chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. In January 2017, from 20-JAN-2017 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of with PROQUAD (anatomical route of vaccinations was not provided) for prophylaxis. Involved lot # were M022399 with expiration date on 01-NOV-2017, lot # L046508 with expiration date on 17-MAY-2017, lot # M023931 with expiration date in 09-NOV-2017, lot # M035690 with expiration date on 06-FEB-2018, lot # M037012 with expiration date on 21-FEB-2018 and lot # M019233 with expiration date on 17-OCT-2017. It was reported, that , PROQUAD was exposed to a temperature excursion of >5°F but < 14°F (> -15°C but < -10°C), on a time frame of 40 minutes. It was also reported, the the vaccine was not exposed to a previous temperature excursion. Data logger was involved. Furthermore, no adverse events were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002205:
Day1 & 2 sore arm fatigue Day 3 swollen lymph nodes, Day 18 palpitations
Pt experienced febrile seizure X 15 minutes temp 103, pt also developed rash
Paralyzed left arm, swollen glands, sore throat, cough mucus/blood, sharp pains in both legs, fever, sharp pains in neck and back, overly tired, sweat
Mild skin rash and irritation on arm and upper torso, focused left side, presented in late evening, responded to oral antihistamine (benedryl), observed on 1st and 2nd night post vax
Mom noticed the injection site was red the first day after getting the injection, the next morning it was swollen, very red & warm to the touch. Today, 9/23/20 the swelling is increased to her elbow and is still warm to the touch after using Benadryl. Treatment Plan: Advised mother to apply warm compress to the area. Use Benadryl (oral or topical) as needed for itching. Discussed signs & symptoms that would prompt follow-up.
Patient is a 75y.o. year old  female who presented to the ER on 9/29 with family members reporting altered mental status. The patient is currently awake, and can respond to questions although she is confused and unable to provide any history regarding the events prior to presentation. History is therefore obtained from review of the chart. At the time of presentation, her son reported that she had been more confused and lethargic that morning. She is reportedly oriented ×2-3 at baseline. She was also incontinent of urine. At presentation here she had an O2 sat of 92% breathing room air, RR 20, BP 93/58, and temperature 96.9 degrees. SARS CoV 2 by NAA was positive. WBC 5.4 with lymphopenia. Ferritin 45, CRP 5.0, d-dimer 1715. CXR with no acute process, and CT head with no evidence of acute intracranial pathology. She was placed on steroids, but was not given remdesivir at the request of family members per my discussion with the internal medicine team. She is also been placed on treatment dose heparin. At present, she is breathing room air with an O2 sat of 92%. Per my discussion with nursing, they had placed her on supplemental O2 via NC, but she keeps removing her oxygen. The nurses monitoring and will replace if she drops below 92. Her other vitals remained stable. She was sitting up eating when I entered the room. She appears comfortable and has no complaints, although she is confused.
pt recv vax SEP95 & @ end of APR97 pt devel chickenpox;
This spontaneous report was received from a register nurse and refers to multiple unspecified patients of unknown age and gender. The register nurse reported that the shipping of GARDASIL 9 was received "last within 3 days, instead of 2 days, however, the checkmark indicator enclosed in the shipment was checked as OK, indicating that the temperature conditions were maintained". The nurse also reported that multiple patients on multiple unspecified dates, were vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) that may had been improperly stored during the shipping as the temperature during the shipment could not be determined. No adverse effects reported. No product quality complaint was involved. Additional information is not expected because reported refused additional contact.
At an unknown time lapse following vaccine administration the patient experienced SOB and unilateral facial swelling for which it is unknown what course of action/treatment /intervention was taken.
About 6 hours after the injection, my husband began complaining of tingling and burning over his right scapula and  right trap area.  I imagined it was an allergic reaction and gave him OTC allergy medications.  He continued to complain and three days later appeared a rash of about 3 inches in diameter above his right scapula.  I called the my insurance's virtual urgent care and sent the doctor pictures.  I was thinking it was shingles, but she stated it was a reaction to the vaccine and recommended benadryl 3 times daily  and alternating ibuprofen and  Tylenol for the pain.  By Friday morning, I was sure it was shingles as the rash had spread and stopped midline on his back and chest and up the right side of his neck to his ear.  So we went to urgent care, and they diagnosed it as shingles and started him on an anitiviral.   I thought maybe it was a coincidence (although my first reaction was that the vaccine provoked it and had woke up the virus).  But then later I read a report from a study in Spain linking shingle outbreaks to the vaccine.  So I thought I should report my husbands case.
Elongated red, warm, and inflamed rash on arm; bicep/tricep area, spread to elbow.
L arm red, hot to touch, bruised area.  Redness spreading out.  (IM site)
This spontaneous report was received from an office manager refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of RECOMBIVAX HB of lot # M000442 with expiry date 31-MAR-2018 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd 1st dose of vax 22OCT90 & following vax devel intense itching @ the inject site which lasted less than 24 hrs; 20DEC90 was vaxed w/2nd dose & again devel intense itching @ inject site which resolved;
Adverse Event: Vomit, Stool, Chills, Fatigue, Sweat, Headache, Soreness (Left Arm, Left Leg)   Treatment: Tylenol, Cold Water (to Drink), Layers of Clothes/Blankets & Heat, Sleep, Disrobed/Cool Fan   Time Course: Fatigue  & Soreness- 24 hours Post Vaccine  Adverse Event - 48 hours Post Event (8a-10a)   Fine after Treatment (3:30p) - No symptoms
Breakthrough case admission after two vaccines Moderna 11/8/21 NO LOT #; 12/13/21 Moderna NO LOT #  NO LOT # RECORDED IN LOCAL STATE DATABASE
Flu like symptoms.  Chills/Sweating, Muscle and Body Aches, Joint aches.  Low energy.  No Fever.
This was my first booster shot, more than 1 year after my set.    Similar to my first dose the year before (already reported), I had changes to my menstrual cycle.  Also, like that first dose, the symptoms began within 14 days.   It started with nipple tenderness and some "outside" breast tenderness.  Within a week, I started a menstrual cycle.  This one lasted about 7 days, but the nipple tenderness never fully resolved.  For the next 10 days, the nipple tenderness continued, along with a low grade fever (peaked at 99.5).  Then on day 10, I started another menstrual cycle and all symptoms resolved.  This cycle last another 10 days.  I am positive these vaccines impacted my menstrual cycle.  It is way too coincidental that both caused a change in my menstrual cycle within 14 days of receiving the vaccine and both times, last 17-18 days (this last one split by 10 days, but it was a different vaccine).
short pain in my heart; my heart feels like it beating faster than usual/pulse was 130 and today is 108; my pulse was 130 and today its 108; short of breath; agitated; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 24Mar2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that  2 hours after getting the vaccine she had a short pain in her heart and her heart feels like it beating faster than usual. Yesterday, her pulse was 130 and today is 108. The pain it comes and goes and sometimes she's a bit short of breath and agitated. She wanted to wait it out but how long should i wait before seeing a doctor. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Patient presented to ED from local nursing facility with shortness of breath, fever and cough. Patient had CK D stage III, anemia, hyperlipidemia, hypothyroidism, hypertension, hypercalcemia, and hypernatremia. Patient is fully vaccinated. Patient died.
muscle soreness/ chills across her upper back; rash on her arm; muscle soreness/ chills across her upper back; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 2nd June 2023) for prophylaxis.   On 18th April 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced chills, rash and muscle soreness. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the rash and muscle soreness were recovered/resolved.   It was unknown if the reporter considered the chills, rash and muscle soreness to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: This case was reported by the patient. After receiving Shingrix, the patient experienced muscle soreness and a rash on her arm that has resolved. The patient also experienced chills across her upper back that persist. The patient gave medical disclaimer and referred to the healthcare professional. The patient was provided with medical information phone number for the healthcare professional reference and offered after call survey. The consent to follow up was given.
Patient began having extreme fatigue the day after the 2nd vaccination. Pt had first dose on 02/04/21. Pt usually active all day long, walking all day long, dose carpentry, fixes windows and build windows and does installation. Pt now lays in bed or sits in the chair all day long per son. Patients Son, reports drastic change in daily activity. Son reports much slower movements, lack of coordination and pt had Fall on 3/30/21 from standing position while at the kitchen sink. Pt has no  memory of the event Pt had 2 vomiting episodes post fall.
Immediately following injection patient complaining of severe pain at injection site. Patient ranks pain at 6/10. This nurse observes patient  acting concerned and moderately distressed. During 15 minutes observation time, patient states that pain is decreasing. Appx 1-2 hours after injection this nurse followed up with patient. Patient states that arm is still rather painful, with pain radiating all the way down to the finger tips.
Fever; Back pain; Sick; like the flu, a bad flu; could not get up; body looked like somebody hit her, like she had a crash , had body pain; body was very heavy; She now has her period.; This is spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a 42-year-old female patient received second dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, Batch/lot number: ER8729, Expiration date: Unknown), via an unspecified route on right shoulder on 13Apr2021 at around 16:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Pfizer Covid 19 vaccine, Solution for Injection, LOT: ER8727, Expiration date: Unknown) on 23Mar2021 at around 16:00, on right shoulder, as a single dose for covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Family history included diabetes (mother) and high cholesterol (husband) and prostate cancer (Father-in-law). She received the vaccine at like 2:00pm or 3:00pm. Initially reported as around 2:00 or 3:00pm; but when time of administration later queried reported she thinks they were both at the same time, like 3:00 or 4:00pm, thinks it was around 4:00pm By 9:00pm that day, her body looked like somebody hit her, like she had a crash on 13Apr2021. After the vaccine, she was sick for one day on 13Apr2021. She had a fever, and was like the flu, a bad flu on 14Apr2021 and she could not get up on 13Apr2021. Was like fever, body pain, and couldn't get up, she was very sick. After 24 hours, it was like nothing happened. On 13Apr2021, the back pain was a lot and on an unspecified date in 2021, her body was very heavy but had no headaches. She preferred being in bed. She had a fever at night, like at midnight. She didn't take any medicine. The next day, around 3:00pm, she took Tylenol and at about 7:00pm, it was like nothing happened, like she didn't receive the shot. It was very crazy. Like 24 hours after, she didn't feel anything. She thinks this was normal. The fever started in the middle of the night, around midnight, 3:00am. She does not remember she was in bed. The fever came and would go out and would come and go again. Was only for one night. On an unspecified date in 2021, She now has her period. The clinical outcome of the event was didn't feel anything after 24 hours (13Apr2021) and thinks this is normal, at about 19:00 on 14Apr2021 it was like nothing happened, like she didn't receive the shot, fever, she was sick, like the flu, a bad flu, body looked like somebody hit her, like she had a crash, had body pain was recovered on 14Apr2021 and events back pain, couldn't get up, body was very heavy, She now has her period was unknown.  No follow-up attempts are possible. No further information is expected.
Antiphylactic reaction; Flushed; Trouble breathing; Mouth swelled up; Heartrate high; This spontaneous case was received on 29-Mar-2022 from other non-healthcare professional (the patient's mother) via Med Communications (reference number: SEQW22-01089) and concerned a 14-year-old, male patient.  The patient's concurrent condition included Von Willebrand's disease. The patient was not taking any concomitant medications.  On 22-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention. The batch number reported was 308460 and expiry date was 30-Jun-2022.  On the same day, 30 seconds after receiving Flucelvax Quadrivalent, the patient developed anaphylactic reaction. He experienced flushing and trouble breathing. The patient's mouth swelled up and his heart rate was high. The pharmacist called 911 and the patient was taken to hospital by ambulance. At the hospital the patient was given unspecified steroids and the imaging was taken as reported, but no details provided. The patient was not admitted to the hospital and was sent home with unspecified medications.   On an unspecified date, the patient had recovered from the events.  On an unspecified date, the patient was followed up with an allergist, but no details provided.  The reporter assessed the events as related to Flucelvax Quadrivalent. The patient's mother wanted to get some information on reimbursement for hospital bills and doctor visits after the reaction.  The events were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 14-year-old male patient experienced anaphylactic reaction 30 seconds after receiving Flucelvax Quadrivalent vaccine as reported. The patient experienced dyspnea, mouth swelling, increased heart rate and flushing. Based on information provided and plausible temporal relationship, causality for the reported events is assessed as possibly related. Information provided meets level 2 of Brighton Collaboration criteria for anaphylaxis.; Reporter's Comments: The reporter (the patient's mother) assessed the events as related to Flucelvax Quadrivalent as she wanted to get some information on reimbursement for hospital bills and doctor visits after the reaction.; Sender's Comments: A 14-year-old male patient experienced anaphylactic reaction 30 seconds after receiving Flucelvax Quadrivalent vaccine as reported. The patient experienced dyspnea, mouth swelling, increased heart rate and flushing. Based on information provided and plausible temporal relationship, causality for the reported events is assessed as possibly related. Information provided meets level 2 of Brighton Collaboration criteria for anaphylaxis.
Information has been received from a medical assistant concerning a 14 year old female who on unknown date was vaccinated with two doses of GARDASIL from another provider and was diagnosed with experienced celiac disease.  At the time of reporting, 25-FEB-2009, the patient's celiac disease persisted.
By 8 PM the day of the shot (6/29), my arm was very sore, and a little tender.  I started developing joint pain in my hips, knees, and ankles, as well as back pain later that night.  The next day (6/30) the arm and joint, and back pain worsened, treated with Tylenol.  Also got some minor muscle soreness, but the worst pain was in my joints.  Then at about 8PM I started to feel nausea.  Today (7/1) the pain has lessened but is still intermittent, and the nausea isn't as bad, but still comes and goes.  Also noticed rash at the spot of the injection this morning.  I've never had a reaction like this to any vaccines in the past, so it has thrown me off and worried me.  I looked up the side effects today and saw that this isn't abnormal and should be gone after today so I'll just grin and bear it.
This spontaneous report as received from a medical assistant refers to a 4 year old patient who on 16-JUL-2014, was vaccinated with a dose of M-M-R II HSA (lot number reported as J002866, Exp. Date: 12-MAR-2015 and J008154, Exp. Date: 08-JUL-2015) that was improperly stored. Dose and route not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient was in the office for his routine check up on 3/3/05. There were no problems noted and his history and physical exam were completely within normal limits. A complete examination was performed, and he received five vaccinations (Acel-DTP, Prevnar, Inactivated Polio, HIB, and Hepatitis B). All of these vaccinations had been administered in the past, and there had been no untoward unusual reactions noted. The prior vaccinations had been at another pediatric practice. Prior to this visit, he was in good health with no significant past illnesses or significant family history of note. There are no known allergies. On 3/9/05, the patient's mother called me and informed me that for the past 2-3 days there were multiple head jerking movements noted, and they seemed to be getting worse. There was no overt tonic clonic seizure activity reported. The parents were told to come into the office the first thing the next morning. The patient was seen on 3/10 and had a completely normal physical exam. Because of this history, the patient was admitted to the hospital for evaluation. He remained in the hospital for one day and had an MRI and an EEG which were both unremarkable. He had some blood work done as well and was seen by a pediatric neurologist. The pediatric neurologist was not certain what these activities were and suggested that he have a video EEG scheduled since all of the activity was while he was awake, and the initial EEG was a sleep study. Over the course of the next couple of days the abnormal movements remained and the patient was scheduled for a video EEG on 3/18 for 24 hours. When I spoke to the parents, they reported that the movements were now much improved and only minimally seen. They felt that he was acting very normal and there was only a very occasional jerking movement. They were very happy he was acting like his normal self. Even during the time he was having the most abnormal movements, he maintained his normal happy personality.
This case was reported by a consumer via Interactive Digital Media and described the occurrence of unwell in a infant male patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced unwell, fever, stiffness, tenderness, breast feeding problem (infant) and drug allergy. On an unknown date, the outcome of the unwell, fever, stiffness, tenderness, breast feeding problem (infant) and drug allergy were unknown. The reporter considered the unwell, fever, stiffness, tenderness, breast feeding problem (infant) and drug allergy to be possibly related to DTPa vaccine. Additional details were provided as follows: This case was reported by the patient's parent. One of sons got the DPT shot as an infant. The patient became very ill, high fever, pain when you touched him, stiff body, did not want to nurse. The patient was allergic to the pertussis part of the vaccine. From then on he had to only get the DT. And to go to school he had to have a medical waver.
Headaches; Nausea; Muscle cramps; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 (45-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Workplace clinic. The patient's medical history included known allergies of Sulfa, hypertension. The patient's concomitant medication(s) included lisinopril 2.5mg and hydrochlorothiazide 25mg within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with Covid-19. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 01Jul2021, the patient had experienced headaches, nausea, muscle cramps. Since vaccination the patient was tested for Covid-19. The patient underwent lab test and procedure which include (SARS-CoV-2 test) Nasal swab, Binax: result was negative, Doppler ultrasound: results not provided. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Zofran (unspecified route) as treatment medication for resulted events. Device date was reported as 18Aug2021. The outcome of the events was not recovered. The seriousness of the events was assessed as non-serious by the reporter.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.