chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors of the published literature article. The authors used a Public Streams Application Programming Interface (API) to collect live data. Between November of 2014 and January 2015, they systematically endeavored to select an optimal set of terms that would be parsimonious enough to be feasible yet broad enough to capture sufficient relevant information. Of the 2,000 responses, 1,887 (94.4%) were relevant to human papillomavirus (HPV). Thus, these 1,887 composed their final data-set. The vast majority (n=1,668, 88.4%) originated from unique user accounts. Two hundred and four tweets (10.8%) were from users who posted between two and five times, and 30 (1.6%) were from users who posted 10 or more times. Ninety-five (5.0%) were coded as having negative sentiment. These  generally discouraged GARDASIL or GARDASIL 9 vaccination or expressed a particularly negative view toward it. Specific terms characteristic of these tweets included "beware," "destroys lives," and "mystery illness." While sentiments were nearly always directly incorporated in to the responses themselves, negative sentiment could also often be inferred by the hashtags at the end. 78 (4.1%) explicitly claimed lack of safety. Examples of phrases included in tweets describing lack of safety included "GARDASIL or GARDASIL 9 ruins live [sic]" and "girl dies shortly after receiving HPV vaccine." This case concerns to a girl who died shortly after receiving HPV vaccine. The case was coded as lack of safety 77 (4.1%). The reporter considered death to be related to GARDASIL 9 and/or GARDASIL. Upon internal review death was considered to be a medically significant event. This is one of 2 reports derived from the same literature source, linked to case # 1801USA001975. Sender's Comments: US-009507513-1801USA001975:
little anxiety; has had ongoing issues with tinnitus and stated he thinks the tinnitus has worsened since the vaccine/has a condition, tinnitus, it seems like its kind of maybe worsened it a little bit/tinnitus; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: EW0153, Expiry Date: Unknown), via an unspecified route on 09Apr2021 15:00 (at the age of 62-year-old), administered in left arm/shoulder at 0.3 ml as single dose for COVID-19 immunization administered at Hospital. Medical history included ongoing issues with tinnitus (Diagnosed: 6-8 years ago) and high blood pressure (Diagnosed: 8-10 years). Concomitant medications were reported as none. The patient reported that he did not take any concomitant medications or had done was a change in his life or medications, before or after the injection everything was the same. On an unspecified date, the patient stated he thinks the tinnitus has worsened since the vaccine. Patient stated he was afraid of getting the second shot. The patient had tinnitus after the first dose of the Pfizer COVID-19 vaccine and said he should have had the second dose at the end of April or beginning of May but didn't get it because of the tinnitus. Patient asked have there been any reports of tinnitus. Patient asked if later down the road if they have a booster would it be an option for him or not if he does not take the second vaccine. Has Pfizer provided a statement on the need for a booster dose (3rd dose)? Is Pfizer investigating the need for a booster dose. Patient wanted to know, what percentage of protection does he have with one shot. He has had tinnitus for several years, and says it was not a result of this, and it may be incorrect but he felt like it worsened it a little bit. He says he had a little anxiety and decided not to take the second injection at the time. He says that his question is about the second dose that would have been 30Apr, whether he can go ahead and take the next one as the second vaccine dose or if he needs to have booster instead. Upon follow up on 29Apr2021, the patient reported, No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient reported that he gets a little anxious as he doesn't know if there was a treatment for tinnitus. The outcome of  tinnitus was not resolved and anxiety was unknown.  Follow-up (29Apr2021): New information received from a contactable consumer includes: Age of the patient with units, Lot Number, complete dosage regimen, Vaccination Facility Type (Hospital), Medical history (high blood pressure) and ongoing status, Date of start of reaction/event tinnitus (Apr2021 to ongoing), Outcome of the event (not recovered) updated.  Follow-up (01Sep2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. This 62-year-old male consumer (patient) reported that: Added new event (little anxiety), clinical date updated.  Follow-Up (09Sep2021): Follow-up attempts are completed. No further information is expected.
some mild fatigue that last a few days after injection, site pain 12 hours following shot that lasted about 24 hours.  Upset stomach on 48 hours after vaccination, cramping, lose stool.  Did not cause nausea or vomitting.  resolved within 24 hours.  No other symptoms.  did not seek care.
Breast pain; Cyst; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST PAIN (Breast pain) and CYST (Cyst) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Breast pain) and CYST (Cyst). At the time of the report, BREAST PAIN (Breast pain) and CYST (Cyst) 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.   Reporter did not allow further contact
Slight fever, chills, muscle and joint pain, fatigue. Started about 12 hours post-vaccination and lasted until 48 hours post-vaccination.
BURNING REDNESS AND EXTREME SWOLLEN. WENT TO ER. EVER SINCE THE SHOT SHE HAS HAD PAIN. WAS GIVEN BENADRYL ORIGINALLY WHICH TEMPORARILY HELPED. PAIN IN ARM AT INJECTION SITE ACHES (LIKE A TOOTHACHE). THERE IS ALSO INTENSE HEAT AND SHE USES ICE PACKS FOR RELIEF. THE PAIN AND TINGLENESS ALSO RUNS DOWN INTO OR LEG AND THIGHS. SHE HAS CALLED 911 ON A FEW OCCASIONS. WAS AN OTHERWISE HEALTHY AND PAIN FREE INDIVIDUAL BEFORE GETTING THE VACCINE SHOT.
The patient developed shingles on October 26, 2022 after administration of the moderna and shingrix vaccines on 10/24/2022. The patient was treated with gabapentin and valacyclovir on 10/27/2022.
Swelling of both hands and left side which began 2 days after injection of vaccine and cleared 24 hours later
Shot 9/3 at 1:20 pm by  6 pm became very sleepy.  I  woke the following day  at 6 am ; then could not stay awake slept til 3 pm.  Was very  sleepy/groggy.  After taking a shower I went to take evening pills.   Had such brain fog I could not remember which were my evening pills so I skipped them.  I just stared at them  which is not normal.  Brain cleared 2 days later.  I am better now.
covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Aug2023 as dose 6 (booster), single (Lot number: GJ3268) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. No follow-up attempts are possible. No further information is expected.
8/16/21 pt admitted to hospital with dyspnea, weakness, and rhinorrhea; given O2 supplementation; had a positive COVID test; (pt had a previous positive COVID test ordered by Rehab Center  on 8/6/21);  pt passed away in the hospital the next day
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  The vials were placed in refrigerator on 06 Dec 2021.   This case was linked to MOD-2022-449524 (Patient Link).
Headache; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and TINNITUS (Tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache) and TINNITUS (Tinnitus). At the time of the report, HEADACHE (Headache) and TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
pt recv vax 23JAN98 & pt devel a gen, mild varicella-like rash w/greater than 50 lesions on arms, legs, trunk & chest;
Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28JAN2021 but got COVID-19; Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 28JAN2021 but got COVID-19; This is a spontaneous report from a contactable pharmacist from Pfizer sponsored program. A 82-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 (at 82-years age) as SINGLE DOSE for covid-19 immunization. The patient medical history was and concomitant medications were not reported. After receiving the Pfizer-BioNTech COVID-19 Vaccine first dose last 28JAN2021 patient got COVID-19 and asked when was it recommended for him to get their second dose. Caller mentioned she was advised to transfer. Offered transfer and Caller accepted. Unsuccessful transfer due to long hold time. Caller preferred the online safety reporting tool instead. Call transferred. Pharmacist. Has questions about covid vaccine. Wants to know on when antibodies go into system. And if patients get 1st dose of covid vaccine and then test positive for covid virus when do they received 2nd dose. Clarified if knows anyone who has tested positive after 1st dose, said yes but unsure if it was Pfizer or Moderna vaccine, also doesn't know anyone with antibody issue or needing testing. Relayed number. Cold transferred due to hold time. Will fax into. 159558. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow up (17Feb2021): This is a spontaneous report received from Pfizer sponsored program. A contactable pharmacist reported no new reported for patient.; Sender's Comments: Based on the information provided, the causality between the event and the suspect drug cannot be excluded.
Fatigue, Sore Throat, Chills, Headache, Some Nausea, Soreness at the Injection Site, Fast Palpitations
Patient presented in December 2022 for first dose of primary series Moderna Covid-19 vaccine.  Patient was inadvertently administered Moderna Bivalent booster dose formulation in lieu of Moderna monovalent primary series formulation.
Patient got injection on 4/9/21 and on 4/11/21 started having severe muscle weakness lasting about a week and a half. He said it was very severe for a few days requiring assistance to walk. Patient visited his doctor for evaluation and was told not to get second dose.
PT. HAD A NOSE BLEED am 11/4/09/PATIENT DEVELOPED A"TIC" IN HIS UPPER BODY MUSCLES AROUND NOON OF 11/04/09/TOOK PATIENT TO ER AROUND 3:00PM. 11/12 and 11/13 Medical records and discharge summary received for DOS 11/4-11/5.   Final DX: myoclonic activity CC of twitching upper extrems for several hours in am. Returned at lunch time, epistaxis. Jerking. Etiology unk.  Involuntary mvnts resolved. Later some fictitious jerking. EEG WNL. Out patient testing scheduled.  D/C to home.  12/09/09 Consult received for DOS 11/04/09 and 11/05/09. DX: Myoclonic activity. Pt presented with jerking movements of body, N/V, diplopia, hallucinations. Dr noted that myoclonic movements got worse when Pt stressed/upset and they stopped if Pt distracted.  On 11/05/09, neurologist assessed Pt as having some voluntary movements, but no involuntary movements. Event resolved. Pt to follow up with neurology.
A report has been received from a Study Investigator concerning a 30 year old, female subject, Height 5.8 inches, Weight: 171.0 Pounds. A post marketing Safety study of Q/LAIV in Subjects 2 through 49 years of age.  The patient did not receive any concomitant medications. No relevant history was reported. The study therapy was started on an unknown date. The date of last menstrual period was 09-OCT-2013. The patient experienced pregnancy which started on 09-OCT-2013. The estimated date of delivery was 08-FEB-2014. The outcome of the pregnancy was reported to be a healthy baby born on 10-JUL-2014.  The baby was male and weighed 3.08Kg. The report was considered to be non-serious. The investigator considered that there was no casual relationship between pregnancy and study therapy.
Headache, Myalgia, NauseaVomiting, site pain Narrative: used on SL day for side effects, took benadryl and tylenol, excedrin prn  Other Relevant History:
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient concurrent condition and medical history were not reported. On an unknown date the patient was mistakenly vaccinated with SHINGRIX when he should have been vaccinated with VARIVAX. No adverse symptoms reported. No product compliant reported.
Moderna COVID Vaccine  1st dose: 1/9/21 (lot 027L20A ? Left deltoid)  2nd dose: 2/6/21 (lot # 012M20A ? Left Deltoid)   Patient is fully vaccinated. He received both doses of Moderna vaccine (on 1/9 and 2/6).  Patient had a history of cell lymphoma (he was on rituximab until February). Patient initially presented to ED on 4/14/21 complaining about fatigue, cough, and fever.  At that time, patient stated that he tested positive for COVID 8 days prior. Patient was evaluated and sent home.  Two days later, on 4/16/21 he came back to the ED for SOB/fever.  At this time, he reported that he had chills, fever, malaise/fatigue, cough, nausea and myalgias.  His CXR suggested worsening COVID-19 PNA.
Started developing rash beginning 10/9/15 approximately 9pm raised, red rash, hot to touch - approx. 4" diameter, got worse through 10/12/15 approx. 5" diameter. Treated with hydrocortisone cream and diphenhydramine tabs.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Between 16-OCT-2014 and 06-NOV-2014 the patients were vaccinated with an improperly stored dose of M-M-R II (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Date and time of vaccination: 12/17/21 19:30 Age at vaccination 52Y 10M Adverse symptoms: - Visual migraines 12/19,12/20,12/21 with loss of vision/aura for about 30m-1h, mild headache followed. -numbness, intermittent in left ring and pinky finger 12/19,12/20,12/21
DTaP received in L thigh on 7/31/02. On 8/12/02 experienced tender, warm, red, indurated area approx. 6cm in width at injection site. No trouble with ambulation. No drainage from site. No other rashes.
12:30pm - received the vaccine 12:35pm - began to feel slightly lightheaded and dizzy 12:36pm - passed out Was unconscious and shaking for about 15 seconds - 911 was called Awoke and felt very lightheaded/dizzy and difficulty breathing Within a minute of waking, my fingers were tingling and body was shaking Paramedics arrived and took vitals - blood pressure and pulse both very low Paramedics stayed about 30 minutes unit I no longer felt any symptoms and was ok to walk on my own
exhausted & very tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (exhausted & very tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:*Declined to share name/initials, age/DOB,.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (exhausted & very tired). At the time of the report, FATIGUE (exhausted & very tired) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported   Reporter did not allow further contact
Near syncope. Monitored in clinic. Vitals stable. Self-resolved after 5 minutes. Monitored for 30 minutes
possible lymphatic system issue; bartholin cyst on right side and severe swelling in surrounding area; severe swelling in surrounding area; painful; sore arm; headache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 11:45 (at the age of 68 years) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included breast cancer, Allergies to Hazelnut, Lumpectomy from an unknown date and unknown if ongoing (I had breast cancer removed by lumpectomy twice on left breast with 1 sentinol node removed), targeted radiation from 03Feb2020 to an unknown date. The patient's concomitant medications were not reported. 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. The patient stated, ''24 hours later I Developed Bartholin cyst on right side and severe swelling in surrounding area. I had breast cancer removed by lumpectomy twice on left breast with 1 sentinol node removed. Last treatment with targeted radiation was 03Feb2020, clear mammogram Jul2020. I was concerned about possible lymphatic system issue but was surprised by this reaction. I never had a cyst before, and it was very painful, and I was still trying to resolve. I had normal reaction otherwise sore arm, headache, and fatigue. I was concerned about my next injection in 4 weeks. What was your recommendation''. The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included mammogram: clear in Jul2020. The patient received the treatment for adverse events as Antibiotic. The clinical outcome of the events was recovering at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE details or PQC; A patient was inadvertently administered a dose of ROTATEQ past it's expiration date; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.      On 21-MAR-2022, the patient was vaccinated inadvertently with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (expiration date: 10-MAR-2022) for prophylaxis (strength, dose, anatomical location, route of administration, and lot # were not reported) (expired product administered).         No additional adverse events were reported.
Fever 101- 103.5 began 10 days after administration of MMR and Pentacel vaccines. Fever is gone but now has rash.
Pt recv vax on 11/13/98; on 11/21/98 pt exp measles like illness
I experienced the symptoms of chronic fatigue syndrome after receiving the vaccine. The symptoms have not abated. This seems to be a permanent, and untreatable condition.
Arm was very painful & sore for two months. I did not have this reaction on the 1st injection in the left arm. This progressed to constant pain/stiffness/loss of range of motion in my right arm. This constant pain lasted until I received a Kenalog injection from my Orthopedic Specialist due to 'adhesive capsulitus'
Colitis; Purpura rash, red part in lower back; Fever; Chills; Nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of COLITIS (Colitis), PURPURA (Purpura rash, red part in lower back), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in an 84-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COLITIS (Colitis), PURPURA (Purpura rash, red part in lower back), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COLITIS (Colitis), PURPURA (Purpura rash, red part in lower back), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) 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.   No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Live follow up received: Email address of reporter was added.
Within 5 minutes of administering the vaccine, the patient began complaining of face numbness. She had no issues with breathing, no swelling,  and blood pressure and heart rate remained consistent.
third day after second shot  arm was red, slightly hard lump, very warm to touch painful and very itchy. shot was in opposite arm from first dose.  i used cold compresses and topical benedryl it is slightly better today (day 5)