chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my last shot in November 2021 I did not notice a black mark on my left side of scalp till July 2022 after receiving a haircut.  The black mark begin to grow and move across and down my scalp. I did know what or where it was from. It kept moving till  it reached my facial skin just past my left side hairline.  I went to one dermatologist and wasn?t satisfied so I found another and the appointment was like 5 months out in May of 2023 .  The Dermatologist did a biopsy and found it was Lichen Planus .   They did  not tell me the cause. I just found on a Website that Lichen Planus could result from the vaccine.
adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Under arm pain (lymph node); Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, TORSEMIDE and METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient washed with antibacterial soap when the irritation first started, however no additional treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional; Sender'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.
The flu shot formed a sizeable red blotch with pain and itchiness and has lasted 4 days and is finally calming down some.  The blotch was approximately  6" by 4" in size and is located below the injection site.
sore shoulder; pain radiates to armpit and towards the ribs; pain radiates to armpit and towards the ribs; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 66-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In October 2021, less than 2 weeks after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced axillary pain and rib pain. On 18th October 2021, the patient experienced shoulder soreness. On an unknown date, the outcome of the shoulder soreness, axillary pain and rib pain were not recovered/not resolved.   It was unknown if the reporter considered the shoulder soreness, axillary pain and rib pain to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. 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 patient self-reported this case. The patient received Fluarix Quadrivalent vaccine and experienced a sore shoulder which started the same day of vaccination. The pain was unresolved and now radiated to the armpit and towards the ribs.  This case has been linked with US2021222733, reported by same reporter The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222733:same reporter
3 hrs after vaccine awoke w/tightness in throat, swollen eyes and face. Sx lasted 2 full days. Had rash on trunk. No true hives. No GI Sx. Treated herself w/BENADRYL oral. No ER visits. MD.
Information has been received from a school medical assistant concerning a 12-year-old male who in approximately 1985, at the age of 12 months, was vaccinated with a dose of Varivax. On approximately 10-DEC-2006, the patient developed varicella disease. No medical attention was sought. There was not known. There was no other information to report. No additional information is expected.
Fever to 100.2 8/11/02. Emesis. Purple streak anterior thigh distal to injection site L leg.
The patient was in observation area, standing at desk while nurse rewriting vaccine card. He stated he felt dizzy and collapsed immediately, falling forward and hitting chin on desk. He was partially caught by RPH and nurse immediately attended to him. The patient woke immediately and said he could breathe easily and slowly sat up. Vital signs were stable, he rested for about 30 minutes, drank several bottles of water and felt better. Patient went home on his own accord and denied further medical evaluation.
High Fever. Went up to 103.1 and then we gave him junior strength Advil.
Within 1-2 hours of vax, the child was noted to be cyanotic, turned pale and vomited 2 times. No loss of consciousness and no difficulty breathing.
very weak; it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot; felt dizzy; lightheaded feeling, if she turns quickly, everything spins; it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), FEELING ABNORMAL (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot), DIZZINESS (felt dizzy), DIZZINESS (lightheaded feeling, if she turns quickly, everything spins) and VACCINATION SITE PAIN (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Mar-2021, the patient experienced ASTHENIA (very weak), FEELING ABNORMAL (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot), DIZZINESS (felt dizzy), DIZZINESS (lightheaded feeling, if she turns quickly, everything spins) and VACCINATION SITE PAIN (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot). At the time of the report, ASTHENIA (very weak), FEELING ABNORMAL (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot), DIZZINESS (felt dizzy), DIZZINESS (lightheaded feeling, if she turns quickly, everything spins) and VACCINATION SITE PAIN (it hurt, it felt like a lot of pressure going in and as if the liquid going in was hot, it did not feel like a normal shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-052972 (Patient Link).
vaccine was administered to a patient after the expiration date with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient  to whom experienced diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2023, the patient received unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength and lot number; not reported) Expiration Date: 30-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination after the expiration date with no reported adverse event (expired product administered) (latency: on same day).  Action taken: not applicable.  Outcome:  Unknown.   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 Directive and Regulatory Authority 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.
This spontaneous prospective pregnancy report was received from a registered nurse via company representative and refers to a 16-year-old female patient. No information regarding the patient's medical history and concurrent conditions was provided. The patient received no concomitant medications. On an unknown date (reported as "over the summer months"), the patient was vaccinated with GARDASIL 9 first injection in the series, as a HPV prevention (route of administration, lot# and expiration date were not provided). On an unknown date (reported as "later"), the patient found out that she was pregnant. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known. On an unknown date (reported as "while receiving the GARDASIL 9 , the patient fainted in the medical office. The patient regained consciousness after she was treated with ice packs (also reported as "no treatment was received"). The pregnancy outcome was outcome pending. The causal relationship between the event of fainted and GARDASIL 9 was not provided.
A week after the shot, starting at the injection site wrapping around inside of my bicep and down towards the elbow a: red; occasionally warm; hyper sensitive; pain with touch mark appeared.  It was rectangular in shape approximately 3" x 5 ".  It was present for no less than 1 & 1/2 weeks. I do not believe it was anaphylaxis in nature.  I did not take anything.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 59 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injection of LYMErix on 5/12/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease." with symptoms including "headaches, numbness, fatigue, neck, shoulder, back, hip and knee pain, rashes, insomnia, joint stiffness, stomach distress, and dyspepsia." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a general practitioner, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued throught the litigation process and will be reported if obtained.
Patient started with general malaise, cough, and sore throat 9/21/04. Saw nurse practitioner and received treatment. Then continued with chills, fever, and arm itching, redness on 9/23/04. Symptoms persisted and was taken to ER and admitted with cellulitis on 9/26/04. Receiving antibiotic IV (Unasyn).
prior lab eval revealed a neg titer to varicella;pt recvd 1st & 2nd dose of vax 5SEP95 & 11OCT95;4wks later pt had a titer drawn which was neg;no adverse rxn was noted @ the time of report;MD notes indicated that titer should be rechecked
Immediately after administering vaccine, patient became pale and lost consciousness. She experienced a brief period of muscle tremors/spasms. She was unconscious for a very short time about 5 seconds. Once she regained consciousness, she complained of chest pain, arm discomfort in the arm she received the vaccine, and also foot pain. (She started to slide out of her chair when losing consciousness and may have put a lot of pressure on her foot). Her skin was clammy.  Within seconds her color started to return to normal and she stated her chest pain was gone. She was given an orange juice and monitored for 25 minutes. She refused care by paramedic.
This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a GlaxoSmithKline representative on behalf of a healthcare professional. The representative received notification via email, that 2 children were experienced adverse reactions after receiving BEXSERO vaccine. The representative was only able to provide the phone number for the healthcare professional and a follow-up call was placed and voice message was left, requesting a call back to provide additional information. No further information was provided. This case has been linked with US2016GSK090355, reported by the same reporter.
Hospitalized for bacterial endocarditis did have a cough and dyspnea with this short term.
diagnosed with Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 05Apr2021, the patient was diagnosed with covid (COVID-19). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Apr2021 diagnosed with covid. The patient wants to know if it's ok to get the second dose which has scheduled for this Friday 16Apr2021. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose, refer case ID US2019GSK019668). On 24th January 2019, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced fever, muscle pain and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, muscle pain and nausea were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The reporter gave consent to follow up. This case was 1 of the 2 cases, reported by the same reporter.
Whole upper right arm became red, painful, and heavy. Pt has been on Ibuprofen 400mg 1 tid, and also took APAP extra strength. Also applied cold pack.
1st dose was Moderna. 2nfd dose was given Pfizer in error. parents instructed to return for a 3rd dose in 8 weeks per the CDC recommendation.
Information has been received from a pharmacist via field representative concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not provided). Co-suspect and concomitant therapy were not provided. On an unknown date, a "couple of days" after administration of ZOSTAVAX, the patient developed mouth sores, mucosal sores. The outcome of the events was unknown. Additional information has been requested.
Febrile seizure and ataxia.  Patient admitted on 12/8/2010 to Hospital 12/8/10-12/17/10, epidural fluid collection.  Pt in PICU x 3 days for concern of possible compression of thecal sac.  No compression occurred and neuro surgery did not intervene.  Patient still ataxic and is to get out patient physical therapy.
7:50 pm on 02/02/2021 Severe fever of up to 102.3, body sweats and aches, loss of apatite, nausea,  head ache. today i still have a mild fever, loss of apatite
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 9:41 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 9:41 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.03.  Concomitant products were not provided.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  On 24-May-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 35, 10 AM: 42, 11 AM: 40, 12 AM: 40, 1PM: 39, 2 PM: 37, 3 PM: 37 and 4 PM: 32.  On 24-May-2021, Excursion time was 08 AM and 09 AM, temperature was 35 and 35 respectively, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 03-May-2021, vial was moved to clinic on 24-May-2021. 1 vial was sent to clinic. Vaccine BUD date was 02-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Treatment medications were not reported.
He vomited on three separate occasions. Experienced loss of appetite & vomited two more times on 03/24-2011 &
I had a herpes ( shingles breakout after each vaccine. More severe after second dose.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:30 (at the age of 56 years) (Batch/Lot Number: EP7534) as DOSE NUMBER UNKNOWN, SINGLE via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at the age of 56 years) (Batch/Lot Number: EN6299) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation at Public Health Clinic. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Feb2021 the patient experienced I had a herpes (shingles breakout after each vaccine. More severe after second dose). The treatment received for the event was unknown. The clinical outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.