chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pediatrician refers to a 9 month old female patient. The patient's medical history included work-up for possible macrocephaly. On an unknown date the nurse's assistant accidentally gave the patient an injected of 0.5mL VAQTA (lot # and expiration were not reported), in the left thigh. The patient did not have any relevant concomitant medications and past drug history. The pediatrician was unaware of any adverse reactions. there was no relevant laboratory data. As of 21-DEC-2013, she would not continue to be injected with VAQTA. Additional information is not expected.
No adverse effect reported; The third dose was GARDASIL 9 and not GARDASIL quadrivalent; The third dose was GARDASIL 9 and not GARDASIL quadrivalent; on 12/16/2015 patient received a first dose of GARDASIL quadrivalent. Then on 1/13/2016, patient received a second dose of GARDASIL quadrivalent which was earlier than the indicated dosing regimen per PI; This spontaneous report was received from a Registered Nurse referring to a 16 year old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 16-DEC-2015, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) by intramuscular route (dose, anatomical location, lot number and expiration date were not reported); then, on 13-JAN-2016, he received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vial lot # K010215 the expiration date was not reported, but upon internal verification has been confirmed as 17-JAN-2016, intramuscularly, both for prophylaxis. It was specified that this dose was earlier than the indicated dosing regimen (inappropriate schedule of product administration).    Furthermore, the nurse reported that on 17-JUL-2020, the patient received a third dose of vaccination, but it was with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in prefilled-syringe intramuscularly, for prophylaxis, lot # 1602284, the expiration date was not reported, but upon internal verification has been confirmed as  26-SEP-2021 (dose and anatomical location were not reported), instead of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (interchange of vaccine products and wrong product administered). 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: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
High fever; Chills; Body aches; Headache; Loss of taste; Diarrhea; Swollen lymph nodes in arm pit and up left side of neck; Earache; Congestion; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at age of 56 years (not pregnant) on 17Jun2021 14:00 (Lot Number: EP7533) as single dose for covid-19 immunisation. The patient medical history included Hoshimoto's thyroiditis, hypothyroid, Sjogren's Syndrome, mixed connective tissue disease, mitral valve prolapse, fibromyalgia, carotid artery disease. Concomitant medications included unspecified drugs the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose1 at left arm at age of 56 years on 20May2021 14:00 (Lot number EW0162) for COVID-19 immunization. On 18Jun2021 03:30am, The patient experienced high fever, chills, body aches, headache, loss of taste, diarrhea, swollen lymph nodes in arm pit and up left side of neck, earache, congestion, loss of appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. No treatment received. The outcome of the event was recovering.  Lot/batch number is available; Additional information has been requested.
muscle twitches over whole body; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 28-Jan-2021, the patient experienced MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever). At the time of the report, MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Relevant concomitant medication was not reported.   This case was linked to MODERNATX, INC.-MOD-2021-022474, MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018071) MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018071)
Both eyelids feel and look puffy. I Have to make an effort to open my eyes all the way. This occurred after the first dose, I thought it was due to old make up. After the second dose it is occurring more often and is more bothersome.
pt recv vax 3OCT95 & pt devel an ear infect for which was taking Cefzil since 27NOV96 & Tavist;3DEC96 pt exp a mild case of varicella w/first lesions appearing on back of thigh;4DEC96 pt lethargic;4DEC96 devel 8 addtl lesions;
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored doses of PROQUAD (Merck) of lot/batch # L024497 with expiry date 01-JAN-2017, lot/batch # L046506 with expiry date 27-MAY-2017 and lot/batch # L042817 with expiry date 26-APR-2017 (dosage, strength, dose number, vaccination site and route of administration not provided) on unspecified dates. Concomitant therapies were not reported. No adverse effects were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.
Patient taking potassium oral and amlopiphine and simvastatim. Hx of HTN and high cholesterol. If symptoms worsen, report to clinic immediately.
Patient reported arm being swelled, warm and painful around the site of the injection about the size of her palm. Patient called her Dr. initial who said for her to take BENADRYL. Pt also took ALEVE for the pain and swelling.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Weakness-Severe, Additional Details: EMS STATED TO NOT GIVE ANTHING BY MOUTH
No Adverse Advents. Vaccine was given beyond use date. Manufacturer and Patient both notified
Fine red rash starting on buttocks spreading to legs, back, arms and chest. Itchy. Denied any swelling, difficulty breathing or chest tightness.
within 30 minutes of vaccine, sugar dropped 55mg to 60. Later in the day it went to 280+ and stayed there for extended time Also, since the vaccine he is experiencing extreme tiredness at times and difficulty focusing his mind.  He said it's like he doesn't know what he is doing.  Sometimes he seems fine, but most of the time he's a little off, more forgetful than usual and lack of concentration.   Other medications that would not fit above, Atorvastatin, CoQ10, low dose aspirin, Furosomide, Trospium, Meloxicam, D3, Vitamin C, Vitamin B Complex, Zinc,.  We had the list of meds at vaccinie  location, but nurse said she did not need it, only wanted to know about blood thinners
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 29-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 16-APR-2015, the patient was treated for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir and gabapentin for management of her 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.
At the beginning chills body aches chills and dizziness. These symptoms lasted 10 days. And the chest pain started as a severe shooting pain in my chest. The pain was constant,  After two days of chest pain I visited the Emergency room on 01/11/2021. I got IV fluids. EKG was not normal.  Discharged from hospital and referred to a cardiologist for follow up.  No Health Insurance so no follow up yet.  Chest pain still present but not constant. I never had chest pain before the vaccine. No second dose of vaccine yet.
Received first dose COVID 19 vaccine and started to notice subtle hair loss on head and turning gray quickly.  Received second dose COVID 19 vaccine and within 24 hours noticeable head hair loss (hair now completely gray/white) and in immediate days following noticed  hair loss to arms,  facial hair not growing in (i.e. beard)  as well.
Patient received first Covid vaccine 5/16/21, second Covid vaccine 7/23/21.  Two and half weeks after first vaccine he developed lower extremity rash, arthralgias, myalgias, and sinus congestion.  Two days after the second vaccine he developed gross hematuria.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 11-JUL-2012, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2014, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Rash on lower extremities, 12 hours, post vax. Lower extremity "soreness/weakness:, 12 hours, post vax.
Information has been received from a physician concerning a 39 year old female who is four months post childbirth and is breast feeding, with no remarkable past medical history and no known drug allergies, who on 7/2/02 was vaccinated with one dose of MMR II. There were no concomitant medications. On 7/12/02 the pt experienced a generalized aching of muscles. On 7/13/02 the pt developed a fever which peaked on 7/14/02 at 102.7 degrees. On approximately 7/14/02 the pt developed a rash described as erythematous papules with facial confluence along cervidal and occipital lymphadenopathy. The pt sought unspecified medical attention. Additional info has been requested.
At injection site reaction pain in the muscle joint pain, redness on the injection site and Sharp pain in the upper back.
Co administration of the Engerix-B and Pediarix on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 7-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number k329e, expiry date 24th April 2023) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The physician reported that the co administration of a dose of Pediarix and Engerix B to patient on the same day, which led to overdose of hepatitis B antigen. No further events were reported.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000110:Same reporter
Patient was given bivalent vaccine instead of monovalant by error. No adverese effects noted.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Parents reporting that after patient received COVID vaccine #1 that she then developed an asthma flare with cough, shortness of breath, wheezing  on 01/07/2022 that was not manageable with prescribed at home medications. She required being seen in walk-in 01/10/2022 with report of treated with oral steroids with continued asthma/allergy management with her Flovent, albuterol, cetirizine, and singulair. Parents report concerns that COVID vaccine may have induced asthma flare as adverse event. Event was not witnessed by this writing provider, but reported to me as primary care provider with vaccine completed at alternative clinic listed above. Parents chose to still complete COVID vaccine #2 on 01/26/2022 before reporting their concern for adverse event to vaccine #1, and patient has tolerated it thus far without reported concern.
got so sick afterwards; Initial information received on 15-Nov-2022 regarding an unsolicited valid Social -Media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got so sick afterwards after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine once (dose, lot number, expiry date, route, administration site, manufacturer: not reported) for Prophylactic vaccination.  On an unknown date the patient developed a non-serious got so sick afterwards (illness) (unknown latency) following the administration of influenza vaccine. The patient never had been so sick. Patient rarely got sick.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got so sick afterwards.
Patient had cold chills and sweats evening of vaccine 9/18/15. Next day noticed swelling in right arm which continued to get worse and go down patients arm.
Periferal vascular disease; shingles on her eyes/vision problems; painful and debilitating shingles on her eyes, face scalp, hands and fingers; PHN; Information was received from a lawyer regarding a case in litigation concerning a female patient(pt) of unspecified age.  It was claimed the pt was inoculated with Zoster Vaccine Live (ZOSTAVAX) on 11-DEC-2014, at pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. Shortly after vaccination with Zoster Vaccine Live (ZOSTAVAX), On unspecified date in October 2015, pt suffered debilitating injuries including painful, debilitating shingles on her eyes and vision problems (herpes ophthalmic), significant scarring, throbbing pain, face scalp, hands and fingers (herpes zoster), as well as post herpetic neuralgia (PHN), peripheral vascular disease.  It was claimed that as a direct and proximate result of defective Zoster Vaccine Live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX) product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. On unspecified date in 2018, the patient recovered from the herpes ophthalmic, herpes zoster, PHN, peripheral vascular disease. The reporter considered herpes ophthalmic, peripheral vascular disorder, post herpetic neuralgia and herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, herpes ophthalmic was considered to be medical significant.  Additional information was requested.
Information has been received from a physician (M.D.) concerning a 5-year-old male who at one year of age (approximately March 2003) was vaccinated with a 0.5 milliliter dose of MMR . At 5 years of age on 16-Apr-2007, the patient was vaccinated with a subcutaneous injection in the deltoid of PROQUAD (lot# 656551/1532F). On 17-MAY-2007 the patient developed pain and swelling over the parotid glands bilaterally that was believed to be mumps. Unspecified medical attention was sought. Laboratory data included mumps IgG of 2.59 and mumps IgM <1:20. It is reported that the patient recovered on 19-May-2007. No product quality complaint was issued. No more information is expected.
Pt vax hepta B; during which time some of injection squirted into left eye.  eye was irrigated w/ isotonic, buffered sol of purified water, NaCl, KCl, NaOH, NaP. No adverse Exp.
First symptom was lower throat started to feel tight, like congestion there. Then lower lip started to tingle. Slight sinus drainage. Felt like something wasn't right in upper chest & lower throat.
It was reported that a 53 year old female received Yellow Fever, Hepatitis A, Hepatitis B and Typhim VI vaccines on June 14, 1999. Approximately two days after the injection site the pt developed a warm red area at the injection site. Three days later the red area was 2 x 1 wide. Treatment with Benadryl 25 mg on June 21, 1999 and reports much better today 06/22/1999.
Since June 2021, I have noticed heart flutters about 7-8 times per day. The sensation feels like the heart skips a beat and a little bit of anxiousness, but it goes away rather quickly.   This did not happen in the past.  I have no other symptoms at this time.
After receiving the hpv vaccine I was diagnosed with premature ovarian failure at the age of 15. I received these vaccines in 2008, and twice in 2009, I was 11 and 12
patient breakout with hives all over the body after the second dosage of covid-19 vaccine.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneosly, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515:
Severe chill, aches and pains x 8 hours Fever <101 for 36 hours Cough developed at 36 hours and is ongoing
Flumist given 2/14/07 had expired 2/11/07. No adverse events have occurred.
4-17-14 Shot site puffy. 4-18-14 Site started to turn red with swelling. 4-19-14 Site still red and swollen. 4-20-14 Went to ER because of redness, swelling and red streak. Told to use cold compress.
Localized redness, swelling, and hard induration measuring 3.5 x 5.5 cm.
Mom reports fever was 105 crying consistently during the night, gave APAP pt seen in clinic 28AUG91;
The day following the shot my arm began swelling and turning red.  The swelling, above the elbow only,was considerable and was sensitive to the touch.  The swelling and redness lasted for two days and then began subsiding slowly.  It took several days and is still not completely gone.
Hospitalization  Fever  Fatigue  Rash on arm that was hot and itchy  Swelling on whole upper arm