chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is a 22 year old female who received her primary smallpox vaccination on 2 Dec 06, because of a no take she was revaccinated on 9 Dec 06 and 15 jabs. Within a couple of days she began to notice a reaction at the site. She denied fever but stated she felt tired and noticed increase lymph nodes. Six days following repeat immunization on 15 Dec she noticed pain in the left of her sternum and under her left breast. The pain would last a second or two and the subside. Pain would occur approx 2 times daily and would either be under her breast or left of her sternum. Pain not associated with activity or changes with change in position. She stated that the pain would take her breath away for about 1 second. No diaphoresis, SOB, N/V or radiation. She states that she never had pain like this before. She was advised to seek medical treatment and went to the hospital on 19 Dec. She stated they did and EKG and drew blood. Because her D Dimer was elevated she had a CT done and that was neg. She was told that she had atypical chest pain. Currently she states that her vaccination site is healing well and starting to scab over. She states that her pain is decreasing and did not have any pain today. Symptoms chest pain start 12/15/2006 comment sharp, L of sternum under L breast.
Patient called the office on 4-16-08 stating that she developed a rash on her chest, arms, and back the evening after her vaccine.  Patients that she feels fine otherwise.  Advised pt to take Benadryl, call back if needed; no further vaccines (HPV).
first dose was administered at 11:24am. Patient came back to the clinic at 2:20 complaining about itching all over the body, trouble breathing. EMS was called. while waiting on EMS RN gave 15mg of Bendaryl p.o, When EMS arrived EPI was given.
Intense shoulder pain for 2 days. No pain at injection site.  I needed to cradle shoulder and protect its movement.  Pain in arm pit and front of shoulder joint. Subsided some for 10 days then returned with a vengeance 10/31/2016.  Doctor prescribed Prednisone 5 day course.
2 and half months old patient was administered a dose of Kinrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30-SEP-2022) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 and half months old patient was administered a dose of Kinrix.). The outcome of the inappropriate age at vaccine administration was 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: 09-MAY-2023 The reporter informed that a patient was administered a dose of Kinrix. 2 and a half months patient was administered with a dose of Kinrix which led to inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter. HCP didn't mention administration date. The reporter consented to follow up.
burning at the injection site; received most of the dose, not all; This case was reported by a other health professional via call center representative and described the occurrence of injection site burning in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number GS57B, expiry date 29th September 2023) for prophylaxis.   On 1st November 2022, the patient received the 1st dose of Shingrix. On 1st November 2022, less than a day after receiving Shingrix, the patient experienced injection site burning and incomplete dose administered. On an unknown date, the outcome of the injection site burning and incomplete dose administered were unknown.   It was unknown if the reporter considered the injection site burning to be related to Shingrix.     Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The medical assistant reported that the patient received her first dose of Shingrix in unknown arm and jerked her arm toward the end of the administration when it started burning at the injection site.   The reporter believed that the patient had received most of the dose, but not all.  At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received most of dose, but not all, which led to incomplete dose administered.
Patient arrived to receive Pfizer vaccination. RN obtained new vial of Pfizer vaccine. Lot #301358A Exp Date: 11/2021 Nurse drew 0.3 ml of medication, and confirmed with patient and assisting RN dosage, medication, and vaccine information. RN administered dosage to patient. Patient was given vaccination card and instructed to be monitored for 15 minutes.  The administering RN read the Pfizer vial afterwards to discover that the medication should have been diluted with a saline solution. The patient received the concentrated amount of .03 of the Pfizer vaccination. Dr. CMO and OccMed Manager, was notified. The patient was immediately notified of the error, and Dr. closely monitored the patient. The patient declined to go the ED for overnight observation at the advice of Dr.  Patient c/o headache and cervical muscle soreness, fatigue, sore throat, left earache, left jaw pain in right arm . 2nd Pfizer vaccine at the discretion of the patient and Dr. Patient has followed up with Occupational Medicine on 09/07/21 with Dr.  No work restrictions. OccMed will follow up with patient on 09/20/21.
A significant intolerance for activity. Generalized Fatigue. Feeling wiped out after a normal course of activity. Energy level greatly decreased.
5CM  IN  DIAMETER RED AND WARM LESION WITH DTaP IN THE MIDDLE. NO DISCHARGE IS PRESENT. NO FEVER . AND NO OTHER SYMPTOMS.
I received the 1st dose of the SHINGRIX vaccine. Before the vaccine I was active. A month after the injection, I started to notice that I was having difficulty walking, difficulty with my balance, I fell frequently and suffered from extreme fatigue, feeling hot in areas that moved around my body, ice cold hands and feet.
Vertigo has lessened since the weekend of the injection but still present everyday. disorienting and concerning.  Fatigue comes in waves but often hard to push through has not improved since injection.  Concerned about amplification with the 2nd vaccine scheduled for tomorrow.
Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; This is a spontaneous report from a contactable nurse (patient).  A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), via an unspecified route of administration on the right arm on 18Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included Gyn issues, migraine and headaches but otherwise healthy. The patient also had allergies with sulfa, leminine, and latex sensitivity but not anaphylactic. Concomitant medications included elagolix sodium (ORILISSA), and calcium carbonate, colecalciferol, phytomenadione (VIACTIV). It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination.  On 19Dec2020 14:00, the patient experienced nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
Adacel that was given to an 11 year old instead of Daptacel with no AE; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (lot number: not reported, expiry date: unknown) via unknown route and site on an unknown date for prophylactic vaccination (wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the Wrong vaccine administered (latency: same day).  At the time of report, no adverse event 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 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.  There will be no information available on the batch number for this case.
flu like symptoms; achy; chills; tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain, chills and tiredness. On an unknown date, the outcome of the influenza-like symptoms, pain, chills and tiredness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after the first shingles shot the patient had the flu like symptoms (achy, tired, chills) for 48 hours. The patient did not have indigestion the first time. The patient wanted to know if it was a side effect anyone had experienced. For tolerance of 2nd dose refer case US2020AMR074730.
The third day after my injection I had extreme tiredness and body aches and a headache. I called out of work, I work in a hospital. Then on April 27th I went to the DR for the mentioned symptoms. The DR put me on some antibiotics and did some tests. I had already reached out to my Gastroenterologist for an appointment later in July but on July 19th I went to the ER. I was admitted to the ER with a UTI and a positive C disc and was dismissed on the 22nd of July. Actually, by the way I had COVID in June of 2020. I have not worked since July 19th 2021.
10 days post COVID19 booster developed hives and was prescribed prednisone 40mg daily x 5 days. Hives subsided but dermatographia has continued. Taking certirizine 10mg daily under the instruction of dermatologist.
pt recv vax 5JUL96 & 9JUL96 pt exp nausea & felt bad; sx cont;
Approximately 23 hours after vaccination, both arms became so stiff I was unable to move them. I then began to have horrible chills. I was unable to move. This lasted for approximately 6 hours. I took ibuprophen and asprin. I was OK the next day.
High fever over 104 for over 24 hours, gave Tylenol to bring down fever.
development of superior sagittal sinus thrombosis with right mid to posterior cortical vein thrombosis with associated venous infarction
After 13 days, she was not using her arm to get up.  Very sore at injection site.  No visable  redness or inflammation.  2nd day she said it felt better.  3 rd day, not using the arm again.  Can?t raise arm over head.
10:00 PM 2/13/21: chills, 103-degree Fahrenheit fever, soreness at the injection site, full-body muscle aches - this lasted for 24 hours. This was followed by 12 hours of a lower fever and cold sweats. This was followed by 12 hours of a throbbing headache all over my head whenever I sat or stood up. After this, all symptoms resolved.
Information has been received from a 31 year old female Doctor of Pharmacy who "years ago" was vaccinated with MMR II. Subsequently, when a titer was drawn not "too long ago" the patient failed to seroconvert. The patient sought unspecified medical attention and received a booster dose. There was no PQC complaint. Additional information has been requested.
Self resolved tachycardia 100-130 6pm x 48 hours, subsequent focal hair loss
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 at 10:00 as dose 1, single (Lot number: FL2249), in left arm, on 08Feb2021 at 13:00 as dose 2, single (Lot number: FL9262), in left arm, on 18Aug2021 at 09:00 as dose 3 (booster), single (Lot number: FD8448), in left arm and on 16Feb2022 at 10:00 as dose 4 (booster), single (Lot number: Fl3209) at the age of 75 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "CVID" (unspecified if ongoing), notes: Have CVID take subcutaneous, Xembify weekly. The patient had no known allergies. Concomitant medication(s) in 2 weeks included: XEMBIFY, start date: 31May2021. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; virus free, notes: Tested almost virus free; Positive, notes: Test showed strong virus presence, stronger than any prior test. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient felt better after third day, completed the course. Tested almost virus free. A couple of days symptoms flared back up and got worse than before treatment. Test showed strong virus presence, stronger than any prior test. Started running a fever again. Still felt pretty lousy. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date was on 10Jun2022 and treatment stop date was on 14Jun2022.  No follow-up attempts are possible. No further information is expected.
red and sometimes burns.; rashes that look like eczema or psoriasis around the trunk of my body; red and sometimes burns.; itching in other places; rashes that look like eczema or psoriasis around the trunk of my body; rashes that look like eczema or psoriasis around the trunk of my body; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm, on 28Feb2021 at 15:00 (at the age of 71 years old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs.  There were no concomitant medications. The patient previously took BNT162B2, at left arm on 07Feb2021 at 15:00, as 1st dose, for COVID-19 immunisation; and, codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 05Mar2021 at 13:15, starting a week after the injection, it was reported that the patient began getting rashes that look like eczema or psoriasis around the trunk of her body. For 2 days, the patient also had itching in other places that did not have patches particularly on her head. The patient took diphenhydramine (BENADRYL) for 3 days, and the itching seems to have subsided and the patches may be improving. No new foods or detergent. The patient underwent laboratory test and procedures for nasal swab on 04Mar2021 and 11Mar2021 and showed negative. The outcome of the event itching was recovering, while for the remaining events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient given dose for pediatric patient 5 to 11.  Was 12 years old at time of dose.
received my first vaccine in 2019 but have not received my 2nd vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. The patient received his or her first vaccine in 2019 but did not receive 2nd vaccine till the time of reporting, which led to incomplete course of vaccination. The reporter enquired did he or she need to get the 2nd vaccine or would have to start over again. The follow up was not required.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 03-NOV-2021, the patient was vaccinated with a non-supported temperature excursion (improperly stored dose) (product storage error) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot number T030749 and expiration date 16-MAR-2023 (route of administration was not provided) for prophylaxis. There was no additional adverse event reported. Administered doses of vaccine experienced the temperature excursion of -0.45 degrees Celsius (°C) for 1 hour. There was previous excursions reported of 0 °C for 3 hours. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-2111USA002691.
Fever of 101, shivering, fatigue, nausea, severe muscle/joint pain starting at 2 hours after vaccine admin and lasting  for 36 hours. Severe muscle pain lasted over 48 hours. Aggravated well controlled chronic pericarditis causing chest pain that has continued since the original admin of the vaccine and lasting at least 4 days after.
Terrible flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Terrible flu like symptoms) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Terrible flu like symptoms) and PYREXIA (Fever). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Terrible flu like symptoms) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) 102 degree temperature.         Concomitant product information includes daily vitamins   This case was linked to MOD-2021-388755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received and contains no new information.
When injected noted sharp shooting pain up shoulder.  Site was three fingers down and also above arm pit. Site confirmed by site contact as well. Ice applied
Patient had a fever of 101 overnight. She took aspirin. She had a headache this morning.
Right when I got the 1st covid-19 vaccine it burned and hurt while it was getting injected. I then had a HA felt nauseous and dizzy right away. Nurse was alerted. I then became ill and had almost all the symptoms headache, fever, chills, bodyache, night sweats, cough,dizziness and nauseous that flactuate for 14 days. I had to go to the UC and  they did some test on me. They thought I had a kidney infection but result came back negative. I was given antibiotic double strenght by the UC provider and that made me more sick. I had to see my Primary care provider and she gave me a different antibiotic to use.  My 2nd covid 19 vaccine I had a headache on the same day and was only sick for 7 days. Headache, fever, bodyache, cough, dizziness and night sweat. I am starting IVF and had to get my blood tested. I have always been O+ and both my parents are O+.  The fertility clinic and another facility had tested my blood as A+. That is impossible from an O+ to become an A+.  Did the vaccine changed my blood type? I had never had a bone marrow transplant or diagnose of any illness that would change my blood type. This is a life threatening situation for me because all my life I have been an O+ baby.  Now I am being told I am A+.  So what is actually happening?  What do I tell people if I ever need a blood transplant? Is the change permanant?  Will it change back to O+?  I Can die if my blood change back to O+ and I was giving A+ blood.
Pt. received ZOSTAVAX vaccine 4/5/10 and started to have a reaction first day if shot. Itching, swelling, and redness where shot was administered. Triamcinolone acetonide 0.52 % was prescribed and reaction healed over the course of 3 days.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 29-DEC-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult 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 18-JUN-2016, the patient was treated at a health center for the onset of a severe vesicular rash accompanied, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Breakthrough case after two vaccines  Pfizer 3/11/21 Lot# EN6199;  Pfizer 4/1/21 Lot# Er8733
On approximately March 27, two weeks after Janssen vaccine, patient began having pain in right hip and started to have difficulty with walking and using stairs. Between April 3 and 10th patient began having severe right hip pain. She was unable to do stairs and had pain with ambulation.  She contacted her family physician but was unable to get in to see her until May 17th. patient was still having the severe pain in her right hip. Doctor ordered x-rays and blood work which did not have any unusual results. The doctor thought possibly sciatica or nerve pain. Pain in hip is slowly improving but now that info is out about guillain-barre syndrome she feels that could possibly be the cause. patient is contacting doctor to determine diagnosis.
Chills, fever, nausea, vomitting, diarrhea,  and body aches