chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration unknown) at a pharmacy on or about 08-OCT-2013 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-MAY-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir for the management of his painful symptoms. On or about 26-AUG-2016 the patient was treated again for ongoing and worsening symptoms of shingles outbreaks. The patient has been prescribed VALTREX and PERCOCET for management of her persistent and painful symptoms. 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. Additional information has been requested.
Sore arm  on Friday 10/15 and then Headaches off since. On Saturday 10/16 Extremely fatigued and still on going. Slept all day Saturday and Sunday still  had headaches. Monday-Wednesday trouble staying up during the morning and day. Feel lightheaded if I don?t lay down then soon as I lay down I?m sleep that fast and snoring. I can hear myself snoring or breathing heavy as well as everything in my background. It?s like I?m sleep but still awake at the same time. And then I?m tired again by evening and some nights I can?t sleep. And this been going on since Saturday
It began with a small read area on the front of my left arm about 3 inches down and to the side of the injection spot. I started to notice it about 30 minutes after the injection. About an hour after the injection I began to have severe pain under my arm around my lymph nodes. I also had severe pain around the red spot growing on my arm. It continued to expand and be very painful for 3 days. I was unable to put any pressure or use my arm. On day 3 the arm pain started to go away but I began to have a migraine that lasted another 3 days.
Received flu vaccine last night.   Area was about the size of a silver dollar last night and parents applied ice.  Itchy, warm to touch. Arm is swollen.  Redness has enlarged.  No streaking.  No fevers.  Normal appetite.
pt recvd vax 14JUL93 about 930AM pt given APAP had low temp all day @ 2AM on 15JUL93 t104; mom took pt to ER; temp down to 101, sent home; mom returned to ER 15JUL93 in afternoon t104 again; given motrin told it was a pertussis react by ER;
This spontaneous report was received from a physician via a company representative concerning to a 9 year old female patient. The patient had no pertinent medical history, drug reactions/allergies or concomitant therapies. On an unspecified date in 2008, the patient completed the vaccine schedule with VARIVAX, subcutaneously for "prevention from varicella" (the lot #, expiration date, dose, strength and frequency were not provided). On 22-MAY-2017, the patient went to the doctor's office, and the physician stated that the patient had shingles. The patient was treated with acyclovir. At the reporting time, the patient had not recovered from the event of shingles. No laboratory tests were performed. The causal relationship between the event and the therapy was not provided. Additional information is not expected because there was no consent to contact physician.
Vomiting, nausea, chills, shivers, fever, large rash on each arm where each shot was given, swelling, heat, and redness. Vomiting subsided within 15 hours. Rashes persisted about a week.
Information has been received from a certified medical assistant concerning her daughter with no medical history and no allergies who 5.5 or 6 years ago was vaccinated with a first 0.5ml subcutaneous dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  There was no concomitant medication.  One week after vaccination, she developed rubella.  The only symptom she had was a rash.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information is not expected.
Pregnant and received Moderna vaccine 2 doses; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna vaccine 2 doses) in a 36-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion (Miscarried on 07-May-2020) on 07-May-2020, Bipolar II disorder, Hyperandrogenism, ADHD and Nissen fundoplication (Linx , Nissen Fundoplication). Concomitant products included RHL G Immunoglobulin Injection, DOCUSATE SODIUM, ONDANSETRON, TRAZODONE HCL, FLUOXETINE HCL, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), QUETIAPINE FUMARATE (QUETIAPINE [QUETIAPINE FUMARATE]), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and IRON (SLOW RELEASE IRON) for an unknown indication, METFORMIN.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-May-2020 and the estimated date of delivery was 15-Feb-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna vaccine 2 doses). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna vaccine 2 doses) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2020, Pregnancy test: positive (Positive) Positive.         Treatment information was not provided. Ultrasound and Blood work were reported as Normal for an unknown date.  The number of fetuses was reported as 1 and had established prenatal care. The patient had no maternal history of subfertility. The patient had no complications or acute illness during this pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
red swollen arm-some temp-unsure as to how much; No APAP given until 5AM today; advised to give APAP every 4 hrs for 2 days;
pt recvd vax;sxs began about 3:30am on 25aug94 w/ n, severe h/a & earache & aching all over;got up about 9am vomiting & extremely weak;had red areas appear on tongue & inside mouth;saw MD about 4pm;fever 100;tx w/ phenergan x 12 doses;
Herpes labialis outbreak, started on Thursday 10/14. Began using abreva immediately. Saw MD via telehealth on the evening of 10/14. Started on Valtrex on 10/15.
muscle pain; severe joint pain in hands and fingers; This is a spontaneous report from a Pfizer received via contactable consumer or other non-health care professional. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced muscle pain and severe joint pain in hands and fingers on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
At 7am Saturday - 1 degree above normal temp, body aches.  Saturday evening - 2 degrees above normal temp, continued body aches. Sunday - continued body aches and weakness.
Pt recv vax on 12/10/98; on same day pt exp cellulitis of upper Rt arm; tx=Rocephen; pt imp 12/14/98
Tinnitus in both ears; Mild dizziness; Mild sore shoulder; Mild latent fatigue; administration date: 09Apr2021, 1st dose/administration date: 14Apr2021, 2nd dose; This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in right arm on 14Apr2021 at 11:15 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization at hospital. Medical history included was reported as none. There were no concomitant medications. No known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7533, Expiry date: unknown), via an unspecified route of administration, administered in right arm on 09Apr2021 at 10:15 (at the age of 56 years old) as DOSE 1, SINGLE for covid-19 immunisation and experienced mild sore shoulder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient had inappropriate schedule of product administration (date: 09apr2021, 1st dose/administration date: 14Apr2021, 2nd dose) on 14Apr2021 at 11:15, and experienced tinnitus in both ears, mild dizziness, mild sore shoulder, mild latent fatigue on 14Apr2021 18:00. The patient did not receive any treatment for the events. The outcome of the event tinnitus in both ears, mild sore shoulder, mild latent fatigue was not recovered, and mild dizziness was recovered on 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100952509 Same patient, same product in different dose, partial same event
Dull headache started within a few hours. The headache became more severe in the evening. At 24 hours, I became achy and feverish, with nausea and vomiting. My temperature was 102.5. The injection site had a red blotch, about the size of a tennis ball. I had the same redness and arm pain with the first dose of the vaccine. At 48 hours, the fever subsided to 101 and then to 100. The dull headache lasted 72 hours.
2 days after getting immunizations patient refused to eat, tongue thrusting, he was fussy after immunizations but then 2 days refusing to drink, no changes in formula, not vomiting but had one mucus stool. We brought him in for evaluation at day 4 after the immunizations (9/15/17).
Pt was given first Moderna vaccine on 3/3/2021, but had received his first Pfizer vaccine on 2/16/21.
patient got the pneumovax vaccine first and then received the prevnar 13 vacccine; This spontaneous report as received from a physician (primary care) via Pfizer (#2019195978) refers to a currently 82 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-NOV-2012 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose 1 for prophylaxis, then later on 21-JUN-2016, she received a pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) for prophylaxis (inappropriate schedule of product administration).
Administered Hepatitis A, HPV and Tdap vaccines. Client broke out in hives 4 hours after vaccine - arms covered bilateral in hives and legs bilateral had a few hives. Mother gave child 2 BENADRYL 25 mg each. Child was fine this morning.
Child already showing symptoms after 11/15/2002 vaccines. After #4 DTaP on 2/25/2003 Child worsened. He became irritable, excitability, outbursts of temper, shyness, avoidance, anxiety, tensions, depression in all areas, no focus or contact at all, uncontrollable crying and fidgeting and hyperactive and biting and pinching.
pt recv vax & pt exp a hypersensitivity-like rxn characterized by elevated blood pressure, SOB, tachycardia & a very uncomfortable feeling;
After being injected with the Evans Flu Vaccine, Lot # 765412, the patient's arm became swollen and ached.  That evening the patient experienced flu like symptoms, i.e. body aches and sore throat.  The MD and a co-worker were also given the same injection and both experienced the same symptoms.
Right hand swollen after 5 minutes of the vaccine.  I was advised by the nurse this happens, she stated if it gets worst contact your primary Doctor. The next day, my face was swollen & numb on the right side and my throat. I  immediatley took benedryl,  and the swelling did go down, But not all the way. I contacted my doctor and he then put me on a steriod to get the swelling down. I have had severe allergic reactions in the past.
cervical stenosis; numbness; tingling; Initial information regarding an unsolicited valid serious case received from a nurse via Information (Reference number- 00346068) and transmitted to Sanofi on 04-Nov-2020.  This case involves an elder female patient (age at onset was not reported) who had cervical stenosis (cervical spinal stenosis) with numbness (hypoaesthesia) and tingling (paraesthesia), after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].   The patient had received Flu shot (unspecified) on an unknown date in 2015 from pharmacy also, she had vaccinated with Fluzone High-Dose (with lot number 165703 and expiration date 01-Apr-2017) on 30-Sep-2016 and another dose of same vaccine on 02-Oct-2017 (with lot number UI884AB and expiration date was not reported) in the past for prophylactic vaccination.  The patient's medical history, past medical treatment(s), family history and concomitant medication were not reported.   On 07-Nov-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (prefilled syringe, lot UJ043AB and expiration date 22-May-2019) via an unknown route at an unknown administration site for prophylactic vaccination.  No information regarding flu vaccination in 2019 reported.  On an unknown date, the patient developed serious cervical stenosis (cervical spinal stenosis) with numbness (hypoaesthesia) and tingling (paraesthesia), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant.  After diagnosis, the patient had surgery on her cervical vertebrae C4 and C5 and was admitted to rehab after this surgery on 26-Sep-2020.  Details of laboratory data were not reported.  Final diagnosis was cervical spinal stenosis.   It was not reported if any other corrective treatment was received by the patient.  The patient was discharged on 06-Oct-2020 from the rehab facility.  At the time of reporting, the outcome of the events were not reported.; Sender's Comments: This case concerns an elder patient who had cervical spinal stenosis, after vaccination with FLUZONE HIGH DOSE. The time to onset is not unknown.  Also, patient had previous vaccination with same vaccines and no adverse events were reported to them at the time of reporting. The patient's medical condition at the time of vaccination, concomitant therapy and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report was received from a registered nurse and refers to an 18 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD lot # M022402 with expiration date of 01-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Redness/swelling/itching at site of injection/lasted approx. 24 hrs/applied BENADRYL cream.
Menveo had been reconstituted with the incorrect diluent; Menveo had been reconstituted with the incorrect diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong diluent used in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong diluent used (Verbatim: Menveo had been reconstituted with the incorrect diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo had been reconstituted with the incorrect diluent). The outcome of the wrong diluent used and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter called in to report that a nurse accidentally gave a dose of Menveo that had been reconstituted with the incorrect diluent and wished to know how to proceed. The patient received Menveo with wrong diluent, which led to wrong diluent used and inappropriate dose of vaccine administered.
constant rapid heartbeat for months, had ct scan,  xray, heart doctor.  2nd heart doctor in 5 days
1722 - Patient received 0.3mL Pfizer covid vaccine IM in L deltoid.  1740 - Patient reports headache, scratchy throat, and has dry cough. Pt denies SOB, breath sounds clear, no mouth swelling or throat tightness. BP 114/68, HR 60, 98% pulsox on room air. 1742 - Patient given 50mg IM diphenhydramine R deltoid.  1745 - Patient reports she is starting to feel better but agrees to be evaluated by EMS. 1800 - Patient taken to ER by ambulance.
I was having severe uncontrolled coughing, pain in my chest, bad wheezing. I went to the emergency, they took my blood pressure it came back at, 200/100 that is way too high. They did a chest x-ray that showed I had water in my lungs. I was given a prescription for Z-PAK to help clear the infection. I am feeling a tad better I do feel like my head is going to blow off I am so congested. I was advised to follow up with my primary care physician.
Immediately after receiving the vaccine, I didn't have any reactions. About 28 hours after, I had a slight fever and went to lay down and woke up  and was fine. About 2 weeks after, I was washing dishes and noticed a high-pitched ringing in my ears like a soft-pitched whistle. I tried shaking it off thinking it would help go away. Later that night, I took some cold and sinus medicine to try settling it. It seems as if the medicine triggered it to become higher pitch; when I woke up in the middle of the night, it was unbearable. When I woke up fully in the morning, it lessened but would get worse as the day goes on. Sometimes, I can't work or do anything at night or watch TV because I can't tune it out. Sometimes, I have to take melatonin for 6 months to try to ignore the ringing to help sleep better. I started getting acupuncture twice a month to see if it'll help settle the tinnitus.  Now, it has its days; sometimes, it's moderate and some days it's very bothersome, but it hasn't gone away completely. I saw an ENT and audiologist on 04/29/2021 to get better clarity and treatment advisement; they performed a hearing test to ensure there wasn't damage to the eardrum. I was diagnosed with bilateral tinnitus and decreased hearing with new onset left hearing after receiving my COVID-19 vaccine. No apparent damage or loss was found in my ears; she didn't think there was a reason to do an MRI because there was no indication of any brain damage causing the ringing in the ears. I was informed if it got worse or too unbearable, they would further investigate. As of now, there hasn't been a solution found for my tinnitus and I just bare with it daily.
Pain, swelling, redness both arms started in evening of same day given and continued swelling  for next 48hrs. Pressure to areas painful but able to move arms. No fever or rash or joint swelling. LD erythema 9x12cm and RD erythema 20x13cm. No distal swelling and not circumferential around arm, no numbness or tingling, intact distal pulses. Much better when called on am of 10/13/17 with ibuprofen.
large, red rash  and roughened skin on injection site on right arm, itchy, sore, lymph node discomfort beginning 14 days after injection
I had a slight fever, cough, chills, and body ache. I tested positive for COVID-19 and my doctor prescribed me PAXLOVID. I tested negative around 5 days after taking PAXLOVID. A couple days later I tested positive again for COVID-19. I had fatigue, chills, coughing, and body aches. I tested positive for COVID-19 for 8 days. My kidney disease is also acting up and my feet and hands are swollen. I have to go to the doctor for a check up.
One day post vax pts arm was severely hot, red, large type knot. Pt was not feeling well and very achy.
Extreme flu like symptoms after the flu shot. 99.8 fever and body aches and nausea
muscle aches, fever, chills, nausea and vomiting for 6 hours that started 12 hours after vaccine. Headache following the initial 6 hours for another 12 hours. Took advil and tylenol
The vaccine was hospitalized in a a psychiatric facility. On 04/28/02, he completed a 10 day course of doxycycline. He started a regimen of tetracycline for acne and had taken a total of five doses. On 06/08/02, the  vaccinee received his first injection of Engerix-B. On 06/09/02, he started turning red and was treated with diphenhydramine hydrochloride (Benadryl) 50 mg intramuscularly. He then had tightness in his throat and difficulty breathing. An epinephrine  (Epipen) injection was then administered. He developed cyanotic nailbeds and lips, and a rash and was transported to the medical center. He was given supplemental oxygen and 2 liters of intravenous normal saline solution. He had an electrocardiogram, chest x-ray and pulse oxygen performed. He was observed in the emergency room and was released  back to the psychiatric facility. The physician thought that the patient had a tetracycline reaction but the pharmacist wanted to "check into the Engerix as a possiblity since he had previously taken doxycycline". the tetracycline was discontinued  "and they are wondering about the Engerix B." The reporter stated that the events were possibly related to Engerix-B. The information received on 06/11/02 notes the events to be resolved.
1st (before going to bed) fatigue, tiredness, and headache; 2nd (trying to go to bed) cold feeling, extremities cold to the touch, extreme shivering (causing teeth chattering, thighs shaking, louder breathing), shivering causes inability to seep.  Duration: about 2 hours; 3rd (waking up in the middle of the night) hot flashes, sweating, thirst, slight muscle pain in right hand.  Duration: 2-3 times throughout the night for about 10-15 minutes each 4th (waking up the next day) dizziness, slightly blurry vision, orange foamy urine (my urine is normally pale yellow and not foamy)
Pt ? with ? self annoculation to R arcola X 4 days. Also has papular lesions on chest/back. Had a H/A but only post anthrax shot. Pt denies any other ? concerns. Also has another small pustular lesion just above vaccination site.