chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Information has been received from a certified nurse midwife assistant for the pregnancy registry for GARDASIL, concerning a 27 year old female with a history of papanicolaou smear abnormal (1998), caesarean section (1999), normal deliveries (2002 and 2006) and no known allergies who on 02-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot # 657005/0314U) into the left deltoid.  Concomitant therapy included NORDETTE and prenatal vitamins daily.  The patient had her last menstrual period on 10-JUL-2008.  In August 2008, the patient experienced light bleeding.  On 10-SEP-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660393/0067X) into the right deltoid and was pregnant.  On an unspecified date, a routine blood work was performed (results not provided).  The patient sought an initial pregnancy exam as medical attention.  The patient had 3 previous pregnancies and 3 full term deliveries (40, 39 and 40 weeks).  No birth defects in previous pregnancies and no infant complications were reported.  On 10-OCT-2008, an ultrasound was performed but was too early for evaluation dating.  A second ultrasound was scheduled for 27-OCT-2008.  The estimated date of delivery was 16-APR-2009.  Additional information has been requested.
patient was administered a vaccine post-excursion (with no reported adverse event); Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 18 years old female patient who was administered a IPV (VERO) (IPOL) vaccine post-excursion (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient previously had an oral Polio dose from outside the country and on 18-Sep-2023, the patient received dose 2 of 0.5 ml of suspect IPV (VERO) Suspension for injection (Batch number: W1A101M, expiry date: 10-Feb-2025, strength: standard) via intramuscular route in the left deltoid as Immunization  On 18-SEP-2023 the patient was administered a vaccine post-excursion (with no reported adverse event) (poor quality product administered) (Latency: same day)  It was reported" A doctor is reporting a temperature excursion that occurred one month ago and was advised to call us to determine if the vaccines are still viable for use. He also stated that the vaccines were used for three patients after the temperature excursion. Product/s: IPOL was Opened products and the reason: unknown Max temperature reached: 47.1°F Duration out of labelled range: 15 minutes Human error was unknown. The extended stability data did not cover the excursion. 3 patients were involved. Previous excursion: None. The patients were fine, and the reporter did not report any side effects."  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
Pt called complaining of large local reaction with redness, swelling and pain. Benadryl and ice that night. 11/16/2001 swollen arm from shoulder to elbow, 2 pack of medroldone.
Pt devel red welts (5-10cm) & itching @ inject site p/receiving flu vax;
Sore arm at the site of injection. Extreme pain and swelling in big right toe. Toe also felt hot to the touch. I iced both locations and ultimately took 2 200mg Advil tablets. Arm is still tender the second day. The toe felt fine all day then at 5:30pm it started to feel like it was swelling again. I immediately took 2 200mg of Advil.
Minor Headache; Stomach, and intestinal distress; Tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: EN6198, Expiration date: Unknown), via an unspecified route of administration in the left arm on 24Feb2021 08:15 (at the age of 71-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history included Heart Disease, Diabetes, Neuropathy and morphine, penicillin allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks. Had other medications within two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after administration, the patient experienced Minor Headache, Stomach, and intestinal distress, Tired on 25Feb2021 07:00. No treatment medications were received for the adverse events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
11YR OLD RECIEVED PFIZER 0.3 ML DOSE.. AS HER SECCOND DOSE
Patient passed away the day after his well exam. Vaccines were not indicated as a reason for death.
Case number PHEH2014US024981, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 68-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 NOV 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Localized injection site pain has continued and increased to strong incapacitating pain in left shoulder and injection site.  Difficult to lift and rotate left arm at the shoulder.  Pain radiates into left side of neck, ear area and into shoulder blade.  Occasionally causes numbness in the left arm.
Very painful joint pain in shoulder/Very painful joint pain in elbow; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow). At the time of the report, ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) outcome was unknown.            No concomitant medications was reported by the reporter.  No treatment medications was  provided by the reporter.
630PM 27MAR96 started feeling itchy all over then noticed red, blotchy areas esp around neck & jaw;seen to come & go
slight headache; Nausea; Woke up very dizzy; His head was spinning; Could not focus his eyes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up very dizzy), VERTIGO (His head was spinning), DISTURBANCE IN ATTENTION (Could not focus his eyes), HEADACHE (slight headache) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (Woke up very dizzy), VERTIGO (His head was spinning) and DISTURBANCE IN ATTENTION (Could not focus his eyes). On 01-Feb-2021, the patient experienced HEADACHE (slight headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Woke up very dizzy), VERTIGO (His head was spinning), DISTURBANCE IN ATTENTION (Could not focus his eyes), HEADACHE (slight headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication given no treatment provided
Information has been received from a physician concerning an adult pt who was recently vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (lot 647985/0061R or 647354/0254P). Subsequently, the pt developed a rash that covered their torso. Unspecified medical attention was sought. The physician reported that the pt recovered. No product quality complaint was involved. Additional information has been requested.
Fatigue; Headache; Dose number 1: 17Dec2020/dose number 2: 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 45-years-old female patient received second dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 04Jan2021 on Left arm at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient previously received COVID 19 (Pfizer), lot number=EK5730, administration date=17Dec2020, administration time=04:15 PM, administrator route=Intramuscular, vaccine location=Left arm, dose number=1. The patient received second dose of bnt162b2 on 04Jan2021, experienced fatigue and headache on 04Jan2021 23:00. The patient had no covid prior vaccination, no covid tested post vaccination. No known allergies. The patient did not receive treatment for events. The event outcome of Fatigue and headache was not recovered.
p/vax pt exp fatigue; arthralgias and flu-like symptoms; supportive measures were given as tx
pain from inject was throughout entire rt arm & hand; fell unconscious, sweating profusely w/cold & clammy skin; BP taken by paramedics was low BP; taken later @ hosp/norm;
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered improperly stored LIQUID PEDVAXHIB for prophylaxis lot #R005118 and expiration date 28-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported. The lowest temperature of excursion was below 36 degrees F / 2 degrees C (34.9 degrees F) for 28 minutes including below 32 degrees F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA007858.
Tinnitus type symptoms of odd  back and forth sound in right ear. Have never had anything like this before. Notice it mostly if all is quiet and then it?s quite loud. Haven?t tried any treatments yet.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients. The patient's medical history was not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (lot#, expiration date, dose, route and site of administration were not reported) in an area other than the deltoid region because she did not agree that ZOSTAVAX should be administered into the deltoid area. No adverse effects were reported. Additional information has been requested.
Pain at injection site; Welt at injection site; Severe Stomach pain; Headache; Unable to go about daily activities; having to resume their normal diet slowly, due to the severity of the stomach pain; Slight fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 592RY, expiry date 31st August 2023) and (batch number 5392T, expiry date 31st August 2023) for prophylaxis.   Previously administered products included Shingrix vaccine with an associated reaction of injection site pain (1st dose received on 16 June 2022 for the tolerance of the 1st dose, refer linked case US2022AMR127400).   On 24th August 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. In August 2022, less than a day after receiving Shingrix, the patient experienced fever, activities of daily living impaired and food intolerance. On 24th August 2022, the patient experienced stomach pain and headache. On an unknown date, the patient experienced injection site pain and injection site wheal. Rechallenge with Shingrix was positive. On 25th August 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site wheal, stomach pain and headache were recovered/resolved and the outcome of the activities of daily living impaired was unknown and the outcome of the food intolerance was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site wheal, stomach pain, fever, headache, activities of daily living impaired and food intolerance to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR127400   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine, the lot number of adjuvant was 5392T and expiration date 31st August 2023. The reporter stated that after received Shingrix vaccine the patient experienced severe stomach pain around 1 or 2 in the morning, the stomach pain was so severe as they were unable to do their daily activities, reporter reported that had to resume their normal diet slowly due to the severity of the stomach pain. patient had fever in the middle of the same night and lasted approximately 12 hours, patient started headache after 7-8 hours of received vaccine and lasted for 2-3 days.  The reporter reported that pain at the injection site and a welt at below the injection site, that has since resolved. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 1st dose, refer linked case US2022AMR127400, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR127400:Same reporter
Information has been received from a health professional concerning her approximately 31 month old daughter with seasonal allergies who on 05/03/2000 was vaccinated with a subcutaneous dose of varicella virus vaccine live.  There was no concomitant medication.  About 3 to 4 months after receiving varicella virus vaccine live, in approximately September 2000, the child developed two small bumps on her upper back at the base of her right shoulder.  The two bumps were small and sometimes thy itched and other times they seemed to burn.  The diagnosis of molluscum contagiosum was made and imiquimod cream was prescribed.  The lesions crusted and fell off over the course of the following month.  The child was left with 2 small pits where the lesions occurred.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other inforamtion was provided.  Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In 2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a store (supercenter) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
on vaccination date, child c/o inj site pain & c/o felt funny, but denied SOB w/confirmation h/a;instructed to take OTC APAP & place ice on inj site;child presented to clinic 2 days p/vax c/o swollen eyelids, h/a, severe inj site pain;
shingles; This initial spontaneous report was received from a  lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 24-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's  inoculation, patient was treated by a healthcare provide for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Woke up on 02/24/2021 with sweeling under the right arm (between armpit and breast). Swelling is stated to be the size of a softball in diameter.  Client was asked to follow-up with her primary care physician.
Pt. states that after receiving the 2nd dose of Phizer 12/15/2021, started experiencing symptoms immediately of severe pain in the lower back pain (sprain). Headache, fever, loose stool, chills, and disorientation lasting 24hrs. No noted Primary visit/communication.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients received improperly stored doses of (Oka/Merck) VARIVAX lot # L027287 with expiration date 01-JUL-2017 (dose and route of administration were not reported). No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
sore arm; This is a spontaneous report received from contactable reporter. This reporter reported for a male patient (reporter's son). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm after receiving the Pfizer Covid 19 Vaccine. It was reported that consumer and her son got the vaccine and they both had a sore arm, but it has gone away now, only lasted a half of day. They said that was to be expected. The outcome of event was recovered on an unspecified date.
This spontaneous report as received from a registered nurse. The nurse stated doses of VAQTA (doses unspecified in series) were administered between 24-JUL-2014 and 01-AUG-2014, doses were exposed to -1.5 C for 5 hours. No adverse effects reported. Nurse stated she had no patient specific information. This is one of several reports received from the same reporter. Additional information has been requested.
First 24 hours was fever, fatigue, nausea and pain at injection site. Next 24 hour was the same. Day 3, fever reduced, nausea was gone. Day 4 at 6am, woke to red, warm, itchy, puffy and painful circle - about 3 inches - near injection site.