since vaccine Recommended treatment with benadryl, antibiotics and ibuprofen
Improperly stored VARIVAX administered to patient; No adverse event; This non-valid spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and previous drug allergies or reactions were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis  (dose and vaccination scheme frequency, were unknown by the reporter; route of administration and anatomical location were not reported; lot number T006345 with expiration date 20-FEB-2022 and T010298 with expiration date of 24-MAR-2022). It was unknown which of the two lot numbers was the one administered to the patient. The administered dose of the vaccine experienced a temperature excursion on 03-OCT-2020, at -6 degrees Celsius for 3 hours, as recorded by a data logger (product storage error); there were not previous temperature excursions.  This case was considered to be non-valid due to the lack of patient's identifiers.  As of 16-OCT-2020, an inbound telephone call was received from the clinic manager and Licensed Practical nurse who informed that the varicella virus vaccine live (oka/merck) (VARIVAX) administered to the patient was safe and no adverse event occurred, nor no side effects were reported.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 (BNT162B2 NOS) cannot be excluded. This case will be reassessed should additional information become available.
11 years old was administered Flublok, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA281959 (same reporter).  This case involves a 11 years old patient (gender not reported) who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
pt recv vax 9FEB95 & called in 10FEB95 to report arm had 2" lump & was sore but not itchy; called back 13FEB to report 3" reddened sore arm w/pruritis
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 28-DEC-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.
received YF-VAX via intramuscular route instead of subcutaneous route with no reported adverse event; Initial information received on 06-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 27 years old female patient who experienced received yf-vax via intramuscular route instead of subcutaneous route with no reported adverse event after receiving vaccine yellow fever vaccine - [yf-vax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine polysacch vi (typhim vi) for Immunisation.  On 06-Feb-2023, the patient received a 0.5 ml once of standard strength suspect yellow fever vaccine - Solution for injection lot UJ654AB, expiry 11-Oct-2023 via intramuscular route in the left deltoid for Immunization.  On 06-Feb-2023 the patient developed a non-serious received yf-vax via intramuscular route instead of subcutaneous route with no reported adverse event (incorrect route of product administration) (Latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome was Unknown for the event received yf-vax via intramuscular route instead of subcutaneous route with no reported adverse event.  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 the guidelines. 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.; Sender's Comments:  01479414:
Swelling in the throat, swelling of the eyes and mouth, rapid heart beat, fever, chills, nausea.
Info has been received from a health care provider concerning a 7 year old white female (previously reported as 5 years old), with no pre-existing allergies, birth defects, or medical conditions, who on 6/24/98, also reported as approximately April 2002, was vaccinated in the left leg with a 0.5 ml first dose of varicella virus vaccine live. On 3/28/05, the pt had "flu-like symptoms". On 3/29/05, it was noted that there was an outbreak. On 3/30/05, the pt had 35-40 lesions scattered everywhere which lasted 7 days. It was previously reported that the pt had 2 pox, had a fever of 101F and developed less than 30 pox. The physician stated that it was a mild case of breakthrough chicken pox. No relevant diagnostic tests or lab data were performed. Outcome reported as recovered. Unspecified medical attention was sought. No product quality complaint was involved. No additional info is expected.
Since receiving Flu vaccine on 10/16/19 I have and is currently experiencing nerve pain in left shoulder at site of injection. The pain is excruciating with arm movement and especially when trying to dress myself in clothing
Started experiencing fatigue and general aches around 8:00 PM on a Friday night. Woke up at 2:00 AM with a low-grade fever, flushed skin, and sweating. Woke up again at 5:00 AM with chills and trembling. This same cycle repeated itself at about the same times each day for three days, after which the fevers stopped. I experienced four days of chills only, a stiff neck, and severe headaches. At this point I spoke with the doctor who recommended taking two Motrin 30 minutes before bed to help control body temperature and aches. This brought relief. All symptoms finally subsided after another three days of rest and fluids.
a few hours later I had a headache and went to bed. I woke up after midnight coughing and  wheezing, double vision, my face swollen, unable to speak coherently. I fell out of bed reaching for my phone and glasses, but was tangled in the bed sheets. I was shivering and terrified that I was dying. I peed myself, eventually crawled the the bathroom, crying and confused and tried to clean myself up but was staggering and couldn't think straight. I passed out and woke ten hours later with a dull headache. The injection site is red and puffy. It felt very much like being blind drunk, if that makes sense (I was not drinking) in that I couldn't coordinate my thoughts and actions. I have someone here with me now and I'm just very very tired.
doctor told her that it was an adverse reaction to the vaccine and not to get the second dose; She's been sleeping for days  so she is not feeling well; She's been sleeping for days  so she is not feeling well; Broke out in hives and hives went around her mouth; Throat  was getting swollen; This is a spontaneous report from a contactable consumer (parent). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported; Expiration Date: Aug2021, patient was 22-year-old at the time of vaccination), via an unspecified route of administration in Arm Left on 15Jun2021 at 08:00 as single dose for covid-19 immunisation. No medical history was reported. Concomitant medication(s) included spironolactone and birth control (unspecified). Reported that caller was not sure about lot number, it just says EW, it could be 0 or it could be an O, it just says EW it might be 0, its just say EW0178 or O187, I am not sure. It was reported that caller reported on behalf of patient and stated that caller and her daughter got a vaccine on Tuesday morning and Tuesday afternoon, she broke out in hives and I had to take her to the emergency room and get her shot of epinephrine (Treatment) and they put her prednisone (Treatment) on because her hives were around to her mouth and throat was getting swollen and their doctor told her that it was an adverse reaction to the vaccine and not to get the second dose and they told us to call an report it. she's been sleeping for days so she is not feeling well. Patient was about about 5 (feet) 7 (inches) and about 200 (pounds) and she will be 23 on Saturday. Patient not received prior Vaccination within four weeks. On 15Jun2021, the patient experienced broke out in hives and hives went around her mouth, throat was getting swollen, on an unspecified date, She won't be getting her second dose, she's been sleeping for days so she is not feeling well. Reporter seriousness for Broke out in hives and hives went around her mouth, Throat was getting swollen, she's been sleeping for days so she is not feeling well was unspecified. Patient visit emergency room after the Broke out in hives and hives went around her mouth, Throat was getting swollen. Reported that the hives went away, and they have not come back, she just went all off. Reported that doctor said that we should call because she has definitely a serious reaction so, she won't be getting her second dose, but I will. Patient received treatment for event (broke out in hives and hives went around her mouth and throat was getting swollen). The outcome of event (broke out in hives and hives went around her mouth) was recovered on an unspecified date in 2021 and the outcome of events (Throat was getting swollen, she's been sleeping for days so she is not feeling well) was unknown.  Information about lot/batch number has been requested.
This case was reported by a pharmacist via sales rep and described the occurrence of numbness of upper extremities in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the numbness of upper extremities and tingling of extremity were unknown. The reporter considered the numbness of upper extremities and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing whole arm numbness and tingling. No other specifics were known at the time of reporting. This reporter stated another person would also be reporting as she in the same meeting today, which had not been done by the time of this report completion.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 2/3/22, LOT #069H21A; pt resides in a SNF; congested and coughing; positive COVID test on 7/25/22; that same day pt went into cardiopulmonary arrest, Code Blue called; CPR with ACLS protocol; pt didn't respond; she passed away in the facility.
pt recv vax 5APR99 & 3hr later pt had apparent sz episode @ home w/body twitching, pallor & unresponsiveness, lasting several minutes;
Male patient alert x3 with stable at 98 sat, 96 pulse, 36.3 temp, 100/70 HBP. Patient reports having head pain scale 1 to 10 and indicates an 8 pain level. Patient is in observation for 10 additional minutes. After the 10 minutes we asked if he was feeling better and he reports feeling the same. Patient reports taking Panadol 10 minutes before reporting to staff feeling head pain. The patient is asked if he wants to go to the hospital and indicates that he will go to his preferred room and his sister indicates that they will take him later. Patient leaves alert x3 in his car with his 2 sisters.
Pfizer-BioNTech COVID-19Vaccine EUA Parents called clinic at 1645 on 1/4/21 and reported hives being present to child's waist, groin, chest, and neck. Child was reporting some itchiness. No other symptoms reported. PHN advised parents to administer Benadryl dosage per child weight and age. PHN advised parents of allergic reaction warning signs to monitor for and to seek medical attention from a physician especially if symptoms worsened or other warning signs developed. PHN followed up with Father on 1/5/21 at 1400. Father reports that child received a dose of Benadryl at 1630 and one again at 1030. Father reports that when second dose was given the hives/rash had resolved. Father stated that they had not taken child to a physician.
Dizziness, diaphoretic, weakness, disorientation, and not responding to questions for few seconds. She was monitored closely at the clinic. Vital sign obtain, F/s obtained. Po fluid offered when she regain consciousness and was able to drink.
104 fever Shaking uncontrollably Chills Body aches Skin sensitivity Diarrhea
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Medium, Additional Details: immediately follwing administration patient appeared to be incoherent ( could not support head)/ fainted and became rigid and had a seizure. Patient fell out of chair and then became responsive. Patient was not in pain, was breathing okay and coherent. Paramedics were called and all vital signs were okay.
Patient returned to District Health Office 48 hours post vaccination with swollen, reddened area 60mm by 50mm on back of right arm.
Patient started to breathe  deep for a bout 30 seconds , skin got a little clammy ,. Was conscious but said he felt "woozy" .  Sat down on his own seemed a little disoriented.  The whole episode took about 3 minutes . Sat down for about 10 minutes and was coherent throughout . left on his own with his cousin after about 10 minutes . Said he had been traveling and was hungry
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.
Within 4 hours post shot - swelling and red bullseye rash surrounding injection site, pain and unable to lift arm, headache, fatigue. Took ibuprofen to manage symptoms.  Within 12 hrs post shot - felt as if my body had been lit on fire, felt as if my body was burning from the inside out, extreme headache, nausea, chills and sweats, elevated body temperature, body aches, joint pain. Severity was enough that I was unable to get out of bed and took ibprofen every 6 hours.  48 hours post shot - symptoms started to abate in severity but left with brain fog and overwhelming fatigue, body aches and joint pain. Increase in allergy symptoms requiring allergy medication.  3 weeks post shot - finally feeling almost back to normal
Anaphylaxis shock became dizzy weak and throat started closing up had to be given an epi-pen rescue was called decided not to take her to the hospital pediatrician decided not to let her have a second shot too risky
patient had already received the whole series of Havrix . HCP reports that the patient accidently received a 3dr dose of Havrix today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 3-year-old male patient who received HAV (Havrix 720 Junior) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   Previously administered products included Havrix 720 Junior (received whole series).   On 13-OCT-2023, the patient received the 3rd dose of Havrix 720 Junior (intramuscular). On 13-OCT-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced extra dose administered (Verbatim: patient had already received the whole series of Havrix . HCP reports that the patient accidently received a 3dr dose of Havrix today).  The outcome of the extra dose administered was 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: 13-OCT-2023 The reporter was a nurse (health care professional).  The HCP reported patient had already received the whole series of Havrix and accidently received a 3rd dose of Havrix on the day of reporting, which led to extra dose administered. No additional information was provided.  The reporter consented to follow up.
6 hours after injection, "not feeling well", fatigue injection site pain.  Approx 12 hours after injection temperature=101.3, fatigue, achy.   Four days after injection, reported rash on both arms, face and back, bruise under arm where injection administered as well as 3 "red streaks on shoulder of injection site.  14 days after injection some rash still on face.  Consulted with PCP who advised against receive COVID19 vaccine dose #2.  willing to provide pictures of event.
Lightheaded; Headache; Spinal stenosis; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL STENOSIS (Spinal stenosis), DIZZINESS (Lightheaded) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced SPINAL STENOSIS (Spinal stenosis). On an unknown date, the patient experienced DIZZINESS (Lightheaded) and HEADACHE (Headache). At the time of the report, SPINAL STENOSIS (Spinal stenosis) outcome was unknown and DIZZINESS (Lightheaded) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624685.
A day after vaccine she started to notice looking through her glass became a blur. She became blind and went to the ER.
Extreme shoulder pain. Lack of any mobility. No weight bearing possible/lifting of any objects. Can?t raise arm past 90 degrees without extreme pain. Cannot twist shoulder socket at all
PHYSICIAN ORDERED HAVRIX .5ML FOR A 17 YEAR OLD PATIENT. RN USED BARCODE SCANNER TO CHECK VACCINE AND GOT A GREEN CHECK MARK TO GO AHEAD. AFTER ADMINISTERING THE VACCINE SHE SCANNED IT AGAIN AND THIS TIME GOT AN ERROR MESSAGE. SHE REALIZED THAT THE DOCTOR ORDERED .5ML BUT SHE ADMINISTERED 1ML.