chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-MAY-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and 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 08-MAY-2016, the patient was treated at a family medicine facility for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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.
soreness on the injection site on the left arm; she couldn't sleep; could barely move; body aches; sweats; chills; diarrhea; stomach doesn't feel great; headache; muscle aches; This is a Spontaneous report from Pfizer program. A contactable 59-years old female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot number ER8737) as SINGLE DOSE for covid-19 immunisation.  Medical history included torn rotator cuff, tendonitis. The patient's concomitant medications were not reported. The patient reported that she received her first dose of the vaccine on Tuesday, 06Apr2021. Then she started feeling some side effects yesterday 07Apr2021 like, soreness on the injection site on the left arm, she couldn't sleep and could barely move, she had body aches, sweat and chills, diarrhoea, stomach didn't feel great, headache and muscle aches. She stated her arm was feeling a lot better than last night. Outcome of events was not recovered.
Information has been received from a registered nurse concerning a 5.5 year old white female student with no reported allergies who on 04 December 200, was vaccinated subcutaneously with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot# 0637255/1380K). On 04 April 2005, the patient's mother called the doctor's office to report her daughter "broke out in 30-40 lesions which did follow usual course of disease" It was reported that the lesions did blister. Subsequently, on an unspecified date, the patient recovered. It was also reported that a sibling was diagnosed with chicken pox on 21 March 2005 (WAES# 0505USA02575)>
arm got very sore; unable to raise arm up and out; can not lift items; weak; painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got very sore), MOBILITY DECREASED (unable to raise arm up and out), MUSCULAR WEAKNESS (can not lift items), ASTHENIA (weak) and PAIN (painful) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), NABUMETONE (RELAFEN), LISINOPRIL and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm got very sore), MOBILITY DECREASED (unable to raise arm up and out), MUSCULAR WEAKNESS (can not lift items), ASTHENIA (weak) and PAIN (painful). At the time of the report, PAIN IN EXTREMITY (arm got very sore), MOBILITY DECREASED (unable to raise arm up and out), MUSCULAR WEAKNESS (can not lift items), ASTHENIA (weak) and PAIN (painful) outcome was unknown. Not Provided
Rash- left calf, ankle to knee; Received BNT162B2 with medical history of Psoriatic arthritis; Received BNT162B2 with medical history of Psoriatic arthritis; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EJ1686), via an unspecified route of administration in the left arm on 20Jan2021 10:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included type 2 Diabetic, Psoriatic arthritis and had heart disorder, allergic to sulfa drugs. He did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included warfarin, sitagliptin phosphate, aspirin (acetylsalicylic acid). The patient experienced rash in the left calf, ankle to knee on 22Jan2021 08:00 (no treatment). The outcome of event was not recovered.
Case number PHEH2014US025322, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to an 89-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. On 17 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 145701, expiry date: Mar 2015) intramuscularly into left deltoid muscle that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse reaction was reported following this medication error (incorrect storage of drug).
Patient made appointment for Pfizer covid 19 booster shot and received vaccine. However he is 17 and is not indicated for booster shot.
Swollen lymph nodes on the left side and oral Herpes (HSV 1) flare-up at the same time
pancreatitis.  My hands and feet started tingling on Friday, 25 September and continued over the weekend.  The symptoms got much worse on Monday, 28 September.  I had a bad pain in the center of my stomach and the tingling extended into my left arm and both feet.  The doctors eventually diagnosed me with pancreatitis.
Office has seen 2 other kids in past exp with rxn. Mom called 2 days after receiving DTaP reports 4x4 area red warm, swollen on arm where DTaP given. Mom describes much more significant after 48hours. Mom to given ASA med prn, Benadryl and cool compresses. Care with significant changes or further concerns.
Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who on 14-APR-2008 was vaccinated IM with a dose of GARDASIL. Concomitant suspect therapy included a dose of VARIVAX, and a dose of MENACTRA. On 14-APR-2008 the patient experienced headaches, vomiting, nausea and dizziness. At the time of this report, the outcome of the events was not specified. The patient sought unspecified medical attention. Additional information has bee requested.
This spontaneous report was received from medical assistant, concerning to an 8 year old patient (gender not provided). The patient's pertinent medical history, drug reactions/allergies were not provided. On 11-APR-2014, the patient was vaccinated inadvertently with a dose of PROQUAD (Merck) (total dose, route and lot number were not provided), instead of a dose of VARIVAX (Merck) (total dose, route and lot number were not provided). No symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
swelling of throat, hives, and long-term continued fatigue, headache, nausea, vomiting, diarrhea These symptoms occurred starting 8 hours after dose one, and resolved.  They occurred starting 2 hours after dose two and the fatigue, n/v/d/headache have persisted
high pitched inconsolable screaming for over 12hr;difficulty sleeping, lethargic the next day;large hard 1/2 softball size lump @ the DTP site;APAP useless;
Came in on 2 days after administration w/ a red thigh inflamed approx 4in in diameter, red & warm to the touch, on the right thigh.
Edema in face and eyes, itchy all over the body, not relieved with antihistamines.
Per patient arm started out as itching around 1:00 pm and became red/swelling around 2 pm. Patient iced arm and started OTC pain medications at 5 pm. Arm is red, swollen to touch and is a 14 cm width. Patient is afebrile. Patient started on Abx 6/17/15 per MD.
Several times in the last month I've become lethargic and nausous feeling and diarrhea for a day or 2 then fine but still feeling very tired. Since the 3rd shot the injection site would flare up every once in a while, but this last one has been pretty constant. Yesterday it started to hurt and has a hard round knot and the more I touched it the worse it got. I was unable to move my arm without shooting pain. Today was even worse, can't lift or move hardly and no strength to even open a cat food can. Nausea feeling & lethargic and slight chills thruout the day today but no diarrhea. I'm very concerned about how it's made me feel. I have tested negative for covid every time I've felt like this and checked it to make sure. I don't have insurance so I haven't been seen by a physician. No extreme reactions to any of the vaccines other than sore arm and tired for a day and then it was fine. This is very troubling why I keep feeling bad
On 4/1 and 3/31 T 102+. On 4/2/14 T 103+ and one arm twitching, witnessed by EMS and ER. Given ATIVAN/fosphenytoin and observed. Recurrence focal and generalized sz with (+) EEG findings until put on phenobarbital. All viral and bacterial cultures (-), HSV negative. MRI - diffuse changes c/w seizures. Dx Complex Febrile Sz - focal status epilepticus.
Pfizer vial was diluted with 0.8 cc provided sterile NACL.  Pt was given 0.3 cc dose from the vial resulting in a higher-than-authorized vaccine dose.  Pt was observed for 15 min and let in satisfactory condition.    Error was noticed 3 hours after administration, unable to reach pt at the time of this report but we are still trying.
Respiratory distress - wheezing, SOB. Admitted to ICU Dx bronchiolitis 3/5/03.
I had double vision, close and far distance. It started about month after vaccine. It lasted about 6 months. I have macular degeneration in my eyes. I saw a macular specialist. The specialist doesn't believe the double vision I'm experiencing is from the macular degeneration though. In March 2023, I started having pain in my left eye. I saw my primary doctor a week ago and he referred me to a neurologist.
Child with congenital heart disease, twin gestation and prematurity. G-tube present about 50 hours after administration of vaccines with hyperthermia, dehydration and death.
Pt. received the adult dose of Hep A vaccine. Mom was immediately informed that it had happened and that he may have a stronger than expected response to vaccine. He did with increased fussiness, increased pain, swelling, redness, and not walking as usual. He was given warm baths, Motrin & Tylenol and after 1 week he recovered to normal activity.
Patient was at the pharmacy to get their annual flu vaccine, and we were supposed to administer the regular Fluzone Quad for those <65 years of age.  Fluzone HD for those 65 and older was grabbed out of the fridge and administered to the patient instead. It was noticed that the wrong vaccine was given to the patient right after they had left the pharmacy.  We called to let the patient know they got the HD instead of the regular flu vaccine and to watch for any signs of an adverse reaction. We also called the patient's primary care provider they designated on the vaccine consent form to notify them of the error.
The morning after my son?s vaccine, he woke up and urinated and walked to the kitchen to get a glass of water. As he was standing drinking his water he mentioned he felt lightheaded and my husband grabbed him and laid him down and he seem to either pass out or have a very short seizure? He was sweaty and he was unsure what had happened. He said he went to bed feeling terrible and he was thinking it was as a result of vaccination response from his booster.
This report describes at the injection  site in a five year old female who received DTaP. On 07/26/01, the vaccinee received her fourth left thigh dose of Infanrix. "Within Hours" post-vaccination, she developed swelling heat, blisters and itching at the injection site. The vaccinee was seen in the emergency room. The reporter was "not sure if treatment was given". As of 08/02/01, the adverse events had resolverd.
Caused my Fibromyalgia to flare, started have inflammation in my joints especially my ribs, headaches, dizziness, nausea, anxiety was also having RUQ pain which hasn?t been figured out yet. My bones and muscles and joints and tissue hurt.
diagnosed with Shingles 3/17/21; Route of administration: Subcutaneous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 subcutaneous on 03Mar2021 (Lot number and expiration date not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose on an unspecified date for Covid-19 immunization. The patient was diagnosed with shingles on 17Mar2021. The outcome of the events was unknown.  Information on the lot/batch number was requested.
Late reaction at the injection site, started on Day 8th with a red patch or rash around 6 inches big, very itchy accompanied by pain and tenderness. Pain seems to be better on Day 12th but still red and itchy. Exactly same symptoms as described for COVID arm after Moderna?s first dose.
Patient says she felt dizzy, lightheaded Kw/ blurred vision, and chills, several  hours after administration of vaccines. Along Kw/ intense right arm pain to where she couldn't put her shirt on.
2nd dose inadvertently given 23 days after first dose (one day outside grace period)
Moderna bivalent 10 mcg given instead of bivalent 25 mcg dose
Had Gma Seizures starting at 10pm on 08-24-09. They lasted about 45sec. He was having a seizure every 2 hours, But they have been every for hours today 08-25-09. There is no focality to the seizures. He becomes stiff and has generalized shaking. His eyes remain open and midline with dilated pupils.  9/9/09 ED records received DOS 8/25/09. Also Labs from 8/28/09. Assessment: Seizure disorder with frequent grand mal seizures. Seizures every hour since 10 pm last night. Stiff, generalized shaking, dilated pupils. Some crying, complains of stomach ache. Not eating well. Seizure in ED office. Not fully alert. Postictal. Ankle clonus. Patellar DTRs brisk. Mild thromocytopenia.
Redness, swelling, itchng, fever in a 6inch patch around and including the injection site.
This spontaneous report as received from a healthcare worker refers to patient of unknown age (gender not reported). In December 2013, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, frequency and indication not reported). On 17-JUL-2014 (today), the patient visited the office and would receive the dose two of RECOMBIVAX HB. No adverse event reported. Additional information has been requested.
This is a 30-year-old male who had been in his usual health until he returned from overseas. In 2002, he reports feeling exhausted all the time regardless of the amount of sleep that he received. He contributed this to being older. It did not affect his job performance or activities of daily living. However, during his most recent deployment 02/2003 he noted a marked increased in his level of fatigue. He reported this to his corpsman. It was attributed to his lack of sleep and the extreme heat.  He now sleeps about 8-15 hours of sleep and still feels exhausted. He is often late to work. He hires someone to do lawn work and has a maid's service twice a month.  In addition he has joint pain in his knees (4-6/10), elbows bilaterally (3-4/10) and left shoulder (4-6/10). The knee pain started in 2002 and the elbow and left shoulder pain began with deployment in 2003. The pain does not limit his work or activities of daily living.
Administration to child under 4-year-old. Case previously recorded as MA2009-4591. Initial case report received from physician on 17 NOV 2009. A patient 3-year-old or younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. Reference no: NA09-008308
J96.00 ACUTE RESPIRATORY FAILURE 7/22/2021 ABNL LIVER ENZYMES
Chills for several hours, fever, sweats, achiness. Next morning achiness and fever.
Pt complained of swollen lymph node under left arm and tender to touch. She also stated she had a temp of 100 in the morning and it was back to 99 a couple of hours later. She said she had a slight headache and drowsiness as well.
Patient is a 78 y.o. male patient of, MD with a history of SOB   Discharge Diagnoses:   1. Covid 19  2. AKI on CKD stage 3a 3. Acute on chronic respiratory failure with hypoxia              -On 4 L nasal cannula, baseline is 3 4.  Acute CHFpEF 5. COPD, not acutely exacerbated         6. HLD //  HTN // CAD         7.  Acute right lower quadrant abdominal pain-- > right lower quadrant intramuscular hematoma         8.  Right pulmonary nodule             -CT chest will be obtained outpatient to further evaluate this.   Patient presented to Facility for shortness of breath.  Chronically requires 3 L of oxygen but had an increased oxygen requirement and was found to be COVID-19 positive.  Vaccinated. Was initiated on Resdismivir x5 days along with Decadron.  Patient chest x-ray showed some small effusions and small pulmonary nodule that needs further outpatient follow-up.  His course of stay was complicated by development of acute abdominal pain.  A CT scan was performed and found an acute large right anterior abdominal wall intramuscular hematoma measuring up to 15 cm.  This is thought to be secondary from his coughing.  Anticoagulation was stopped.  Patient was seen and evaluated by general surgery Dr.  Managed nonoperatively.  Hemoglobin has remained stable.  No new pain.  Actually feels improved today.  Will write for pain medication for patient.  Just prior to discharge she did have a few PVCs.  Patient was not having any chest pains or new shortness of breath.  EKG was reviewed and similar to previous.  Magnesium was normal.  Patient will follow-up with primary care regarding this.   Patient's labs reviewed today and does have elevated CRP and white blood cell count that are likely reactive to his hematoma development as well as recent Decadron.  Did discuss will need close outpatient follow-up for recheck of labs within the next 2 to 3 days.  Outpatient CBC has been ordered.  Discussed any evidence of active bleeding or sudden onset of shortness of breath to return to the hospital
I started with itchy palms, then I had a red rash spread all over my body. Every day it got worse and started to burn and itch. The rash was not raised or blistered.  It would start on parts of my body then disappear within seconds, then spread to another part.
she started with a rash about 3 days after the injections, she had a fever as high as 102, redness at the site and a hard lump at the injection site as well and her leg was swollen, symptoms started to subside about 3 weeks later
First dose fine - no reaction or pain in arm Second dose - pain in arm for day 1, 2, 3 day;  Day 2 - Fever  101.4-101.8 with chills  & diarrhea & wheezing with tightness in chest  Day 3 Fever 101.2-101.6 with chills  & diarrhea with extreme exhaustion
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves an adult patient (age and gender was not reported) who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (lot UJ005AF; expiry date: UJ005AF) that was left the vials out of fridge on 22 Oct 2018. The patient had no other concomitant medications reported. It was a case of actual medication error due to incorrect product storage. It was reported that the vials were left out of fridge. No specific adverse events reported. The patient didn't visit to doctor. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Initial report from the healthcare professional on 31 Dec 2009: This patient was administered FLUVIRIN at a dose of 0.25 ml instead of 0.5 ml. The outcome of the event was not reported.
Bone, joint, muscle aches. Headache. Weakness. 2/20/21 to 2/21/21 Swollen lymph nodes under arm and into breast, bruising and tenderness. 2/20/21 to current Nausea and diarrhea 2/20/21 to current Exhaustion 2/20/21 to current
I never had Sciatica. So I took Ibuprofen for a few days. We were traveling, the pain made it hard to drive, Rash right leg, foot, toes and bottom of foot (11/27/21). Rash, headache, and continuing pain in the leg, came a week later.
Severe Headache and body aches with 10-12hours of receiving vaccine. Headaches with intermittent chest pain which continued for month until I went to my annual physical. My blood pressure was taken and I was in hypertensive crisis with a blood pressure of 182/118. Blood pressure two weeks prior to vaccine was 130/82. Was put on valsartan/hctz. EKG came back normal, but chest pains have persisted along with dizziness and bouts of losing my  balance.
PATIENT CAME IN FOR THE SECOND DOSE SHINGRIX AND THE NEXT DAY SAID THAT HER ARM HURT AND THE PAIN RADIATED TO HER HANDS.  PATIENT SAID OVER THE COUNTER PAIN MEDICATIONS DID NOT PROVIDE RELIEF.  PHARMACIST ADVISED PATIENT TO CONTINUE WITH OTCS, COLD COMPRESS AND IF SHE DOESN'T IMPROVE TO CALL HER DOCTOR.
Had flu shot and about 2 to 3 hrs later he had onset of nausea, lightheadedness, and weakness. Was seen in urgent care clinic and given 2 lites of NS and zofran. Patient then felt better overnight but came back to urgent care the next morning. Reported symptons of weakness, nausea, and lightheadedness which became more severe with time.
21 year old female  stated that she felt lightheaded after taken the vaccination. Patient stated that she gets light headed when she gets vaccinations. Vital signs was taken at 10AM BP 138/60 HR 78 RR16. Patient was in observation for 30 minutes. 1030AM vital signs was taken before leaving BP 118/67 HR 81, RR16, Patient stated that she feels good.