chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient's husband reported that she had experienced brief weakness/paralysis in her legs and was unable to walk for approximately 10-15 minutes.  I strongly recommended he take her immediately to the emergency room nearby for evaluation even though she reports the symptoms have resolved.
I almost fainted.  Now ,4 days later I'm unable to walk, I'm so dizzy I can't stand up, walk without assistance.  Was in Emergency room day after.  Had MRI done
Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Just had a little fever took Tylenol but was not hospitalized.) in September 2020. Concomitant products included METOPROLOL, RIVAROXABAN (XARELTO), SIMVASTATIN, OMEPRAZOLE, VITAMIN D NOS, ZINC and PARACETAMOL (TYLENOL) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Palpitations). At the time of the report, PALPITATIONS (Palpitations) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-051779 (Patient Link).
Near syncope 10 minutes after vaccine administered. Severe drop in heart rate. Transported by ambulance to the ER medical center. Overnight stay in hospital. Weakness, dizziness, headache, shaky.
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 to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-NOV-2013, a pharmacist administered the ZOSTAVAX (lot# and route not provided) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. On or about 19-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious 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.
I was down for 2 days after each injection. Miserable!; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer linked case US2022AMR084026).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling miserable. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR084026   Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. the patient received 2nd dose of Shingles vaccine and had reaction that could not be imagine what Shingles feels like. The patient was down for 2 days after 2nd dose and it was miserable.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084026:Same Reporter
I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.; I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed; I feel like the door shut in my head; The muscles in my arms & legs & my back. It was like my arms & legs were frozen; fever; ill; cold; shivering; was very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold), CHILLS (shivering) and FATIGUE (was very tired) in a 78-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had gate unsteady at times & uses walker at times.  The patient's past medical history included Breast cancer. Concurrent medical conditions included Blood pressure high and Unsteady gait (gate unsteady at times & uses walker at times).    On 02-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold), CHILLS (shivering), FATIGUE (was very tired) and MUSCLE SPASMS (The muscles in my arms & legs & my back. It was like my arms & legs were frozen). On an unknown date, the patient experienced SPEECH DISORDER (I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.), GAIT DISTURBANCE (I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed) and FEELING ABNORMAL (I feel like the door shut in my head). At the time of the report, PYREXIA (fever), ILLNESS (ill), NASOPHARYNGITIS (cold) and CHILLS (shivering) was resolving and FATIGUE (was very tired), SPEECH DISORDER (I could barely talk. My voice sounded awful & terrible. It gets worse if I talk longer.), GAIT DISTURBANCE (I couldn't go 2 steps without my walker. I was losing my ability to walk/I feel like I'm paralyzed), MUSCLE SPASMS (The muscles in my arms & legs & my back. It was like my arms & legs were frozen) and FEELING ABNORMAL (I feel like the door shut in my head) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient felt like paralyzed. Physical Therapy done. On 10-Nov-2022 patient went to urgent care. They said it was a severe reaction & that it would go away.
Patient went to pharmacy on 11/9/16 complaining of raised red area approx. 3" in diameter around injection site and a radiating pain in arm to scapular area. RPh on duty asked when it started and if she had been doing anything to treat symptoms. Patient stated she had been icing the area. RPh told patient to continue icing and take NSAIDS if not contraindicated. He then drew a circle around the perimeter and told her that if it got worse to seek medical attention.
PAIN AND STIFFNESS IN RIGHT ARM. FEVER FOR 36 HOURS. THAT WAS 24 HOURS LONGER THAN WHEN I ACTUALLY HAD COVID IN DECEMBER 2020.
None--pt was given two doses of vaccine that had been stored in a conventional freezer for > 2 weeks.  Second dose administered 3/9/22.  Error was not caught until after 2nd dose given.  Pt offered another dose.
She has a circle on the left deltoid area; the area is 7 cm. The area is warm to the touch. She has sweats; she is shaking.  She has pain all over.
This spontaneous report was received from an administrator,referring to a 56 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 31-MAY-2017, the patient was vaccinated with an expired dose of VAQTA 50/0.1 U/ml (route, dose, frequency and anatomical location were unknown) with Lot # L036449 and expiration date 26-MAY-2017, for prophylaxis. There was no product quality complaint. Additional information has been requested.
Information has been received from a RN concerning a 25 year old white male pt with no drug allergies who on 06/24/03 at 8:30AM was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 645853/0256N), "Intradermally instead of PPD" in the left forearm. Subsequently on 06/25/03 in the AM, the pt developed a swollen area at the site and also had 12x30 cm redness of arm. It was reported that the pt had "arm cellulitis." The pt was given cephalexin (Keflex) and was given a "new TB (PPD)" which was negative. Additionally it was reported that a nurse inadvertently administered pneumococcal vaccine 23 polyvalent rather than the PPD tuberculin skin test. The nurse indicated that a similarity in the product's names contributed to the confusion. No further information is expected.
Seven hours after vaccination, I experienced muscle pain in shoulders. Twelve hours after vaccination, I experienced fever, chills, nausea and vomiting. I was able to fall back asleep and by twenty one hours after vaccination felt considerably better.
ONE HR POST-INJECTION, PT EXP RASH ALL OVER BODY; HIVES ON BACK, BUTTOCKS AND AXILLAE; EARS WERE HOT.  NO SHORTNESS OF BREATH.  BENADRYL GIVEN ORALLY.  NO ADDITIONAL DOSES WILL BE GIVEN.
patient was given only the liquid part of the Pentacel and ActHIB has to be given separately, No AE; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a six-month-old female patient who was administered with the Dtap-IPV liquid part of the PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and throwed the powder part, Thus Act-HIB have to be used separately as there is no diluent left to administer.  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HEPATITIS B VACCINE (HEPATITIS B VACCIN) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 10-Dec-2020 , the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [lot number: UJ341AA and expiration date: 21-Jun-2021] via intramuscular route in left thigh for prophylactic vaccination.  This was an actual medication error due to inappropriate reconstitution technique (PT: product preparation issue) (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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.
Started crying for no reason for about 30mins then sat very still as if about to fall asleep. Loss of appetite. Woke at 2AM 1/27/17 vomiting 5 times in first hour and a half then every 20 mins following until 7:40AM then again 3:30PM then again 9:35PM and 10PM. Appetite returned 1/29/17. Patient had never vomited before this.
iN THE HOURS FOLLOWING FLU VACCINE, MMR VACCINE AND PPD SKIN TESTING PLACEMENT PATIENT STARTED TO FEEL BAD INCLUDING SOME RESPIRATORY SYMPTOMS WITH SHORTNESS OF BREATH AND SOME CHEST TIGHTENING INITIALLY SELF TREATED WITH BENADRYL 50 MGS ORALLY BUT SYMPTOMS RETURNEDTHREE TO FOUR HOURS FOLLOWING VACCINE PATIENT WAS ADMITTED TO EMERGENCY ROOM AND TREATED WITH ALBUTEROL AND SOLUMEDROLDISCHARGED HOME LATER SAME DAY
pt stated he was tired, had a headache, and arm right arm pain around the injection site.  Next morning his right arm was hurting more, he had body aches and pains and felt like he had the flu.  Temperature was 98.8.  He was fatigued so he went back to bed and woke up feeling  some better. Pt has not contacted his PCP at this time.
pregnant women patient recieved a shot of Infanrix; 25 year old / recieved a shot of Infanrix; received Infanrix instead of Boostrix; This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female patient who received DTPa (Infanrix) (batch number K92A4, expiry date 9th February 2021) for prophylaxis.   On an unknown date, the patient received Infanrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Infanrix, the patient experienced vaccine exposure during pregnancy and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.  Additional details were provided as follows: The age at vaccination was not reported. The pregnant patient recieved a shot of Infanrix instead of Boostrix, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter consented to follow up.  Doctor gave phone number office and personal cell phone.  Upon internal review below correction is done on 14th September 2020: Additional narrative updated.   Follow up information was received on 2nd July 2021: The additional event was added as wrong vaccine administered. The pregnancy outcome was updated as lost to follow up. No further information was reported.
7 days after booster dose of Moderna Vaccine-woke up and was unable to perform some normal morning activities.  Dropped some things, couldn?t swallow well.  Called local daughter-took to ER which is about 40 minutes away.  During ride patient kept talking with another daughter on the phone.  Speech became increasingly slurred, and started having right side facial droop.  Upon arrival at ED immediately had CT-diagnosed with brain stem stroke.  Not sure how long the stroke had been evolving so consulted with larger medical center.  Life flight to OSF-MRI positive, received TPA.  Started on 1 baby ASA/day and Plavix for 20 days.  Complete resolution of symptoms.  During this time period all of the attending personnel stated she was having a stroke.
This spontaneous report as received from a nurse practitioner via a company representative refers to a currently 13-year-old female patient. The patient had no pertinent medical history and no concomitant medications. The patient's drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with her first and second dose of GARDASIL 9 (dose, lot#, expiration date and route of administration were not reported). On an unknown date, after receiving the second dose of GARDASIL 9, the patient experienced fever and recovered from the fever on an unknown date. On 21-OCT-2016, the patient was vaccinated with her third dose of GARDASIL 9 0.5 ml (lot#, expiration date and route of administration were not reported). On an unknown date in October 3016, after receiving the third dose of GARDASIL 9, the patient experienced vomiting, diarrhea and fever. The patient was taken to an emergency department and reported that she was "seeing things". She received ZOFRAN for the vomiting and TYLENOL. Unspecified lab tests and chest x-ray were performed (results were not provided). The outcome of the vomiting, diarrhea, "seeing things" and fever (after the third dose of GARDASIL 9) was recovered on an unknown date in 2016. The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Awoke with pain all over on 1/24/21,  Much worse on 1/25/21.  And have had pain every day since that time, and the vaccine on 2/27/21, caused Neuropathy in feet and legs, and have had it ever since
BURNING SENSATION WHEN URINATING; CHILLS; HIVES; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned an 18 year old male. The patient's weight was 168 pounds, and height was 68 inches. The patient's concurrent conditions included food allergy, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies, patient is very healthy (athlete).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the subject experienced burning sensation when urinating. On 17-JUL-2021, the subject experienced chills. On 17-JUL-2021, the subject experienced hives. On 17-JUL-2021, the subject experienced headache. On 17-JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 17-JUL-2021, and had not recovered from hives, headache, burning sensation when urinating, and chills. This report was non-serious.
Documented in H&P, patient expierinced fever, shortness of breath and fever shortly after being given the second dose of the COVID vaccine. Resulted positive for COVID on 9/8.  Patient admitted on 9/8/21 for COVID 19 pneumonia.  Patient is still admitted at this time.
The 6 weeks old child, who is breastfed by previously vaccinated mother (on 06/12/2017), had fever of 99.5 F. The temperature decreased to normal the following morning.
Increased heartbeat Facial swelling  throat swelling  Shortness of breath Itchy skin
This spontaneous report was received from a physician via company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 09-SEP-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -1.66 Celsius Degrees for 120 hours, 0 Celsius Degrees for 152 hours, 0.55 Celsius Degrees for 64 hours, -0.55 Celsius Degrees for 272 hours and 1.11 Celsius Degrees for 88 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Vaccine was given after being at room temperature for 6 hours and 25 minutes after dilution.
PATIENT RECEIVED VACCINE DOSE AT 16 YEARS AND 9 MONTHS OF AGE.
Six year-old accidentally got Bexsero; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 02-NOV-2022 Reporter's Comments:  The reporter was patient's parent. The reporter reported that his/her six years-old accidentally received the Bexsero vaccine on the day of reporting.  The reporter asked as what were his risks. The reporter mentioned as his/her healthcare provider was the one who made the error. Additional supportive information: The patient received Bexsero at six years of age, which led to inappropriate age at vaccine administration.
Fever; This is a spontaneous report from a contactable other health care professional. A non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: Unknown) via unspecified route of administration as a single dose for COVID-19 Immunisation on an unspecified date. Medical history and concomitant drugs were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient tested positive for COVID-19 since having the vaccine. On an unspecified date, the patient experienced fever. No therapeutic measures were taken as a result of these events. The clinical outcome of the event was recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Fussy, ok if held; would play if held; mom knew pt was hot so kept checking temp to 104 R called MD; pt had APAP a/shots given again p/talking w/MD; MD also recommended cool bath; t101 R p/bath; MD requesting DT on next visit;
Got shot Friday Monday early morning had vertigo call my primary physician she said to take Dramamine I am taking the Dramamine and still suffering from vertigo
C/o persistent R arm pain >2mos after vaccine, worst at injection site radiating down humerus and into forearm, worse with movement/ feels like 'any movement stretches muscles', tingling / neuropathic pain, describes R arm as 'useless'
Severe dizziness; vertigo; Loss of balance; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: EN6208), via an unspecified route of administration in the right arm on 17Mar2021 at 12:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included Asthma, allergies, high blood pressure and coronary artery disease on unknown dates. The patient was allergic to codeine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. Concomitant medication included BRILINTA, SINGULAR, AZELASTINE from unknown dates for unknown indication and unknown medication for high blood pressure. The patient experienced severe dizziness, vertigo, off balance and nausea on 17Mar2021 at 22:00. Therapeutic measures were not taken for the reported events. The clinical outcome of the events dizziness, vertigo, off balance and nausea was recovering.   No follow-up attempts are needed. No further information is expected.
rash on rt arm w/vesicles that spread all over;had fever & malaise;As of 17OCT95 just starting to feel better;father is MD & prescribed steroids;mom also had rxn;