chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had been having severe pain in my wrist, having problems even picking up anything. It felt as if they were dislocating. I went to the doctor to have them looked at, to see if there was anything going on. A year ago, I had x-rays on my wrist to have them file for preemptive baseline for any possible changes as I have been having issues with other joints. The x-rays I had in the fall showed that I had already started to show I had ligament tears and denigrative bone loss. The x-ray that were taken in April showed that my right wrist has already collapsed. I have degenerative changes in my bones that are way worse than I showed have for someone my age. I am now awaiting an MRI to see how far the bone loss is to see if the there is a surgery that can repair my bones.
Patient with history of diabetes type II and ESRD on dialysis T/Th/S. She was brought to the ED by EMS on 12/24/22 for back pain. Notably, a few weeks ago the patient had a groin surgery performed due to acute and sub-acute infective endocarditis. She has since been in a rehab facility. Earlier that evening, she developed lower back pain. She presented to the ED, and was discharged that day with acute on chronic low back pain.   The patient returned to the ED on 12/25/22 reporting that she missed dialysis due to transportation issues. She reported chest discomfort and stomach fullness. In the ED, she was found to be mildly hypoxic to 89% and was placed on 3L O2. Additionally, she was noted to have hyperkalemia. A COVID PCR was performed and resulted positive. Patient was admitted 12/25/22 - 12/28/22 with discharge diagnoses of hyperkalemia secondary to missed dialysis and COVID-19 infection. Patient was able to be weaned to room air during her admission. She is fully vaccinated.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date (reported as a over year ago), the patient was vaccinated with first dose of GARDASIL (lot number, expiry date and route was not reported). On 19-JUN-2013, the patient was in the office to receive the second dose of GARDASIL (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Information has been received from a physician concerning a 11 year old (also reported as 10 year old) male who on 14-OCT-1999 and 31-OCT-2002 was vaccinated with the first and second dose of MMR II respectively (route, site, and lot number not reported). On 25-JAN-2010 the patient experienced mumps. The patient was diagnosed on 26-JAN-2010. The patient parotitis was on right side and had right side of neck swollen. On 26-JAN-2010, the first blood work was done which revealed serum IgM <1:10, serum IgG 9.11 and serum Amylase 69. The outcome for mumps was not reported. This is one of several reports from the same source. Additional information has been requested.
pt became cold, clammy & dizzy gradually felt better in 8-10min;p/eating crackers & drinking water was t/o into the wheelchair to the car;
Pt likely presented to vaccine appt with asymptomatic/early infection of COVID-19, as he presented 2 days post-vaccination and tested positive for COVID-19 on rapid and PCR test. He was hospitalized where he eventually died of complications from COVID-19 while in ICU. Date of death was 1/15/2021.
1st dose in 2020, 2nd in October of 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 21-FEB-2023 Reporter's comment: The reporter was a Pharm D. The reporter stated that did a person had to restart the series if missed the 6-month window. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Pins and needles; numbness in left side of face; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 09Apr2021 at 10:15 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient's concomitant medications included mirabegron (MYRBETRIQ), ethinylestradiol, norethisterone (PIRMELLA) and fluconazole (DIFLUCAN) from unknown start date for unknown indications. The patient's medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 20:00, the patient experienced pins and needles and numbness in left side of face. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of the events pins and needles and numbness in left side of face was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Hives on inside of thighs with red rash and very itchy; very dry skin on lower legs and skin flaking off on legs.
Information has been received from a registered nurse concerning a patient who on an unspecified date, was vaccinated with PNEUMOVAX, intradermally. The registered nurse reported that the patient inadvertently received the vaccine intradermally instead of "PPD skin test" due to human error. No adverse reaction reported. Additional information has been requested.
Expired Moderna Doses Administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Doses Administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Doses Administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Doses Administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 22 Apr 2022, the vial was initially stored in the refrigerator.The vial did not undergo any temperature excursions.  No treatment medication was reported.
This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, immediately after receiving SHINGRIX, the patient experienced skin warm, injected limb mobility decreased and pain in arm. On 14th March 2019, the patient experienced headache, diarrhea, appetite absent and weight loss. On 15th March 2019, the patient experienced sleepiness. On 19th March 2019, the patient experienced swelling of eyelid, facial swelling and allergic reaction. On 20th March 2019, the patient experienced periocular swelling. In March 2019, the outcome of the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea and appetite absent were recovered/resolved and the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the weight loss was unknown and the outcome of the swelling of eyelid, facial swelling, allergic reaction and periocular swelling were recovering/resolving. It was unknown if the reporter considered the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea, appetite absent, weight loss, sleepiness, swelling of eyelid, facial swelling, allergic reaction and periocular swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her upper left arm. Immediately following the vaccination, the patient started having fever in her arm and had trouble lifting it. On 13th March 2019 at night, the patient could not sleep on her left side because her arm hurt too bad. On the next day, the patient had a headache and severe diarrhea. She had no appetite over the next few days and lost 5 pounds. On 15th March 2019, 2 days later, the patient slept for 6 hours during the day. On 19th March 2019, after 6 days, the patient's left eyelid began swelling and the bottom of her face. On 20th March 2019, there was swelling all around her eye and down her cheek. She saw her eye doctor and was told it was an allergic reaction. The patient's arm was no longer hurting, but she could felt where she got the injection if she rub it. Emergency room visit was required. The consent to follow up was given.
Vaccinated pt admitted to hospital with covid infection. Unknown date, manufacturer and all other vaccine info. Pt reported vaccination status and no further information is available
Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via office staff. This case involves two-month old female patient who received an expired dose of PENTACEL (batch number C5384AA), expiry date 30 June 2018 in left thigh. It was actual medication error due to expired vaccine used as 2 month old was administered PENTACEL that expired on 06/30/2018. It was unknown if any adverse event occurred. 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. Documents held by sender: none. Follow up information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse via office staff. No new information updated. Documents held by sender: none.
SIRVA due to injection being delivered too high and delivered to shoulder capsule instead of deltoid muscle.vaccine was delivered One centimeter form the Acromion.
Severe vertigo needing hospitalization  Lasting 2 weeks and I still have dizziness
I got sick a week after injection. I was feeling very weak, a sore throat and a fever. I went to the doctor and tested negative for COVID. Two days later I still had a fever and had a PCR test done. I was given a Z-pack. I found out a couple of days later that I had COVID.
This spontaneous report as received from a healthcare worker via a company representative refers to several patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (route, dose, lot# and expiration date were not reported). The reporter stated that the patients experienced severe pain and numbness after receiving the GARDASIL injection (date unspecified). No specific information was provided on whether it was at the injection site or the arm. The patients did not seek any medical attention. The outcome of "severe pain and numbness" was unknown. The relatedness between the event of "severe pain and numbness" and GARDASIL was not reported. Additional information has been requested.
if she needs to give another dose of IPOL as she has given the last dose from a MDV of IPOL that is the 11th dose from the vial and it is only half filled with no reported adverse event; Initial information received on 24-Mar-2022 regarding an unsolicited valid non-serious case from a nurse via call center.  This case involves a 6months old female, and it was reported that "if she needs to give another dose of ipol as she has given the last dose from a mdv of ipol that is the 11th dose from the vial and it is only half filled no reported adverse event" while receiving vaccine IPV (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) for Immunisation.  On 23-Mar-2022, the patient received a 3rd dose of suspect IPV (VERO) (batch number: T1E872M) at a dose of 0.5 ml via intramuscular route in the left thigh (formulation, strength, expiration date: unknown) for immunization.  On 23-Mar-2022, it was reported that "if she needs to give another dose of ipol as she has given the last dose from a mdv of ipol that is the 11th dose from the vial and it is only half filled with no reported adverse event" (incorrect dose administered) following the administration of IPV (VERO).  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event (incorrect dose administered).  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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 02Jan2018; HYDROXYZINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: it was reported that patient received vaccine. Patient received other medication in 2 weeks. Patient received treatment for suspected covid-19 with Anti-viral, Brand as Paxlovid, treatment Start Date on 09Jul2022 and Stop Date on 13Jul2022. Began feeling worse after starting Paxlovid. Discontinued Wellbutrin and hydroxyzine. It was asked if Interaction between drugs. Covid rebound symptoms 19Jul2022 after being completely recovered. Symptoms seem worse than original Covid symptoms 08Jul2022. Before taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 days after receiving her first Shingrix / developed shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tingling (experienced for 1 week before 30th October 2020).   On 28th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th October 2020, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: 2 days after receiving her 1st dose of Shingrix she developed shingles.  The reporter did not consent to follow-up.
Information has been received from a physician concerning an unspecified amount of patients.  The patients' medical histories, concurrent conditions and concomitant medications were not provided.  On unspecified dates, unspecified patients were administered improperly stored VAQTA, lot # M047658, expiration date 28-OCT-2017  (route not specified) and RECOMBIVAX HB, lot# M042322, expiration date 21-FEB-2019 (route not specified). The temperature excursion for both vaccines: 47 degrees F to 77 degrees F.  Time Frame:  44 minutes. Previous temperature excursion for VAQTA : 48 degrees F for 76 minutes. Previous temperature excursion for RECOMBIVAX HB: 48 degrees F for 45 minutes. A data logger was involved. No adverse events were reported. The  outcome of the event was unknown. Additional information has been requested.
the patient was administered an improperly stored dose of Rotateq; No adverse effect; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported.  On an unknown date, the patient was administered an improperly stored dose  of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) injection for prophylaxis (lot # R033254, expiration date 04-JUL-2020; dose, frequency, route of administration were not reported).      The dose of vaccine experienced a temperature excursion of 34.8 degrees Fahrenheit for 31 hours. No previous temperature excursion was reported. Data logger was not involved in recording the excursion details. No adverse event was reported.
Horrible time breathing; Sleeping all the time; Arm was Red; Arm was very hurt; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was Red), PAIN IN EXTREMITY (Arm was very hurt), PERIPHERAL SWELLING (Arm was swollen), DYSPNOEA (Horrible time breathing) and SOMNOLENCE (Sleeping all the time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Lung infection in 2015, Adverse reaction to antibiotics and Pleural effusion. Concurrent medical conditions included Oxygen supplementation. Concomitant products included OXYGEN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Arm was Red), PAIN IN EXTREMITY (Arm was very hurt) and PERIPHERAL SWELLING (Arm was swollen). On 18-Feb-2021, the patient experienced DYSPNOEA (Horrible time breathing) and SOMNOLENCE (Sleeping all the time). On 22-Feb-2021, ERYTHEMA (Arm was Red), PAIN IN EXTREMITY (Arm was very hurt) and PERIPHERAL SWELLING (Arm was swollen) had resolved. At the time of the report, DYSPNOEA (Horrible time breathing) and SOMNOLENCE (Sleeping all the time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included oxygen during the day and night.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 29th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th November 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were reported as follows: The case was reported by the patient. The patient received 1st dose of Shingrix and immediately had pain in his arm at the injection site. The pain resolved after an unknown amount of time. The reporter had nothing else to report. The reporter did not have batch number or expiration date information.
High fever 101.6 Chills  Lymph node pain in armpit and breast
No additional AE reported; temperature excursion for VARIVAX and MMR II; This spontaneous report was received from an office manager referring to a 22-month-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On 30-SEP-2020, two vaccines varicella virus vaccine live (oka/merck)(VARIVAX) (lot# T003706 with expiration date 30-JAN-2022) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# S029454 with expiration date 19-SEP-2021) had temperature excursion. The temperature excursion was -14.27 C for 20 minutes.   On 01-OCT-2020, the patient was vaccinated with both vaccines (dose details, frequency and route were unknown) for prophylaxis (product storage error). No additional adverse event was reported.       There was no previous temperature excursion. Data logger was involved.
He fell over on his own house; He fell over on his own house and was injured; Balance issues; Always felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FALL (He fell over on his own house), ACCIDENT AT HOME (He fell over on his own house and was injured), BALANCE DISORDER (Balance issues) and DIZZINESS (Always felt dizzy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (He fell over on his own house), ACCIDENT AT HOME (He fell over on his own house and was injured), BALANCE DISORDER (Balance issues) and DIZZINESS (Always felt dizzy). At the time of the report, FALL (He fell over on his own house), ACCIDENT AT HOME (He fell over on his own house and was injured) and BALANCE DISORDER (Balance issues) outcome was unknown and DIZZINESS (Always felt dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy was not reported. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # J009721 expiration date 07-AUG-2015, lot # K002047,. expiration date 10-FEB-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your bone".  When I got home and took the Band-Aid off there was a small red mark, which went away  by the next morning. Then  next day after that I started having extreme pain and numbness in my left arm. The pain is from my shoulder, to my fingertips, and under my arm. It is still hurting today. I have been taking Advil, putting pain cream on it. It is still hurting as of now.