chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; blister on thigh and groin area; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and BLISTER (blister on thigh and groin area) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     no medical information reported.  The patient's past medical history included Shingles (20 years ago and was supposed to receive the vaccine but was never vaccinated). Concomitant products included AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR), ATORVASTATIN, ALLOPURINOL, DILTIAZEM and PLANTAGO OVATA SEED HUSK (PSYLLIUM HUSKS) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021 at 9:00 AM, the patient experienced HERPES ZOSTER (Shingles). In April 2021, the patient experienced BLISTER (blister on thigh and groin area). At the time of the report, HERPES ZOSTER (Shingles) had resolved and BLISTER (blister on thigh and groin area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided.  It was reported that patient Developed SHINGLES ( second time , had 25 years ago) typical symptoms , small blisters on and across upper thigh and goin area, MOST PAINFULL no none treatment , had to take It course, lasted 3 months and finally healed and pain went away, the blisters did leave a scared area. I have since had the SHINGLES shot ( one of two) . Patient is not looking to go through that again    Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: significant follow up received on 01-sep-2021,including concomitant medication and patient height and weight, race and ethnic information and batch/lot no.of both doses
Starting about 29 hours after receiving dose, experienced chills and severe muscle aches. Chills and muscle aches lasted for about 6 hours. Then, starting on May 2nd and going until May 7th, I've been extremely fatigue, sleeping 10-12 hours a night and body aches, particularly in thighs, arms, and back.
mom called office at 1630 and reported pt had called her and was crying with HA and vomiting. Asking to go to the ER. Pt was with g-parents at the time.
vaccine liquid did not go through the patient's arm/ more than 50%  was administered; This case was reported by a pharmacist and described the occurrence of accidental underdose in a female patient who received Herpes zoster (Shingrix) (batch number PK5B9, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 11th May 2021, the patient received the 2nd dose of Shingrix. On 11th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. No patients data provided. The patient while receiving dose of Shingrix moved and some of the vaccine liquid did not go through the patient arm and more than 50 percent of vaccine was administered but there was no way to know for sure, which led to accidental underdose It was administered on the same day as reported. The reporter consented follow up.
customer asked how felt was ok, gave covid-10 im sat for 2-3 minutes, fell off chair. pharmacist picked up patient patient woke(said not aware of falling out of chair and on floor) no injuries reported, noticed excessive sweating/said vision blurred/ bp normal(taken by rph). 911 called by front store. rph stayed with patient until emt arrival gave  info as to events prior to theier arrival. emt came in and reported patient was ok and on there way home.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patients medical history and current conditions were not provided. On an unknown date the patients were vaccinated with an improperly stored dose of GARDASIL (lot #, expiration date, dose and route were not reported). No concomitant medications were reported. Additional information is not expected because the reporter details were not provided.
expiration date of 18SEP2019 on the label was given today/no AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old female patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5254AA via intramuscular route in the left thigh.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme pain and immobility in arm with eventual swelling and bright redness all the way down past the elbow. Also experienced low grade fever and chills.
yeast infection; This is a spontaneous report from contactable female consumer via Pfizer Sponsored Program COVAX US Support.  An unspecified age female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not provided), via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. On an unspecified date, after vaccine came down with yeast infection. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Do noy remember if left or right arm.  After sitting for a few minutes i started to feel very hot heart racing and lightheaded BP taken was 159/95 i was given water and had blood pressure checked every 15 minutes for 3 hours last BP check was 131/85.  Since first vaccine i have felt my heart goes up more often not sure if related or not
Tuesday after my injection I started getting nauseous, my right arm was very red and swollen along the injection site and overflowed into my upper arm.  These symptoms lasted 7 days.   When I went to bed on Tuesday night, I woke up early in the morning with palpitations, very nauseated, and light headed.  The palpitations lasted about 2 hours, light headedness about 30 minutes.  I had no further palpitations or light headedness after this.
10/5/21 Tuesday Tuesday 10:30am Felt very tired almost immediately. Went home, slept until 3pm. Ate something for dinner, went back to bed. COVID Booster 10/6/21 Wednesday 9am Woke up with a rash and a 101.3 fever, joints and back ache. 1 Benadryl, and 2 Tylenol for fever  Wednesday 10am Rash all over my chest, abdomen, arms, back, and tops of legs, arches of feet. Loose stools. 2 Prednisone 10mg each ? 20mg total  Wednesday 2pm  Rash slightly better. Fever gone.  1 Benadryl  Wednesday 6pm  Rash slightly better Took 1 Benadryl  Wednesday 10pm Rash improved but not gone which is unusual for me. 2 Prednisone  10mg each ? 20 mg total and 1 Benadryl 10/7/21  Thurs. 10am Rash slightly better 1 Benadryl, and 1 Prednisone 10 mg  Thurs. 3pm Rash slightly better 1 Benadryl  Thurs. 5:40pm Teleconference. Provided photos. Got a new prescription for Prednisone. Rash still present but not as bad as Wednesday.   Thurs. 8pm Legs swollen, tongue swollen, drank lots of water,  1 Benadryl  Thurs. 2am Went to bed late 1 Benadryl 10/8/21 Fri. 9am Rash improved but not gone which is unusual for me. Why the persistent rash? 1 Benadryl 10/9/21 Sat. 9am lingering rash but no fever, extremely tired in the morning. Checkin call from Doctor. Slept and finally felt better. 10/10/21 Sun. Rash getting better. Not as visible on arms, torso, upper legs. Fairly itchy. 10/11/21 Mon. Fairly itchy finally. Applied topical soothing oil. Rested. 10/12/21 Tuesday (today) no rash visible but itchy and tired today.
Didn't remove bandaids until 4/13/00 and found that he had a rash on upper arm, no fever, no swelling, no itching and no other symptoms. Rash is disappearing today. Mom will watch and report if worsening rash or other symptoms to public health.
After first dose of Moderna COVID-19 vaccine, patient started to experience dizziness and lightheadedness. Patient stated that she had Botox injections in the previous 2 weeks. Patient was given water/juice and was subsequently discharged to home.
Soreness at injection site for 10+ days with some limitation in movement of shoulder. Now has full range of motion (10 days later) but mild persistent pain. Also experienced some soreness right side of neck and 'feeling run down'- these have now elated.
hands started shaking; lightheaded; This spontaneous case was reported by a nurse and describes the occurrence of TREMOR (hands started shaking) and DIZZINESS (lightheaded) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Apr-2021, the patient experienced TREMOR (hands started shaking) and DIZZINESS (lightheaded).      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 118/72. On 06-Apr-2021, Heart rate: 06-apr-2021. On 06-Apr-2021, Oxygen saturation: 06-apr-2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
pt had a recent hospitalization from 12/15 - 12/20/21 with COVID 19; was on O2, Remdesivir, and dexamethasone; back to hospital on 12/27/21 with fever, AHRF; bacterial pneumonia superimposed on COVID 19; given dexamethasone, ABX; worsened respiratory status; transferred to ICU; intubated; dismal prognosis; family decided on comfort care and the pt passed away in the hospital
Constant pain in my  left shoulder area.  Pain has increased from a mild dull pain, similar to a Charlie horse. to a sharp throbbing pain in the upper arm/shoulder area.
lump at injection site; injection site arm itched; fever of 101 degrees Farenheight in the morning.; sore arm; face hot to touch; chills; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (face hot to touch), INJECTION SITE MASS (lump at injection site), INJECTION SITE PRURITUS (injection site arm itched) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (face hot to touch), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 17-Mar-2021, the patient experienced INJECTION SITE MASS (lump at injection site), INJECTION SITE PRURITUS (injection site arm itched) and PYREXIA (fever of 101 degrees Farenheight in the morning.). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (face hot to touch), INJECTION SITE MASS (lump at injection site), INJECTION SITE PRURITUS (injection site arm itched), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and PYREXIA (fever of 101 degrees Farenheight in the morning.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
still got severe shingles / suspected vaccination failure; still got severe shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: still got severe shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got severe shingles). 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date:15-JUN-2023. This case was reported by a consumer via interactive digital media  The reporter stated that he received both the dose of Shingles vaccine still got severe shingles. The reporter stated that vaccine did not always work. This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not reported. The follow up would not be possible.
Patient got first covid dose in Feb. Restarted series and got 2 additional doses in June and July
hair on his arms were standing on its end; both arms (from his biceps to his hands) felt like they were on fire; felt like they were on fire; lot number provided is expired. Patient may have also received expired vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of piloerection in a male patient who received Herpes zoster (Shingrix) (batch number 4h9g2, expiry date 25-SEP-2021) for prophylaxis.   In SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced piloerection (Verbatim: hair on his arms were standing on its end), burning sensation (Verbatim: both arms (from his biceps to his hands) felt like they were on fire), muscle burning sensation (Verbatim: felt like they were on fire) and expired vaccine used (Verbatim: lot number provided is expired. Patient may have also received expired vaccine).  The outcome of the piloerection and muscle burning sensation were not reported and the outcome of the burning sensation and expired vaccine used were unknown.   It was unknown if the reporter considered the piloerection, burning sensation and muscle burning sensation to be related to Shingrix.     It was unknown if the company considered the piloerection, burning sensation and muscle burning sensation to be related to Shingrix.   Additional Information: GSK Receipt date: 26-SEP-2023 The patient was self-reported. The patient who received his first dose of Shingrix 2 weeks ago and he stated that a few days after the dose, both arms (from his biceps to his hands) felt like they were on fire.  He also stated that the hair on his arms were standing on its end.  The lot number provided was expired and the patient might had also received expired vaccine based on the lot number which led to expired vaccine used. The reporter consented to follow up.
It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix; It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix; This non-serious case was reported by a consumer and described the occurrence of wrong vaccine administered in a adult patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-JUL-2023 It was for a dose of Infanrix inadvertently administered to an adult instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter had everything but the expiration date for the Infanrix but cannot view the details as could not find the case.
Information has been received from a physician concerning a 79 year old male patient who "5 years ago", in approximately October 2005, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 21-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # reported as 667913/1021Z). On an unspecified date the area was red and hot to the touch. The patient did not look good. He appeared tired, looked drained and looked like he was getting sick. The patient was treated and was recovering at the time of the report. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
upper arm became red & swollen to the elbow; It was sore for 2-3 days; pt had a fever for which mom gave APAP;
Client stated received Moderna as primary series. Client requested Moderna for booster. Client was given Pfizer in error.
Shortness of breath; High fever; Cough; Swelling in left armpit; Never ending headache.; Inability to quench thirst; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 15May2021 at 10:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 24Apr2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 16May2021, the patient experienced shortness of breath, high fever, cough, swelling in left armpit, inability to quench thirst, and never ending headache. 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 the events shortness of breath, high fever, cough, swelling in left armpit, inability to quench thirst, and never ending headache was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
DIFFICULTY/TROUBLE BREATHING; MIGRAINES; SINUS FLUID BUILDUP FEELING; TASTES SOME KIND OF WATER-LIKE LIQUID IN MOUTH; SNEEZING ON AND OFF; ITCHY NOSE ON AND OFF; STRONG HEADACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced difficulty/trouble breathing. On 23-MAY-2021, the subject experienced migraines. On 23-MAY-2021, the subject experienced sinus fluid buildup feeling. On 23-MAY-2021, the subject experienced tastes some kind of water-like liquid in mouth. On 23-MAY-2021, the subject experienced sneezing on and off. On 23-MAY-2021, the subject experienced itchy nose on and off. On 23-MAY-2021, the subject experienced strong headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from strong headaches, migraines, sinus fluid buildup feeling, tastes some kind of water-like liquid in mouth, difficulty/trouble breathing, sneezing on and off, and itchy nose on and off. This report was non-serious.
SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20211033119.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
PT woke up on April 1, 2021  not feeling well.  Went to work that afternoon.  Around 3:30 pm while working PT fainted.  Upon waking she had a neurological response and the left side of her body (the opposite side of her vaccine injection) was shaking uncontrollably and she could barely walk.  She was taken to ER and given an IV.  She was given Toradol and Ativan to relieve symptoms. The final diagnosis was an Adverse Effect of the Covid 19 vaccine. She was sent home and the uncontrollable shaking lasted 2-3 days.  PT still has tremors in her right arm when at rest, holding something and even more noticeable after exertion.
I experienced a miscarriage in February 2021 and did not menstruate after that (though my normal cycle was 21-28 days). I started menstruating unexpectedly 2 days after my second dose of the COVID-19 vaccine. I would think it might be a coincidence except I've heard from a lot of other women that their cycles were affected by the vaccine. So I thought I'd offer the feedback. I believe the vaccine may have triggered early menstruation for me. Additionally I believe I may have passed remaining pregnancy tissue during this unexpected menstruation.