chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other adverse events reported; seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported.  On 08-MAR-2022, the patient was administered an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot # U008899 (presentation established upon internal validation as syringe), expiration date: 12-AUG-2023 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine underwent temperature excursion of 33.4 degrees Fahrenheit for 2595 hours (product storage error). There was no previous temperature excursion. No further information provided. No other adverse events were reported.  This is one of multiple reports received from the same reporter, who reported seven doses of improperly stored suspect vaccine being administered to seven different patients. ; Sender's Comments:  US-009507513-2203USA007997: US-009507513-2203USA007825: US-009507513-2203USA007812: US-009507513-2203USA007915: US-009507513-2203USA008053: US-009507513-2203USA008063:
Pharmacist on duty diluted empty vial with saline, and gave saline in place of vaccination
This spontaneous report was received from a Certified Medical Assistant refers to a 33 year old female patient with no relevant drug reactions or allergies and with no pertinent medical history. On 05-OCT-2011, the patient was vaccinated with a first dose of VARIVAX (Merck), IM, (lot # 670098/0331AA, expiration date: 07-MAR-2013, dose, frequency and route were unknown). On 09-NOV-2011, the patient received the second dose of VARIVAX (Merck), IM (lot # 670098/0331AA, expiration date: 07-MAR-2013, dose, frequency and route were unknown). Other concomitant therapies included vitamin D (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). It was stated that the patient had titers drawn during a physician's office visit on 30-JUN-2015, which were negative for immunity to varicella (PT:Antibody test negative). The outcome of the antibody test negative was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
After receiving this vaccination - my son stopped speaking completely. He began showing signs of autism after that and was diagnosed with autism 3 months later. Eyes changed color to full blue from crystal blue. Speaks in full sentences but I refused anti psychotics and anti depressants at 3 years old and was made to look insane because of this.
Received vaccine, was well, stood up and stepped off exam table and was syncopal. Woke within a few minutes, aao x 4, c/o dizziness. Has him recline, slowly raised head and gave food.  Neuros intact, no dizziness when dc'd.
Vaccinated with shaken vaccine; Pain at the injection site; A spontaneous report was received from a pharmacist concerning a 24 year-old female patient who received Moderna's COVID-19 vaccine and experienced vaccinated with shaken vaccine and pain at the injection site.                           The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.     On 04 Jan 2021, the reporter stated that the technician shook the vial while administering the vaccine on an unknown date.They also reported that symptoms included pain at the injection site.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The event, vaccinated with shaken vaccine was considered resolved. The outcome of the event, pain at the injection site, was unknown.; Reporter's Comments: This case concerns a 24 year-old female, who experienced a non-serious expected event of injection site pain and wrong technique in product usage process. The event occurred soon (exact time not provided) after first dose of mRNA-1273, lot # unknown. Based on the current available information and temporal association between the use of the product and the start date of the event, for the event of injection site pain a causal relationship cannot be excluded. There was no reported AE associated with this case of wrong technique in product usage process.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-002858: US-MODERNATX, INC.-MOD-2021-002872: US-MODERNATX, INC.-MOD-2021-002862:
local rxn @ inj site 8x8cm area of erythema, induration non tender lt deltoid area;
This spontaneous prospective pregnancy report as received from a registered nurse via company representative refers to a 15 year old female patient. On an unknown date the patient was vaccinated with a first dose of GARDASIL (dose, route of administration, LOT# and expiration date were not provided). On an unknown date, the patient became pregnant. The date of last menstrual period (LMP) and estimated due date (EDD) was not known. The pregnancy outcome was pending. On an unknown date the patient experienced prolonged vagal response after receiving a first dose of GARDASIL. The patient sought medical attention by visiting the office. The outcome of prolonged vagal response was not reported. The relatedness between prolonged vagal response and GARDASIL was not reported. Additional information has been requested.
Pt felt like she had a knot in her throat, difficulty swallowing. No problems breathing, just swallowing.
To ER 5APR91 w/r. temp 104.4F, had vomited x 2, temp to 104.6F rectally in ER adm for observation & temp control;
No additional adverse event reported; PEDVAX HIB was administered to a patient after a temperature excursion; This spontaneous report was received from a health care professional referring to a specific patient of unknown age or gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 17-NOV-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026066, expiry date on 01-APR-2023; at 0.5 milliliter for prophylaxis (route not reported) after a temperature excursion: temperature at 9.13C, time frame of 30 minutes and no previous temperature excursion occurred. No additional adverse event reported. No product quality complaint involved.
First dose administered 12/28/2020 and developed hemorrhagic lesion/rash with blister, and pain to Right second  and third toe (no blister on 3rd toe, hemorrhagic rash only) on 1/15/2021. On 1/22/2021 administered Second dose of COVID-19 vaccine. On 2/7/2021 developed hemorrhagic rash to Right great toe and fourth toe (painful). . On 2/12/2021 developed hemorrhagic lesion to left 2nd toe, no blister, tender to touch. Lesions documented by photography and reported to Hospital as per hospital policy to nurse practitioner. Nurse Practitioner  has the details of batch and lot numbers. 1/5/2021 Real time PCR result: Naso-pharyngeal Swab: NEGATIVE for COVID-19 2/17/2021 Real time PCR result: Naso-pharyngeal Swab NEGATIVE for COVID-19. Evaluated by primary care provider Dr. and bloodwork ordered 2/10/2021 , CBC, CMP, ESR, CRP, COVID IgG antibodies ordered. All bloodwork results "within normal limits" and COVID IgG antibodies POSITIVE. Primary care provider advised to continue to monitor as patient is clinically stable and able to work.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female with no medical history or drug allergies, who on an unspecified date was vaccinated IM with a second 0.5 ml dose of GARDASIL (lot # 666163/0664Z). On an unspecified date after receiving GARDASIL, the patient became pregnancy. Lab diagnostics studies performed included urine pregnancy test. No adverse effect reported. The patient sought unspecified medical attention. At the time of report, the patient's present status was not provided by the reporter. Follow up information has been received from a Registered Nurse (R.N.) reported that she had scanty details about outcomes. The patient's LMP was 27-OCT-2010 and on an unspecified date in December 2010; the patient had a dilation and curettage (D&C) and aborted the pregnancy. The nurse was asked to clarify if the D&C was performed due to an incomplete spontaneous abortion or as an elective abortion. She stated that was not clearly specified in the patient's record. There was no information regarding an examination of fetal contents done post D&C. The patient had a history of 2 spontaneous abortions. One spontaneous abortion occurred in April 2006 and one in October 2006; both at 7-8 weeks gestation. In 2008, she gave birth to a live healthy infant at 40 weeks. Upon internal review dilation and curettage (D&C) and aborted the pregnancy was considered to be an other important medical event. Additional information is not expected.
8 days after 1st vaccine shot a hard hot red ball appeared at shot site.  At 10 days ball seem to break up became blotchy redness below shot site. Raised redness possible what is being called "covid arm" from pictures and detail other report. Applied hydrocrotozne crem ceve took Oct benadryl. 11 days right hand pins needles cold. 12 days after shot still have redness, very little itch, no pain, warm to touch, not much change from cream and benadryl. Feel warm sensations in right calf. Not sure related or not.
mom states pt cried w/o stopping for 7 hr;was unable to confort gave APAP as rx & was ready to go to ER;
10/14/2016, The patient is a 58 year old female. Pt calls C/O "sideways smile" and right side of lip swollen. Pt thinks it is related to flu vac that was given on 10/11/16 because symptoms began on 10/12/16. I instructed pt to go to ER for eval. Pt plans to go tomorrow but I instructed pt to go today. 10/20/2016, 11:37 AM, The patient is a 58 year old female. See 10/14/16 phone encounter note pertaining to C/O facial weakness "sideways smile." Pt comes to pharmacy for refills and pharmacist directs her to me. Pt's smile is noticeably asymmetric. Pt states she is unable to control or move the right side of her mouth and it feels numb. Pt states she did not go to ER as instructed on 10/14/16 because she knows "it is Bells Palsy which is treated by steroids and I don't really want to take steroids." Pt has printed information from the internet RE: Bells Palsy and FLULAVAL immunization. Pt strongly instructed to go to ER although she voices several reasons for reluctancy. Pt given copy of general VIS for flu vaccines (not specifically for FLULAVAL). Pt requests this to be reported to VAERS. Pt given VAERS number and will report this on her own. Instructed pt to go to ER first but she is calling the VAERS number right now while still at pharmacy. 10/21/2016, 10:29 AM, I completed VAERS form and faxed to phone number provided. Copy in scanned documents. 10/20/16, Time seen by Doctor: 13:13. Chief Complaint, CVA/TIA Symptoms. Attending Note: I supervised the patient's care throughout the ED course. I have personally interviewed and examined the patient, reviewed and agree with the findings documented, unless otherwise addendumed. Patient is a 58 year-old F that states 10 days ago she noticed she had a right facial droop. This was shortly after receiving her flu shot. Patient also complains of full feeling of her right face and full sound of her hearing. Patient denies pain at time evaluation. No other modifying factors or associated symptoms.
Patient states received flu vaccine 9-26-2016 states still having pain in area that goes down arm when she reaches out.
Extra dose given; Extra dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 30-MAR-2024) for prophylaxis.   Previously administered products included Boostrix (1st dose received on 14th June 2022 with batch number C5788BA and expiry date 14th October 2022) and Menveo (1st dose received on an unknown date with batch number AMVA659A and expiry date 30th January 2023).   On 19-JUN-2023, the patient received the 2nd dose of Boostrix. On an unknown date, the patient received the 2nd dose of Menveo. On 19-JUN-2023, an unknown time after receiving Boostrix and not applicable after receiving Menveo, the patient experienced extra dose administered (Verbatim: Extra dose given). On an unknown date, the patient experienced extra dose administered (Verbatim: Extra dose given). The outcome of the extra dose administered and extra dose administered were 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: 22-JUN-2023 A nurse called in to report that a patient accidentally received a second dose of Boostrix and Menveo one year after the first dose and wished to know how to proceed.  The information for both doses was given, including lot number, expiration date, patient information and vaccination event. The vaccine administration facility was the same as primary reporter. The information for Menveo was provided by a Menveo second line agent after the call was escalated.  The reporter consented to follow up. The patient received second dose of Boostrix and Menveo one year after first dose, which led to extra dose administered.
Patient displays a reaction to the site of injection. The reaction consists of red rash, bruising in the upper arm. No fever.
Clammy hands, warm wave rushed over my body, felt very hot, racing heart, tightness in my chest-lasted approx 15-20 minutes
just 24 hrs. after receiving shot developed fever of around 102 and chills.  Fever kept going through the second night, developed several small itchy bumps on body, and also developed pain in lower abdomen.  On the third day went to an urgent clinic because of lower abdomen pain and felt as though my diverticulitis had started.  Was prescribed antibiotics, Flagyl and Cipro, for the diverticulitis.  Fever broke that night I believe.
This spontaneous report as received from a licensed practical nurse refers to a 54 years old female patient with allergy to IV contrast dye and no pertinent medical history. The patient was vaccinated SC with a dose of ZOSTAVAX (lot # not reported) on 22-AUG-2012. No concomitant medications were taken. On 23-AUG-2012 the patient experienced "a red, swollen, warm, and painful area the size of a 5-cent piece at the site of ZOSTAVAX injection." The patient came into the office to seek medical attention. No treatment was given for the events. No laboratory tests were done. The patient's present status is not recovered. Additional information is not expected.
SWELLING SKIN; PAIN IN BACK; PAIN IN ARMS AND LEGS; TINGLING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1)(suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced swelling skin, pain in back, pain in arms and legs, and tingling (all events series 1). Patient stated she has visited some doctors and had some failed treatments. On 29-OCT-2021, she received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) as booster dose for prophylactic vaccinations. No events reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling, swelling skin, pain in arms and legs, and pain in back. This report was non-serious.
Case PHEH2016US027475 is initial spontaneous report received from nurse on 20 Oct 2016. This report refers to 50 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with double dose of FLUVIRIN (batch number: 1619221, expiry date: Apr 2017) 0.5 ml intramuscular on 20 Oct 2016 (overdose accidental). It was stated that, the two doses was given to patient and no adverse reaction noted. No adverse event was reported following this medication error (overdose accidental).
I had three days of hives - significant hives - everywhere except my face and the soles of my feet. My doctor put me on Prednisone. I took that, Pepcid and Zyrtec and Singulair. It stopped the hives.
Rash on both legs just above the ankles.  No treatment. Subsiding now.  I have no changes in lifestyle or habits that would oterwise explain the rashes.
Redness erythema & itching to site of varicella or TD vaccine. Received 4 vaccines 2 to left arm.
right-sided HA with pain around rightt eye x 5 days with dizziness and nausea coming on yesterday since receiving J&J vaccine on 10Apr21; denies any vision changes or vomiting; light and noise sensitivity present. 25 yo f c/o ongoing R sided post-orbital/temporal ha w/stated light sensitivity but w/o other visual changes x5d, states got J&J covid19 vaccine 10APR and sx's started 2-3 hrs after that; Pt states ongoing nausea w/o vomiting; Pt states taking multiple doses of OTC ibuprofen w/o sig relief; Pt concerned for relation to J&J vaccine; Pt denies any fevers/ns/chills, neck pain, cp, sob, dyspnea, abd pain, diarrhea, rashes, prior hx of similar ha
Patient recieved covid vaccine #2 4/7/2021. Of note first dose was Moderna, second dose was Pfizer. Tested +Covid 4/15/2021, admitted to hospital with weakness.
Pt arrived to the ER with weakness, fall, and a fever since yesterday. Pt found to have COVID-19 infection with no respiratory symptoms.
This spontaneous report was received from a social media via company representative regarding a 144 female patients of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that on unspecified date, the patients died from unknown cause and it was also unknown if autopsy was performed. Additionally it stated that the pharmaceutical companies which made the GARDASIL, as well as the Agency which hold patents and earns profits from the GARDASIL said that they were all coincidence also that the mainstream media denied that these events were even happened. The relatedness between the event and therapy with GARDASIL was not reported. Upon internal review, death was determined to be medically significant event. This is one of several reports from the same source. Additional information is not expected as follow up information cannot be obtained. Sender's Comments: US-009507513-1706USA010923: US-009507513-1706USA010924.
Could hardly walk; Weakness in her legs; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), MUSCULAR WEAKNESS (Weakness in her legs) and PYREXIA (Fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever). On 18-Mar-2021, the patient experienced GAIT DISTURBANCE (Could hardly walk) and MUSCULAR WEAKNESS (Weakness in her legs). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, GAIT DISTURBANCE (Could hardly walk) and MUSCULAR WEAKNESS (Weakness in her legs) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101-102 (High) 101-102 and 97.1-98.1 (Inconclusive) 97.1-98.1.         No concomitant medications were provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
The HCP states that the patient had already received all doses of RECOMBIVAX HB in the 3 dose series and reports that the patient had been vaccinated with RECOMBIVAX HB at 2, 4, and 6 months of age; no additional AE's; patient was supposed to receive a dose of Havrix and was inadvertently administered RECOMBIVAX HB instead; patient (...) was inadvertently administered RECOMBIVAX HB instead/the patient had already received all doses of RECOMBIVAX HB in the 3 dose series; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, patient had been vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided) at 2, 4, and 6 months of age (inappropriate schedule of product administration).  The Health Care Professional (HCP) reported that the patient was supposed to receive a dose of hepatitis a vaccine inact (HAVRIX) and was inadvertently administered hepatitis b vaccine (recombinant) (RECOMBIVAX HB) instead - on 08-FEB-2023, intramuscular injection, 0.5 milliliter, lot #W002452, expiration date: 26-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (Wrong product administered). The reporter stated that the patient had already received all doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) in the 3 dose series (Extra dose administered).  There were no adverse events reported (no adverse event).
I had severe shivering and felt like I was freezing for about 10-12 hours. Teeth chattering, I could not feel warm no matter how many layers I put on, my thermostat said my apartment was 72 degrees F.
pt recv vax 14OCT96 & 17OCT96 mom noticed large localized rxn @ vax site;redness, heat, swelling from above knee to groin;3DEC96 present w/non tender BB sized SC knot @ inj site;tx NONE;
Large area of erythema & warmth extending from AC joint, 3 cm in width medially down arm to 3" above medial elbow.
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ per oral route (Lot # M041815; expiration date 28-JUN-2018), (Lot # M046008; expiration date 29-JUN-2018), (Lot # M035456; expiration date 01-MAY-2018), (Lot # M040268; expiration date 14-MAY-2018), (Lot # M044030; expiration date 13-JUN-2018) for prophylaxis (dose not reported).  The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA011937:
Patient became nauseated and lightheaded after receiving vaccine, symptoms were resolved after 5 minutes with no known re-occurrence at this time