chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; This is a spontaneous report from a sponsored program Support. A contactable consumer (patient's mother) reported for patient (daughter). An unspecified age of female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: not reported), via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) on 13Feb2021 for covid-19 immunisation. On unspecified date the patient experienced that reporter and reporter daughter had their first dose the 13th of February and second dose last 6th of March. reporter daughter had Hives all over her body (reactions) 2 weeks after the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Small amount of vaccine approximately one drop exuded from vaccine site upon withdrawal of needle. Vaccinator notified myself, Clinical Lead to evaluate. I confirmed that approximately one drop of vaccine on patients arm. Since patient received greater than one half dose, no countermeasure was done.
This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with COMVAX (strength, dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored COMVAX on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
fever 105.2 given APAP 2 hr p/inject by evening in spite of APAP; cried & lethargic-drank normally from bottle; wouldn't eat-flat red rash over body gone w/in 24 hrs;
Mom reports infant developed fever of 105 @ 3AM 1MAR91 & incessant crying; Fever lowered to 102 p/Tylenol q4h & tepid sponging;
A few days post vax the pt developed chickenpox consisting of approximately 40 lesions. The pt was seen in the ER. He was administered breathing treatments, including albuterol. On 5/13/99, it was noted that the pt was prescribed acyclovir. Additional information has been requested.
weakness; This is a spontaneous report from a contactable consumer. An 88-year-old female patient  to received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified at a single dose for covid-19 immunisation, apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date and ongoing at an unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced weakness. It was further reported that patient got the first shot scheduled to get the second on 08Jan2020.  The patient had weakness from the shot and would like to known how long will the weakness last. The action taken in response to the event for apixaban was dose not changed. The outcome of the event was unknown.  Information about lot/batch number is requested
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) lot# L005297, expiration date: 17-AUG-2016, (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse, the dose was exposed to a temperature excursion from 12-AUG-2015 at 12:30 PM to 14-AUG-2015 at 5 PM, for a total of 53 hours at 13.1 C. This is one of several reports from the same reporter. Additional information has been requested.
their hart beating really fast; not being available to sleep; soar arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (their hart beating really fast), INSOMNIA (not being available to sleep) and PAIN IN EXTREMITY (soar arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037c21a and 037c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soar arm). On 28-Aug-2021, the patient experienced HEART RATE INCREASED (their hart beating really fast) and INSOMNIA (not being available to sleep). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (their hart beating really fast), INSOMNIA (not being available to sleep) and PAIN IN EXTREMITY (soar arm) outcome was unknown.            Concomitant drugs were not provided.   This case was linked to MOD-2021-300344 (Patient Link).
Arm redness/rash extending down to elbow appeared 1 week after injection. Warm to touch and itchy. Applied cool compresses. Took Motrin when needed. Resolved  approximately 10 days later.
Dry skin, Hives, Itchy skin, redness, sensitive skin, fatigue, severe sinusitis, common allergies, prostate inflammation
Received Fluarix IM right deltoid 10/18/06 at 8:30 am woke with pain at 2:21am 10/19/06 with right arm pain extending to axilla. Treated with erythromycin. with resolve of pain in 2 days.
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included DOLUTEGRAVIR SODIUM (TIVICAY), EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) and IVERMECTIN for HIV disease.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drugs were reported.  The patient had no known allergies
This spontaneous report has been received from a medical assistant and refers to a 4-year-old patient of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 13-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. The reporter also stated that she had a printed report of the patients who received vaccines that had undergone the temperature excursion. The report included vaccine name, date given lot number and the name, gender and birth date of patient. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has already been received. This is an amended report, as corrected. This report was previously submitted with the incorrect Worldwide unique case identification number US-009507513-1705USA005093', and this new follow-up submission is to provide the correct identification number US-009507513-1706USA003935'. US-009507513-1705USA005093' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique identification number. Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094: US-009507513-1705USA005093: US-009507513-1706USA003934: US-009507513-1705USA005093: US-009507513-1706USA003936: US-009507513-1706USA003937.
I contracted COVID-19 on 4/26/2022 with symptoms of sore throat, felt feverish, productive cough, congestion, fatigue, myalgia, chest tightness on day 3 and 4, and this symptoms lasted for 4 days before beginning to resolve. I was prescribed Paxlovid on 4/29/2022. I had a slight cough lingering, but my other symptoms have resolved.
Multiple vulvar ulcers; This is a literature report.   Background: Vulvar ulcers have been associated with viral and bacterial infections and accompanying prodromal symptoms. These ulcers have been reported during infection with SARS-CoV-2. Authors describe a case of adolescent female who developed vulvar ulcers after COVID-19 vaccination without SARS-CoV-2 infection. Case: A 13 year old post-menarchal female with celiac disease and one prior episode of vulvar ulcer presented with fevers, chills, myalgias, vulvar pain and dysuria one day after receiving the second dose of the Pfizer-BioNTech Covid-19 Vaccine. Multiple vulvar ulcers were noted. She was treated with topical lidocaine, ibuprofen, and acetaminophen. She re-presented three days later urinary retention and pain. An indwelling catheter was placed and she was treated with cefalexin and prednisone. Vulvar culture was positive for corynebacterium and the work-up including HSV, EBV, CMV, ANCA, HLA B27, and ANA were negative. She was discharged after five days and reported resolution of symptoms and healing of the ulcers on day 14. Comments: These cases illustrate the association of vulvar ulcers with Pfizer-BioNTech Covid-19 vaccination in adolescent female. Future investigation is needed to understand optimal treatment modalities without disruption of vaccination efficacy and immune response.; Sender's Comments: Based on the available information provided, the causal association between the reported event Vulval ulceration and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200052891 Same article/drug/event and different patient;US-PFIZER INC-202201104493 Same article/drug/event and different patient;
Roughly 3 weeks after my initial dose I developed a rash on my forehead. I assumed it was a reaction to a hat I had worn or something but it got worse every day.  I saw a doctor yesterday via tele visit and I believe it is a shingles outbreak which has spread to most of my face.  I'm about in the middle of the outbreak so it is better than it was but still very painful.
Right  side of face hot feeling  and reddening with numbing feeling  in check  ,lips jaw, lasting  about 5 to 6 hrs then pain from my neck and whole  shoulder socket down  to my hand all on th right side skin extremely  sensitive  to touch, hot to touch with  swelling very  limited range Unable to extend  arm outward as of 03/02/2021 @ 12:15 a.m. .  Ibuprofen  and Tylenol taken through  the night with not much relief now trying  aleeve if not feeling  better  tomorrow  may need  to  see primary dr. Also had a very strange bitter/metal  taste to my lips and mouth  when they were feeling  hot and numbing.
Fever the day after (14 hrs after vaccine) of 100.7 when I took two tylenol, which I continued for the next 15 hrs. 2 tylenol reduced the fever.
Pt. given BOOSTRIX and Varicella #2 in lt arm & then given HPV #3 & immediately (Rt deltoid) eyes glazed & felt faint, went to lay back & then became diaphoretic & jerky movements of arm & legs. Then stiffened out. Laid pt. back, yelled for help & then took B/P which was 104/82. Gave cold compresses for forehead & a glass (4 oz) orange juice. Patient was not incontinent of urine or stool. Was alert & oriented x 3 immediately afterwards. Doing fine after. Had physicians see, both Drs. Pt. apparently vomited after HPV #2, but did not advise us of such. Told to advise anyone who gives her a shot of what happened after this event. Mom with pt. & drove her home after physician did physical on her. Pt. fine when left. (Seemed vasovagal but not sure it wasn't caused by immunizations).
Immediate itching at site, then perioral itching, numbness, "not feeling right", hypotension.
Large area of Redness on Entire (L) thigh spreading to entire thigh - hot to touch and swelling
Vaccine administered to (L) delt 10/13/08. Had progressive atrophy at injection site beginning 10/23/08.
Pt developed rash near site of injection. Rash developed day after inj. Pt visited urgent care on day 2 and was given BENADRYL & MEDROL DOSE PACK. On 10/24/09 pt visited pharmacy and stated feeling much better.
Sx onset same day of vaccination:  fatigue.  Later in evening R deltoid edema and erythema. Starting 4/4/21 pt reports difficulty w/R arm active range of motion.  Had to use L  hand to lift R arm.   5/3/21 range of motion began to return 5/5/21 range of motion back to baseline.  On exam injection site w/very mild edema, no erythema.  Pt describes as "bruised inside".
Sleepiness; Arm discomfort/ Heaviness in arm; Pain in the arm/ Tenderness in the arm; Swelling in the arm; Redness in the arm; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm) and VACCINATION SITE ERYTHEMA (Redness in the arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (Redness in the arm), FATIGUE (Tiredness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (PANADOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepiness), VACCINATION SITE DISCOMFORT (Arm discomfort/ Heaviness in arm), VACCINATION SITE PAIN (Pain in the arm/ Tenderness in the arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (Redness in the arm), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-378132 (Patient Link).
Guillain barre, Attacked his immune system Neurological disorder; Initial information was received on 18-Oct-2021 regarding an unsolicited valid serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211021001514).  This case involves adult male patient (unknown age) who experienced Guillain Barre syndrome, attacked his immune system neurological disorder (Guillain Barre syndrome), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(s), vaccination(s) 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 developed a serious Guillain Barre syndrome, attacked his immune system neurological disorder (Guillain barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.; Sender's Comments: This case involves an adult male patient (unknown age) who presented with Guillain Barre syndrome (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Fever 102-103, lethargic, very irritable & periods of high pitched crying;
Allergic reaction; It affected her breathing and heart rate/shortness of breath; It affected her breathing and heart rate/shortness of breath; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 30Dec2020 for immunization. The patient's medical history and concomitant medications were not reported. Patient received the vaccine on 30Dec2020 (day before reporting) at her place of work and about 12 hours after she received it during the night, she had an allergic reaction. Nurse thought it's an allergic reaction versus side effects because it affected her breathing and heart rate. They called 911 and it came in waves and they didn't go to hospital. She was better the day of reporting, although she was still having some waves of the shortness of breath and the nurse gave her one 25 mg (diphenhydramine (BENADRYL). Nurse asked do if company had a plan for allergic reaction after the vaccine to avoid having to go to the hospital. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Initial medication error report received on 05 December 2013 from nurse. A patient whose age, gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination was not reported) on an unknown date. Reporter stated that consumer received incorrect route of vaccination. Patient did not have any adverse events. List of documents held by sender: none.
pt cried constantly for several hr p/vax;there was a small red area @ shot site;complete recovery no tx required;
hospitalized 9/22/2021. Symptoms include shortness of breath, nausea, fatigue, and abdominal pain.
On 4th day, shingles on right side. Lasted 10 days 2 big bumps. Red 4in around.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-MAR-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K008927, expiry date 17-MAR-2016) (dosing regimen, frequency and route unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of the events was unknown. Additional information has been requested.
Severe daily hair loss from hair follicle. The hair follicle are attached to each strand. I am currently losing four times the average daily hair loss.  This has occurred non-stop after receiving the Covid-19 Pfizer vaccine.  This fallout occurs during every shower, brushing and throughout daily activities. This has occurred as of 6/23/2021 approximately two consecutive months and counting.
This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a licensed practical nurse concerning a 16 year old female with migraine and a history of termination of pregnancy 1 year ago in 2006 who on 31-JUL-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of Gardasil (lot 655205/1426F). Concomitant therapy included hormonal contraceptives (unspecified), promethazine and cyproheptadine hydrochloride. On 13-SEP-2007, the patient came into the office complaining of right side pain that was radiating to the back. Pregnancy was confirmed on 13-SEP-2007 by pelvic and transvaginal ultrasound and by HGC level.  Date of LMP was 03-AUG-2007. On ultrasound on 04-OCT-2007 was within normal limits. Additional information has been requested.
fever 104 2 days p/the vax; febrile sz 29JUL94 observed @ home; did not see a MD;
Serpiginous exanthema on feet, thighs, and hands with swelling of hands onset 5 days after vaccine. Consistent w/serum-sickness.
A non-serious spontaneous report of "gave H1N1 mist to our doctor and he is over 50" has been received from a medical assistant concerning a 53-year-old male patient, subsequent to H1N1. The patient's medical history and concomitant medications were not reported. On 12-Oct-2009, H1N1 was given to the patient. Per the reporter, the patient had "no problems" and no treatment was administered. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Mild swelling and redness 1 day after received vaccine.  No fever, no LOM.  6x5 cm erythema lateral aspect of left thigh, no hematoma no induration no warmth no tenderness.  Treatment: Motrin as needed, warm compress.
Patient experienced high fever. Mother said her work called and said patient needed to be picked up due to hallucinations. Left arm started swelling.
Patient was given high dose influenza instead of quadrivalent dose. Patient was monitored for 15 minutes which is typical time following vaccination in the office no adverse reaction noted, he was allowed to leave.
14 hours after immunizations were administered, developed a low grade fever. Two hours later, she began seizing. She had 3 seizures in 20 minutes. Was taken to the ER, had a temp of 101.4, was given Motrin, seizures seemed to stop, was discharged with "fever related tremors." Later that day, she had 2 more seizures, went back to ER, was admitted after having 3-5 more seizures. Episodes continued for 9 days, approx 5 minutes to 4 hours apart, lasting anywhere from 10-15 seconds to 3 minutes. Testing included an MRI, EEG, spinal tap, and much blood work to check for viral or bacterial infections. Was given Phenobarbitol to control seizures. Was hospitalized for 11 days.