chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bivalent doses administered after the BUD to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
One month after receiving his third Pfizer COVID-19 vaccine, patient presented with significant SOB.  Patient was found to have pneumonia and a right lung mass. Patient ultimately diagnosed with metastic Small Cell Lung Cancer.
a few hrs p/vax pt devel temp as the evening progressed pt started twitching & staring; pt was given APAP t104 & pt had convuls;
TASTE CHANGE; SMELL CHANGE; This spontaneous report received from a patient concerned an elderly male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced taste change. On 27-MAR-2021, the subject experienced smell change. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from taste change, and had not recovered from smell change. This report was non-serious. This report was associated with product quality complaint.
Pain in her right hip/pain; Blisters in the right hip area; Full-blown case of shingles/blisters, which patient thinks is shingles; Sore arm (at injection site)/sore arm, which is anticipated; This case was reported by a physician via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3S3X7, expiry date 20th March 2023) for prophylaxis.   The patient's past medical history included shingles (patient had shingles episode 26 years ago). Concurrent medical conditions included pain in arm (patient has a normal and regular condition of sore arm).   On 30th September 2021, the patient received the 1st dose of Shingrix (intramuscular). In September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 1st October 2021, the patient experienced pain in hip. In October 2021, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles, pain in arm, pain in hip and blister were not recovered/not resolved.   The reporter considered the shingles, pain in arm, pain in hip and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix shot in the left deltoid and reported sore arm in her left arm  that was anticipated; but had not yet resolved as of the time/date of reporting. On next day after vaccination, the patient started having pain in her right hip Two days after vaccination; in the morning, within 48 hours, she woke up with blisters in the right hip area.  The patient was sure that the blisters were shingles. The patient developed a full-blown case of shingles within 48 hours of Shingrix shot and she did attribute that to Shingrix. The patient consented to follow-up via e-mail.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206983:SAME REPORTER - FU1 - deleted from database
Expired vaccines were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccines were administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccines were administered). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccines were administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As per the reporter, the expiration date on vaccine had been extended, however it had not. All vials were discarded at end of day and never used after >12 hours post initial puncture. Never used past 30 days in refrigerator. Date the vial(s) were moved from freezer to refrigerated conditions was 04-Nov-2021. There were no temperature excursions.
He was seen at clinic for his 4-yo WCC 2 days prior to visit and received varicella vaccine in R thigh. His school first noticed a reddish area on the left upper thigh 7/25/17 which was non-painful. Since yesterday, the area of redness has doubled in size, remains warm to touch, and is starting to become tender to touch. He has been afebrile. No other rashes. He has never had any reaction to any vaccine. He is walking without difficulty.
Patient states that later that afternoon following H1N1 vax she started feeling dizziness with nausea and diarrhea. Patient did not go to ER or DR, but did call her PCP.
Slowly developed itchy rash of course of treatment. 1 pill a every other day - total 4 pills. Rash progressed across back, legs, more welt-like bumps on lower face.
EXPIRED VACCINE ADMINISTERED TO THREE FEMALES; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-SEP-2021, the patient experienced expired vaccine administered to three females. The action taken with covid-19 vaccine  was not applicable. The outcome of expired vaccine administered to three females was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941376.
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in April 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023 The pharmacist reported that a patient received a first dose of Engerix B back in April 2023 and never received a second dose. The reporter consented to follow up via mail. The reporter was not at their facility at the moment of call, age, gender and initials of the patient were given but not sure of veracity. No more information about exact date was available. Patient had not received a second dose at the moment of the call. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Information has been received from a respiratory therapist concerning a male patient who on an unspecified date was vaccinated with a second dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009.  On an unspecified date after he received the vaccine he developed low grade of fever 100-101 degrees F, swelling from the elbow to the shoulder and painful at the injection site. The symptoms had been lasting about 24 to 48 hours. The patient sought medical attention by telephone. At the time on the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow up information has been received from a respiratory therapist concerning a 75 year old patient with cervical spondylosis started on 08-NOV-2006; hyperactivity of the bladder started on 22-OCT-2007; esophageal reflux started on 17-SEP-2008; cerebellar ataxia and impaired fasting glucose started on 15-JAN-2009; abnormal weight loss, and taking high-risk medication started on 17-MAR-2009; benign essential hypertension, bipolar disorder, bladder cancer, hyperlipidaemia, hypothyroidism, prostate cancer, and rheumatoid arthritis started on 01-JUL-2009; and hypertension illness at the time of vaccination who on 01-JUL-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659922/1667U) intramuscular into left deltoid at 2:00pm. Concomitant therapy included aspirin, CADUET, folic acid, acetaminophen/ hydrocodone bitartrate, lithiumC03, methotrexate, metoprolol succinate, MIRALAX, MUCINEX, nabumetone, pantoprazole sodium, TYLENOL, vitamin D (unspecified) and VOLTAREN. On 01-JUL-2009, in the PM, the patient experienced achiness, low grade fever and tenderness at injection location. On 01-JUL-2009 fluocinonide 0.05% external cream therapy was started. On 02-JUL-2009 methylprednisolone 4 mg oral tablet therapy was started. On 04-JUL-2009, the patient recovered from fever, achiness, tenderness at the injection location. The outcome for swelling from elbow to the shoulder was reported as recovering. On 13-JUL-2009, levothyroxine sodium 88 mg oral tablet therapy was started. A standard lot check investigation was performed. All in-process quality checks for the lot number 659922/1667U were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information has been received via telephone call from a respiratory therapist who verified that the form sent was a listing of the patient's current health issues for evaluation. All the conditions listed on this form were pre-existing conditions and were present at the time of the patient's vaccination. None of the problems listed began after the patient was vaccinated with PNEUMOVAX 23. This is one of four reports from the same source. Additional information is not expected.
47 -year-old female with a history of sleep apnea and lymphedema. The patient presents with concern of covid 19 infection. She is fully vaccinated. Pt did test positive for COVID on 11/5/2021.  She states for the last 2 days she has experienced cough, sneezing, sore throat, runny nose, body aches, feeling feverish.No hypoxia. In no acute distress.She is instructed to return to the ED if her condition deteriorates in any way.
I had a stroke in April after the vaccination. I was working from home doing my usual daily routine and started feeling dizzy, I couldn't talk, and my speech was impaired. I left home and we went to ER, I was originally diagnosed as dehydrated and knew that wasn't correct, so we went to a different hospital and after more testing, MRI and diagnosed with having multiple strokes, when I went into the first ER, I was having a stroke for the second time and the first was at home. I was admitted for 24 hours following a call from my doctor telling me to come in immediately.
Hot effect / hot to the touch; Injection site went tall and swollen, bigger than half a dollar; Injection site went [tall and swollen, bigger than half a dollar,] red; Tender to the touch; Severe headache; This spontaneous case, initially received from other health professional (nurse) on 28-Sep-2018, concerns a 56-year-old, adult, female patient.  The patient did not have any medical history and did not take any medications at the time of vaccination.  On 25-Sep-2018, the patient was administered Afluria (QIV) [(influenza vaccine), dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02444611A and expiry date: 06-Jun-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.   On 26-Sep-2018, one day after vaccination, the patient's injection site went tall and swollen, bigger than half a dollar. The site was red and hot to the touch (for 24 hours), the area was also tender to the touch. The patient also reported severe headache, but not fever. On 27-Sep-2018, the patient had recovered from the event- injection site warmth. On an unspecified date in 2018 (reported as within one week of vaccine administration), the patient had recovered from the events injection site swelling, injection site redness, injection site tenderness and headache. It was reported that, the patient felt better.  The reporter assessed the case as non-serious.  Follow-up received from the other health professional on 24-Oct-2018 (combinedly processed with follow-up received on 26-Oct-2018): The expiry date of the vaccine was added. The outcome of the events (injection site swelling, injection site redness, injection site tenderness and headache) was changed from unknown to recovered (within one week after vaccination). It was reported that, the patient felt better. Narrative was amended accordingly.; Reporter's Comments: A 56-year-old female patient experienced injection site warmth, swelling, redness, tenderness and severe headache one day after the administration of suspect vaccine Afluria (QIV). The company assessed the causality of the events related to the suspect vaccine due to anatomical site-specific reaction and plausible temporal relationship between the suspect vaccine and the events.
Significant left-sided facial swelling with significant nerve involvement. Not painful but very concerning swelling and tingling and numbness.  Swelling on the right side of my face but minimal.
pt recv vax;27mar94 devel fever over 104-105;few erythematous macular lesions on face & arms,dec appetite & agitation; sx resolved w/in 2 days;
pain in the upper gastro track.   across the front, from left to right side.  Lasted one week
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old male patient of unspecified ethnicity received 1st dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation.  The patient's medical history was not reported. Concomitant medication included GARDASIL 9 the same unspecified date of Trumenba. The patient experienced malaise, fever chills, no appetite, sweating and tender at injection site on an unspecified date at 06:00 PM. The events lasted 48 hours. No follow-up attempts possible. No further information expected.
feeling very badly after this dose; low grade fever; fatigue; cold and hot; lethargic; pain in the site that radiates to her arm and chest; pain in the site that radiates to her arm; pain in the site that radiates to her arm and chest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot) and LETHARGY (lethargic) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), LETHARGY (lethargic), VACCINATION SITE PAIN (pain in the site that radiates to her arm and chest), MYALGIA (pain in the site that radiates to her arm) and CHEST PAIN (pain in the site that radiates to her arm and chest). At the time of the report, FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), LETHARGY (lethargic), VACCINATION SITE PAIN (pain in the site that radiates to her arm and chest), MYALGIA (pain in the site that radiates to her arm) and CHEST PAIN (pain in the site that radiates to her arm and chest) outcome was unknown.            No treatment and concomitant medications were reported.     This case was linked to MOD-2021-187135 (Patient Link).   Reporter did not allow further contact
Information has been received from a physician concerning a 9 month old patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot # not reported). No adverse experience was reported. It was not specified if the patient sought medical attention. This is one of two reports received from the same source. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose, lot number. Additional information has been requested.
(L) arm injection site redness, swelling, pain and induration. Pt seen 3 days after injection. Sxs started after injection worsened per mother.
Exhaustion, generalized pain, 101.3 fever. Numbness and tingling with pain on whole right arm (vaccine was administered on left). Nausea. Went to urgent care. Dr. Stated that paresthesia can be a side effect.
High fever 101.5 degree, high heart rate 144 bpm next day 7:17am, sustained at 100 for 3 hours, went to ER via ambulance.
6" cellulitis-red, sore to touch, itchy circle where got inject;gave Keflex;problem resolved fine or f/u;
Mainly I noticed it at night, because it would wake me up 45 minutes I would try to go to sleep. It was like someone was tearing the muscles of my bone. I could not sleep. It was so bad. That would be form my thigh all the way to my ankle. If I got up and move around it lessen but would not go away. It was a huge discomfort. I went to my general practitioner, and he diagnosed it as restless leg and gave me a medication that I did not like because it did not take the pain away and would make me really high so he gave me another one. They did not do any tests they just assume it was restless leg. I went to my husband's doctor and he said it was restless leg as well. So, I went to a specialist and he prescribed me Neupro. I take that at night. It does not make the pain away it just makes it tolerable. That only lasted for about 6 weeks. Into the 4th week I noticed it was not working as well so I contacted my doctor and asked if he would increase it. That was on 08/30/2021. For whatever reason he was so slow getting back to me. He also prescribed gabapentin. I started taking the gabapentin because I could not get the Neupro. But it is not working. They are just trying to figure out what it is. I only had blood work done and everything was normal. I am going to a vein specialist on 09/14/2021. I do have a stabbing pain on my chin and so I am hoping this is just a vein issue.
Patient called 6/13/16, stated he has pain in all joint. Started after vaccination and has gotten worse. States that ibuprofen helps but does not make pain go away. States he has difficulty using TV remote and opening car door. Also states he stepped on a rusty nail 6/5/16.
What Happened: A covid bivalent booster was administered that was drawn up yesterday. approximately 20-24 hours after it was drawn up in a syringe and at room temperature.  Why it Happened: Yesterday when I was salvaging at the end of the night I was interrupted. I finished the salvaging on the handheld but never went back down to then of the counter to dispose of the vaccine.  This morning my vaccinating tech thought I drew it up this morning and administered it.
abducens nerve palsy right eye and fever; fever; This is a spontaneous report from a non-contactable healthcare professional. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant. The patient experienced abducens nerve palsy right eye and fever on 18Apr2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event abducens nerve palsy right eye cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
One day post vax, pt began to experience a headache which was close to the migraine level of intensity. She was treated with ibuprofen, which was ineffective. Most recent information reports her condition as ongoing.
he now has a diagnosis of Hodgkin's lymphoma; her son received GARDASIL 9 in the buttocks; This spontaneous report was received from a office manager who is the patient's mother via company representative and was referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) also reported as quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), (conflicting information), in the patient's buttocks (product administered at inappropriate site), (strength, dose, dose number, frequency, lot number and expiration date were not reported), as prophylaxis.  On an unknown date (also reported as "now"), the patient had a diagnosis of Hodgkin's Lymphoma (hodgkin's disease).  At the time of reporting, the outcome of hodgkin's disease was unknown, and the reporter did not assess the causal relationship between the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) with Hodgkin's Lymphoma (hodgkin's disease).     Upon internal review Hodgkin's Lymphoma (hodgkin's disease) was determined to be a medically significant event.
pt recv vax 26MAR98 & 26MAR98 pt exp lightheadedness, dizziness, nausea, watery eyes & blurry vision;