chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) at a pharmacy 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. On or about 07-JUN-2016, the patient was treated by a nurse practitioner for a persistent vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and amitriptyline for management of her painful symptoms and chronic pain. 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.
swollen node under lt jaw 2 days p/vax;resolved p/3 days;felt weak since day p/cont to feel weak;in 72hr had large bruise on lt thigh;
I had my labs drawn for my Endocrine appointment on 12/30/20, one day following my first Moderna shot. It appears to have impacted my liver enzyme results. The v-safe questionnaire does not ask for specific information like this.
1541: 7 minutes after receiving vaccine patient reports having a dry cough. This RN to carside immediately, pt reporting scratchy throat and dry cough.Radio to call EMS immediately. Pt reporting some itching to lips (lips appear slightly swollen however pt did have fillers 2 weeks ago). Pt states lips are more swollen than baseline. Pt has epi pen with her, offered to administer epi pen, pt declines states "I think I'm just feeling nervous." Continued to monitor, HR 90s. 1553:EMS arrived, report given, care assumed by EMS. 1608:Pt monitored in ambulance by Paramedic. Pt reports improving and symptoms resolved. 1611: Pt refuses transport by EMS. States symptoms completely resolved. Pt left site via POV
My mother became short of breath over the course of the week after her second dose of the the Pfizer Covid19 vaccine.  She was taken to the emergency room and was diagnosed with pericardial effusion and admitted for treatment that included draining fluid from the sac around her heart.  She was released and then developed the same symptoms again within a week.  She again had pericardial effusion, and was told she had severe emphysema with no prior diagnosis.  She is still hospitalized and is now suffering heart failure with no clear diagnosis as to why, no acceptable plan of treatment, and a prognosis of wait and see.  She has consistently tested negative for Covid19.
Patient received a shot of ZOSTAVAX on 9/28/11 around 8:45pm and called the pharmacy on 9/30/11 at around 8:40pm complaining of a rash at the site of injection (upper left arm). She said rash was filled with pus. She also complained about redness and itching.
Approximately 2 years subsequent to receiving one dose of varicella virus vaccine live the pt developed four rash on her arm and back without blister. It was indicated that the pt was not sick nor had any complication. Pt was treated with calamine and oatmeal bath. Symptoms resolved.
A nurse administered a COVID booster dose (correct dose and administration route) to a patient who was consented by parent mistakenly and who was 13 years of age (without immunocompromise)  and was 10 days short of six months after his second PFIZER Covid vaccine. There were no adverse event at the time of the injection or in the 6 hours after the medical error but the patient is being monitored.
An expired Act-Hib was administered to a patient/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional and pharmacist  via Medical Information (reference number: 00628854) and transmitted to Sanofi on 04-Jun-2021.  This case involves a 1-years-old male patient, who received expired fourth dose of 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, batch number: UJ263AA and expiry date: 02 June 2021 via an unknown route at an unknown administration site) (expired product administered) on 04 Jun 2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, 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 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.
48 hrs. after vaccine, onset of diarrhea; fever at 100 degrees for several hrs. with fatigue; diarrhea continued for 48 hrs. Leg fatigue for several days.
urticaria to trunk, arms & legs, no SOB; seen in military sick call p/immun;
Headache, tongue swelling, canker sores in mouth, big red welt on right side of tongue.
Vaccine was given at 10:30 am.  At 2:20 pm began having hives that began on the neck and moved to the chest, arms, and belly.
patient walked to the observation room independently and about 5 mins after arrival to the observation room, he become very pale, eyes rolled back, and appeared to  have a seizure type of activity. Patient was transferred to a cart with assistance, was able to respond to commands,  and was transported to the Emergency department.
AGITATION, VERTIGO, BLIND VISION, BLOOD PRESSURE VARIES, DRY MOUTH, ENERGY LOSS, ENERGY LOW LEVELS, FATIGUE, GASTRITIS, MIGRAINES, HEADACHES CONTINUOUS HOT FLASHES, NOSE BLEEDS, NECK RIGID, LOWER BACK, LEGS, PAIN GROIN, KNEE AND HIPS, THROUGHOUT HIS BODY, STOMACH, BONE AND JOINT PALPITATIONS, SWEATING, SWELLING JOINT, TIREDNESS, POOR TOLERANCES FOR BRIGHT LIGHT, VISION LOSS DUE TO DETACHED RETINA, TACHYCARDIA, TASTE LOSS FLAVOR, RESPIRATORY PROBLEMS, PAIN EAR, PALPITATIONS, SKIN DISCOLORATION, STOMACH PAIN, PAIN KNEES AND HIPS.
swelling and redness in her injection site; swelling and redness in her injection site; This is a spontaneous report from a contactable consumer reporting on behalf of a female patient.  A female patient of an unspecified age received an unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and redness at her (vaccination) injection site. To help with the discomfort, the reporter wanted to know if ice or warm application on the vaccination site can be done or Tylenol should be taken. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
I've had a headache, muscle aches and joint pain since I had covid a few months ago but it has gotten worse yesterday and today and I haven't been out of bed I'm so sore and tired.  Then today I have been nauseous off and on.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with VARIVAX (Merck) lot # K010338 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 02-MAY-2013, the patient received the dose of HAVRIX (dose and route of administration were not provided; batch/lot# AHAV8692CA, expiration date: 18-SEP-2015). On 22-MAY-2017, the patient was vaccinated with VAQTA injection administered by intramuscular route (lot # M039055, expiration date: 22-JUL-2018; dose was not provided). The patient has not experienced an adverse effect. Additional information has been requested.
Information has been received from a registered nurse concerning a 4 year old male with no pertinent medical history and no known drug reactions/allergies who on 28-AUG-2001 was vaccinated intramuscularly (previously reported as subcutaneously) in his left leg with a 0.5 ml initial dose of  VARIVAX (Oka/Merck) (Lot# 638907/0560L). On the same day, the patient was also vaccinated with PEDVAX HIB (MSD) and MMR II (MSD). Concomitant therapy included DTP (manufacturer unknown). There was no illness at time of vaccination. On 20-JUN-2005 the patient got shingles, he never had chickenpox (as previously reported). Subsequently, the patient recovered from shingles. The patient did not require any medical treatment. The patient sought medical attention at the office visit. There was not product quality complaint. A hospital vaccine specialist advised this patient to receive the  VARIVAX (Oka/Merck) again. Additional information is not expected.
A nurse reported that a child received an injection of Prevnar and within 24 hours, post vax, the child developed an injection site reaction characterized by swelling and redness. The redness extended "half way down the elbow". No further information was available at the date of this report. One of the lots was reported as 47653; however, this is not a valid Lederle lot number. This is 1 of 2 reports from this facility of adverse experiences following receipt of Prevnar.
He was healthy when he recieved the second shot within days he was sick, 3 weeks he was retaining fluid and supposedly had pneumonia and glassy patches in his lungs, 1 and a half months in he had a heart attack and gall bladder stones, 3 months in kidney failure and diagnosed with severe congestive heart failure with 0-6 months to live that didn't exist before this shot, cirrhosis of the liver, last week he died.
PAIN IN THE CHEST; PAIN IN LEFT ARM; TINGLING IN THE ARM; This spontaneous report received from a consumer concerned a 28 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, the patient experienced pain in the chest. On SEP-2021, the patient experienced pain in left arm. On SEP-2021, the patient experienced tingling in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left arm, and pain in the chest, and the outcome of tingling in the arm was not reported. This report was non-serious.
Sore throat, body aches, fatigue, and cough in the morning of 12/13 and had a bad coughing episode that threw out my back. Saw a general practitioner and found that after a physical exam that it is sciatica. On 12/27 was given a tramadol shot for the pain, took an x-ray and sent home. After 24 hrs the pain was back and took Tylenol to ease the pain, but it wasn't enough. Tried topical hot and cold, stretches, tried a oxytocin that was spare from other medical visits, yet nothing got rid of the pain. Using telehealth was able to get a prescription on 12/28 for prednisone. As of today 1/3/2022, nothing has worked yet and will be talking to the doctor again soon.
On day of event, patient  received Neulasta and IV zofran approximately 45 minutes prior to event. When getting ready for discharge, he received 1 dose of Pfizer COVID vaccine and then began to feel naseous ~15-20 minutes later. He vomitted x2. BP was 70/40s. Confirmed on manual. Blood glucose normal. Started NS bolus. Afebrile. Blood cultures, labs drawn. Ceftriaxone given for rule out sepsis. Blood pressure not responsive to drip bolus, initiated push pull, with response in BP after 1L. Improved mental status. Patient observed overnight and discharged next day.
fever; achiness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient wanted to know how long does the fever and achiness last after 2nd dose of Shingrix.
Injection site raised approx 1cm and approx 2cm in diameter per pt. Warm to touch on 9-23-09. Spoke to pt and she stated area has went away. Not seen in office.
My period is back.  Massive headaches and a menstrual cycle after almost two years.
One week after the second dose of Covid 19 Pfizer vaccination. presented palpitations, tingling and fasciculations of the four extremities. Cardiologist did an echocardiogram and results were normal. On December 4th 2021 the symptoms persisted and were more frequent.  Neurologist Dr. ordered a Brain MRI and the results were normal. Today 18 th December finally the symptoms are starting to fade.
Swelling and pain in Left arm (site of injections), gastric distress.  Diagnosised as cellulitis
Initial report was received on 26 October 2010 from a health care professional. A 23 year-old female patient with unspecified allergies and no illness at the time of vaccination, had received an intramuscular right deltoid injection of FLUZONE No Preservative 2010-2011, lot number UT3569BA and an intradermal injection of TUBERSOL 5 TU, lot number C3508AA (site not reported) on 26 October 2010 approximately four hours later, experienced shortness of breath, a knot in her throat and was unable to sit up. The patient was treated with epinephrine, SOLU-MEDROL, BENADRYL, oxygen (O2) and IV fluids. The patient continued to "get worse" and was sent to the emergency room (ER). Concomitant medications were not reported. The patient has a previous history of receiving tuberculin skin tests but was reported "never" to have had any flu or H1N1 vaccine. No further information was reported at the time of the report. The patient's outcome was not recovered. Document held by sender: none
Pt experienced nausea, dizziness, headache and clammy feeling at time of injection.
Breakthrough infection Covid-19 requiring emergency room visit on 01/03/2022 for severe cough and syncope.
Sore arm; Painful neck; This is a spontaneous report received from a contactable consumer. A male patient of unspecified age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient was tested for COVID-19 or not. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced sore arm and painful neck. No therapeutic measures were taken for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm and painful neck were recovering at the time of report.   No follow-up attempts are needed; information about batch/lot number cannot be obtained.
make work day impossible, upper arm hotter than rest of body; This case was reported by a consumer via interactive digital media and described the occurrence of extremities hot feeling of in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extremities hot feeling of. On an unknown date, the outcome of the extremities hot feeling of was not recovered/not resolved.   It was unknown if the reporter considered the extremities hot feeling of to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that a vaccine could make a work day impossible.  The patient had at day three and my upper arm was measurably hotter than the rest of my body.  The reporter stated no reaction to vaccines. The follow-up would not possible as no contact details were available.
Petechiae like rash to sides of face, neck, and chest; swelling to cheeks near ears.
Started with a minor sore throat and cough.  Cough worsened and experienced and included considerable phlegm and mucus in throat.  Felt tired and had low energy (not normal for me).  It took about two weeks before I began to feel better.
Developed area (11cm X 11cm) of erythema, induration and swelling. No fever.
On 02/24/2002 at 10:40am, the pt received immunizations. Mother called office at 2:40pm stating the pt developed generalized hives with itching. Benadryl started. Then the pt went to ER on 02/22/2002 with thigh red, swollen, still some hives. Was prescribed 5 day of steroids by the ER physician.
Patient given wrong vaccine for the 1st dose of the primary series.  Patient did not have a reaction to vaccination
epilepsy; This case was reported by a consumer via interactive digital media and described the occurrence of epilepsy in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced epilepsy (serious criteria GSK medically significant). On an unknown date, the outcome of the epilepsy was unknown.   It was unknown if the reporter considered the epilepsy to be related to Meningococcal B vaccine.  Additional case details were reported as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient developed epilepsy after getting the vaccination for college. The follow up was not required.
She ran 103-104 fever and was throwing up. Something was not right. It was the evening after she had received her vaccinations that day. We contacted the on call nurse and have told her doctor of her reactions. Not sure if she has any long term effects at this point.
Patient returned after receiving vaccine with unit nurse complaining of flushing in upper body.  Temperature was immediately taken and was 97.2 forehead.  She was asked to be seated and monitored for her heart rate.  Breathing appeared normal.  Patient then complained of having swelling in her throat and difficulty swallowing.  She was then offered a diphenhydramine 25mg tablet PO.  Patient took with water.  No help.  I offered to call 911.  She accepted.  Paramedics arrived.  Conducted diagnostics.  BP was 150/80 with HR 80.  AMR administered diphenhydramine 50mg via IV and patient was placed in stretcher and taken to Hospital.  Facility with follow up with care.
I am writing this message to inform you of a vaccination error that occurred at a mobile vaccination event on 5/27/ 2021. This event serviced migrant workers in the area.  A 16 year old male was given a dose of the Janssen vaccine.  The error was noted on site and the patient's mother was notified. All questions were answered. No adverse reactions were witnessed as a patient was monitored post vaccination. The patient information and his mother's information were recorded.
HANDS SWOLLEN; RASH ON ARMS, THIGHS, BOTH FEET AND HANDS; JOINTS HURT; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced rash on arms, thighs, both feet and hands. On 13-MAR-2021, the subject experienced joints hurt. On 14-MAR-2021, the subject experienced hands swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on arms, thighs, both feet and hands, hands swollen, and joints hurt. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Got her vaccine, was fine when she left.  Then she started getting a little bit of a headache, then it disappeared by driving home.  By 6:30 she had nausea, and by 8:30 had vomiting until 3:00 AM, and now the nausea is back 3/31/21.  She now has tiredness, chills since midnight.  Her temp was 99.8.  She has not taken anything for her symptoms.   The nausea came back around 9:30 and is killing her.  No reactions on the arm itself, just a little warm to touch.   She called her doctor and he told her to call us.
One day after receiving a whooping cough shot in one arm and a shingles shot in the same office visit my right upper arm began to get sore. Stiffness & pain progressively worsened.
The pt experienced swollen and sore muscles. Later that day, the pt experienced chills and fever all night including sweating. The following morning the pt experienced a raised bright red rash around the vaccine area. This spread to the shoulder and to the elbow and was very itchy. The pt saw her MD and was told she should not have another Tetanus vaccine.
Patient developed clinically diagnosed case of herpes zoster on her right chest along the T6 dermatome.  Proceeded in typical course
Information has been received from the mother of a 5-week-old female patient with no relevant medical history or illnesses at time of vaccination who on 11/04/2002 was vaccinated intramuscularly in the "LT" with a dose of hepatitis A virus vaccine inactivated (lot # 644325/0922M) 0.5mL.  Follow-up information from the physician revealed that no reactions were reported from the mother of the patient up to 1 week after the inadvertantly given hepatitis A vaccine inactivated to the infant.  However, it was reported by the mother that the patient developed a slight fever.  No further information is expected.
Seizures started 2/3/05 subsequently multiple seizures. Pt has been evaluated by pediatric neurologist. Seizures
My arm turned red and swollen at the injection sight on my arm, BUT 7 days later.