chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A vaccine expired by 8 hours was administered as a first dose to a male patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a male patient) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a male patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a male patient) had resolved. Not Provided      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.   Relevant concomitant medications were not reported.  Treatment information was not provided.
patient stated that he noticed yesterday (4/20) that there is a lump that came up on his lower left abdomen , he felt it but didnt look at it. he drink some water and laid down . it starts going away . it was painful , on scale og 0-10 , he said the pain level was like 5.
tooth ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "tooth ache".  Additional Information: Patient wants to know if she should get her second Covid dose that she has scheduled today, says she has a tooth ache and will need surgery.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath when exercising or active. Slight fluid in lungs...lungs feel heavy. Must stop and catch breath, cough and rest. Has happened 7-10 times since vaccine.  No fever. Some fatigue
Hives covering body.  Mild difficulty breathing.  Contacted primary care physician, who said to come in if it got worse.  Breathing has almost returned to normal as of 10/03/2011, but hives are still appearing and original hives have not receded.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On an unknown date the patient received PNEUMOVAX23 and FLUZONE, concomitantly in the same arm, 1 inch apart. Within 48 hours, the patient experienced redness and warmth at the injection-site and soreness under axillary region; the person did not report any fever or chills. No information was available on the duration or outcome of these AEs. The person was treated with KEFLEX for suspected infection. The outcome of event was unknown. Additional information has been requested.
Patient presented today with c/o left-sided facial drooping and numbness to the mouth. Patient states "It feels like when dental anesthesia wears off."  Able to drink without difficulty.  Denies other symptoms, hx of COVID or previous antibodies. CT offer and declined.  Patient verbalizes understanding of medical plan. Discharged home with Prednisone and Valtrex
received an extra dose of Arexvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 30-OCT-2023, the patient received the 2nd dose of Arexvy (intramuscular, left deltoid). On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received an extra dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 31-Oct-2023 The reporter stated that he has had no symptoms at all since receiving his second Arexvy vaccine. The patient received second dose of Arexvy, which led to extra dose administered.
9:55AM Patient complained of swelling to lips and itching tongue. V/S T98, RR18, HR97, BP127/108, O2SAT 98%. Benadryl administered. Patient is AAOx3. Complains of tingling to tongue. V/S O2SAT 99%, T98.3, HR96, RR20, BP172/107. EMT called. EMT arrived and evaluated patient. Patient refused to go to ER. EMT told patient to self monitor.
Patient received a Pfizer booster vaccination instead of a Moderna booster vaccination.  Patient monitored for 30 minutes following administration.  No signs or symptoms of allergic or adverse reactions observed.  Patient left clinic site with no issues.
Feeling like my heart is beating out of my chest, pounding heart, fast heartbeat, uneasiness
This spontaneous report was received from a nurse referring to a 60 year old female patient. The patient's pertinent medical history and concomitant therapies were not reported. Concurrent conditions included high cholesterol. Drug/allergies reactions included hypersensitivity to morphine and codeine. On 08-NOV-2016, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously, lot # M027117, expiration date 26-JUL-2017. On 08-NOV-2016, the patient developed redness, erythema and swelling at the ZOSTAVAX injection site, the reporter also mentioned that the injection site grew in size to be 7 centimeters by 11 centimeters. On 10-NOV-2016, the patient visited a medical facility in regards to the events, and was prescribed with cephalexin and an unspecified antihistamine as treatment. There were no laboratory diagnostics studies performed. The outcome of injection site erythema and injection site swelling was not recovered. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening.  left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
The patient developed fever for 48 hours post vaccination with MMR, Hep A, Varicella and PCV13. Subsequently on day 5 developed a maculopapular rash - diffuse. No fever at that time.
After receiving the Dose 2, Moderna, lot 046A2lA around May 1, 2021, I started having double vision that progressively gotten worsen over time. I went to my eye doctor who referred to the eye specialist, the migraine neurologist recommended a neurologist for vision issue and I am currently a cardiothoracic surgeon for who reviewed MRI and CAT scans. Surgery was recommendation from the eye doctor but the specialist I am currently awaiting next step directives on this eye issue with neurologist.
no medical records; no known hospitals or facilities to contact; pt passed away per information on 8/25/21 meeting  vital records criteria
This spontaneous report was received from a registered nurse refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 13-OCT-2014, the patient was vaccinated with an expired lot of PNEUMOVAX 23 (lot # H014653; expiry date: 19-APR-2014) (strength, dose, route of administration, and site of administration were not reported). There were no concomitant medications reported. The nurse reported that the PNEUMOVAX 23 did not have any previous temperature excursions and PNEUMOVAX 23 was found to be supported with post expiry data. No adverse symptoms were reported. There was no product quality complaint (PQC) involved. The outcome of the patient received expired PNEUMOVAX 23 was unknown. Additional information has been requested.
Fever, chills, severe body pain, total feeling of malaise that incapacitated normally active person into bed, hives on arm and chest then developed, large fleshy swelling started at top of deltoid area and moved down bicep to elbow, increasing in size each day, fever, pain and stiffness, wheezing like asthmatic breathing challenge, days to weeks to a month later blue veining down the arms and then across the left chest to the breast area. Dermatologist noticed blue lines 6 weeks after vaccine and remarked that he had never seen any thing like that.
Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old patient who was accidently administered with a 0.5 ml dose of QUADRACEL (lot number: C5222AA, expiry date, dose in series was not reported) via intramuscular route in the right thigh on 13-Aug-2018 instead of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PREVENAR for Immunisation; and ROTARIX for Immunisation. It was also a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was not reported whether the patient experienced any adverse events following the vaccination. 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 Directive 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. List of documents held by sender: none
14 year old patient received a dose of Flublok instead of Fluzone QD/no AE; 14 year old patient received a dose of Flublok/no AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA257773 and 2020SA258275. (Same reporter)  This case involves a 14 year old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: UJ455AAA, expiry date: 17-May-2021] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] once via unknown route at the left deltoid for prophylactic vaccination (wrong product administered and product administered to patient of inappropriate age).   Medical history, past medical treatment, vaccination and family history were not provided.  No other vaccine was administered concomitantly.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. (Latency: same time as of vaccination)  At the time of report, no adverse event was reported.  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 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.
This spontaneous report was received from a nurse prescriber, referring to a 18 year old female patient. The patient's historical drugs, medical history and concomitant therapies were not reported. The patient's concurrent conditions included low or no titers. On an unknown date, the patient, who was attending college, was vaccinated with PROQUAD for prophylaxis  (strength, dose, route, frequency, lot#, expiration date were not reported).
pt had  a positive COVID test on 2/17/22, and was left with chronic hypoxic respiratory failure; 4/20/22 pt presents to Medical Center with acute on chronic dyspnea; increasing SOB, wheezing, non-productive cough x 1 wk; saw PCP (name not included in med records) and was treated with steroid and Bactrim; no improvement; increase in fatigue and malaise; severe COPD exacerbation with acute renal failure and hyperkalemia; treated with IV steroids, O2 supplementation, duoneb, pulmincort; dc'd to home on 4/22/22; pt passed away in her home on 5/8/22 with acute respiratory failure
woke up spitting up clear, thick mucous like liquid; chills; tingling down her leg like a blood clot; heart was racing; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thrombosis since an unknown date and Vertigo since an unknown date. Concomitant products included WARFARIN SODIUM (COUMADIN), LORATADINE (LORATADIN) and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Jan-2021, the patient experienced ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm). At the time of the report, ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Night chills/sweating; HR of 130/HR was 120; soreness and bumps to anus; soreness and bumps to anus; Bodyaches; fever; chills/Night chills; nausea; headache/mild headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 07Jan2021 at a SINGLE DOSE for COVID-19 immunization. Medical history included palpitations. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 on 18Dec2020 at 17:00 via intramuscular route of administration in the left arm for COVID-19 immunization.  Concomitant medication included atenolol, vitamin b complex, colecalciferol (VITAMIN D), vitamins (MV), esomeprazole magnesium (NEXIUM), omeprazole (PROTON) and fish oil. The patient previously took morphine and experienced allergies. On 08Jan2021, 1 day post-vaccination after the second dose of vaccine, the patient experienced body aches, fever, chills, nausea, headache and muscle weakness. Then on 18Jan2021, she had night chills and sweating, HR (heart rate) of 130, and mild headache. She also noticed soreness and bumps to anus on 18Jan2021. On 19Jan2021, patient still had chills, HR was 120 and continue to feel muscle weakness Took 100mg atenolol to decrease HR. Usually prn 25 mg atenolol. The soreness and bump increase and was growing. Patient will consult with cardiologist regarding HR. The outcome of events body aches, fever, nausea, headache and was recovered on 13Jan2021. The outcome of event chills, muscle weakness, soreness and bumps to anus was not recovered. The outcome of the other events was unknown. Patient did not receive any treatment for the events body aches, fever, nausea, headache and muscle weakness. Whereas therapeutic measure was taken as a result of "HR of 130/HR was 120".   No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Full day of flu like symptoms and second day felt better but weak especially climbing stairs to office and slightly short of breath.
Severe chills for several hours later that afternoon and night (helped by Tylenol), light headache.  Mostly gone after 24 hours.  Arm pain.
1 hr p/inject pt began screaming inconsolably; left leg swollen & red; 4hrs later mo took pt to ER; told to monitor & if pt did not stop screaming w/in 8 hrs, ER would intervene; dx: possible rxn to Tetramune;
got an extra hib dose with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid non-serious case from health professional. GMI number: 01227578   This case involves a 2-year-old male patient who experienced got an extra HIB (PRP/T) VACCINE [ACT-HIB] dose with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA329894(pentacle case).  Concomitant medications included POLIO VACCINE INACT (IPV) for Immunization; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 08-Aug-2022, the patient received ACT-HIB VACCINE at dose 0.5ml once (lot UJ647AAA, expiry date: 05-Mar-2023) via intramuscular route in the right arm for prophylactic vaccination with no reported adverse event (extra dose administered) following the administration of HIB (PRP/T) VACCINE.  It was reported that "Caller states that a patient was given an extra Hib dose and IPV 1 year early. The doctor ordered Dtap, hib and Prevnar13 but the patient was administered PENTACEL and ACTHIB, which means the patient got an extra hib dose as well as the 4th IPV dose before age 4. Requesting information on whether this will harm the child and what to inform the parents. "  Action taken: Not applicable.  At time of reporting, the outcome was 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 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.
pt found unresponsive & not breathing; no fever; given mouth-to-mouth & taken to hosp;
This spontaneous report was received from a medical student (consumer) referring to himself, a 25 year old male patient. Patient's medical history, concurrent condition and concomitant medications were reported as none. On an unknown date, when the patient was a child, he was vaccinated with first dose of VARIVAX (dosing details unknown) for prophylaxis. On an unknown date (reported as 'a couple of years ago'), a titer drawn for varicella was negative (varicella virus test negative). On an unknown date in JUL-2017, the patient was vaccinated with second dose of VARIVAX (dosing details unknown) for prophylaxis. In approximately, on an unknown date in 2017, the patient developed local injection site reaction after vaccination. The patient's arm was red and hard for 2 to 3 days. No treatment for reaction was needed and it went away on its own on an unspecified date. On 12-NOV-2018, another titer was drawn which was also negative for immunity to varicella (varicella virus test negative). The outcome of varicella virus test negative was unknown. The outcome of injection site reaction was reported as recovered/resolved. Causality assessment was not provided. No product quality compliant was present.
Full body hives. One month of prednisone benadryl and clariton.  Continue to have hive breakouts for another month after finishing medication.
Pt received TIV in previous year & developed itchy eyes/ trunks but room being cleaned and it was very dusty. On filling in permission form pt stated allergic to eggs - on questionnaire she said she vomits after eating cooked eggs but not when eggs included in backed goods. About 1 hr after administered vaccine pt had cough, difficulty in breathing, red, itchy eyes, stuffy nose, wheeze (pt requested vaccine be given).
I administered these vaccines to patient. Afluria in right arm and Shingrix in left arm. The patient walked up to front of store when she felt very hot and lightheaded. She was leaning on counter and sitting on the floor when I reached her. I helped her to lie down flat on the floor. She was very cold to touch, clammy and sweating profusely. We called 911 but patient began to feel better and she refused the ambulance to come. Patient was talking and said now she was feeling cold but stopped sweating. We helped her off the floor and she sat in a chair and drank gatorade. Patient never lost consciousness. Afterwards, she said that she had radiation therapy this morning also and that she suffers from hot flashes.
Pt was stable upon arrival. Denies any current discomfort or illness. Denies adverse reactions with prior vaccines. States he needs booster dose to leave the country soon. Received moderna for primary series but desired Pfizer for a booster dose. Vaccine administered intramuscularly without complications; tolerated well by patient. Patient was observed in an auditorium by staff.  Approximately 30-45min later, staff notified me of patient having difficulty breathing. I immediately instructed them to call EMS and rapidly presented to patient with epilepsy-pen. Staff was already administering the patients own epi pen.  Patient able to talk and breath and this point. Dr. immediately presented to the scene to evaluate patient. Patient was sent to ER for further evaluation.  Contacted patient today to follow up with patient. Patient reports feeling fine with some lip numbness today but knows to carry his own epic-pen due to allergy of wasps/bees.
Diarrhea Stomach ache nausea Headache Chills Fever Severe fatigue Unfocused thought process Sore arm at injection site
2 hours after shot complain of headache-several hours later warm, complain of rash-arms and back feeling bad next day continue to complain of rash red, warm to touch, headache, temperature 98.6.
Patient was vaccinated at @1:30pm on 1/2/19 and by @6pm that evening she said she developed a severe headache and started having chills. Her fever was 102 F when she checked it that evening.  She felt severe fatigue all over similar to flu she said this did not resolve until lunchtime on Friday 1/4/19. Her arm was also swollen, red and very itchy at injection site.