chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine-strain varicella zoster virus (vVZV) meningoencephalitis; This literature marketed report has been received from the authors of a published article, titled as stated below, and refers to a 10-year-old male patient with attention-deficit hyperactivity disorder (ADHD). His medical history and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of varicella virus vaccine live (manufacturer unknown) subcutaneous injection (dose, site and route of administration, lot#, and expiration date were not reported) for prophylaxis and he completed the two-dose series.  On an unknown date, he presented to a emergency department (ED) with headache and rash. Symptoms started five days prior to presentation with left upper extremity (LUE) pain, followed by the appearance of multiple blisters on the LUE. His doctor diagnosed him with shingles and recommended supportive care. The rash worsened and he developed severe frontal headache. In the ED, his temperature was 38.1 degree Celsius (C). All other vitals were normal. Exam revealed LUE coalescing vesicles on an erythematous base, particularly in the C7 dermatome. Additional solitary lesions were noted on the left thigh and bilateral scapulae. While in the ED, he became confused, mistaking providers for school classmates. Head computed tomography (CT) was unremarkable. Cerebral spinal fluid (CSF) revealed lymphocytosis (red blood cells 4 (units not reported), white blood cells 26 (units not reported), 82% lymphocytes, glucose 53 (units not reported), protein 32). Ultimately, LUE vesicles and CSF were varicella zoster virus (VZV) polymerase chain reaction (PCR) positive. Genotyping showed vaccine-strain VZV (vVZV) rather than wild-type (wtVZV). On an unknown date, he was diagnosed with vVZV meningoencephalitis. Initial immune workup was normal, including total immunoglobulin G (IgG) and subclasses, varicella IgG, human immunodeficiency virus (HIV), and pneumococcal titers. The patient completed a 10-day course of intravenous acyclovir and a 14-day course of oral acyclovir. At 4-month follow-up, he was asymptomatic. Outcome of the event was unknown.  The event of vaccine-strain VZV meningoencephalitis was considered to be related to varicella virus vaccine live (manufacturer unknown).  Upon internal review, the event of vaccine-strain VZV meningoencephalitis was considered to be medically significant.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience
After the second shot, she also had a mild reaction; Low grade Fever 99.9F after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After the second shot, she also had a mild reaction) and PYREXIA (Low grade Fever 99.9F after 2nd shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Cataract operation (Summer 2021).Concurrent medical conditions included Diabetes and Hypothyroidism.Concomitant products included METFORMIN HYDROCHLORIDE for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, INSULIN GLARGINE (LANTUS XR) for an unknown indication.On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (After the second shot, she also had a mild reaction) and PYREXIA (Low grade Fever 99.9F after 2nd shot). On 25-Feb-2021, VACCINATION COMPLICATION (After the second shot, she also had a mild reaction) and PYREXIA (Low grade Fever 99.9F after 2nd shot) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No treatment medications were reported. This case was linked to MOD-2021-404053, MOD-2021-403866 (Patient Link).
No additional AE reported; one dose of PEDVAXHIB was administered during an ongoing temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unkonwn age and gender.  The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 23-JAN-2023, the patient was vaccinated with one dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, at dose of 0.5 milliliter (lot number U024091 was verified to be a valid number, expiration date reported and established as 29-OCT-2023) administered for prophylaxis (strength, route of administration and anatomical location of vaccination were not provided); that underwent a temperature excursion of 34.8 Fahrenheit degrees for 144 hours, which started on 12-JAN-2023 (product storage error). There was a previous temperature excursion of 54.14 Fahrenheit degrees for 2 hours and 12 minutes. No additional adverse events were reported.
He can't get his oxygen up above a certain level; It could be some swelling; His back and arms are covered with hives; This is a spontaneous report from a non-contactable consumer (wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported. The patient received yesterday (05Jan2021) and during the night he has developed hives. The concern was if the patient should he get the next shot. The wife doesn't consider what's happened to the husband was a severe reaction although his back and arms are covered with hives. The wife doesn't think that they will go to the hospital or anything. The patient can't get his oxygen up above a certain level and he can't get it to where it normally comes when it does on oxygen. But the wife assumes that's going to improve during the day. It was probably from the hives it could be some swelling and guessed it was going to change. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
swollen arm, swelling traveling down arm; severely itching; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swollen arm, swelling traveling down arm) and PRURITUS (severely itching) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm, swelling traveling down arm) and PRURITUS (severely itching). At the time of the report, PERIPHERAL SWELLING (swollen arm, swelling traveling down arm) and PRURITUS (severely itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Extreme sweeling and raised area 3" around, Hot and Red, Next day extreme Itching.
This is one case out of a cumulative total of 245 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 December 2014. These 235 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 16 December 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 27 month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received four doses of PENTACEL; dose one on 02 October 2012 (lot number C4230AA), dose two on 06 December 2012 (lot number C4355AA), dose three on 31 January 2013 (lot number C4358AA) and dose four on 27 November 2013 (lot number C4487AA) (routes and sites of administration for all doses not reported). Approximately 11 months after the last dose, on 19 November 2014, the subject developed cough. Eleven days later, on 30 November 2014, the subject developed a paroxysmal cough. The subject also experienced post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included a positive PCR on 02 December 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 December 2014 for three days. The subject was not hospitalized. At the time of final contact on 04 December 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Had vaccination, had pain, next morning had 102 degree temp and rash, rash got worse pt went to physician got steroid shot Cephalexin and Ibuprofen.
After receiving the vaccine, I felt achy for a day. Over a couple of years, I have had symptoms that indicated a problem with my thyroid. I have had unexplained weight loss, tremors, weak nails that split easily, digestive issues and a lot of stress. On 10/02/2022 I started having heart palpitations. I had to go to the emergency room and was hospitalized for two days because I was in a "thyroid storm". I was diagnosed with Grave's Disease.
Rapid onset stomach cancer with metastases to peritoneal cavity, lung, lymph, pancreas and colon resulting in death.  Presented with pancreatitis.  Stomach ache in early November 2022 led to concerning bloodwork, which led to hospitalization, which led to many diagnostic tests, which eventually showed rare and aggressive stomach cancer with many metastases.  Immunotherapy was attempted but ineffective, possibly exacerbated the issue.  This was the first of three Pfizer covid shots over the course of nine months.  Illness onset occurred approximately 13 months after the last shot.
Patient fainted approximately five minutes after HPV vaccine administration, vitals taken, patient given O2 via NC, alert & aware. No permanent injury. Cleared by MD.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 12 years old, female patient with no pertinent medical history reported. On 15-OCT-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 19-FEB-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Full body rash, started within 2 or 3 hours after receiving the vaccine. Slight inflammation around the body. Some itchy areas around the body.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 18-DEC-2015, the patient was vaccinated with am improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
fever, chills, naseau for first 2 days then on day 4 swollen lymph node in left clavical area.  the lymph node is painful and hasn't gone away .  It got worse after second dose received on 4/13/21, batch #019B21A.  After second dose, fever of 101, chills, aches, naseau.  Lymph node got more swollen and painful.  Received first does on 3/11 and on 4/25, I still have swollen and painful lymph node.
This spontaneous report as received from a registered nurse refers to a patient who was vaccinated with a expired dose of GARDASIL (lot # 666162/0565Z; Exp Date 15-SEP-2012) on 17-SEP-2012. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Kinrix extra dose/Patient already had 5 Dtap, last one Kinrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (1st dose received on 1st December 2021) and Dtap vaccine (received 4 doses on an unknown date).   On 23rd August 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The nurse reported that patient received a dose ofKinrix as extra dose by error. Patient already had 5 Dtap vaccines where the last one was a Kinrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received by error a Kinrix extra dose which led to extra dose administered.
Patient experienced rash all over her body.  The day after the shot, she said she had cold chills and aching.  The patient was instructed by the pharmacist on duty to take benadryl and to contact her primary care physician.
Ruptured ovarian cyst one month after vaccine/Second ovarian cyst one month after the first ruptured cyst; Prolonged menstruation starting 2 days after vaccine.; Second prolonged menstrual cycle shortly after ruptured cyst; This is a spontaneous report from a contactable consumer (patient). A 17-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, in left arm on 19Apr2021 at 13:30 pm (at the age of 17-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Known allergies reported as to dairy products, Elidel. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, in left arm on 29Mar2021 at 13:30pm (at the age of 17-year-old) as dose 1, single for covid-19 immunisation and experienced no reaction. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 17May2021 at 07:00 am, the patient experienced prolonged menstruation started 2 days after vaccine. Ruptured ovarian cyst one month after vaccine. Second prolonged menstrual cycle shortly after ruptured cyst. Second ovarian cyst one month after the first ruptured cyst. She had no prior history of prolonged/irregular menstrual cycles or ovarian cysts. The patient did not receive any treatment for the event. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of all events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
headache fever tiredeness tiredness nausea body pain arm pain rash in my cheeks
Parents note pt became "unresponsive" later in the day after the vaccine, and that her "eyes rolled back."  Parents could not get her to look at them. She would not feed well. They became worried and called our office at approx. 10:30 pm. Our triage nurse documented the patient being more sleepy than usual and difficult to feed. She urged parents to wake pt for feeds and to call back if pt would not take the next feed. Parents state by 2am patient was more awake and fed better. She gradually returned to baseline by the next morning. Parents state her decreased arousal lasted just under 24h.
tongue tingliNg, chest tightness, chills, HR(118) Tx: BenadRyl, D/c homE Allergy Review Recommended Cleared to received 2ND Dose c 60 miNutEs of monitoriNg - Received 1/14/21
Flu vaccine injected on 11/11/06. Redness at site noted 20-24 hours after injection. Applied warm compress. Increased in size over next 24 hours - scheduled appt with Pediatrician. 10 cm x 8.5 cm redness, warm, positive induration. Rx Duricef. Also seeing allergist.
Patient was fine before and right after administration of immunization. After 5 min I went to check on him in waiting area and he seemed as though he was asleep. I attemted to wake him up and he woke up and said he was dizzy and immediately lost conciousness again. I called an ambulance and they contiued treatment.
This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of URTICARIA (Severe urticaria), DYSPNOEA (Shortness of breath) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after vaccination) in a female patient of an unknown age 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) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced URTICARIA (Severe urticaria), DYSPNOEA (Shortness of breath) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after vaccination). At the time of the report, URTICARIA (Severe urticaria), DYSPNOEA (Shortness of breath) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after vaccination) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medication information were not provided. Patient was 14 weeks and 4 days pregnant and received Moderna COVID-19 vaccine in summer.
pt recvd vax 10NOV95 & devel puffiness of face & hands red patches, itching;poss chicken pox;hives discoloration & edema of feet, swollen joints, cyanotic toes;dx erythema multiforme 2ndary to allerg rxn;also feet painful to stand or walk;
Rash bump at site of injection. Appeared 7 days after receiving the vaccine. Warm/hard to the touch. Itches. Increased in size from day 7-8
Extreme drowsiness/ exhaustion (this started around 7pm on the day of the vaccination and lasted about 48 + hrs afterwards) upper back pain (in the 'lats' area) to the point of it being difficult to breathe (this lasted only about 30-60 min about 24 hrs after vaccination) chills (this started 12hrs after vaccination and lasted until about 36+ hrs after vaccination) fever (this started about 24 hrs after vaccination and last until about 36 hrs after vaccination; peaked at 100.3F) general body aching nausea (this started 12hrs after vaccination and lasted until about 36+ hrs after vaccination) arm pain at site of injection (this started about 4 hrs after vaccination and lasted for about 5 days; the pain started at the site of vaccination but seems to move to my underarm area after day 3)
ARM SORE AND PAINFUL TO LIFT ON FIRST DAY AFTER VACCINATION. THEN BETTER. ON 11/04/21 CLIENT WOKE UP IN MIDDLE OF THE NIGHT TO BURNING SENSATION AT VACCINE SITE AND ARM. LOOKED AT ARM - ARM WAS RED, INFLAMED, HOT TO TOUCH, SLIGHTLY SWOLLEN AND FELT HARD AT INJECTION SITE. 12 HOURS LATER STILL WARM TO TOUCH, SLIGHTLY LESS RED AND LESS BURNING SENSATION. HAS IMPROVED
Erythematous patch over deltoid oval measuring about 10 by 6 cm; lasted two days, followed by mild  itching in area for another two days.  Painful red spots on multiple toes lasting about 5-7 days.
Mom reports redness, itching, and swelling at site 24 hours after vaccine. Upon presenting to the Health Department, nurse observed left arm was red and slightly swollen. Capillary refill in less than 1 second. Peripheral pulse left wrist intact.
1 week later had an itchy rash at site of vac, had some welts on the arm injection site. painful to touch, lasted 3-4 days, then turned into a yellow bruise, lasted 3 days. that was it
BROUGHT TO OUR ATTENTION ON 10/31/17. STATES LEFT ARM IS STILL SORE, AT FIRST COULDN'T LIFT IT, HAD PAIN RIGHT AWAY AT UNDERSIDE OF ARM AND SHOULDER.
On that Wednesday afternoon I developed cough and runny nose. I took Mucinex and Phenylephrine. On Thursday I felt all the symptoms. I had super fatigue, coughing, runny nose, muscle aches and headache. I had no fever. I took an at home COVID-19 test on Thursday. I continued the medication and called to arrange a PCR test on Friday the 4th and it was also positive. The doctors prescribed Paxlovid which I completed yesterday. They are improving. I still have a mild cough and mild confusion. I am having slow and continuous improvement. Prior COVID infection resulted in pneumonia so that was the rational for using Paxlovid. I have recovered around 98% good. I still have infrequent cough and confusion.
normal side effects; sore arm; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (normal side effects), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and MYALGIA (body aches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0276) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) and RIZATRIPTAN BENZOATE (MAXALT) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (normal side effects), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and MYALGIA (body aches). At the time of the report, VACCINATION COMPLICATION (normal side effects), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.