chrisvoncsefalvay/vaers-outcomes huggingface dataset:
During labor, the patient lost a lot of blood and had to have blood transfusions; She had to have "one of the twins removed."; bed rest; Maternal exposure before pregnancy/separate pregnancy after the miscarriage; This spontaneous report was received from the patient's sister who is currently a 31-years-old female patient. The patient's pertinent medical history included miscarriage. The patient's current conditions included neurological diseases and reproductive issues. Drug/allergies were reported as yeast allergy that ran in the family. Concomitant medications were unknown by the reporter.  On an unknown date, also reported as at approximately age 18, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, vaccination scheme frequency, route and anatomical location of administration, lot number, and expiration date were not reported) with indication reported as "vaccine" (prophylaxis). The reporter was not certain if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but stated that it was "the first one that came out".  On an unknown date, during a separate pregnancy after a miscarriage, the patient was due to have twins. It was verified that the vaccine was administered before the pregnancy. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. During that pregnancy, the patient was on bed rest. On an unknown date, during labor, the patient lost a lot of blood (intrapartum haemorrhage) and had to have blood transfusions. The pregnancy outcome for the first twin was unknown and for the second it was reported that she had to have "one of the twins removed" (foetal death). The patient sough medical attention. It was unknown by the reporter if any other treatment was given for the events, if laboratory diagnostics or studies were performed and no product quality complaint was reported. The outcome of the events was not provided.  The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the events was not reported.  Upon internal review, the events "during labor, the patient lost a lot of blood" and "she had to have "one of the twins removed"" were determined to be medically significant.  This is one of several reports for the same patient.; Sender's Comments:  US-009507513-2107USA006556: US-009507513-2107USA005773:
PERICARDITIS; This 37-year-old, female subject was participating in Blind, Placebo-Controlled Study.    The subject's medical history, as provided by the investigator, included polycystic ovarian syndrome, anemia, multiple cysts on ovaries, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation, mitral valve regurgitation, nummular eczema, and acne of the back. Concomitant medications reported included cetirizine hydrochloride, iron ferrous sulfate, methylprednisolone, metformin, betamethasone, tazarotene, colecalciferol, ethinylestradiol/norgestimate, paracetamol, and nirmatrelvir/ritonavir (prescribed for symptomatic covid-19 infection, from 7-Sep-2022 till 09-Oct-2022).   The subject was randomized to receive intramuscular mRNA-1273 (Dose 1) on 09 Aug 2020 and (Dose 2) on 11 Sep 2020. Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3, booster) for SARS-CoV-2 vaccination on 26 Oct 2021, approximately 10 months and 29 days before onset of the event.   On 23 Sep 2022, the subject experienced pericarditis. Treatment for the event included oral colchicine.   The subject received all scheduled doses of study drug prior to the event; therefore, action taken with study drug in response to the event was not applicable.    The event, pericarditis, was reported as resolved on 02 Dec 2022.    The investigator assessed the event, pericarditis, as not related to study drug and not related to study procedure.  Follow-up received on 07 Dec 2022 included removal of the event seriousness criteria (previously life-threatening), updated event outcome and end date.    Company comment: This case concerns a 37-year-old, female subject with a medical history of polycystic ovarian syndrome, anemia, congenital atrioventricular septal defect, pulmonary stenosis, tricuspid valve regurgitation and mitral valve regurgitation among others, who experienced the non-serious adverse event of special interest of pericarditis. The event occurred 2 years 1 month 15 days after the first dose of IP, and 10 months 29 days after the third and booster dose. The event was reported as resolved and was considered unrelated to IP in agreement with the Investigator. The event might be explained by COVID-19 infection as suggested by indication of nirmatrelvir/ritonavir that was administered from 7-Sep-2022 till 09-Oct-2022.
6 Patients received the vaccine past the beyond used date; Accidental underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (Accidental underdose).    No concomitant medications were reported. No known allergies were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No treatment medication was reported.  This case pertains to the 1st child patient of the total 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-705188, US-MODERNATX, INC.-MOD-2023-705194, US-MODERNATX, INC.-MOD-2023-705203, US-MODERNATX, INC.-MOD-2023-705217, US-MODERNATX, INC.-MOD-2023-705220 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705194:Master US-MODERNATX, INC.-MOD-2023-705188:Master US-MODERNATX, INC.-MOD-2023-705203:Master US-MODERNATX, INC.-MOD-2023-705217:Master US-MODERNATX, INC.-MOD-2023-705220:Master
Burning numbing and tingling on the left side of my face. Which traveled  down my neck and then to my left arm. Still partially numb at this point which is three weeks later.  The left side of my face is still very stiff feeling
Tues 4/15/14 I was given the shingles vaccine. On Weds I experienced a headache, fever, chills and overall achiness. The soreness in my arm increased Weds and Thurs and with a larger area of redness and swelling. I saw my Dr. on Fri who recommended treatment with VALTREX.
a little bit "headachy"; a little bit of soreness in the muscle of his arm; This is a spontaneous report from a Sponsored Program, from a contactable consumer, the patient. A male patient of unspecified age (reported as 70 without units) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201, expiration date Jun2021), via an unspecified route of administration 21Feb2021 at as a single dose for COVID-19 vaccination.  Medical history was unknown. The patient's concomitant medications included hyaluronate sodium (SUPARTZ) as injection on patient's knees, the patient is scheduled to start another series of 5 sets of this medication.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.  On an unknown date the patient experienced a little bit of soreness in the muscle of his arm as well as feeling a little bit headachy, but the patient stated he has this normally and would describe it as very, very mild. The patient was also inquiring for information regarding Supartz gel injections and the Pfizer BioNTech COVID-19 vaccine. The patient explained that these shots are 'some version of hyaluronan acid' and states he is set to receive them once every week for 5 weeks starting today. The patient is concerned because these doses will fall around the same time he is scheduled to receive his second dose of the vaccine on 14Mar2021. The patient also mentioned that in his research of the injections online, he read that when these injections are given for dermatology purposes, they can cause some swelling after use. The patient further stated  he had absolutely no response to the vaccine whatsoever, there is nothing out of the ordinary, other than the other injection (Supartz).The patient was inquiring if he should consult his orthopedics doctor to postpone this until after he had his second dose of vaccine. The patient further stated he does not have "any allergies or any history of those kind of things, and he does not expect that, but he does not want to in any way affect the efficacy of the vaccine, so he thought it would be prudent to make a call before he did this" (started next series of Supartz). The clinical outcome of the little bit of soreness in the muscle of his arm as well as feeling a little bit headachy was unknown.
No adverse effects reported; One dose of an improperly stored vaccine, VARIVAX, was administered to one patient of 9/12/2019; Assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 12-SEP-2019, the patient was vaccinated with an improperly stored vaccine of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, once, intramuscularly, lot# S002877, expiration date 29-JAN-2021, for prophylaxis (strength was not reported). Varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT), possible lot # S000130, expiration date reported as 23-AUG-2021.  The temperature excursion was of 8.1 Fahrenheit degrees, during 20 minutes. However, a previous temperature excursion of 8.1°F for 17 minutes and 9.5°F for 21 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
pt comes to hospital with mental status change, D/V; positive for COVID; treated with steroids, ABX, baricitinib; O2 supplementation; pt's condition worsened and she was transitioned to comfort care; pt died in the hospital
Left arm deltoid red and swollen. Hot to touch. MM 1" x 2" area of redness in deltoid region of (L) arm. No induration, no tenderness, using arm well.
Red hardened area to bilateral legs. Right leg worse than left. Right leg blister at site of injection. Daycare and caregiver administered children's Benadryl and motrin. Applied ice to bilateral legs.
After the 15 minutes patient reports left arm tingling and burning. Patient reports tingling down to her fingers. Patient reports arm feels weaker. Took patient's blood pressure and it was 132/70 with pulse of 68. Patient was examined by LBST. Having patient stay a couple more minutes. Patient stayed for another couple minutes- patient reports arm feeling better-  Symptoms resolved.
Patient had an observed seizure that lasted about 30 seconds. Patient had a full evaluation by a medical provider. Provider did an EKG that showed patient in Atrail fibrillation. Patient transported via ambulance to the emergency department at this time in stable condition.
PERSISTENT CHEST PAIN  ON THE UPPER SIDE OF MY CHEST. VERY SHAP WHEN I SNEEZE OR COUGH. NO RELIEF WITH PAIN MEDICATION (IBUPROFEN 400MG)
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 23-NOV-2021, it was administered therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (lot number T033814 had been verified to be a valid number; expiration date: 05-OCT-2022; strength, dose, route of administration, and anatomical location were not provided) that underwent temperature excursion (product storage error). It was reported the temperature excursion was above 9 degrees Celsius (C) (12.4C) for a time frame of 0 hours, 53 minutes and 0 seconds; above 9 degrees C (9.6 C) for a time frame of 0 hours, 34 minutes and 0 seconds; above 9 degrees C (9.5C) for a time frame of 0 hours, 23 minutes and 0 seconds; and above 9 degrees C (8.5C) for a time frame of 0 hours, 9 minutes and 0 seconds. It was reported that no had previous temperature excursion. No additional adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007428: US-009507513-2112USA007429: US-009507513-2112USA007430: US-009507513-2112USA007431: US-009507513-2112USA007432: US-009507513-2112USA007433: US-009507513-2112USA007434: US-009507513-2112USA007435: US-009507513-2112USA007437: US-009507513-2112USA007440: US-009507513-2112USA007441: US-009507513-2112USA007442: US-009507513-2112USA007443: US-009507513-2112USA007444: US-009507513-2112USA007446: US-009507513-2112USA007447: US-009507513-2112USA007427: US-009507513-2112USA007426: US-009507513-2112USA007425: US-009507513-2112USA007436:
Warm around injection site after 1st dose; circle and knot around injection site; Itchy around injection site after 1st dose; red around injection site after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm around injection site after 1st dose), VACCINATION SITE MASS (circle and knot around injection site), VACCINATION SITE PRURITUS (Itchy around injection site after 1st dose) and VACCINATION SITE ERYTHEMA (red around injection site after 1st dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm around injection site after 1st dose), VACCINATION SITE MASS (circle and knot around injection site), VACCINATION SITE PRURITUS (Itchy around injection site after 1st dose) and VACCINATION SITE ERYTHEMA (red around injection site after 1st dose). At the time of the report, VACCINATION SITE WARMTH (Warm around injection site after 1st dose), VACCINATION SITE MASS (circle and knot around injection site), VACCINATION SITE PRURITUS (Itchy around injection site after 1st dose) and VACCINATION SITE ERYTHEMA (red around injection site after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication included thyroid medication.  Treatment medication for event was not provided
cold-like symptoms; stuffy nose/Nasal congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): (Janssen).  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (covid-19 vaccine ad26.cov2.s), administration date: Apr2021, for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 25Apr2022, outcome "unknown", described as "stuffy nose/Nasal congestion"; NASOPHARYNGITIS (non-serious) with onset 26Apr2022, outcome "unknown", described as "cold-like symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever 102,acrocyanosis,hives like rash bilat knees resolved;pain
Pt developed bilateral lymphadenopathy post vax, for post exposure prophylaxis. Following day he complained of itchiness of the right and left axillary areas left more than right, as well as swelling unilaterally in axilla. On June 30, 2000 the pt received Benadryl and Solu-Medrol prior to 2nd dose. No reaction, reporter assessed the event as related to RabAvert.
Information has been received from a physician concerning a 5 year old female patient with a history of coxsackie viral infection (about 2 weeks before vaccination with VARIVAX (Merck)) who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (Lot # not reported). About 14 days after vaccination, the patient developed a generalized rash. The patient was taken to the Emergency Room but not admitted to the hospital. She was treated with antihistamines and oral fluids. At the time of reporting, the patient was not recovered. Additional information has been requested.
cellulitis @ inj site;tx Duricef, warm compresses, rest advil PRN
Pt recvd Engerix-B & the noc of inject devel neck pain; the next morning felt off-not up to par; that afternoon exp chills, swollen lymph nodes under the arm of inject & a low grade temp;
suspected vaccination failure; shingles all over his face and body; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received Shingles vaccine and got the shingles all over his face and body. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
3/27 flu-like symptoms until 3/31 but continues to have sore hands and feet; inflamed joints and swelling in hands and feet spoke with PCP on 4/5/21 for regular telehealth f/u and PCP recommend she report symptoms to Covid hotline; Caller has been taking OTC NSAIDS without relief
Headache, Myalgia, FATIGUE, SORE ARM  Narrative:
pre-existing lung condition; he was hospitalized due to a pre-existing lung condition.; he missed the 2nd dose; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included pre-existing lung condition. The patient's concomitant medications were not reported. The patient missed the 2nd dose (28Feb2021) because he was hospitalized due to a pre-existing lung condition.  Outcome was unknown.  Information about lot/batch number has been requested.
Patient given a 3rd dose of Pfizer covid vaccine.  Previous dose given on 1/25/22 (dose #2) not entered on Privacy; did not pull up on Privacy.  Did not realize patient had already had a 2nd dose until after vaccine given today when grandmother presented patient's covid vaccine card.  Grandmother stated that she noticed that the patient had already had 2 vaccines and didn't know if she should say something.  Patient was observed 15 min and no adverse reaction noted. Grandmother educated on vaccine.  Dr. notified also.
Breakthrough case admission after 3 vaccines Pfizer 4/8/21 Lot# Ew0158;  Pfizer 4/29/21 Lot# Ew0158;  Moderna 11/5/21 Lot# NONE  DO NOT SEND REQUEST FOR LOT NUMBER; IT IS NOT IN LOCAL DATABASE
Information has been received from a female consumer who on 28-APR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot# not provided). On 23-JUN-2008 the patient received the second dose of GARDASIL vaccine (yeast) (lot# not provided). The patient reported that she continuously had nausea and dizziness a few days after the injection. She had pain in her stomach for about 15 minutes. The patient's outcome was not known. Additional information has been requested.
Chills, slight fever, body aches, headache. Treated with Tylenol. Symptoms began 10.5 hours after injection. Chills, fever, body aches subsided in 12 hours, headache was gone after about 15 hours. No symptoms remain.
Immediately that afternoon arm was sore. Next day, woke up shivering, fever was 101, headache, arm was sore/swollen and had very distinct red blotch at administration site--about 2 inches in diameter. Arm did continue to get larger, redder and circle got larger by evening.  Felt exhausted like if hit by a truck. Took Tylenol but did not seem to make difference.   By 4/26, fever was 99.2, arm was quite swollen still/sore, 4-inch red circle on arm and arm was very itchy.   Symptoms continued 4/27 and 4/28.  On 4/29 fever was gone, arm tender still, had red circle, and still itchy.   Called the pharmacy and PCP (Dr) who recommended to continue ice packs and lotion.   By 4/30, arm symptoms beginning to subside and feeling better.  By 5/1, arm issues resolved.  On 5/23 woke up and could not see on left eye.  When to ophthalmologist and diagnosed with shingles on eye. Patient given prescription of steroid eye drops Durezol and prescription for Valacyclovir.  Patient went back to ophthalmologist 1 week later and vision had cleared.  Doctor started weaning patient off steroid eye drops; last drops were on 6/17.
reported r. sided (only) headache & r. facial discomfort;  VS - 132/80 - 52- 96% SpO2;  A&O x 3;  symptoms resolved w/ mask removal, fresh air, emotional support & water.  Remained in observational lot total of 40 mins.  Drive home by spouse.
Initial spontaneous report received on 08-OCT-2103 from a nurse. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. Nurse reported that patient administered 1.25 ml dose to adult instead of 0.5 ml dose. List of documents held by sender: none.
perforated appendicitis with abscess.  3/17 Abdominal pain started sought treatment.,  Appendix removed 3/19