chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a painful persistent rash located on her neck, back and torso/ herpes zoster/ painful outbreaks of shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for the prevention of shingles. On an unknown date, after receiving the vaccination, the pt suffered a painful persistent rash located on her neck, back and torso. As a result of these symptoms, she presented to a medical provider and was diagnosed with herpes zoster. Thereafter, the pt continued to suffer from painful outbreaks of the shingles. As a result, she has suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the event was not recovered. The event was considered to be related to  zoster vaccine live (ZOSTAVAX).
Information has been received from a registered nurse concerning a 4 year old male who in 1998 at 1 year old was vaccinate with varicella vaccine. In June 2001 the pt developed chicken pox. It was reported that according to the nurse, treatment was not necessary. Unspecified medical attention was sought. Additional info has been requested.
About a week and half to two weeks after getting the shot, I had a short (3-4 days) but severe spike in the symptoms of my ongoing mental health issues. Symptoms of the spike included wild mood swings, VERY strong emotional reactions to otherwise manageable situations, and very erratic, even reckless, behavior.   I can't remember ever having symptoms this severe before. No other source for the symptoms could be identified.
As soon as the injection had been completed, the pt immediately put her head in her hands and stated she was not okay and she felt nauseous. Pt vomited x2. Pt stated she was sweaty but denied feeling as if she was going to have a syncopal event. After 20 minutes of sitting pt felt well enough to stand and walk around. Pt left after 30 minutes without anymore complaints.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit). In May 2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis), MASS (lumps on her face (one on the forehead and another one on the nose which extends down to her lower cheek)/lumps on her left lower arm (on the elbow and wrist)) and RASH ERYTHEMATOUS (lumpy red rash on her left armpit) had not resolved. Concomitant medications were not provided. Patient consulted a dermatologist who initially thought it was cellulitis for which a blood test and puncture biopsy was done and also given a unspecified medicine but it did not resolve. She was then referred to neurologist and MRI was done and awaiting results. The lumps were still present at the time of the call. Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: follow up received on 02-Jul-21 with no new information. Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Redness about 22-24cm, swelling and pain left arm at site of DTAP, noted 2 days post vax. Parents call 3/20/2000 and stated it was still red, swollen and sore. Advised to give Motrin and warm soaks. Pt was seen on 3/27/2000 for bilateral ear infections and left arm is still red and painful. On 3/30/2000, mom said arm still red but pain is improving. Pt had Tetramune at 2 months, 4 months, 6 months and 15 months of age.
passed out; fainted; This spontaneous report was received from a physician assistant (PA) via a company employee referring to a female child patient of unknown detailed age (reported as 11 (units not reported)). Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown.  On 17-SEP-2020 (reported as 3 weeks ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were not reported) for prophylaxis.  The patient was not be made to wait the 15 minutes after received the vaccine, and she stood up, passed out and fainted. The patient did not seek medical attention and no treatment was given for the events. The patient had recovered from the events. The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the events of passed out and fainted were determined to be medically significant.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX (batch number A5X5B, expiry date 7th March 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, fever, chills and swelling. On an unknown date, the outcome of the injection site pain, fever, chills and swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, fever, chills and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 66 or 67 years. The caller reported adverse event for patient. The reporter stated that the patient had pain, swelling, fever and chills for about 2 days after injection. The permission to be contacted healthcare professional was given by caller.
c/o local inflammation lt arm tenderness; also had low grade fever & general body aches x 3 days p/vax administration; still has same lt arm inflammation tender & warm to touch;
nausea, started within 15minutes of vaccination, waxing and waning, still present, responsive to ondansetron abdominal pain, started within 1 hour of vaccination, waxing and waning, worse 24 hrs after vax, still present, no improvement with medication (antacids, simethicone, ondansetron) or bland diet diarrhea, started within 36hrs after vaccination, still present, no tx  fever, started within 12hrs of vaccination, poorly responsive to tylenol, improved but not resolved within 36hrs headache (severe), started within 1hr of vaccination, worse 8 hours after vaccination, improved after 36hrs, only after ibuprofen, no improvement with tylenol moderate muscle pain (generalized), started within 8hrs of vaccination, mostly resolved within 24hrs, tylenol and ibuprofen lymphadenopathy - multicentric (mostly cervical and axillary), started approx 36hrs after vax, still present fatigue - started within 8hrs of vaccination, improved within 36hrs of vaccination, tx - rest, tylenol, ibuprofen (1dose)
little bit of discomfort in her arm; cold; slight headache; tired; little nausea for 20 minutes; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (little bit of discomfort in her arm), NASOPHARYNGITIS (cold), HEADACHE (slight headache), FATIGUE (tired) and NAUSEA (little nausea for 20 minutes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included SULFASALAZINE, VITAMIN D3 and MAGNESIUM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced LIMB DISCOMFORT (little bit of discomfort in her arm), NASOPHARYNGITIS (cold), HEADACHE (slight headache), FATIGUE (tired) and NAUSEA (little nausea for 20 minutes). On 26-Jan-2021, NAUSEA (little nausea for 20 minutes) had resolved. On 28-Jan-2021, LIMB DISCOMFORT (little bit of discomfort in her arm) had resolved. At the time of the report, NASOPHARYNGITIS (cold), HEADACHE (slight headache) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-049610 (Patient Link).
pt recvd 1st,2nd & 3rd dose of hep B on 7dec92,27jan93,29jun93,respectively; Anti-HBS neg 28jan94;anoth vax of hep adm 25mar94;tests revealed anti-HBS neg;subsequently pt died of a myobacterium ovium infectious disease;
Patient seen slumped over by staff,  Had syncopal episode  Appeared diaphoretic, and fatigued Blood pressure and heart rate low  Patient had emesis Ambulance called for medical transport to hospital
Gerd started 3 days after first Moderna covid vaccine.  Took Prilosec for 14 days and it fully resolved.  Gerd came back with a vengeance the day after the 2nd Moderna covid vaccine.
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) outcome was unknown.        The action taken with 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.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) outcome was unknown.        The action taken with 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.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Head ache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache) and MYALGIA (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 HEADACHE (Head ache) and MYALGIA (Body ache). At the time of the report, HEADACHE (Head ache) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter.    No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
This case was received from a physician on 18 June 2009. A 14-year-old female patient, with no reported medical history, received the following vaccinations on 26 March 2009: a first intramuscular right deltoid injection of MENACTRA (lot number U2580AA); a first intramuscular right deltoid injection of BOOSTRIX (GSK, lot number AC52B018BA); and an intramuscular left deltoid injection of GARDASIL (Merck, lot number 1312X). She was recovering from a cold at the time of vaccination. One month post-vaccination, the patient developed a rash on the left cheek. A few months later, she was diagnosed with Lupus. No additional information was reported. Additional documents held by sender: None.
pt recvd vax & exp chemical hepatitis, jaundice, nausea & vomiting;
Patient with erythema, tenderness and a palpable nodule in the site of vaccination for 1 week. Has not changed in size. He did not have any other symptoms after vaccination
feeling hot and cold and hot and cold; cough; sneeze; She had a little fever/behind her leg was 100.4F; a tiny hemorrhage in her eye; gigantic headache/very bad headache; wasn't feeling good; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took diclofenac sodium. On an unspecified date in Feb2021, a couple of days before receiving her first vaccine dose, the patient took a dose of diclofenac (2 tablets, 15 mg each) and wanted to know if the vaccine will still work. Moreover she was going to receive Botox injections in between her two vaccine doses, her neurologist says that it's fine, but she wanted to have more information, if available. She also stated that she is due for her Botox injection but might postpone the shot so that it will not interfere with her COVID-19 vaccine. On an unspecified date she experienced a tiny hemorrhage in her eye that may have resulted from a cough or a sneeze; she had a rough night feeling hot and cold and hot and cold and she had a little fever stating that her infrared thermometer said that behind her leg temperature was 100.4 F (but her arm was different, along with her forehead). On 11Feb2021 the patient experienced gigantic headache/very bad headache, but she does not think the headache was caused by the vaccine, and wasn't feeling good. She wanted to know if she can take diclofenac for her headache. The patient underwent lab tests and procedures which included body temperature: 100.4 Fahrenheit on an unspecified date. At the time of the report the events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
got a chest tightness/chest constriction/cough-y feelings has gotten slightly worse; got a chest tightness/chest constriction/cough-y feelings has gotten slightly worse; extremely fatigue; This is a spontaneous report from a contactable consumer (patient) reported herself.   A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: ER8736) via an unspecified route of administration in left arm on 01May2021 (at the age of 54-years-old) as dose 2, single for COVID-19 immunisation at pharmacy. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing and experienced rash (get a rash from some penicillin drugs). Concomitant medications included estradiol (ESTROGEN), estradiol and progesterone; all were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: ER8737) via an unspecified route of administration in left arm on 03Apr2021 at 15:30 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation and experienced she got a chest tightness, feeling like she could cough, but not productive within about 25 hours after her first dose and extremely fatigue. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced got a chest tightness or chest constriction or cough-y feelings has gotten slightly worse, although not considerably so and also extremely fatigue. The patient visited physician office due to events. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
feels kind of funky, like he may have a bronchial infection; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (feels kind of funky, like he may have a bronchial infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-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 BRONCHITIS (feels kind of funky, like he may have a bronchial infection). At the time of the report, BRONCHITIS (feels kind of funky, like he may have a bronchial infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
06/22/2021- bumps on the back of my head. They spread rapidly to my jaw line, shoulder, and neck all on the right side. 06/28/2021- I went into an urgent care, walk-in clinic- they told me it was poison ivy and they put me on Prednisone. It was not getting better it was getting worse. I went back to the clinic on 06/30/2021. They said the same thing, poison ivy, and they increased the Prednisone. Still was not getting better, so I called. And she did a zoom call and diagnosed me as shingles. and put me on a shingles  medicine. I started feeling better about 2 weeks later. The lesions were gone within  6 to 8 weeks later. It took a long time. After that I got both Shingles vaccinations- 1st dose 08/05/2021 and 2nd dose was 10/06/2021.
58 y/o M, PMHx of DM, alcohol abuse, substance use, HTN, bipolar disease, who presents after he was found to be lethargic by his son. Patient endorses that his reason for being at the hospital is a cough and sore throat. Endorses dry cough for the past few days. Denies chest pain, SOB, fevers, chills. Denies sick contacts. COVID vaccinated in April and May 2021, did not receive booster. Regarding his diabetes, patient reports that he takes his insulin as prescribed (however, patient has had multiple admissions for similar presentation and medication compliance is questionable). Reports decreased appetite.
48 hrs p/vax inc muscle soreness; inc back, buttocks, legs began subsiding 24 hrs past onset;
Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021) in a 66-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 Crohn's.    No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-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 received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 11-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered Dose 1 on 18-SEP-2021, Dose 2 on 11-NOV-2021) outcome was unknown.            Patient received 3rd MODERNA COVID-19 VACCINE on 11-MAY-2022. No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2022-576009 (Patient Link).
Evening of vaccinations, patient has pain swelling at the injection site - left arm; later become red then stabilized and shortly resolving (Per med symptoms likely varicella location)
temp and upper arm soreness; temp and upper arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 23Mar2021 at 09:25 as dose 2, single (Lot number: ER8730) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6200), administration date: 27Feb2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "temp and upper arm soreness", "temp and upper arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), BODY TEMPERATURE INCREASED (non-serious), outcome "unknown" and all described as "temp and upper arm soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, body temperature increased.  Additional information: Patient reported that the side effects were minor (temp and upper arm soreness). Patient had no medicines other than Tylenol taken day 1, 2 of vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101946 same patient, different vaccine dose/event;US-PFIZER INC-202300259176 same patient, different vaccine dose/event;US-PFIZER INC-202300259180 same patient, different vaccine dose/event;US-PFIZER INC-202300259179 same patient, different vaccine dose/event;US-PFIZER INC-PV202300128433 same patient, different vaccine dose/event;US-PFIZER INC-202300259178 same patient, different vaccine dose/event;
15 yo m presented 1 d after HPV#3 and Hep A #1 with sx of HA, fever no nausea. No v/d. No appetite, poor sleep. Well appearing on exam. Tx: Acetaminophen as needed for pain/fever.
Pt seen 4-1-19 w/cough/wheeze.  Diagnosed w/BOM Rx Augmentin -Given Immz at 11AM. Aprox 9PM -Hot, fully body shaking/limp. Pt seen ED w/101 temp.
I had no pain in area but after two days the spot got very red, hot to the touch.  I had the chills but no fever  for one evening. The spot on my left arm was 5 inches long down the arm.  After 7 days it began to itch for two days and began to fade.  It is well now.
Itching and rash on chest, under bilateral breast, back and neck for past four days, since Friday morning 7/31/15.