chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense headache frontal lobe; Intense swelling of legs; hard to bend weakness in legs; hard to bend weakness in legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 13:30 (Lot number: EN6207) at the age of 64 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE. The following information was reported: HEADACHE (non-serious) with onset 28Mar2021 13:30, outcome "recovering", described as "Intense headache frontal lobe"; PERIPHERAL SWELLING (non-serious) with onset 28Mar2021 13:30, outcome "recovering", described as "Intense swelling of legs"; MUSCULAR WEAKNESS (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset 28Mar2021 13:30, outcome "recovering" and all described as "hard to bend weakness in legs". Therapeutic measures were not taken as a result of headache, peripheral swelling, muscular weakness, joint range of motion decreased.  Additional information: The patient was not pregnant at time of vaccination. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccine in 4 weeks. The event happened 10 days after 1st vaccination.  No follow-up attempts are possible. No further information is expected.
2cm x 2cm hive @ inject site accom w/general erythema 2 hrs p/vax; inc itching all over body hives;  12 hrs p/inject low grade fever, chills, malaise, h/a, pain @ inject site; rx w/DPH;
every day her legs they get red and allergies on her legs and arms; anaphylactic shock; every day her legs they get red and allergies on her legs and arms; This is a spontaneous report from a contactable consumer (husband) or other Non-HCP.   A 26-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an 22Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not allergic. On 22Mar2021 at 07:00 PM (same day of vaccination), the patient experienced anaphylactic shock. The patient had allergy every day. Clinical course of the event was as follows: The patient had red and allergies on her legs and arms all started after vaccination.  Patient had not got attention required where she needed an allergist, she went to the hospital, they said they don't have an allergist. And this needs to be treated. She had got appointment to see an allergist which was after 4 months. She does have a primary doctor and took appointment for next day however she did not get any solution at that moment. She was informed that that a contact would be made but not done. On an unspecified date, the patient went to the doctor and they gave her medicine but she had allergy felt like she was about to die they had to give her a shot so she could come back after the vaccine. She was taking medicine but had continuous allergy every day. The patient wanted to report the event to pharmacy and FDA. Outcome of anaphylactic shock was unknown and outcome of red and allergies on her legs and arms was not resolved.   Information on lot/batch no. has been requested.
Got vaccine Friday. Very feverish all day Saturday and  Unable to control bladder. Sunday I was fine.
Patient was given the pediatric dosage of covid 19 vaccine.  The pediatric dose was undiluted and patient was given 0.3 ml.  Patient remained in the office following vaccine, and had no reactions.  We contacted patient several hours later, and he denied symptoms.  He was advised to call the office if he experienced symptoms, or go to ER/Urgent care if severe symptoms.
1_fever on and off for almost 3 days; 2_Heart inflammation or Myocarditis/Pericarditis 3_More specifically, chest pain, abnormal heart rhythms, mild diarrhea, fatigue, shortness of breath, chest pain, and lightheadedness.
body and bone aches; body and bone aches; This non-serious case was reported by a physician via sales rep and described the occurrence of general body pain in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of bone pain (had body and bone aches experienced with the COVID vaccine).   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced general body pain (Verbatim: body and bone aches) and bone pain (Verbatim: body and bone aches). The outcome of the general body pain and bone pain were not reported.   It was unknown if the reporter considered the general body pain and bone pain to be related to Menveo.     It was unknown if the company considered the general body pain and bone pain to be related to Menveo.   Additional Information: GSK receipt date: 27-JUL-2023 Reporter was the patient. She received Menveo 5-year booster due to research in the Congo in August. She shared that she had body and bone aches that worse than what she experienced with the COVID vaccine. The reporter did not consent to follow up.
I was fine throughout the morning of 5/10 with mild body aches developing in the afternoon. The body aches worsened in the evening and were then accompanied by cold chills throughout the body and a moderate headache, especially an occasional sharp pain in the lower right side of the back my skull.  As I tried to make my way to bed at 8:30 pm, I got extremely lightheaded and nauseous and ended up passing out for a second and falling to the floor. The lightheadedness and nausea lasted for about 15 minutes before finally passing. I took Advil at this point and went to bed. Throughout the night, my body alternated between cold chills and burning up, profusely sweating. A mild headache persisted throughout the night. I took Advil again in the morning of 5/11. I continued to have minor body aches and a slight headache throughout most of the day,  including the same occasional sharp pain in the lower right of the skull, but no more chills, lightheadedness, or nausea.  All side effects subsided by the morning of 5/12.
G40.89 FOCAL MOTOR SEIZURE 1/16/2023 HTN (HYPERTENSION)
temperature excursion which was administered to multiple patients. .; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history, and concomitant medications.  On 06-APR-2021 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) with dose reported as 1 administered subcutaneously (lot number T031602 and expiration date 15-MAR-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported and information was provided via data logger. No additional adverse event was reported and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002802: US-009507513-2104USA002803: US-009507513-2104USA002804: US-009507513-2104USA002807: US-009507513-2104USA002808: US-009507513-2104USA002809: US-009507513-2104USA002801: US-009507513-2104USA002800: US-009507513-2104USA002799: US-009507513-2104USA002805: US-009507513-2104USA002806:
patient reports that shortly after her first cousin injection she started having pain in her bilateral hips back and knees and shoulders.  Patient continues to have these symptoms
Initial reaction was swelling of surrounding are of injection site, soreness, mildly warm to the touch. Tingling feeling in injection arm. By Day 4, these symptoms subsided. Day 9, soreness again at injection site with redness. Area of redness increased and mildly warm to the touch. Redness continued with a short period of itchiness on Day 11. Intermittent tingling feeling continues.
Flumist was administered outside of recommended age range of 2-49. Employee is 53 years old.  No adverse reaction or events were reported after administration.
DIFFICULTY IN SWALLOWING; TOOK VIVOTIF WITH TWO DRIED APRICOTS; This spontaneous case (PVX2019-1550) was received from a nurse on 14-Jun-2019. It describes a 71-year-old elderly female consumer who had difficulty in swallowing, while being on Vivotif capsule for an unknown indication. She also "took Vivotif with two dried apricots".   Case report: The consumer took the first dose of Vivotif with two dried apricots as she had difficulty in swallowing the pill. She thought that difficulty in swallowing was due to gastroesophageal reflux disease (GERD)  The consumer's medical concurrent conditions included GERD and allergies.  Concomitant medication included Allegra (fexofenadine) and Claritin (loratadine) tablets as needed for allergies.  Action taken with Vivotif with respect to the event difficulty in swallowing was unknown while with respect to the event "took it with two dried apricots" was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a 71-year-old elderly female consumer had difficulty in swallowing while being on Vivotif. Considering the medical history of gastroesophageal reflux disease, the causality of the event is assessed as unlikely with Vivotif. The causality of the event "took it with two dried apricots" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 71-year-old elderly female consumer had difficulty in swallowing while being on Vivotif. Considering the medical history of gastroesophageal reflux disease, the causality of the event is assessed as unlikely with vivotif . The causality of the event "took it with two dried apricots" was considered as not applicable.
w/in hr of  receiving vax had vomit, diarrhea & temp of 101-103;crying & screaming all day;
AROUND 8PM THE EVENING OF THE VACCINE WAS STARTING TO FEEL ACHE. WAS VERY RESTLESS THREW THE NIGHT AND COULDN'T SLEEP. AROUND 8 AM THE MUSCLE ACHES WERE GETTING WORSE AND MORE TIRED. BY 3PM GOT SEVERE CHILLS . 6PM WOKE UP WITH A FEVER OF 101.6 AND EXTERMLY HOT AND MISERABLE. TOKE TYLENOL ,9PM FEVER DOWN TO 100.1 AND BY 12 AM ALL SYMTOMS WERE GONE.
PATIENT WAS TEARY-EYED, DIZZY, AND HAD A RAPIDLY RISING TEMPERATURE TO TOUCH (NOT EMPIRICALLY MEASURED).
Flu symptoms coming on evening of shot and lasting through next day. Ache, chills, fatigue. Unable to perform usual activities, rested in bed day after shot.
Diffuse rash with papules and vesicles on 08/15/2003; seen by office 08/19/2003.  Rash resolved 1 week after being seen on 08/19/2003.
This case was reported by a pharmacist and described the occurrence of sore shoulder in a 56-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 September 2009 the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). At an unspecified time after vaccination with FLULAVAL, the subject experienced sore shoulder and bone pain. It was reported that the subject's shoulder hurt in the bone. She has received the flu vaccine "every year for a while and had never had this happen before". At the time of reporting the outcome of the sore shoulder and bone pain was unspecified.
Patient had first dose of Moderna vaccine on 12/26, and developed a diffuse red/raised petechiae rash on lower abdominal/groin area and underarms down sides  and up near her shoulders. Rash began one week later on 1/3. She called her PCP who recommended to take Benadryl and OTC allergy medicine. Later that night the rash continued to spread so she did go the emergency room at received a prescription for a Medrol taper regimen. Denies any resp distress at that time. Has reported her symptoms
TROUBLE SLEEPING; LITTLE BIT OF HEAD PRESSURE; A GENERAL FEELING OF BEING "OFF"; SHOULDER HURT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination.  The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On 31-MAR-2021, the subject experienced trouble sleeping. On 31-MAR-2021, the subject experienced little bit of head pressure. On 31-MAR-2021, the subject experienced a general feeling of being "off". On 31-MAR-2021, the subject experienced shoulder hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shoulder hurt, trouble sleeping, little bit of head pressure and a general feeling of being "off" was not reported. This report was non-serious.
Sore injection site; This is a spontaneous report from a contactable consumer reported for himself. A 68-year-old male patient received bnt162b2 (Solution for injection), via an unspecified route of administration, administered in arm right on 27Jan2021 17:00 as for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021 17:45 patient had ore injection site. There was no treatment for the event. The outcome of the event recovering.
20x13cm left lower extremity erythema, red hot, pruitic and non tender.
soreness near the area of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 09Apr2021 (Lot number: ER8735) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "soreness near the area of injection". The event "soreness near the area of injection" was evaluated at the physician office visit.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had the first shot and was fine, maybe some soreness near the area of injection for 1 day but nothing she had to take anything for.  No follow-up attempts are possible. No further information is expected.
Diagnosis of decreased immune system; This case was reported by a pharmacist via other manufacturer and described the occurrence of decreased immune responsiveness in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOVAX) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Shingrix, PREVNAR 13 and PNEUMOVAX. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Shingrix, the patient experienced decreased immune responsiveness. On an unknown date, the outcome of the decreased immune responsiveness was unknown.   It was unknown if the reporter considered the decreased immune responsiveness to be related to Influenza vaccine Quadrivalent unspecified season and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient received Flu, Shingrix and Prevnar 13, Pneumovax vaccine at one time and went to the hospital with a diagnosis of decreased immune system. The reporter consented to follow up.
always gotten sick; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via social media.  This case involved a patient with unknown demographics who always gotten sick (Illness), while he/she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient who always gotten sick (Illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Onset of feeling unwell within a few hours of shot, believed to be normal side effects. Fever approximately 12 hours after shot with subsequent onset of AMS, syncope, intractable vomiting, headache, and chest pain at about 0630 the following morning. Patient made it to his vehicle when leaving work and was found slumped over the steering wheel in semi-responsive state. Symptoms described sound consistent with hypotonic-hyporesponsive episode following vaccination. Patient was transported to the hospital via ambulance and treated in emergency department. Full workup to include bloodwork, EKG, head and chest CT, chest xray were performed. Multiple medications were also administered including normal saline (2L), benadryl, compazine, decadron, toradol, zofran,  and electrolyte A (1L). Concerning findings from lab results were limited to a positive d-dimer test, which indicated chest xray and CT for concern of possible PE. At time of CT with contrast, chest pain had resolved and no PE located. Patient discharged home that evening.
shaky; my hands having a slight twitch; tired; slept all day; sustained readings of "signs of atrial fib."; This is a spontaneous report from a contactable consumer. A 68-year-old male consumer (patient) reported that received the third dose (booster dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 26Sep2021 at 12:30 (at the age of 68-years-old) at single dose for COVID-19 immunization. The patient had received another dose of BNT162B2 on 15Feb2021 at 12:45 PM in the Left arm. Within 4 weeks prior the booster dose on 13Sep2021, the patient had received flu vaccine - left arm. Medical history: included atrial fib; mild asthma; high blood pressure; high cholesterol; thoracic aortic aneurysm. No known allergies. Concomitant drugs included eliquis; montelukast; amlodipine; melatonin, budes. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Sep2021 04:30 PM approximately four hours after the shot the patient's Apple Watch showed sustained readings of "signs of atrial fib."  On the next morning he was shaky, with his hands having a slight twitch.  He was tired and slept all day. On the subsequent day (i.e. day 2) he was fine. The event resulted in Doctor or other healthcare professional office/clinic visit. no treatment was given. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the event was recovered on 28Sep2021.  The Lot number for BNT162b2 was not provided and will be requested during follow up.
Pt stated her arm started to swell and she felt pain which radiated down to right elbow.  There was a knot about 80mmx80mm.
On 04/21/2021, immediately after the vaccination- my throat started getting tight and it felt like it was closing up. The nurse on site gave me Benadryl. On 04/22/2021, by the next day I got up, I had chills, my legs felt weak and would give out from underneath me. I was dizzy, fever, my heart would race, and this kept continuing for a couple of days. I went to the Emergency Room as well. My heartrate was resting around 120- 130, and it would just rise and fall really fast and I would  just collapse. I had to wear a heart monitor. The doctor could not determine what was happening. There was no cause why that was happening. I would get heart palpitations. The heartrate last for like 3 months. It had decreased some. Every once in a while I would feel my heart race up until August. It wasn't as bad as the beginning. By August, it was occasionally. I was still being affected from my fast heartrate and dizziness, up until I got COVID-19. I got COVID-19 08/21/2021.
An 18-year-old female patient with no relevant medical history, had received an intramuscular intramuscular left arm injection of Menactra, lot number U2393BA on 09 August 2007 and six days later complained of fatigue and numbness and tingling in her hands and feet. The patient had also received an intramuscular left deltoid injection of Gardasil (Merck), lot number 0525U on 24 July 2007. The patient had not received any concomitant medications, had no relevant medical history and had not been ill at the time of vaccination. The reporter stated that the patient had received a meningococcal immunization one year ago, however the specific vaccine was unknown at the time of the report. The reporter did not indicate any prior events had occurred. On 15 August 2007, six days after she had received the vaccine, the patient complaint of fatigue and numbness and tingling in her hands and feet. Laboratory testing had been performed 15 August 2007 which included CBC, Sed rate, BMP, TSH, and Lyme titer. All laboratory results had been pending. The reporter indicated that the patient had not yet been evaluated by their physician. No further information has been provided. At the time of the report, the patient had not recovered from the event.
pt recv vax & exp the flu months p/recv each of first two doses;No further details were provided;
1/19- 6 hours after receiving vaccine, patient experienced fever, weakness, joint pain 1/20- developed a severe throbbing headache and fatigue.  1/21- headache continued 1/22- severe dizziness, extremely weak and pale: presented to Hospital Emergency Dept presently still experiencing  headaches and dizziness
Feeling unwell after shot, put head down, was giving smelling salt and ice pack, was helped to walk to room, fainted on the way.
Patient reported that the next day after receiving both vaccines he broke out in a mild rash scattered throughout his body. He describes the rash as "mini bug bites that itch a little bit". The rash started the day after he received the vaccines (10/30/19) but the patient did not report the adverse reaction until 11/9/19. I confirmed that he had no allergies and did not change laundry detergent or soaps recently. He says the rash is getting a little better. I instructed the patient to try Benadryl, and second generation antihistamine, or hydrocortisone.
LVN states as she injected left arm with stated Pfizer dose with syringe the dose (large amount) leaked down the patient's arm.  LVN stated the patient did not get the dose of 0.3.  Per MD and healthcare providers and according to the CDC guidelines the dose was repeated in the left arm with no issues. There was no adverse reaction to the patient and patient waited the stated observation time of 15 or more minutes.