chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-Sudden onset of dermatographia and  urticaria with no reason for appearing. Hives would appear even when skin was touched gently. This is daily. -Prednisone was prescribed for a week where the skin didn't have hives but had the sensation of itchy skin. -Zyrtec is being taken daily, but the symptoms would return during the 24 hour period -Diet, environment, and lifestyle did not have any changes.
Patient began experiencing swelling of the left arm at about 2 hours after the Pneumovax vaccine was administered. The patient indicates that she put ice on the affected area and took acetaminophen, but the swelling continued until the next day. She thought about going to the prescriber's office but it was sunday, so she called the pharmacy. The pharmacist in charge told her to continue with the ice applications on the area and to take diphenhydramine. On monday morning, the symptom was resolved, and she felt like nothing has happened.
Mild uncontrollable shaking; Basic flu symptoms; Fever of 102; Chills; Headache; Nausea; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 00:00 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vilazodone hydrochloride (VIIBRYD), buspirone (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Mar2021 at 00:00 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. On 19Apr2021 at 04:00, first day the patient experienced sore arm. On 20Apr2021, second day, the patient experienced fever of 102, chills, headache, nausea and basic flu symptoms. On 21Apr2021, third day, the patient experienced mild uncontrollable shaking with no more flu symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 20Apr2021, the patient underwent lab test and procedure which included body temperature and result was shown as 102 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event basic flu symptoms was recovered on 21Apr2021. The clinical outcome of the events sore arm, fever of 102, chills, headache, nausea and mild uncontrollable shaking were unknown at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a nurse concerning a 12 year old male who on 10-AUG-2009 was vaccinated with the second 0.5ml dose of VARIVAX (Merck) (lot #, route and site of administration not reported).  On 10-AUG-2009 the patient developed swelling and redness at the injection site after the second vaccination.  On 12-AUG-2009 the patient also developed a low-grade fever in addition to the injection site reaction.  Unspecified medical attention was sought.  It was unspecified if laboratory studies were performed.  At the time of reporting, the patient had not recovered.  No further information is available.
Patient developed scalp sensitivity with rash, blotchy red hypersensitive symmetrically over temples and scalp. 3 weeks an d1 days after the first COVID vaccine. He sought medical attention at the emergency room 3-21-2021
Ee c/o fever, nausea, faintness within 5 minutes of vaccine.  Itchiness x 2 days (without rash).
This spontaneous report was received from an approximately 70-year-old female patient of unknown age with no pertinent medical history. Current conditions included allergy to ZANTAC IV. On 14-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on an unknown date in February 2013, the patient developed bright red hard spot that spread about 8 inches down the arm where (she) received ZOSTAVAX. The patient stated the spot was "itchy". As the spot faded, the patient stated that "it turned darker brown and got smaller". Treatment was not rendered for the events. The events recovered on an unknown date sometime in early March 2013. The patient did not seek medical attention for the events. Laboratory diagnostic studies were not performed. Causality was not reported. Additional information has been requested.
Information has been received from a pharmacist concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient developed lymphadenopathy. The pharmacist thought that the patient went to the emergency room, but was unsure whether the patient was admitted to the hospital. The pharmacist also believed that the lymph node was removed, but was not aware which procedure was utilized for the removal. The patient visited the emergency room, however it is unknown if the patient was hospitalized. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Team alert called at 1227.Pt had second Pfizer Covid vaccine at 1155. C/O dizziness around 1215. Sitting in chair with son at her side in wheelchair. Waiting for daughter-in-law. A&OX3. Head down. Denies pain. Skin warm and dry to touch. Feet elevated. BP 76/44. O2 sat100%, P-60. No breakfast this morning. Denies diabetes. Apple juice 6oz provided and consumed. Declined water. Daughter-in-law arrived, reports BP never that low. Patient remains dizzy. Team Alert called. Daughter-in law took patient's son to restroom. 1230-BP-89/50, P-60, O2sat-100% on RA. Report given.  Daughter-in-law and son returned, advised patient taken to Dr. department/office
Raynaud's phenomenon; This spontaneous case was reported by a physician and describes the occurrence of RAYNAUD'S PHENOMENON (Raynaud's phenomenon) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RAYNAUD'S PHENOMENON (Raynaud's phenomenon). The patient was treated with Physical therapy (Rewarming the limb) for Raynaud's phenomenon. At the time of the report, RAYNAUD'S PHENOMENON (Raynaud's phenomenon) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Added patient contact details, Patient demographics. and Route of administration details.  Updated treatment details.
After the vaccine, patient said he felt hot.  Later that day,he was starting to have muscle aches and then he noticed testicular and prostate swelling.   He followed with his PCP and the PCP prescibed an antibiotic; however, patient did not recall the name of it.  He is still being treated.  He noticed an improvement.  He started the antibiotic on 12/21/2020.
Went to a restaurant with family and went to get something to eat.  Took off her mask. On day two I woke up at 2 am and coughing and coughing an me throat hurt, and head hurt. Then called the doctor on web conference and he proscribed Molnupirazir. I took those for five days and i kept couching and couching for about two days and then the medications started to kick in and help. Then on day five that night I tested negative.  Just the cough remained.
inadvertently administered with an expired product with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 48-year-old male patient who was inadvertently administered with an expired product of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Mar-2022, the patient received a dose of 0.25 ml to 2 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once) (strength, formulation: unknown) (lot number: U6621BA and Expiration Date: 21-Mar-2022) via intramuscular route in the left deltoid for Immunization.  On 23- Mar-2022 the patient had non-serious event, "inadvertently administered with an expired product with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported, "RN requesting information regarding ADACEL PFS. The product was inadvertently administered with an expired product to an employee. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age. 48 YEARS. Dosage Information o Frequency = once ONCE o Therapy Date: From = Date of immunization To = leave blank 23Mar2022 o Route = route & site INTRAMUSCULAR, LEFT DELTOID o Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25mL o Strength = standard except for Fluzone HD o Indications = Immunization or TB skin test. Event Information o Treatment ADACEL." Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had my first shot on 4/21/21. I didn?t have a bowel movement until the morning of 5/13/21 before I received my second shot. I asked the nurse if my upset stomach was side affect with the constipation. She said she didn?t know. Since then I?ve been doubled over in pain. I haven?t had a normal BM since the morning of 5/13. I don?t eat meat or dairy. I have a very healthy lifestyle. My last last colonoscopy at the age of 58 was whistle clean. I?ve never had gastrointestinal issues.
Outcome: abnormal female mensus, had skipped menstrual cycle for 4+ months, experiencing bloating and pain in ovaries, Was prescribed Provera 5MG on July 19, 2021 to on start menstrual,  End of July: had a menstrual, August: No menstrual, September: had menstrual, October: No menstrual, November 19th: Vaginal Ultrasound + No menstrual, November 29: Vaginal ultrasound results containing 2cm cyst.
Patient presents on 4/21 with  sudden onset of severe headache start about 4 days ago and has been persistent since.  The pain is all over her head with no particular focal area. CT head: RIGHT PARIETAL CORTICAL INFARCT  She had an echo on 4/21/2021 showed normal LV size and function with LVEF 55-60% with no regional wall motion abnormalities. Normal RV structure and function. 1+ AI. No PFO by color doppler. No valvular issues. No history of atrial fibrillation. Patient then had two episodes of seizure on telemetry unit on 4/23/2021 followed by post-ictal phase  Patient was discharge 5/26/21 to home with neurology follow-up scheduled in 2-4 weeks. Patient will also receive a Holter for 2 weeks.
Menstrual spotting began and has not stopped since.; This is a spontaneous report from a contactable consumer. A 36-year-old (Non-pregnant) female consumer (patient) reported that he received First Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Jun2021 11:00 (at the age of 36-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. On 03Jul2021 patient experienced menstrual spotting began and has not stopped since. Patient did not receive any treatment. Patient was not tested for COVID post vaccination. Outcome of event was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Positive for Covid-19; A spontaneous report was received from a patient who is also nurse of unknown age and gender. The patient is participating in the mRNA-1273 Emergency Use Program and had a  positive for Covid-19 after vaccination.    There was no relevant medical history or concomitant medications provided.  On 29 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient was tested positive for Covid-19. The patient reports she received the Covid-19 vaccine on 29 Dec 2020 and after 24 hours started to have a fever and aches. There was no treatment information provided.  Relevant laboratory test on 30 Dec 2020 included a positive SARS-CoV-2 by RT-PCR nasopharyngeal swab.   Action taken with mRNA-1273 in response to the event of Positive for Covid-19 not reported.   The outcome for the event of Positive for Covid-19 was unknown at the time of this report.  Causality was not provided for the event of Positive for Covid-19.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report a received from a physician via a company representative refers to a 67 year old male patient. Medical history and concurrent conditions were not reported. In 2013, reported as about two years ago, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. In April 2015, reported as this week, the patient went to physician's office and was diagnosed with an outbreak of shingles. The patient complained of mild pain associated with the shingles, and the patient was treated with an unspecified antiviral and unspecified steroid. The outcome of herpes zoster was reported as not recovered. The causality was not reported. No lab diagnostic studies were performed. Additional information has been requested.
BlurredVision, Headache, Fever, NauseaVomiting, chills, sweating, nasal congestion Narrative:
Fever, chills, injection site soreness, swollen lymph nodes in neck, body aches, headache, and dizzyness. Went away after 12 hours.
Patient received first dose of Moderna covid vaccine 8/19/21. Came in for appointment 12/22/21 for second dose in series and received pfizer vaccine. patient waited in store and did not have any adverse reaction after shot for 20 minutes. consulted cdc website and let patient know she will not have to revaccinate
after the first dose of Shingrix developed shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and developed shingles The reporter consented to follow up.
no adverse ffects reported; one dose of improperly stored MMRII was inadvertently administered to the patient; This spontaneous report was received from a Medical Assistant, concerning a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and drug allergies or reactions were not reported.   On 03-OCT-2019, the patient was vaccinated with an improper storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) (product storage error), lot number R028003 with an expiration date on 01-OCT-2020 (strength, route of administration, and anatomical site of injection were not reported) for prophylaxis. The vaccine was administrated concomitantly with the sterile diluent which was stored properly. No adverse effects reporter nor product quality complain involved.  The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) experienced a temperature above 47 degrees Fahrenheit (52 degrees Fahrenheit) for 10 hours. It was not a previous temperature excursion. The temperature was recorded by the data logger.
She had the flu shot at about 10:30am and by ab out 6:30 that evening she was coughing wheezing and seemed to be struggling to breath. I watched her and held her for a while but it didn't go away and then her coughing became uncontrollable. i checked her SATS because i kept an oxygen moniter in the house and they were in the 70's.  By about 9:30pm after consulting the doctor on call we took her to the hospital ER.  She was given high levels of oxygen and a steroid breathing treatment and then admitted into the PICU.  She had a chest xray that showed similar signs to pneumonia and she continued for the next 3 days to receive oxygen, breathing treatments and chest palpations until she could safely return home.  For another week after being discharged, she needed breathing treatments and lower levels of oxygen.  02/05/2008 MR received for DOS 11/3-5/2005 with D/C DX:  Presumed viral syndrome.  Bronchospasm. Pt presented to ER with 1 day hx of cough, increased RR, and increased work of breathing. On PE pt was tachypneic, in mild respiratory distress with nasal flaring and intercostal retractions. (+) coarse breath sounds with expiratory wheezing. Temp 39'C. O2 sats 82% on RA, up to 92% on 50% FiO2. Suctioning revealed thick, yellow secretions. Weaned off O2 on hospital day #2.  D/Cd on Xopenex nebs PRN.
Redness and swelling with heat covering entire upper arm for about 2.5 weeks post injection
Rec'd flu vaccine on 10-17-16. Arm was sore. Then on 10-21-16 left side of body started feeling strange. Extreme pain 10/10 mostly in left leg from knee to foot. Pain continued. Went to urgent care. They sent patient to ER. Pain moves up and down leg. Started on steroids. After 3 days of steroids pain came back. Pain has not gone away.
SWEAT; BODY ACHE; CHILLS; DIARRHEA; VOMITING; NAUSEA; A spontaneous case report was received from a healthcare professional on 07-Jun-2019 for two consumers.  Based on the information obtained from the reporter, two individual case safety reports PVX201906-000466 (first consumer) and PVX201906-000467 (second consumer) were created and cross-linked in the database.  This case describes a 57-year-old female consumer (weight: 207 lbs/ 93 kg) who had diarrhea, vomiting, nausea, body aches, chills, and sweat, after taking Vivotif for unknown indication.  Case report: The consumer took the first dose of Vivotif on 27-May-2019 and the third dose on 31-May-2019. On an unknown date, she had diarrhea, vomiting, nausea, body aches, chills, and sweat. She took no treatment medication for the events.  The consumer's medical history included urge incontinence, asthma, borderline elevated cholesterol, and seasonal allergies.  Concomitant medication included oxybutynin (5 mg: once in a day), multivitamin (once in a day), and cetirizine (10 mg; once in a day).  Action taken with Vivotif was dosage discontinued.  The consumer had recovered from the events on 04-Jun-2019.  Company's Comment: In this case, it was reported that female consumer had diarrhea, vomiting, nausea, body aches, chills, and sweat after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.  Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that female consumer had diarrhea, vomiting, nausea, body aches, chills, and sweat after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events.  Hence, the causality of the events with Vivotif is assessed as possible.  US-PaxVax Berna GmbH-PVX201906-000467:
Information was received from a mother of a male consumer who on 13-OCT (year unspecified) received his second dose of GARDASIL, 1 single injection, route not specified. Concomitant medication included an unspecified nasal spray flu vaccine. On 18-NOV-2014 the patient broke out with chronic hives and developed a lump on the right side of his neck, a lump on the right wrist, and a lump on the right side of his hip. The patient sought medical attention at the emergency room. Treatment was not reported. The outcome of the events was not recovered at the time of this report. Additional information has been requested.
Nasal Swab Positive; Nasal Swab Positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose 1 (orange cap), single (Batch/Lot number: unknown) and as dose 2 (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Aug2022, outcome "unknown" and all described as "Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (unspecified date) Positive; (07Aug2022) Positive; Polymerase chain reaction: (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse issues - we were suppose to give Moderna second shot but gave pfizer; will complete the cycle per patient request
Patient became faint after her waiting period and had to be moved by wheelchair to the medic suite.  She was fairly unresponsive but did respond to verbal commands.  She was  assessed by the medic.  Her  respirations and blood pressure and pulse ox were normal, but she showed atrial fibrillation on the monitor. Called 911, and patient was transported to the Hospital by ambulance at 3:30 PM.