chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. The reporter stated that a few unspecified patient received improper stored doses of GARDASIL 9 on multiple unspecified dates since 12-SEP-2018, for prophylaxis (lot # # N032956, expiration date: 13-JUL-2020) (dose, frequency, route of administration were not reported). There were no adverse effects reported. The doses of the vaccines were exposed to a temperature of 47 degrees Fahrenheit (F) to 77 degrees (F) for a time frame of 20 hours. A previous temperature excursion (below 32 degrees (F) (30.9 degrees (F)) was reported with a time frame of 1 hour. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. This report was considered to be non-valid due to lack of patient identifiers.
This is a spontaneous report from a contactable pharmacist. A 17-year-old patient of an unspecified gender received TRUMENBA, (lot number: S58879), via an unspecified route of administration in Jun2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had an injection site reaction 2 days after getting the vaccine. The patient had redness and swelling and the child was put on an antibiotic in Jun2018. The pharmacist inquired if there was a recall of Lot S58879 and presumed that the office was given a bad batch. Outcome of the event was unknown.
slight fever - tylenol  sinusitis - azithromycin, initially, but did not resolve completely; then clarithromycin, resolved  diminished hearing, especially in right ear - otitis media was not present  conjunctivitis - tobramycin, but did not resolve completely; warm compresses on the eye
my face feels numb, it's very red, it's very hot to touch and feels like burning; my face feels numb, it's very red, it's very hot to touch and feels like burning; my face feels numb, it's very red, it's very hot to touch and feels like burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Lot number: FC3181) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Verbatim: Migraine. Concomitant medication(s) included: MOTRIN [IBUPROFEN] taken for migraine. The following information was reported: BURNING SENSATION (non-serious) with onset 26Aug2021 18:00, outcome "unknown", HYPOAESTHESIA (non-serious), ERYTHEMA (non-serious) all with onset 26Aug2021 18:00, outcome "not recovered" and all described as "my face feels numb, it's very red, it's very hot to touch and feels like burning".  Additional information: Migraine and I take Motrin for them and ADB and I take like Motrin and Ibuprofen (Further clarification unknown). Clinical course reported as I got my vaccine two days ago my first dose and today out of nowhere my face feels numb and its very red and it's very hot to touch, it's feels almost kind of like a burning when I do touch.  No follow-up attempts are possible. No further information is expected.
On about 3/30/22, Itchy rash, red bumps,  on body, back, chest, arms, legs.  Went to Dermatologist and got Rx on 2/5/22 for Methylprednisolone, 4 mg dspk, qty 21,d ays    6:  Day 1: 6 , Day 2: 5, Day 3: 4.  Day 4: 3,  Day 5:  2.   Day 6:  1. TRIAMCINOLONE 0.1% CREAM  2X A DAY. Rash went away after a day.   Rash reappeared on 3/10/22 and got Rx: PREDNISONE 10 MG TAB   4/day for 4 days, 3/day for 4 days, 2/day for 4 days, 1/day for 4 days, ½ a day for 4 days  (Rash)   3/10-3/29/22.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On an unknown date the patient was vaccinated with a dose of an improperly stored ZOSTAVAX (lot#, dose, route not reported). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Tongue feels thick 8:05 slight headache 0819 headache better.  Lungs clear b/p 122/78 pulse 68 respirations 18. Patient cheerful and talkative, color pink.  0821 Swelling in tongue better.  Denies shortness of breath.  0824 left arm feels tight. 0831 patient denies further care. States she going to have a work up for MS.  Her sister has MS.  Patient refuses further medical care here and states she is feeling ok.  Tongue is feeling less thick and arm is less heavy.  Patient states she would like to leave with her husband to go home.  Patient is talkative and cheerful at this time.  Speech is clear(husband states she had anxiety about getting the vaccine) Advised to call MD or 911 if needed.
patient received half the dose of a Moderna vaccine in error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error). At the time of the report, ACCIDENTAL UNDERDOSE (patient received half the dose of a Moderna vaccine in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Patient is on STRATTERA. Mother reports changes on behavior. Child more opositional and inattentive after receiving vaccine
On 03/21/2021,  very itchy burning hot red rash in the shape of a triangle in the upper arm, at the site of the injection. my arm particularly my lower arm swelled up dramatically in the next week. My arm was 47% bigger as measured.  My arm is still swollen that way today, except the rash went away gradually 10 days later. I went for my 2nd Dose of Pfizer, with my arm still swollen,  They sent me to an express treatment and the doctor's  there told me it was an allergic reaction and to take Benadryl. Then I went to my own GP, who was alarmed of my swollen arm and sent me to a vascular surgeon to check for a blood clot - which I did not have. She then thought it was cellulitis and gave me antibiotics for a week- no progress. And then she sent me to an infectious disease doctor, Dr.. He also thought it was an allergic reaction, strong antihistamine and encouraged me  get the 2nd dose in the other arm.  I received the 2nd dose of Pfizer on 04/23/2021 - no adverse reaction, just a little sore.  When the steroids did no good.  By then , 3 weeks after the 2nd vaccination, we all thought this looks like lymphedema and that lead to the diagnosis. I got a mammogram, which lead to the diagnosis. It took from 04/02/201 to May 28, to get a diagnosis. For anyone to suggest it was cancer. But lucky to have found it.  On 05/28/2021, I was diagnosed with breast cancer. It put a spot light in a good way but it took the doctors a long time to recognize what it was spot lighting. My arm is still swollen (which is the adverse reaction, but it lead to an important diagnosis.
Loose stool...MB has never been fully solid...  not full diarrhea...  85-90% hard, but nickel to quarter size pieces. ..
Chest pain  difficulty breathing fever of 102 Uncontrollable shaking (not just chills) Effects still in effect
Severe headache that will not go away.   Have tried Sinus pressure OTC, tylenol, etc.
Vaccine given at 11:40 AM. Patients reports feeling jaw pain at 12:30PM. The next morning at 5:00AM patient states he began feeling thickness in the tongue. By 6:30 AM it was worse and he went to the Emergency Room. He was unable to communicate with the staff, but handed them the VIS statement on the vaccines. Patient states that they did an EKG but no other workup.
The morning after the vaccine administration I experienced symptoms very similar to when I had COVID approx 2 months ago, except this time it felt a lot worse than when I actually had it. Whole body chills, severe body and head aches, slight on and off "brain fog", slight cough, heavy fatigue, and a fever that was recorded every few hours ranging from 101.2 to 103.5. It lasted all day long that I was awake (0600-2000). Treated with Dayquil and Nyquil Severe Cold and Flu. Woke up the next day, and all that was left was slight body and head aches and slight cough; temp back to normal, ranging 98.9 to 99.2.
Day after had severe gum bleeding at dentist cleaning, on February 24th had a blood nose hemmorage, needed to go to emergency department. They had to insert a nasal balloon because I wouldn't clot for about 4 hrs.
on 1/15/22 pt received vaccine of 1/9/22. No adverse reactions.  Offered revaccinations per CDC guidelines
This spontaneous report was received from a healthcare worker, who reported that M-M-R II (lot number and expiry date were not reported) appeared on the product list as temperature stability questions were asked. However, no doses of improperly stored M-M-R II were administered to any patients. Temperature excursion was not reported. It was unknown, if data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.
Received MMR & Varicella vaccine at 1-2 pm - went home. At approx 8pm - mom states infant very sleepy, pale, rapid breathing. Took to ER. ER doctor thinks possible reaction to vaccines no rash or swelling noted. Saw private physician yesterday et mom sent to HD to fill out VAERS report.
Fussy and fever the following day after receiving vaccines.  This lasted for five days then was followed by a red non itchy rash over entire body.
increase in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increase in blood pressure) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (increase in blood pressure). At the time of the report, BLOOD PRESSURE INCREASED (increase in blood pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
HYPOTONIC HYPORESPONSIVE EPISODE APPROX 5-6 HRS AFTER ED VISIT - NL ECG + LYTES. 0 TX
22MAY95 p/receiving vax pt had dec appetite & inc sleeping; pt has had temp (max  101) for last 4 days; on noc of immunization, pt cried for more than 4 hr & eventually cried self to sleep; pt also had 7 bowel movements on 25MAY95;
pt recvd vax & had mild otitis med on exam & t101; devel high fever 3-4 hrs later;
TONGUE SWELLING, ITCHY ALL OVER, CHEST PRESSURE AND SOB. PT SELF-ADMINISTERED ALBUTEROL INHALER. PARAMEDICS CAME, VSS, TRANSPORTED TO HOSPITAL
Patient is 7 years old. In database, his first dose of COVID vaccine is documented as the Pfizer SARS-COV 2 Peds 6 mo-4 years, given 9/8/22. He received the correct dose for his age on 10/5/22.  Nursing alerted me to this discrepancy while patient was in office today for an ADHD visit, which was just identified today. I disclosed to mom that patient appeared to be underdosed for his first COVID vaccine or this could be a clerical error on our side. I apologized and stated that no harm was caused to her son, but we do need to make a plan forward. MOC stated she had his COVID vaccine card at home - advised nursing leadership would call tomorrow to f/u and confirm which vaccine was given 9/8/22.
This is a spontaneous report received from a received from a contactable consumer patient reported for herself via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6205), via an unspecified route of administration in left arm on 04Mar2021 14:00 (at the age of 74 years old) as a dose 1 single for COVID-19 immunization. Patient medical history included FLU Vaccine from unspecified start and stop date (She and her father both always got a light case of the flu after receiving the flu vaccine). Patient had family history of Her father has passed away, Father reacts to the flu vaccine. Patient had not received any concomitant medications. Patient was not administered with any other additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 the patient experienced arm hurting and aching, very tired, chills, dizzy. On 05Mar2021 patient experienced low grade fever, strange stomach like pressure, bloated and cough. Patient stated that, she had side effects on the 1st vaccine shot that her friends didn't have until their 2nd Pfizer vaccine dose. Patient stated that her second vaccination was on 24Mar2021 and had been to her doctor and she had right eye discharge and upper respiratory symptoms on 08Mar2021. She was on antibiotics. Patient was visited to physician or ER (emergency room) for the events reported. Outcome of events right eye discharge, very tired, a strange sensation in her stomach like pressure or bloated like, cough was not recovered, and upper respiratory symptoms was unknown. Outcome of arm was hurting and aching, chills, dizziness, had a low-grade temperature was recovered on 07Mar2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On unspecified dates, the patients were administered with improperly stored GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, dose and route unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a consumer refers to a female patient of unknown age. The patients medical history included unspecified musculoskeletal disorder similar to fibromyalgia. On an unknown date the patient was vaccinated with unspecified hepatitis B vaccine (manufacturer unknown). On an unknown date, after the first dose the patient experienced muscle aches and pain. The same adverse symptoms occurred after she received second dose of the unspecified hepatitis B vaccine. Patient sought medical attention by informing her physician. Outcome and causality was unknown. Additional information has been requested.
Swelling and redness/warmth at site and fever greater than 101 the day after the injection.  No difficulty breathing or hives.  Pt was seen in clinic on 10/24/20 and advised to return to clinic prn and reach out to patient's transplant team and let them know of the reaction.
Thyroglobulin test that had very high results; This case was reported by a consumer via call center representative and described the occurrence of thyroglobulin increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included thyroidectomy (had Thyroidectomy in 2017). Concomitant products included DENOSUMAB (PROLIA).   On 11th November 2019, the patient received the 1st dose of Shingrix. On 11th November 2019, less than a day after receiving Shingrix, the patient experienced thyroglobulin increased. On an unknown date, the outcome of the thyroglobulin increased was unknown.   It was unknown if the reporter considered the thyroglobulin increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after receiving Shingrix just had  a thyroglobulin test that had very high results. The reporter stated to report for retesting to determine if there was a fluke and was awaiting results. The reporter did not consent to follow up.
Acute arm numbness within 15 minutes of receiving vaccine, mild weakness, appeared to have erythema at injection site.  No pain during injection, side effects as aforementioned post injection within 15 minutes and continuing until this point.  Numbness has improved slightly but remains present several weeks post injection.   No history of any other injection side effects.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (route and lot number were not reported), 0.65 ml unspecified site. Concomitant medications were not reported. Pharmacist stated that "a few weeks after that administration of ZOSTAVAX vaccine, patient started having muscle pain, then lost of control of his muscles, and then lost of control of his urine". The outcome of the patient at the moment of the report was not reported. The relationship between ZOSTAVAX and the events was not reported. Patient sought unspecified medical attention. Patient performed a blood test to rule "out other viruses". Additional information has been requested.
Got Covid positive after receiving our first dose/ Had an active infection; Got Covid positive after receiving our first dose/ Had an active infection; This is a spontaneous report from a contactable pharmacist via a Pfizer sponsored program.  A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 07Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Covid-19 Vaccine and did not receive the second dose that is because that someone got Covid positive. This is a gentleman and older gentleman and he can't get around very well. He was in the facility when he got the first dose and he is no longer in that facility. the second dose that is because that someone got Covid positive. He also had Covid and he had an active infection previously as well. Obviously, it is like seventy or more days out from the first dose, it is beyond the recommended window. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (drug ineffective) with BNT162b2 can not be fully excluded.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Arthritis.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. On 18-Feb-2021, HEADACHE (Headache) and PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-070391 (Patient Link).; Sender's Comments:
I experienced itching and hives, which moved throughout my body, that lasted 10 days. I took ALLEGRA and used an anti- itch cream. I went to the doctor after it had resolved, and no tests were run. I am fully recovered with no lingering symptoms.
Vertigo, nausea, diarrhea, fatigue,  mantel cell lymphoma, anemia, puncture of colon wall
pain; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were unknown.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had local reactions of pain and swelling.
Patient  called pharmacy stating that for 3 days, patient has had severe pain on half of body.  I referred her to contact her prescriber.
I experienced weakness, dizziness, muscle quivering, headache, vertigo, fatigue, nausea and exhaustion.
p/vax pt exp high fever & legs jerking uncontrollable lasting less than 1hr. resolved w/treatment. inject site swollen