chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness , warmth and some slight swelling at the injections site, rash on face, itchy skin. No fever and child was active at school and had an appetite. Dr. contacted regarding this matter and per Dr. ok for client  to take some ibuprofen or  Benadryl and ice the area of swelling.  Parents to monitor child and if symptoms persist or get worse then they are to follow up with PCP.  Parents verbalized understanding and agreement.   Nurse to call parents tomorrow morning and follow up.
bilat wrist pain, fatigue, malaise, anorexia 3 days p/vax;ppt took ASA on own w/improvement in sx;sx all resolved over a 1wk period, no fever, no rash;formaldehyde is preservative;maybe allergic to this;
Acute onset of weakness, tachycardia, shortness of breath, numbness of peripheral extremities, followed by loss of consciousness. Assessed in the Emergency Department, believed to be a possible generalized seizure.
As per mom child had skin lesions on face, hands, feet, chest and abdomen since 9/17/06. Also she stated that child had Hep B and PPD done at the clinic on 9/14/06. Child was seen in the clinic for follow up on 9/18/06, was given Diphen 1/2 tsp TID, and calamine lotion. Advised to return to clinic on 9/22/06.
In December, 1997, the pt developed varicella  and sought unspecified medical attention. No further information is available.
Information has been received from a 70 year old male physician with no allergies and a history of chickenpox as a child and no recent exposure to chickenpox or herpes zoster and no other medical history who on 10-AUG-2006 was vaccinated in the right upper arm with a 0.5 ml dose of ZOSTAVAX (lot #652966/0623F). There was no concomitant medication. On 10-AUG-2006 and 11-AUG-2006, the patient had erythema at the injection site. On 03-OCT-2006, the patient developed shingles after vaccination. He had four lesions on the left lower anterior abdomen. Three of the lesions were clustered and the one lesion was outward. He described the symptoms as "shingles, unilateral, erythematous papules, and a surrounding pallor-like a halo." He mentioned that he was not experiencing any pain, but there was itchiness involved. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information was received from the patient who reported that on 05-OCT-2006 he collected and would be submitting lesion (papule) specimens. He had two slides and a cotton swab. He noted that he developed "four itchy papular lesions, three in a cluster and one by itself on the left side - T-11 dermatone." He did not have any pain currently, but would evaluate the pain initially at a three out of a scale of 10. He was very concerned that the vaccination was causing a reactivation of natural VZV disease to present now as herpes zoster or that it was actually causing the herpes zoster. Additional information was received from the patient who reported that the date of onset of the herpes zoster was 03-OCT-2006. The area of involvement included the right lower anterior abdomen at T-11. There were found lesions, three in a cluster and out outlier. His body temperature was noted to be normal. He rated his pain as 3 to 4 on a scale of 1 to 10, with 10 being the most. He had no other systemic symptoms and subsequently recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the vaccine VZV strain. Results indicated that the specimen was inadequate, negative for B-globin, no strain ID. No further information is expected.
Pt had trouble focusing eyes upon first waking up 09/6 thru 09/08
Regression in autistic symptomology and PANDAS diagnosis.  Had recently begun to show some affection toward parents through hugs and then abruptly quit after the vaccinations, ritualistic/repetitive behavior has begun to interfere with daily functioning, aggressive behaviors have resurfaced, can not make easy transitions in routine now.  His school sent home a note asking what had happened to him recently because they noted he had regressed by three years in his behavior.  They have been calling behavioral services into the classroom again for him sometimes up to twice a day.  At home, I noticed a couple of episodes where his seizure activity was stronger.  These were problems he had in the past and was finally overcoming in the past few months.  Lastly, his digestion is somewhat off and he is having some toileting issues.  We have begun antibiotic treatment and prescription strength probiotics.  We will be consulting with a doctor to determine how we can boost his immune system to repair this damage.
Within 5 minutes of vaccine patient complained of chest tightness and headache.  Evaluated by EMS - elevated blood pressure and heart rate.  Patient transported by EMS to Sentara Albemarle Medical Center ER.  Patient evaluated for several hours in the ER then sent home.
received a dose of ACTHIB in which the diluent is expired, with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received a dose of HIB (PRP/T) vaccine [ACT-HIB] in which the diluent is expired, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-May-2023, the patient received 0.25 mL to 2 mL dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (Lot number = UJ677AA (carton) UJ677AA (product) U7261AA (diluent) (Expiry Date for all the Lots = JUNE 5, 2023 (product) APRIL 7, 2023 (carton and diluent) Frequency = Once, Dose = 0.1 mL for TB skin test = 0.5ml, (Strength = standard) via intramuscular route in the thigh not otherwise specified (nos) for Immunization or TB skin test.   On 01-May-2023, the patient received a dose of HIB (PRP/T) vaccine in which the diluent is expired, with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
He had the vaccine on 05/12/2021. It started at 1 am, he had a pretty normal night, he went to bed and woke up vomiting, that continued through the night, the vomiting continued, he had a head ache, he called me and told me that his stomach really hurt, I told him to check his blood sugar, he also had  hot flashes, chills, and body aches, but mainly he had vomiting, then the next day 5/14/2021 he was getting more sleepy and less responsive, his friends tried to give him water and different things, his blood sugar went up, his friends took him that afternoon to the ER because he started not responding to me, his friends would tell me he was sleeping, so they took him to the ER, they found that he was very dehydrated, they were giving him fluids and did blood work, he was very unresponsive when he arrived, he could not answer his questions, he had a friend that was there that told them he had the vaccine, the blood work said he had a very high white blood cell count they were worried he had sepsis, they found his kidneys were not working ok, because his levels were very crazy and chest pain and severe stomach pain, and he had pancreatitis, they ruled out a heart attack, he then was admitted because he was in DKA, diabetic keto acidosis, like a result of his type 1 diabetes that got flared up because of all his reactions. They admitted him to the ICU and he was there until 05/16/2021 and basically they were just giving him fluids, potassium and other things to help his body calm down and stabilize his blood sugar. He was released and he still continues that his heart hurts but doctors say that these things resolve after a while.
Erectile dysfunction; This is a spontaneous report from a contactable consumer (parent). This consumer reported for two patients. This is the second of the two reports.   A 19-year-old male patient received bnt162b2 (BNT162B2, lot unknown), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced erectile dysfunction on 26Apr2021 08:00 (2-3 days after receiving his second Pfizer shot). This caused extreme mental distress for his family and it has been 4 months and it was not resolved. Had a doctor or other healthcare professional office/clinic visit and no treatment for event.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101299769 Same reporter/drug/event, different patient
Information has been received from a 68 year old female consumer with "hypersensitivity to many products" and a history of fibromyalgia in December 2006, was vaccinated SC with a dose of Zostavax. Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant therapy included Nexium and "thyroid medications". In January 2007, the patient experienced radiating pain from spinal column and headache. At the time of report the patient was not recovered from symptoms. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been requested.
46 y o female who received a Varicella # 1 on 3/07 and Varicella # 2 on 3/3/08. 11 days after vaccination she noted a burning and tingling sensation along the breasts, underarms, and across the back for 3 days. The sensation progressed to include the back of her head and then her eyelid a few days later.  She denies a visible rash or itch just the sensation. She was referred to her primary care physician who did not treat the symptoms.  The reason this patient requested vaccination in because there had been multiple cases of chickenpox in the daughter's pre-school. However the daughter has been immunized and did not have any side effects or rash.    Patient had not had any side effects from varicella #1 in 3/2007.
Muscle Pain; This case was reported by a other health professional via call center representative and described the occurrence of myalgia upper extremities in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th May 2019, less than a day after receiving Shingrix, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingrix.  Additional details were provided as follows: The pharmacist intern reported that the patient received Shingrix in left arm and experienced muscle pain in arm described as achy that started day of vaccination and has gotten worse on pain scale. The intern inquiries if it was common for pain to last beyond 30 days. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Night of vaccination: sweats, fever, headache, stomach ache, injection site pain  Day after vaccination: sweats, fever, headache, injection site pain swelling and tenderness, nausea, diarrhea, muscle pain, chills, fatigue
This spontaneous report was received from a nurse referring to an approximately 13 year old male patient. The patient's concurrent conditions, medical history, concomitant therapies, drug history, and allergies were not reported. On an unknown date in October 2018, the patient was inadvertently vaccinated with PROQUAD (dose, frequency, route of administration, expiration date, and lot number were not reported) for prophylaxis. No adverse effect was reported.
Systemic: Abdominal Pain-Mild, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Second dose in series given at 14 days post first dose. First dose given on 12/2/21
Over 10 years of very few outbreaks of HSV2, and now I'm having consecutive back to back outbreaks, and everything that comes with that including chronic fatigue. I was diligent about my diet and health to manage this, and now it won't seem to stop after 2+ months. I know the medical community doesn't care much about HSV, and there's news about it not giving you the zoster virus, but it seems that it can absolutely trigger outbreaks in people who already have HSV. This should've been disclosed, as having ongoing outbreaks is no way to live.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 21 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 19-FEB-2014 00:00, the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperature above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Temp 103.2 at 0240 AM, rapid respirations began approx 12 hours later. 10/19/09 Death Certificate DOD 10/5/09 - Complications / effects of Influenza Vaccine.   10/19/09 Nursing Home medical records received service dates 10/1/09 to 10/5/09. Patient develops elevated temperature. Tylenol given, blankets removed and cool cloths applied. Oxygen via face mask. Respiration rate increased, mouth breathing. Appetite poor, not eating. Lethargic. Coughing. Unable to swallow. Unresponsive to voice or painful stimuli. Unable to obtain BP or radial pulse. Labored respirations. Stopped breathing. Death.  Concurrent Illness: Toe has red flat area.
No additional AE details; they administered a dose of ROTATEQ involved in temperature excursion; Temperature (48.8F); This spontaneous report as received from a medical assistant refers to a 4-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: 1661010, expiration date: 29-MAY-2021, dose and route of administration were not provided). The vaccine was stored in temperature 48.8 degrees Fahrenheit (product storage error temperature too high) for 4 hours and 26 minutes. There was no previous temperature excursion. Digital data lodger was involved. No adverse event was reported.
Between 36 and 48 hours I started to develop welt-like hives, redness, and severe itching all over my body. Lasted over two weeks.
NextAm, slight swelling (2nd day), arm red, aching like toothache:. possible low grade temp (3rd day (same, (4th + 5th days) sl: better Good ROM: :at HD 4x6 redness, upper arm at shot site, 12/03/02 12 days after, pt says she is fine-no redness
Dad reports " He ran a fever at home that eve. and had a seizure" (Has had febrile seizures in the past). His teacher said he got the injection vs nasal flu vaccine. Kept home two days. Parent hadn't yet contacted PCP, which I encouraged. Vaccine given at School District flu clinic.
Right arm and hand pain Underarm pain Fever with severe chills/shaking Back pain and shoulder pain Nausea
12:45 Patient states he felt "dizzy and tired" immediately after the vaccine -  RN placed him in the recliner. Vitals at 12:47 150/72, HR 52, O2 99%. No other complaints. Dizziness subsided at 12:55.
Covid 19; Drug ineffective; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. Concomitant medication(s) included: VALSARTAN; LEXIPRON. The following information was reported: COVID-19 (medically significant), outcome "not recovered", described as "Covid 19"; DRUG INEFFECTIVE (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Aug2022) Positive, notes: Still testing positive. Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid from 08Aug2022 to 13Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gave Varicella vaccine R arm subq. area red, swollen. 30mm x 30 mm (Quarter size).
Starting within a week of receiving the vaccine, I got random chest pains that were quite painful (not just pressure). They would last about 3-5 seconds each time. These were happening at least 2x weekly and sometimes pounding on my chest seemed to alleviate some of the pain. I went to the doctor and they did an EKG but didn't find anything. They told me it was likely stress. I was told I should probably see a cardiologist.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2016 (reported as it was administered since 25-AUG-2016), the patient was vaccinated with improperly stored VARIVAX, lot # M010481, expiry date 01-MAR-2018 (route and site of administration were not reported). No adverse effects were reported. Administered dose of vaccine experienced temperature excursion of -14 degrees Celsius for 2.5 hour. Data logger was involved. There was no previous temperature excursion reported. This is one of two cases received from the same reporter. Additional information has been requested.
After sitting down in the observation area and I was just starting to register for vsafe my heart started to pound then I experienced a hot flushed feeling that went through my entire body and my heart started racing and felt not well. I told the nurses what happened and they said I looked pale. I laid down and started to feel better after a few minutes.
administrated an expire dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently administrated an expired dose of Kinrix, which led to expired vaccine used.  No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
12/8/2021 - 7 mo pregnant - presents to ED with c/o chest pain/cough/nausea/SOB. Covid + on admit, elevated Troponin 3.180, Chest XR norm. Vitals WNL. Admitted for observation to r/o viral myocarditis vs covid booster related myocarditis. Received booster 12/5, followed by body aches/fever.  12/9 - Troponin peaked 4.3 trended down to 1.02. Treated with Aspirin and Propanolol. Echo and EKG unremarkable. Elevated Troponin ruled likely chest pain related to viral myocarditis in the setting of Covid 19 infection. Discharged to home
On 08/16/2021- I had an appointment with my doctor, they routinely check blood pressure and hear rate. My heart rate was 41. They did an EKG found PVCs. She referred me to a cardiologist. I never had any heart PVCS. I am currently wearing a heart monitor for a week and I am supposed to wear it for another week. And then I am going to have an echocardiogram and follow up with a cardiologist. I had seen my doctor on 06/07/2021 and everything was normal, except cholesterol was high, and the cardiologist ran labs and everything was normal. Unknown whether I have recovered from the AEs because I am still being monitored.
Severe inflammation, severe itching, hardness, pain, heat to the touch, and redness to the injection site - spreading to the entire arm. This required antibiotics and specialized treatment by a dermatologist. It took almost an entire month for my son's arm to return to normal.
Nausea headache and sore arm. Arm - swelling and redness worse on 26Sep18 and improving on 27Sep18.
Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigued. Nausea the first two days, with diarrhea.
INCORRECT PRODUCT STORAGE; VACCINE WAS ADMINISTERED AFTER A TEMPERATURE EXCURSION COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 24-SEP-2022) dose was not reported, administered on 28-JUL-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 21 years old. No concomitant medications were reported. On 28-JUL-2022, the patient experienced vaccine was administered after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945957, 20220945933, 20220948245 and 20220948255.