chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt arrives pov with sob. Pt has no chest pain. tp has home o2 but has not needed to wear it. Pt then says he is here for sob and wasnt using his home O2 he has for copd. Pt has had J and j vaccine a while back pt is a former smoker. Pt has Nausea nd vomiting and has not been eating well. Pt denies fevers. Pt has lost sense of smell and taste. Pt had a cough that has improved, he says he had a cough on Friday.  Associated Symptoms: nausea, shortness of breath, vomiting 69-year-old male with history of diabetes mellitus, hypertension, former smoker with COPD, acute kidney injury January 2020 attributed to acute tubular necrosis with recovery and baseline creatinine around 1.2-1.3 mg/dL, presents to the hospital with cough, wheezing with phlegm (does not know the color), poor appetite and oral intake.  Found to be COVID-19 positive, patient is vaccinated with Johnson & Johnson (does not know when) and was found to have bilateral infiltrates on chest x-ray.  No fever or chills reported, no nausea or vomiting, no diarrhea.  No joint pains or rash.  Patient is saturating 85% on room air and placed on supplemental oxygen and saturating 95% on 2 L nasal cannula.
Patient reported possible adverse effect symptoms when patient was called to remind the second dose of SHINGRIX on 4/11/19. The symptoms of possible adverse reaction occurred approximately six hours after SHINGRIX 1st dose. Symptoms include flu like symptoms including fever, joint pain, difficulty in breathing that was lasted for the 2 days. Patient did not seek for the medical care and symptoms resolved its own.
Severe chest pain, very short of breath, felt like might be a heart attack, diagnosed as pericarditis. Severe pain lasted 2 days. Breathing effected for 2 weeks. Seem to be back to normal now.
Information has been received from a registered nurse regarding a female patient of unknown age. The patient's medical history, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not provided). Three years ago, approximately in 2010, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not provided). The patient received a second dose of GARDASIL on an unspecified date 3 years ago and now was in the office to receive her third dose. Approximately on 19-SEP-2013, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not provided). No adverse symptoms were reported. Additional information is expected.
Redness and swelling and injection site. 24 hours of aches chills and fever. Body hives, rash began 72 hours after injection.
BLOOD CLOTS; This spontaneous report received from a consumer via a Business partner (Pfizer Inc.) on 25-JUN-2021 concerned three patients of unspecified age and gender. 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: unknown and expiry date: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, three patients were developed blood clot after vaccination. The patient died from blood clots on an unspecified date. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210666397-Covid-19 vaccine ad26.cov2.s -Blood clots. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: BLOOD CLOTS
arthritus had advanced 10 fold and I can hardly walk[ambulate]. Before my scan showed it would be reversible arthritus.
Good afternoon, I had a hard attack on Jun 27th .2021, around 12 weeks after my 2nd dose of the Pfizer Vaccine. I received the booster on November 22nd, 2021 and a week after I developed a pain headache that only goes away after taking Excedrin. The problem is that it has been a week and I have the headache every single day and I am afraid to continue taking Excedrin as I am taking several medications that may be impares or perhaps or the perhaps cause me either an aneurisma to burst or a serotonine syndrome. I will appreciate if someone from FDA or CDC or the Pfizer team can reach out with informed advice on how should I proceed. Perhaps I need an MRI of my brain to discard an aneurysm or brain swollen that is happening as an undocumented adversed reaction to the Pfizer booster vaccine. Here is the list and time of the medications I am taking: 08:00am- Escitalopram 10mg 09:00am- Metropolol succinate 25mg 12:00pm- Aspirin 81mg and Clopidogrel 75mg 04:30pm- Dinner 09:00pm- Synthroid 112mcg 10:00pm- Losartan 25mg 11:00pm- Atorvastatin 80mg
Frozen shoulder. Unable to raise arm past shoulder. Cant move arm back and front. Pain on shoulder to touch and radiating down bicep to elbow.
Muscle stiffness, redness surrounding vaccine site 3 1/2" x 5" sl raised.
Facial numbness rash hand numbness. All on side of injection. Lasting over 3 weeks.
Patient received the wrong vaccine. Patient was due for second dose of Moderna and received a dose of Pfizer by mistake
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number 3 (boster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 completed, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 2 completed, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Covid positive day #4 after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine bnt162b2 omi xbb.1.5 administration.
It was reported that a 41-year-old male patient received a Rabies Imovax vaccination on 15-Aug-2000. Reportedly 2 hours after the vaccination the patient developed tingling of the tongue, raspy throat and headache. Further information requested.
Severe headache that brought tears due to pain.  Chills. Nausea. Burp up bile. Exhausted. Subsided after 7 hours. Intermittent headaches that only last for a few minutes and then subside.
Red and painful. Loratadine 10 mg every day, Methylprednisolone 4 mg UD.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 18-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State currently. It was reported that no adverse reactions were experienced by any patients.  Treatment information was not provided by the reporter.
This is a spontaneous report from a nurse referring to a 65 year old male who on 7/14/99, received his 1st dose of Lymerix and 3 days later, he developed a rash which covered 1/2 to 3/4 of his upper left arm. The rash lasted 4 days. The most recent information, received on 8/20/1999, reports the condition of the pt is resolved.
2/2/2022   Chief Complaint:  Fatigue, weakness   Source of Information:  Patient   History of Present Illness:  This is a 78y.o. female with a history of HFpEF, CKD Stage IV, Paroxysmal Afib, CAD and DM II who presents to hospital with a chief complaint of bilateral lower extremity weakness for the past week. Of note, patient is alert and oriented x3, however she is a questionable historian. She states that she has been having difficulty ambulating with a walker because her legs shake. She often feels like her legs are "going to give out."  Patient states that this has happened in the past. She also reports mild shortness of breath on exertion, occasional headaches and back pain. It is unclear whether the patient has had any recent changes in appetite. Patient also does not know which medications she takes and it is unclear if she it taking all of them regularly. She states that some changes were made recently to three of her medications, but she doesn't know which ones. Denies chest pain, cough, wheezing, fevers, chills, abdominal pain, nausea, vomiting, diarrhea, lower extremity edema, lightheadedness or dizziness. Patient is vaccinated against COVID.
Initial unsolicited report received from a consumer via partner company (Pfizer) (manufacturer reference number- 2015362182) on 17 February 2016. This case involves 75-year-old female patient who was vaccinated with a dose of Flu shot (batch number, route and site of administration not reported) on an unspecified date in October 2014. The patient had also received capsule of Lyrica (150 mg, once a day, orally) for fibromyalgia from an unspecified date to 08 February 2016. The patient's medical history includes allergy, compromised immune system, respiratory illness, genetic/ chromosomal abnormalities, endocrine abnormalities, obesity and concomitant medications were not reported. On an unspecified date in October 2014, few days following the vaccination, the patient had experienced Guillain Barre Syndrome (diagnosed on March 2015). On an unspecified date in December 2015, few months following the vaccination, the patient had experienced urinary tract infection, Fell and hit her head. The patient's concurrent conditions includes well controlled diabetes from 2010. The patient was hospitalized on an unspecified date in December 2015. Laboratory data includes test (needles placed in feet and back) was performed and platelet was 14 times than normal. MRI and X-ray was performed in December 2015, no abnormalities found. On December 2015, blood test was performed, diagnosed with ear infection. The patient had received antibiotic (unspecified) for urinary tract infection as corrective treatment. The outcome of event Guillain Barre Syndrome was reported as recovering. The patient was not recovered from event urinary tract infection and outcome of event Fell and hit my head was not reported. The patient was discharged from hospital on an unspecified date in first week of January 2016. List of documents held by sender: none. Sender's Comments: The patient experience Guillain Barre Syndrome and Urinary tract infection with INFLUENZA VACCINE (unknown manufacture). Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details ruling out any congenital condition metabolic disorders, maternal pre and postnatal history would help assess the events better. The patient received other vaccines so making it difficult to assess the role of each vaccine in particular based on the information available, the role of the vaccine cannot be assessed.
Patient presented to the ED on 5/12/2021 with hyperglycemia, hypertension, hypothyroidism. Patient presented to the ED on 5/14/2021 with hypertensive emergency, NSTEMI, atypical pneumonia. Patient presented to the ED on 5/15/2021 with elevated troponin and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
patient reported he has previously fainted immediately following vaccine. His wife brought an ice pack and water.  Aftervaccination i sat with pt a few minutes to make sure he was feeling well and ready to move to a chair in front of the pharmacy to sit for 30 minutes and make sure he is feeling well. I notified my manager that pt in front has fainted before and he kept a close eye on him. I was administering shot to the next pt and heard a sound. I left vaccination booth and saw pt on the ground. I placed his legs/feet in front of him and his wife held his head and ice pack. Our pt reported that he did not hit or hurt his head and did not need other assistance. we monitored the patient an additional 20 minutes and he was feeling well, vital signs good and accompanied by his wife.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a seven-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 07-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
sore arm; mild sweats; mild chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "mild sweats"; CHILLS (non-serious), outcome "unknown", described as "mild chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He developed enlarged lymph node 2 days after vaccine in axilla region on the side of injection. Had low grade fever and chills for over a week and developed lymphadenitis. It worsened to the point he had to have Incision and Drainage 10 days after vaccine.
Diaphoretic, lightheaded, rapid pulse (120), face flushed lasting approx 45 min. Given Juice and crackers cool compress, supine position.
4/21/05 Mom called reported 3" red circle rxn R thigh. Red and swollen when awoke this AM. Unsure if it was right upper Dtap or R low IPV. No fever, no pain. Called to Pharm. Ibuprofen 2 tsp PO every 6 hrs. Will observe for swelling/fever/pain per BG/DM. Doing better 5/02/05.
gradual onset & offset of 24-48 hrs of mild nasal stuffiness, occasional sneezing, mildly but definitely clouded mentation, & mild physical ennervation; (mood fine, no rash, fever, arthralgia, diarrhea, abd pain, etc; mild cold
Swelling around injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling around injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 16-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling around injection site). At the time of the report, VACCINATION SITE PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment information included ice for swelling.
A non-serious report of expired dose of vaccine administered has been received from a nurse concerning a 38-year-old male patient.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 14-Jan-2008.  The FluMist had expired on 10-Jan-2008.  The reporter indicated that no adverse events have occurred since the time of the report.  The patient did not experience a rechallenge while receiving the suspect product.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  29-Jan-2008:  Follow-up information obtained and incorporated in above narrative: clinical outcome.
Adverse Treatment - patient was given Moderna covid-19 2023-2024 formulation for 6mon-11 years old (NDC 80777028792) incorrectly, instead of the intended Moderna SpikeVax 2023-2024 formulation for 12yo+
Disseminated vaccinia, mild, treated symptomatically with oral Benadryl.
This case was reported by a healthcare professional and described the occurrence of erythema multiforme in a 3-month-old subject of unspecified gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date in 2007 the subject received unspecified dose of hepatitis B vaccine.  At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced erythema multiforme.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.
No additional AE reported.; GARDASIL 9 that had undergone temperature excursion was administered to a patient; This spontaneous report has been received from a registered nurse, referring to a 12 years old male patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The reporter reported the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number: 1780867 with expiration date: 08-AUG-2023, indication: prophylaxis, dose, strength and route were unknown) that had undergone temperature excursion was administered to a patient on 11-JAN-2022 (reported as yesterday) (product storage error). No additional AE reported.
This case was reported by a pharmacist via sales rep and described the occurrence of measles-like rash in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced measles-like rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the measles-like rash was recovering/resolving. It was unknown if the reporter considered the measles-like rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the field representative (account manager) who received an email from the director of clinical within the pharmacy chain. The pharmacist was contacted by the wife and the pharmacist told her to take the patient to the emergency room. The age at vaccination was not reported. Two hours after the injection, the patient experienced a rash on the upper torso and was described as measles-like. The patient went to the emergency room and was given an injection of (IM) BENADRYL intramuscularly and famotidine and went home that evening. The PA stated that they have not seen any other reaction to the vaccination as of yet. After doing follow up with the patient's wife, she informed that the patient condition was improving.
feeling anxious/ like a wave of anxiety; confusion; brain fog; uneasiness; headaches; bumps and itchiness on my back, sides, and stomach./The itchiness was worse with pressure, around her bra and waistline and while showering, and with sleep.; light pink or white welts; These were light pink or white welts; arm swelled; red rash (arm); tenderness at the injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (red rash (arm)), ANXIETY (feeling anxious/ like a wave of anxiety), SKIN DISCOLOURATION (These were light pink or white welts) and DISCOMFORT (uneasiness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (red rash (arm)) and VACCINATION SITE PAIN (tenderness at the injection). On 03-Aug-2021, the patient experienced SKIN DISCOLOURATION (These were light pink or white welts), PRURITUS (bumps and itchiness on my back, sides, and stomach./The itchiness was worse with pressure, around her bra and waistline and while showering, and with sleep.) and URTICARIA (light pink or white welts). On 04-Aug-2021, the patient experienced ANXIETY (feeling anxious/ like a wave of anxiety), DISCOMFORT (uneasiness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (brain fog) and HEADACHE (headaches). On 04-Aug-2021, PERIPHERAL SWELLING (arm swelled), RASH ERYTHEMATOUS (red rash (arm)), ANXIETY (feeling anxious/ like a wave of anxiety), DISCOMFORT (uneasiness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (brain fog), VACCINATION SITE PAIN (tenderness at the injection) and HEADACHE (headaches) had resolved. At the time of the report, SKIN DISCOLOURATION (These were light pink or white welts), PRURITUS (bumps and itchiness on my back, sides, and stomach./The itchiness was worse with pressure, around her bra and waistline and while showering, and with sleep.) and URTICARIA (light pink or white welts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.