chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After getting the first shot of SHINGRIX vaccine, next day the patient came to pick up something from the Doctor's office, when health care professional saw the patient asked her how she was doing. The patient complained of injection site pain. The health care professional also mentioned she gave to 5 patients 4 of them did not call back.
Sore arm (4 days later still sore). Nausea for 48 hours. Dizziness for 24 hours. Weakness for 48 hours. Chills for 48 hours. Sweating for 12 hours. Body aches for 60 hours. Joint aches for 48 hours.
Tested positive for COVID 31Aug2022; Tested positive for COVID 31Aug2022; Dose Number: 1: Moderna/Dose Number: 2: Moderna/Dose Number: 3: Pfizer; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012L2UA), in left arm and on 11Feb2021 as dose 2, single (Lot number: 031L20VT), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOXYL. Past drug history included: Known allergies:daypro, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "Dose Number: 1: Moderna/Dose Number: 2: Moderna/Dose Number: 3: Pfizer"; DRUG INEFFECTIVE (medically significant) with onset 31Aug2022, outcome "not recovered", COVID-19 (medically significant) with onset 31Aug2022, outcome "not recovered" and all described as "Tested positive for COVID 31Aug2022". The event "tested positive for covid 31aug2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19..  Clinical course: Patient did not have vaccine in four weeks. Adverse event resulted in [Doctor or other healthcare professional office/clinic visit]. Patient had no covid prior vaccination. Covid tested positive post vaccination. Covid test type post vaccination: Nasal Swab on 31Aug2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective  and Covid-19 and  interchange of vaccine product  the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Caller reports patient vomited after the administration of ROTATEQ vaccine.; This spontaneous report was received from physician, referring to a 2-month-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient  was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter PO, (lot #W004504 has been verified to be valid lot, expiration date: 16-JUN-2023), for prevention of rotavirus (strength, and indication were not provided).  08-SEP-2022, the patient vomited. Then, on an unspecified date in 2022, he was recovered from the event.  The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  was unknown.
cough; difficulty breathing; lethargy; decreased appetite; high Fever; muscle weakness; headache; dehydration; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   On 18th September 2019, the patient received Fluarix Tetra 2019-2020 season (intramuscular). On 23rd September 2019, 5 days after receiving Fluarix Tetra 2019-2020 season, the patient experienced fever, muscle weakness, headache, dehydration, difficulty breathing, lethargy and decreased appetite. On 25th September 2019, the patient experienced cough. The patient was treated with salbutamol sulphate (Albuterol). On 30th September 2019, the outcome of the fever, muscle weakness, headache, dehydration, cough, difficulty breathing, lethargy and decreased appetite were recovered/resolved.   It was unknown if the reporter considered the fever, muscle weakness, headache, dehydration, cough, difficulty breathing, lethargy and decreased appetite to be related to Fluarix Tetra 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix tetra 2019-2020 in the laft arm. The developed high fever of 103.7 degree F and this was associated with headache, muscle weakness. lethargy, dehydration due to decreased appetite and difficulty to breath. Seven days after vaccination, the patient experienced cough.  On 25th September 2019, the patient was seen at the doctor's office and flu test was done which was negative.  Again, the patient was seen at the doctor's office on 28th September 2019 and she was given nebulizer treatment with Albuterol. She had completely recovered at the time of reporting. The reporter consented to follow up.
Information has been received from a nurse concerning a female patient, demographics not provided.  On an unspecified date the patient received a dose of GARDASIL (unspecified dose and lot# not provided).  The nurse reported that on an unspecified date, post vaccination, the patient "had an allergic reaction like hives" at the injection site.  No additional AE information was provided.  Additional information is not expected.  This is one of several reports from the same source.
Swollen, red arm, very itchy , swollen lymph nodes under arm.  Cellulitis treated with Celaphlex for 7 days
Patient developed watery diarrhea 1/2/09. The diarrhea lastd until 1/6/09. Patient also developed irritability and a decrease in appetite.
Information has been received from a doctor of pharmacy concerning a 60 year old male with cholesterol and hypertension who on 8-JAN-2009 was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, lot # 663638/1706X. Concomitant therapy included amlodipine, methotrexate, ezetimibe (+) simvastatin and lisinopril-HCTZ. The patient received the vaccine and on 18-JAN-2009 developed a rash on the body. Pharmacist indicated that the rash started as a quarter on the back. As of 19-JAN-2009 the rash spread to the abdomen and to the chest. The rash was not painful but sensitive to touch. Lying back on rash or putting pressure on the back area was sensitive. It was not reported that a physician friend of the patient looked at the rash and believed it was not shingles. The patient had not recovered. Additional information has been requested.
A day after immunization infant developed a cough fever and vomited.  Went to local hospital emergency room received IV fluids and came home.  Highest temperature 103.2.  Next day evaluated in the office - infant normal and asymptomatic.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Patient lied to pharmacist to obtain his first Pfizer Covid Vaccine. He was given a Janssen Covid Vaccine at a different location on 5/30/2021.
- Soreness at injection site restricting left arm mobility, particularly when raising arm such that elbow is above the shoulder, started approximately 4 hours after receiving vaccine  - Headache that started mild approximately 9 hours after receiving vaccine that intensified over the next three hours until taking 1 over the counter generic ibuprofen. Woke up the next morning (today) with intense headache that has become full body aching and soreness  - Developed low grade fever of 99 confirmed with thermometer 12 hours after receiving vaccine  - approximately 21 hours after receiving vaccine, woke up with all the same above mentioned symptoms but exceptionally more intense, about to take standard adult dose generic Publix brand Daytime Cough/Flu relief gel capsules (comparable to DayQuil)  - Symptoms intense enough that I needed to call off of work and be on bed rest
I got the shot at 6:36 pm,  I was fine until 11:45pm when I got shaky and got the chills but 4am I had the hot sweats and but 7am I felt super weak and the weakness got worse as the day went on, I had to leave work because walking down the hallway felt like running a mile
Stuffy nose, blurry vision, ringing in my ears. It was mainly like cold symptoms. I had sneezing and running nose. I still have those issues. I'm not sure if its allergy related or not. Every now and then I become flushed and you sweat a lot. It's like having a hot flash. The ringing in the ears and blurry vision is on and off. It happens every once in a while.
received expired ACT-HIB, with no reported adverse event; Initial information was received on 29-Aug-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case is linked to case 2023SA264892(CLUSTER).  This case involves an unknown age female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  On 21-Aug-2023, the patient received a 0.5ml, once dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UJ739ABA, expiry date: 10-Aug-2023, Strength: standard) via intramuscular route in unknown administration site for Immunisation and received expired act-hib, with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Administration of a dose of Boostrix to a 15 month old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number C5JL7, expiry date 28th November 2021) for prophylaxis.   On 24th June 2021, the patient received Boostrix. On 24th June 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided are as follows : Reporter called to informed about the administration of a dose of Boostrix to a 15 month old patient which led to inappropriate age at vaccine administration. Patient was given this dose 20 minutes prior to the call on 24th June 2021. Reporter consented to follow-up via email.  Note: The product start date was captured as 24th June 2021 conservatively as per narrative it seems that the patient received vaccine 20 minutes prior to the call on  24th June 2021.
Swelling; Redness; Pain; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had severe swelling, redness, and pain at the injection site after receiving the Shingrix. The symptoms resolved after 10 days.  The swelling was the diameter of a tennis ball. The field representative indicated that she was at a conference and was provided information from two separate contacts for three adverse events reports. This was report 2 of 3, reported by same reporter. The reporter unable to obtain additional details.
Patient was given undiluted pediatric dose .2ml Patient was contacted.  Left voicemail to return call to schedule full booster in 8 weeks, per CDC guidelines
Information has been received from a registered nurse concerning an 82 year old male with renal failure and on routine dialysis, "maybe" diabetes, unspecified blood pressure disorder and no known drug reactions or allergies. On 20-Oct-2004 the patient was vaccinated with pneumococcal 23v polysaccharide vaccine. At the time of vaccination, the patient was treating with vancomycin and ceftazidime (Fortaz) for an unspecified leg infection. Concomitant therapy included unspecified dialysis medications, unspecified blood pressure medication, unspecified phosphorus binders, and unspecified therapy ("Renajel"), unspecified gastrointestinal preparations (stool softeners), morniflumate (Flomax (morniflumate)), esomeprazole magnesium (Nexium), rosiglitazone maleate (Avandia), furosemide (Lasix (furosemide)), amlodipine besylate (+) benazepril hydrochloride (Lotrel), atorvastatin calcium (Lipitor), an unspecified therapy ("Koreg") and aspirin. On 22-Oct-2004 (onset date of adverse event reported as 20-Oct-2004) the patient presented to his routine dialysis appointment with severe redness, swelling, itching and warmth at the injection site. On 27-Oct-2004 the patient had the same symptoms with the addition of itching. The patient was treated with diphenhydramine hydrochloride (Benadryl) and prednisone. On 29-Oct-2004 the patient developed a rash, fever and chills. At that time the patient was treated with IV cefaxolin sodium (Ancef) and oral levaquin. On 01-Nov-2004 the patient's skin was noted to be "peeling all over his body" and the patient was hospitalized. On 09-Nov-2004, upon discharge from the hospital, the patient was examined by a dermatologist and diagnosed with "acute allergic dermatitis probably secondary to pneumococcol 23v polysaccharide vaccine, resolving with significant xerosis". The patient underwent a skin biopsy of the right forearm which showed solar elastosis and was otherwise unremarkable. As of 23-Nov-2004 the patient was reported to be 90% improved, however, in March 2005 the patient redeveloped a rash. At the time of this report, the outcome of the event was unknown. The nurse considered the acute allergic dermatitis to be an other important medical event. Additional information has been requested. OMIC
2nd dose interrupted and delayed by covid pandemic; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient reporter that second dose of Shingrix was interrupted and delayed by the covid pandemic well over a year ago, which led to social problem. The patient asked would it still receive the second dose now or had to start over.
After receiving the vaccine, my arm was very sore and I felt like I had the flu. My throat felt like it was draining and it was raspy and very tired. I tested positive for COVID-19 on 07/13/2022 from the doctors office. My test at home was negative the day before 07/12/2022. I quarantined for five days. They prescribed PAXLOVID and it really helped me feel better. Side effect of the PAXLOVID was the after taking it and long term.
Received the updated pfizer booster and the very next day I noticed a large swollen lymphnode right clavical/collar bone.  It is painful.  furthermore the lymphnodes under the arm are swollen again.  The underarm swollen lymph nodes also occurred when i received the first booster shot 11/9/22.  Those lymph nodes remained swollen for 9 months on and off.
administered the Shingrix second dose at 4 weeks and 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 77427, expiry date 25th March 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd September 2021, the patient received the 2nd dose of Shingrix. On 3rd September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The Pharmacist stated that they administered the Shingrix second dose at 4 weeks and 2 days to a patient, instead of at 2 months, which led to drug dose administration interval too short. The reporter did not consent to follow-up.
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored (at a temperature excursion of 0 degree centigrade to 1 degree centigrade for 5 hours) PEDVAXHIB lot # N003537 (expiry date: 17-NOV-2019) for prophylaxis (dosage not reported). A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1804USA011456: US-009507513-1804USA011627: US-009507513-1804USA011629.
shortness of breath, lightheaded and rapid heartbeat 45 minutes after injection. Body fatigue and muscle aches 24 hours after injection
30 minutes after my vaccine I started to feel tingling and numbness on my face, mouth and nose. The bottom part of my face was numb. I was also nauseous and  I had a metal taste in my mouth.  Today is the 5 day since my vaccine and the numbness is less. I did not have facial droop.
arrival of the shipment outside the acceptable 2-day window with no reported adverse event; children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA124713, 2023SA129826, 2023SA130667, 2023SA130874, 2023SA130917, 2023SA130922, 2023SA130029 and 2023SA129826.  This case involves Infant patient of unknown age and demographics who received dose of HIB (PRP/T) vaccine [ACT-HIB] that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date, a non-serious event arrival of the shipment outside the acceptable 2-day window with no reported adverse event (product storage error) (unknown latency), was reported.  On an unknown date, the patient developed a non-serious event children received doses of HIB (PRP/T) vaccine that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event arrival of the shipment outside the acceptable 2-day window with no reported adverse event and was Unknown for the event children received doses of acthib that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window with no reported adverse event.   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 guidelines. 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.; Sender's Comments:  US-SA-2023SA130415:
Pt came in with her daughter and daughter informed one that since 11/4/17 pt arm was itchy, red, bruised, swelling and hot to the touch. States tried hot compress but did not work so tried cold compress. Cold compress worked. Informed daughter to massage. 11/9/17 spoke to daughter, pt doing much better.
Staff nurse was given order to administer Dtap and Polio, but instead she administered Pediarix (Dtap-Hep B-IPV). Ordering provider aware. Child tolerated well, no adverse effects.
9 days after the vaccine, I was rushed to the ER with no vision in left eye, migraine. Scans were done and it was determined I suffered a stroke in my left cerebellum
No additional AE details were provided.; patient that was administered PROQUAD after it was involved in a temperature excursion; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 06-SEP-2022, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) 0.5 ml subcutaneously, administered as prophylaxis, lot number W019626 with expiration date of 19-DEC-2023. The mentioned vaccine underwent an excursion of -9.5 degrees Celsius (C) for 3 hours, and also had a previous temperature excursion of -10.2 C for 1 hour. No additional adverse event details were provided (No adverse event).
heart palpitations and a fast thready pulse, bladder infection within 24 hours of the shot, intestinal distress, severe cramping in my feet and legs, slurred speech  this morning but that seems to be improving, loss of appetite, fatigue