chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VOICEMAIL MESSAGE LEFT BY CLIENT- UNABLE TO REACH MY PHONE CURRENTLY - THIS INFO GIVEN-CLIENT STATES 72+ HOURS POST VACCINE, LEFT DELTOID AT INJECTION SITE WARM, RED AND TENDER, WHICH IS INCREASING . PURITTIS NOTED. ALSO LEFT SIDED LYMPHADENOPATHY , NO PARTICULAR SITE NOTED.  NO OTHER SYMPTOMOLOGY VOICED.
Patient received ROTATEQ ON 1/12/09.  She is breast fed.  On 1/13/09 mucousy stools were noted.  On 1/20/09 stools were dark, tarry and heme-positive.  Patient continued with melena until 1/26/09.  At that time, stools became normal.
no adverse event reported after the vaccination. The reportable error is actually that the patient received the Moderna Covid-19 vaccine 3/24/21 at a different pharmacy, and then was subsequently given a dose of the Pfizer Covid-19 vaccine on 7/19/21. The error was realized when processing the rx for the patient's scheduled 2nd Pfizer Covid-19 vaccine on 8/10/21.
Information has been received from a licensed practical nurse concerning an 11 year old female with eczema, reactive airway disease, mild mitral valve prolapse/ regurgitation, multiple food allergies: honeydew, Brazil nuts, lentils, chick peas (severe reaction-per mother), and subacute bacterial endocarditis. On 1/21/03 and on 3/3/03 the pt was vaccinated with a first and second dose of hep B vaccine (642923/0159M).There was no concomitant therapy or illness at the time of vaccination. On 3/4/03 the mother contacted the doctor's office to report that the pt's fingers had swollen slightly on the right hand and pt complained of pain. There were no markings at the injection site. There was no fever or other systemic symptoms. The physician recommended to try anti-inflammatories and call back in a few days. The physician "does not feel this was related to the hep B vaccine administration," but was reporting on the mother's request. It was noted that the pt "had no problems" after the first dose of hep B vaccine. Follow-up reported that on 3/5/03 the pt had "history of swelling of arm and shoulder." There were no relevant diagnostic tests or lab data. Additional info has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant products reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No adverse reactions reported for the patient.  No treatment products reported.
Blister; Wound; wound that will not heal; lump at the injection site; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72-years-old male patient who had blister, wound and lump at the injection site and wound that will not heal after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient is not a diabetic and has never had any type of healing problems prior to the shot. Concomitant: no other vaccines.  On 27-Aug-2023, the patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine, injection (Frequency: once) (batch number, expiry date: not reported) via unknown route in the right arm for Immunization.  On 27-Aug-2023 the patient had lump at the injection site (vaccination site mass) (same day latency) following the administration of influenza quadrival A-B high dose HV vaccine.  On an unknown date the patient had blister (vaccination site vesicles), wound (administration site wound) and wound that will not heal (impaired healing) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, Patient states that when he received the shot there was a lump at the injection site. The lump since became a blister and is now a wound that will not heal. He states that this situation is very stressful and he is fearful that the product may have contained bacteria that got into his bones. He mentioned that he is not a diabetic and has never had any type of healing problems prior to the shot. He did call a specialist and will be going for a medical exam. Patient does not have any lot or expiration information at this time.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.   No additional details.
pt recv vax 3OCT96 & 5OCT96 pt presented w/jaundice;an ER or MD visit was required;pt had a workup which showed elevated liver function tests;repeat labs on 10OCT96 were better pt shwing improvement;no tx given;
Pt had syncope & fell in reception room w/in 5 min of receiving DTP; Pt treated by MD fainting probably due to anxiety due to "shot"; Pt slept & left the clinic 439PM; f/u next day pt fine no further problems;
Severe vomiting and diarrhea over 12 hours, similar to food poisoning.
Bodily itching, especially in the nose, mouth and arms.  The itching started on my hand about 5 mins. after my shot.  As the day progressed it began to itch on my legs, back, arms, face, eyes and nose.
The patient had a breakthrough case of covid despite getting the moderna vaccine on 1/14/2021, 2/10/2021 and a booster (due to immune-deficient status) on 8/17/2021.  The patient's symptoms started on 9/28/2021.  She had a positive covid test on 10/5/2021.
Since receiving my vaccine I've had a weird nervy feeling throughout my body.  I've also experienced numbness in my leg and commonly in my face (cheeks and lips).
Information has been received from a mother concerning her 21 year old daughter who on unknown dates was vaccinated with the first and second doses of GARDASIL vaccine (yeast). The patient's mother reported that her daughter gained 20 pounds after her 1st and 2nd doses of GARDASIL vaccine (yeast). It is unknown if the patient sought medical attention. Caller did not have time to fill out an AE report and will call back. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 8/14/2008. Follow up information was received from a medical assistant. On 21-MAR-2008, the female patient, was vaccinated in the physician's office at 11:38 am, wtih the first dose of GARDASIL (Lot  # : 655327/1287U) intramuscularly, into the left deltoid. The patient weight was 120.6 Lb. On 23-MAY-2008, the patient was vaccinated in the physician's office at 10:50 am, with the second dose of GARDASIL (Lot # 0152X) intramuscularly, into the left deltoid. The patient's weight was 127.2. No further information is available.
pt recv vax; swelling glands neck 28apr95 x 3 days;epistaxis 24apr;joint pain 5may95, knees & ankles swelling;seen by MD;physician feels rxn unrelated to vax;
pt recv vax 29AUG95 & died 12-15 hrs later; reporting nurse indicated that the death was most probably attributable to sudden infant death synd (SIDS);
On approx 22APR92 pt recvd 2 Engerix-B; on approx 23APR92 pt underwent routine PE & were found to have inc liver function tests;
positive for strep; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient was positive for strep (in 2021) and put on antibiotics. The patient was on antibiotics for 24 hours and second dose was due today and wanted to know if it was okay to be on the antibiotics with vaccination. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event "patient was positive for strep" is attributed to an intercurrent medical condition that was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a physician concerning an 18 week old male who on 13-MAY-2008 was vaccinated with the first dose of ROTATEQ. The patient sought medical attention in the physician's office. No adverse symptoms from the vaccine series were noted. There was no product quality complaint. No other information available. Follow-up information from the reporting physician and healthcare worker indicated that the 18 week old Indian male had no illness at the time of vaccination. No medical attention was sought. No labs or diagnostic studies were performed. Additional information has been requested.
HERPES ZOSTER IN 2 DOSE VARICELLA VACCINE RECIPIENT.
Fatigue,  Body aches, Headache, fever 1- 2 degrees  Lasted 24 Hours.    Took Tylenol but did not help much.
I had filler injections in my whole face in June 2021. This Injection  has given me  swelling under my right eye.  My prior injections gave me no adverse reactions to my face. Also, I have swollen lymph nodes under my right arm and my right breast is tender.  Not worried about the lymph nodes as this happened after the first booster shot. I am concerned about the swelling under my eye. Will take Benadryl and call Dr.
Patient exhibited difficulty getting into the car by herself.  By the end of December of 2009, she was unable to walk up stairs quickly, could not run, could not jump, and could not stand from a seated position on the floor.
This spontaneous report was received from a healthcare worker refers to a 6 month old patient of unknown gender. On 25-APR-2016, the patient was orally vaccinated with expired dose of ROTATEQ (dose was not reported, lot #K016279 with expiration date: 24-APR-2016). No adverse effects reported. Additional information has been requested.
COVID arm:  red, itchy, swelling at injection site. Delevoped suddenly a week after the vaccine administered.
Error resulting in administration of expired vaccine; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Included updated Patient initials.
headache, dizziness, nausea, arm soreness. Began the morning after the injection and lasted the entire day. Ibuprophen taken.
Information has been received from a medical assistant concerning a female who last month, in December 2009, was vaccinated with a dose of GARDASIL (lot number not reported). As of 20-JAN-2010 the patient was 2 weeks late for her menstrual cycle. It was unknown if medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Patient received day seven vaccine at our facility on 8/3/23 without any issues by RN. She previously  received day zero and day 3 at hospital, they do use Rabivert. Pt. called us on 8/7/23 with complaints of  a severe migraine and dizziness that developed an hour after receiving day seven at our facility and it didn't subside until 8/6/23. Pt. did report a history of migraines as a child. She also reported peeling skin on her hands that developed 8/7/23 . She continues to feel dizzy if she stands longer than 10 minutes. Pt. was advised to follow up with her PCP if symptoms persist and  return to hospital to receive day 14 on 8/10/23.
Was eating at restaurant that evening and had allergic reaction with trouble breathing/throat swelling. Had been eating carrots; had never had a reaction to this food before but has continued to react ever since then; Epi Pen was administered; patient went to nearest ER and was treated there. Do not information from that ER visit.
Pt received KINRIX and PROQUAD along with flu shot. Pt already complained the KINRIX and PROQUAD series and did not need to receive vaccines. There was a mix up with the MICR and the error was found when documenting injections.
Swelling of the (L) deltoid warmth, no erythema or cellulitis.
Approximately 30 minutes after my injection I experienced tinnitus. It is very loud and has not stopped since the vaccine.
Information has been received from a physician concerning a pt who in Jul 2006, was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant therapy included lansoprazole (Prevacid). The physician reported that in July 2006, the pt experienced rash. Unspecified medical attention was sought. At the time of this report, the pt was noted to be recovering from the rash. Additional information has been requested.
On March 19, 2021 started to feel nauseated, had aches and felt like she had the flu. Two weeks after that started to have hot flashes, was sweating, stomach was hurting, dizzy, and was dealing with diarrhea. Went to the an urgent care because of the symptoms worsening.
injection site was Itching; injection site was swollen; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (injection site was Itching) and VACCINATION SITE SWELLING (injection site was swollen ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was Itching) and VACCINATION SITE SWELLING (injection site was swollen ). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE PRURITUS (injection site was Itching) and VACCINATION SITE SWELLING (injection site was swollen ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 09-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot #K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
WEIRD FEELING FROM NECK TO ARM; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ortho surgery, and surgery, and concurrent conditions included: vascular issues, allergy to shell fish, and x-ray dye allergy, and other pre-existing medical conditions included: Patient was healthy and took vitamins daily. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2020 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included clopidogrel bisulfate.  On APR-2020, the patient experienced weird feeling from neck to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird feeling from neck to arm on APR-2020. This report was non-serious.
I had a runny nose, a lot of congestion 03/03/23, I felt very fatigued that evening, a headache, sore throat, I also felt feverish. I used a home COVID-19 test that came back positive. My wife called the doctor's office to get the COVID-19 nurse. We spoke to the nurse giving her my symptoms and letting her know that I had tested positive for COVID-19. I was prescribed Paxlovid that I started taking immediately. It took me a few days to feel better, but my stamina is not as good as it was before I got COVID-19.
Fine, raised, non-red, bilateral rash on upper thighs lasted 4 days.  ER visit.
Received the Moderna COVID vaccine past the 6 hours mark; A spontaneous report) was received from a nurse concerning a 68-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received the Moderna COVID vaccine past the 6 hours mark/expired product administered.  The patient's medical history was not provided. No concomitant product use was reported.  On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, a nurse reported a patient received their first dose of the Moderna COVID-19 vaccine after the 6 hour mark. Per the reporter, the patient did not report any side effects.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, received the Moderna COVID vaccine past the 6 hours mark/expired product administered, was considered resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (lot # 042L20A)  with no associated AEs reported.
Large swelling under left arm in the pit area; A large swelling under my left arm in the pit area. Extending down towards my left breast; Extending down towards my left breast with redness; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Aug2021 (at the age of 57-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Aug2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included ropinirole hydrochloride (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Aug2021 at 00:00, in addition to the common symptoms listed for most people, the patient had a large swelling under her left arm in the pit area extending down towards her left breast with redness, which was a lot. The events did not result in doctor/other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of events large swelling under left arm in the pit area, swelling extending down towards left breast with redness was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
INJECTION SITE INFECTION; WRONG ADMINISTERED INJECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 4 lung cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site infection, and wrong administered injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site infection and wrong administered injection was not reported. This report was non-serious.
Occurring in late evening of 2/8/21 and all day 2/9/21: Muscular aches/soreness/stiffness (no intense pain)...primarily lower back, lower sides (kidney area), upper back, neck. Left upper arm "pain" at injection site. Slight fatigue. Very slight headache (not serious). Fingers of both hands ache (not sure if arthritis flareup). NO fever.
Numbness and tingling of bilateral arms started after vaccination Numbness and tingling of right side of face and mouth 2 days after vaccination
Immediately as injection being administered felt burning form injection site to elbow.  4hours later had swollen lymph nodes to neck bilaterally and under jaw, unable to swallow. Temp 99.9 every joint in body aches.  8hours later had increased heart rate with any exercise( walking up stairs)  Day1 still swollen lymph nodes and now with night sweats Day 2 now with pressure and pain behind Left eye- advised by employee health NP to see Ophthalmologist Day 3 Ophthalmologist was told it was likely secondary to swollen lymph nodes   Day 5 went for thyroid sono - "shotty lymph nodes"  Day 6 petechiae to bottom of feet, lymph node swelling decreased on right and under chin now able to swallow without difficulty Day 11  Bruising noted on tongue and under tongue 4weeks  to the day arrhythmias- bigeminy trigeminy