chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. On 07-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10PK 50U/1 mL) lot number K008984, expiration date 0f 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temperatures: 34F for 64 hours and 33 F for 16 hours. No highest temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Fatiguue, ache in arm, large firm red ring around injection site; lasted for 8 days before stopping  Ring appeared again 4/8/2021 (lighter color, but still a large red ring around the old site) after contracting a sinus infection and taking Doxycline to prevent a relapse of pneumonia (prescribed by Kettering Health Network On Demand Care on 04/03/2021)
Mother states patient developed hives and whelps at approximately 1930 on 11/20/2006. Denies difficulty breathing or any respiratory distress.
SORENESS, HEADACHE, FEVERS, NUMBNESS FOR 48 HOURS AFTER VACCINATION
15 minutes after receiving MMR and influenza vaccine, fell suddenly to the floor while watching sister receiving a vaccine. Noted bruising and small laceration over right ear.  Child was crying and stated his head hurt.  BP=80/60; Pulse=100; R=20.  EMS transported child to ER. Report will follow.
Menstrual bleeding continued for 19 days, then immediately resumed after receiving the second shot.  Much shorter duration after the second shot (3 days.) *Not due to normal menstrual cycle, which has been regular and never with excessive or prolonged bleeding.
Site: Redness at Injection Site-Medium, Additional Details: Patient got benadryl and will treat herself.  She said it was mild and will contact us if it becomes more severe.
First day out had pain behind right ear, thought it was muscle but went into my head, lasted 4-5 days now I have severe tenitus in right ear and my head has not felt right since. Like my hearing hoes in and out. I thought it would go away but it?s been two weeks. My head feels cloudy and my right eye feels messed up like blurry. No other injury have occurred. This all started a day after the vaccine.
Multiple maculo papulo lesions blister like some, urticarial UUE most.
Sore and very itchy injection site, unlike first 2.  Very itchy.  Headache on most days since the last vaccine.  I had headaches a few times after the 2nd, but they didn?t last long.  I have had intense headaches on-going since the 3rd vaccine.
A non-serious spontaneous report of administration of full dose in one nostril was received from a pharmacist concerning a 38-year-old female subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 23-Sep-2009, the patient inadvertently received a full dose of FLUMIST into one nostril. There was no adverse event associated with this vaccination error, therefore treatment and reporter sponsor causality assessment are not applicable and the event is considered to be resolved.
Hives developed on 1/14/2020 B/L lower extremities. Medications: Hydrocortisone cream and Claritin PRN Outcome: Improving
Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3102) via an unspecified route of administration in the left arm on 01Sep2021 at 20:45 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported as not applicable. On 05Sep2021 at 00:00, the patient experienced loss of taste and smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events loss of taste and smell was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Received vaccine at 9:30 am, began exhibiting symptoms around 7 pm. Symptoms included fever (101+ for over 12 hours), chills, full body aches and pains, sharp headache, pain at injection site, disorientation. It has now been over 28 hours since receiving the vaccine and the fever, aches, and chills are persisting.
C/o vomiting 2 days after received vaccine then started allergy type symptoms runny nose, sneezing then rash started 4 days later - c/o getting worse. Went Dr. on 9/7/11 and given pain medicine because rash painful. Rash generalized but mostly on face. Clt. returned follow N.P. 9/12/11 and tx antibiotic - rash dark red to black & circular.
circular redness around site with no pain, minimal swelling; circular redness around site with no pain, minimal swelling; chills; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), INJECTION SITE SWELLING (circular redness around site with no pain, minimal swelling) and INJECTION SITE ERYTHEMA (circular redness around site with no pain, minimal swelling) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 03-Apr-2021, the patient experienced CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue). On 05-Apr-2021, the patient experienced INJECTION SITE SWELLING (circular redness around site with no pain, minimal swelling) and INJECTION SITE ERYTHEMA (circular redness around site with no pain, minimal swelling). On 04-Apr-2021, CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. At the time of the report, INJECTION SITE SWELLING (circular redness around site with no pain, minimal swelling) and INJECTION SITE ERYTHEMA (circular redness around site with no pain, minimal swelling) outcome was unknown. Not Provided          Concomitant information use was not reported.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-068983 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068983:
Patient presented to the ED on 1/4/22 for elevated bilirubin. This visit was within 6 weeks of receiving covid vaccination.
Resident experienced chills, fatigue, nausea, coughing, weakness, loss of appetite, and tachychardia on 2/15/21. She was transferred to the ER and admitted to the hospital (attached to nursing home) for NSTEMI and cholelithiasis/cholecystitis.
patient received Pediarix (combination Dtap, IPV and Hep B) lot number B4722 AND. a dose of Hep B (lot number LP724) at the same appointment
Day of Booster shot- soreness in arm,  Day 2- low energy,  headache  Day 3- lingering headache Day 4- lingering headache, borderline migraine
Severe Swelling of Lymph nodes under arm, (left). Persistent, chronic pain in muscles and joints
10/26/12: Patient's left arm is swollen and painful touch after receiving PNEUMOVAX 24 hours earlier. 10/28/12: Arm still swollen and tender - pt via doctor is to take IBU for pain/swelling. He says it feels better everyday.
p/vax inc T & constant crying; admitted via ER; septic work-up neg; Annual follow-up received on 2/21/01 provided no additional data.
My cousin who had just gotten this shot. She broke out/Suspected vaccination failure; She broke out; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (the patient's cousin and grandmother had shingles).   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 Information: GSK receipt date: 6-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient was reporter's cousin who had just gotten this shot and she broke out. The reporter got shingles once and his/her grandma did too. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
extreme headache, fever over 103 for multiple days, fatigue, weakness, difficulty breathing, pain around heart for two days
I took the first Hep B injection on January 16th, 2007. Approximately 1 1/2 weeks after that I began to experience joint pain in my right arm. The second injection was given on February 13th, 2007. The pain in my arm had increased from the elbow area to my shoulder and finally my entire arm. I went to the doctor on 2/19/07 and was diagnosed with what seemed to be 'tendonitis'. I wore a brace on my right arm for over 2 months. The pain lasted much longer than the doctor had initially suspected it would. Thereafter I began to experience additional joint pains that would last from 2-3 days in one area and then move to another area. The joints affected were my knees, shoulders, arms, hands. The third and final Hep B injection was administered on June 14th 2007. Still experiencing intense joint pain that finally became unbearable, I ended up back in the doctor's office on October 19th, 2007. Lab work was ordered and it was discovered that I had a high Rheumatoid Factor. I began to see a Rheumatologist shortly thereafter and I was diagnosed with full blown Rheumatoid Arthritis. I began Plaquenil treatment with no success. Methotrexate was added, with a steady dosage increase, with still no success. My test results are higher each month than they were the month before. I am about to add a third medication to the treatment program which is 'injectable' Humira. I am also on Prednisone therapy. I have always been very healthy. This disease attacked my body very suddenly, very unexpectedly, and is progressing at a rapid pace. There is NO genetic history of Rheumatoid Arthritis on either side of my family. I had often wondered if the Hep B vacination could have had anything to do with the sudden onset of Rheumatoid Arthritis, but did not mention it to my doctor until two days ago. Since that time I have learned of the case studies and possible links between immunizations and Rheumatic disease.  7/31/2008 MR received from rheumatology consult dated 3/20/08-7/9/08 with DX:  Seropositive RA.  Pt reports onset of joint pain, stiffness and inflammation beginning 10/2007.  Pt dx with RA based on earlier labs. PE (+) for limited ROM of the R shoulder. Swelling of MCP, MTP & PIP joints with dusky color/redness and warmth. Joints are tender. Knees show swelling and effusion. F/U 7/9/08 with continued pain, swelling and stiffness in hands, ankles, and feet.  PE (+) for joint synovitis, tenderness and effusion.  Only partial resolution of sx with meds.
possible kidney stones/has experienced a possible kidney stone or some type of kidney function problem; possible kidney stones/has experienced a possible kidney stone or some type of kidney function problem; she has very frequent urination and would say she urinates 15-20 times per day and in large quantities; she has blood in her urine also; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EP6955 via an unspecified route of administration, administered in right arm on 29Mar2021 09:48 as single dose for Covid-19 immunisation. Medical history included atrial fibrillation from 2007. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation and levothyroxine. On an unspecified date, over the last few days, the patient has experienced a possible kidney stone or some type of kidney function problem; she stated that she went to the HCP and they wanted to start her on an antibiotic tomorrow or the next day and she has to have kidney function tests and different things like that and she is not really sure and does not think this is related to the Pfizer Covid vaccine but thinks it is a kidney stone. The patient has very frequent urination and would say she urinates 15-20 times per day and in large quantities and it is ongoing and has been pretty much the same as when it began. Stated she has blood in her urine also. The outcome of the event polyuria was not recovered. The outcome of other events was unknown.
2nd dose given too early, 1st dose 12/29/21, 2nd dose 1/14/21
CDC reports: 2 mo infant had temp 99, local rxn & screaming episode following DTP/OPV immunization, Duration of illness 1 day.
he received the Arexvy Vaccine, as a SC injection by his pharmacist, instead of an IM injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-AUG-2023, the patient received Arexvy (subcutaneous). On 27-AUG-2023, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: he received the Arexvy Vaccine, as a SC injection by his pharmacist, instead of an IM injection).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The reporter was the wife of the patient. The reporter had no further information available about this event. Consent to follow up with health care professional was not asked as the patient was not there. This is report 2 of 2 reported by same reporter.  The patient received Arexvy vaccine 3 pm as a subcutaneous injection by his pharmacist, instead of an intramuscular injection, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2023118662:1st report
Became very ill within hours of receiving Anthrax vaccine. Shortness of breath, achy, chills. Lasted for days afterwards. Still have chronic respiratory problems.
10 days after initial shot right arm flared red, irritated and hot for a few days, went to urgent care
B Uveitis (par planitis) treatment with steroids on-going 04/25/07-records received from PCP-eye exam by ophth on 4/5/07-3 week history of blurred vision in left eye. Ocular exam slowed acuities of 20/20 OD and 20/30 OS. Right eye had a few keratic precipitates, trace vitreous cells and a nevus along the superior arcade. Left eye had keratic precipitates, 10 AC cell/hpf, much more vitreous cell, pars plana exudation and mild macular edema. DX:acute bilateral uveitis most like pars planitis. PMH: anxiety.
slight nausea off and on for about a week, rashes on arms and back -- no treatment -- nausea still present occasionally
Left Deltoid injection sight with increase redness, warmth, and itching. Aprox. 4 1/2 inches width. Complaints of fatigue, muscle aches, chills for first 24hrs.
Swelling, redness, and itchiness at injection site, headache, nausea, dizziness, fever (highest of 101.2). Delirium due to fever. No appetite. Side effects lasted 3 days.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 15 year old son who experienced a "bad headache" and was "very fatigued".  At 15 years of age, the pt received a dose on 12/23/03. The pt's concurrent illness includes ADHD. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/23/03.  Dose regimen was 0.5mL (IN). Concomitant therapy included Concerta (methylphenidate).  After receiving Flumist at 9:20am on 12/23/03, the pt developed a "bad headache" and became "very fatigued" that afternoon.  No additional information was available at the time of this report.
patient was administered with the product PENTACEL but with sterile diluent with no reported adverse event; Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 months old male patient who was administered with the product Pentacel (DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE) but with sterile diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Nov-2022, the patient received a one dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ680ABA, expiration date: 16-Sep-2023 via intramuscular route in the right thigh as Immunization.  On 30-Nov-2022 the patient was administered with the product pentacel but with sterile diluent with no reported adverse event (product preparation error) (same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Caller was asking some guidance with regards to Pentacel that was administered to a patient separately. The lyophilized portion was diluted with a different diluent instead of the diluent supplied with the vaccine thus wanted to know if that would count as a valid dose.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was administered with the product Pentacel but with sterile diluent with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   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 the guidelines. 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.
Sore throat-WATERY EYES-RUNNY NOSE-worn ousore right shoulder(shot was in left bicep)-Phlegm-hoarseness-
slight fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever) and CHILLS (Chills). At the time of the report, PYREXIA (slight fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported by reporter that her son and sister who had a slight fever and chill which lasted the afternoon they got the vaccine. No treatment medications were reported.   This case was linked to MOD-2022-524342 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up received contains no new information.
Patient experienced headache, nausea, redness at injection site, and left arm tenderness for 24 hours after receiving this vaccination.
lower back pain, right side body pain, chills, sweating, Tylenol, exhausted
Pt vaccinated with FLU developed fever, chills & sweating, cough, runny nose.
Sore arm, hardness the next day. Soon gone. About a week later a not-too-itchy rash on the upper arm. Rash remains three weeks later. It's not too itchy. The injection spot looks like an insect bite.
The Friday after my second shot, I was feeling a tightness/pressure in my chest and SOB. I just didn't feel well, but continued on with my plans. I had a cocktail and felt better. The following Thursday (02/11/2021) I was taken from work in an ambulance with the same symptoms. I was admitted to the hospital for an echocardiogram and stress test the following morning,and given nitro paste and heparin. Come morning my troponin had risen to 100, so was sent for an echo and angiogram. When they found my arteries were clear, they sent me for a CT scan for suspected PE. They found nothing,  and Dx was acute cardiac syndrome. I was discharged on 81mg aspirin, 2.5mg amlodipine, and nitroglycerin prn. My birth control was discontinued. The attending cardiologist could only guess I had a coronary artery spasm.
vials were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again).    Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday as reported from vials that were put in the fridge and after that refrozen and thawed again 100 adult male patients were involved, lot numbers unknown to the health care professional.  This case contains information for patient 21 out of 100 patients reported by the reporter.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE