chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Noticed tinnitus in both ears got louder around December.  I went to an audiologist on January 11 and they did not find anything wrong.  The ringing is noticeably louder than it used to be.  I'm not sure that it is a result of the vaccine, but after reading an article on this possibility, I thought I'd report it.
severe body aches, swelling at injection site, exhaustion. began about 12 hours after shot was administered.
Dizziness, Headache, Myalgia, c/o chills,fatigue,injection site sore. Told to follow up with primary care physician if no improvement in symptoms Narrative:
separate administration of the PENTACEL components with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2023SA314333.  This case involves a 3 years old male patient and reporter reported separate administration of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] components with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included heparin sodium (heparin [heparin sodium]); measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunisation; and varicella zoster vaccine (varicella vaccine) for immunisation.  On 09-Oct-2023, the patient received Dose 1 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ869AA, Expiry date: 23-Mar-2024) (Strength: standard, Frequency: once) via intramuscular route in the right deltoid for immunisation.  On 09-Oct-2023, it was reported separate administration of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine components with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported, Nurse called to report about the administration of the PENTACEL components to 2 patients. Nurse wanted to know if the dose given would be valid. Please see case 01799136. This situation is reported as a medication error due to separate administration of the PENTACEL components.   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 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.
Patient received  1st dose of COVID vaccine at 2:19pm. started feeling unwell within 5-10minutes. C/o palpitations, sweating, chills / heat, headache. chest discomfort, cold extremities, dry mouth. Vision was blurry but now resolved to normal vision. Accompanied to PWC and examined by a primary care provider who advised ED transport for further evaluation and observation. VS as follows: BP: 175/107 automatic LA.;  176/110 manual LA;  5-10 min later 165/94 LA and 164/98 RA manual.  O2 100% throughout. HR 94. Nursing team to connect with patient after ED discharge to schedule TOC as needed.
LARGE, RED, TENDER AREA IN THE RIGHT ARM, DESCRIBED AS ITCHY AND PAINFUL BY THE PATIENT.  AFTER EVALUATION BY THE PHARMACIST WHO ADMINISTERED THE VACCINE, A CELLULITIS WAS SUSPECTED AND THE PATIENT WAS REFERRED TO HER  PRIMARY DOCTOR. PRIMARY DOCTOR DID NOT CONSIDER THE REACTION TO BE A CELLULITIS AND PRESCRIBED DICLOFENAC GEL AND ACETAMINOPHEN TO TREAT THE PATIENTS SYMPTOMS AND DISCOMFORT.
Patient says after vaccination his arms feels continually sore, and he is feeling "paresthesias down his arm when it is put in certain positions "
This spontaneous report was received from a physician refers to a 69 year old male patient without drug reactions or allergies. The patient's medical history included mild renal failure and hypertension. On 26-JUN-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, one dose, intramuscular, lot # K005957, Expiration date not reported, in the right arm. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), NIFEDICAL XL and simvastatin (manufacturer unknown). On 27-JUN-2014 (within 24 hours of receiving PNEUMOVAX 23) the patient developed massive swelling, warmth and discomfort at the injection site. The patient was treated with ice and ADVIL. There were not laboratory diagnostics studies performed. Caller also stated the patient was in the office during a routine physical when he was administered the vaccine and then followed up with the office soon after to schedule an appointment to be seen due to the AE. Caller stated it was noted that the swelling had slightly improved by the time the patient was seen in the office. Additional information has been requested.
Pt recv vax in 2/97; in 3/97 pt exp hair loss
Breakthrough COVID infection after 3 Pfizer doses.; Breakthrough COVID infection after 3 Pfizer doses.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Name of drug as reported: unknown, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Breakthrough COVID infection after 3 Pfizer doses.". The patient underwent the following laboratory tests and procedures: Smear test: (Jul2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not diagnosed with COVID-19, prior to vaccination. Patient been tested for COVID-19, since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Adverse events - aggravation of eye disease, and breast cancer, even though years of mammograms before were read as negative. Treatment ongoing for eyes and cancer
I experienced pain at the injection site and flu like symptoms for 2 days after injection. Within a week of dose 3, numbness with severe pain began in my right leg at my toes and progressed up through my calf. I have been to the ER, urgent cares, and seen a chiropractor for this issue. It has not resolved at all. Have missed a lot of work due to trouble walking.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from registered nurse via a company representative, concerning a 12 year old female patient. Information on patient's concurrent conditions, pertinent medical history or drug reactions was not reported. On 18-MAY-2016 at 08:00 hours, the patient was vaccinated with a second dose of GARDASIL intramuscularly, (dosage and anatomical location were not reported). Concomitant and co-suspect medications were not provided. On the same date, around 10:00 hours, the reporting Nurse received a call from the patient's mother who informed that her daughter experienced injection site pain, numbness, weakness in her right arm; additionally her tongue felt numb, she had blurred vision in her right eye and had a severe headache. It was also reported that the patient was incoherent and presented delayed responses. The patient sought medical attention and went to the emergency room. She was treated with TYLENOL for the severe headache and was released from the emergency room. No product quality complaint was filled. At the time of this report, it was informed that the patient had recovered from all the events. after 10 hours. However, the severe headache last 36 hours (recovering). The causal relationship between the vaccination with GARDASIL and the events was not reported. Additional information has been requested.
Didn't sleep well Thursday night-restless. Friday morning arm was slightly sore. Around noon, began feeling achy all over, very tired, got bad chills and had fever (99.3). Legs hurt when I walked. Knuckles on both hands very sore, unable to lift anything heavy or twist anything. Oxygen was 97, heart rate 74 and BP was 132/72. Saturday woke up with pounding headache, knuckles on right hand still hurt. Slept better but woke up with red splotches/rash around injection site. Itchy, warm to touch and sore when pressed. Sunday, rash still there and still tired. Monday knuckles still sore on right hand, not so bad on left. Rash seems to be going away, but area still warm to touch and sore.
Sister did and still got it/ Suspected vaccination failure; Got it on side face up by her eye; Got it on side face up by her eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Sister did and still got it/ Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Got it on side face up by her eye) (serious criteria GSK medically significant) and shingles (Verbatim: Got it on side face up by her eye). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-Mar-2023 This case was reported by a patient's sibling via interactive digital media. The patient got shingles vaccine and still got shingles on side face up by her eye. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up was not possible, as no contact details were available.
about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained slightly numb; This is a spontaneous report from a contactable nurse. A 61-year-old female nurse reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1686), intramuscular at single dose into the left arm on 08Jan2021 at 03:30 PM for COVID-19 immunization. First dose of BNT162B2 was received on 18Dec2020. Medical history included rheumatoid arthritis, coronary artery disease and hypertension.  Past drug history included NSAIDS which caused bleeding. The patient's concomitant medications were not reported.  The patient reported that about 30-45 minutes after vaccination she started feeling numbness on left side of face and left lower lip remained slightly numb. The events were reported as non-serious. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Information has been received from a nurse practitioner (N.P.) concerning a 16 year old female who in September 2007, was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL.  On the same day, the patient developed cellulitis at the injection site, on her arm.  The patient was evaluated in an emergency room and admitted to the hospital overnight for IV antibiotic treatment.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Cellulitis at the injection site, on her arm was also considered to be disabling and a other important medical event (IV antibiotics) by the NP.  Additional information has been requested.
Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 31Jan2021 08:30 (at 64-year-old) at single dose for COVID-19 immunization. Medical history included Type 2 diabetes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. Patient received Diabetes medication within 2 weeks of vaccination. The patient previously took Percocet and Bactrim, and experienced drug allergy for both. The patient experienced higher than normal blood sugar on 31Jan2021 10:30. Therapeutic measures were taken as a result of higher than normal blood sugar, patient took extra insulin. The outcome of the event was recovering. Event was reported as non-serious.
Within 3 days of having it I have numbness in both hands and feet; Brain fog; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Within 3 days of having it I have numbness in both hands and feet), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue) 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 HYPOAESTHESIA (Within 3 days of having it I have numbness in both hands and feet), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue). At the time of the report, HYPOAESTHESIA (Within 3 days of having it I have numbness in both hands and feet), FEELING ABNORMAL (Brain fog) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Per patient: Itchiness, redness, swelling, hard bulky 2.5 inch rectangular area around site of administration.
Vaccine was administered to patient post expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient post expiry) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient post expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient post expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported.  The patient had received the additional dose. The vial was initially stored in refrigerator on 31-Aug-2021. The vial did not undergone any temperature excursions.   In follow up, the reporter wanted to make an update regarding some additional information reporter sent on 06-Apr-2022. Reporter wanted to clarify that the information provided by email was from new patients different than previous patients which was reported on 31-Mar-2022, and that some of these new patients belongs to different clinics, but all of them pertained to the same community clinic.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received and narrative was updated.
After receiving my shot on Friday, my arm began to get sore, my ears felt like they were on fire.  I woke up on Saturday and my arm soreness had increased.  Later that evening I went to bed and was awoken with extreme pain in my back and neck.  It felt as if it may be serve nerve pain.  It lasted all day Sunday, with light headiness.  On Monday, I continued to have muscle tightness and soreness throughout my back; later in the evening my stomach started to hurt and I was extremely nausea.  Today Tuesday, I continue to feel out of sorts, with upset stomach and muscle fatigue.  No treatment as I do not know who to speak to.
Case number PHEH2013US013262, is an initial spontaneous report received  from a medical assistant on 17 JUN 2013. This report refers to a female patient of unspecified age. She received only Men Cy, Y, W-135 liquid conjugate component of MENVEO (batch number: M12027) intramuscularly without being reconstituted with Men A component on an unspecified date (sometime last week). No adverse reaction was reported following this administration error.
Day 2 post vaccine numbness and tingling in fingertips and feet, and face. Over next 2-3 weeks continued n/t that now spread to lower legs and hand and forearms. I was seen by primary care md, going approx 25 days post vaccine I went to ED to be seen for continued symptoms as well as facial spasm uncontrolled. I followed up with my PCP where she witnessed such spasm and sent me to a neurologist.  I saw the neurologist where she witnessed the facial spasm and said the closest thing she can diagnosis it as is atypical hemifacial spasm.
Chronic plaque psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Chronic plaque psoriasis flare-up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, UNK. In 2021, the patient experienced PSORIASIS (Chronic plaque psoriasis flare-up). At the time of the report, PSORIASIS (Chronic plaque psoriasis flare-up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. No treatment information was reported. The reporter's causality for the event with Humira was reasonable possibility. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pain with redness and warmth at immunization site with swelling extending underarm to upper lateral rib area.  generalized muscle aches, with temperature x 2 days of 100.4- medicated with ibuprofen and tylenol and rest
Patient contracted COVID with heavy symptoms; Patient contracted COVID with heavy symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm 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), COVID-19 (medically significant) all with onset 22Jun2023, outcome "recovering" and all described as "Patient contracted COVID with heavy symptoms". The event "patient contracted covid with heavy symptoms" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other vaccine in four weeks. Patent contracted COVID with heavy symptoms (extreme fatigue, body aches, sinus congestion, fever and very sore throat) despite getting the vaccines and booster shot. Events resulted in emergency room/department or urgent care. Patient received Paxlovid as treatment. No covid prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within five minutes: racing heart beat, full body flush, tingling and burning mouth and tongue, itching on chest and arms.
Miscarriage of baby confirmed in ER on 7/4/21. Fetus age based on ultrasound imagining estimated at 6weeks old at time of death. Estimated due date was 1/24/2022. Conception date estimated 5/3/21. Pregnancy at week 10 at time of miscarriage.
DIZZINESS, FEVER, CHILLS, MY ALGIA  Narrative:  DIZZINESS OCCURRED IMMEDIATELY AFTER INJECTION1/26/2021; OTHER SYMPTOMS OCCURRED THE NEXT DAY 1/27/21 (EMPLOYEE MISSED WORK THAT DAY)
Had Headache that did not go away with taking Tylenol.   Started day after she had vaccine.  She kept a headache for 1 week then went to  Her Primary care Dr.  Blood pressure was up 170/60.  Dr Increased  Amlodipine from 5mg to 10 mg  and it has helped some with blood pressure and Headache.   Pt complains she has had more Headaches and Blood pressure is elevated in mornings. has follow up app. with Primary care Dr in 2 weeks.
Nausea, vomiting, diarrhea, tongue swelling, nose swelling, lips swelling.
Patient was given two doses of Flumist one week apart 10/27/2010 & 11/2/10. Mother notified.  No adverse reactions.
shortness of breath, cough, fever, bodyaches, nausea, vomiting and diarrhea
Pt. states received Moderna 03/26/2021, 05/04/2021 starting experiencing extreme fatigue, muscle spasms, unable to lift anymore than foot weight. Physician visit 06/08/2021 referenced to an Immunologist. No recommendations.
Client's wife reports that client began with shortness of breath in April or May of 2021. Client was seen at the Urgent Care regarding same. Wife reports that the provider thought the shortness of breath was due to anxiety due to the lack of other risk factors and client was reportedly going through a stressful time in his life. Reportedly, no lab work such as a D.Dimer or chest XRAY was done at this encounter. On 07/22/2021 client began with redness, venous staining, and swelling in one of his lower extremities. Wife reports, initially client was diagnosed with cellulitis and given a course of antibiotics which did not improve client's symptoms. On 8/3/2021, client had an ultrasound of the extremity and was found to have a blood clot.  Wife reports that client is now taking Xarelto daily and has not had any hematological tests done. Wife reports that client's shortness of breath has resolved and his lower extremity is improving.
Pt received MMR vaccine 1-6-14 for college entry. LMP at that time 12/21/13. Pt discovered she was pregnant on 2/3/14 - confirmed in our office.
Spoke with MOC on 4/25/01, she stated child had no reaction with 1st DTAP. However, with his 2nd DTAP, he had an elevated temperature of 105F, inconsolable crying 6 hours and was very rigid "stiff as a board". Twin sister had no reaction to DTP on 2nd dose.