chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unknown event; 1st dose received in Jan2021, the patient missed her second dose appointment because she was in the hospital; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A pharmacist reported on behalf of the patient. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Jan2021, as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient has been in and out of the hospital for an unknown event which was something unrelated to the COVID vaccine. The caller stated that the patient's hospitalization wasn't related. The patient missed her second dose appointment because she was in the hospital. The reporter wanted to know whether the patient could take their second dose or start all over again. The reporter was aware that the Pfizer shot has to be taken after 3 or 4 weeks at most apart but it had been 4 month or above for the patient. The case was assessed as serious (hospitalization). The outcome of the event was unknown.  Information about lot/batch number has been requested. ; Sender's Comments: Based on current information available, the events was considered unrelated to Bnt162b2.
Pt recvd MMR vax on 10DEC91 & on 21DEC91 pt was presented to MD w/diffuse erythematous maculopapular rash w/some raised blanching lesions;
Immediately after 3rd GARDASIL shot she developed an approx 4 inch red/warm wheal at the injection site. This same reaction occurred years earlier with the 2nd MMR.  Follow-up - Pt age 17 years - Checked in Box, none of the above. Record updated.
Very vascular starting day after the vaccine, bruising easily. Right arm, elbow swollen, bruised and arm puffy, still. March 12 2021 Blood work, arm bled for a day, very bruised. Bruise easily. Blood work shows low platlets, low MCHC and low RBC. Was off RA meds prior to shot, Xjelzane.
This 77 year old white  female received the Pfizer Covid shot on 4/22/21    and went to the ED on4/24/21  with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified
Immediately after administration pt stated she "felt dizzy" then proceeded to pass out. Pt laid flat: 0 injury; Dr. informed and spoke with pt and family
Information has been received from a physician at a Grand Rounds meeting at a hospital concerning another physician's female teenager patient who was vaccinated with GARDASIL and "recently" experienced unknown hand and arm sensations. The reporting physician did not have any patient information because it was someone else's patient. No further information is available.
shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Hepatitis B vaccine.     It was unknown if the company considered the shingles to be related to Hepatitis B vaccine.   Linked case(s) involving the same patient:  US2023AMR067337   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient had hepatitis B shots in 90s and gave him or her shingles. As nurse illegible text. The follow-up could not be possible as no contact details were available. The case was linked with case US2023AMR067337, reported by same reporter for different vaccine for same patient.; Sender's Comments:  US-GSK-US2023AMR067337:Same patient, same report, different vaccine
Fever, bilat arm et leg pain, bilat tingling/numbness in legs et arms, slight cough, low back pain, chest pain, short of breath x 2 days.
FEVER /FUSSY /INCONSOLABLE CRYING FEVER IN OFFICE 101 RECTALLY.   DX: FEVER /PHARYNGITIS/PERTUSSIS REACTION.
got both shots, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got both shingles shot still experienced shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium
Dull pain at the injection site; second shot seemed fairly high on my shoulder/ pain at injection site and general shoulder area was severe; I could'nt move my arm at all due to pain; barely sleep due to shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9266, Expiration Date: Not provided) via unspecified route on 16Feb2021 at 09:45 AM in the left arm as single dose for covid-19 immunisation. Patient's medical history included shoulder injury due to fall (5 years ago). Concomitant medications were none.The patient previously took Ibuprofen and Amoxicillin and experienced allergies, also historical vaccine includes on 26Jan2021 at 10:00 AM, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EN5318, Expiration Date: Not provided) via unspecified route in the left arm as single dose for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. On 16Feb2021 at 15:00, the patient experienced pain at the injection site, "barely sleep due to shoulder pain", shoulder injury. Clinical course of the event as follows: On 16Feb2021, about 5 hours after the shot in the left arm, patient started feeling the typical dull pain at the injection site, about at 11pm (13 hours after injection) the pain at injection site and general shoulder area was severe. About 9 out of 10 he could barely sleep due to shoulder pain. Patient couldn't move his arm at all due to pain. The pain began receding about 24-36 hours later till 8 days after injection, he still had shoulder pain when he moves arm a certain way. It was reported that it felt like a shoulder injury for him. It was further stated that, the same shoulder was injured mildly about 5 years ago due to a fall but made a full recovery a couple months later. The patient informed that pain after first shot was only mild dull pain at injection site. Also, of note is that the injection site for second shot seemed high on shoulder as opposed to the side of the deltoid for the first shot. Events were not treated. Outcome of events was resolving.
sore arm; Expired Product Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (Expired Product Administered) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (Expired Product Administered). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Expired Product Administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant or treatment information provided.  Patient is going to seek an antibody test to ensure that she is covered.   This case was linked to MOD21-075500, MOD21-074055, MOD21-075351, MOD21-075527, MOD21-075532, MOD21-075540, MOD21-075544, MOD21-075549 (E2B Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY-2021 contains significant information- Patient demographics, event added; Sender's Comments:  MOD21-075500:Cross linked case MOD21-074055:Cross linked case MOD21-075351:Cross linked case MOD21-075527:Cross linked case MOD21-075532:Cross linked case MOD21-075540:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
Fever over 102. Fussiness. Loose stool. Lack of sleep.
Information has been received from a physician concerning a 20 year old female allergic to CECLOR and with mild hypertension who on 06-JUL-2007, on 04-MAR-2008 and on 04-FEB-2010 was vaccinated 0.5 ml IM with the first (657737/0522U), second (659441/1446U) and  third (662304/1013Y) doses of GARDASIL. Concomitant therapy included WELLBUTRIN, clonidine and oral hormonal contraceptives (unspecified). The physician reported that the patient experienced pain with each administration. The patient's pain recovered on the day of injection reintroduction pain reappeared. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a elderly male patient who received Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included shingles (8 years ago, prior to receiving ZOSTAVAX). Previously administered products included ZOSTAVAX (8 years ago) and Neurontin.  On an unknown date, the patient received the 1st dose of Flu vaccine. On an unknown date, 7 days after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), numbness in toes (serious criteria hospitalization) and strabismus (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and strabismus were recovered/resolved and the outcome of the tingling of extremity and numbness in toes were not recovered/not resolved.  It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, numbness in toes and strabismus to be related to Flu vaccine. Additional details were provided as follows: This case was reported by the patient for himself. The age at vaccination could be 69 or 70 years. Four years ago, in 2014, the patient received flu vaccine (unknown manufacturer) in the left arm and 1 week after receiving the vaccine, the patient had Guillain-Barre Syndrome. He noticed that his eyes were going in separate directions so he drove himself to the hospital and he was hospitalized for 10 days. He was in the hospital he had to have plasmapheresis to filter his blood. Every now and then he felt a tingling feeling or numbness in his toes. The patient had denied permission to contact their physician.
Patient was given the Pfizer 12 & older for the 1st dose. Today the patient has received the pediatric dose for the 5-12 year old. Mother notified of the vaccination error.
Patient experienced pain swelling and redness after injection. Seen in office 5 days later. Tylenol, warm compresses and follow up given.
I am shaking, feeling nauseous and my head and body is warm. I feel like I am going to throw up and feeling very sick.
Feeling unwell; This is a spontaneous report from a contactable consumer (patient).   A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has received both doses of the Pfizer COvid-19 Vaccine. Patient was asking what "feeling unwell" on the fact sheet means. Caller reported to DSU 16 Adverse Events. The outcome of event feeling unwell was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. No concurrent conditions, medical history and concomitant medications were reported. The excursion occurred on 26-SEP-2016 and the vaccine was exposed to a maximum temperature of 11.6 F for 7 hours and 30 minutes and a maximum temperature of 6.2 F for 20 minutes.  On 27-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX lot # M020902,expiry date:18-JUL-2017 subcutaneously for prophylaxis. No adverse event was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1609USA012216:
After 20 minutes the patient began to feel swelling in her mouth. EMS checked all vitals and they were all good. They looked inside her mouth and saw some swelling. At 2:05 the EMS gave a shot of Benadryl to patient. Patient was seen fine and working after.
tested positive for COVID-19 infection; felt cold; congestion sometime after receiving the first dose; bacterial congestion; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: MEASLES and MUMPS AND RUBELLA VACCINE in May 2020. Concurrent medical conditions included Hearing aid user.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills). At the time of the report, COVID-19 (tested positive for COVID-19 infection), FEELING COLD (felt cold), NASAL CONGESTION (congestion sometime after receiving the first dose), BACTERIAL INFECTION (bacterial congestion) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medications were provided. Patient was prescribed antibiotic medication for bacterial congestion.   This case was linked to MOD-2021-273575 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: The follow up document contain no new information. On 02-Aug-2021: Significant Follow up received and felt cold and nasal congestion was added as events. Second dose case was linked. Action taken was updated.
Patient received Fluad first. After Shingrix administration, she started to tremble and was unresponsive for a few ~30 seconds. After 2-3 mins she was to keep herself up on her own. She was given glucose gel and seemed to recover. Fire department came and took her away roughly 20-30min following A/E. She came back later to the pharmacy recovered. Said it was vasovagal syncope.
mild intermittent tingling throughout body lasting for more than 24 hours after vaccine.  More consistent tingling in mouth/throat began approximately 7 hours after injection and continued for 3 hours.  Throat began to close up and I took a Benadryl which stopped the tingling in my throat and I was able to breathe better. I repeated a second dose of Benadryl before bed that night to ensure that the event did not repeat itself.  Tingling and swelling in throat and mouth never returned ,  Mild intermittent tingling in rest of body continued throughout day two post injection but it tolerable and did not require medication.  Fever (101), body aches, chills and muscle pain began 12 hours after injection and persisted for approximately 18 hours.
4 yr old male seen back in clinic for skin reaction on his R thigh . Pt was seen in clinic on 09Aug for his 4 yr well visit and received MMRV and Kinrix vaccines. The Kinrix (DTaP-IPV) was given in the R thigh, MMRV was given in the L thigh. Pt developed a small area of redness around the injection site the following day however this AM the area became significantly larger. Area is red , raised and warm. not itchy, pt does not c/o pain. He is walking normally, and maintaining normal activity , jumping and running not affected. He has not had fevers, no swelling of his R leg. no other skin rashes , no other illness symptoms.  He has never had a reaction to vaccines previously other than fevers.
No adverse symptoms reported; The patient was vaccinated with PNEUMOVAX 23 on 11/21/2018 and 11/13/2019.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 21-NOV-2018, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. On 13-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccine dosage detail, route of administration, lot# and expiration date were not reported) (inappropriate schedule of product administration) for prophylaxis. No adverse symptoms reported.
fever & vomiting, h/a & sl pain @ the inj site & the inj site was swelling;
2 days after injection the arm where I received it turned bright red and swollen along with muscle pain and weakness. 6 days later it has become itchy and it's still sore and weak but improving.
Night after  injection patient has pain around the site , no swelling , he took some Tylenols. Four days  after injection still  in pain feel  little bit better 10 days after he still in pain but little bit better , He  said he will see his doctor
pregnant and vaccinated; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and vaccinated) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LANSOPRAZOLE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and vaccinated). On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and vaccinated) had resolved.            No treatment information was provided.
pt devel daily severe h/a (constant) 4 hr p/vax until present;pt was hosp for new onset of daily persistent h/a & put on preventative meds;pt has also exp gait difficulties since vax; (mild unsteadiness);
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 09-MAY-2016, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately one day after receiving the ZOSTAVAX, the patient suffered bilateral pneumonia and abnormal nodules within her lungs and was diagnosed with atypical pneumonia of an unspecified organism. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, bilateral pneumonia/atypical pneumonia of an unspecified organism was determined to be medically significant. Bilateral pneumonia/atypical pneumonia of an unspecified organism and abnormal nodules within her lungs were considered to be disabling. Additional information has been requested.
08-28-06 Hepatitis B vaccine 9third shot) given at 10:00 am.  10:15 employee states "dizzy".  Doctor instructed to sit and put head down.  10:30 ambulatory but state he still dizzy, made sit down again, blood pressure 128/84, pulse 87, temperature 98.1. Instructed to lie down but refused and left at 10:45 pm.
Numbness in left arm and face, overheating, fainting, Medical personal fist on site noticed shaking due to Seizure.