chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown demographics. The patient pertinent medical history and drug allergies were not provided. On 02-MAY-2014 the patient was vaccinated with ZOSTAVAX. No other concomitant medications were reported. On 06-MAY-2014 (reported as 4-5 days later) the patient experienced extreme weakness in the body (disability), heart palpitations (disability), dizziness (disability), trouble breathing (disability) and developed irregular heartbeat (disability). Patient waited a couple weeks and it has not gotten any better. Patient was still not recovered. As long as patient is sitting or lying down is ok, but had to sit down 4 or 5 times if the patient was doing house hold chores because the patient was too weak to stand up. Patient body is weak. Patient have not been able to go to church for 3 weeks (disability). Patient took additional B12 vitamins but this is not even helping. The physician reported that the patient had reported that about 4 days after receiving ZOSTAVAX that is on 06-MAY-2014, the patient developed heart palpitations (disability). The palpitations have resolved, but the patient continues to report extreme weakness. The physician stated that the patient's vital signs and blood tests (complete blood count (CBC), "chemistry" and thyroid blood test) are normal. The outcome of extreme weakness in the body, my body is weak, dizziness, trouble breathing, not been able to go to church for 3 weeks and developed irregular heartbeat was reported as not recovered/not resolved. The outcome of heart palpitations was reported as recovered/resolved. The causality of the events is not reported no product quality complaint was reported. Upon internal review all the events of extreme weakness in the body, my body is weak, dizziness, trouble breathing, not been able to go to church for 3 weeks, heart palpitations and developed irregular heartbeat were considered to be disability. Additional information has been requested.
Information has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date in October 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dosage schedule, route of administration, anatomical location, lot # and expiration date were not provided), for prophylaxis. On 28-NOV-2016, 1 month later, the patient was vaccinated "early" with a second dose of GARDASIL 9 (lot # M013636 with expiration date 15-FEB-2018) (dosage schedule, route of administration and anatomical location were not provided), for prophylaxis. No adverse effects were reported. Additional information has been requested.
Contracted COVID-19 symptomatically; contracted the COVID-19 virus and its symptomatic with the virus now; Contracted COVID-19 symptomatically; contracted the COVID-19 virus and its symptomatic with the virus now; Fever; Congestion; Shortness of breath; Lost sense of smell; This is a spontaneous report from a contactable consumer.  A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Jan2021 (Lot Number: EL3247, Expiration date: 31May2021) at the age of 26 years as single dose, and dose 1 via an unspecified route of administration, administered in Arm Left on 29Dec2020 (Lot Number: EH9899, Expiration date: 31Mar2021) at the age of 26 years as single dose,  for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included multivitamin like is generic multivitamin of men, a chewable Vitamin D3, and L-Lysine. On unspecified date the patient contracted covid-19 symptomatically; contracted the covid-19 virus and its symptomatic with the virus now, experienced fever, congestion, shortness of breath, lost sense of smell. Therapeutic measures taken as a result of the event contracted covid-19 symptomatically, included Sudafed 120 mg once a day and Ibuprofen 400 mg twice a day first 3 days. The outcome of the events was unknown. Subsequently Product Quality Complaint Group provided the following conclusions: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EH9899 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EH9899, fill lot EH9783, and the formulated drug product lot EH9782. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
no additional adverse event; patient was supposed to have been administered a dose of TDap, but was accidentally administered a dose of GARDASIL 9; This spontaneous report was received from medical assistance and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-OCT-2022, the patient was accidentally administered a dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, anatomical location, and route of administration were not provided) as  prophylaxis; instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided). No adverse event was reported.
CONTRACTED COVID 8/27/2021, GOT TESTED 8/30/2021, MINOR SYMPTOMS - COUGH, SORE THROAT, NO FEVER
Arm sore/lower arm sore/ left hand pain; Heart feels burden; Left shoulder muscle cramps; Heat up from heart; Breathe faster; Fever; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 13:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, right after the shot, the patient experienced left shoulder muscle cramps, heat up from heart, breathe faster, fever and dizziness. On 16Apr2021, the second day, the patient experienced arm sore/lower arm sore/left hand pain and heart feels burden. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of left shoulder muscle  cramps, heat up from heart, breathe faster, fever, dizziness, arm sore/lower arm sore/left hand pain and heart feels burden was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the COVID-19 vaccine on Thursday, March 25, 2021. On Tuesday April 6, 2021 he had a massive stroke, blood clot to left side of his brain. On Friday morning April 9, 2021 doctor's advised he had another stroke due to bleeding in the brain  (paralysis on right side and racing heart beat). He died on Saturday, April 10, 2021 @ 5:45 AM.
patient received an expired dose of IPOL with no reported adverse events; Initial information received on 14-Feb-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 5 years old female patient who was diagnosed with patient received an expired dose of ipol with no reported adverse events while receiving vaccine ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]).  On 14-Feb-2023, the patient received suspect ipv (vero) lot R1F80 (dose, strength, frequency, formulation: unknown) via subcutaneous route in unknown administration site for prophylactic vaccination.  On 14-FEB-2023 the patient had a non-serious patient received an expired dose of ipol with no reported adverse events (expired product administered) following the administration of IPV (VERO).  Action taken was 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 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.
Mom reported a 2-3 inch area of redness and swelling at injection site. Area is no painful. History of egg allergy. Does not eat eggs. Passed a scratch test to rule out egg allergy but has not done an oral challenge.
swollen,hot and red area (3inches x 3 inches) at the largest measurement at the injection site. Has lasted 48 hours so far.
Case number PHEH2012US011649 is an initial spontaneous report received from a nurse on 07 Jun 2012: This report refers to two patients of unknown age group and gender. They were given only the CYW-135 liquid component of MENVEO vaccine (Batch number: unknown) intramuscularly on 31 May 2012. No adverse reaction was reported following this administration error.
A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 24-Nov-2015. She had administered the FLUMIST to a 16 months old patient. The outcome of the event of VACCINE GIVEN TO A CHILD UNDER 2 YEARS OF AGE was unknown. The reporter's description of the event (s) was as follows: healthy child. The report was considered to be non-serious. The reporter considered that there was no causal relationship between VACCINE GIVEN TO A CHILD UNDER 2 YEARS OF AGE and FLUMIST. The company physician agreed to it.
From phone conversation with mom in the evening of day after shots right thigh had area of redness and swelling. No streakiness. No pain or fever noted. Follow up: treated with Benadryl
By 11 pm extremely restless. Feeling confined. Cold outside turned furnace off and open windows. Felt fatigued. Easy irritated. Excessive sleep
Started with mild headache.  Turned into severe migraine with stroke like symptoms (numbness in hands and face, loss of vision in one eye, seeing waves, dizziness, difficulty speaking).  Vomiting, neck pain. PRN medications did not help.  Went to ED at Hospital for 4 hours. MD ordered troponin level, metabolic panel, CBC, COVID test, and head CT.  ECG.  Given multiple rounds of toradol, Ativan, Benadryl, Reglan, fioricet.  Sent home with fioricet.  Continue to have daily headaches and neck pain.
Jaw muscles hard to open mouth first thing in morning Nov. 14, 07 - wasn't told about mercury.  Severe aches and pain in all joints, swelling of ankles, can hardly walk in morning, couldn't use arm.  Symptoms ongoing, no strength in hands & arms.  Pain med.
Since 12 January he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affected soles, and resolve without post-inflammatory changes. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Initially he felt hot showers were also a trigger but episodes not currently associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 5 January, 7 days prior to onset of symptoms. He has used oral antihistamines with limited benefit. He denies constitutional symptoms. UCT score today is 8 (0, 1, 0, 2, 0, 3, 1, 1). No history of adverse reactions to prior vaccines.
Narrative:  Per chart review patient reported receiving COVID-19 vaccine April 1, 2021. No details available other than date, manufacturer, and city where patient received since obtained outside facility. Patient presented to the ED with lethargy. No reported fever, chills, nausea, vomiting or diarrhea but he did have minimal cough-- in the ED he was found to have AKI, mild elevation of trops and possible sepsis. Patient tested positive for COVID-19 on 6/30/2021. Patient admitted to ICU and as of date of entry remains hospitalized in ICU.
dose expired 08Aug2021; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose expired 08Aug2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose expired 08Aug2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose expired 08Aug2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved.        For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Myalgia, Fever, sweats, shakes and chills, abd cramping, weakness, metallic taste in mouth, trouble sleeping Narrative:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Obesity, Hyperlipidemia and Hypertensive heart disease. Concomitant products included GABAPENTIN (NEURONTIN), ALBUTEROL SULFATE, ROSUVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 07-Sep-2021 at 4:02 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Day 1-2  aches, headache, fatigue, severe hand and joint pain that lasted 10 days Day 7 -14  Hives, lasted for 1 week Day 15-23  New Hives, very large, episodes of very rapid heartbeat ( which last 30-60 minutes) Lasted 1 week, chronic fatigue for several weeks Day  40  New Hives, rapid heartbeat  (current)
A non-serious spontaneous report of FLUMIST given to a 21-month old female with CP was received from a registered nurse. The patient's medical history included cerebral palsy. She has no history of wheezing. The patient was administered FLUMIST on 07-Oct-2009. She is doing fine with no symptoms observed. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Narrative: INITALLY ADMITTED ON 03/25 WITH ACUTE PERICARDITIS AND DISCHARGED ON 03/27. THEN RE-ADMITTED ON 04/03 WITH ACUTE PERICARDITIS AND REQUIRED AN EMERGENT PERICARDIAL WINDOW BY CARDIOTHORACIC SURGERY.
Felt wobbly; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Felt wobbly) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. SLTHC and SU91C) for COVID-19 prophylaxis.     The patient had no allergies and had no previous Diagnosis of Covid.  The patient also reported that they had no other medical conditions and was a healthy individual. The patient did not received any vaccination within 1 month of Covid-19 Vaccines.  The patient's past medical history included Kidney stones (Kidney Stones removed 35 years ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Headache, CYANOCOBALAMIN (B-12) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second 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 (Felt wobbly). At the time of the report, FEELING ABNORMAL (Felt wobbly) outcome was unknown.            The patient stated after their primary vaccination series the patient felt wobbly.  It was also reported that the patient was unsure about lot numbers.   No treatment information was provided.   This case was linked to MOD-2022-588507 (Patient Link).
Severe site soreness within hours, Severe general malaise and nausea within hours that lasted for 5 days. Bed ridden the evening of the inoculation and for the next 2 days.
fatigue for two days; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). Upon Fu date (18Jun2021) case was upgraded to valid. A 74-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history included cholesterol. Concomitant medications included ongoing simvastatin 20 mg (SIMVASTATIN) taken from years for cholesterol and probiotics (PROBIOTICS) (ongoing). The patient previously took atorvastatin (LIPITOR) and reported of "Having a reaction from taking Lipitor". No other products that were taken together with those indicated suspect. It was reported that the patient had first shot and experienced just fatigue for 2 days on an unspecified date in 2021. The patient stated, "Nothing previous". The patient was taking probiotics. She will have colonoscopy in beginning of 2022. If anything will be shown on the colon the patient will contact. The patient did not think there was any problem with shot and simvastatin for cholesterol. The outcome of the event fatigue was reported as resolved on an unspecified date in 2021.   Information on batch/lot number has been requested.
Received immis at 0930 AM 121510. At 1900 pm same day adverse reaction began. Feet warm to touch but did not take temp. Father found child on floor with eyes rolled back breathing shallow, face was blue. Went to ER-Dr. Had fever of 103.6. Gave her MOTRIN at ER - sent child home. Fever broke next day. Released from ER at 10-10:30 PM.
Member developed strong burnt chemical taste 1 week after the second COVID-19 Moderna injection.
Mom reports today @ appt for 2nd series of vax pt had unusual rxn to vax mom reported pt slept about 1 hr p/vax recvd then started crying & crying persisted for 4-5 hrs; t102;
Pt recv vax on 8-12-98; on 8-14-98 pt exp local reaction of an induration the size of an orange (red, swollen, painful) Pt went to E.R.; tx=Keflex.
Discomfort in left calf beginning 1 day after vaccine; discomfort persisted and later diagnosed as a blood clot
Pfizer 1st dose on 9/18/2021. Mild to medium chest pain on 9/28/2021. The chest pains are on and off.
November 23, 2021 MI 100% LAD occlusion proximal to previous stent.  New stent placed, accompanied by 7-8 defibrillations
I'm reporting about SPIKEVAX.  It wasn't listed in the choices under vaccine.  Started having intense pain about 11 hours after shot.  Had fever, intense aches and headache all night.  Next morning was very dizzy and almost passed out.  Went back to bed, and about 2 hours later my heart started racing.  My HR went to 165 and I called 911.  EMTs in ambulance did BP, IV, EKG, pulse ox, started oxygen, blood draw, and then shot some medication into my IV that shocked my heart to go back to a slower rhythm of 103.  They then transported me to ER.  At ER they did more EKGs, chest X-ray, blood draws, blood pressure, and everything tested out ok.  The ER doctor said the tachycardia was probably due to the Spikevax shot. Told to check with cardiologist and maybe get a stress test.
approximately 2 hours post injection the patient developed an itchy red rash on her face and chest.  No swelling of lips or tongue.  No SOB.  Treated with antihistamines with improvement.   This is a very common reaction to medication for this patient.
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 19 September 2011 at 15:45 the subject received unspecified dose of FLULAVAL (.5 ml, unknown route, left arm). Less than one year after vaccination with FLULAVAL, the subject experienced extensive swelling of vaccinated limb, erythema of arm at injection site and hardness injection site. According to the nurse, the subject's arm was swollen, red and hard four inches [101.6 mm] across at the injection site. At the time of reporting the outcome of the events was unspecified.
C/O EXTREME FATIGUE AND WEAKNESS, MALAISE  PULSE HIGH ACCORDING TO SPOUSE PATIENT FELT BETTER BY END OF DAY DID NOT SEEK MEDICAL ATTENTION
Developed shingles on the same arm in which the vaccine was administered. Seen at urgent care and treated with valacyclovir tablets, triamcinolone cream and cephalexin capsules for 7 days.