chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported an injection site reaction that started 7/30/18. Patient reports inflammation/swelling in the form of a line starting near the injection site on her left arm and extending underneath her arm with a painful, inflamed lump at the termination of the line that the patient thought might be a lymph node. Other than some discomfort the patient does not feel the need to seek immediate medical attention, but was advised by pharmacist to monitor the reaction and to seek medical help for continued or worsening symptoms.
Information has been received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's concomitant therapy, historical therapy and concurrent condition were not reported. On 16-AUG-2018, the unspecified 4 years old patient was inadvertently vaccinated with GARDASIL 9 (strength, dose, unit, route was not reported) (lot # N026814, expiration date was 15-JUL-2020) for prophylaxis (drug administered to patient of inappropriate age). It was also reported that the patient was administered with BOOSTRIX and MENACTRA on the same day. No adverse effects reported. Information regarding treatment given, lab diagnostics/studies performed, sought medical attention were not applicable.
Patient started with a fever the afternoon after the vaccine was given and had a febrile seizure which she was seen in the ER for.
6 month old female was given (...) Proquad instead of M-M-R II; 6 month old female was given (...) Proquad instead of M-M-R II; 6 month old female was given (...) Proquad instead of M-M-R II; no adverse event; This spontaneous report was received from a nurse and refers to a 6 months old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a properly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, injection, lot # S002496, expiration date 23-JUL-2020 (dose and route of administration were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported). The patient was getting measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) due to a family travel to a high risk area. Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent (STERILE DILUENT) (formulation, strength, dose, frequency, route of administration, indication, lot # expiration date were not reported). No adverse effect was reported.
pt recvd vax; Bell's palsy; f/u: partially recovered w/ tx of pred;
This spontaneous report as received from a health professional refers to five patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unknown date, patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
injection site is swollen to about the size of a half dollar; Initial information regarding an unsolicited valid non-serious case received via patient husband on 12-Oct-2022. GMI number: 01318954.  This case involves a 26-year-old female patient who experienced injection site is swollen to about the size of a half dollar after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant vaccination includes Bivalent COVID.    On 11-Oct-2022, the patient received a dose of suspect Fluzone Quadrivalent vaccine flu shot at dose 0.5 ml total (lot: UT7689NA, expiry date: Jun-2023) via unknown route in unknown administration site for immunization.  On 12-OCT-2022 the patient developed a non-serious injection site is swollen to about the size of a half dollar (vaccination site joint swelling) at 1 day following the administration of Fluzone Quadrivalent vaccine.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Not Recovered for the event Vaccination site joint swelling.
Pt called 2 days following vaccine to report arm swollen, reddened & itchy, had tried cold compresses with no relief.  Advised by nurse in our office for pt to contact pt's primary MD to report same.  MD saw patient next day & began antibiotics to treat possible cellulitis.
Patient woke up in morning complaining of "leg pain", and fever (101 F). Pt presented in office with localized mild edema approximately 4 inches around injection site. Minimal redness at site. Temp was normal at office. Mom had given ibuprofen at home. Mom reported pt had rash on trunk and limbs this morning.
Constipation. Normally I am very regular -- bowel movement at approximately the same time everyday. After receiving this vaccine on Monday, I have not had a bowel movement and it is already Thursday (3 days since vaccine).
I had no reaction after the first dose. However about 24 hours after the second dose my blood glucose levels remained elevated for about 48 hours, regardless of how much insulin I administered both via my pump (increasing basal and bolus rates) and MDI. The levels remained in the mid to upper 200s. With an average A1c in the high 5s and low 6s, this was unusual for me.
evening of 16JUL93 very tired slept 10+ hrs; still very tired 19JUL; c/o stiff/sore neck & arms on lt; chills, sweats;
pt recv vax & a couple of weeks p/vax a titer was drawn;the results indicated that pt did not seroconvert;no further details were provided;
This spontaneous report was received from a 43 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Approximately on 06-FEB-2019 (reported as "two weeks ago"), the patient was vaccinated with PROQUAD subcutaneously (dose, vaccination site, lot# and expiration date were not provided), for prophylaxis due to the measles outbreak in her area and her being worried she might get sick. No adverse effects reported.
HYPOXIA 10/30/2022,  1/2/2023,  11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Recent hospitalization 6/28- 6/30 for constipation likely 2/2 stercoral colitis, found to be Covid + on swab x2 since asymptomatic and was fully vaccinated no treatment was given.   Presented to Hospital 7/4 with altered mental status and hypoxia to 80s, found to have symptomatic COVID-19 pneumonia. CTH negative. OSH course also significant for E faecium bacteremia, Liver doppler 7/5/21 w/ complex 7 cm cystic/necrotic mass within the right hepatic lobe transplant. Patient started remdesivir at Hospital - 5 day course completed at Hospital. Patient received 10 days of dexamethasone 6 mg daily. Patient actively being treated for VRE bacteremia and infected biloma. Patient intubated on 7/17. Stroke code called on patient 7/24 Noted to have L dilated, non-reactive pupil. Neuro & NICU on board, s/p 23% x 2 and mannitol 2 bags with improvement in R eye & no improvement in L pupil.  Unable to obtain CTH to evaluate for ischemic stroke vs ICH vs other etiology, since pt cannot tolerate moving to CT.  Eliquis held.  iNO at 30 with goal O2 sat >88%.  L femoral shiley clotted, s/p alteplase administered to shiley with clot removed. CVVH off.  Prognosis poor overall. Patient is currently in the SICU.
Began crying & had fever of 104.7 taken to ER; Took med in ER & temp came down; Given suppositories for nausea;
This is a spontaneous case, initially received on 03-Jan-2018, was reported by other health professional (consumer) and concerns a 37-year-old adult female pregnant patient. The patient had no medical history. The patient had no previous pregnancy. The patient had no relevant maternal or paternal medical history pertinent to pregnancy. The patient did not receive any contraceptive methods or concomitant medications. The fetus's father received an unspecified medication prior to conception. The patient's LMP (last menstrual period) was reported as an unspecified date in Jun-2017. The patient did not receive any medications prior or during the pregnancy. It was reported that, there was no evidence of defect or adverse finding from a prenatal test. On 11-Nov-2017 (during second trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). It was reported that, the fetus had no adverse event. The EDD (estimated date of delivery) was reported as 27-Mar-2018. The reporter assessed the case as non-serious.
I had a runny nose, sneezing, cough, general malaise, it felt like a cold coming on. I used a home COVID-19 test that came back positive. I called my doctor's office to have a telehealth visit to discuss my symptoms. I was prescribed the Paxlovid, that I started taking that day. On day four I did notice a rash that I was developing but I continued the medication. I never felt like I was fully recovered from having COVID-19, I took another home test on April 10 that came back positive. I waited until April 16, 2023, to test again this time it was negative. I do not feel one hundred percent back to myself yet.
Throat tightness, closing. Rash. Evaluated by EMS-Refusal to transport.
Developed acute onset chest pain and shortness of breath on 5/11 with nausea/vomiting x1. He didn't have any prior systemic symptoms, URI symptoms, rashes, and was in his usual state of health. Other ROS was negaitve other than longstanding right shoulder pain without weakness.
Patient could not ambulate for entire 2 days after vaccination and had to be lying down on the floor unable to get up at all, admitted to Medical center  with AKI and rhabdomyolysis
Myalgia, Arthralgia, NauseaVomiting, LETHARGY Narrative:
This spontaneous report was received from a physician and healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 25-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, lot # J010668, expiration date 29-APR-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 49 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient started Paxlovid from 12Dec2022 to 17Dec2022.
Approximately 12 hours after the second moderna covid dose, I experienced high fever (104.3) muscle aches, sever headache, and shaking. At approximately 23 hours after second dose I began having Premature Ventricle Contractions( PVCs).  I have an at-home ecg (kardia) that I use to monitor heart health. I began taking readings as the arrhythmia felt unlike any normal heart rhythm experienced in the past. The PVCs continued on a regular occurrence so I scheduled to see a cardiologist at the time the doctor didn?t seem alarmed and prescribed me metaprolol twice daily with no testing.  After the cardiologist visit I learned of potential heart effects from the Moderna shot. To date, it has been 6 months since the second dose and the PVCs have continued  on a constant basis without  relief.  I have hundreds of ecg readings from my Kardia device leading up to the second dose showing no continuous arrhythmia. Following the second dose, it is daily readings indicating. PVCs and has brought great angst and uncertainty to my well-being.
I received the Pfizer Bivalent booster for COVID-19 on 10/21/2022. On the afternoon of 10/26/2022, I began to have stomach cramping and loose stools. I continued to have loose stools and cramping for several days. The loose stools then turned into diarrhea by 10/30/2022, plus I still had the cramping. The diarrhea and cramping got progressively worse, and I went to an urgent care clinic on 11/3/2022. I was prescribed LOMOTIL and ZOFRAN. They also instructed me to give them a stool sample on 11/4/2022. I gave them a stool sample, which was tested for C difficile, giardia, parasites, and ova. The results were negative for all of those. I saw a gastroenterologist on 11/14/2022. He did a repeat of the C difficile test, which again yielded a negative result. He decided to still prescribe me ciprofloxacin in case the cause of the symptoms was bacterial, anyway. He also prescribed more LOMOTIL and ZOFRAN and told me to eat a "low-residue diet," about which he handed me some information. I have taken the medications faithfully and eaten the low-residue diet, but I have still not had any improvement in my symptoms. The cramps are now even worse than they were when they started. The LOMOTIL helps keep the diarrhea away. However, when it wears off, the diarrhea comes back and is really bad.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included PRE NATAL FORMULA, CHLORAL HYDRATE, PROMETHAZINE HYDROCHLORIDE (PHENERGAN AND CHLORAL HYDRATE) and DOXYLAMINE SUCCINATE (UNISOM 2) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Jun-2020 and the estimated date of delivery was 18-Mar-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy.  On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The estimated date of conception was 25 Jun 2020. Glucose tolerance test and ultrasound scan was performed results unknown. Patient had previous one pregnancy on 04 Sep 2018.
Psoriasis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2021 as dose 2, single (Lot number: EW0172) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "severe pain", start date: Jan2021 (unspecified if ongoing), notes: I have been in severe pain with this disease since that time, Jan2021 /Feb2021; "Obstuctive Sleep Apnea" (unspecified if ongoing), notes: Other medical history: Obstuctive Sleep Apnea; "Anti-Body Thyroid Disease" (unspecified if ongoing), notes: Other medical history: Anti-Body Thyroid Disease. Concomitant medications included thyroid meds and a statin. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 02Apr2021, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (disability) with onset 15Nov2021, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Biopsy: (Nov2022) Unknown Results, notes: biopsy was done in Nov2022 and diagnosed as a rare form of Psoriasis; SARS-CoV-2 test: (06Jun2022) Negative, notes: Covid test type post vaccination=Nasal Swab. Clinical course was reported as follows. A patch of discolored skin developed on her right ankle area in Nov2021, as well as discolored skin on her left lower leg area. The skin developed in a red rash over a few months and burning stinging ensued. She stated she never had any skin issues ever. She was misdiagnosed for nearly a year as 'fungal' a biopsy was done in Nov2022 and diagnosed as a rare form of Psoriasis. She had been in severe pain with this disease since that time, Jan2021 /Feb2021. There are others who have reported similarly, never having this until the vaccine/boosters for COVID. Therapeutic measures taken as a result of psoriasis included ointments, steroid shots, and photo light therapy. The event psoriasis results in doctor office/clinic visit and was considered serious (disability or permanent damage).
PATIENT REPORTED NUMBNESS ON THE BACK OF ARM AND ALSO IN RING/PINKY FINGER.  HAD PATIENT WAIT FOR ABOUT 10 MINUTES MORE, CHECKED TO MAKE SURE SHE STILL HAD GOOD GRIP AND FELT WHEN I APPLIED PRESSURE TO ARM.  CHECKED IN WITH PATIENT AFTER A COUPLE OF HOURS, SHE STATED THAT "IT IS NOT WORSE, BUT HAS NOT GOTTEN BETTER" SO I ADVISED HER TO CONTACT HER MD.  WHEN SHE LEFT, SHE DID STATE " I ALWAYS HAVE WEIRD MED REACTIONS"
A LARGE REDDISH CIRCLE APPEARANCE MEASURED 70mm BY 110mm AROUND THE SITE OF ADMINISTERED VACCINE. INSTRUCTED PATIENT PARENT TO GIVE TYLENOL AND APPLY COOLING MEASURES.
The patient presents with Viral symptoms.  Started 6 days ago.  Is having low-grade fever, chills, loss of taste, loss of smell, headache, body aches, rhinorrhea, cough, dyspnea, diarrhea.  Has been taking Tylenol.  Had both of her COVID shots with Pfizer finishing in June 2021.  Husband is sick with similar symptoms..  The onset was 6  days ago.
9/27/13: raised, warm and red at site; 9/28/13: pt saw doctor prior to travel to foreign country, did not feel it was infected; cold compress and Benadryl. Advised to have next yr flu shot at doctor office.
feeling down; difficulty maintaining previous activities; "big drop" in energy; Redness at injection site; Burning in legs; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (feeling down), DECREASED ACTIVITY (difficulty maintaining previous activities), ASTHENIA ("big drop" in energy), VACCINATION SITE ERYTHEMA (Redness at injection site) and BURNING SENSATION (Burning in legs) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M204) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Bypass surgery). Concomitant products included ATENOLOL and CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (feeling down), DECREASED ACTIVITY (difficulty maintaining previous activities), ASTHENIA ("big drop" in energy), VACCINATION SITE ERYTHEMA (Redness at injection site) and BURNING SENSATION (Burning in legs). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at a dose of 1 dosage form. At the time of the report, DEPRESSED MOOD (feeling down), DECREASED ACTIVITY (difficulty maintaining previous activities), ASTHENIA ("big drop" in energy), VACCINATION SITE ERYTHEMA (Redness at injection site) and BURNING SENSATION (Burning in legs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-241696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: significant follow-up
This is a case of SECONDARY OR PROXY transmission of the Varicella Zoster virus after 15 month old got vaccination on Oct 15, 2005. 15 month old had a few vesicles on her bottom 1st week of November. Mother (myself) got Bells Palsy on Nov 11. The BP was after 2 days of SEVERE postauricular pain, and pain around Cranial nerve VII and trigeminal nerve, which continued and was accompanied by very mild rash, very few vesicles in 3 different places. Took Acyclovir from Nov 13 to Dec 4, had few vesicles Nov 24 - 30. Had fever, malaise 1st month. Have semi-permanent facial palsy with no recovery yet. No additional terms added from Medical Record rec'd 12/30/2005/sr Per 60 day follow up report- Not recovered but the Bells Palsy was caused by cytomegalovirus, not by Zoster (secondary exposure from daughter's vaccine) as expected. I had to persuade the Dr.s for both the Zoster and cytomegalovirus titiers-they thought it unlikely that the vaccine/Zoster caused it. And pretty much impossible that cytomegalovirus caused it but my cytomegalovirus IgM titer was 66-pretty conclusive.