chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of benign paroxysmal positional vertigo in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included gastroesophageal reflux disease and blood pressure high. Concomitant products included Losartan and hydrochlorothiazide. On 24th April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, 30 days after receiving SHINGRIX, the patient experienced benign paroxysmal positional vertigo. The patient was treated with Physical Therapy. On an unknown date, the outcome of the benign paroxysmal positional vertigo was not recovered/not resolved. It was unknown if the reporter considered the benign paroxysmal positional vertigo to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient's concomitant medication included gastroesophageal reflux disease (GERD) medication, and cholesterol medication. The patient received SHINGRIX in the left arm. One month later, the patient was diagnosed with benign paroxysmal positional vertigo (BPPV). The patient stated that, she was about 75 percent better and was doing physical therapy to deal with the condition. The patient stated that, it was unknown if the vaccine caused that condition, but it probably did not. The patient went to her doctor and they sent her to the emergency room when this first occurred.
Extremely low white blood cell count. First herpes outbreak after no known herpes exposure. It is possible I was a carrier and the shot triggered the first outbreak.
Pt had vomiting, fever, chills. All symptoms resolved by 5 pm on 1/8/13.
cellulitis; Sepsis; Elevated heart rate; Rash from the waist down on left side of body; chills; Fever; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) and SEPSIS (Sepsis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate increased (elevated heartrate).   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criterion hospitalization) and RASH (Rash from the waist down on left side of body). On an unknown date, the patient experienced HEART RATE INCREASED (Elevated heart rate). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to CELLULITIS and SEPSIS. At the time of the report, CELLULITIS (cellulitis), SEPSIS (Sepsis), HEART RATE INCREASED (Elevated heart rate), RASH (Rash from the waist down on left side of body), CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: 132 (High) 132 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. She was admitted to the hospital and hospitalized for four days. She was diagnosed with cellulitis and sepsis. She was discharged  home from the hospital with Augmentin (Amoxicillin / Clavulanic acid) for 10 days.  Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested   This case was linked to MODERNATX, INC.-MOD-2021-081503~, MODERNATX, INC.-MOD-2021-081439, MODERNATX, INC.-MOD-2021-081647 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested MODERNATX, INC.-MOD-2021-081503 :Fourth patient-Same reporter MODERNATX, INC.-MOD-2021-081439:First patient-Same reporter US-MODERNATX, INC.-MOD-2021-081647:Third patient-Same reporter
About 26 days after vaccine, had been unusually fatigued. Took a nap and when I woke my heart was racing and BP was elevated. Called my Doctor and he had me make an appointment with him on Monday, April 12th. Went to the appointment and got second dose of Moderna Vaccine. Doctor changed Blood pressure med and ordered EKG. Med change helped with Blood pressure and rapid heart rate. Followed up with Doctor in August. Doctor order Holter monitor and results where normal. In Feb of 2022, had annual physical. BP was higher than it should have been on medication. Doctor changed BP med. Woke up that night with burning chest pains and rapid heart rate again. EKG and chest x-ray preformed in ER both normal. Went back to Doctor and he performed another med change to help control tachycardia. Also began having headaches a couple weeks after receiving 1st vaccine. Symptoms are controlled with meds but are not resolved. Received Moderna booster December 2021.
pt recvd vax 8OCT93 & w/in 2 hrs pt began w/high-pitched crying which lasted for 1 hr; no sequelae or other sx; w/in 4 wk prior to 8OCT pt had recvd HIB vax only w/no problems; 8OCT pt recvd DT w/no problems;
I had a red rash in the injection site, the next day my arm was painful, and was unable to lift it, it went away and today January the 17 of 2021 it came back. It feels warmth, and no pain.
Fever to 39.4.  Generalized tonic clonic seizure for 90 seconds.  Brought to ER.  Observed, noted to be febrile.  Discharged in good condition.
Fever; Chills; Headache; Malaise; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included Never had shingles..   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), headache (Verbatim: Headache) and malaise (Verbatim: Malaise). The outcome of the fever, chills, headache and malaise were not reported.   It was unknown if the reporter considered the fever, chills, headache and malaise to be related to Shingles vaccine.     It was unknown if the company considered the fever, chills, headache and malaise to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by patient via interactive digital media. The reporter reported that it was a worst vaccine. The reporter reported that he or she never had shingles, so he or she did not know what that's like. The reporter reported that 8 hours into each vaccine he or she was out for over 24 hours and experienced fever, chills, headache, malaise. The reporter reported that he or she did not get the second dose.
Fri, Oct. 19:   10 AM - vaccine administered  Early afternoon  - did not feel well.  6 PM - felt weak, tired.  8 PM - chills and fever  10 PM - fever of 102.3  Called insurance nurse line. Began taking Tylenol for the fever. Sat, Oct. 20:   I noticed a red rash - almost like a sunburn in the area - about 4? around the site of the injection of the Shingrix vaccine. It was itchy. Fever continued, but was reduced. I also recall a headache at one point. Sun, Oct. 21:  Symptoms continue - rash and fever. Applied hydrocortisone ointment to rash. Oct. 22 and 23 - continued to feel unwell. Stayed home from work. Oct. 24 - Returned to work, but rash remained for a few days.
a 12 year old patient got a dose of Quadracel today; Initial information received on 15-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.   This case involves a 12 years old patient (gender not reported) who was vaccinated with 0.5 ml once dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number: C5500CA, expiry date, dose in series and route of administration were not reported) in the left arm on 15-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) on an unspecified date.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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 the sender: none.
patient received dose on 10/6/22, the manufacturer date of expire was 9/30/22
Woken up in the middle of the night covered from head to toe in bright red, itchy rash with hives.  Eyes and lips were swollen.   Rash then went away however itchiness persisted and itches were scratched bright red rash with hives appeared in the exact patter of the scratch.  Reaction is now consistent with dermatographia.
sudden onset dizzy and lighthedness(about 25 minutes after shot)  symptoms remained for 1/2 hour at which point i took 2 benadryl's.  shortly after dizzy and lightheadedness subsided
Monovalent COVID 19  Booster Vaccine was administered incorrectly, since the FDA removed the authorization.
This spontaneous report was received from a pharmacist and refers to a patient of unknown gender, between 40-49 years of age who on an unknown date was vaccinated with ZOSTAVAX. No adverse effects reported. The outcome of inappropriate schedule of drug administration was unknown. No further information was provided. Additional information has been requested.
Child developed shoulder and axilla pain with radiation down arm soon after receiving vaccine.  Office was notified on 2/15/2021 (6 days following vaccine)  that pain was still present. Child was examined via a telehealth visit on 2/ 16/2021 (7 days following vaccine).  Could have been considered a neuritis based on presentation, but could also have been related to vaccine administration.  Attempted to follow up today, 2/23/2021, unable to reach mother.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 28-APR-2016, the patient received an expired dose of PNEUMOVAX23 (strength, dose, frequency, route of administration, lot number and expiration date were not provided), lot # L017406 with expiration date of 26-FEB-2017, for prophylaxis. No adverse effects were reported. No further details provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient complained of dizziness and nausea at 1230, then vomited twice after lunch.  Continued with vomiting and diarrhea throughout the day, also continued with complaints of dizziness.  Recommendations to push fluids and watch for s/s of dehydration.  No swelling or redness at the site of injection per mom, or hives, difficulty breathing, or pain also per mom. Pt was doing well the am of 10/23/2009 no longer vomiting.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Reportedly, 168 doses or vials were initially stored in the refrigerator on an unknown date. It was reported that vials had not undergone any temperature excursion. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU was received with non-significant information.
A spontaneous report has been received from a pharmacist and a physician via the regulatory authority concerning a 3 year old female patient. No medical history was reported. No concomitant products were reported. On 07-Feb-2019, the patient was administered with FLUENZ TETRA (intranasal), via nasal route, for flu vaccination. On 08-Feb-2019, the patient experienced wheezy and increased work of breathing. The patient recovered from the event of wheezy on an unspecified date. The outcome of the event of increased work of breathing was unknown. The events were considered serious (important medical event) by the reporter. Sender's Comments: Wheezing and dyspnoea are not listed in the company core data sheet for Q/LAIV. Due to limited information on relevant medical history, concurrent diseases, concomitant medications, outcome of dyspnoea, detailed aetiological and diagnostic work up (pulmonary function tests, allergological work up) it is not possible to make a conclusive assessment of the causal relationship of the events and suspect drug.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: high blood pressure; "herniated disc L4" (unspecified if ongoing), notes: herniated disc L4. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 01Jan2022, stop date: 01Jun2022. The following information was reported: DRUG INEFFECTIVE (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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Report about covid treatment: Yes. Reporter type: Patient. If vaccine received: Yes. Other medication in 2weeks: Yes.  No follow-up attempts are possible. No further information is expected.
Red, hot, swollen, hard at injection site. As of 10/15/12, getting better per patient.
after the 2nd shot, my platelets were lower to 369 which was normal for me; This is a spontaneous report received from a contactable (reporting for self). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, lot number and Expiration date was not reported) via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunization. Medical history included polycythaemia vera, essential thrombocythaemia. The historical vaccine included first dose of BNT162B2 received on Jan2021 for COVID-19 immunization. The patient's concomitant medications were not reported. The patient previously took jakafi for polycythaemia vera and experienced skin lesion. It was reported that patient received her/his two BNT162B2 Covid 19 vaccine back in Jan2021 and 03Feb2021. After her/his 2nd shot of BNT162B2, her/his platelet dropped down around 400. Patient was using medication Jakafi up until Dec2020. But patient had skin lesions and he/she dropped it. So, at the time patient received the vaccines, he/she was not on any medication. Patient was asking that can you look into if BNT162B2 or similar medication can possibly be produced to drop down the platelet level and hemoglobin for the patients who have Polycythemia Vera and Essential Thrombocythemia. Patient wrote to Pfizer because the BNT162B2 could be a way to find a medication for Polycythemia Vera and Essential Thrombosis. Because right after the 2nd shot, "my platelets were lower to 369 which was normal for me". Pa-tients platelets were over 1000 when he/she started the Jakafi medication. It did drop to 500-600 but not lower than that. Patient not sure if it was the vaccine that helped to lower platelet but, patient was trying to see if it can be studied to find a medication for the referenced diseases. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
BODY ACHES; LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches and low grade fever was not reported. This report was non-serious.
Fever of 102, coughing, sore throat, feeling like she is going to vomit, loss of appetite.
Major migraine, severe intestinal stuff, diarrhea, nausea, severe fatigue, beyond what I normally have.
Pt recvd a series of Engerix-B on 8MAR91; 18APR91 & 6SEP91 & upon completion of series pt discovered to have not responded;
Inflamed lump, painful below the jaw. This has never happened before. Doctors don't know if it is a node or something else.
Warmth, redness, induration beginning to develop, complains of moderate pain with movement.
swelling & erythema w/sl induration @ site of shot;rx w/ice packs w/some improvement;
This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 28-OCT-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L003218 Expiration date: 30-APR-2016) (dose, route and anatomical location of administration were not reported). No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Addiitonal information has been requested.
pt c/o SOB, difficulty breathing 1/2-1hr p/vax;no hives;inc nervousness;seen in clinic for epi & eval x 3hr;
rt leg red swollen & hot to touch, very tender reaction lasted 72 hrs; started on DPH;
first Covid-19 Vaccine last Mar2021. On May2021, she has "absolutely no symptoms" of rheumatoid arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis", start date: 2018 (unspecified if ongoing), notes: diagnosed with rheumatoid arthritis last 2018. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset May2021, outcome "unknown", described as "first Covid-19 Vaccine last Mar2021. On May2021, she has "absolutely no symptoms" of rheumatoid arthritis".  Additional information: Caller is reporting a "good news" regarding the Pfizer BioNTech Covid-19 Vaccine. Caller mentioned that she has been diagnosed with rheumatoid arthritis last 2018. She has been taking Methotrexate injectables since then. She had her first Covid-19 Vaccine last Mar2021. On May2021, she has "absolutely no symptoms" of rheumatoid arthritis. Her rheumatologist took her off of her Methotrexate. Her rheumatoid arthritis has been on remission for a year now. She has no medical questions, she just wants to check if the shot could have caused her remission. She thinks that her rheumatoid arthritis remission might be a coincidence with the Methotrexate. If it were the COVID shot, she suggests Pfizer to investigate on it. Follow-up attempts are completed. No further information is expected.
Right knee joint effusion started approx 2 days after immunization. No fever or other sx. Effusion continued to persist at 2-3 wks after vaccination.
Symptoms reported, "I was driving home after the vaccine and felt really hot, like a hot flash and felt my heart palpitating", that lasted for approximately one hour. Symptoms of "tingling at all 10 finger tips that has gone away but now have a little numbness in both hands".  Reported driving home and calling  primary care physician to report symptoms but has not received a call back.
Thick mucus draining on the back of their throat,it was terrible; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Thick mucus draining on the back of their throat,it was terrible) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 11J20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LORAZEPAM, ATENOLOL, VENLAFAXINE, ESOMEPRAZOLE MAGNESIUM, FAMOTIDINE, ATORVASTATIN, MELOXICAM and ESTRADIOL for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SECRETION DISCHARGE (Thick mucus draining on the back of their throat,it was terrible). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SECRETION DISCHARGE (Thick mucus draining on the back of their throat,it was terrible) had not resolved.            Relevant concomitant medications included Bupropion XL. Treatment medication included common allergy medication.   This case was linked to MOD-2021-388022 (Patient Link).
About six days after I received the vaccination, I got a large red hot area in the area the vaccine was given. I had previously not had any symptoms or reactions. My arm became more sore, but was not tender to the touch. The indurated, erythematous area was a circle with about a 6 inch diameter.