chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate tingling (pins & needles)/ Over course of1 hour same symptom moved to add left hand, then right and left foot.; Physical coldness (very cold) inright hand (all fingers).; Physical coldness (very cold) inright hand (all fingers). Over course of1 hour same symptom moved to addleft hand, then right and left foot.; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA165969) via an unspecified route of administration in the left arm on 20Mar2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. Concomitant medications included unspecified antihistamine (MANUFACTURER UNKNOWN), and WAL-PHED D (MANUFACTURER UNKNOWN); both for an unknown indication and from on an unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 15:00, the patient experienced immediate tingling (pins & needles) and physical coldness (very cold) in right hand (all fingers). Over course of 1-hour, the same symptom moved to "add" left hand, then right and left foot. (Right hand symptoms longest and most intense and felt very similar to cortisone shot given for carpal tunnel syndrome). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events included oxygen & pulse check (Pulse Oximetry test). The clinical outcomes of the event tingling (pins & needles), physical coldness (finger cold) in right hand (all fingers), cold feet and hands (very cold) were recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
The pt developed high fever of 104 deg F on 09/23/1998 lasted for 24 hrs. Then it dropped to 100.6-101 deg. F. over 3-4 days. Pt developed rash on arms and upper trunk. Atypical measles reaction to vaccine. Developed bladder infection on 09/28/1998 and fever returned. Also cold-like symptoms with wheezing and coughing.
Mom reported raised red spots to diaper area & trunk approx. 3 hrs after vaccine with itching 2 hrs. later. Improved with Benadryl per MD instructions. 10-9-09 more red spots appeared slight swelling noted to ankles & knuckles/hand started Prednisolone Dx hives per MD. Symptoms improved few hrs. after starting Prednisolone. MD uncertain viral vs. vaccine reaction MD advised no 2nd dose influenza vaccine this year.
After second dose on 03/17/2021 developed chest pain, SOB. Went to Emergency room and was cleared but still had chest pain. Was admitted and had angioplasty to check if my Right Coronary Artery developed  stent thrombosis. I was cleared but still had chest pain. Was eventually diagnosed with pericarditis and prescribed Colchicine.
got covid /sars-cov-2 test positive; got covid; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable male consumer (patient) reported that, a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date, the patient received the first dose and after receiving the first dose patient experienced COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
The pt experienced the croup, gagging, vomiting, cough, fever, red rash, blotchiness with bumps with white hands and arms.
This spontaneous report was received from a patient's aunt and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 02-JUN-2017, the patient was vaccinated with VAQTA one time, lot # was reported 017982 (dose and route of administration were not provided). On an unknown date, the patient experienced persistent headaches. The outcome of the event was unknown. The causality assessment was not provided.
This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. Co-suspect products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta) inhalation powder for product used for unknown indication and fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for product used for unknown indication. On an unknown date, the patient received Flu vaccine at an unknown dose, Breo Ellipta at an unknown dose and frequency and Trelegy Ellipta at an unknown dose and frequency. On an unknown date, unknown after receiving Flu vaccine and not applicable after starting Breo Ellipta and Trelegy Ellipta, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The action taken with Breo Ellipta was unknown. The action taken with Trelegy Ellipta was unknown. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine. It was unknown if the reporter considered the influenza to be related to Breo Ellipta and Trelegy Ellipta. Additional details were provided as follows: The age at vaccination was not reported. The nurse practitioner reported this case for one of their patients. The patient had a flu shot in the past but did not know which flu vaccine it was. The field representative did not remember if the patient was on Breo Ellipta or Trelegy Ellipta but stated that it was very unlikely that the patient was on both the products at the same time, but it was not confirmed with the nurse practitioner. The patient developed flu while on Breo Ellipta or Trelegy Ellipta. This case was considered as suspected vaccination failure case as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting. No further details were provided.
knocked him down" for 3 days; This case was reported by a consumer via call center representative and described the occurrence of unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling regarding her physician and the physician who was also the patient. The reporter stated that, her physician told her that, he personally got 1st Shingrix shot and it knocked him down for 3 days but he had no problems with his 2nd Shingrix shot. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203774:same reporter US-GLAXOSMITHKLINE-US2021203778:same reporter
PATIENT REPORTS SEVERE SHOULDER PAIN AT INJECTION SITE.  LIMITS RANGE OF MOTION DUE TO PAIN. SEEN AT DR 7/29/2015.  XRAY SHOWED NO SIGNS OF NEEDLE BREAK OFF NOR ANY DAMAGE TO BONE.
Kidney Disease; This is a spontaneous report from a Pfizer sponsored program  via contactable consumer or other non hcp (Patients wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient experienced kidney disease on an unspecified date.The Pfizer Covid 19 Vaccine about a month ago thinking they were fully vaccinated but has no antibodies. The patient underwent lab tests and procedures which included that sars-cov-2 antibody test: no. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was new to practice and establishing. While rooming patient it showed that she was overdue for a second HPV vaccine. I administered the vaccine, and while charting it the banner appeared to reconcile outside vaccines. I clicked on reconcile and saw that she received a second dose of HPV in 2021. Pt had no adverse reactions and three doses are often indicated for patients, but had I reconciled the outside vaccinations sooner, I would not have given patient extra dose. Primary care provider made family aware during visit and provided education
Red, warm and painful to touch - pain radiating into shoulder. Rx - warm soaks, MEDROL dose pk.
SM developed redness, swelling and pain in upper arm each time after receiving his anthrax shots SQ.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 20th March 2018, the patient received the 1st dose of SHINGRIX. On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain. On 21st March 2018, the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported muscle pain, which only lasted a day. This case was linked to the case US2018144763, reported by the same reporter for the same patient.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient described upper part of arm as being swollen, red, and hot with a goose-egg like area that lasted for 5 days. Red and purple circular bruise keeps reappearing. She has faint red rash/ discoloration still (2 months later)
Area was painful and then in morning noted to have redness and warmth. This cont to worse through the weekend until it extended to elbow. Started taking BENADRYL, today there is improvement.
Hives at injection site and down the left torso, joints aching, weakness, fatigue.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/4/2021, 4/1/2021 and 11/22/2021. Presented to ED on 1/3/2022. PMHx follicular lymphoma currently getting radiation and chemo. Chief complaint of cough onset x 3days, watery diarrhea, sore throat, and decreased appetite. Admitted for acute respiratory failure due to Covid19 PNA. Treated with dexamethasone, Remdesivir x 5 days, antibiotics. Had acute deterioration on 1/18/2022 and patient/family opted for comfort care. Expired on 1/19/2022.
Soreness at the injection site Swollen Lymph nodes under arm  Throbing headache
Patient fainted about 5 to 7 minutes after the injection. We had to use the ammonium inhalant.
Child developed a serum-sickness like reaction on 10/22/2012. Started as hives, then rapidly progressed to swollen knees, refusal to walk. Hands and feet swollen the following day. Child miserable. Rash progressed to erythema multiforme with classic coalescing target lesions covering 50% of her body surface area. See by ER and Rheumatology. Labs drawn with CRP 69. Started on prednisone, 1mg/kg x 10 days, then tapered. Rash worse on 10/23/2012, with dusky centers of the lesions. Seen by burn/plastics. Concerned that she could progress to Stevens-Johnson and need skin grafting, but marked improvement by 10/25 on steroids. OF NOTE, child first noticed to have a "sentinel hive" on her left thigh, the site of two immunizations given on 10/8/2012 (influenza and Hep A). Serum sickness, when caused by an injectable protein based drug, is known to produce this sentinel hive prior to the full body rash. (She also received a varicella vaccine the same day, but in the opposite leg). Seen by allergy in follow-up, believes influenza vaccine potentially to blame. Please note, mother of child is a physician (hence the vocabulary used in this report).
This spontaneous report was received form a Registered Nurse refers to a male patient of 0 day old. On 28-JUN-2014 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # J012520 dose 1, intramuscular. No adverse events were reported. This is one of several reports received from the same source. Additional information is not expected, all follow ups requested to complete the case were received.
Severe swelling and pain at site of injection x2.  Initially received vaccination 1 dose of vaccine in June and developed severe swelling and pain requiring medical attention.  Upon second dose on 12/08/2014, patient redeveloped similar symptom of severe swelling and pain which pt described as worse than first.  Patient treated with antibiotics and pain medication.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
This spontaneous report was received from a nurse referring to 11 unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX  for prophylaxis, lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) (dose, route, lot# and expiration date were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6 ËF to 14 ËF (degrees Fahrenheit) for 121 days. No previous temperature excursion was performed. The call was not because of a "data logger". No further information was provided. There was no Product Quality Complaint (PQC) involved in this case. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA013888: US-009507513-1705USA014052:
Severe arm pain, dizziness symptoms started same day of vaccine and severe vertigo and whole-body achiness on day two. The vertigo continues with sudden sharp pains in my head. They feel almost like an electric shock comes out of nowhere at the top of my right side of brain. It is very frightening especially when driving when this happens. Sharp pain happens more when I am lying in bed look to right or look up. I have also had swollen lymph nodes under arms and breast areas since vaccine.
Information has been received from a nurse concerning a 5 year old male who on an unknown date, was vaccinated with the first dose of VARIVAX (Merck) (lot# 662583/0059Y) 0.5mL. Subsequently, the patient experienced warmth and swelling at the injection site. Subsequently, the patient recovered from the warmth and swelling at the injection site. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
Approx. 1-2 min after Menactra administered, client became unresponsive and facial muscles tightening, mouth clenching, eyes closed, rigidity of both arms. Episode lasted approx. 2 min. When eyes opened, pupils dilated. Color extremely pale. Recovery after 30 min, (complete).
Patient immediately c/o intense pain at injection site and parents noted bruising and swelling immediately.  Pain continued over the next week. 10 days after injuction noted rash begining at injection site and extending down arm to radial aspect of R hand including R 1st and 2nd digits.  Rash is vesiculpapular.  Pain improved but persists 12 days later.
Mom called and spoke with our triage nurse to report redness and swelling at injection site, was advised to monitor and call back with worsening symptoms. Pt came in the office on 4/21/16 for cold symptoms and still had redness at the site.
About 2 hours after the dose administration, constant tinnitus started. It has not stopped since it began that day.
Nausea, diarrhea, migraine, chills, body aches, dizziness, sinus and chest congestion
Children over the age of 9 getting GARDASIL 9 vaccination and the physician has noticed a decrease in common warts; Children over the age of 9 getting GARDASIL 9 vaccination and the physician has noticed a decrease in common warts; This spontaneous report was received from a physician and refers to unspecified children over the age of 9 with common warts. The patients' drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.     On an unknown date, the patients were vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route and indication were not reported).   On unknown date, the physician noticed decrease in common warts the children had in his practice (therapeutic response unexpected).       At the time of the report, action taken regarding therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the outcome of therapeutic response unexpected and the relationship between therapeutic response unexpected and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) were not reported.
p/vax pt was found dead;it it unk if an autopsy is being performed;
Narrative: COVID infection following COVID vaccine series 01/19, Moderna , dose #1 02/16, Moderna , dose #2 09/09 SARS-COV-2 Variant Sequencing result: pending 09/09 COVID swab, result: detected 09/05 pt cc: cough, myalgias, cough, rhinorrhea exposure: unknown
fever/chill at beginning during night of 9/22 body rash noticed about 10:00 am 9/23 queasy stomach and a bit of lightheadedness with sweaty neck
my lower legs were aching; I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (my lower legs were aching) and MUSCLE SPASMS (I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it) 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 05-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (my lower legs were aching) and MUSCLE SPASMS (I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it). At the time of the report, PAIN IN EXTREMITY (my lower legs were aching) and MUSCLE SPASMS (I experienced severe charlie horse cramping in one leg/It's very painful and has continued for 3 hours/The pain is more intense and feels like it) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided. Patient did not experience any other adverse reactions.   This case was linked to MOD-2021-395985 (Patient Link).
Patient began experiencing suicidal thoughts six days after receiving the vaccine. This resulted in an ER visit November 11th. He started Lexapro, but got worse. By November 16th, he was articulating a plan to kill himself. He was taken to the ER again on November 19th. His prescription was changed to Zoloft. Two days later, he attempted to kill himself and had to be physically restrained for 1.5 hours.
This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye) and PAIN (achy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), EYE PAIN (pain in her right eye), RASH (rash), HEADACHE (headache) and VACCINATION SITE PAIN (vaccination site pain). On 08-Apr-2021, the patient experienced CHEST DISCOMFORT (muscle pull / tightness in her chest), MYALGIA (body aches), PYREXIA (100.5 fever) and CHILLS (chills). On an unknown date, the patient experienced PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying) and RASH (a big rash on her forehead). At the time of the report, HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye), PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying), RASH (a big rash on her forehead), RASH (rash), HEADACHE (headache), MYALGIA (body aches), PYREXIA (100.5 fever), CHILLS (chills) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Heart rate: (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.Treatment for the events included ice pack.    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up information received on 09 Apr 2021. Added new events.