chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representative refers to an elderly male patient of unknown age. The patient's concurrent conditions included hypertension and diabetes mellitus. The patient's concomitant medications included medications for hypertension. Approximately in 2016 (reported as a year and a half ago), the patient was vaccinated with ZOSTAVAX, (lot#, expiry date, route were unknown) 0.65 ml once for prophylaxis. At the time of vaccination the patient was 70 years of age. On an unknown date approximately in 2017, the patient experienced severe case of shingles herpes zoster on his right leg. On 30-JUL-2017, the patient visited the physician's office. Treatment was given for the event. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. Causality assessment was not reported.
administered with the PENTACEL liquid component alone without the Hib component with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 7 months old male patient who was administered with the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] liquid component alone without the hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine and Pneumococcal Vaccine for Prophylactic vaccination.  On 20-Jul-2023, the patient received 0.5 mL dose 3 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (batch number: UJ807AA; expiry date: 01-Oct-2023) via intramuscular route in the left vastus lateralis for immunization with the pentacel liquid component alone without the hib component with no reported adverse event (product preparation error) (same day latency).  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event administered with the pentacel liquid component alone without the hib component with no reported adverse event.  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.
Gave donor injection turned around to dispose of needle and when I turned back to donor he was pale, sweaty - asked if he was ok? Donor stated he does not do well with injections. Donor wanted to lay on bed and stood to his feet and I stood up to guide donor to the floor. No complaints of SOB, hives, rash, CP. Was alert within 15 sec. Form was not initially filled out because did not feel it was related to vaccine but after taking med- ops form nd to be completed.
Patient presented with transaminitis and hepatic encephalopathy of unclear etiology. Her depakote level was not elevated. She was found to have pneumonia. No known viral infection.
Patient received first dose of COVID 19 vaccine at 1:30 pm on 5/4/21, at 11:00 pm on 5/4/21 patient was at home sitting on couch when his body went stiff,  eyes rolled into the back of his head, legs began shaking for about 20 seconds, once patient came to he was extremely nauseous and vomited. Patient did not seek medical attention that evening, called his PCP next day and was advised to follow up. Two days later patient still experiencing some headaches and nausea, advised to go to local ED (hospital) patient had labs drawn and received a CT scan, reported all were unremarkable. Patient is in the process of following up with Neurology and undergoing and EEG for suspected seizure.
1st day after immunization - local "golf ball" size erythematous, edematous lesion. 2nd day 3/31/03 - Shoulder to elbows - erythema, fever, edematous encircling upper arm. Full range of motion.
Pt first developed rash day after injection 7/15/15 around site of injection, then entire arm turned red.  Pt called clinic 7/20/15 stating rash spread to back and chest and was raised with blisters.  Pt was then brought back to clinic on 7/21/15 and assessed by provider.  Pt diagnosed with shingles at that time and treated for this diagnosis.
Pt. states that after receiving the 1st dose of Phizer 08/07/2021, started experiencing symptoms 08/08/2021 of woke up with extreme dizziness, intense nausea, (mild) vomiting, cold sweats, shaking, Glucose (10pm 198), (04:17am 292), and weakness. Primary communications suggested VAERS reporting. 08/09/2021 symptoms subsided with mild weakness and continuing to subside.
Information has been received from a medical assistant concerning a 13 year old female who on 06-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # reported as 0903U").  On 25-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 659435/1265U)  On 26-FEB-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 660387/1967U).  There was no concomitant medication.  On an unspecified date, the patient had "blood work for hepatitis C".  The medical assistant reported that the patient has a "reported elevated Hepatitis C blood result" (not further specified).  Since 24-MAR-2008, the patient has had elevated fevers (not further specified).  The patient denied recreational drug use or sexual activity.  The patient was reporting to be recovering.  The patient sought unspecified medical attention with a phone call to the office.  No additional information is available.  Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown dates, since 30-OCT-2014, those patients were vaccinated with doses of GARDASIL injection (strength, dose, route of administration, lot# and expiry date unspecified), that were exposed to a supported excursion. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient noticed a red itchy rash on upper arms, upper thighs and abdomen about 2 weeks after her first COVID shot. It was slight but persistent. After her second shot it worsened approximately 10 days later. No other symptoms. She has not taken any medications for it. Has hx of skin sensitivities to multiple substances.
"Moderna arm" large raised hive, very hard, very warm to touch, very very itchy, around injection site, oval shaped maybe about 3 inches by about 4.5 inches
Four days after 1st vaccine woke up with blurry vision and ophthalmologist diagnosed me with Glaucoma on Monday Feb.1, 2021.  My eye pressure was at 42.  Day after 2nd vaccine my blurry vision doubled.  Saw ophthalmologist again who confirmed it was due to the vaccine due to no other issues or changes on my body or health.
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
Sat, 8/21/21 PM - body aches Sun, 8/22/21 AM - body aches, chills, low grade fever, fatigue Sun, 8/22/21 PM - body aches, chills, low grade fever, fatigue Mon, 8/23/21 AM - body aches, chills, fatigue Mon, 8/23/21 PM - body aches, chills fatigue Tue, 8/24/21 AM - fatigue Tue, 8/24/21 PM - fatigue Wed, 8/25/21 AM - fatigue Wed, 8/25/21 PM - fatigue Thu, 8/26/21 AM - fatigue Thu, 8/26/21 PM - hives on arms and legs Fri, 8/27/21 AM - hives on arms, legs, chest and back Fri, 8/27/21 PM - hives on arms, legs, chest and back Sat, 8/28/21 AM - severe hives on arms, legs, hands, feet, back, chest, scalp (symptoms subsided after Diphenhydramine HCI 25mg) Sat, 8/28/21 PM - no symptoms Sun, 8/29/21 AM - severe hives on arms, legs, hands, feet, back, chest, scalp (symptoms subsided after Diphenhydramine HCI 25mg) Sun, 8/29/21 PM - hives lessened to feet only and subsided on own (no medication taken) Mon, 8/30/21 AM - no symptoms Mon, 8/30/21 PM - no symptoms
Warm near the injection site; Fatigue; Nausea; Muscle pain; Joint pain; Redness on the right arm; Puffy arm near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm near the injection site), FATIGUE (Fatigue), NAUSEA (Nausea), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESYLATE and VALSARTAN for an unknown indication.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm near the injection site), FATIGUE (Fatigue), NAUSEA (Nausea), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Redness on the right arm) and VACCINATION SITE SWELLING (Puffy arm near injection site). At the time of the report, VACCINATION SITE WARMTH (Warm near the injection site), FATIGUE (Fatigue), NAUSEA (Nausea), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Redness on the right arm) and VACCINATION SITE SWELLING (Puffy arm near injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.
7 days after injection, the site was red and painful and itchy. It was itchy so I scratched and it hurt and I looked and saw a large raised and red area on my arm.
cough, ST, fever, HA, nausea started day after vaccine given. Seen in ED 1 day after vaccine givem
Red rash on arm around injection site that I first noticed on 2-10-21, about 12 days after the 1st Moderna vaccine.  It has spread to a larger area each day  since I first noticed it  It feels warmer than the surrounding skin, and started itching on 2-12-21.  I started taking Benadryl on  the evening of 2-13-21.
HEADACHE; TINGLING IN ARM; BODY ACHES; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was 118 pounds, and height was 60 inches. The patient's concurrent conditions included apples and nuts allergy, alcohol consumer, and non smoker, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tingling in arm. On APR-2021, the subject experienced body aches. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and had not recovered from headache, and tingling in arm. This report was non-serious.
Approximately 2 weeks post vaccination developed rapid AF, CHF.  Admitted to Medical Center.  Discharged home on hospice.  Patient died at home on 2/13/2021.  Reported to this reporter at second dose clinic on 2/16/21.  Other details not known.  Unknown if related to vaccine.
This spontaneous report was received from a nurse refers to a 26-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with PROQUAD (dose, units, frequency, lot # and expiration date unknown) subcutaneously instead of M-M-R II due to human error (interchange of vaccine products and wrong product administered). No adverse effects were reported. No product quality issue was reported.
Narrative:  Patient became "woozy" about 30 mins after administration of vaccine. Patient thought could be low blood sugar (non-diabetic patient). Had head lowered/feet elevated for 20 mins. Patient slowly transitioned to upright seated position and then standing. Denied symptoms returning and had no trouble walking.
Redness, swelling hot to touch; given Avelox 400mg PO QD for 7 days. Advised to notify MD if no improvement.
Started with upper respiratory infection in lungs with cough leading to headache, chills, body aches, restless legs, sneezing and exhaustion.  Fever started within 32 hours from onset and reached 103.8 degrees.  (Started Azithromycin 250mg 12 hours after onset.)  Fever broke after 84 hours of onset.
This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 23Jul2021 at 19:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and high cholesterol. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jul2021, the patient experienced mildly lethargic. On 25Jul2021 at 17:00, the patient experienced dry coughing, deep, dry cough persisted for two days. On 27Jul2021, the patient felt legitimately ill with coughing (semi productive with mucus), body aches and sinus pressure. The patient had no fever at any point. On 28Jul2021, the patient had more sinus drip than he had ever had in his life. He went through a box and a half of Kleenex in 24 hours. The patient had to stand in shower and let nose just run, several times throughout the day and experienced lots of vigorous sneezing, coughing largely subsided by that point. On 29Jul2021, the patient's sinuses began to clear up but the patient woke up at night in an aggressive, unexplained fit of coughing that persisted for about 30 minutes. On 30Jul2021, the patient felt he was on the mend and symptoms were finally subsiding. The patient had scheduled an appointment with his doctor for next Wednesday for antibody test. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 28Jul2021, the patient underwent coronavirus (COVID-19) YHL test and the result was negative. The clinical outcome of the events vigorous sneezing, mildly lethargic, dry coughing, legitimately ill with coughing (semi productive with mucus), body aches, sinus pressure and sinus drip was resolving at the time of this report.
shortness of breath; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and FATIGUE (fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (medical history was not reported.).    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
cough; heart rate went up; not feeling well; chills; This is a spontaneous report from a contactable consumer (patient's son) via Medical Information team. An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1283, NDC number and expiration date were unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 at a single dose for COVID-19 immunization. The vaccination facility type was reported. The vaccine was not administered at the military facility. The patient had no medical history. She had no family medical history. There were no concomitant medications; the patient had no other products. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on the same date of the Pfizer suspect vaccine. The patient did not require any visit to a physician or emergency room (ER) for the adverse events (AEs). The patient had no prior vaccinations within 4 weeks. The reporter provided information on the side effects of the patient. The patient had the vaccine on 24Jan2021 and she had "basic" not feeling well that evening, chills that night; and had developed a cough on Monday evening, on 25Jan2021. She was still coughing and didn't feel well. The reporter didn't know if it was due to the vaccine. The patient was still with coughing and just not feeling good. The reporter was asking if the coughing was related to the vaccine, was it normal for the vaccine, or should she get the test. The reporter further stated that in the afternoon of 24Jan2021, the patient was not feeling well and had chills that evening. The reporter added that the patient's heart rate went up with the chills on 24Jan2021 in the evening, but then went back down when the chills went away on 25Jan2021. The reporter mentioned that the patient's husband had it (vaccine) at the same time and had no problem. The patient was scheduled for the second dose of the vaccine, but the reporter did not have the paper to provide the date. The reporter assessed the events as non-serious. The patient recovered from the events "chills and heart rate went up" on 25Jan2021, while she was not recovered from the events "not feeling well and cough."
Symptoms equivalent to upper respiratory infection, as well as Rosiola (per doctor) and a fever that lasted for several weeks. Started digressing where milestones concerned. Diagnosed w/Autism Spectrum Disorder 11/07/06  4/21/08 Reviewed PCP medical records of 6/23/04-2/22/07.  No vaccine record included. FINAL DX: autism spectrum disorder Records reveal patient w/asymmetric cry & referred to peds neuro 6/23/04 for evaluation of congenital absence of depressor angularis ovis muscle palsy.  6/8/05 was well child visit w/o concerns except mild anemia.  Returned 6/10/05 w/fever, decreased appetite, rash, loose stools.  Dx w/viral syndrome/prickly heat rash. 7/25/06 MD concerned w/developmental delay, speech delay & possible autism.  Noted facial asymmetry. Parents refused developmental evaluation until 11/2006. ST/OT/psychologist eval 11/2006 revealed delayed social skills, decreased eye contact, cognitive skills delay, receptive/expressive language significantly delayed, global delays in motor/sensory skills, sterotypical repetitive behaviors.  Was to continue OT/ST & early intervention program.  4/22/08 Reviewed vax which confirms as reported.
Patient c/o tingling in mouth and tongue, and in hand 25 minutes post vaccination. Patient states this happened last time and resolved with Benadryl. No c/o SOB, lightheadedness, itchiness/rash. Does not appear to be in respiratory distress. Gave 25mg liquid Benadryl at 11:15am. Pt stayed 20 minutes, no change in symptoms. Advised to ER for possible reaction but patient declined and said she would be with someone and they would call 911 if any worse.
24 hours, post vax 1st Anthrax, developed painful area that progressed to stiffness and large red macule.
The day following administration, the patient felt very lethargic and noticed the injection site was very swollen and hard to the touch. At the time of reporting (11/01/22 approximately 5pm) swelling has reduced per patient but is still present. The site is also still hard to the touch.
Pt experienced a large erythematous reaction on left deltoid extending from shoulder to almost elbow 7 x 5 in size. Site is hard and reddened.