chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/26/16 her Rt arm swelling and redness. She developed fever and body aches. The patient was admitted overnight and IV antibiotic therapy. Patient responded well to treatment and recovered 100%.
symptoms on 3/16/21- Fever- his temperature at 10 am 100.4  - his temperature at 1:45 - 101.4 currently experiencing -moderate chills, severe headache, moderate joint pain, severe muscle and body aches, severe fatigue, mild nausea
Patient with father waited in waiting room 15 minutes. Left office and patient fainted in elevator after leaving office. Dad returned to office. Pt escorted to room to lay down. Pale, nauseous, diaphoretic. BP 98/60. Seen by MD.
has a rash going up and down her arm that resembles chicken pox/Rash going up and down her arm; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced vesicular rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The patient received first dose and had rash which were going up and down her arm that resembled chickenpox. The patient's doctor prescribed her Benadryl. The patient did not want to provide health care professional information. The patient was hesitant to provide any adverse event details, demographic and information. The reporter did not consent to follow up.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral (lot #, expiration date and dose were not reported). There was no adverse effect reported. Administered doses of vaccines experienced excursion of temperature range between 32 and 36 degrees Fahrenheit for 80 hours. Data logger was not involved. There were no previous excursions reported. Additional information is not expected as there was no consent for further contact.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt has had fainting spells within the last year, pt and parents did not want to seek medical attention or call 911, pt stayed in pharmacy for 45 minutes
Lethargic, SOB, emesis, Altered mental status, respiratory failure  Starting day after 2nd vaccine dose of Thursday afternoon
Throat tightening/discomfort after the vaccine.  The clinical lead gave 25 mg Benadryl and monitored x 30 minutes with a return to baseline.
Information has been received from a mother concerning her 6 year old daughter with no allergies who in May 2002, was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . There were no concomitant medications. Two weeks later, the pt broke out in hives all over her body. The pt was treated with diphenhydramine hydrochloride (BENADRYL) liquid and diphenhydramine hydrochloride (BENADRYL) cream on the sores. The pt recovered in approximately one week. It was reported that the pt had the same reaction two weeks after being vaccinated with poliovirus vaccine inactivated in Sept 1999. No further information is expected.
26May2021: Dose Number: 1/ 28May2021:Nasal Swab: Positive; This is a spontaneous report from a contactable consumer. A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 17:30 (Age at vaccination 37 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included venlafaxine (VENLAFAXINE); colecalciferol (VITAMIN D [COLECALCIFEROL]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, patient been tested for COVID-19. The patient experienced 26May2021: dose number: 1/ 28May2021 nasal swab positive on an unspecified date. The patient underwent lab tests and procedures which included nasal swab test was positive on 28May2021. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
severe rash over entire body 5 days after immunizations with fever pt seen in ER/.RX of Bendadryl was given were notified today.
Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was feeling light headed when his girlfriend called me over. The patient explained that he was dizzy and may pass out. He lost conciousness for approvimately 10 seconds. He came to and we laid him on the floor where the Pharmacist monitored him. He felt better and leftm here feeling fine.
Very little side effects for the first 4 days,  then hypotension for 3 days,  BP got down to 85/42. In and out of consciousness,  fainted once,  had to lay down or have lots of pain in abdomen. Treatment forced fluid until I was well enough for them to bring me to urgent care.  Urgent care prescribed antibiotics and gave me a liter of fluids.
Hospitalized Fever  vomiting  muscle aches and pains from head to toe Sore throat Chest pains
Big red rash below the injection area.  The skin was hot to touch, burning and itching.  Size of a medium mango.
She was amazingly thirsty; Ache; Generally weak; Her memory dull; Sick; Feeling fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull) and ILLNESS (Sick) in a 54-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.     Concurrent medical conditions included Allergy to nuts.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull), ILLNESS (Sick) and FATIGUE (Feeling fatigued). At the time of the report, THIRST (She was amazingly thirsty), PAIN (Ache), ASTHENIA (Generally weak), MEMORY IMPAIRMENT (Her memory dull), ILLNESS (Sick) and FATIGUE (Feeling fatigued) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication were provided.  Patient stated that flu shot had never bothered her.   This case was linked to MOD-2022-484102 (Patient Link).
Information has been received from a female registered nurse concerning her husband who about 5 years ago, in approximately 2006, was vaccinated SQ with a 0.65ml / one time dose of ZOSTAVAX (Merck) (lot number not provided). The registered nurse reported that her husband got the vaccine and on an unspecified date developed shingles. It was unspecified if the patient sought medical attention, if any treatment was given for the adverse event or if any lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Follow-up information has been received from the registered nurse concerning her approximately 69 year old husband, who "a few years ago" (also reported as about five years ago) was vaccinated subcutaneously with a 0.65ml/one time dose of ZOSTAVAX (Merck) (lot number not reported). The registered nurse reported that on approximately 02-MAY-2011, approximately six or seven weeks ago, her husband developed shingles. She also reported that on approximately 13-JUN-2011, last week, her husband was diagnosed with viral meningitis and was hospitalized (date unspecified). Registered nurse wanted to know if there was any scientific connection between shingles and meningitis. At the time of the report, the registered nurse stated that her husband had recovered. No further information is available.
2.5 by 2.5 cm hive distancing to injection site on left upper arm.
injection of MCV4 and Tdap in (L) deltoid 5/3/07. Erythema swelling, pain in area of injection site 5/3/07 Area measured 8 x 6 cm
10/14/2013 at approximately 12:30 received vaccination stating later that day in evening she had lethargy and low grade temp 100.3 (max) she reported headache (migraine) and lethargy she stated she continued to take TYLENOL and c/o of N and V and diarrhea 10/16.
I experienced headache, fever, chills, fatigue, that lasted for 24 hours. I developed the initial rash on my abdomen that that lasted for 14 days. The rash returned 3 weeks later and has spread over my abdomen, back, armpits, chest with itching, and burning. I was prescribed a steroid cream and instructed to take BENADRYL by my physician. The rash has not resolved and is continuing to spread, worsen.
Itching at vaccination site; Swelling, the size of a chicken or goose egg; Injection site warm and red; Injection site warm and red; Tender, injection site, only when touched; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 02Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EP7534), via an unspecified route of administration on 21Mar2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient received unspecified medication as concomitant drug. The patient states that she did feel great for basically the first 8 and a half days, she had no side effects. On 30Mar2021, she decided to put rubbing alcohol and swab the area, as she hadn't done that before. She was in the car, with the sun on her shoulder and she noticed that it was starting to itch at the vaccination site, but she tried not to itch it. Later that night, she went to bed and it started itched again. She realized she had swelling the size of a chicken or goose egg. She got up and took her temperature, it was normal. She noted the site was warm and red, not alarmingly, but red with a 2.5-inch circumference, and it was swollen. She did not panic because she did not have a temperature. it remained swollen for the next day, but she still had no temperature, but it was itchy and warm. She stated she didn't do anything and tried to stay calm. She looked over the pamphlet that she got, and saw what it might be. The outcome was recovered for swelling, the size of a chicken or goose egg on 31Mar2021 and recovering for rest of the events.  No follow-up attempts are possible. No further information is expected.
Posterior vitreous detachment in the left eye resulting in a vitreous hemorrhage. Examination showed bleeding near the optic nerve with no retina damage. Treatment is a follow-up in 3 weeks to monitor the retina and no heavy lifting or gym for 2 weeks.  There is a large blood swirl/floater in the left eye.
received pediatric doses; received pediatric doses; received pediatric doses; received pediatric doses; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix 720) (batch number 2K57N, expiry date 11th December 2022) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, Havrix 720 and Havrix Pre-Filled Syringe Device. On 4th March 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose, adult use of a child product, underdose and adult use of a child product. On an unknown date, the outcome of the underdose, adult use of a child product, underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: The reporter was practice manager. The reporter stated that a patient received pediatric doses of Havrix and Engerix-B. The reporter consented to follow up via postal. Additional Supportive Information: The reporter stated that, a patient received pediatric doses of Havrix and Engerix-B, which led to underdose and adult use of a child product.
On Friday 1/7/2021 I noticed my arm was red and swollen. It also hurt and I was not able to lift it. I went to urgent care on Saturday on 1/8/2021 and they prescribed my antibiotics. Today 1/12 it has gotten worse. It?s still red and hot, but less swollen. It has began to itch and stings.
initially resp problems & fatigue then to clinic for tetanus induced encephalitis;initially fever, aches & pains, nasal congestion;
Hives at injection site, gave BENADRYL advised mom to give in 6 hours if hives came back or go to ER, call 911 if any trouble breathing.
Donor stated she felt nauseous when she woke up on the morning of 10/21/15 (23 hours after the Tdap injection given). She then ate crackers and drank juice. Nausea resolved after ingestion of food.
PATIENT CALLED STATING SHE HAD REDNESS, SWELLING, AND PAIN AT INJECTION SITE.  SHE STATED IT WAS SWOLLEN, BUT NOT FLUID OR PUS COMING FROM SITE.  SHE STATED SHE WAS GOING TO TAKE SOME IBUPROFEN AND WOULD CALL BACK IF IT GOT WORSE.
pt recv vax 16MAY97 & 60hr p/vax pt exp possible 2min sz & posturing, eyes were nearly closed, had pallor & was unresponsive to proding by paramedic;no jerks, afeb, no high pitch cry, mild irritability;adm to hosp;
I started running a 101-102F fever; when I woke up that morning of 07/13/2022, I had that terrible fever that lasted for about 3 days. I had a really dry cough, headache, body and muscle aches, and that fever. I took an at-home COVID-19 test that came back negative. So I went to the local pharmacy to take a PCR test, but that one also came back negative. So I waited until my symptoms subsided to visit my physician. He took a chest x-ray and monitored my breathing and noted that I may have had COVID-19, but I'm doing better. As of now, I still have some minor fatigue since recovering.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. The expired vaccine was administered on 3 different dates, 4JAN2022 (20 patients), 6JAN2022 (29 patients), and 11JAN2022 (14 patients).  HCP stated that some patients had reported flu-like symptoms after receiving the vaccination. The number of doses/vials-63 doses, 3-4 vials. Date the vial was initially stored in the refrigerator-01-Dec-2021. The vial doesn't undergo any temperature excursions.
pt called reporting pain and swelling under in her underarm and near her breast. She stated she thought her lymph nodes were swollen and one was golf ball size.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age or gender. No medical conditions or allergies were reported. On 14-OCT-2008, also reported as 14-OCT-2013, the patient received the first dose of M-M-R II (dose, route and lot number were not provided). On 26-AUG-2013, the patient received an expired M-M-R II as the second dose, lot number 1123AA and expiration date 12-JUL-2013, (dose and route were not provided). No adverse event reported. Additional information is not expected.
ADMINISTERED VACCINE APPROXIMATELY 6 HOURS PAST THE EXPIRATION TIME; VACCINE STORED 6 HOURS PAST EXPIRATION TIME; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 08-DEC-2021, the patient experienced administered vaccine approximately 6 hours past the expiration time. On 08-DEC-2021, the patient experienced vaccine stored 6 hours past expiration time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine approximately 6 hours past the expiration time and vaccine stored 6 hours past expiration time was not reported. This report was non-serious.
dizziness, weakness, palpitaitons   Treated with rest, lying supine  and oral fluids
Low grade fever; A spontaneous report was received from a nurse concerning a male nurse patient who received Moderna's COVID-19 Vaccine and experienced the non-serious event of low grade fever.  The patient's medical history included post COVID. No relevant concomitant medications were reported.   On 21 Dec 2020, prior to the onset of the event, the patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient developed a low-grade fever which resolved the next day. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The event, low grade fever, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a male patient who experienced a non-serious expected event of Pyrexia, which occurred the day after first dose of mRNA-1273 administration. Very limited information regarding the event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Towards the end of March, every time I ate it started to bring about pain on my left side. After visiting my GI doctor, they stated that I would need more bowel movements. I have started taking herbal teas that are helping with my movements however every now and then I still have those pains come about.
Primary Care Physician at Discharge:  Hematologist/Oncologist:  Admission Date:  Discharge Date:  Patient's Discharge Disposition:  Home in stable condition.  Admission diagnoses: Covid Dyspnea Mild Anemia Neutropenia Localized Esophageal Adenocarcinoma Treatment related Nausea Cerebral Aneurysm  This is a 66 y.o. year old patient who was admitted on 9/25/2022 with PMH of esophageal cancer who has had dyspnea for several weeks prior to arrival.  His initial symptoms of fatigue, cough, and dyspnea with activity started around 9/9/22 and he presented to ED with this on 9/13/22 but it does not appear he was screened for Covid at that visit and he was diagnosed with B/L lower lobe PNA, which was treated with Ceftin.  Patient had since completed all abx for Pneumonia, but symptoms of cough and dyspnea with activity persisted. He was in the office on 9/24 for chemo, which was held because of neutropenia, at that visit he was started on a prednisone taper for possible pneumonitis. He did go to the pharmacy and get a Covid test later that day which was positive.  His wife called the office requesting paxlovid, but patient was directed to the ED for IV treatment.  In the ED patient was found to be 97% on room air and was afebrile.  CT scan was repeated and showed slight increase in consolidation of B/L airspace disease. Upon admission interview with oncology, he did tell us he was actually feeling better and afrible and less SOB; however he was admitted for monitoring per Dr recommendations.  As symptoms have started > 2 weeks ago, not a candidate for Remdesivir.   Pulmonology was consulted and did not suspect checkpoint inhibitor pneumonitis but felt his history and findings were more significant for aspiration pneumonia and residual COVID19.  SLP was consulted and assessment showed swallowing function was normal and GERD education done.  Pulm recommended short steroid taper, antibiotics for 5 days (unasyn while IP and augmentin upon DC).  Pulm recommended outpatient f/u with them after CT in 4-6 weeks though if symptoms not improving, they recommended bronch.  Dr. recommended follow up CT in 2 weeks which will be arranged as well as follow up per below (patient educated on same day clinic if needed).  Chemo is on hold until after outpatient follow up.   Prior to discharge today, patient denies new, worsening or changes in ROS at this time, including no fevers/chills/sweats, no CP/SOB/DOE, no abd pain/N/V/D, and no neuro changes.  Patient eating/drinking/voiding well and ambulating as tolerated.  Patient will plan to follow up in our office as per below.  Patient's discharge medications were discussed and new prescriptions were sent to patient's requested pharmacy prior to discharge as per generated list below.  Patient is aware to call our office should further questions or concerns arise following this discharge.    I spent 65 minutes performing and arranging this hospital discharge.
Administered vaccine (Varicella, MCV4, & Tdap) to her left arm on 9/15/08 in the morning. Pt returned to clinic 9/16/08 in the afternoon c/o moderate reaction from vaccine: left arm painful, red, and swollen. Patient denies fever. Patient afebrile at the time of visit. Instructed patient to apply cold compress to affected area and take tylenol or advil for pain if not contraindicated. patient and mother vervalized understandin.