chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a female consumer of unkonwn age with penicillin allergy and KEFLEX allergy. The patient's medical history included thyroid. On 30-JUL-2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant therapies included SYNTHROID. On an unknown date, the patient experienced redness, but no rash, at the injection site after receiving ZOSTAVAX. The patient did not receive treatment. No lab diagnostics studies were performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected because the consumer declined to provide demographics for her physician.
a patient received a dose of Proquad following a temperature excursion; No adverse effects were reported; This spontaneous report has been received from a physician referring to a male patient of unknown age. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On an unknown date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, Lot# R013575, expiration date reported as 10-NOV-2019 (strength, dosage schedule, anatomical site and route of administration were not reported) for vaccination. (Product storage error)  The doses of vaccine were stored between 15 degrees Fahrenheit (°F) to 46 °F (-9 °C to 8 °C) (35.2 °F) for 20 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. However, the second administration occurred after only 4 weeks with no reported adverse event; Initial information received on 07-Mar-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 45 years old female patient who experienced patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. however, the second administration occurred after only 4 weeks with no reported adverse event while receiving meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Immunocompromised.   On 04-Mar-2022, the patient received 0.5ml  of suspect meningococcal a-c-y-w135 (d conj) vaccine solution for injection lot U7273BAwith unknown expiration date via unknown route in the right deltoid.  on the same day (04-MAR-2022)  the Pharmacist reported that a patient received a dose meningococcal a-c-y-w135 (d conj) vaccine of at an earlier interval than prescribed. The patient was immunocompromised and was supposed to have two doses administered 8 weeks apart. However, the second administration occurred after only 4 weeks (inappropriate schedule of product administration) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  it was reported "The first administration occurred on 04FEB2022 and the second on 04MARCH2022".  Action taken: Not applicable for the event.  corrective treatment: not reported.  outcome: 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 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.
pt brought to ED with c/o SOB, cough, and wheezing x 2 days; port surgically placed 6 days ago; found to be positive for COVID; given dexamethasone, remdesivir, ABX, Vitamin C and zinc; pt worsened; coded; intubated; transferred to ICU; made a DNR; went into asystole and expired in the hospital
Patient stated she received INFLUENZA vaccine at that evening started feeling itchy. When she got up the next morning she had a rash on the inner and upper thigh and lower abdomen which she believes is a reaction to the vaccine. She has not had previous reactions in the past.
About 24 hours after the immunization the infant developed 1.)  conjunctivitis (left eye), 2.) a measles-like rash on his face and lower back, 3.) Injection-site pain apparent (left leg), 4.) ataxia, 5.) the infant also had malaise and was highly irritability.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 31Oct2022 to 04Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soon after receiving the vaccine and on the car ride home, the patient began to feel hot. Later at home in the evening, she experienced chills, aches, and weakness. This morning she reports the symptoms fading and asked if she could take Tylenol. I advised her it was a good option for her symptoms. No reported fever. I advised her to monitor herself for a fever, and to contact the doctor if her symptoms persist for more than 2-3 days or if they worsen. I will follow up with a phone call in one week.
fever; felt "crummy"; This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female 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 fever and feeling abnormal. On an unknown date, the outcome of the fever and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-DEC-2022 Reporter's Comment: The reporter was a GSK representative who stated that he was speaking to an HCP(health care professional) pharmacist who shared that her mother experienced symptoms after receiving a dose of Shingrix. The patient experienced 2 days of fever and feeling crummy. The reporter reported that it was unknown if after 1st or 2nd dose of Shingrix The reporter did not consent to follow up.
The pt developed a fever of 102 approximately 1-2 hours post vax. The mother found the infant in his bed with eyes wide open and with a fixed stare. She said the infant was limp for approximately 2-3 minutes. She immediately called 911 and the infant was transported by ambulance to the ER. The infant was observed for 23 hours. The infant was diagnosed with a seizure. No prescriptions were given and the pt has not experienced any sequelae. The pt's maternal great uncle and great-great grandmother have a hx of seizures beginning in childhood.
My son was given the adult vaccine instead. I was called on August 19, 2022 to verify his birthdate, I did.  A couple of hours later I received another call about his birthdate so, I asked what was going on.  I was then asked how my son was doing and if I'd noticed any side effects.   His arm was sore but, I did notice that he was extra sleepy that afternoon of the vaccine.
2" x 3" swelling, very hot, red area 2" x 3" 1/13/2013 swelling down, redness now 2" x 5" and only dark red, hot, and swelling a 1" x 1 1/2" right where the Shingles shot was given.
Red, hot swollen where injection given. Only noticed it starting today - 13 days after received.
About 5mins after she received the vaccine she had a flushed sensation over whole body followed by dizziness and then trouble swallowing.  Approximately 2hrs after vaccine the reaction subsided but then developed a rash over whole body.  The rash lasted until late evening and then started to subside.  She took  Zyrtec and Motrin by that point.  She has an immunologist involved in the care of her asthma. He recommended she carry an EPI PEN.  We do not recommend she proceed with the second vaccine.
This was second moderna dose. patient also passed out after first dose. I gave vaccine, patient seemed fine then passed out about 30 seconds later.  was out for 30-40 seconds then came back to feeling very light headed and he was also very pale. I offered water and crackers. he sat with me and his mom for 20-30 minutes and was feeling fine when they left. -mom stated that his sister also reacted the same way.
Began Swelling in right foot 4 days after receiving injection. Then swelling began up the right leg, a week later the left foot began to swell the up the left leg. Never experienced swelling in legs before
immediate swelling, some bleeding at sight. It looked like maybe blood pooling at site which caused inflammation and swelling. I had patient stay around for 20 minutes. After checking on him, the swelling did go down and it was just a bump around a pea size.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-JAN-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a medical center/hospital (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated at a medical center/hospital (by an unspecified health care professional) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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 proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 22-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 24 and 48 hours respectively. The lowest recorded temperatures were 34 (1.111111111 Celsius degrees). The highest recorded temperatures were 47 (8.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt broke out in a rash over his entire the day after receiving the vax.  Pt had office visit w/ PCP on 1/20/2021 which was  then referred to a Dermatologist.  Doctor took biopsy that showed he was allergic to something and was told that it could be the vax but it could also be from something else as well.  Pt was told to change soaps and detergents.  He was prescribed Aquaphor healing ointment, Claritin,  Fluocinolone.  Pt still has the rash on his entire body.
This spontaneous report as received from a pharmacist refers to a 62 year old male patient. No concomitant medication, pertinent medical history, pertinent drug reactions or allergies were reported. On 11-AUG-2014 the patient was vaccinated with ZOSTAVAX lot# K000995, subcutaneous (strength and route not reported). On 12-AUG-2014, the patient developed a 3 inch welt/swelling at the site of ZOSTAVAX. Patient sought medical attention and no treatment was given for the reported adverse events. No laboratories were performed. At the time of the report the outcome of the events was reported as recovered. Additional information has been requested.
I was vaccinated for covid with the Pfizer vaccination. My second shot was on 2/21/21. It is now almost 7 weeks later and I still have pain in my arm at the injection site (not rash or redness). It seems to be getting worse.  I?ve read about SIRVA online and I am concerned that this is what I have. Do I need to be revaccinated?
YF-VAX being administered to a patient through the intramuscular route instead of the subcutaneous route with no reported adverse event; Initial information received on 14-Jul-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 38 years old male patient to whom YELLOW FEVER VACCINE - [YF-VAX] being administered through the intramuscular route instead of the subcutaneous route 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 HEPATITIS A VACCINE (HEPATITIS A) for Hepatitis A; HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Hepatitis B; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 14-Jul-2022, the patient received a 0.5ml  dose of suspect YELLOW FEVER VACCINE -  (formulation , strength was unknown, lot UJ602AA and expiry date: 13-Jul-2023) via intramuscular route in the left deltoid for Immunization.  On 14-Jul-2022 the patient developed a non-serious event of yf-vax being administered to a patient through the intramuscular route instead of the subcutaneous route with no reported adverse event (incorrect route of product administration, Latency: same day).   Action taken : not applicable.  Outcome: 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.
4 cm mild induration and erythema surrounding injection site on right upper thigh. Parent directed to apply Benadryl cream and call if worsen.
This is a spontaneous case, initially received on 22-May-2018, reported by a 50-year-old, adult, female patient. The patient's current condition included minor heart problem (since an unspecified date) and was allergic to penicillin (since an unspecified date). The patient's concomitant medication included unspecified blood pressure medication. On an unspecified date in Dec-2013 (reported as around Christmas), the patient was administered with influenza vaccine, (route of administration: injection (as reported), dose, batch number, expiry date, trade name and manufacturer: not reported). It was reported that, patient received multiple injections flu vaccines. On an unspecified date in 2014 (reported as in the month of January or February), the patient experienced flu like symptoms, bronchitis, hacking cough, cold, ear symptoms (unspecified), muscle degradation, strength (as reported), knee pain, rhinorrhoea and weight loss. On an unspecified date, the patient's blood was drawn, and scans (unspecified) were performed, results were not reported (reported that, patient was not sure, if these tests were performed before or after the influenza vaccination). No product quality complain was reported. On an unspecified date in 2014, the patient was hospitalized for the events and treatment (unspecified) was given. On an unspecified date, the patient had recovered from the event bronchitis (reported as 2 to 3 years ago) and rhinorrhoea (reported as a few days ago). The outcome of the events (flu like symptoms, cough, ear discomfort, muscle degeneration, strength loss of, weight loss, cold and knee pain) was unknown. The reporter assessed the case as serious due to hospitalization and causality of the events as related to suspect vaccine.
Patient developed temperature of 102F and headache on 2-18-2009 around 1:45pm. Parent reported symptoms to clinic at approximately 4:30pm and reported no OTC analgesics had been given but would begin administering OTC on nurse's recommendations every 4-6 hours.
Swelling of the arm from 15cm to 21 cm in circumference around the bicep, firmness of the skin approximate 10 centimeters in diameter around injection site. Signs and symptoms took less than 48 hours to occur child was taken to the health clinic where the vaccine was given for check up. The child was given antibiotics and a cold pack regiment to treat. The child still has the symptoms and is currently being monitored by parents. This was because of the last DTaP vaccine in the series.
I95.9 HYPOTENSION 7/17/2022 ANEMIA I95.9 HYPOTENSION 7/17/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Initial and follow up information was received from a medical assistant, and refers to a 4 week old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided. On 15-JAN-2019, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, (lot # R001529 with an expiration date in 07-NOV-2020), for prophylaxis (strength, dose, route and frequency were not provided), that underwent a temperature excursion above of 47 degrees Fahrenheit during a time frame of seven minute, but it was stated that her vaccine storage issue was not a problem. Digital data logger was involved and no previous temperature excursion was reported. Moreover, it was also reported that, the dose of RECOMBIVAX HB and other vaccine doses were found viable and ok to use. No adverse effect reported.
Eyelids became heavy and weak .  Eyes strain to keep eyelids open . Pain weak and cramping.  With the these symptoms my eyeballs hurt . Started the night 9/14/2021
Multiple pain, swelling, and cysts in left breast.    First vaccine:  3 cysts, Aetna Teledoc Visit, given 10-day Antibiotic (Bactrim) - pain for about 6 weeks   Booster: 4 cysts, went to family practitioner, received mammogram and ultrasound, given 10-Day Antibiotic (Bactrim) - pain for about 8 weeks
Pain at injection site = 2 hours; cough = 45 mins; red eyes = 24 hrs; low-grade fever = 6 hrs; headache = 6 hrs; fatigue = 6 hrs; nausea = 30 mins; vomiting = 15 mins; no treatment required.
After 15 min I walked to my car. In car felt NUMB LIPS, FAST HEARTRATE, over the next 3 hours I felt EXTREME DIZZINESS, LIGHTHEADED , CONFUSION, THROAT SWELLING, NAUSEA,  FOGGINESS, FLUSHED, WEAKNESS and TIRED. I felt like I might die, yet I couldnt do anything to get help because I was out of it.  At the first signs I sent my Doctor a message that said "Got my shot today. Have extreme dizxziness., fast heart rae,, num blips, fogginess. Lump in throat .  Is this normal feel hotl? They sent me back a phone number for covid. I called the number and asked for help, they told me the symptoms of the covid shot, not the reaction. They did not offer help.
Left Arm bursitis/shoulder pain since even on 10/14/20.  Slight improvement with time, ibuprofen, ice, Arnica.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown ages and genders. Information regarding the patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported) for prophylaxis. Information regarding concomitant medications was not reported. On an unknown date, the reporter stated that the patients were experiencing injection site pain and inflammation and he stated that "phenol from the vaccines" might be responsible for these events. At the reporting time, the outcome of injection site pain and injection site inflammation were not reported. The physician considered injection site pain and injection site inflammation to be related to PNEUMOVAX 23.
Information has been received from a registered nurse concerning a 17 year old female who on 07-JUN-2007 was vaccinated with Gardasil. (Lot # 655620/0171U). It was reported that on 07-JUN-2007, a few hours after she was given Gardasil, the patient had a fever, chills and fatigue. The patient recovered one week after she was given the vaccine. The patient spoke with the nurse regarding her fever, chills and fatigue. No other information was available from the nurse. Additional information has been requested.
Around 2 o?clock in the afternoon, I was sitting at my kitchen table and the skin over  my knee started burning and tingling.  I got up and it felt very strange.  I pulled up my pant leg to find a golf ball size lump that was warm and burning and tingling just under the skin towards the bottom of my patella.  It swelled very quickly then slowly subsided.  You could palpate it and feel the fluid.  After two nights, the fluid is mostly gone but it is very sore.  I am unable to kneel on it and it is bruised.  Post shower the skin is mottled with bright red.  I looked everywhere for signs of a spider or other insect but but there is no puncture mark.  My thigh and calf on the same leg are achy.
Dizziness, Fever, NauseaVomiting, chills, fatigue, stomach ache, torso cramps Narrative:  Other Relevant History:
Approximate time, not exact. Parent states R deltoid at site of meningitis vaccine became red, swollen, and he developed itching on both arms, some rash on both arms? No respiratory difficulty, no vomiting or other reaction.
One wee after injection, having dyspnea, difficulty breathing normal temp, felt like breathing in smoke, after 3 weeks - went to the doctor - inhaler ordered, chest x-ray, PFT, CT Chest, Echocardiogram. Resolved in 1 1/2 months.
Information has been received from a healthcare worker (Medical Assistant) concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA (lot # L023936 with expire date 15-MAR-2017) (dosage and route not reported). The improper conditions of storage was reported as 9 degree centigrade for 2 hours. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.