chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult female patient who experienced allergy to nickel, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Allergy to metals and Fibromyalgia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to nickel (allergy to metals) and it worsened her condition (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was allergy to nickel. It was not reported if the patient received a corrective treatment. On an unknown date, the event outcome was reported as Unknown for allergy to nickel. List of documents held by sender: none.
Hep A vaccine expiration noted after administration. (06/14/2022). Pharmacy recommends additional dose to be administered.  Order placed to replace current lot of expired meds. Attempts to reach pt not successful at the time of this report.
was given an expired tenivac with no reported adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 59 years old female patient who was given an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2022, the patient received standard diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT suspension for injection at a dose of 0.5 ml once (lot U6831AA, expiry date - 10-Aug-2022) via unknown route in unknown administration site for Immunization and was given an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
This spontaneous report was received from a licensed practical nurse refers to a 5-year-old male patient with no pertinent medical history and drug reactions/allergies. On 15-APR-2013 the patient was wrongly vaccinated with PROQUAD (Merck) (lot # H020137, expiration date 07-MAY-2014) instead of his second dose of MMR II, intramuscularly in the right arm. The vaccine PROQUAD was improperly stored and was exposed to the refrigerator temperatures not greater than 46 Fahrenheit (F) for 30 days (720 hours). Other suspect therapies included MMR II, KINRIX, KINRIX and VARIVAX (Merck). On 19-FEB-2009, patient was vaccinated with dose 1 MMR II (lot #, expiration date and route not reported). On 15-APR-2013, patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiration date not reported) intramuscularly in the right arm and a dose of KINRIX in the left arm. On 16-APR-2013 patient developed a "red, raised and hot area" around the injection sites on both the arms. Ice was given as a treatment for the event. No laboratory diagnostic studies were performed. Patient sought medical attention for the event by office visit. Approximately on an unknown date in April 2013, the patient recovered from the events. Causality was not reported. Additional information has been requested.
Baby developed a fever and vomiting 6/7/15 PM, subsequently found to have transaminitis.  She was admitted, developed encephalopathy and brain death by 6/8/15. She was also found to have an E. coli UTI.
Large ( 3 inchesX 2 inches) red, hot, raised hard swelling developed over 24 hours on upper arm at injection site. Headache developed also.
Initial an dfollow up information has been received from a physicia's assistant and a 26 year old female with a drug hypersensitivity to tetracycline, prochlorperazine maleate (COMPAZINE) and doxycycline and no other pertinent medical history reported. On 15-JAN-2007, at 8:03 AM, the patient was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL vaccine (Lot# 655165/1425F). Concomitant therapy included a "steroid shot" and unspecified hormonal contraceptives. On 15-JAN-2007, the patient developed a terrible rash.  The patient sought unspecified medical attention.  At the time of this report, the patient had not recovered from the event.  Additional information has been requested.  This is in follow-up to report previously received on 2/14/2007. There were no illnesses noted at the time of vaccination. That same day, the patient developed a terrible rash. On 16-JAN-2007, the patient went to the emergency room and was treated with unspecified steroids. On 17-JAN-2007, the patient followed up with the physician assistant and there was no significant rash noted at the time. At the time of this report, the patient had recovered fromthe event (date unknown). Additional information has been requested.
Patient's husband contacted the pharmacy and noted that patient had to visit the ER on the morning of 7/31/18 due to heart palpitations. The ER ran a blood panel and heart function tests but could not attribute the increase in BP and HR to anything. She was then discharged from the ER since nothing conclusive was gained from the tests. The patient was recommended bed rest and TYLENOL for the fever and pain.
Left side of face & neck heated up; then left side of face, neck, tongue and back of mouth went numb.  Numb like when novocane is wearing off.  Felt drooping & tight also, but no visual signs of drooping.  This was constant for a few days now it is like waves, never feels right, but then waves up to the numbness again No treatment.  Primary won't see me being it is caused by a covid vaccine.  Their answer is go to the ER.  This is not an emergency.  But still need help.  It sucks that drs. Won't help once I say it started right after a covid vaccine shot.  So no treatment , no help.  I hate feeling lost & not knowing if my face will go back to normal.  All they want me to do is get the 2nd shot, but cannot answer if this will get worse.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Information has been received from a consumer concerning her 33 year old daughter with epilepsy who on 11/18/03 was vaccinated with Rubella virus vaccine (lot # not provided). Concomitant therapy included lamotrigine. On 12/1/03, the patient developed a rash on chest and back after being immunized with Meruvax II. On 12/2/03, the reporter's mother called to report that the patient had gotten the rash on her chest again. The patient's rash on chest and back persisted. Unspecified medical attention was sought. Additional information has been requested. Follow up 03/03/05: Patient date of birth and lot number for vaccine number 1 was not provided.
patient / date of birth was 29-Aug-2020, received a dose of Bexsero on 12-Nov-2020; received a dose of Bexsero on 12-Nov-2020 in the hospital anticipating an splenectomy (indication); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-week-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th November 2020, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 12th November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a patient received a dose of Bexsero at 10 weeks of age in the hospital anticipating an splenectomy (indication), which led to inappropriate age at vaccine administration and off label use. The reporter consent to follow up.
Febrile seizure in office 12/28/07.  Varivax vaccine administered 12/20/07.  02/21/2008 MR received for DOS 12/28-30/2007 with D/C DX: Complex Febrile Convulsions.  Acute Respiratory Infections. Pt presented to ER from PMD's office where she had had a seizure, mainly consisting of eye fluttering. Pt became apneic requiring Ambu bag ventilations.  The child had presented to PMD with several day hx of croupy cough with vomiting of mucus. Axillary temp 105'F at OV. Pt was transported to ER and then transfered to higher level of care.  PE was (+) for wheezing, crusting of the nares, mildly erythematous throat, and cough. No further seizure activity during stay.
Pain at the injection site and down the arm.  Very painful and sore muscle and can not lift arm up.  It is hard for patient to drive and function normally without muscle pain.  Reported this pain on 11/10/2013.
Moderna COVID-19 :  (2) Red blotches have appeared on my right arm; (1) on my left arm.  Is not raised or above the skin. No increased or decreased sensitivity.  Watching.
Patient's legal guardian requested to have patient receive influenza vaccine on 11/4/2021 medical visit.  Influenza vaccine was administered on 11/4/2021; however, it was later discovered that patient had already received an influenza vaccine on 11/3/2021.
flu-like symptoms; Chills; Fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle aches) outcome was unknown.            No concomitant drugs and treatment drugs are provided. Treatment information not provided.
DID NOT COMPLETE VIVOTIF COURSE ONE WEEK PRIOR TO TRAVEL; FLU; This spontaneous case report was received from a pharmacist (PVX2019-589) on 06-Mar-2019. It described a 9-year-old female child consumer who had flu following the intake of oral Vivotif (one capsule every other day) for typhoid prophylaxis. The consumer was also "did not complete Vivotif course one week prior to travel".  The consumer's concurrent medical condition includes asthma. Also, she was allergic to amoxicillin (rash).  The consumer's concomitant medications included Proair (albuterol; 90 mcg; as needed), Flovent 110 HFA (fluticasone propionate; twice in a day) for asthma, and oral Zyrtec (loratadine; 10 mg; once in a day) in liquid form for allergies.  It was reported that the consumer took the first dose of Vivotif on 04-Mar-2019. On 06-Mar-2019, she was diagnosed with flu and had a fever of 100-degree Fahrenheit. On 05-Mar-2019, she had a fever of 103-degree Fahrenheit, which was reduced to 100-degree Fahrenheit on 06-Mar-2019. She was planning to leave for an endemic area on either 15-Mar-2019 or 17-Mar-2019.   The consumer was rotating between oral Tylenol (paracetamol; 360 mg) in every 6 hours and oral ibuprofen. Along with that she was taking oral Tamiflu (oseltamivir; 60 mg; twice in a day) for 5 days for flu.  The action taken with Vivotif with respect to the event flu was unknown while with respect to the event "did not complete Vivotif course one week prior to travel" was not applicable.  The clinical outcome of the events flu and "did not complete Vivotif course one week prior to travel" was unknown.  Company's Comment: In this case, it was reported that a 9-year-old female child consumer had flu following the intake of oral Vivotif. She also "did not complete Vivotif course one week prior to travel". There seems to be a temporal association between the intake of the vaccine and the event. However, flu is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif. The causality of the event "did not complete Vivotif course one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 9-year-old female child consumer had flu following the intake of oral Vivotif. She  also "did not complete Vivotif course one week prior to travel". There seems to be a temporal association between the intake of the vaccine and the event. However, flu is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif. The causality of the event "did not complete Vivotif course one week prior to travel" was considered as not applicable.
Pt received Moderna vaccine dose #1. became lightheaded and sweaty approxiimately 10 minutes after administration while in observation.  Stated she felt very tired.  BP- 80/48 p-52 02- 97% room air. noted to be diaphoratic.  EMS contacted.  Patient moinitored by RN- Remained alert and oriented. EMS arived on scene within 8 minutes of initiating 911.  Patient reported to EMS feeling better.  Was drinking water,  VS assessed by paramedic- post episode BP- 110/65  p-88  02- 98% room air. Patient refused transport to hospital.  Stated feeling better.
Patient was admitted on 12/29/2021 for leukocytosis and thrombocytosis found on routine labs at nursing facility. She was transferred from  the COVID unit. PT/OT was recommending post acute therapy and patient was tested again for COVID-19 to determine placement.  She tested positive but this is likely lingering from her active infection approximately 1 month ago, as she had no COVID-19 symptoms.
Erythematous discoloration with slight induration approximately 9-10 cm, no c/o pain.
despite being previously being fully vaccinated  with two doses of the COViD-19 vaccine, he tested positive for COVID; tested positive for COVID; More Energy; feeling congested; he had a slight fever of between 99 and just over 100 degrees; This is a spontaneous report received from a contactable reporter Consumer for a Pfizer sponsored program. The reporter is the patient.  A male patient of unspecified age received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), outcome unknown, described as "despite being previously being fully vaccinated  with two doses of the COViD-19 vaccine, he tested positive for COVID"; COVID-19 (medically significant), outcome unknown, described as "tested positive for COVID"; energy increased (non-serious), outcome unknown; nasal congestion (non-serious), outcome unknown, described as "feeling congested"; pyrexia (non-serious), outcome unknown, described as "he had a slight fever of between 99 and just over 100 degrees". The patient underwent the following laboratory tests and procedures: body temperature: between 99 and 100 degrees, notes: between 99 and just over 100 degrees; sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT FAINTED AND AS A RESULT SUFFERED A SKULL FRACTURE. WAS HOSPITALIZED AND IN A TRANSITIONAL CARE FACILITY.
6 hours after vaccine-arm pain; 12-19 hours after vaccine-shakes and chills; 14-22 hours after vaccine-muscle aches; 24 hours after vaccine-fatigue.
Fever, headache, muscle pain in left arm into shoulder and neck, bodyache, back pain/ rt side, chills, fatigue
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a five-year-old male. The patient's medical history included no history of asthma. Concomitant medications were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications). There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 that included the results of a lot investigation: Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.
Two years post vax, the pt was dx with multiple sclerosis. The pt sought unspecified medical attention.
Patient reports blood in urine; This spontaneous case was reported by a pharmacist and describes the occurrence of HAEMATURIA (Patient reports blood in urine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No medical history was reported.  Concomitant products included WARFARIN for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATURIA (Patient reports blood in urine). At the time of the report, HAEMATURIA (Patient reports blood in urine) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. It was reported patient on warfarin experienced blood in urine approximately 3 weeks after Moderna Vaccine. No treatment medication was reported. This case was linked to MOD-2022-525821 (Patient Link).
15 minutes after getting vaccinated patient stated that her tongue felt itchy . I ask if she felt anything else she said it felt itchy and maybe swollen. I ask if she can breathe. She said she can. I told her to wait 15 more minutes and let me know if I should call EMS. In about 10 minutes, she told the front counter technician that she needed EMS. I call 911 and was routed to paramedic. They told me to watch patient with an Epipen ready. While sitting in chair, she said she felt bump on her legs and was trying feel it and showed me . I couldn't see anything.  When EMS arrive , she said that her daughter also felt itchy tongue.  After closing at 7 pm , I call patient to follow up. She said she is ok.
Date and time adverse event started:  02/13 arm was sore  (first dose) 03/12 readness, soareness, swollen  03/13 slight fever, neck ache, headache, gasto symp. (5 bowel movements) 03/14 redness expanded, and started itching  03/15 itching and red  Date and time of vaccination: (list both if they received both shots):  02/13  7:00p.m.  03/12 2:00p.m apply a cold compress to site, and you can continue to use the benadryl spray for the itching. I would also recommend for you to speak to your PCP so he could do a check up or recommend any additional information. Pt. wanted a follow up call tomorrow regarding her symp.
Lt arm pain 4/9, morning 5/10 reports entire Lt  upper arm swollen, red, painful, seen 5/15 & swelling nearly resolved, has 4 cm firm knot  with redness at vaccines site, recommend warm compress
Vaccine was administered without dilution.  No reported signs or symptoms at the time of vaccine. Recipient was observed for 15 minutes after administration.
Ct. received Adult Td 0.5cc ID in left forearm on 8/16/04 instead of 0.1cc PPD for TB skin test. Left arm began to swell, turn red and itch soon afterwards. On 8/19/04 Ct. experienced vomiting/diarrhea.
Immediately after shot I had an allergic reaction.  Sweating, hot, extremely light headed.  After 30 min it had subsided and I was able to drive myself home.    4 Days later I started having weird muscle spasm and a warm sense in both of my calves.  This progressed to some tingling and other different sensations.  I saw a Dr to check for clot and they didn?t think that was it.   Ran some tests and sent me home.   This has now progressed to my left arm being week.   The feeling in my calves is now in my face.   Especially in my cheeks and around my eyes.  Sometime causing vision issues.   I am running a low grade fever on and off. I am fatigue all of the time.   Dizziness is also with me a good part of the day.    I have a. MRI scheduled as well as an appt with neurologist to further investigate.
Global rash (urticaria) that started from the trunk and radiated to all four extremities and neck lasting over an hr
Fever of 101.5 at 10 hours after immunizations; associated with shaking spell and became very pale 5 hours after. No reaction with previous shots.
Suspected vaccination failure; Shingles flare up; Rash and Shingles flare up; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received Shingrix. On 17th September 2019, 35 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   The reporter considered the vaccination failure, shingles and rash to be unrelated to Shingrix.  Additional case details were reported as follows: The patient had rash and shingles flare up after taking Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided.
This spontaneous report as received from a registered nurse refers to a 79 year old patient of unknown gender. Pertinent medical history, drug reaction or allergies were not reported. On 17-JAN-2014 and 18-AUG-2014, the patient was vaccinated with ZOSTAVAX, (dose, dose number, route, anatomical location, lot number and expiration date were not reported) (also reported as patient received 2 doses of ZOSTAVAX). No adverse symptoms reported. Concomitant therapies were not reported. The outcome the event was unknown. Additional information has been requested.
9:10 vaccine 0.5 LT deltoid, c/o pain, site w/ 4(+) edema, hand with numbness, tingling, followed by resp distress. 10:05 Benadryl 10:27 solu-cortef 250IV 10:10A epinephine 0.3.