chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a cardiac surgeon concerning a female who was vaccinated with a dose of GARDASIL (lot #660618/0572X). Subsequently the patient developed hemiparesis, headaches and "other neurological symptoms". At the time of the report, the patient's outcome was unknown. The cardiac surgeon considered hemiparesis, headaches and "other neurological symptoms" to be were considered to be disabling since they have become longstanding and incapacitating. This is one of several reports received from the same source. A lot check has been requested. Additional information has been requested.
Developed a white lesion on the side of my tongue in early April.  Saw general dentist in March for routine dental checkup in March and dentist saw a small epithelial cyst under the lower front tooth so referred me to oral surgeon.  When I saw the oral surgeon in early April she said the cyst was not troublesome and did not need attention, but she then found a white lesion on the left side of my tongue that she felt was important to biopsy.   The lesion was not there in March.  I sought a second opinion from another oral surgeon who ended up doing a biopsy of the lesion and it came as dysplasia, so she then recommended that the lesion be lasered.  I had the laser procedure in late April and saw her for a follow up visit post op in May, and I am scheduled to see her again next week to be sure the lesion is gone.
This case was reported by a healthcare professional (nurse), via a sales representative, and described the occurrence of injection site reaction in a 65-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included erythema with latex allergy and sulfa allergy. On 19 July 2012 the subject received 1st dose of TWINRIX (unknown route, right deltoid). In 2012, less than one year after vaccination with TWINRIX (sometime before or on 21 August 2011), the subject experienced injection site reaction described as right shoulder weakness and right shoulder limited range of motion in the injection arm. The subject went to the office for her second dose of TWINRIX on 21 August 2012 and reported that "she has weakness in her right shoulder with limited range of motion". According to the nurse, the subject still wanted the second injection of the series and received in on 21 August 2012. The nurse reported that the physician did not feel the weakness and limited range of motion were related to the vaccination. The physician noted that the subject had been to the office between the first and second dose and had not mentioned the weakness or limited range of motion. At the time of reporting the events were unresolved. The healthcare professional considered the event was unrelated to vaccination with TWINRIX. Follow-up information was received on 17 September 2012 via healthcare professional who reported additional events of shoulder pain and soreness. The onset of the injection site pain, shoulder pain and soreness was 19 July 2012. The healthcare professional noted the subject received the 2nd dose of TWINRIX and reported no adverse events. At the time of the report the injection site reaction, shoulder pain and soreness had improved.
Fever, runny nose, itching started evening of 4-3-09 along with start of rash.  Diagnosed with chicken pox on 4-6-09 by family physician  Rash mainly on trunk, arms & face.  Rx for pain Rx for antihistamine.
plantar wart on his right foot was getting better after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (plantar wart on his right foot was getting better after the first dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Plantar warts (Plantar wart, Patient has been receiving treatments unsuccessfully for 6 years was getting better).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (plantar wart on his right foot was getting better after the first dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (plantar wart on his right foot was getting better after the first dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   Concomitant and treatment medication were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-118533 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-118533:Second Dose Case
diarrhea, muscle loss, loss 20lbs, stomach pain, nerve pain, electric shocks all over body, eye floaters, pain through out body
Information has been received from a physician concerning an 18 month old pt who in approximately February 1998, was vaccinated with a first dose of MMR II. Ten to fourteen days post vaccination, the pt experienced temperature of 104, an elevated alkaline phosphatase and clay colored stools. It was noted that the clay colored stool persisted for weeks. The symptoms have resolved. Unspecified medical attention was sought. Additional info has been requested.
I got an eye infection the day after my shot and then after the second shot, got another one (it was getting better).  It took about a week for it to completely go away after second shot.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 12-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.67 ml, Lot # L024997, expiration date: 06-OCT-2016), which was improperly stored for 50 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2014US022760, is an initial spontaneous report received from a nurse on 12 Nov 2014 and with a follow up information received from the nurse on 30 Jan 2015. This report refers to 11 years old female patient. Her medical history and concomitant medications were not reported. The nurse stated that MENVEO (batch number: not reported) reached below the recommended temperature with lowest documented temperature being 32 F since 12 Aug 2014. MENVEO reached temperature below 36 F on 12 Aug 2014, 13 Aug 2014 and 18 Aug 2014 and the patient was vaccinated with this vaccine intramuscularly in the right deltoid at a dose of 0.5 ml on 18 Aug 2014. The vaccine dropped to 32 F between the hours of 2:15 pm on 18 Aug 2014 afternoon until 8:45 am in the next morning. The other days that the refrigerator detected MENVEO reaching temperatures below 36 F to a documented minimum temperature of 32 F were 21 Aug 2014, 25 Aug 2014, 28 Aug 2014, 08 Sep 2014, 09 Sep 2014, 01 Oct 2014, 02 Oct 2014, 03 Oct 2014 and 07 Oct 2014. The nurse insisted that she was not aware of any freezing that occurred with MENVEO. No adverse events were reported following the inadvertent administration. Follow up information received from the nurse on 30 Jan 2015: Updated patient identifiers (date of birth, age, gender), site and dose of vaccination.
Menstrual period stopped, fever, chills, nightmares, injection pain, severe headache, ear pain, tiredness
PALPITATIONS; ALL OVER PAIN; HEADACHE; HIGH BLOOD PRESSURE; LIGHTHEADED.
exactly a year after shoots, got shingles/suspected vaccination failure; shingles; covid; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-MAR-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. This case was reported by the patient. The patient was pretty sure this was a side effect of Covid because he/she had always been a healthy person but did not take medications and exactly a year after his/her shots, he/she got the shingles. Additional supportive information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Right arm redness, swelling, warmth, with rashes/hives over body and chest
Itch and redness (R) arm 23 x 10 cm about 5 d after shot (L) arm red only 5 x 10 cm.
Dizzy, Brain Fog, headaches, body throbbing, rumbling in chest, cough up specs of blood, cholesterol increased, blood pressure increased higher and higher from what it normally is, Right wrist a cyst appeared on my wrist after two weeks, complete exhaustion, no energy, memory problems, couldn't work due to high anxiety.  I had horrible brain fog omg it's horrible. and I can't remember things.  I almost feel like everything has been erased from my memory if I could explain how I started feeling after the second shot.  I now feel worse, horrible, and i keep fighting for my life.  Remembering is a struggle.  I've noticed my hair coming out and I'm an actress/model.  Not cool!! I went to hospital seeking medical help from a Dr. and then sweitched to dr.   Dr. told me she thought I had long term covid since I told her in August how long I had these symptons.  She did nothing.  She could have prescribed ivermectin yet she ignmored every possible sign which is why I switched to Dr. who was worse.  She's so in fear of losing her license she would not medically treat me for anything.  I asked her about the cyst on my wrist and she played it off even thought this did not appear on my body until after the second shot from Phizer.  Shortly after leaving I found out several of the doctors there were not legally set up to practice yet.  Thats what I was told.  Now that's thrid party so I won't accuse anyone of that but that is what I was told .  I just kept feeling sicker and sicker.
sick; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who was sick (illness), after he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
patient is 17 and got vaccinated; A spontaneous report was received from a consumer concerning a 17-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On an unknown date, the patient received mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On an unknown date, the patient, who was 17-years old, was vaccinated.   Action taken with mRNA-1273 in response to the event was not reported.  The event "patient is 17 and was vaccinated" was considered recovered / resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
soreness comes and goes; soreness radiates up to shoulder; fever; bodyache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness comes and goes), PAIN (soreness radiates up to shoulder), PYREXIA (fever) and MYALGIA (bodyache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness comes and goes), PAIN (soreness radiates up to shoulder), PYREXIA (fever) and MYALGIA (bodyache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness comes and goes) had not resolved and PAIN (soreness radiates up to shoulder), PYREXIA (fever) and MYALGIA (bodyache) outcome was unknown.            Concomitant drug details include High blood pressure medication. Patient was recently prescribed with high blood pressure medication in May after the vaccine.   This case was linked to MOD-2021-379624 (Patient Link).
Initial expected pain at injection site approximately 5pm on date of vaccine 1/30/21. Pain continued to worsen instead of getting better, now nearly 48 hours later. It is too painful to move my left arm at all. When I saw where the bandaid was placed on the night of the injection, I noticed, and even sent a picture to my daughter about how high it was on my shoulder. I have received multiple flu vaccines with no adverse reactions except for a bit of soreness that went away within 24 hours  and they have always been much lower than this vaccine. I had been expecting pain/soreness but this is extremely painful and not getting better at all. I am fearful that it may have been administered too high and possibly into the bursa. I need advise ASAP as I?m sure that my GP will have little or no experience of this.
I have an IUD and had not had a menstrual cycle for 6-7 years prior to receiving the vaccine.  Soon after receiving my first dose, I began menstruating regularly again.
Child presented for HEP A #2 immunization.  Had 3 pages of scattered history that dad had with him.  Review of records and missed HEP A adm 4/5/07.  Our records had HEP A #1 listed 11/14/07.  HEP A reported as being received at hospital.  HEP A adm 8/11/08 as scheduled.  After further review of records - HEP A #1 listed as 4/5/07.  Thus patient received HEP A 3 separate times.
HCP called to report TE on PROQUAD and it was inadvertently administered. HCP also inadvertently administered PROQUAD and VARIVAX at the same time; HCP also inadvertently administered PROQUAD and VARIVAX at the same time; No additional AE/PQ; This spontaneous report has been received from a licensed practical nurse concerning a 12-month-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was inadvertently vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number W024967 with expiration date 05-FEB-2024 (dosage regimen, frequency and route of administration were not provided) (Product storage error). On the same date, the patient was also vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), both vaccines were administered as prophylaxis (dosage regimen, frequency, route of administration, lot number and expiration date were not provided) (Accidental overdose). No additional adverse events were reported (No adverse event).
Started getting chills real bad. Her body was aching real bad. All throughout the night she had hot / cold flashes.
The patient states that when she was at camp she received Yellow Fever and HepA/HepB #2 vaccinations on 9/24/04 - injection site and time of administration unknown. (Of note, this was the first Yellow Fever vaccination that the pt received). A review of the medical record indicates that the pt had been ill for about 2 weeks with a cold and she had been seen in medical several times - treated with TYLENOL, DECONAMINE SR, CEPACOL lozenges, ROBITUSSIN DM, MOTRIN. The pt reported to medical on 9/25/04 at 0700 with complaints of a 2 hour history of an itchy rash, which the pt described as hives, on her left arm and a red, itchy left eye. When examined the rash had resolved. The pt was diagnosed with conjunctivitis. The pt reported to medical at 0028 9/26/04 with complaints of hives (same rash as the pt had previously noted) on her arms, abdomen and chest (none on her legs or face) which started at 1800 9/25/04. Additionally, she complained that her "head" was swollen (the pt had to expand the strap on her cover). She denied facial swelling, swelling of the lips or tongue, SOB, difficulty swallowing, nausea, vomiting, diarrhea, abdominal pain. The PE noted: "NAD, throat clear, lungs CTA, RRR, scattered urticaria. She was treated with Epi .3cc sq, TAGAMET 800mg po and ATARAX 25mg po. She was released with a prescription for TAGAMET and ATARAX. She was told that she was allergic to the Yellow Fever vaccination and this allergy was documented in her Electronic Medical Record and hard copy medical record. The pt states that she received HepA/HepB #3 without incident. She has received several Influenza vaccinations (TIV and LAIV) without adverse event.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored dose of LIQUID PEDVAXHIB (lot#, expiration date, route of administration, dose and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 12 weeks old female patient with no pertinent medical history or drug allergies who on 25-MAY-2011 was vaccinated orally with a dose of ROTATEQ (Lot#: 669523/1556Z). There was no concomitant medication. On 07-JUN-2011 (reported as 13 days after therapy), the patient experienced hematochezia. There was no lab diagnostics performed. The patient did not seek medical attention. At the time of the report, the patient had recovered. Follow up information has been received from a registered nurse who stated that on 25-MAY-2011, the patient received the first dose of ROTATEQ (Lot #: 669523/1556Z), and concomitantly received the second dose of RECOMBIVAX HB (Lot#: 668062/0979Z) and received the first dose of PREVNAR 13 and the first dose of PENTACEL. On 27-MAY-2011, the patient's mother reported that the patient had bloody stools with red streaks. The patient's stools tested positive for blood. The patient's mother was advised to male some dietary changes for the patient. On 23-JUN-2011, the bloody stools persisted. In July 2011, the physician felt that the patient's bloody stools were the result of a milk allergy. The patient was placed on Alimentum formula. The patient had not had bloody stools since she was placed on the Alimentum formula. The patient recovered. The physician discontinued ROTATEQ (Lot #: 669523/1556Z). Additional information was received from a physician regarding a 9 week old (previously reported as 12 week old) female patient who on 25-MAY-2011 received a first dose of ROTATEQ PO (Lot#: 669523/1556Z), and concomitantly received the second dose of RECOMBIVAX HB (Lot #: 668062/0979Z) IM in LAT, and received the first dose of PREVNAR 13 (Wyeth) (lot #: E84910) IM in RAT, and the first PENTACEL (Sanofi Pasteur) (Lot #: C3869AA for DTaP-IPV component and lot# C3724AA for ACTHIB component) IM in LAT. Subsequently, on 26-MAY-2011, the patient experienced blood in stool. The patient was recovered from this event on approximately 03-JUN-2011. At the time of this report, the patient was reported as 7 months old. All available medical records will be provided upon request. Additional information has been requested.
Muscle spasm; patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021) in a 52-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) for an unknown indication.    Concurrent medical conditions included Crohn's (Outcome reported as not recovered.).   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. On 30-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasm). The patient was treated with CEFIXIME (FLEXERIL [CEFIXIME]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Muscle spasm) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 10-Jun-2021 and second dose on 30-Jun-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken for co-suspect ADALIMUMAB (HUMIRA) was reported as unknown with respect to the event Muscle spasm.  Primary reporter did not have the lot number information, because the packaging was discarded.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the event muscle spasm with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Live follow-up was received additional reporters causality of the event Muscle spasm was updated to not related from related, co-suspect drug dosing information updated, medical history was updated and narrative was updated.
Patient was Moderna COVID-19 Booster on 7/21/22. Immediate supervisor, RN was contacted immediately on 7/22/22 when mistake was realized. RN, Immunization Coordinator was also contacted. Patient's grandmother/legal guardian was also notified on 7/22/22. She states he is doing "fine" and has had no adverse reactions at this time.