chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About a week later I woke to a paralyzed arm on mu left side. I spent about a week in the hospital and underwent just about every test imaginable and was finally released with no answer other than it was probably a side effect of the vaccine. My arm is still paralyzed.
Information has been received from a nursing assistant referring to a currently 5 month old patient of unspecified gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (dose unknown, lot# K009900, expiration date unspecified, route of administration defaulted to oral) that was stored improperly. This is one of 2 reports received from the same source. Additional information has been requested.
This spontaneous report was received from a register nurse concerning a 49 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 06-FEB-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015 (also reported as 20-SEP-2014), batch number H017436, albumin status RHA. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a supported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients. This case pertain to one of them who received the first dose for travel purpose and had decided not to received a repeat dose of M-M-R II. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1404USA010165, 1404USA014293, 1404USA014294, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Rapid heart beat; weakness; headache; burning sensation in arm; redness at vaccination site; confusion; brain fog; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 12Apr2021 at 13:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The patient had known allergies which included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 14:00, the patient experienced rapid heartbeat, weakness, headache, burning sensation in arm, redness at vaccination site, confusion and brain fog. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heartbeat, weakness, headache, burning sensation in arm, redness at vaccination site, confusion and brain fog were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 28Oct2023, outcome "recovered", described as "sick". Additional information: The patient received the vaccine, and he was sick for two days.  The patient's wife stated he "reacts to everything."    The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
patient could not move her leg even; patient can not even get out of bed; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (patient could not move her leg even), BEDRIDDEN (patient can not even get out of bed) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced LIMB DISCOMFORT (patient could not move her leg even), BEDRIDDEN (patient can not even get out of bed) and ARTHRALGIA (Joint pain). At the time of the report, LIMB DISCOMFORT (patient could not move her leg even), BEDRIDDEN (patient can not even get out of bed) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt became diaphoretic after receiving (covid) vaccine. Pt moved to stretcher to medical tent for evaluation. vitals as noted. with bottle of water. pt denies any medical hx. pt is alert to people. place and time. Moderna COVID-19 Vaccine Vaccine Lot Number: 040B21A 09:24 97/44 p57 r14 09:33 102/53 p58 r14 09:41 103/65 p80 r 14
That evening (Wednesday) began experiencing fever and shaking chills, pain and swelling at the injection site. The next day (Thursday) the shaking chills had subsided, continued to have a fever and nerve/joint aches and sensitivity. Called Dr.'s office and was told "this happens" and to take Tylenol or Motrin.   By Friday afternoon, the fever and aches had subsided. Today, (Monday, 5 days after the shot) the injection area is painful, hot, and red, an area about the size of the palm of my hand. The rest of my arm and shoulder now also ache.
Vomiting, rash on face, welt/rash at injection site, knot near injection site, fever
If you are marketing this vaccine as a preventative for "Shingles" . . . it is NOT. I contracted my second case of Shingles as diagnosed by my doctor one year after taking the {$400.00 shot} vaccine for Shingles. The vaccination apparently, did NOT work as designed.
late 2nd dose is to get it as soon as possible; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's Comments: The received from pharmacist during business hours he/she know the recommendation for a late 2nd dose was to got it as soon as possible and not to restart.  The reporter had a prescriber telling patients they need to restart because they did have enough immunity.  The reporter wanted to know that did you had any resources regarding this he/she could provide. The reporter did not provide further details.  The reporter submitting for potential late second doses and potential third doses. The reporter consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt exp sx similar to pts who were dx w/fibromyalgia; details of these sx @ the time of the report were unk;
inner corner of the eye is black and blue; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EYE COLOUR CHANGE (inner corner of the eye is black and blue) and COVID-19 (COVID-19) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A and 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced COVID-19 (COVID-19). On 27-Dec-2021, the patient experienced EYE COLOUR CHANGE (inner corner of the eye is black and blue). At the time of the report, EYE COLOUR CHANGE (inner corner of the eye is black and blue) had not resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication provided. Patient states no medical conditions or medications. Patient does not have a health insurance or PCP. Company comment: This spontaneous case concerns a 34-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event AESI of COVID-19. The event COVID-19 occurred five days after the second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 test: positive was performed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event AESI of COVID-19. The event COVID-19 occurred five days after the second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 test: positive was performed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Information has been received from a nurse concerning a 15 year old female with no known drug allergies, who was vaccinated with the first dose of GARDASIL (lot# 0152X) (date and route of vaccination was not reported).  There was no concomitant medication.  About ten minutes after the vaccination the patient fainted a physician nearby evaluated her. They propped the patient feet up. She was vaery pale. She came to in 2 minutes. Observed for 20 minutes and discharged home. It was unknown whether medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  Additional information has been requested. The patient was recovered.  Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a 61 year old male patient. The patient's medical history, concurrent conditions, and historical drugs were not reported. Concomitant therapies included aspirin (manufacturer unknown), and hydrochlorothiazide. On 22-JAN-2018, the patient was vaccinated with ZOSTAVAX subcutaneous route (dose, frequency and anatomical location were unknown) with lot # N021172 and expiration date 01-NOV-2018 indication reported as "recommended for Age". On 24-JAN-2018, the patient returned to the pharmacy with rash at the injection site, the pharmacist described the event as it was a small red area around the injection site just like what it was stated in the prescribing information. At the time of the report, the outcome of injection site rash and injection site erythema was reported as not recovered. The pharmacist did not mention the causality assessment between the events of injection site rash and injection site erythema, and ZOSTAVAX.
101° Fever, High Pulse Rate ~ 110, Malaise & Lethargy x 4 Days. Symptoms Lasted x 4Days Not Experienced With Other Doses
10:00 AM PC from mom: Injection given on 6/27/11 - on 6/28/11 child c/o sore (L) arm & redness around area on 6/28/11, mom states (L) arm was red & swollen from shoulder to elbow with redness - ice was applied. Today 6/28/11; mom states child has red raised areas on face & chest. Referred to PMD.
FEVER; CHILLS; HEADACHE; NOT FEELING GOOD; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 09:30 for prophylactic vaccination on Left arm. No concomitant medications were reported. On an unspecified date, the subject experienced fever, chills, headache, and not feeling good. Treatment medications (dates unspecified) included: Acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, headache, and not feeling good. This report was non-serious.
Resident received a Moderna vaccine from Clinic on 1/13/2021.   Sixteen days later, on 1/29/2021 he received a 2nd vaccine of Pfiser at Nursing home.  There have been no noted signs or symptoms as it relates to vitals etc.  Everything has been stable.
Patient is a nurse. About 6pm the evening of the injection I.M. to the Left Arm Deltoid Muscle she noticed a slight feeling of pain and associated slight stiffness. Especially when lifting arm vertically (above her head). The positive of the bandage that covered the puncture site was noticeably high on the left appendage, almost at, where the Deltoid Muscle connects to the Clavicle. The patient suspected if the injection was at this height, it may have missed the Deltoid and the vaccine may have been deposited in the sub deltoid bursa. She reports that as of date of this report (12/15/2017), that there is still tenderness and soreness at the site and that vertical lifting of the arm is still impaired. It is showing improvement. But advised by other medical personnel whom she works with to mention the adverse event when next time at the Pharmacy. There was no redness or swelling or discoloration at the site at time of injection or afterwards. Pt is not physically impaired by the noticeable soreness when arm is lifted or moved at this time but discomfort upon movement as described continues to be present. Her thoughts are that healing is still ongoing and prognosis is good for full recovery at this time.
Pentacel was administered 4 days after the expiration date with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received from a pharmacist on 07-Jun-2022.  This case involves Infant female patient who experienced DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered 4 days after the expiration date with no reported adverse event.  The patient's past medical history included She was 25.4 weeks at birth (Premature baby). The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing baby is in the neonatal intensive care unit since birth (Hospitalization).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunization; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunization.  On 02-Jun-2022, the patient age <1 year received 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.5ml dose once of suspect Pentacel vaccine of standard strength (lot UJ502AA, expiry date: May 29, 2022)  via intramuscular route in the right thigh for prophylactic vaccination (expired product administered, latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
thought I was dying: Uncontrolled shivering, twitching, heart; stomach felt like electrical shock, very scared! Left eye went blurry - discussed this with Opthmolgist. Layed in Bed - Don't know when it passed 5hrs later?! This was the most scarist feeling Ive ever had! I take meds perscribed, nothing I did different that day! Please contact me on this issue.
Administered frozen vaccines from 03/07/2022 to present; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of the patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, HAV (Havrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B, Boostrix, Shingrix, Havrix, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Boostrix, Shingrix, Havrix, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 7-Apr-2022 Reporter's comments: Nurse reported administration of frozen vaccines to the patients from 7th March 2022 to the date of reporting. Vaccines were Engerix-B, Boostrix, Shingrix, Bexsero, and Havrix. Chat was disconnected before additional details were provided. The consent to follow up was given. Additional Supportive Information: Frozen vaccines were administered to the patients which led incorrect storage of drug. There were total 43 patients. For 10 patients 10 cases were created. For rest patients this case was considered as master case. This was 1 of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061864:Same reporter. US-GLAXOSMITHKLINE-US2022061865:Same reporter. US-GLAXOSMITHKLINE-US2022061866:Same reporter. US-GLAXOSMITHKLINE-US2022061868:Same reporter. US-GLAXOSMITHKLINE-US2022061870:Same reporter. US-GLAXOSMITHKLINE-US2022061871:Same reporter. US-GLAXOSMITHKLINE-US2022061872:Same reporter. US-GLAXOSMITHKLINE-US2022061873:Same reporter. US-GLAXOSMITHKLINE-US2022061874:Same reporter. US-GLAXOSMITHKLINE-US2022061875:Same reporter.
On 11/18/2022 in the morning at 08:00AM. I woke up with a headache. I also had a little breathing problem. On 11/19/2022 soreness, fatigue and all the COVID-19 symptoms. I did a telehealth on 11/29/2022 with my doctor who prescribed PAXLOVID for 5 days. I tested positive on the 11/19/2022. On 11/26/2022-11/27/2022 I tested negative after taking PAXLOVID. After finishing PAXLOVID on 11/24/2022 I had a rebound of COVID-19 on 11/28/2022 with symptoms of cough, slight fever, runny nose, congestion and sore throat. I tested positive again on 11/28/2022. I am taking over the counter medications ibuprofen and SUDAFED. I am recovering slowly.
No adverse event; They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation).    Concomitant medications were not reported. Nurse reported that they had 2 pediatric patients who were administered with the Covid-19 vaccine which was intended for the 6-11years on 09Dec2022. They were given 0.25 ml (25mcg) of the vaccine which was the correct dose but not the correct formulation.                                   No treatment information was provided by the reporter.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 29-NOV-2015 at time- 18:08, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.3 and 1.8 (units unspecified) for 1 hour and 35 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Had gotten rash and sore body; Had gotten rash and sore body; This is a spontaneous report from a Pfizer-sponsored program via non-contactable consumer (son) for a male patient (father). A male patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 01Apr2021 as dose 1, single for COVID-19 immunisation; infliximab (REMICADE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included  Still disease. The patient's concomitant medications were not reported. The patient had infusion close to vaccine. On an unknown date, the patient had gotten rash and sore body. The patient's healthcare professional (HCP) kept patient back on Prednisone 06Apr2021. The patient had not taken Remicade in 4 or 5 months. The patient's son was wondering when the patient can get 2nd dose of covid vaccine. It was not clarified if after 1st dose of vaccine, patient had to get treatment of Remicade. Therapeutic measures were taken for the events. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right arm painful, generalized body aches, chills, progressed through out the day fever 100.2. Redness/Swelling spread throughout the whole upper arm. Red ring around circumference of arm
I walked upstairs and at the top I started sweating and had real sharp pains in the middle of my chest I called the hospital switchboard and was told to come in. I went the the ER room at the hospital and they said I had no issues after running many tests and I have gone in  multiple times since then. On  02DEC2022 they took me by ambulance to the hospital and performed a cardiac catheter and I had a reaction afterward which put me in the ICU for three days and then the CCU for three days.