chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 09-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old male patient who experienced "they gave one 18 year old and he had one when the records were checked 6 month ago/no adverse event", while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported. It was a case of actual medication error due to extra dose administered. No adverse event was reported. 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 Directive 2001/83/EC 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. Documents held by sender: none.
Redness, swelling and tenderness noted on LD. Patient instructed to place ice pack and Motrin pain. Per mother redness going down since administered slightly redness noted RD advised given to report for worse symptoms.
Left upper arm entire deltoid area down to anticubital area (but not involving AC space) mild erythema with swelling, warm. Warm packs, reassured.
Fever of 104.2 with vaccine #1.  Fever of 103.8 with vaccine #2.
Redness & swelling @ inject site; temp; mom didn't measure; Pt crying all the time since evening of inject; some paleness & jerking @ times; Parent instructed to take to MD;
No other adverse event reported; Temperature excursion on PROQUAD that was administered on 04/23/2021 to two patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 23-APR-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) first time dose (route of administration was not reported), lot # T037957 rHA and expiration date 09-MAY-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 7.5 fahrenheit (°F) for 30 minutes on 22-APR-2021 and 6.0°F for 15 minutes on 23-APR-2021, for a total time out of range of 45 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.  This is one of two reports from the same reporter.
I suffered with heel spurs 30 years ago, and 20 years ago, my heel spur pain was illuminated totally.  The day after the vaccine, I woke up and my left heel spur was back in full force and I was unable to walk without holding on to furniture.  The pain has continued to persist to this day.
late PM p/vax pt had consistent hard cry over a period of 2-3 hrs; noted small white dots around bilat thigh inject site; next day cont crying, no fever detected, pt given APAP; hives raised areas, around both thigh; fussy;
Fatigued to the point can barely walk; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued to the point can barely walk) in a 77-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigued to the point can barely walk). At the time of the report, FATIGUE (Fatigued to the point can barely walk) outcome was unknown.            concomitant medicines was not reported by reporter  treatment information was not provided  Action taken with the mRNA-1273 in response to event is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Want to know if there is something we can do to not cause fatigue or at least fix the condition fatigue.    .
50 yr of healthy, moderna shot 9/2, 9/3 Local redness. Chest pain 9/10. Hx visit 9/28 w/ Dx of idiopathic pericardial effusion.
vaccination site pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L0A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included L-THYROXINE [LEVOTHYROXINE] and ALENDRONATE SODIUM for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 09-Jan-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported by reporter.   This case was linked to MOD-2021-339522, MOD-2021-322828 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a  74-year-old, female patient with no relevant medical history, who experienced the expected event of vaccination site pain. The event occurred during the same day after the first dose of Moderna COVID-19 Vaccine. The rechallenge was negative since the event did not re-occur after the administration of the remaining doses of the vaccine. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
pt recvd DTP/OPV/Monovac; mom took pt out to the car & pt fainted in the car; brought back to office & tx w/oxygen; hospitalized overnight for observation; tx in hosp consisted of oxygen only; d/c the following day; pt recovered;
2 in swelling, redness, itching, firmness, tenderness , raised, swollen immediately after injection to L deltoid
urticarial rash @ inj site 2 days post vax;DPH given-resolved;
I went in for a routine mamo gram in the middle of June. I went in for a follow up mamo gram and ultrasound 2 weeks later. After another 2 weeks I went in for a 3rd mamo gram and biopsy. The biopsy results showed grade 3 cancer cells.  I am schedule to meet with a surgeon.
Warm to the touch, inflamed for a couple of days then flattened into a bruised spot with a square shape around vaccine area. Hives on the outside of the area. Extremely itchy. Took benedryl today for the first time.
Pain at injection site, malaise, nausea, photosensitivity, headache, diarrhea and trouble sleeping.
Vaccine induced Alopecia (if unfamilliar with the term it means hair loss &/or balding).
got the shot n still got it; still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient stated that he/ she got the shot and still got it. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
I had a sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 28Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 29Mar2021 as dose 1, single for COVID-19 immunization and experienced sore arm, warmth at injection site and fatigued on 30Mar2021. On 18Apr2021 before bed around 22:00, patient noticed a small number of petechia on chest and a few (small number) on arm. Patient woke up and find new: 4 on back, single one on neck, 1-2 on each leg. On an unspecified date it was reported that patient had a sore arm and fatigue starting late last night and lasting throughout the day today 29Apr2021 and tonight at the time of reporting. The patient underwent lab tests and procedures which included full blood count: unknown on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administration of the moderna CV19 vaccination should have been given on 03/08/2021, however it was administered 5 days early. At present it is unknown of any adverse events, however this report is being filed to inform of the administration error. My role in this VAERS is a reporter and did not administer the vaccination.
1/28/21 at 1400 patient noticed a lump on right arm where vaccine was given and could barely lift arm. Placed cold compress on right arm. Patient states that the next day she could not lift her right arm. Pt. reports that on 1/29/21 she had nausea and headaches and called out of work. Pt. states that today she is feeling better, "no problems at all." Pt. states that all of her symptoms: right arm lump has resolved, headaches have resolved, nausea has resolved.
pt recv vax & noted rash on abd;pt started holding & shaking head, then laid down on floor;pale & a little lethargic, not really active;maculopapular rash;? allerg react to immun (shock-collapse);rash;
Site on arm that was vaccinated Is red hard and swollen. Fever of 100.9
Pt developed hard bump size of a silver dollar @ injection site, as well as ? pink skin 2" diameter. Currently redness has gone, the size is half size of a dime. C/O fatigue and cough 15 wks after injection.
1/31/11- Varicella & MCV4 administered (L) arm 2/1/11 mom noticed warm pink area at varicella site (pm) 2/2/11 AM - varicella site larger; MCV4 site pink & warm 2/2/11 afternoon - pt seen by MD & prescribed BACTRIM; 2/2/11 varicella site 8x4cm; MCV4 site 4.5/3.5cm.
Within 12 hrs developed low grade fever of 100.1. Stayed in bed next 24 hrs going through several periods if cold sweats. Next day I went to take shower and noticed my entire upper body was blotchy and red though not itchy or irritating. If anything the skin feels warm.
patient erroneously received reconstituted HIB portion of the PENTACEL vaccine after diluting with sterile water/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician and other healthcare professional via Medical Information via call-center (Reference number- 00609908) and transmitted to Sanofi on 20-May-2021.  This case involves a 2-months-old male patient (unknown demographics) to whom nurse administered the first dose of 0.5 mL HIB portion DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, strength: standard, batch number: UJ415AA and expiry date not reported via intramuscular route at an left thigh administration site) after diluting with sterile water then administered the DTaP-IPV portion of PENTACEL in the right thigh (product preparation error) on 20-May-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  Nurse requests escalation for question: Did the patient receive any protection from the erroneously reconstituted HIB portion of the PENTACEL vaccine. She asks why it is not valid and requests information regarding why specific diluent; 0.4 percentage NaCl must be used.  At the time of reporting, no adverse event was reported.  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 2001/83/EC 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.
Muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Muscle pain) 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 MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
DEATH; ILLNESS PROGRESSED FASTER; This spontaneous report received from a consumer via social media via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered, for prophylactic vaccination (dose number in series:1). The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. The reporter stated that "I am pretty sure this vaccine made my brother's illness progress faster than it should've and now he is no longer here". On an unspecified date, the patient's illness progressed faster than it should had (condition aggravated) and was no longer there (death). On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of illness progressed faster was not reported. This report was serious (Death).  Version created to amend previously reported information on 19-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: This version updates: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. The prior causality assessment remains unaltered with this added information. 20220140120-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Parent called - described significant behavioral changes over 36-48 hours after flu vaccine - aggressive, fussy, much more significant than baseline - no fever- no tenderness at injection site - mom also said uri present over the week
hip flexor pain; This is a spontaneous report from a contactable physician. This physician reported similar events for three patients. This report is for 3rd of three patients. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, approximately 5 days after vaccine, the patient started to get hip flexor pain on an unspecified date. Stated that, the reporter was an EM physician and the reporter know 2 others with similar experiences and advised them to contact Pfizer also. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
My son revived his Covid 19 booster on 1/15 2922 at 10:00 AM. Approximately 14-18 hours after this vaccine is given my son begins approximately 5 min episodes of hallucinations in which he says and does things that do not make sense.  15 hrs after his vaccine at 1:00 AM on 1/16/2022 he woke up and became extremely agitated, yelling, screaming, crying, heart racing and this time started saying he was going to die or needed to die. He is not lucid. When asked questions he does not make sense or does not know basic information such as his age or birthdate. He walked to the banister from his room on the 2nd story and began climbing over the edge. My husband grabbed him and took him to his bed holding him down and asking him to count to 10. He slowly begins to calm and all of a sudden becomes lucid again and starts making sense. He has no memory if his actions during the hallucinations. He did have a mild fever of 100.9 and the hallucinations happen after sleeping or when he appears to wake up from sleeping. The following day he was fine and lucid. The next night 10/16/2022 at 10:30 PM after sleeping for 1.5 hrs he awoke and began having a 2nd hallucination. He did not have a fever this night. He enters he hallways and began yelling at his brother as if he was there, but his brother was in his room sleeping. He ran downstairs to my bedroom and started yelling he was going to die. I walked him back upstairs and he told my husband to kill him. When we asked him what he did that day he had he jumped over the edge and jumped off a cliff. He then began answering questions correctly and became lucid again. He had no memory of the episode.
101 Fever, chills and headache 24hrs Today 4/8/21 - Rash Appeared on arm
No additional adverse events reported.; MA states a dose of MMRlI was given on 09/07/2021 and a dose of V ARlVAX was administered too early today, 09/30/2021, less than the recommendation of a months time.; This spontaneous report was received from a certified medical assistant referring to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 07-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliters (ml) "once" (lot number S035356 which has been verified to be valid, expiration date 05-NOV-2021). On 30-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml "once" (lot number T022313 which has been verified to be valid, expiration date 30-JUN-2022) (routes of administration and anatomical sites of injection were not reported for any of them); both for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: er8737), on 26Apr2021 as dose 2, single (Lot number: ew0171) and on 05Jan2022 as dose 3 (booster), single (Lot number: fl3198) for covid-19 immunisation.  The patient's relevant medical history included: "allergies (multiple)" (unspecified if ongoing), notes: allergies (multiple); "asthma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "Known Allergies: some topical antibiotic preparations" (unspecified if ongoing), notes: allergies to some topical antibiotic preparations; "Known Allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR SODIUM; MONTELUKAST; FEXOFENADINE; DIPHENHYDRAMINE; MELOXICAM; ESTRADIOL; MEDROXYPROGESTERONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Course of events: Known Allergies: some topical antibiotic preparations, latex. Patient received anti viral treatment with Paxolovid for Covid 19 infection from 15Dec2022 to 20Dec2022.
I have a sore arm and I am experiencing severe back pain, nausea and a headache that comes and goes.
Inconsolable Crying; Initial information received on 13-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2020SA041917 (same reporter).  This case involves a female patient (age not reported) who experienced inconsolable crying (crying), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) on 30-Jan-2020  On 30-Jan-2020, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ148ARA and 03-Feb-2021) via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious inconsolable crying (crying) (Unknown latency), following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No lab data was reported.  Final diagnosis was crying.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.