chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 31-DEC-2015 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose and route not reported, lot # K016322 with expiration date 24-DEC-2015). No adverse effects had been reported. Additional information has been requested.
Patient had muscle ache and swelling on injection site & cannot lift her arm. Benadryl was given orally. Advise to see MD.
SM developed redness, swelling, pain, induration at injection site that went from shoulder to elbow within 24 hours.  Edema at injection site >120 mm not beyond elbow start: 01/09/2008, erythema start: 01/09/2008, swelling start: 01/09/2008, tenderness start 01/09/2008.
This spontaneous prospective pregnancy report as received from a physician, refers to an approximately 16 year old female patient. Patient's current condition included pyelonephritis for which she had been treated in the past. On 07-NOV-2014 the patient was vaccinated with GARDASIL dose 3. The patient received her first dose of GARDASIL on 22-FEB-2010 and second dose of GARDASIL on 22-AUG-2013. Other suspect therapies included hepatitis A virus vaccine (unspecified) and influenza virus vaccine (unspecified), administered on 07-NOV-2014. Concomitant medication included unspecified birth control. Patient sought medical attention on 10-NOV-2014, she was hospitalized for pyelonephritis (hospitalization, disability) and was discovered to be pregnant by ultrasound upon admission to hospital. The patient became pregnant with last menstrual period (LMP) of 09-AUG-2014 and estimated delivery date (EDD) of 16-MAY-2015. Initial exposure to GARDASIL was at 13 week(s). Physician stated that the patient was currently disabled and incapacitated because she was receiving unspecified intravenous pain medication and unspecified antibiotic as treatment. The physician agreed to be contacted for further information on the patient's hospitalization. Outcome of the events was not reported. The pregnancy outcome was outcome pending. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
pt exp numbness of arm & legs;entire body began to hurt w/lower back aches;40min post vax unable to walk by self & unable to carry a book;over 5hr to regain some feeling;13NOV98 general aches & pains in back of legs, joints, rash @ inj site
Vaccine given immediate flushing face, decreased increased legs with cold packet. 15 min pt left, no red face but complaint of lower back pain. Patient called 2 hours later with numbness, arm pain and flushing. She was sent to the ER for evaluation.
So the first thing that happened in April was I developed plantar fasciitis in my foot. I saw my PCD and an orthopedic DR and that is not set until August so I had to go to a walk in clinic. They gave me a shot of cortisone in my foot and it still hurts and is very present. Then about six weeks ago the top and front of my hair got a lot thinner, I noticed I could see my scalp. I started taking Biotin and Multivitamin and biotin shampoo/conditioner to help with the hair loss, that is the same and has not improved. No treatment yet and I did not go to the DR for my hair, just have been doing stuff that I have heard has helped.
Left arm is swollen, hot, red, and itchy.  Very tender and hurts to move.
child very irritable & would not eat; Did not sleep much; felt warm - temp not taken; This lasted x 2 days;
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-448109 (Patient Link).
The patient felt dizzy and had blurry vision about 5 minutes after the vaccine administration. I talked to the patient and mother who reported a history of anxiety that may be contributing. They asked if he could lay down in the vaccine room and upon entering he lost his balance and fell to his knees but did not get injured or lose consciousness. The patient said he was not hurt but I called 911. they arrived about 15 minutes later and evaluated the patient. The patient revealed he had ran 2 miles earlier that day and had nothing to eat or drink besides a Yoo-hoo all day. The EMTs said he was very dehydrated. The patient felt fine after another 10 minutes and the mother declined medical transport.
TDAP administered on 1/10/11 on to (L) deltoid. Pt developed (L) arm erythema, swelling and tenderness, fever to 101, joint aches, malaise.
Had a fever over 103 up to 3 days after shots then he developed a rash all over his body and rash went away after 3 days then the rash came back again. Rash looked just like the measles
No additional AEs/no PQCs.; a dose of PROQUAD was administered on 10/31/2022 after a temperature excursion.; This spontaneous report has been received from an office manager referring to a 12 month old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.     On 31-OCT-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) lot # W017571 with an expiration date on 29-NOV-2023, for prophylaxis, after a temperature excursion.  The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) up to 14°F (10.91 F), during a time frame of 1 hour. There was no prior temperature excursion and no adverse events were reported.
This is a spontaneous report from a contactable nurse through a Pfizer sales representative. An adolescent female patient received TRUMENBA (Lot number and expiration date were not reported) and influenza vaccine; both on the arm, with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had redness, heat and swelling in the upper arm. The outcome of the events, 'redness, heat and swelling in the upper arm', was not recovered.
3JUN92 9AM parent reports difficulty to arouse, t103, lethargy while awake; 4JUN92 730AM parent reports cyanotic episode heart monitor alarm triggered w/bradycardia; pulse 38; hospitalized in AM;
Initial misuse report received from a health care  professional on 03-Nov-2013.  The patient had administered only  half the does of FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
I started getting symptoms of a cold with a cough. My symptoms started progressing to a low grade fever of 100.4 and with some flu like symptoms. I did an at home COVID-19 test that was positive. I did a telehealth visit and was prescribed a cough meds and Ivermectin. My symptoms lasted for approximately 4 days. I still have an intermittent cough.
No symptoms reported; PNEUMOVAX 23 was leaking from where the needle attaches to the hub; the patient was unable to receive the full dose of PNEUMOVAX; PQC: YES; This spontaneous report was received from a registered nurse and refers to a 66-year-old patient of un unknown gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided. On 02-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S006777, expiration date 28-NOV-2020, intramuscular (dose was not provided) for prophylaxis. The pre-filled syringe of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was leaking from where the needle attached to the hub. The leaking occurred when the nurse was giving the injection. The patient was unable to received the full dose of the vaccine, because of the leaking. No symptoms were reported.   The outcome was unknown.
Initial local swelling, warmth, pain and itching - resolved over 3 days family believes CLARITIN helped. 4 hours of palpitations with new diagnosis of 2nd degree AV block in ER.
Rash at the injection site spread all over the arm, redness, swelling, itching. Pt went to dermatologist and was given prednisone by doc.
Tinnitus coupled with mental anxiety, insomnia.  Symptoms started approximately 24 hours after vaccine.
Patient reported back to the pharmacy on 6/22/17 around 5:45PM with a very red injection site and 2 blisters around the injection site. Patient stated she did not feel like she needed to go to the doctor, and was counseled to apply some hydrocortisone cream to help with the itching.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient was dismissed from pharmacy 15 mins after vaccination with no ADR but she returned crying after half hour saying that she had rapid heartbeat and difficulty breathing. Patient showed no objective signs of respiratory distress so I did not administer EpiPen, only emotional distress. I called ambulance and medics assess patient. She declined to go to hospital.
Patient presented with right arm swollen, hot, itchy and rash along upper outside right arm in the afternoon day after injection. Recommended BENADRYL & to seek medical attention if worsened.
Mother reported little blisters around injection site.  Suggested she see family physician.  Physician said it was not a reaction to vaccines.
On the day of the vaccine 1st dose Pfizer,  about 45 minutes later, I started feeling like I was having a heart attack.  I had tingling down my arm, increase heart rate,  and chest pains. This lasted for a couple of hours.  I did not do anything and it went away with time.  I did not seek any medical care.   I felt well enough and decide to get the 2nd dose.  About 2 days after the 2nd dose, I start to get heart palpitations and it was not going away.   I was also having syncope multiple times a day.  About a month and 1/2 later, I decided to go to the emergency room.  I was hospitalized for 4 days.  I was tested for many things and everything came back normal.  I was prescribed folic acid and lidocaine pain patches for my lower back pain.   I am still having symptoms of accelerated heart rate, syncope and heart palpitations.  I am to be followed up  with a cardiologist and my appt is next month.   Lot number of both vaccine doses unknown (it was not on the vaccine card).
This is a single dose injection that the patient received and this is the first Flu Vaccine the patient ever received in his life. He awoke this morning with severe hives covering his upper arms and severe itching.
Pt c/o itchy hands that started wed 4/7/2021. Progressed to itchy, red macular rash over entire body on time of visit 4/9/2021. Oral steroid prescribed at at on 4/9/2021
very bad joint pain; headache; chills; body pain/body aches; back pain; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 28Dec2020. On 01Jan2021, she had very bad joint pain, headache, body pain/ body aches and chills; but no fever, most have gone away but still have back pain. She doesn't have any shortness of breath or fever. She added that she was confused if this was from the vaccine or from Coronavirus and queried what she should I do. She confirmed that she did not get tested for corona virus. She did read that her symptoms could be from vaccine. She also asked that, since she received the vaccine, if it will affect the results of test for corona virus i.e. false positive. The outcome of the events very bad joint pain, headache, body pain/ body aches and chills was recovered on an unknown date in Jan2021 while not recovered for back pain.  Information about Batch/Lot number has been requested.
Patient is fully vaccinated. 58-year-old male who presents emergency center for evaluation of chest pain shortness of breath, and myalgias.  Patient states that he has a history of deep venous thrombosis and Manera embolism.  Patient states that he has been having congestion, cough, shortness of breath has been going for the past 3 days.  Patient states that he went to his primary care provider today and was tested for COVID.  Patient states that his COVID test was positive. BP 154/72  | Pulse 62  | Temp 98.3 °F (36.8 °C) (Oral)  | Resp 18  | Ht 188 cm (6' 2")  | Wt 101 kg (222 lb)  | SpO2 97%  | BMI 28.50 kg/m² CXR: No evidence of an acute process.No CT evidence of acute pulmonary emboli. Patient stable and discharged.
It started that night, 02/14/2023, as a small welt. Then it increased in size where the entire tricep area (today) is red, edematous, and tender to the touch. It is also slightly itchy.
At approximately 1630 on 9/7 the patient developed myoclonic jerks. At about 1700 the patient developed right arm and leg tonic posturing with head and eyes deviated to the right. This then progressed to full body clonic movements. This required Diastat, phenytoin, and phenobarbital. Patient's seizure lasted for about 1 hour and require respiratory support and transfer to the ICU. Patient was afebrile during this time. Patient had had a seizure with previous immunizations and another seizure that was unrelated to immunizations or other illness. Generalized clonic seizure on 9/3/06 at approximately 11:00.  PMH: 1st seizure @ 4months after vaccinations of Prevnar, PVT, DTP, Hep B Hib, lasted 45 minutes to 1 hour questionable fever prior to seizure.  FH: distant great, great, great relative with seizures.  Mom reports that "restless leg syndrome" when patient sleeps she moves jerks her legs and arms around. Admitting diagnosis: prolonged focal seizure with secondary generalization. Epilepsy focal seizure with secondary generalization, hypotonic. evaluate for new onset epilepsy, evaluate for hypotonic. EEG 9/5/06-normal. current medication Carbamazepine.  Medications: diazepam, phenobarbital, phosphenytoin and carbamazepine.  10/16/06-DC Summary requested.  10/31/06-DC Summary received for DOS 09/03-09/11/06 HX 8 1/2 month old with HX of generalized tonic-clonic seizure at 4 months of age after immunizations. HX of restless leg syndrome that she moves and jerks her legs around when she sleeps. Has multiple startles per week since her first seizure.  Feeding and language delay. At time of hospitalization mother requested child receive 6 month  immunizations which were administered. Afternoon after immunizations developed myoclonic jerks and generalized seizure with deviation of eys to right and right arm and leg in tonic positioning. Developed clonic movements. After seized now has right hemiparesis, required additional phenobar and bag mask for 30 minutes. In PICU required jaw thrust maneuver to maintain airway. Sedated, intubated and ventilated. Discharged on day 9 to home with mother.
Muscle weakness, 101.9 temp (normal temp 97.4), severe sweating, confusion.
Oculo-respiratory syndrome - Of note, I am the pt's spouse, and am an Allergist/Immunologist with special training in immunization medicine. I did not feel she needed a visit for these sx, but if I was not her spouse, she likely would have sought care. Patient had a little soreness in deltoid and in armpit shortly after the injection, but not out of proportion to what was expected. Within 4 hours of injection started to have nasal congestion and scratchy feeling in eyes. Within 6 hours got increased nasal sx, postnasal drip, eyes watery and slightly red. That evening had worsening sx with cough, ache in chest, redness in eyes. Overnight eyes got very gummy with crusting and dry feeling. Cough kept her awake and nose was very congested with copious thick post nasal drip. The following day had persistent sx in the AM, still felt very ill/unwell. Began to feel better that by evening and all sx were fully resolved by the 48 hour mark.
No further information was provided; PNEUMOVAX 23 was administered to three patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T039322, (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered vaccine experienced temperature excursion of 23.9 degrees Celsius for 31 minutes on 11-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.  This is one of tree reports from the same reporter. ; Sender's Comments:  US-009507513-2110USA005005: US-009507513-2110USA004952:
two staff members who tested positive for covid after receiving the first dose.; two staff members who tested positive for covid after receiving the first dose.; This is a spontaneous report from a Pfizer-sponsored program from a contactable pharmacist reported similar events for 2 patients. This is a first of two reports. A staff member of unknown age and gender received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date  at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were unknown. The reporter stated that have a staff member took the first shot and afterward got a positive COVID test. He is asking about the recommendation regarding taking the second shot. The reporter explained he is the immunizer and 2.5 weeks ago he gave the employ at the facility the first does of the vaccine. He has very little information to provide on this event. He called to go over the procedure for administering the second dose and that is when in was inform. Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and SARS-CoV-2 test positive cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021011912 Same reporter/ drug/ event for different patients.
Breakthrough case admission after 2 vaccines Pfizer 3/22/21 Lot# ER2613; Pfizer 4/12/21 Lot# Ew0150
Information has been received from a nurse concerning her 16 year old daughter who in approximately December 2006, was vaccinated with her first dose of HPV vaccine (yeast).  Subsequently, the patient developed three nosebleeds. Medical attention was sought.  The patient was recovering.  Additional information has been requested.
Patient was sitting in the waiting room and fainted hitting his head on wall. Patient was visibly pale.  upon getting the patient in a prone position on the cot, a pulse of 86 and irregular was taken. Patient blood pressure was 130/80. Patient respirations were 18 and regular. Arrival of Ambulance at 16:48 findings of  BP  167/105, 146/112 patient signed off with Ambulance at 17:00.
pt devel malaise,gen body aches,upset stomach,arm soreness & swelling (drug interaction);these rxn lasted 24hr;sx reoccurred when pt was switched to ampicillin 1wk later;
Severe muscle pain throughout body, legs and arms weak to the point of not being able to walk or get to the bathroom, chest pain, severe head/face pain, dizziness/vertigo, chills, fever, vomiting.  Was so bad that I thought about calling 911.  15 hours later  - muscle pain remains, head exploding pain, dizzy.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Approximately since January 2015, an unspecified number of patients was vaccinated with PROQUAD (Merck) (lot number, strength, dose, frequency and route was not reported) that had been exposed to a supported temperature excursion and additional doses of PROQUAD (Merck) that had been exposed to additional temperatures outside of the recommended range. No adverse experiences had been reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
BREAKTHOUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 10/03/2021. PATIENT WAS FULLY VACCINATED ON 02/28/2021
prepared syringe was administered to a patient between 20-25 minutes past the beyond use time for the dose; prepared syringe was administered to a patient between 20-25 minutes past the beyond use time for the dose; This is a spontaneous report from a contactable other healthcare professional (Nurse).  A 12-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date caller explained that prepared syringe was administered to patient between 20-25 minutes past the beyond use time for the dose. Caller also explained that vaccine dose in question was diluted, drawn into a syringe, with the prepared syringe was labeled with expiration and dose and stored in the fridge. The undiluted vial was placed at room temperature, then reconstituted with diluent, drawn into syringes, then placed in the fridge after being labeled with expiration time. outcome of events was unknown.  Information about batch/lot number is not available. Follow-up attempts completed and no further information is expected.
CLIENT RECEIVED PEDIATRIC PFIZER FORMULATION APPROVED FOR 5-11YO. CLIENT WAS 12YO AT TIME OF VACCINATION AND SHOULD HAVE RECEIVED GRAY CAP FORMULATION OF 0.3ML.