chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a male patient, age not reported. The patient was vaccinated with ZOSTAVAX on or about 16-APR-2014 at a pharmacy for general health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-SEP-2016 the patient was treated at a family practice for a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as herpes zoster or shingles. On or about 13-OCT-2016 the patient sought treatment at another clinic for ongoing and worsening symptoms of herpes zoster infections. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further and proximate result the patient suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Outcome of herpes zoster and weakened immune symptoms was unknown. Additional information has been requested.
Information was received from a pharmacist via a company representative concerning a male patient with unknown age who is a company employee.  No information was provided regarding patient's medical history or concomitant medications. The patient was vaccinated  Intramuscularly with ZOSTAVAX  19400 PFU  (Lot number and dosage unknown) on 07-MAR-2017. The patient experienced "stomach issues" on  07-MAR-2017 after receiving ZOSTAVAX. The patient went to the restroom and the symptoms subsided. The patient recovered. No other information was provided. Additional information has been requested.
3 hours post vax, the pt developed "flu-like" symptoms, but no fever. The pt also experienced a nervous condition, panic attacks, and developed flu like symptoms when doing any activity. Further information has been requested.
Patient describes a delayed onset rash that developed (approx 1 1/2 inch diameter) around the injection site. Rash has since resolved.
fatigue; body ache severe; headache; arm left pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PAIN (body ache severe), HEADACHE (headache) and PAIN IN EXTREMITY (arm left pain) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PROLIFE for Asthma, ASCORBIC ACID (C VITAMIN), VITAMIN D3, ZINC and VITAMIN B COMPLEX for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), PAIN (body ache severe), HEADACHE (headache) and PAIN IN EXTREMITY (arm left pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue), PAIN (body ache severe), HEADACHE (headache) and PAIN IN EXTREMITY (arm left pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications, Allergy medication Vitamin C, Vitamin D3,Zinc,Vitamin B complex,Prolife (medication for asthma).
I have had three months of intense pain similar to a current of electricity radiating from left shoulder down to four fingers on left side. I have had a significant loss of mobility and use of my left arm and hand as it feels similar to when you've had a limb that has fallen asleep and you suffer the intense tingling and discomfort. Sleep, working on my computer, cooking etc has all been painful as the pain is constant and does not diminish nor go away for any period of time. I have cut and burnt my fingers as I have a loss of mobility and sensitivity on all fingers other than a mild impact to my thumb. I had hoped that given time it would dissipate however it has not. My most recent symptom is pain and intense itching in my left palm and increase in the tingling in my elbow. Dr. prescribed a week of steroids in addition to gabapentin to assist with the pain. Unfortunately, I am almost at four months post injection and the pain continues to be chronic and has not reduced in it's intensity.  Dr. had concluded that the shot may not have been properly administered and hit a nerve. I continue to take the gapapentin and had been recently prescribed with tramadol hoping to have some relief of my symptoms.  Both medications slightly improve the intensity of the pain however I do not want to be on these two medications long term.
Pt vaccinated with RecombivaxHB developed rt hemiparesis which persisted for twelve hrs. At time of the report hemiparesis was gradually resolving with some residual rt arm numbness, rt leg numbness, & motor deficit.
pt recvd vax 25APR94 during well child exam 430PM;fussy through noc & early morning;26APR starting about 345PM, began screaming no-stop until seen @ 7PM;unable to console or feed;1 hr later was consolable  & pleasant? delayed immun react;
This spontaneous report was received from a registered nurse who reported that M-M-R II, (lot # not reported), was given to multiple unspecified subjects after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported after the vaccine was administered. This is one of several reports from the same reporter source. Additional information has been requested.
Went home, rested, kept hydrated and did not move arm much as advised. later on when tried to move arm it was painful, had trouble breathing, hoarseness, dry mouth.
loss of appetite; elevated temperature; perspiring chills; shivering so bad; aches on the joint; This spontaneous case was reported by a  and describes the occurrence of DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported adverse event).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint). At the time of the report, DECREASED APPETITE (loss of appetite), PYREXIA (elevated temperature), CHILLS (perspiring chills), CHILLS (shivering so bad) and ARTHRALGIA (aches on the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact.
Patient presented to health clinic with concern for ongoing allergic reaction potentially due to Pfizer vaccine. She received her first Pfizer dose about 3 weeks ago with some fatigue side effects afterwards but no additional reaction. She received her second dose on Fri 5/7 and developed swelling and itching of the lips, tongue, uvula that evening. She denied SOB or abdominal pain, no dizziness. She had a telehealth appt with an ER doc that day and they prescribed 50mg prednisone daily x1 week as well as daily benadryl and pepcid. She was also given an epipen to take with her. She started taking the medications and the symptoms resolved, however, she forgot them at home this morning and now has developed throat itching without swelling. She has no additional symptoms, no abd pain, no dyspnea, no rashes. She denies any hx of anaphylaxis, she had one episode of hives from an unknown source years ago but no additional known allergies. Vital signs are normal today.
Brain fog; anxiety; (minor) sudden brief sharp headache; soreness at injection site; This is a spontaneous report from a contactable consumer reporting for self.  A 81-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL9261,via an unspecified route of administration on 19Jan2021 15:30 (at the age of 81-years old), Dose 1, as a single dose, left arm  for COVID-19 immunization.  Medical history included high cholesterol and hypothyroidism.  The patient had not been diagnosed with COVID-19 prior to vaccination. Concomitant medication included levothyroxine, guaifenesin (ROBITUSSIN), and rosuvastatin calcium (CRESTOR).  The patient did not receive any other vaccinations in the 4 weeks prior to the COVID-19 vaccination. On 19Jan2021 at 15:45, the patient experienced brain fog and anxiety, which lasted approximately 20 minutes. Also (minor) sudden brief sharp headache and soreness at injection site. There was no hospitalization for the events. The patient received treatment for the events, reported as "Calming talk, deep breathing, rest." The events were reported as non-serious. The patient recovered from the events brain fog, anxiety on 19Jan2021 at 16:05 and recovered from sudden brief sharp headache and soreness at injection site on unspecified date(s). The patient had not been tested for COVID-19 since the immunization.
patient described having usual soreness at the immunization site, but said the soreness started to travel down to fingertips. The next evening the patient noticed hive marks around the area. They marked the area affected and reports that it increased by about an inch the next morning. Marks are not itchy but described as not normal feeling.
pulse rate 140, 10 mins p/inject 9AM BP 120/68; lightheaded, queasie; slept 4 hrs & felt fine;
this is 1 of 6 pt from this site to have an unspecified adverse exp p/vax;
Patients daughter reported her mother had a stroke (cerebral thrombosis). Patient was admitted to hospital on  3/28/21. Patient has surgery and was admitted to the ICU. Patient also has rehabilitation. Patient is currently recovering at home .
After 1st dose 1/6/21 at 6:10am I had severe chest pain, Went to ER . Had a cardiac cath that day and a stent placed in my LAD
Had the common side effects: headaches, fevers up to 101.5, severe body aches, fatigue in the the morning after the shot, but also had concurrent severe vomiting and nausea.  Vomited approximately 20 times day after the vaccine, starting about 18 hours after the vaccine.  Other symptoms were present about 13-14 hours after the vaccine.  Vomited continued for 14 hours.  Severe nausea continued for 2-2.5 days.  No diarrhea.  No abdominal pain.  Too weak to drive to the ER.  Had Zofran at home and took 8 mg of Zofran ODT every 4-6 hours for 36 hours beginning with the onset of vomiting.  Missed 3 days of work but was able to orally rehydrate.
Arm extremely sore, red and swollen at the injection site. There is actually like a knot at the injection site.
received an expired hib vaccine with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old female patient who experienced received an expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria, Tetanus and Acellular pertussis vaccine (Daptacel) for Immunisation; and Pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 17-Oct-2023, the patient received an expired 0.5 ml dose of suspect HIB (PRP/T) vaccine (frequency: once; Strength: standard) Powder and solvent for solution for injection of lot UJ73AA and expiry: 07-Oct-2023 via intramuscular route in the left vastus lateralis for immunization, with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.   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 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.
I got the vax 3 years ago and got shingles last Friday/Suspected vaccination failure; Got shingles last Friday.; Nerve pain; Pain; tingle in my left eyebrow; swollen blsiter; swollen blsiter; shooting arrows into my head; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles for 41 years.), tingling skin, blister, swelling, pain, headache and nerve pain. Previously administered products included Antiviral.   On an unknown date, the patient received Shingrix. In June 2022, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache. On an unknown date, the outcome of the vaccination failure, shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pain, tingling skin, blister, swelling and headache to be related to Shingrix.     Additional Information: GSK receipt date: 11-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles for 41 years. The patient lost count how many times he/she had shingles. The patient felt a tingle in left eyebrow. That was where it always started. It turned into a horrible, swollen blister that was incredibly painful. The patient stated that he felt someone standing over him/her shooting arrows into head. The patient got immediately 2 scripts, an anti- viral and 1 for nerve pain. The patient got the Shingrix vax 3 years ago.  The physician said he/she would never get shingles again. Unfortunately the patient got shingles last Friday. Same place, same pain, same yuck. 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 not provided.
Patient miss his second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient miss his second dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient miss his second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient miss his second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a pharmacist refers to an 84 year old female patient with penicillin allergy, sulfa allergy and diabetes. The patient's medical history included unspecified cancer and heart disease. On 04-FEB-2013 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # H012519, exp 09-OCT-2013) subcutaneously. Concomitant therapy was unknown. On approximately 08-FEB-2013, the patient broke out in a rash and a lot of pain. The patient developed shingles. The rash was on her right side. The patient visited her primary care physician on approximately 08-FEB-2013. At the time of the report, the patient was still experiencing quite a bit of pain however rash was mostly gone. No lab drawn. The relatedness for the events to ZOSTAVAX was unknown. Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6207) and on 13Apr2021 as dose 2, single (Lot number: ER8729) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 15Dec2021 as dose 3 (booster), single (Lot number: 213D21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol/triglycerides; "Triglycerides" (unspecified if ongoing), notes: High cholesterol/triglycerides. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment; result was fain, notes: Took an antigen test 2 days after finishing treatment and the result was fain compared to the control; result is as strong as the control, notes: Re-took antigen test 4 days after finishing treatment and the result is as strong as the control. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Adverse event: Started symptoms again 4 days after last dose of treatment. Symptoms are mild and include runny nose, sore throat and diarrhea. Took an antigen test 2 days after finishing treatment and the result was fain compared to the control. Re-took antigen test 4 days after finishing treatment and the result is as strong as the control.  No follow-up attempts are possible. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Lot number: Fe3592), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: Flc9895) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing); "pneumonitis" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: now positive AGAIN covid home rapid test checked twice; Positive, notes: now positive AGAIN. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Symptoms started again 27Jun2022 sore throat nasal drainage with a now positive again covid home rapid test checked twice. Adverse event start date & start time reported as  26Jun2022 04:00 AM. No AE treatment and no known allergies .; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
numbness in lower face; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (numbness in lower face) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 013A21A) for COVID-19 vaccination.     No medical history was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in lower face). At the time of the report, HYPOAESTHESIA (numbness in lower face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was taking unspecified antidepressants as concomitant medications.
Information has been received from a physician concerning a 17 year old female who on 23-OCT-2007 was vaccinated with GARDASIL (lot number not specified).  In October 2007, the patient experienced an increase in the number of menstrual cycles.  The doctor is trying an unspecified birth control to help regulate her cycles.  On approximately 14-Feb-2008 the patient received her second dose of GARDASIL (lot number not specified).  The patient sought unspecified medical attention in the office.  Additional information has been requested. Initial and follow-up information has been received from a physician concenring a 17 year old female with no medical history and no allergies who on 23-Oct-2007 was vaccinated intramuscularly in right deltoid with first dose of GARDASIL (lot # 657006/0188U). It was reported that "sometime" in October 2007, the patient experienced an increase in the number of menstrual cycles, previously always regular. Frequency described as every 2 weeks instead of monthly. On an unspecified date, the patient started an oral contraceptives to regulate her menstrual cycles. On approximately 14-Feb-2008 the patient received her second dose of GARDASIL (lot number not specified). The patient sought unspecified medical attention in the office . At the time of this report the outcome was unknown. No additional information is available.
complained of numbness in lips, itchy, dry throat, sharp chest pain and slight shortness of breath.  BP- 149/87, p-81, O2sat- 97% Lungs clear, no wheezing, resp even and unlabored, Chest pain 6/10 and sharp.  Examined by Doctor. 1700-Patient laying on gurney, BP-  125/71, p-80, O2 sats- 98%  EKG-  Normal sinus rhythm, with normal t waves and ST waves (read by Doctor).  Patient given juice 1705-  states feeling better.  Chest pain 2/10, no further shortness of breath, no dizziness,  Patient's daughter did state that her mother's husband had passed away 11 years ago today and that may have contributed to the symptoms. Released home with her daughter with ER precautions