chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with her first dose of GARDASIL. In January 2008, she was vaccinated with her second dose of GARDASIL and pain, nausea, fever and vomiting. Subsequently, on an unspecified date, the patient recovered from pain, nausea, fever and vomiting. The reporter also indicated the patient's sister developed the same symptoms after receiving GARDASIL. Additional information has been requested.
Fever, chills, body aches and fatigue that lasted approximately two weeks. Bruising on deltoid and bleeding gums that started a week later but resolved with steroids.
Received Moderna COVID-19 Vaccine EUA Fever, chills,  extreme fatigue and aches (especially back/shoulders/neck).
dose of ACT-HIB was given to a patient, and realized afterwards it was expired with no reported AE; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from other-health care professional and physician and consumer via [medical information (MI) - 00799417].  This case involves 14 months old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX DTP) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), for prophylactic vaccination.   On 05-Oct-2021, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (total, lot number: UJ399AAC and expiry date 02-Oct-2021) via unknown route in the leg, for prophylactic vaccination.  It was reported "office manager states a dose of ACT-HIB (095 - ACT-HIB) was given to a patient, and realized afterwards it was expired. Vaccine expired on 02Oct2021. Looking for information in regards to any side effects to look out for, as well as if they need to re-vaccinate. A dose of ActHIB was administered to a patient in the leg. The Medical Assistant was attempting to enter the dose in the electronic medical record when the system rejected the dose because it expired on 02Oct2021. It was then that it was realized that an expired dose was administered to the patient. The caller is not able to see in the record which leg was used for the injection site, since the system would not allow the dose to be recorded".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   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.
This spontaneous prospective pregnancy report was received from a 26 year old female patient regarding herself. The patient's drug allergies and pertinent medical history was none. On 23-JUN-2014 the patient was vaccinated with GARDASIL (Dose/Frequency: three shots, got one shot) in the right arm. Concomitant medications were unspecified. The patient became pregnant with LMP of 06-JUN-2014 and EDD of 13-MAR-2015. The patient became pregnant on 20-JUN-2014. The pregnancy outcome was unknown. On 23-JUN-2024, the patient received her first shot of GARDASIL on 23-JUN-2014 after she became pregnant on 20-JUN-2014. The patient inquired as to any side effects she may encounter from receiving GARDASIL. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Headache, Myalgia, Fever, malaise, injection site pain Narrative:
Tiredness - couple of days; Headache - day; Chills - day; Fever - few hours; Nausea - few hours; Couldn't pee or have a bowel movement - few hours
became huge/ swollen; soreness / pain is on the outside muscle of the arm; pain goes into the joint; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (became huge/ swollen), MYALGIA (soreness / pain is on the outside muscle of the arm) and ARTHRALGIA (pain goes into the joint) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (became huge/ swollen), MYALGIA (soreness / pain is on the outside muscle of the arm) and ARTHRALGIA (pain goes into the joint). At the time of the report, PERIPHERAL SWELLING (became huge/ swollen), MYALGIA (soreness / pain is on the outside muscle of the arm) and ARTHRALGIA (pain goes into the joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.
Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318), via an unspecified route of administration on the left arm on 27Jan2021 09:00 at a single dose for  COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included esomeprazole magnesium (NEXIUM), ibuprofen (ADVIL), beclometasone dipropionate (QNASL), diphenhydramine hydrochloride (BENADRYL) and doxylamine succinate (UNISOM). The patient previously took naproxen (ANAPROX) and experienced allergy. The patient experienced mental fog, soreness at injection site, fatigue and fever ( low grade: 1-2 degrees over basal) on 27Jan2021 18:00. No treatment and hospitalization was caused by the events. The outcome of the events was not recovered.
SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Systemic: Fainting / Unresponsive-Medium, Systemic: vomitting-Mild, Systemic: Vomiting-Mild
Had the worst nightmare, all matters of death,Severe nightmare; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Had the worst nightmare, all matters of death,Severe nightmare) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z8AZ1A) for COVID-19 vaccination.     The patient's past medical history included Herpes infection (Herpes shingles in the right eye). Concurrent medical conditions included Post herpetic neuralgia. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Pain management, DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 29-Mar-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 NIGHTMARE (Had the worst nightmare, all matters of death,Severe nightmare). At the time of the report, NIGHTMARE (Had the worst nightmare, all matters of death,Severe nightmare) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided. It was reported that the patient was advised by doctor to receive booster shot because of the reactions experienced by the patient.   This case was linked to MOD-2021-433796 (Patient Link).
Administered all vaccines at 10:00 am, by 3:00 pm, pruritis rash had erupted. Seen in clinic, mild papular-urticarial rash on body. Gave Benadryl. Within 6 hours had resolved. First time Rotateq given.
Joints started to hurt; Extreme fatigue, sleeping 14 hours a day; Diarrhea; Pain at the injection site; Extreme fatigue, sleeping 14 hours a day; Nausea and vomiting; Nausea and vomiting; Headache; sour stomach; Congestion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 27-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), DYSPEPSIA (sour stomach), SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day) and NAUSEA (Nausea and vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced NASAL CONGESTION (Congestion), DYSPEPSIA (sour stomach) and HEADACHE (Headache). On 06-Mar-2021, the patient experienced NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting). On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Extreme fatigue, sleeping 14 hours a day). On 11-Mar-2021, the patient experienced ARTHRALGIA (Joints started to hurt). On 22-Mar-2021, SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day) and FATIGUE (Extreme fatigue, sleeping 14 hours a day) had resolved. At the time of the report, NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), DYSPEPSIA (sour stomach), NAUSEA (Nausea and vomiting), VOMITING (Nausea and vomiting), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) was resolving and ARTHRALGIA (Joints started to hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Laboratory investigations included blood test, lung test, pressure test and heart test were normal.
My father went for his yearly flu shot despite my having told him that I no longer trust what is going on with the vaccines and clinic. I knew there were (wicked) people in the clinic who were hacking their activities and that they were also associated with vaccines and other "big pharma" associates. Two days after receiving his flu shot the palms of his hands started peeling and bleeding. I do not have his med records to indicate which vaccine he received but he has been getting the same one for years from the same place so there should not have been an issue. The peeling and cracking and bleeding of his hands went on for the next year until his passing away in May 2020. He had to use vaseline and wear soft cotton gloves just to get anything done around the house. Then they dumped bleach on the rug in his house and they told me to "drink some bleach". Now everywhere I go, they leave bleach lying around. Don't report hacking in this country lest they try to kill you and your family. I am utterly horrified and disgusted by the stench of the associates. Who better than to kill/assault than a patient and their family (just long enough until they're not)....just to further their own sick agenda. Promoted a blood thinner (Hydroxychloroquine) BEFORE the first autopsies (blood clots) came out in June 2020 - so why has nobody investigated this? Because vaccines are nothing more now than big business. And if you're in the medical field remaining blind to this, open your damn eyes.
pt states that about 20 minutes after getting the vax her neck had a hot, itchy rash.  By the time she was ready for bed she noticed the rash had spread to her face.  When she woke up the next day the rash had developed into hives that covered her neck and face.  Her right eye is swollen shut.  Pt has not taken any medicine for her symptoms and plans to call her PCP for medical advice.
The jab was administered directly into my joint approximately 1 inch from the top of my left shoulder which, at the time, I did not realize was the wrong place.  That evening I was up all night in a great deal of pain from my shoulder and directly across my should blades.  It has now been 2.5 months and I still have limited movement in my left arm and still experience a sharp pain when I move my arm in certain directions.  Hoping this will eventually go away.  I did not have any trouble with the 2nd jab which I had administered into my right arm and in the correct place approx 3 inches below the top of my shoulder.
swollen butthole; This case was reported by a consumer via call center representative and described the occurrence of anorectal swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anorectal swelling. On an unknown date, the outcome of the anorectal swelling was not recovered/not resolved.   It was unknown if the reporter considered the anorectal swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comments:  The reporter reported to the agent that the patient received the Shingrix vaccine  The patient butthole was now swollen.  The reporter asked for further details, the caller promptly disconnected the call.  The reporter did not consent to follow up.
The clinic nurse did not dilute the dose and my child was given an undiluted dose straight from the vial of the bivalent booster.
Diarrhea x 1 day, swelling and redness to the site of injection (right arm).  Rash to thighs and back x 3 days (began 2 days after the vaccine). There was  associated pruritus. "My arm swelled, turned red, got hot . I used ice packs for 3 days 2-4  times a day. I had a rash on my back and sides; less rash on my arms and chest.  Day 4: Arm still sore, slightly swollen and warm, rash going away"
Rapid heartbeat; Shaking all over; Eyes crossed; In general felt terrible; didn't get much sleep; Fever(102.4°F); Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible) and SLEEP DEFICIT (didn't get much sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4°F)), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with CLONIDINE for Blood pressure high, at an unspecified dose and frequency. On 31-Jan-2021, HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4°F)), CHILLS (Chills) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood pressure measurement: 200 mmHg (Inconclusive) 200 or something like that at 9pm. On 29-Jan-2021, Body temperature: 102.4 (High) at 9pm.         No concomitant medications were provided.    This case was linked to MOD21-16954 (Patient Link).
COVID-19 symptoms: severe chills and shivering, fever 101.0, lack of energy, body aches. This lasted for a day and a half along with a moderate cough for 2 days. I have also have been unable to sleep post COVID-19 and have a lower than normal BP.
I was achey/fatigued/chilled/feverish the day of, since I got it in the morning, and felt decent the next day. That following Sunday/Monday/Tuesday I had a moderate headache. 4/11 I had a severe headache and started feeling achey in my torso/mid region, especially when I breathed/coughed. 4/12 the headache was more moderate, but the aches were a lot worse, and I felt some mild dull pain in my lung area when I breathed. I woke up 4/13 with a very swollen and puffy face, and the aches are still here. I?m normally very active jogging and in the gym, and I haven?t felt anywhere close to normal - fatigue and aches go hand in hand.  4/14 I had a very swollen face, continued aches and abdominal pain. I went to urgent care 4/14. 4/15 face swelling went down a little, moderate headache, continued aches and abdominal pain. 4/16 (today) face swelling was down more, continued aches and abdominal pain. Fatigue every day and reduced activity levels and work.
TOOK UNREFRIGERATED VIVOTIF; This spontaneous case report was received from a pharmacist (PVX2019-024) on 03-Jan-2019. The report describes a 50-year-old female consumer who "took unrefrigerated Vivotif". The consumer was receiving Vivotif for typhoid prophylaxis.  It was reported that the consumer took the unrefrigerated doses of Vivotif but not sure how many doses she took.  The action taken with Vivotif with respect to the event "took unrefrigerated Vivotif" was not applicable.  The clinical outcome of the event "took unrefrigerated Vivotif" was unknown.  Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated Vivotif" was considered as not applicable.
my wife got the moderna and is all the sudden getting low platelets, is this a side affect; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (my wife got the moderna and is all the sudden getting low platelets, is this a side affect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (my wife got the moderna and is all the sudden getting low platelets, is this a side affect). At the time of the report, PLATELET COUNT DECREASED (my wife got the moderna and is all the sudden getting low platelets, is this a side affect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low (Low) Platelet count was low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I started to experience heart palpitations and chest pain/tightness randomly.  I was fatigued/weak , shaky and had cold hands and feet. I'm 27 years old, healthy and never have experienced these symptoms before. On the 4th day of having symptoms (January 19th) I went to an urgent care. They did tests which I will mention below. As of today (February 7th) I still feel fatigued and am having heart palpitations/flutterings randomly. I am currently now working with a cardiologists and still have more tests to go through.
Breakthrough case admission after 2 vaccines ; Pfizer 12/29/20 Lot# EL0140;  Pfizer 1/19/21 Lot# EL3249
acute hemolytic anemia; she developed DIC; Hbg was 6.0; This is a spontaneous report from a contactable physician.  A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. Medical history included ongoing Wilson's disease, copper overload syndrome (taken Penicillamine for decades). Concomitant medication included ongoing penicillamine taken for Wilson's disease and copper overload syndrome. The patient was admitted to the hospital last week with a life-threatening illness. After multiple tests the physician believed it was related to patient's 1st dose of the vaccine. She had acute hemolytic anemia and her HBG was 6.0. The physician also stated patient developed DIC (disseminated intravascular coagulation). She was transfused with 3 units of blood due to adverse reactions and improved. She then received 2 more units of blood and was steadily improving. The patient has a history of Wilson's disease, copper overload syndrome, and has taken Penicillamene for decades, which can cause hemolysis. The patient was still taking this medication and was still getting better. This patient was due for her 2nd dose soon. The physician will defer to a later date. The physician would like to request if there was any information/data regarding hemolysis, DIC associated with the vaccine. The events were reported as life-threatening. Patient was admitted to hospital in Mar2021 due to the events. Multiple tests done in Mar2021 with unknown result. Outcome of the events was recovering.  Information on lot/batch number has been requested.; Sender's Comments: Due to a plausible drug-events temporal association, the company cannot completely exclude a contributory role of vaccine BNT162b2 administration in the development of the reported, serious events: "hemolytic anemia and disseminated intravascular coagulation, with HBG 6.0, as consequence of anemia.  The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Received vaccines MMR & varicella 11/29-10. At one of sites, (R) leg, swelling, redness. No fever (99 degrees). Acting fine. Using leg. Bright red knot at (R) thigh, injection site, firm, slight tenderness. Normal ROM. Hip, leg, without pain. Not fluctuant, no drainage, nothing expressible.
Patient began experiencing pain in his right leg on 4/5, sought treatment at walk-in clinic on 4/12. Healthcare provider he saw sent him to ultrasound at a medical center, who then referred him to the emergency deptartment. Patient was diagnosed with a DVT and prescribed Eliquis 10 mg BID x7 days then 5 mg BID for 6 months.
Fluvirin w/ Thimerosal given to OB pt. LMP = 2/18/09. EDC = 11/25/09. Pt does NOT have an OBGYN. Pt NOT hospitalized after receiving H1N1 vaccine.11/17/2009 OB records for 10/30 and 11/13/2009, patient c/o's nausea/vomiting, dysuria and pelvic pain on day of vaccine. Doing well next visit.