chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received SHINGRIX vaccine on 7/25. On 8/7 he had fevers, chills, and sweats. But he recalls not feeling "right" from the moment he got the injection. My workup found elevated LFTs, acute renal insufficiency, and anemia. Hepatitis A, B, C serologies negative. US of abdomen showed fatty liver disease. His LFTs began to improve after a week, as did his clinical status.
No adverse event; Inadvertenly admistered a dose of proquad and a dose of varivax on 23-DEC-2019; This spontaneous report was received from a nurse prescriber referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies were not reported. The concomitant therapies included sterile diluent. On 23-DEC-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route, lot # and expiry date were not reported for both the vaccines) for prophylaxis (inappropriate schedule of product administration). There was no product confusion and no adverse symptoms reported (no adverse event).
Patient received her 2nd dose of moderna vaccine 3 days early then recommended per CDC (on day 21). No adverse RXN.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Initial information received on 18-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender not reported) who was inadvertently administered only the diluent from an ACT-HIB vaccine. The patient's past medical history, medical treatment, vaccination and family history were not provided. On 26-Jun-2018, the patient received a primary fourth dose of suspect HIB (PRP/T) VACCINE lot UI916AAA via intramuscular route in the left deltoid. It was an actual medication error due to wrong technique in product usage process. Final diagnosis was lpn inadvertently administered only the diluent from an acthib vaccine that had not been/no signs or symptoms of adverse (Wrong injection technique). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
rash all over his body; rash is a little itchy; This is a spontaneous report received from a contactable consumer or other non hcp. A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021) via an unspecified route of administration in Arm Right on 26Feb2021 (age at vaccination 65years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, blood cholesterol increased, thyroid disorder, drug hypersensitivity (Caller stated that he is not allergic to anything but penicillin that he is aware of), all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported. On 05Mar2021 the patient experienced rash all over his body, rash is a little itchy. Clinical course was reported as he received the first dose of the Pfizer covid19 vaccine on 26Feb2021. He reported he developed a rash all over his body on 05Mar2021. His dermatologist took a sample of the rash and gave him Benadryl and a cream. He was not allergic to anything but penicillin that he was aware of. He wanted to know if this is a common side effect. The patient underwent lab tests and procedures which included blood potassium: level high, 5.9 on unspecified date, blood potassium: second time it 5.3 on unspecified date, blood potassium: came back 5.3 on unspecified date this was all way before the vaccine. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of rash all over his body, rash is a little itchy.  No follow-up attempts are possible. No further information is expected.
Describes peripheral neuropathy in  62 year old male receiving Re Quip for the treatment of Parkinson's disease.  the vaccine developed "intermititant twinges in legs" and his "ankles were sensitive to touch." In April 2000, he developed "numbness" in his feet and pain (NOS) in his legs.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-JUN-2013, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided), for its intended purpose the prevention of shingles. On 09-JAN-2017, the patient suffered from a shingles outbreak; in addition to chronic pain, rash and lesions to various parts of her body as a direct result of the ZOSTAVAX. As a direct result of ZOSTAVAX vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient has sustained severe and permanent personal injuries, suffered serious, progressive, and incurable injuries, as well as conscious pain and suffering, mental and emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of ZOSTAVAX use. The outcome of the event was unknown. Causality assessment was related. The event of shingles outbreak was considered disabling. Additional information has been requested.
injection site still tender.developed a rash/hives on arms & legs in february lasting 6wks.then fever(103-104) accompanied by lymphadenopathy on april 4.fever lasted 1 wk.viral work-up negative
improperly stored medication given to patient; Information has been received from a health care professional (also reported as the "office manager"), referring to a 12 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-AUG-2020, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T005401, expiration date on 12-AUG-2021, subcutaneously for prophylaxis.      The vaccine had one temperature excursion of 2 hours with 7.9 Celsius (C). It was confirmed that a digital data logger was involved.
I did not know at the time they were related but now I am having what is called a delayed allergic reaction to the dermal filler Juvederm Volbella, injected into my tear troughs by Dr. at Facility. I got the fillers less than one week following my second booster of the Moderna vaccine
Presented to ER on 12/3/21 for COVID-19 pneumonia with acute hypoxic respiratory failure with ARDS and admitted. He was treated with remdesivir and course of Decadron.  He required prolonged intubation and mechanical ventilation and was subsequently trached and PEGged on 12/23/21.  Hospital course complicated by superimposed ventilator associated pneumonia with tracheal cultures growing Klebsiella species. He also grew Candida parapsilosis in the blood. He was treated with a course of cefepime and initially fluconazole, subsequently switched to IV micafungin from December 29th.  He had septic shock at some point and required pressors. Bacteremia is now resolved. Patient has been followed by pulmonology/Critical Care, Infectious Disease service, Cardiology and  Surgical Services. Patient also did develop bilateral upper extremity DVT and was treated with full-dose Lovenox. He developed AFIB/Flutter with hypotension and following Cardiology evaluation was started on an amiodarone drip and was cardioverted on 1/2/22 due to persistent hypotension, and eventually converted to sinus rhythm transition to p.o. amiodarone and metoprolol. Patient has remained on ventilator via tracheostomy.  He has been getting daily weaning trials; remains on 35% FiO2. He continues to have increased tracheal aspirate and repeat tracheal cultures on 1/10/22 again grew Klebsiella species and he was resumed on IV cefepime from 1/11/22 ; switched to Rocephin 1 gram IV daily to  7 days (end 1/20/22) and Micafungin 100 mg BID to continue for 7 more days (end 1/20/22).   He also had critical illness myopathy, due to long hospitalization, steroid, and paralytic use and has been receiving physical therapy. He had ICU delirium as well; was started on Seroquel which was very helpful.   Patient is hemodynamically stable and was discharged to LTAC on 1/13/22 to continue aggressive physical therapy and ventilator management. Accepting physician is Dr. and verbal sign out was given by myself.
3/30/11-1st HPV Shot 6/6/11-2nd HPV Shot July 2011-Unexplained lumpy rash on hands and elbows August 2011-Wart on Shin September 2011-Hair Loss becoming evident Sept/Oct 2011-Irregular menstruation cycle Sept/Oct 2011- Trouble with memory/brain fog March 2012-Talked to pediatrician and referred to a pediatric dermatologist for hair loss April-Series of blood and hair evaluations...nothing conclusive.
Several swollen and painful lymph nodes in neck, began within a week after receiving the Pneumovax vaccine and has still not resolved.
pt recv vax 5MAY97 & the next day pt c/o 3x2cm erythema, swelling, sl raised & warmth @ site of inj;pt also was reportedly tested w/PPD on 5MAY97;
Patient said that after his second Shingrix shot, he started having numbness and his Dr is suspecting  Guillian-Barre Syndrome.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis, lot # M039202 with expiration date of 11-MAR-2018 (dose and route were not reported). No adverse effects were reported. The vaccine had an excursion during 5 hours 23 minutes with a temperature of  0°C to 1°C, no, data logger was involved. There was no previous temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012670: US-009507513-1703USA012671: US-009507513-1703USA012672:
Patient had previously received Pfizer-BioNTech COVID-19 vaccines on 3/27/21, 4/17/21 and lastly her booster on 1/15/22 at Pharmacy. Approximately a week after the booster, she began developing a rash/bruising (red/purple flat spots on her legs). On the morning of 2/5/22 the spots had spread to her abdomen and were looking darker. Also noted bruising to thighs and spontaneous bleeding when she scratched herself. She went to the urgent care and was referred to alternate local hospital for evaluation. Patient admitted and hematology & oncology data base consulted. Dexamethasone 40 mg daily x 4 days ordered and begun on 2/5/22. At time of report patient's platelet count is improving but still abnormal. She is currently admitted to the hospital and is at Day 2 of hospitalization. (Day 0= 2/5/22)
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Weakness-Mild, Additional Details: Patient complained of having left lower back pain about an hour after receiving their 2nd dose of the Moderna vaccine.  I spoke with her about her issues and she mentioned she had been anxious before receiving the shot.  Patient took two 325 mg tylenol tablets (for her back pain) and two 25 mg benadryl tablets from a coworker (for the redness in her arm). She was observed for 20 minutes and her anxiety had calmed down and she no longer complained of the pain in her back.
Had like angioedema; Arm is like two or three times its size; Arm just hurts a lot; Having chills; Felt nauseous right away after getting the vaccine; Very tired; A spontaneous report was received from a consumer concerning a 59-years-old female patient who experienced having "like angioedema" (swollen mouth), arm is like two or three times its size (vaccination site swelling), arm just hurts a lot (pain in extremity), very tired (fatigue), having chills (chills), and felt nauseous right away after getting the vaccine (nausea).  The patient's medical history was not provided. Concomitant product use was unknown.   On 03 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient felt nauseous right away after getting the vaccine, and she went to bed because she was very tired.     On 04 Mar 2021, the patient had her arm "like two or three times its size" and the arm just hurt a lot. When the patient woke up and looked inside her mouth, she had "like angioedema". She also stated that she was having chills. She was not so concerned at that moment.  Treatment details included pain medication, allergy medication, and stomach/nausea medication.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome for the events of having like angioedema (swollen mouth), arm is like two or three times its size (vaccination site swelling), arm just hurts a lot (vaccination site pain), very tired (fatigue), having chills (chills), and felt nauseous right away after getting the vaccine (nausea), was unknown.  Consent for HCP safety follow up denied.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I inadvertantly gave an influenza shot instead of a pneuococcal shot, to a 4 month old child.  The syringes look very similar, and are pre-filled.  The error was noticed as I went to enter the shots into the computer, after my clinic, at approximately 1500.  CDC was contacted RE: any possible adverse reactions, as well as, the parent, my supervisor, and adminstration.  A detailed report was put into Webcident.  Parent was also instructed to bring the child back to the hosptial for the pnuemococcal shot.  Immunization opportunities offered.
Red, raised, pus at injection site - bleeds if bumped. Used BACTROBAN ordered by physician - still not healed.
2:29pm 110/72, 96, 99% O2Sat, T 98.8.  C/O Sl dizziness + HA. 2:40pm 124/76 Standing accompanied by mother and father.  Both agreed to remain in observation for an additional time period. 3:05pm Exited observation area.
No additional adverse effect reported.; Patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 18-OCT-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  On 20-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error). The nurse reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 hours, as recorded by the data logger. There were not any other temperature excursions.   No adverse effects were reported for the patient.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA005831: US-009507513-2003USA005901:
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with the improperly stored dose of (Merck) VARIVAX (lot number reported as L020000 and expiration date 02-JUN-2017, lot number reported as L020001 and expiration date 02-JUN-2017, lot number reported as L019125 and expiration date 27-MAY-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Patient received Moderna booster at vaccination site, with Pfizer as primary vaccinations. She reported dizziness and left arm tingling. She is A&O x4, denies headaches, SOB, nausea and vomitting, chest pain. No signs of allergic reaction. Vitals at 10:42 am were as follows: blood pressure 189/102, heart rate 67, respirations 18, SPO2 99%. Patient stated she normally takes her blood pressure medication at 9 am and she did not this morning. Also stated after her 2nd primary Pfizer vaccination, she had to go to ER for high blood pressure (but did not know what value it was at when taken). Vitals at 10:55 am: 150/98 blood pressure, heart rate 68, respirations 18, SPO2 99%. At this time, patient said she wanted to leave. Paramedic van and she wanted to go home. Was advised by Safety officer to stay a little longer until her blood pressure decreased, but she denied. She was advised to go home and take her blood pressure medications with food when she got home and take it easy. Safety officer reviewed reasons she would need to go to the ER with her and she expressed understanding. Safety officer followed up with patient on 1/22/2022, she said she went home to take her blood pressure medication and did not need further medical attention or examination.
When sitting in front of a computer, patient noticed she found the vision became blurred for about 10 minutes along with floaters in the vision.  After such time, there was full resolution of symptoms.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, 0.3 ml single (Lot number: EW0151, Expiration Date: 31Jul2021), in left arm, on 30Apr2021 as dose 2, 0.3 ml single (Lot number: EW0167, Expiration Date: 31Aug2021), in left arm and on 03Nov2021 as dose 3 (booster), 0.3 ml single (Lot number: FH8020, Expiration Date: 31Jan2022) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".
08/02/2003 rash at site, 08/03/2003 pain at site, 08/06/2003 fever and vesicles at site- started Keflex 500mg quid x 10 days, 08/08/2003 better