chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles shot and got shingles less than a (unspecified). The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. Note: In the narrative incomplete information was given regarding  and hence the case was processed conservatively as suspected vaccination failure  aunknown.
Joint pain, endocrine disruption: menstruation in previously post-menopausal woman (5 years)
Client reported today by phone - on 11/8/06 left arm red, warm to touch and raised area blotches. Seen at her Dr office the afternoon on 11/8/06 for stomach problems, reflux and COPD did but doctor see the area. reported to health dept 11/16/06 at 3:30 pm to nurse.
It started on the day of vaccination I wasn't feeling very well. I did sit at the pharmacy for half an hour to make sure there wasn't any anaphylaxis. That night the injection site felt very sore. I took TYLENOL and went to bed. The next morning I felt worse and just didn't feel well. It felt like I was coming down with the flu. I thought it would pass. It lasted for 10 days, the main things were muscle aches and fatigue. Then one morning I woke up because I felt better and tried to do some activity but even just the little bit I did I felt fatigued. I have not felt well still I took that shot. It eased up but it seems to reactivate every two to three days. I feel run down, fatigued, and I have aches and pains. They tested me for rheumatoid arthritis and it came back negative. They also did blood work for valley fever and that was negative. I had stomach issues so they tested for celiac and that came back negative. They tested for a lot and everything came back negative except for an explosive reaction of the Epstein-Barr virus that came back positive. I never got my energy back. I also lost my appetite and lost weight. I went to the doctor earlier this week and they told me that I lost even more weight. A lot of the symptoms I felt resembled an Epstein-Barr infection reactivation. I have also experienced some vertigo and diarrhea that is intermittent. I was in the ER 4/29, as well in January.
Severe deep throbbing headache that Tylenol did not work on.   Lasted 8 hrs caused nausea and eye pressure.
little strip of shingles on my lip / it is in my mouth and tongue; little strip of shingles on my lip / it is in my mouth and tongue; severe out break of fever blisters; They painful and are difficult to treat; first Shingrix shot on 9-14-19 due to short supply I got my second Shingrix shot 10-4-19; This case was reported by a consumer via out of hour services and described the occurrence of suspected  vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2019, the patient received the 1st dose of Shingrix. On 4th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), fever blister, blister, shingles and product supply issue. On an unknown date, the outcome of the vaccination failure, fever blister, blister, shingles and product supply issue were unknown.   It was unknown if the reporter considered the vaccination failure, fever blister, blister and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had 2nd dose too early due to short supply. The patient experienced severe out break of fever blisters that last 6 weeks or so, as soon as it got clear up another one poped up. The patient never had a fever blister in his/her life, blisters were painful and difficult to treat. The patient also had a little strip of shingles on lip that has cleared up but in it is in the mouth and tongue at the time of reporting. The patient was very upset and wanted to know how to get it corrected. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
the first dose on 9/11/2019, and that the 2nd dose was delayed due to COVID; received the first dose of Shingrlx and developed shingles 2 weeks ago; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 7 months 18 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and social problem. The action taken with Shingrix was unknown. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles and social problem were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows:  The age at vaccination was not reported. The pharmacist stated that a patient received the first dose of Shingrlx and developed shingles 2 weeks prior to the reporting date.  Asked what were the recommendations for the 2nd dose. The 2nd dose was delayed due to COVID. The reporter consented to follow up.  This was a medication error without harm.
13 days after the vaccine patient had a swollen lymph node in my left side of my collar bone; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 12:15 (Lot number: EN6198) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression disorder" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Allergic to trees" (unspecified if ongoing); "Allergic to pollen" (unspecified if ongoing); "Allergic to dogs" (unspecified if ongoing); "Allergic to walnut" (unspecified if ongoing); "Allergic to cats" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Mar2021 20:00, outcome "not recovered", described as "13 days after the vaccine patient had a swollen lymph node in my left side of my collar bone". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The patient did not receive any other vaccination in the last four weeks. It was reported that the patient never had COVID prior vaccination and was not tested for COVID post vaccination. The other medications in two weeks was Zyrtec   No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 3 vaccines Pfizer 3/21/21 Lot# EN6202;  PFizer 4/17/21 Lot# Ew0150;  Pfizer 1/20/22 Lot# FJ1611;
Itching, firmness, inflammation at site of injection. First noticed 3/31/21 around 8:30 central time
Lymph nodes were swelling on his left arm; This is a spontaneous report from a contactable consumer or other non hcp.   A 44-year-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH COVID 19 VACCINE SOLUTION FOR INJECTION) (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 26Sep2021 11:30 as dose 2, single for covid-19 immunisation. Patient Age at Time of Vaccination: 44 Years old. Medical history included. There were no concomitant medications. No Prior Vaccinations within 4 weeks none aside from first dose of covid vaccine.Patient previously took first dose of vaccine BNT162B2 on unknown date of sep 2021, unknown route of administration on left arm Batch lot number was unknown for covid 19 immunization. It was reported that, her husband got his second dose of the Pfizer covid vaccine Sunday morning at a local pharmacy and he has swelling under the lymph node that is growing to about half a baseball size. The patient experienced lymph nodes were swelling on his left arm on 28Sep2021 with outcome of not recovered.Therapeutic measures were ibubrofen taken as a result of lymph nodes were swelling on his left arm (lymphadenopathy).  Follow-up(29Sep2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a 44-Year-old male patient reported information included:  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
From initial information received on 06/19/03 from the pt regarding an adverse event occurring in the USA, it was reported that the pt, a 25 year old female, received  TD Adult vaccination, Lot # not reported, administered IM in the right arm on 06/18/03.  About one hour after vaccination, the pt developed muscle cramps. The next morning the pt had generalized muscle aches and also pain and redness at the injection site. Reportedly the pt recovered from this experience. From additional information received on 10/27/03 from a health care professional, it was reported that the pt did not develop redness at the injection site. In addition, the pt's full address including the county was provided. Reportedly, the pt did not receive any other vaccines within four weeks of the date of this vaccination and did not take any concomitant medications at the time of vaccination. No further information is anticipated, this case is considered closed.
This spontaneous report as received from a physician via field representative refers to 2 female patients of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with GARDISIL (dosing details, strength, lot # and expiry were not reported). Fifteen minutes post vaccination, the patients fainted as they were about to leave the physician's office. The patients sought medical attention as they were in the doctor's office. The outcome of syncope was unknown. The reporter did not provide the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.
One week after vaccines administered, patient began occasionally stuttering and turning head and eyes to the right when stuttering. Patient is no longer turning head and eyes to the right but continues to occasionally stutter.
On 5/8/21 I received the 1st dose of Pfizer at 12:00 pm at hospital. I was tired when I went back to work at 2:00 pm but was able to work. Pain in my right arm was starting to be felt by evening of 5/8. In the middle if the night of 5/8 I had night sweats and tightness in my chest with the sore arm. The morning of 5/9 at about 9:00 I starting getting random sharp pain on each side if my body by my hip area, maybe my kidneys throughout the day along with the pain in my arm continued and the tight chest and sweats went away.  By Monday 5/10 I no longer felt pain in my arm or sharp pains but will remain cautious of it coming back in my kidneys area on each side of my body. My next shot is June 4th but notified my Dr. On 5/10/2021
Pain in arm since noon that got worse. Headache at 8:00 pm. Diarrhea at 4 AM, vomiting at 4:30 AM, muscle aches all day on 1/5/2021 (day after shot).
Over a week since getting my first shot of Moderna COVID19 vaccine, I started getting a rash at the injection site and other little skin irritations. The rash was red, had some raised bumps and was warm to the touch. It itched sometimes. Lasted around 3-4 days. It seemed to be gone but today it started itching a little and just a little red again. I have also felt fatigued since getting the shot.
fever 105.5 less then 24hrs p/vax given subjective fever the afternoon p/vax;
Injection site feels bruised. There is a quarter size area around the injection site that is red and raised. My arm became itchy around noon (23 hours after injection) and has remained itchy since.
Patient awoke the evening 12/6/00 with hives and eyes swollen shut. She took Benadryl, and the hives resolved. She received a 4th dose due to the recall of Imovax P0313-3 which she received for her 1st dose.
Metallic taste in mouth within minutes of receiving shot. Arm pain and soreness. Slight headache.
Despite prior vaccination, specific antibody testing showed negative for rubeola IgG and protective levels to only 3 of 23 pneumococcal serotypes; vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine showed an inadequate response; This literature marketed report was received from the author's of a published article, concerning a 9-year-old female patient.The patient was a 13-year-old at the reporting time with Autoimmune-Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (APECED) caused by homozygous AIRE c.967_979de113, who manifested chronic mucocutaneous candidiasis (CMC), hypoparathyroidism, adrenal insufficiency, Sjogrens-like syndrome, autoimmune hepatitis, intestinal dysfunction and autoimmune pneumonitis. She suffered from recurrent sinusitis and severe pneumonias requiring hospitalization and administration of intravenous antibiotics several times per year.   At age 9, she presented to the authors' institution with fever and cough, a computed tomography (CT) of the chest revealed bilateral pulmonary infiltrates and bronchiectasis. Bronchoscopy showed mucopurulent secretions in the bilateral lower lobes with culture of the bronchoalveolar lavage fluid growing Streptococcus pneumoniae. Further evaluation for an underlying disorder such as primary ciliary dyskinesia and cystic fibrosis including exome sequencing and sweat chloride testing was unrevealing. Quantitative immunoglobulins were normal. Despite prior vaccination (manufacturer unknown measles and pneumococcal 23 vaccines), specific antibody testing showed negative rubeola IgG and protective levels (> 1.3 mcg/mL) to only 3 of 23 pneumococcal serotypes. Lymphocyte enumeration showed normal B cell subsets. As approximately 15%of APECED patients may experiencesplenia, splenic ultrasound was performed confirming the presence of a 7 cm spleen and peripheral blood smear did not reveal Howell-Jolly bodies. Serotyping of the S. pneumoniae isolate confirmed serotype 33F, which is part of the 23-valent vaccine.  Follow up vaccine challenge with the 23 valent pneumococcal polysaccharide vaccine (manufacturer unknown) showed an inadequate response. Hence, she was started on monthly immunoglobulin replacement and over the following 4 years she has experienced a single methicillin sensitive Staphylococcus aureus pneumonia. She has missed very few school days and other parameters including linear growth have improved, she is now along the fifth percentile for height and along the tenth percentile for weight. Although she continues to experience intermittent cough she remains active participating in sports without limitation.  A copy of the published article is attached as further documentation of the patient's experience.
Red mark about the size of a 50 cent piece with raised bumps with yellow tops slight ooze, like poison ivy but only in one spot and itched like crazy. Tried to dry it up with witch hazel for a week, then calamine lotion for a week and then finally cortizone that finally stopped the itch in 2 days and 95 percent of the rash is gone now.
COVID clinic conducted on 3/26/2021 where patient was presented for vaccination. On follow-up visit 4/23/2021 for second dose it was discovered that patient had previously received 2 doses of Pfizer COVID vaccine from another provider (1/19/21 and 2/9/21).  2nd dose of Moderna was not administered.
Shortly after receiving flu shot - rt arm started shaking, ot felt weak and nauseated. Called dr. Told her to take BENADRYL and rept 400pm dr called pt - she stated she was much better, no more shaking.
Pain, redness and swelling in her upper left arm. She has noted it worsening and redness and warmth enlarging. Has had also HA and fevers and generally not feeling well. Treatment: acetaminophen (TYLENOL) 500 mg tablet; Take 1 tablet (500 mg total) by mouth every 6 (six) hours as needed for Pain. As needed. cephALEXin (KEFLEX) 500 mg capsule; Take 1 capsule (500 mg total) by mouth 4 (four) times daily.
This spontaneous report as received from a certified nurse midwife refers to a 19 years old female patient with irregular period, diagnosed with polycystic ovary syndrome in 2010 and with no pertinent medical history. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # H011350, expiration sate 21-FEB-2011) IM on 05-SEP-2012 and received a second 0.5 ml dose of GARDASIL (Lot # not reported) IM on 04-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that 24 hours after receiving the second dose of GARDASIL, on 05-DEC-2012, the patient started developing cystic acne on her upper neck and face. The nurse noted that the patient did not immediately seek medical attention but eventually contacted the office and was seen on 19-DEC-2012 when cystic acne would not resolve. The patient was treated with erythromycin and ZYRTEC. There were no Lab diagnosis or studies perform. At the time of the report, the patient was recovering. The relatedness for cystic acne on her upper neck and face was unknown for GARDASIL. Additional information has been requested.
Pt. received vaccinations at at 10:00am on 1-13-11 - no problems noted after receiving vaccinations. Infant found not breathing at 0930 on 1-16-11 by parents. Had been sleeping in car seat (not strapped in)- in living room. Unable to resuscitate. Pronounced dead at hospital. Autopsy listed cause of death SUIDS - Sudden Unexplained infant death. Awaiting toxicology reports/results.
Patient informed Front Desk employee that "she could feel her heart beat, it wasn't a pain, but uncomfortable."
Heart rate raced, felt light headed hungry and sleepy.  I looked pale and clammy.  Paramedics took pulse ox, bp and heart rate.  HR was high in 90s and BP was 120/97  They make me breath deep and gave me water and crackers to eat.  Waited for 15-20 mins.   Pulse rate came down in 70s and BP came down to 110/80
Patient had site redness, fever, and swelling.  She went to ER and was diagnosed with cellulitis and  placed on antibiotic therapy (cephalexin).  Now site is improving well.
This spontaneous report was received from a physician via a company representative and concerns a 2-year-old patient of unknown gender. No information about patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. The physician read, on an unspecified website, that the patient was administered GARDASIL (dose, route of administration, lot# and expiration date not reported) (date not specified). It was confirmed that the patient was not administered GARDASIL 9. No further information was provided. Additional information has been requested.
pt recvd vax 1MAR93 & on 8MAR93 had fever 100; 9MAR93 ran fever off/on all day (up to 102); 10MAR93 530 AM began convuls; called 911; eyes were rolled back in head breathing was fast & shallow; initially thought wasn't breathing;  to hosp
Patient contracted COVID-19 infection after being fully vaccinated with Moderna vaccine series given on 1/14/2021 and 2/8/2021.
PATIENT RECIEVED PNEUMOVAX ON 8/20/08 AT 1900.  PT REPORTED ITCHING TO SITE TO RN.  RN ASSESSMENT NOTED SWELLING AND SLIGHT REDNESS.
Patient is having elbow pain and pain with full extension which they feel started at the time of the vaccine.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022).    No concomitant medication information was reported. Patient received half dose. The vial was initially stored in refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment information was reported.
I am 7 weeks pregnant and received my second Covid vaccine. 3 days later I started spotting and HCG levels are decreasing (threatened miscarriage)
patient  had  the  2nd  moderna  vaccination  intohe  right  arm  same used for  1st  vaccination , 1st  vaccianiton no issues   lot  number of moderna  was  001L20Aon  02/18/21  then had   second  vaccination moderna  lot number   626L20A on 03/16/21  then on  march 18, 2021   her  right  arm  approx.  4 inches  below the  site  started to get  red , with a rash and  swell up.  only in the middle of the forearm  approx.  a  4 x 4  patch.     and on   3/20/2021  it  was  less red  and  less warm  and  came to the clinic for a evaluation.   Discussed    Tylenol or motrin   antihihistamine  ice to arm  and  steroid cream topical    can take up to 1-2 weeks to  return to normal      no antibiotic  prescribed    arm was improving  on 3/20/2021   patient used  ice  on the area,    took ibuprohen
Presented w/ generalized weakness; found to be COVID positive, not hypoxic.  CTA chest showed no evidence of PE or pneumonia.  Patient was treated w/supportive care of Vit C & zinc.
ON 4 NOV 2006 PATIENT NOTICED REDNESS, SWELLING, HARDNESS AND HOT TO THE TOUCH AT INOCULATION SITE.