chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a flu shot instead of Shingrix; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Linked case(s) involving the same patient:  US2022030608.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, there was a patient with a potential vaccine error. The patient was supposed to receive the 2nd Shingrix and he/she might have received a flu shot instead, which led to wrong vaccine administered. The reporter was not sure if the patient had received a flu shot instead or if they actually received their 2nd Shingrix. No additional information was provided. The reporter did not consent to follow up. Note: This case was kept valid conservatively, considering the possible error and no event was regarding the incomplete course was added as no vaccine dates or schedule was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022030608:Same reporter
Patient is a 75 y.o. female patient of CNP with history of seronegative RA, ANCA-vasculitis, GERD, hiatal hernia s/p Linx, HTN, HLD, CVA, CAD, chronic hypoxemic respiratory failure, who presented to Hospital with weakness.   Covid-19 Virus Infection Chronic hypoxemic respiratory failure Date of onset of symptoms: 8/21/2023 Symptoms present on admission: weakness, fatigue, vomiting,  Date of covid positive test: 8/23/2023 Vaccination status: vaccinated Imaging: CXR non-acute Oxygen requirements on admission: 2 Lpm by NC Current oxygen requirements: on RA  Medical therapy: Started on IV remdesivir and IV dexamethasone by ID Consultants following: ID Anticipated special isolation end date: 9/1/2023 Antiemetics PRN Acetaminophen PRN   Patient improved was on room air discharged home in stable condition   Metabolic acidosis: Resolved   Falls: PT/OT Care management   HLD: Statin   RA: Plaquenil   CAD: CVA: HTN: ASA, atorvastatin, Toprol   Depression: Zoloft
mom states p/recvd vax pt started having elevated temp; mom gave APAP; temp cont to go up & pt became lifeless; pt taken to ER & adm w/t105.5 & dx w/croup for 24 hrs obseervation;
Initial unsolicited report received from a consumer via other company (Pfizer, 2016185665) on 06 April 2016. This case involves a male (age not reported) patient who was vaccinated with a dose of Tetanus Toxoid (batch number, expiry date, route and site of administration were not reported)on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient was allergic to Tetanus Toxoid. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 021C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 12-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 12-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Pt received a 3rd dose of Rotarix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 31st January 2023, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 31st January 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: 31-JAN-2023 Reporter's Comments: A pharmacist reported that a patient accidentally received a 3rd dose of Rotarix.  No symptoms reported. HCP did not have patient info or lot/exp and the formulation was undetermined. HCP consented to follow up via email. Additional Supportive Information: The patient received 3rd dose of Rotarix, which led to extra dose administered.
Mother states pt has "cellulitis" of immunzation site- Diagnosed by ER (although has bronchitis- also- was given Zithromax for both.
Patient received Pfizer 0.3 ml which is available for those 12 yrs old and older, not pediatric (5-11 yr old) dose.
Red bumps, rashy with some blistering break out on arms, under arms, hands and legs. Went to his Physician's office and saw the N.P. We thought it was his eczema flare up, so she treated with Steroids for 6 days. After the 2nd day of steroids, noticed progression of the bumps and blistering spreading to face and more bumps in the same areas as noted. Went back to Physician's office and saw N.P., as well as Drs. Dr. determined after discussion that he had an allergic reaction to the immunization, most likely the HEP A and HPV4 shots given on 6/11/12 and 8/17/12. He said NOT to get the 3rd immunization which was to be administered in December to complete the series. Patient also had the TDAP and MCV4 vaccinations administered on 6/11/12, but Dr. believed the reaction was from the HPV4 vaccine.
Injection site reaction per patient he had redness initially and then it developed into a scab. He cleaned it with alcohol and scab went away after 10 days.
Pt given 0.2ml of undiluted COVID-19 vaccine (orange cap) in right deltoid. Monitored patient in office. No adverse affects noted.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. Guidance from the Department of Health, Centers for Disease Control and Prevention (CDC), and Pfizer has determined that the dose of vaccine that you received is valid.
RN reporting adverse event was training another RN and was supervising event. RN had the patient on exam table and had a good hold on her legs, RN told mom to make sure she had a good hold on her hands but when RN went to administer MMRV, the patient grabbed for the needle prior to it being placed in her right thigh, when she tried to reach for the needle, the needle scratched her leg and subsequently some of the MMRV vaccine was dispensed out prior to administering vaccine. Supervising RN stepped in and helped mom grab hold of the patient's hands and other RN continued to administer MMRV and then DTap-IPV and Flu in her left thigh. Supervising RN did make mom aware after all immunizations were administered that due to the patient trying to grab the syringe, she did receive a scratch on her leg but was otherwise completely fine. Mom verbalized understanding. Since event, mom has been spoken to and updated on recommendations.
I am post menopausal and I have not had my period since 2018 and I started spotting and bleeding and they told me to go in, I got an ultrasound and it showed that the wall of my uterus was thick, more than it was supposed to be. They sent me to a biopsy which was abnormal - benign proliferative endometrium. But my endometrium is not supposed to be doing that because I am in menopause. So I researched this and it has also happened to other women as well. So basically doctors do not know.
Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; Caller states she started having "a headache, chills that started last night at 11pm, I am also tired and weak."; she has a flu; eyeballs hurt; her joints and muscles hurt; her joints and muscles hurt; she had no energy/ I am also tired and weak."; She was cold around 11:something pm; This is a spontaneous report received from contactable consumer. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6298) via intramuscular, administered in Arm Left on 27Mar2021 11:00 (age at vaccination 63-years-old) as dose 1, single for covid-19 immunisation. Medical history included lupus-like syndrome from 2008 to an unknown date and it is in remission now, ongoing kidney diseases maybe from 2 year ago or 3 years ago, deteriorated discs in the neck and the back from 2010 and ongoing. The patient concomitant medications were not reported. On 28Mar2021 23:00, patient stated that she started having a headache, chills that started last night at 11pm, I am also tired and weak, she has a flu, eyeballs hurt, her joints and muscles hurt, she had no energy/ I am also tired and weak. She was cold around 11 something pm. She was weak, she had no energy at all. Reporter asked are these normal side effects of the vaccine. No treatment was received. No other vaccine was received prior to vaccination with in four weeks. No ae prior to vaccination. she does not even get the flu shot. Outcome of the event cold was unknown and other events was not recovered.  No follow-up attempts are needed. No further information is expected.
After my 2nd shot on May 19th I started  having symptoms  may 23 in my hip.. then it started to travel down  my leg to the point where I couldn't  walk.. by may 27 my left leg gotten worse to the point where I couldn't  walk sit or anything  I went to my primary  doctor  on may 28 and was told by him go to the ER.. went to the ER they ran test to find out I have huge blood clots in my whole left leg.. my thigh was very swollen  with a huge bulge on the inner side of it.. on May 28th I was admitted  into the hospital
Irritation and redness in both eyes; Flushing of the face; Irritation and redness in both eyes; This is a spontaneous report received from a non-contactable consumer (patient herself). An elderly female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: EL9264), via an unspecified route of administration on arm left on 05Feb2021 16:15 at single dose for COVID-19 immunisation at hospital. Medical history included occasional rosacea with stress or excitement. Concomitant medication included metformin and zinc, which are received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tetracycline and experienced allergy. On 05Feb2021 16:30, the patient experienced irritation and redness in both eyes and flushing of the face. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not received any treatment for the events. The events were assessed as non-serious by the reporter. Outcome of the events was recovered on unspecified date in 2021.
10-10 a.m. - swollen right thigh, reddened and hot, no fever; applied cold packs 10-14-08 - Unable to see doctor. Leg (r thigh) apears to have reddened area 3" diameter, mom says swelling is down but temp was 104 last night, advised to see doctor or ER 10-16-08 - Did not see doc but states child has no fever now and seems fine although right thigh is still slightly reddened.
21:00: Right upper arm pain and swelling.  In ER.  No erythema.  Treatment: warm compresses, elevate, pain meds. 03/05/04: Indurated mildly erythematous circular lesion around injection site.  No lymph adenopathy.  No ecchymosis.  Treatment: Heat and gradual increased activity.
Information has been received from a nurse concerning her previously healthy, menstruating 13 year old daughter with a sibling with seizure disorder who on 19-JUN-2008 was vaccinated with a first dose of GARDASIL. Concomitant suspect vaccination on 19-JUN-2008 included a second dose of VARIVAX. Other suspect therapy included BENADRYL (dose, duration and indication not reported) and BACTRIM given on 23-JUN-2008 and 24-JUN-2008 of the treatment of urinary tract infection (dose not reported). On 20-JUN-2008 the patient experienced severe headache and right arm swelling. On 22-JUN-2008 at 9:30 AM, the patient experienced a seizure for one hour, fell and experienced a "huge abrasion under the chin." The patient began to seizure again at 3:00 PM and was admitted to the intensive care unit. The reporter stated that the seizures started with a headache and then the patient had a blank stare. She had severe right hand spasms and moved her head back and forth. She had involuntary muscle movements with rhythmic movements, mostly of the upper extremity, and jerky, spastic contractions in the lower extremities with plantar flexion of the right foot and a jerky knee. She had dilated pupils and "foaming at the mouth." Sometimes she had wheezing. Sometimes was responsive and sometimes not. Seizure duration was reported as long as 45 minutes and "for hours." On approximately 22-JUN-2008 diagnostic work-up included an electroencephalogram (EEG) which was negative and a magnetic resonance imaging (MRI) and computerized axial tomography (CT) which were normal. "Blood work" and urinalysis were normal. On approximately 23-JUN-2008 the patient had a urinary tract infection that was treated with BACTRIM on 23-JUN-2008 and 24-JUN-2008. The patient was diagnosed with pseudoseizure. On 24-JUN-2008 the patient experienced a 10 minute seizure and was discharged. she was hospitalized for 2.5 days. On approximately 29-JUN-2008, the patient experienced hives and dermatitis which may have been due to an allergy to BACTRIM and was hospitalized. The patient was treated with BENADRYL and experienced seizures several hours after the dose was administered. The patient was discharged in the morning on 01-JUL-2008. She was hospitalized for 2.5 days (also reported as 1.5 days). On 01-JUL-2008 at 5:15 pm, the patient had a headache for 10 minutes, epigastric pain, wheezing and a seizure with unconsciousness. She was transported by emergency medical services to the emergency room. She was treated with ATIVAN. The outcomes of the epigastric pain, pseudoseizures, dermatitis, fell/huge abrasion under chin, severe headache, right arm swelling, urinary tract infection, hives and wheezing were unknown. The reporter thought her daughter's seizures were related to GARDASIL. The reporter did not think her daughter's seizures, hives and dermatitis were due to psychological problems. Additional information has been requested.
It began with my wrists and then moved to arms and lets.  Remains ongoing.  I feel a pin prick and when I look at the area it looks as if I have been stuck and there is a round hole.  the hole quickly fills with a clear liquid and then becomes blood which scabs over.  At first it just hurts terribly and then after a couple of days becomes to itch quite severely.  I now have scars on my arms and legs from previous and multiple clusters of itchy scabs.  After consulting multiple doctors who could determine nothing due to the scabs, I was made aware that there have been skin reactions to the vaccine so I am now reporting mine in the event it is related to the vaccine.  I had a booster a month ago.
Eight days after my first vaccine I got a rash at the injection site which spread further the next day. I had a telehealth appointment with a doctor. He prescribed benadryl, Claritin and ibuprofen, however, the rash didn't improve so two days later I went to the clinic and got a steroid pack which cleared in up in a couple days.
Broke out in round patchy rash on face and body about four days after after receive first dose of Maderna Covid vaccine. Also exacerbated existing eczema on arms.
Pt c/o knot and warm to touch feeling on injection site Lt deltoid also c/o (L) arm pain radiation upper and lower arm.
This spontaneous repot as received from a pharmacist via company representative refers to a 36 year old male patient. The patient had very bad asthma and on an unspecified date, had received his PNEUMOVAX 23 shot (strength, lot#, dosage and route unspecified) at the age of 36. It was reported that the patient was highly asthmatic and was non-compliant in taking his medication. No product quality complaint involved.
Pt stated she felt like she was going to Pass Out. She asked to lay down. While in the process of laying pt down she stiffed up and became unresponsive for approximately 10-20 secs. Noted tremors and twitching both arms and right leg became rigid. Called out for code to be called. Ammonia capsule was placed under pt nose and she began to talk with me. I asked where she was and she was able to respond appropriately. Stated her name and that she would like to lay down. Pt at this point was able to stand and walk to the edge of table to be assisted to lay down. Head of bed raised and Vital signs were taken (Bp 102/58 Pulse 56) . Dr assessed pt. Determined she had a possible vagal/vagal response.
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 01-NOV-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013918:  US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915:
Patient stated she has swelling the size of an orange and warmth at the injection site. It has decreased in size over the last 24 hours.
pt recvd vax & pt's mom reported that 2 days later,pt exp swelling & hives @ the inj site;these sx lasted for 1 1/2months;
Pt. received vaccine at 730 PM. He start throwing up in the morning. His face area swollen per his sister. Tried to call twice to get some more details and what medical help he received but did not get any answer. He got the flu shot 1st time.
1st Vaccine 1/15/2021; 2nd Vaccine 2/5/2021; seen in ED 2/8/2021 for fever, chills, and left arm pain onset x 2 days.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 59 years, in left arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Avocado, reaction(s): "Known allergies: Avocado", notes: Known allergies: Avocado. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, latency 1 year 9 days 11 hrs 30 min after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2023) Negative; (02Oct2023) Positive; (04Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Maculopapular rash the day after varicella, MMR, and KINRIX vaccination.  Given steroid and Benadryl.
30 min out my pointer finger and thumb became numb.  It then moved to the left side of my face (corner of left eye around my cheek bone into the bridge of nose), and the left side of my tongue.  It was a tingly sensation (similar to your face/lip waking up after being given Novocaine).  It remained all evening on 4/5 and has continued to be intermittent in my cheek.
Patient had the normal flu-like symptoms for 2 days which included vomiting.  He started to develop swollen lymph nodes in his armpit, but the it opened like a blister.  Then, he had to be placed on antibiotics for the open wound.
Information has been received from a physician concerning a 21 day old female infant who was full term at birth with no known allergies who on 06/10/2001 was vaccinated with hep  b vaccine recombinant. On approximately 06/10/2001 the pt had symptoms of a rash and lethargy. The infant was hospitalized on 06/12/2001 to rule out sepsis. It was reported that "up to now all the culture results have been negative." It was noted that the infant remains in the hospital with an intermittent rash. Follow-up info has been received from the physician and indicated that she was the pt's intern and is no longer a part of this pt's care; therefore, she does not have access to the infant's medical records. Additional info has been requested.
No adverse event; Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a 91-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent) 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 (Patient administered with monovalent Moderna vaccines (0.5 mL) instead of Moderna bivalent).    The concomitant and treatment medication was not reported.