chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 19th August 2022, the patient received Havrix. On 19th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 19-Aug-2022 Reporter's Comments: A medical assistant reported a patient received on 19th August 2022 a dose of Havrix that had expired on 9th August 2022. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of havrix, which led to expired vaccine used.
Pt. states that after receiving the 2nd dose of Phizer 06/07/2021, started experiencing symptoms 06/08/2021 of Blood in the Urine, fever (100.5), ER visit recommended observation.  06/15/2021 rash across the face, scalp, and left arm. (Still continuing), Dermatologist Appt. 09/21/2021 recommended topical steroids. No Noted Primary visit.
Tested positive for COVID-19 on 02/08/2023. Started feeling really weak and congested and coughing went to doctor and was admitted to hospital. Was feeling bad from COVID-19 and also has Renal Kidney Failure. Was in the hospital for 3 days. Continuously checking kidney functions. Tested negative for COVID-19 before leaving the hospital. Hospitalist said that I have Long COVID-19.
3-15-02 Presented with approx, varicellaform lesions over head, face, trunk and extremities. Varicella vaccine administered 2-28-02 No known contacts. Child not in daycare.
She started to develop hives; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (She started to develop hives) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (She started to develop hives). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (She started to develop hives) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Skin test: results not reported Results not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient after receiving the second shot started to develop hives that have continued up until today, at the time of report. These occur all over their body, which were itchy, red, raised, and occur with swelling. The patient had spoken to their primary care doctor, and an allergist who conducted blood and skin testing for allergies. Reportedly, the patient had been taking over the counter Xyzal, Benadryl, and Allegra.   This case was linked to MOD-2022-474640 (Patient Link).
I had a headache, exhausted and sore arm after receiving the vaccine for about a day. I was diagnosed with hypothyroidism in 02/2023. I am currently taking medication.
blisters on hands and arms; This case was reported by a nurse via sales rep and described the occurrence of blister in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7SK92, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number J3T44, expiry date 30th June 2021) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix and the 1st dose of Fluarix Quadrivalent 2020-2021 season. In September 2020, 1 week after receiving Shingrix and Fluarix Quadrivalent 2020-2021 season, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the blister to be related to Shingrix and Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix in right deltoid arm and Fluarix in left deltoid arm on 21st September 2020 and a week later experienced the symptoms.  The patient experienced blisters on hands and arms.  The reporter consented to follow up. The case has been linked with US2020199114, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199114:same reporter
pt recvd vax & mom stated pt exp rash w/ skin break down on RLT 2 days p/vax; generalized rash over face & trunk 11 days p/vax; PMD stated rash due to vax;
Daycare called around 3:00PM to let me know that patient was running a low grade fever (100.9) and was complaining that her right leg was hurting.  I picked her up and looked at her leg when we got home and noticed two small red whelps at the site of the injection. I gave her Tylenol for the pain and put an ice pack on it.  The next morning (4/03/2012) I noticed that the area was red and swollen and felt warm to the touch.  I gave her Motrin, put and ice pack on it and took her to school.  The school called in the afternoon because she was still complaining about her leg.  I gave her Tylenol and put an ice pack on it.  Later that evening, I gave her Motrin, gave her a warm bath and afterwards put an ice pack on it.  The next morning (4/4/2012) we called the doctors office to report this.  I missed the call back from the nurse and called her back but have not heard from them yet. The daycare suggested giving her Benadryl for the swelling and Tylenol for the pain.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 17-MAY-2016, the patient received GARDASIL (lot #L028664, expiry date: 25-MAY-2017) first dose (route: intramuscular). The patient received second dose on 22-AUG-2016 and did not want to finish series (inappropriate schedule of vaccine administered). No side effects reported. The outcome of the events was unknown. Additional information has been requested.
Initial report received from a health care professional on 25 Jun 2010: This patient was vaccinated with only the liquid conjugate of MENVEO (batch number 090901), (dose: unknown) intramuscularly on an unspecified date. No adverse reaction had occurred following this administration. Follow up report received from a physician on 07 Jul 2010: The patient was vaccinated on 23 Jun 2010 and the batch number for MENVEO was reported as 100002.
No adverse effects; Improperly stored dose; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and allergies were unknown. On 26-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route not reported) lot number S006018 and expiry date 27-FEB-2021 for prophylaxis (Product storage error). The vaccine underwent temperature excursion of total time in range from -14 degree celsius to -10 degree Celsius (-12.9 degree Celsius) for 55 minutes. Previously no temperature excursion was reported. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.
tinnitus very bad in both ears; Very tired for months; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number Er87321phzer as reported) via an unspecified route of administration in right arm on 19Apr2021 (at the age of 56-year-old) at 15:15 for COVID-19 immunisation. Relevant medical history included COVID-19 prior vaccination and enlarged prostate. The patient had no known allergies. Concomitant medications were not reported. On 20Apr2021 at 12:00AM the patient experienced fatigue and tinnitus. Events were described as follows: very tired for months and tinnitus very bad in both ears. Went to multiple doctors, had MRI (unknown results) but no relief. No treatment was received, but the events resulted in Energency room/physician office visit, disability or permanent damage. Patient was treated for COVID-19 post vaccination through blood test on 05Jul2021 and result was negative. Nasal swab on 19Aug2021 was negative. The events were not resolved at the time of report.
JOINT PAIN & MUSCLE FATIGUE (PAIN FROM 1 TO 10= 7) IN SHOULDERS (BOTH) THEN MIGRATED TO L KNEE.  CURRENTLY LOCATED IN BOTH KNEES AND BOTH ELBOWS, BOTH SHOULDERS, HIP, NECK AND L ANKLE.  BURSITIS IN ALL MAJOR JOINT.  8 YEAR PROGRESSION FROM 1ST SHOT.  TO DATE RECEIVED INJECTION IN BOTH KNEES AND BOTH SHOULDERS. CURRENTLY 5 LEVEL PAIN (FROM 1 TO 10). REQUIRED 1 HOSPITAL VISIT REFERRED TO SPECIALIST. AWAITING RESULTS ON BLOOD WORK AND WILL CONSULT WITH MD & ORTHO DOC.
On the second day of my second Pfizer does, I experienced pins/needle and numbness on my hands, feet and left side of my face/lips. It was been over one month and I am still experiencing these side effects. I went to my doctor, got blood work and it came back fine. I sometime get pain on my hands and feet.
I had a fever that was 103.2, vomiting, diarrhea, joint pain, dizzy, fatigue. Was not able to eat taking Tylenol to reduce fever. Went to the ER and blood work was required. Liver enzymes were extremely high and it requires constant intravenous fluids. Diarrhea persisted for 2 more days after hospitalization.
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
May 8  Immediately after vaccine: felt flush, very warm, sore arm. Hot feeling lasted for a few hours.    PM: extreme chills, pounding headache Lasted 8pm-3am  Headache is still dull  as of May 9
extreme sudden onset of fatigue, c/o arms feeling heavy, noted shuffling gait, denies sob, chest pain, itching no obvious signs of reaction
Patient presented to second dose mass Moderna vaccination drive through clinic. Patient did not have an appointment but reports they were supposed to return for second dose. Paperwork given to complete which was checked off that patient had received Moderna previously. Patient did not mark through this or make any comment to the nurse administering that they had not received Moderna originally. The nurse gave immunization appropriately based on paperwork that patient filled out and per patient request. Upon coming back to the department and entering in the shot in CVMS it would not let us enter as it reports that the first dose was Janssen vaccination. Upon going back through paper records we found that patient was
Breastfeeding; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) and BREAST FEEDING (Breastfeeding) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported for the patient.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), MULTIVITAMINS;MINERALS, VITAMIN D [VITAMIN D NOS] and FOLIC ACID (FOLATE) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VISION BLURRED (Blurred vision). On an unknown date, the patient experienced BREAST FEEDING (Breastfeeding). At the time of the report, VISION BLURRED (Blurred vision) had not resolved and BREAST FEEDING (Breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient only notice the blurred vision when she was looking at her computer screen. She worked from home. Patient was breastfeeding. Patient took Tylenol and Ibuprofen to help with the symptoms. The symptoms was ongoing at the time of the call.
SHE STARTED HAVING RED PATCHES ALL OVER THE PLACE WHERE SHE GOT VACCINE AND IT IS PAINFUL SHE WENT TO HER DR, DR TOLD THAT IS IS REACTION TO VACCINE AND REPORT IT TO PHARMACY WHERE SHE GOT IT. SHE CALLED THE PHARMACY.
Information has been received from a register nurse concerning a 25 year old female patient with no known drug allergies or no other pertinent medical history who on 27-APR-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# 663559/1178Y) into her left deltoid. Concomitant therapy included YAZ. On 28-APR-2010 the patient experienced entire hand and feet were red, hot and swollen after receiving GARDASIL. The patient sought unspecified medical attention. No laboratory studies were performed. The patient's symptoms resolved after a few days. Additional information has been requested.
45 minutes after administration patient developed signs of a stroke: inability to speak, facial paralysis, inability to move
The patient was diagnosed with chickenpox on 10/15/2001. The patient received vaccine on 11/26/1996.
Initial unsolicited report received from a pharmacist on 02-MAY-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TYPHOID VACCINE (batch number, expiry date, dose was not reported) orally on an unspecified date. Patient's medical history and concomitant medications was not provided. On unspecified date, following the vaccination the patient experienced hives. Lab data and corrective treatment was not provided. The outcome of the events was not reported. List of documents held by sender: none.
Erythema multiforme/urticaria reaction. Treated with Benadryl syrup and Zyrtec. 9/13/07 10 PM Worsened and needed re-eval in ER.
Rec'd injection for Tdap on 8/28/08 at 1pm around 6:30pm. Starting from my neck down quarter sized whelps and hives appeared. Did take BENADRYL throughout evening. 8/29/08 lip still slightly swollen
Following initial vaccine administration on 11/06/17, patient presented to clinic with concerns of a pruritic, raised, hot-feeling rash covering the area of his right thigh where immunizations MMR and Dtap were given 9 days prior. Despite being afebrile and otherwise well-appearing with normal vital signs upon initial evaluation, in light of hypersensitivity reaction at injection site and unclear origin between administered vaccines, patient referred to local Allergist Dr. in Allergy/Immunology for further evaluation and treatment. Benadryl Q6-8 hours for symptom relief. Immediate evaluation advised if fever, cough, conjunctivitis, sore throat, or body papular rash, per Dr. Per Dr. advised to follow-up in one week if no improvement, sooner if symptoms worsened. Patient was seen by Dr. on 11/20/17, consult notes and subsequent recommendations awaiting provider completion, status currently pending. Awaiting recommendations and consult notes from Allergist Dr. Office will continue to follow patient status and family to ensure optimum coordination of care, providing any updates as available.
Patient reported that half of her body was bruised (Black and Blue)... she went to the ER 3x... 06/18, 06/20, and on was admitted on the 06/21 she was diagnosis with acquired hemophilia
Bilateral eyelid swelling that started about 4-5 hours after vaccination and worsened within 24 hrs.; This is a spontaneous report from a contactable other health care professional (patient).   A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EN6198 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 01Mar2021 at 11:15 (at the age of 34-year-old ) as DOSE 1, SINGLE for covid-19 immunization.  The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 01Mar2021 at 17:00, reported as about 4-5 hours after vaccination, the patient experienced bilateral eyelid swelling and worsened within 24 hrs. Therapeutic measures were taken as a result of event included Benadryl. The outcome of the event was recovering at time of report.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a male physician with no medical history or allergies who on 02-OCT-2007 was vaccinated SC once with a 0.65 ml dose of Zostavax. There was no concomitant medication. On 02-OCT-2007, after vaccination the patient developed high fever, nausea and vomiting. The patient received some intravenous fluids. It was reported that the physician could not work on 03-OCT-2007 due to symptoms. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. The patient's experiences were considered to be disabling by the reporter. Additional information has been requested.
Received Tdap on 6/9/08 at 11:30 a.m. Within 8 hours--extremely achy joints and neck which continued throughout.  Fever at 1 1/2 days. Nerve pain in front left hip and thigh at 1 1/2 days that did not persist (half hour) Constant fatigue.  Sporatic nerve "jumping" throughout hole body. At 3 days nerve jumping was constant but unpredictable. Blood pressure at 160/120, pulse normal in doctors office. Labored breathing, sore throat, ear pain. Feeling of body/mind detatchment. At 3 1/2 days..tingling sensation in left toes and up left side of left calf.  Slight tingling on right large toe for about 3 hours then  disappeared. At the 4 day mark things started to get better..blood pressure was back to normal 117/72. Still had nerve impulses with some desensitivity of the skin, again sporatic and in short intervals, (1-2 minutes) in unpredictable areas of my body.  Neck was still sore and tight until the 11 day. Noticable left side soreness, tightness in bones and muscles. On the 9th day lower back ache, left side as well until the 11th day.Doctor was not sure what to do especially about my blood pressure, She contacted BOH which was NO help.  By the evening of the 3rd day she diagnosed it as Variated Guillen Barre Syndrome and requested that I go to the emergency room for observation.  I assured her that symptoms had gotten any worse, that I would.  I was not to be alone.  Returned to Doctors  office on 6/16/2008 (one week) with only left side effected.
Hot at site, swollen, red, itchy. Site spot continued to grow and wrap around arm. Difficulty breathing, swollen eyes, lips and mouth. Took 75mg-100mg of antihistamine every 4-6 hrs to stop adverse symptoms. Took ibuprofen early and it did not have any effect on symptoms,
Nausea, dizziness beginning approx 24 hrs after anthrax # 1 given. Treated with Phenergan po.
The pt complained of "numbness, tingling" of the right shoulder, neck, upper back, arm, hand and fingers. Also complained of breast pain. Onset within 15 mins post administration of vaccines.
Sore and pain at injection site.  Time: Started 3 minutes after injection. Injection was 10:45 AM ET on 4/19, 2021. symptom worsened, and I followed CDC website recommendation on moving the arm and applying wet cloth on the area. Moving arm and applying  wet cloth were both helpful.  The worst time was around 5:30 PM since I napped between 5PM to 5:30PM. After I check CDC website and applied wet cloth on the area around 6PM, the symptom started to get better.  On 4/20, 2021, the symptom lessens. I still moved/used my right arm and applied wet cloth on the area. On 4/21, 2021, the symptom was gone.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Alendronate. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th July 2018, 6 hrs after receiving SHINGRIX, the patient experienced shivering, and pain. On 26th July 2018, less than a day after receiving SHINGRIX, the patient experienced stomach pain, fever, loose stools, dizziness and headache. On 27th July 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the shivering, fatigue, dizziness, stomach pain, fever, loose stools, pain and headache were recovered/resolved. It was unknown if the reporter considered the shivering, fatigue, dizziness, stomach pain, fever, loose stools, pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 26th July 2018, 6 hours after receiving SHINGRIX, the patient experienced achiness and shivering and on the same day, less than a day after vaccination, the patient experienced headache, stomach ache, fever, loose stool and dizziness. On 27th July 2018, 1 day after receiving SHINGRIX, the patient experienced fatigue. The patient reported that, the representative nurse was very, very kind, and sympathetic for her side effects that she had with the SHINGRIX vaccine, and the only thing that did not get resolved knew whether she was going to have another reaction when she had the second shot. So, it was not a good experience, as far as her shot, but the patient's experience with the representative nurse was excellent. The patient planned to follow-up with her physician on an unknown date. This case has been linked to the US2018139538 and US2018139534, reported by the same reporter.
Agency woke up with a fever of 102 degrees Fahrenheit on 10/20/22 along with cough and wheezing. She was taken to urgent care the following day and was diagnosed with croup and treated with oral dexamethasone.  I don?t believe this is an adverse reaction from the vaccine. She just got sick with a virus from daycare that caused her croup.